1. PRINCETON, N.J., April 7, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has conditionally accepted HyBryte™ as the proposed brand name for SGX301 (synthetic hypericin), the Company's novel first-in-class photodynamic therapy for first-line treatment of early stage cutaneous T-cell lymphoma (CTCL).

    The name HyBryte™ was developed in compliance with the FDA's Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names.  The FDA's conditional approval validates HyBryte™…

    PRINCETON, N.J., April 7, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has conditionally accepted HyBryte™ as the proposed brand name for SGX301 (synthetic hypericin), the Company's novel first-in-class photodynamic therapy for first-line treatment of early stage cutaneous T-cell lymphoma (CTCL).

    The name HyBryte™ was developed in compliance with the FDA's Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names.  The FDA's conditional approval validates HyBryte™ as a proprietary name that is consistent with the FDA's goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use.  Final approval of the HyBryte™ brand name is conditioned on FDA approval of the product candidate, SGX301.

    "We are pleased that the FDA has conditionally accepted the name HyBryte™ for SGX301," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "This is yet another important step towards U.S. commercialization, as we continue to focus on submission of the rolling new drug application (NDA) in 2Q 2021 for this first-in-class therapy.  SGX301 has already received Orphan Drug and Fast Track designations from the FDA.  Additionally, SGX301 was granted Orphan Drug designation from the European Medicines Agency (EMA) and Promising Innovative Medicine designation from the Medicines and Healthcare products Regulatory Agency in the United Kingdom."

    About Cutaneous T-Cell Lymphoma (CTCL)

    CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.  Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin.  These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors.  Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.  Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

    CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the U.S., with approximately 3,000 new cases seen annually.

    About HyBryte™

    HyBryte™ (SGX301) is a novel first-in-class photodynamic therapy utilizing safe visible light for activation.  The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later.  The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure.  Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients.  In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective.  HyBryte™ has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

    The Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received HyBryte™ treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte™ treatment in the first cycle was safe and well tolerated.

    In the second open-label treatment cycle (Cycle 2), all patients received HyBryte™ treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte™ treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte™ treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes.  HyBryte™ continued to be safe and well tolerated. Additional analyses also indicated that HyBryte™ is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

    The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte™ treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte™ throughout all 3 cycles of treatment, 49% of them demonstrated a treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions. Follow-up visits were completed in Q4 2020, and the clinical study report to support the NDA is in the process of being finalized.   

    Overall safety of HyBryte™ is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period.  HyBryte's™ mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects.  Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging.  Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available.  Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product.  HyBryte™ potentially represents the safest available efficacious treatment for CTCL.  With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues. 

    The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.    

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S.  Development programs in this business segment also include our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials.  Despite the statistically significant result achieved in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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    SOURCE Soligenix, Inc.

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  2. PRINCETON, N.J., March 30, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the year ended December 31, 2020.

    "2021 will be another important year for Soligenix on a number of fronts," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial successfully completed, we are now preparing to begin submission of the rolling new drug application (NDA) in 2Q 2021 for this first-in-class…

    PRINCETON, N.J., March 30, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the year ended December 31, 2020.

    "2021 will be another important year for Soligenix on a number of fronts," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial successfully completed, we are now preparing to begin submission of the rolling new drug application (NDA) in 2Q 2021 for this first-in-class therapy. Compared to the currently approved cutaneous T-cell lymphoma (CTCL) therapies for early disease, the SGX301 treatment response was very rapid, being detected in as little as 6 weeks of treatment (Cycle 1, p=0.0416). Responses continued to improve through 12 weeks of treatment (Cycle 2, p<0.0001 vs end Cycle 1) and 18 weeks of treatment (Cycle 3, p<0.0001 vs end Cycle 1), ultimately enabling nearly half of patients who continued treatment to see sustained and significant improvement in their response rates. Moreover, patients with more difficult to treat plaque lesions also showed this same treatment benefit, an advantage over some other therapies which primarily work only for patch lesions. Under our Public Health Solutions business segment, we continue to advance multiple therapeutic and vaccine candidiates, with the support of non-dilutive government funding, including our heat stable COVID-19 vaccine, CiVax™, which recently demonstrated rapid-onset, broad-spectrum, neutralizing antibody and cell-mediated immunity using full-length Spike protein antigens in mice. Overall, our thermostabilization platform has now demonstrated compatibility with two different adjuvants, consistently enabling single-vial vaccine presentations with characteristics for ambient shipping and long-term storage. Further, non-human primate data is expected across our vaccine platform later this year."

    Dr. Schaber continued, "With over $30 million in cash, not including our non-dilutive funding, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including moving towards NDA and U.S. commercialization of SGX301 in CTCL.  As CTCL is a highly specialized orphan market with a discrete prescriber base, it presents a tailor-made market opportunity for us.  We estimate peak U.S. annual net sales to exceed $90 million and the total U.S. revenues during the 10-year forecast period to be greater than $700 million.  With a total addressable worldwide market projected to be approximately $250 million annually, we continue to have ongoing confidential discussions regarding ex-U.S. partnership opportunities."  

    Soligenix Recent Accomplishments

    • On March 9, 2021, the Company announced that it received preliminary approval for a tax credit from the New Jersey Economic Development Authority's (NJEDA) New Jersey Technology Business Tax Certificate Transfer program. As a result, the Company anticipates being able to transfer this credit and receive approximately $865,000 in net proceeds. To view this press release, please click here.
    • On March 4, 2021, the Company announced publication of pre-clinical immunogenicity studies for CiVax™ (heat stable COVID-19 vaccine program) demonstrating rapid-onset, broad-spectrum, neutralizing antibody and cell-mediated immunity is confirmed using full-length Spike protein antigens. To view this press release, please click here.
    • On February 24, 2021, the Company issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. To view this press release, please click here.
    • On February 1, 2021, the Company announced that the Hong Kong Registrar of Patents granted a patent for the application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 16102842.8), published on January 29, 2021 under Publication No. 1214771 B. To view the press release, please click here.
    • On January 26, 2021, the Company hosted an Investor Webcast Event regarding U.S. commercial planning for SGX301 (synthetic hypericin) in the treatment of CTCL. To listen to the webcast, please click here.
    • On January 7, 2021, the Company announced that it signed an exclusive Supply, Distribution and Services Agreement with Daavlin, securing long-term supply and distribution of a commercially ready light device that is an integral component of the regulatory and commercial strategy for SGX301 for the treatment of CTCL. To view the press release, please click here.
    • On December 28, 2020, the Company announced that the National Institute of Allergy and Infectious Diseases (NIAID) awarded Soligenix a Direct to Phase II Small Business Innovation Research (SBIR) grant of approximately $1.5 million to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 and Ebola Virus Disease vaccine candidates in conjunction with the CoVaccine HT™ adjuvant. To view the press release, please click here.
    • On December 22, 2020, the Company announced preliminary top-line results for its pivotal Phase 3 DOM-INNATE trial evaluating SGX942 in the treatment of severe oral mucositis in patients with head and neck cancer receiving chemoradiation. To view the press release, please click here.
    • On December 16, 2020, the Company announced that it entered into a $20 million convertible debt financing agreement with Pontifax Medison Debt Financing, the healthcare-dedicated venture and debt fund of the Pontifax life science funds. To view the press release, please click here.
    • On December 8, 2020, the Company announced that it demonstrated extended protection with its heat stable ricin toxin vaccine, RiVax®. To view the press release, please click here.

    Financial Results – Year Ended December 31, 2020

    Soligenix's revenues for the year ended December 31, 2020 were $2.4 million as compared to $4.6 million for the year ended December 31, 2019. Revenues included payments on a contract in support of RiVax®, our ricin toxin vaccine candidate, grants received to support the development of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases, ThermoVax®, our thermostabilization technology, and the assessment of SGX942 safety in juvenile animals.

    Soligenix's basic net loss was $17.7 million, or ($0.64) per share, for the year ended December 31, 2020, as compared to $9.4 million, or ($0.48) per share, for the year ended December 31, 2019. The increase in net loss is primarily due to increased expenditures incurred to support both the pivotal Phase 3 trial of SGX301 in the treatment of CTCL and the pivotal Phase 3 trial of SGX942 in the treatment of oral mucositis in head and neck cancer, as well as a $5 million success milestone payment in common stock (based upon an effective per share price of $2.56) as a result of SGX301 demonstrating statistically significant treatment response in the pivotal Phase 3 clinical trial.

    Research and development expenses were $10.1 million as compared to $8.1 million for the years ended December 31, 2020 and 2019, respectively. The increase in research and development spending for the year ended December 31, 2020 was related to expenditures incurred in the expansion of the Phase 3 clinical trial of SGX942 as well as the ongoing Phase 3 clinical trial of SGX301.

    General and administrative expenses were $4.0 million as compared to $3.5 million for the years ended December 31, 2020 and 2019, respectively.

    As of December 31, 2020, the Company's cash position was approximately $18.7 million.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of SGX301 (synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S.  Development programs in this business segment also include our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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    SOURCE Soligenix, Inc.

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  3. PRINCETON, N.J., March 9, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received preliminary approval for a tax credit from the New Jersey Economic Development Authority's (NJEDA) New Jersey Technology Business Tax Certificate Transfer program.  As a result, the Company anticipates being able to transfer this credit and receive approximately $865,000 in net proceeds.

    This competitive program enables approved technology and biotechnology businesses to sell their unused Net Operating Loss (NOL) Carryovers and unused Research and Development…

    PRINCETON, N.J., March 9, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received preliminary approval for a tax credit from the New Jersey Economic Development Authority's (NJEDA) New Jersey Technology Business Tax Certificate Transfer program.  As a result, the Company anticipates being able to transfer this credit and receive approximately $865,000 in net proceeds.

    This competitive program enables approved technology and biotechnology businesses to sell their unused Net Operating Loss (NOL) Carryovers and unused Research and Development (R&D) Tax Credits to unaffiliated, profitable corporate taxpayers in the state of New Jersey. This allows businesses with NOLs to turn their tax losses and credits into cash proceeds to fund additional R&D, purchase equipment and/or facilities, or cover other allowable expenditures. The NJEDA determines eligibility for the program, the New Jersey Division of Taxation determines the value of the available tax benefits (NOLs and R&D Tax Credits), and the New Jersey Commission on Science and Technology evaluates the technology and its viability. The State of New Jersey was the originator of this program and the first state to implement and fund it. 

    "As we are always looking for non-dilutive ways to fund our company, we are once again very pleased with NJEDA's decision to support advancing biotechnology companies with the approval of our application in this year's program," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "This is our eleventh year receiving NOL funding.  Over this time period, we have received approximately $6.5 million in non-dilutive NOL funding that has allowed us to advance our rare disease pipeline to where we are now preparing to begin submission of a rolling new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in 2Q 2021 for our first-in-class therapy, SGX301 in the treatment of cutaneous T-cell lymphoma (CTCL)."  

    Dr. Schaber continued, "We are, again, very grateful for New Jersey's continued support of its biotechnology industry.  With over $30 million in cash, not including our non-dilutive funding, we remain focused on advancing towards U.S. commercialization of SGX301 in CTCL where peak annual net sales in the U.S. are expected to exceed $90 million, with the total addressable worldwide market estimated at approximately $250 million annually."

    About Cutaneous T-Cell Lymphoma (CTCL)

    CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.  Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin.  These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors.  Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.  Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

    CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the U.S., with approximately 3,000 new cases seen annually.

    About SGX301

    SGX301 (synthetic hypericin) is a novel first-in-class photodynamic therapy utilizing safe visible light for activation.  The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later.  The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure.  Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients.  In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective.  SGX301 has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

    The Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consists of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received SGX301 treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving SGX301 achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). SGX301 treatment in the first cycle was safe and well tolerated.

    In the second open-label treatment cycle (Cycle 2), all patients received SGX301 treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of SGX301 treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of SGX301 treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes.  SGX301 continued to be safe and well tolerated. Additional analyses also indicated that SGX301 is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

    The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive SGX301 treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received SGX301 throughout all 3 cycles of treatment, 49% of them demonstrated a treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that SGX301 is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, SGX301 continued to be well tolerated despite extended and increased use of the product to treat multiple lesions. Follow-up visits were completed in Q4 2020, and data lock and final analyses remain ongoing.   

    Overall safety of SGX301 is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period.  SGX301's mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects.  Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging.  Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available.  Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product.  SGX301 potentially represents the safest available efficacious treatment for CTCL.  With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues. 

    The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc. 

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and commercializing SGX301 (synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With a successful Phase 3 study completed, regulatory approval and commercialization for this product is being advanced initially in the U.S.  Development programs in this business segment also include our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of our clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future or that we will continue to be able to sell NOLs in connection with the New Jersey Technology Business Tax Certificate Transfer program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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    SOURCE Soligenix, Inc.

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  4. PRINCETON, N.J., March 4, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of pre-clinical immunogenicity studies for CiVax™ (heat stable COVID-19 vaccine program) demonstrating rapid-onset, broad-spectrum, neutralizing antibody and cell-mediated immunity is confirmed using full-length Spike protein antigens. The article titled, "Recombinant protein subunit SARS-CoV-2 vaccines formulated with CoVaccine HT adjuvant induce broad, Th1 biased, humoral and cellular immune responses in mice," has been posted as an accelerated preprint on bioRxiv…

    PRINCETON, N.J., March 4, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of pre-clinical immunogenicity studies for CiVax™ (heat stable COVID-19 vaccine program) demonstrating rapid-onset, broad-spectrum, neutralizing antibody and cell-mediated immunity is confirmed using full-length Spike protein antigens. The article titled, "Recombinant protein subunit SARS-CoV-2 vaccines formulated with CoVaccine HT adjuvant induce broad, Th1 biased, humoral and cellular immune responses in mice," has been posted as an accelerated preprint on bioRxiv (available here). This work will continue under a $1.5M Small Business Innovation Research (SBIR) grant awarded to Soligenix in December 2020.

    CiVax™ is the Company's heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2. Ongoing collaborations with Axel Lehrer, PhD, Associate Professor in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa, have confirmed the feasibility of developing a broadly immunogenic vaccine for COVID-19. Using an efficient expression system in Drosophila S2 cells developed by Hawaii Biotech Inc., full-length Spike protein antigens have been produced and tested for immunogenicity in this latest work. These latest results demonstrate the immunogenic potential of the full-length CiVax™ antigen in combination with CoVaccine HT™, specifically in the context of SARS-CoV-2.

    While a number of vaccines are available worldwide under Emergency Use Authorization, the requirement for cold chain shipping and timely administration, coupled with manufacturing scale up logistics, have limited the world's supply. Rapid vaccine administration worldwide is necessary to curtail disease spread and slow or pre-empt evolution of mutations, which may abrogate the effectiveness of current vaccine approaches. Previous work with the novel CoVaccine HT™ adjuvant, which Soligenix licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation, has indicated that CoVaccine HT™ can be thermostabilized both alone and in combination with antigens, potentially yielding a single vial presentation of the vaccine, which would not require cold chain distribution or storage.   

    "Our work to date has demonstrated not only the feasibility of rapidly adaptable and cost-effective manufacturing of the required vaccine antigens, but also the potential for a broadly applicable and easily distributed vaccine," stated Dr. Lehrer. "We are delighted with our earlier successes on development of filovirus and flavivirus vaccines with this platform. The results in our latest manuscript confirm that the advantages of our vaccine platform with the CoVaccine HT™ adjuvant can also be realized in the context of SARS-CoV-2, while we continue our work to rapidly advance development of a heat stable subunit COVID-19 vaccine in collaboration with Soligenix. Next steps will include evaluation of immunogenicity in a non-human primate model and assessment of antibody coverage with key variants of concern."

    "We believe that creating a vaccine with enhanced stability at elevated temperatures that can obviate the costs and logistical burdens associated with cold chain storage and distribution has the potential to simplify worldwide distribution, leading to a faster resolution of this pandemic and curtailing the further evolution of the virus," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Once fully developed, we anticipate that our platform would be easily updated to address specific variants directly. Our approach appears to be unique in its use of a well-established, well-understood, and safe, subunit platform coupled with a novel adjuvant and a thermostabilizing formulation. We are very encouraged with the latest results and look forward to continuing to advance development of CiVax™ in larger animal models and human clinical trials."

    About Coronavirus Infection

    Coronavirus infections can cause a wide spectrum of disease in humans, ranging from a common cold to a more severe respiratory infection, such as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), which have a case mortality rate of approximately 10% and 30%, respectively. Similar to filoviruses, coronaviruses also are endemic in wildlife populations and can be transmitted to humans with close contact. The COVID-19 outbreak, caused by SARS-CoV-2, is the most recent example of a suspected species crossover seen with this virus family. COVID-19 has been declared a global pandemic by the World Health Organization. The global impact of this emerging infection demonstrates the urgent need for robust technology platforms to rapidly develop new vaccines for novel diseases. Despite vaccines approved under Emergency Use Authorization, the logistical challenges of cold chain distribution and manufacturing scale up are limiting the ability to vaccinate individuals worldwide, a required to curtail further viral mutations and stop the pandemic. More rapid distribution of vaccines worldwide will also curtail the emergence of new variants.

    About John A. Burns School of Medicine, University of Hawai'i at Manoa

    The John A. Burns School of Medicine (JABSOM) at the UHM is one of the leading medical education institutions in the United States. For the last three years, JABSOM has been a leader in National Institutes of Health research awards among community-based public medical schools (i.e., public medical schools without a university hospital). JABSOM has also been a leader in the rate of MD graduates (who are also residency trained in state) retained as practitioners in-state. In addition, Hawai'i's cultural diversity and geographical setting affords JABSOM a unique research environment to excel in health disparity research. JABSOM faculty bring external funding of about $40 million annually into the state.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and commercializing SGX301 (synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With a successful Phase 3 study completed, regulatory approval and commercialization for this product is being advanced initially in the U.S. Development programs in this business segment also include our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of our clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

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    SOURCE Soligenix, Inc.

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  5. PRINCETON, N.J., Feb. 24, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber.  The content of this letter is provided below.

    Dear Friends and Shareholders,

    I would like to start by thanking you for your continued support, and hope that you and your families are all healthy and well.  As 2020 recedes in the rearview mirror, we seem to be turning a corner on the challenges the COVID-19 pandemic has imposed on our everyday lives with promising coronavirus vaccines and…

    PRINCETON, N.J., Feb. 24, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber.  The content of this letter is provided below.

    Dear Friends and Shareholders,

    I would like to start by thanking you for your continued support, and hope that you and your families are all healthy and well.  As 2020 recedes in the rearview mirror, we seem to be turning a corner on the challenges the COVID-19 pandemic has imposed on our everyday lives with promising coronavirus vaccines and a hope to return to a more normal existence in the not too distant future.  Hope and recovery appear to be the early theme of 2021, and we are energized by the promise of the coming year.  Last year posed a number of challenges and some disappointment for Soligenix, but more importantly a number of successes. Most notably, our positive Phase 3 study of SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL), allowing us to advance toward a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for marketing authorization in the not too distant future.  We also debuted new opportunities in our robust pipeline, such as our novel heat stable COVID-19 vaccine candidate, CiVax™, where we announced positive preclinical results and expect more data to follow shortly.  Additionally, we have followed through on our efficient and shareholder-friendly financing strategies, providing us with sufficient capital and cash runway to meet our goals through 2022 as we move towards U.S. commercialization of SGX301 in CTCL.  We expect peak annual net sales of SGX301 in the U.S. to exceed $90 million, with the total addressable worldwide market estimated at approximately $250 million annually.  Overall, we are excited about our near-term and future upcoming catalytic milestones.

    Corporate Highlights

    Since our last update, we have continued to advance our development programs across both the Specialized BioTherapeutics and Public Health Solutions business segments of our rare disease pipeline, where we currently anticipate achieving multiple important milestones in 2021 and 2022

    Specialized Biotherapeutics Business Segment

    In late October, we were very happy to announce completion of our pivotal Phase 3 FLASH ("Fluorescent Light Activated Synthetic Hypericin") study with SGX301 and share the continued positive benefits for our CTCL patients.  Compared to the currently approved CTCL therapies for early disease, the treatment response to SGX301 was very rapid, being detected in as little as 6 weeks of treatment (Cycle 1, p=0.0416).  Responses continued to improve through 12 weeks of treatment (Cycle 2, p<0.0001 vs end Cycle 1) and 18 weeks of treatment (Cycle 3, p<0.0001 vs end Cycle 1), ultimately enabling nearly half of patients who continued treatment to see sustained and significant improvement in their response rates. SGX301 also demonstrated statistically significant responses in both patch (Cycle 2 response 37%, p=0.0009) and plaque (Cycle 2 response 42%, p<0.0001) lesions, highlighting the unique benefits of the more deeply penetrating visible light activation of hypericin. Unlike other second line and off-label therapies for CTCL, SGX301 was both better tolerated with a reduced dropout rate and more broadly effective, with equal efficacy against both plaque and patch lesions. Further, no synthetic hypericin was detected in the bloodstream of patients, minimizing safety concerns of drug effects outside of the tumor area.

    As Brian Poligone, MD, PhD, Lead Enrolling Investigator in the FLASH study and Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, USA stated in the announcement, "Along with SGX301's rapid response time and safety profile, the patch and plaque data from the study are extremely compelling. Current treatments for CTCL are generally less effective against plaques and deeper lesions, very similar to the problem observed in psoriasis.  The ability of SGX301 to target both patches and thicker plaques in CTCL is an important feature for this therapy and, if approved, will be of benefit to patients, regardless of their presentation.  These results are consistent with the positive findings highlighted in a recently reported case study of folliculotropic mycosis fungoides, a hard to treat variant of CTCL where lesions are associated with the hair follicles deep in the skin and more resistant to phototherapy."

    With the study complete, we are now preparing to begin submission of the rolling NDA in 2Q 2021 for this first-in-class therapy.  SGX301 has received Orphan Drug and Fast Track designations from the FDA.  Additionally, SGX301 was granted Orphan Drug designation from the European Medicines Agency (EMA) and Promising Innovative Medicine designation from the Medicines and Healthcare products Regulatory Agency in the United Kingdom.

    January 2021 was a busy month for us.  We announced a strategic partnership with Daavlin, a leading manufacturer of phototherapy products used worldwide by dermatologists and patients, for supply and distribution of our SGX301 companion light device.  This exclusive supply, distribution and services agreement with Daavlin will secure long-term supply and distribution of a commercially ready light device that is an integral component of the regulatory and commercial strategy for SGX301 for the treatment of CTCL.  We also held an investor webcast event to discuss the unique U.S. commercialization opportunity for SGX301 in the treatment of CTCL.  During the webcast, we reviewed in some detail the disease, competitive landscape, and our intent to commercialize SGX301 ourselves in a cost efficient and most profitable manner.  As CTCL is a highly specialized orphan market with a discrete prescriber base, it presents a tailor-made market opportunity for us, where peak annual net sales in the U.S. are expected to exceed $90 million, with total U.S. revenues during the 10-year forecast period projected to be greater than $700 million.

    As Michael Young our acting Chief Marketing Officer and Principal, biomedwoRx: Life Sciences Consulting and a Board member of the Cutaneous Lymphoma Foundation stated,  "The value proposition for SGX301 is designed around maximizing the opportunity while minimizing the needed commercial investment, and represents a significant therapeutic opportunity in changing the landscape for treatment of early stage CTCL disease."

    During this webcast, we also discussed at a high level the analysis that went into our determination to ultimately commercialize in the U.S. versus partnership.  This decision was, in large part, based on maintaining 100% of SGX301's value with a very reasonable commercial build and launch expense of approximately $7 million compared to us retaining less than half of its value with partnering.  I would urge all those that want to better understand what a unique value proposition SGX301 in CTCL represents to listen to the full webcast here.

    We remain steadfast in our plans for partnership in the ex-U.S. markets and are in a number of active discussions with potential partners with similar reputation and expertise in this therapeutic area.  We anticipate receiving marketing approval in the U.S. first, and with this approval in hand we will aggressively pursue marketing authorizations in other key markets worldwide.  Given SGX301's success in CTCL, we are now evaluating other potential cutaneous oncology indications that might similarly benefit from the use of our first-in-class synthetic hypericin.

    As many of you know, in December, we announced preliminary top-line results for our pivotal Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) trial evaluating SGX942 (dusquetide) in the treatment of severe oral mucositis (SOM) in patients with head and neck cancer (HNC) receiving chemoradiation.  The study enrolled 268 patients randomized 1:1 to receive either SGX942 or placebo.  The primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was clearly observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group.  Other secondary endpoints supported the biological activity of dusquetide as well, including a statistically significant 50% reduction in the duration of SOM in the per-protocol population, which decreased from 18 days in the placebo group to 9 days in the SGX942 treatment group (p=0.049), consistent with the findings in the Phase 2 trial.

    As I noted during our investor call, we are very disappointed with this unanticipated outcome of the study.  Despite the fact that SGX942 demonstrated clinically meaningful reductions in oral mucositis consistent with the previous Phase 2 study, the Phase 3 trial did not achieve the statistically significant benefit we expected. We are continuing to analyze the full dataset to better understand why the study did not meet expectations.  Any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from SGX942 therapy, will be communicated to and discussed with the FDA and the EMA.

    Public Health Solutions Business Segment 

    We most recently announced a number of exciting developments in the area of emerging infectious diseases.  We were awarded a Direct to Phase II Small Business Innovation Research grant of approximately $1.5 million from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 (Coronavirus Disease 2019) and Ebola Virus Disease vaccine candidates in conjunction with our CoVaccine HT™ (CoVaccine) adjuvant.  This award also will support immune characterization of this novel, emulsified adjuvant that has unique potency and compatibility with lyophilization strategies to enable thermostabilization of subunit vaccines.

    Ongoing collaborations with Axel Lehrer, PhD, Associate Professor (Vaccinology) in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa (UHM), have demonstrated the feasibility of developing a highly immunogenic vaccine for COVID-19, the infection caused by SARS-CoV-2.  This heat stable subunit vaccine program, we call CiVax™, demonstrated immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity using the CoVaccine adjuvant in-licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation.  With significant research dedicated worldwide to the generation of COVID-19 vaccines, it is noteworthy that the essential attributes of a vaccine successful in controlling the ongoing pandemic are believed to include the ability to rapidly stimulate a Th1/Th2 balanced antibody response, raising significant virus neutralizing antibodies, as well as induce potent cell-mediated immunity.  Previous work with the CoVaccine adjuvant has indicated that it has these critical characteristics.  In addition, unlike other vaccines that have logistical challenges due to cold chain requirements (in some cases requiring maintenance of temperatures less than –70 degrees Celsius), the underlying technology platform has demonstrated the ability to produce single vial vaccines which are stable up to temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit). We expect to have proof of concept data in non-human primates (NHPs) no later than the end of Q2 this year.

    We followed this up with an announcement that we had demonstrated feasibility of developing heat stable subunit protein vaccine formulations for filovirus vaccines, including Ebola virus, Sudan virus, and Marburg virus.  Protective efficacy has been demonstrated in NHPs, the gold standard animal model, against infection with Ebola virus, Sudan virus, and Marburg virus.  Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius.  These most recent results demonstrate the thermostabilization of three virus glycoproteins (from Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus), and the identification of key stability-indicating assays to further support mono-, bi- and tri-valent vaccine formulations. 

    In December, we demonstrated extended protection with our heat stable ricin toxin vaccine candidate, RiVax®.  Mice, vaccinated twice on Days 1 and 21 were protected for at least 365 days against subsequent ricin challenge.  These results demonstrate that the thermostabilized vaccine formulation is capable of eliciting enduring protection in mice.  Coupled with previous demonstration of efficacy in mice and NHPs as well as long-term thermostability (at least 1 year at 40 degrees Celsius or 104 degrees Fahrenheit), these results reinforce the practicality of stockpiling and potentially utilizing the RiVax® vaccine in warfighters and civilian first responders without the complexities that arise for vaccines that require cold chain handling.  This same thermostabilization approach is also being advanced in the development of Soligenix's CiVax™ vaccine for COVID-19.

    RiVax® has received Orphan Drug designation as well as Fast Track designation from the FDA, and, as a new chemical entity, upon approval in the US, has the potential to qualify for a biodefense Priority Review Voucher (PRV).  PRVs are transferable and can be sold, with sales in recent years of approximately $100 million.  Additionally, RiVax® was granted Orphan Drug designation from the EMA.  Recent events, including the news of an envelope addressed to President Trump that was thought to contain this potent and potentially lethal toxin, as well as a foiled bio attack with ricin in Germany, suggest that the RiVax® vaccine may be of increasing interest to multiple countries.

    Balance Sheet and Capital

    With more than $30 million in cash as of February 2021, not including our non-dilutive government funding, we are now sufficiently capitalized to achieve multiple key inflection points across our rare disease pipeline, including moving towards NDA and commercialization of SGX301.  This increase in capital was due to two important events. 

    1. A $20 million strategic partnership with Pontifax Medison, the healthcare-dedicated venture and debt fund of the Pontifax life science funds, in December. Under the terms of the partnership with Pontifax, Soligenix will have access to up to $20 million in convertible debt financing in three tranches, which will mature over a four-and-a-half-year period and have an interest-only period for the first two years.  Upon the closing of this transaction, we accessed the first tranche of $10 million, and have the option to draw the second tranche of $5 million at any time over the next 12 months and the third tranche of $5 million upon filing of the SGX301 NDA, subject to certain conditions.  Pontifax may elect to convert the outstanding loan drawn under the first two tranches into shares of Soligenix's common stock at any time prior to repayment at a conversion price of $4.10 per share.  We also have the ability to force the conversion of the loan into shares of our common stock at a conversion price of $4.92 per share, subject to certain conditions.
    2. The use of our at-the-market (ATM) sales issuance agreement with B. Riley Securities, Inc. over the last two months to supplement our cash runway.  Given the significant increase in both stock price and volume, with more than 186 million shares traded so far during 2021, we were able to add capital to our balance sheet judiciously while limiting sales to an extremely small percentage (approximately 4.6%) of the overall volume. 

    The combination of these two facilities provides significant cash runway through 2022.  With a solid balance sheet and other available resources at our disposal, such as non-dilutive government funding, we are well positioned to aggressively advance and expand our pipeline.  We also continue to have ongoing confidential business development discussions, which may lead to more favorable capital inflows, including the potential to receive additional non-dilutive capital.  Overall, we continue to remain mindful of dilution and will look at all future capital inflow initiatives in the most efficient and shareholder-friendly manner as possible.

    In closing, thank you for your interest and your ongoing support of Soligenix.  It continues to be a very exciting time in our life cycle and late stage pipeline.  We look forward to 2021 being even more productive than 2020, with the potential for multiple near-term catalysts on the horizon as we further advance our development programs towards commercialization.  Best wishes!

    Dr. Christopher J. Schaber

    President and Chief Executive Officer

    Soligenix, Inc.

    February 24, 2021

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and commercializing SGX301 (synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With a successful Phase 3 study completed, regulatory approval and commercialization for this product is being advanced initially in the U.S.  Development programs in this business segment also include our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of our clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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  6. PRINCETON, N.J., Feb. 11, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation at the BIO CEO & Investor Digital Conference taking place February 16-18, 2021.  The presentation will be available to registered conference attendees for on-demand viewing beginning February 15, 2021 at 9:00 AM EST via the virtual conference link. Alternatively, an audio webcast of the Soligenix corporate presentation is available on the Company's website via this…

    PRINCETON, N.J., Feb. 11, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation at the BIO CEO & Investor Digital Conference taking place February 16-18, 2021.  The presentation will be available to registered conference attendees for on-demand viewing beginning February 15, 2021 at 9:00 AM EST via the virtual conference link. Alternatively, an audio webcast of the Soligenix corporate presentation is available on the Company's website via this link

    Key members of Soligenix management will hold one-on-one meetings throughout the conference.  Registered conference attendees may schedule a meeting with Soligenix via the conference scheduling link.

    "On the heels of our recent SGX301 Commercialization Investor Webcast Event, the BIO CEO conference comes at an opportune time as we advance toward new drug application submission to the FDA, while continuing to highlight SGX301's unique commercial value proposition for the treatment of cutaneous T-cell lymphoma in the U.S.," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We remain focused on advancing our rare disease pipeline and look forward to meeting with high caliber investment funds and potential pharmaceutical partners during the conference."

    For more information about the BIO CEO & Investor Conference, please refer to the conference website at https://www.bio.org/events/bio-ceo-investor-digital-conference.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and commercializing SGX301 (synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With a successful Phase 3 study completed, regulatory approval and commercialization for this product is being advanced initially in the U.S.  Development programs in this business segment also include our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of our clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

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    SOURCE Soligenix, Inc.

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  7. PRINCETON, N.J., Feb. 1, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Hong Kong Registrar of Patents has granted a patent for the application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 16102842.8), published on January 29, 2021 under Publication No. 1214771 B.  The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of cutaneous T-cell lymphoma (CTCL), similar to those granted in Europe in 2020.  Synthetic hypericin is the active pharmaceutical ingredient in SGX301…

    PRINCETON, N.J., Feb. 1, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Hong Kong Registrar of Patents has granted a patent for the application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 16102842.8), published on January 29, 2021 under Publication No. 1214771 B.  The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of cutaneous T-cell lymphoma (CTCL), similar to those granted in Europe in 2020.  Synthetic hypericin is the active pharmaceutical ingredient in SGX301, the Company's photodynamic therapy, for which positive primary endpoint results in a pivotal Phase 3 study for the treatment of CTCL were recently announced (available here).  This new patent is the first granted in Hong Kong and expands on Soligenix's comprehensive patent estate, which includes protection on the composition of the purified synthetic hypericin, methods of synthesis and therapeutic methods of use in both CTCL and psoriasis, and is being pursued worldwide. 

    SGX301 (synthetic hypericin) is a novel first-in-class photodynamic therapy for first-line treatment of early stage CTCL. In the recently completed pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 achieved a statistically significant treatment response rate (p=0.04) in the primary endpoint after just 6 weeks (Cycle 1) of therapy when compared to placebo.  This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycles after 12 weeks (Cycle 2) and 18 weeks (Cycle 3) total treatment, reinforcing the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1.  In addition, SGX301 has demonstrated a statistically significant response in both patch and plaque lesions through 12 weeks of treatment (Cycle 2), highlighting the unique benefit of using visible light with its deeper skin penetration.  SGX301 was well tolerated throughout the study and no mutagenic risks have been identified, unlike other second-line or off-label treatments, including other phototherapies, which utilize ultraviolet light. The Company believes SGX301 has compelling competitive advantages over existing therapies for early stage CTCL and represents a significant near-term commercial opportunity, as recently discussed (see webcast presentation here).

    "This recently issued patent continues to expand, strengthen and protect our worldwide synthetic hypericin patent estate," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  "With the recently announced strategic financing with Pontifax and our partnership with Daavlin for supply and distribution of the SGX301 companion light device, as well as important contributions from key patient advocacy organizations, such as the Cutaneous Lymphoma Foundation, we are moving towards SGX301 marketing approval and commercialization in the U.S., while actively pursuing partnership opportunities to leverage ex-U.S. markets."

    About Cutaneous T-Cell Lymphoma (CTCL)

    CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.  Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin.  These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors.  Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.  Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

    CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the U.S., with approximately 3,000 new cases seen annually.

    About SGX301

    SGX301 (synthetic hypericin) is a novel first-in-class photodynamic therapy utilizing safe visible light for activation.  The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later.  The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure.  Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients.  In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective.  SGX301 has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

    The Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consists of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received SGX301 treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving SGX301 achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). SGX301 treatment in the first cycle was safe and well tolerated.

    In the second open-label treatment cycle (Cycle 2), all patients received SGX301 treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of SGX301 treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of SGX301 treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes.  SGX301 continued to be safe and well tolerated. Additional analyses also indicated that SGX301 is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

    The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive SGX301 treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received SGX301 throughout all 3 cycles of treatment, 49% of them demonstrated a treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that SGX301 is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, SGX301 continued to be well tolerated despite extended and increased use of the product to treat multiple lesions. Follow-up visits were completed in Q4 2020, and data lock and final analyses remain ongoing. 

    Overall safety of SGX301 is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period.  SGX301's mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects.  Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging.  Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available.  Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product.  SGX301 potentially represents the safest available efficacious treatment for CTCL.  With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues. 

    The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc. 

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of our clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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  8. PRINCETON, N.J., Jan. 19, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it will be hosting an Investor Webcast Event on Tuesday, January 26, 2021 from 2:30-4:00 PM Eastern Standard Time (EST) regarding United States (U.S) commercial planning for SGX301 in the treatment of Cutaneous T-Cell Lymphoma (CTCL).

    SGX301 (synthetic hypericin) is a novel first-in-class photodynamic therapy for first-line treatment of early stage CTCL. In the recently completed pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 achieved…

    PRINCETON, N.J., Jan. 19, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it will be hosting an Investor Webcast Event on Tuesday, January 26, 2021 from 2:30-4:00 PM Eastern Standard Time (EST) regarding United States (U.S) commercial planning for SGX301 in the treatment of Cutaneous T-Cell Lymphoma (CTCL).

    SGX301 (synthetic hypericin) is a novel first-in-class photodynamic therapy for first-line treatment of early stage CTCL. In the recently completed pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 achieved a statistically significant treatment response rate (p=0.04) in the primary endpoint after just 6 weeks (Cycle 1) of therapy when compared to placebo.  This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycles after 12 weeks (Cycle 2) and 18 weeks (Cycle 3) total treatment, reinforcing the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. In addition, SGX301 has demonstrated a statistically significant response in both patch and plaque lesions through 12 weeks of treatment (Cycle 2), highlighting the unique benefit of using visible light with its deeper skin penetration.  SGX301 was well tolerated throughout the study and no mutagenic risks have been identified, unlike other second-line or off-label treatments, including other phototherapies, which utilize ultraviolet light. The Company believes SGX301 has compelling competitive advantages over existing therapies for early stage CTCL and represents a significant near-term commercial opportunity.

    Conference Call Tuesday, January 26, 2021 from 2:30-4:00 PM EST

    The Company will share information about its commercialization plans in the U.S. for SGX301 on Tuesday, January 26, 2021. A question and answer (Q&A) session with the featured experts and management will follow the presentations.  If you would like to ask a question during the Q&A, please submit your request via email to  at least 15 minutes prior to the scheduled start of the call.

    Live Event: https://sqps.onstreamsecure.com/origin/enliven/players/Soligenix.html

    An mp4 recording of the presentation will be archived for 30 days following the event.

    This Investor Event will include presentations from the following:

    Dr. Ellen Kim, Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine and Lead Investigator of the FLASH study;

    Dr. Brian Poligone, Director, Rochester Skin Lymphoma Medical Group and lead enroller in the FLASH study;

    Mr. Michael Young, Principal, biomedwoRx: Life Sciences Consulting and member of the   Cutaneous Lymphoma Foundation Board of Directors; 

    Mr. Dan Ring, Vice President, Business Development & Strategic Planning of Soligenix; and

    Dr. Christopher J. Schaber, President and Chief Executive Officer of Soligenix.

    About Cutaneous T-Cell Lymphoma (CTCL)

    CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.  Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin.  These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors.  Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.  Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

    CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the U.S., with approximately 3,000 new cases seen annually.

    About SGX301

    SGX301 (synthetic hypericin) is a novel first-in-class photodynamic therapy utilizing safe visible light for activation.  The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later.  The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure.  Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients.  In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective.  SGX301 has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

    The Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consists of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received SGX301 treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving SGX301 achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). SGX301 treatment in the first cycle was safe and well tolerated.

    In the second open-label treatment cycle (Cycle 2), all patients received SGX301 treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of SGX301 treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of SGX301 treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes.  SGX301 continued to be safe and well tolerated. Additional analyses also indicated that SGX301 is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

    The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive SGX301 treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received SGX301 throughout all 3 cycles of treatment, 49% of them demonstrated a treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that SGX301 is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, SGX301 continued to be well tolerated despite extended and increased use of the product to treat multiple lesions. Follow-up visits were completed in Q4 2020, and data lock and final analyses remain ongoing.   

    Overall safety of SGX301 is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period.  SGX301's mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects.  Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging.  Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available.  Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product.  SGX301 potentially represents the safest available efficacious treatment for CTCL.  With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues. 

    The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc. 

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of our clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-investor-webcast-event-us-commercialization-of-sgx301-in-the-treatment-of-cutaneous-t-cell-lymphoma-301209662.html

    SOURCE Soligenix, Inc.

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  9. PRINCETON, N.J., Jan. 7, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has signed an exclusive Supply, Distribution and Services Agreement with Daavlin.  Securing long-term supply and distribution of a commercially ready light device is an integral component of the regulatory and commercial strategy for SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL).

    Daavlin has a 40-year history of innovation and development in the field of phototherapy, providing an extensive line of products and services to health…

    PRINCETON, N.J., Jan. 7, 2021 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has signed an exclusive Supply, Distribution and Services Agreement with Daavlin.  Securing long-term supply and distribution of a commercially ready light device is an integral component of the regulatory and commercial strategy for SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL).

    Daavlin has a 40-year history of innovation and development in the field of phototherapy, providing an extensive line of products and services to health care providers and patients worldwide for the purposes of treating photoresponsive skin disorders such as psoriasis, vitiligo and now CTCL.  The company's corporate headquarters and manufacturing plant are located in Bryan, Ohio.

    Pursuant to the Agreement, Daavlin will exclusively manufacture the proprietary light device for use with SGX301 for the treatment of CTCL.  Upon approval of SGX301 by the US Food and Drug Administration (FDA), Soligenix will promote SGX301 and the companion light device, and facilitate the direct purchase of the device from Daavlin; and Daavlin will exclusively distribute and sell the SGX301 light device to Soligenix, physicians and patients. 

    "We are pleased to be partnering with a company like Soligenix that has such deep expertise in development of products for treating rare diseases such as CTCL," said Dave Swanson, Founder and Chief Executive Officer of Daavlin, "Our extensive history in the commercialization of phototherapy medical devices in both the US and Europe complements Soligenix as they bring SGX301 to CTCL patients in need."

    "Daavlin brings technical, manufacturing and commercial capabilities in both the US and Europe that will assist us in rapidly and efficiently distributing the SGX301 companion light device upon approval by FDA," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Seamless integration of the drug product and companion light device for physicians and patients is critical to the commercial success of SGX301 and working with Daavlin will help us achieve that operational excellence."

    About Cutaneous T-Cell Lymphoma (CTCL)

    CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.  Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin.  These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors.  Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.  Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

    CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually.

    About SGX301

    SGX301 (synthetic hypericin) is a novel first-in-class photodynamic therapy utilizing safe visible light for activation.  The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later.  The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure.  Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients.  In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective.  SGX301 has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

    The Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consists of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received SGX301 treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving SGX301 achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). SGX301 treatment in the first cycle was safe and well tolerated.

    In the second open-label treatment cycle (Cycle 2), all patients received SGX301 treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of SGX301 treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of SGX301 treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes.  SGX301 continued to be safe and well tolerated. Additional analyses also indicated that SGX301 is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

    The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive SGX301 treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received SGX301 throughout all 3 cycles of treatment, 49% of them demonstrated a treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that SGX301 is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, SGX301 continued to be well tolerated despite extended and increased use of the product to treat multiple lesions. Follow-up visits were completed in Q4 2020, and data lock and final analyses remain ongoing.   

    Overall safety of SGX301 is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period.  SGX301's mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects.  Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging.  Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available.  Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product.  SGX301 potentially represents the safest available efficacious treatment for CTCL.  With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues. 

    The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc. 

    About Daavlin

    Daavlin is a privately held company founded in 1981 by David Swanson, and has developed into a leading manufacturer of phototherapeutic products with a world-wide presence. The company's corporate headquarters and manufacturing plant are located in Bryan, Ohio. A network of international distributors offers Daavlin products in more than sixty countries around the world. Daavlin has a long tradition of development and innovation in the field of phototherapy with an extensive line of products and services offered in the field of dermatology. Daavlin products are used world-wide by dermatologists and by patients in their homes to treat photoresponsive skin disorders such as psoriasis, vitiligo, and eczema (atopic dermatitis).

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of our clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-strategic-partnership-with-daavlin-for-supply-and-distribution-of-the-sgx301-companion-light-device-in-the-treatment-of-cutaneous-t-cell-lymphoma-301202571.html

    SOURCE Soligenix, Inc.

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  10. PRINCETON, N.J., Dec. 28, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded Soligenix a Direct to Phase II Small Business Innovation Research (SBIR) grant of approximately $1.5 million to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 (Coronavirus Disease 2019) and EVD (Ebola Virus Disease) vaccine candidates in conjunction with the CoVaccine HT™ (CoVaccine) adjuvant…

    PRINCETON, N.J., Dec. 28, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded Soligenix a Direct to Phase II Small Business Innovation Research (SBIR) grant of approximately $1.5 million to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 (Coronavirus Disease 2019) and EVD (Ebola Virus Disease) vaccine candidates in conjunction with the CoVaccine HT™ (CoVaccine) adjuvant.  This award also will support immune characterization of this novel, emulsified adjuvant that has unique potency and compatibility with lyophilization strategies to enable thermostabilization of subunit vaccines.

    CiVax™ is the Company's heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2.  Ongoing collaborations with Axel Lehrer, PhD, Associate Professor (Vaccinology) in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa (UHM) have demonstrated the feasibility of developing a highly immunogenic vaccine for COVID-19.  With significant research dedicated worldwide to the generation of COVID-19 vaccines, it is noteworthy that the essential attributes of a vaccine successful in controlling the ongoing pandemic are believed to include the ability to rapidly stimulate a Th1/Th2 balanced antibody response, raising significant virus neutralizing antibodies, as well as induce potent cell-mediated immunity.  Previous work with the CoVaccine adjuvant, which Soligenix licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation, has indicated that CoVaccine has these critical characteristics.  In addition, unlike other vaccine candidates that have logistical challenges due to cold chain requirements (in some cases requiring maintenance of temperatures less than -70 degrees Celsius), the underlying technology platform has demonstrated the ability to produce single vial vaccines which are stable up to temperatures at least as high as +40 degrees Celsius.

    The awarded grant enables detailed immunogenicity evaluation of CoVaccine in the presence of either the SARS-CoV-2 Spike protein antigen or the Zaire ebolavirus glycoprotein antigen in both mice and non-human primates, and will significantly enhance both vaccine programs.  It also will enable re-initiation of key CoVaccine manufacturing processes.

    Many programs are focused on the development of vaccines for COVID-19 and two vaccines have recently received Emergency Use Approval by the FDA.  However, the worldwide extent of the problem suggests that a complete solution to the pandemic will require parallel approaches.  Moreover, there is the potential need for annual vaccinations.  The total number of vaccine doses required to control the ongoing pandemic also suggests that multiple vaccines, based on different manufacturing platforms, will be necessary to efficiently vaccinate the worldwide population.  Subunit vaccines are considered the gold standard for vaccine safety, but are relatively under-represented in fast-tracked COVID-19 vaccine candidates to date.  Unlike virally vectored vaccines, there is no limit to the number of times the adjuvant and antigen can be used and the typical safety profile of a subunit vaccine results in a vaccine that is suitable for immune compromised or elderly populations as well.  Further, while RNA vaccines are rapid to manufacture, the requirements for cold chain distribution remain a real constraint.

    "We are appreciative of the continued support provided by NIAID for our thermostabilization program," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "This SBIR grant award will further advance our studies with the CoVaccine adjuvant, as well as our CiVax™ and filovirus vaccine programs.  We remain dedicated to progressing our Public Health Solutions business segment and look forward to accelerating our CiVax™ program in particular with this funding."

    NIAID support is being provided through SBIR grant number 1 R44 AI157593-01.

    About CiVax™

    CiVax™ is the Company's heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2.  Under the Company's Public Health Solutions business segment, ongoing collaborations with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UHM have demonstrated the feasibility of developing heat stable subunit filovirus vaccines, including hemorrhagic disease caused by Zaire ebolavirus, Sudan ebolavirus as well as Marburg marburgvirus, with both monovalent and bivalent vaccine combinations.  Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit).  In March 2020, Soligenix and its collaborators expanded the technology platform to assess compatibility with vaccine candidates targeting SARS-CoV-2, the cause of COVID-19.

    The vaccine platform includes three essential components:

    1. a protein antigen, specifically a viral surface glycoprotein, which mediates entry and fusion of the virus with host cells and is manufactured with a proprietary insect cell expression system coupled with protein-specific affinity purification;
    2. an adjuvant which has been shown to enhance both cell mediated and humoral immunity; and
    3. a formulation which enables thermostabilization of the resulting mixture, avoiding the need for cold chain storage and shipping.

    The resulting vaccine is broadly applicable, including to individuals often excluded from common viral vector vaccine approaches such as children, the elderly and the immunocompromised.  The protection of elderly and immunocompromised populations are particularly important in the context of COVID-19. The ability to provide a thermostabilized, single vial vaccine, is particularly important in the context of rapid and broad vaccine distribution.

    These same components are now being applied to coronavirus vaccine, using the well-defined surface glycoprotein, known as the Spike protein, as the antigen. Nonclinical work in mice with a prototype vaccine recently have been published, demonstrating the ability of the CoVaccine adjuvant in combination with a prototype antigen, to:

    • stimulate immunity within 14 days after the first vaccination;
    • induce a balanced Th1 response, believed to be critical to inducing immunity without aggravating disease pathology;
    • induce a neutralizing antibody response; and
    • induce a cell mediated immune response.

    About Coronavirus Infection

    Coronavirus infections can cause a wide spectrum of disease in humans, ranging from a common cold to a more severe respiratory infection, such as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), which have a case mortality rate of approximately 10% and 30%, respectively.  Similar to filoviruses, coronaviruses also are endemic in wildlife populations and can be transmitted to humans with close contact.  The COVID-19 outbreak, caused by SARS-CoV-2, is the most recent example of a suspected species crossover seen with this virus family.  Although the case fatality rate of COVID-19 is still under investigation, COVID-19 has been declared a global pandemic by the World Health Organization.  The global impact of this emerging infection demonstrates the urgent need for robust technology platforms to rapidly develop new vaccines for novel diseases.  The only FDA sanctioned treatments for COVID-19 are available under Emergency Use Authorization.   There are currently two vaccines available under FDA Emergency Use Authorization.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma; our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942), for the treatment of oral mucositis in head and neck cancer; and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate; SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease; and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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    SOURCE Soligenix, Inc.

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  11. PRINCETON, N.J., Dec. 22, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today preliminary top-line results for its pivotal Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) trial evaluating SGX942 (dusquetide) in the treatment of severe oral mucositis (SOM) in patients with head and neck cancer (HNC) receiving chemoradiation.  The study enrolled 268 patients randomized 1:1 to receive either SGX942 or placebo.  The primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical…

    PRINCETON, N.J., Dec. 22, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today preliminary top-line results for its pivotal Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) trial evaluating SGX942 (dusquetide) in the treatment of severe oral mucositis (SOM) in patients with head and neck cancer (HNC) receiving chemoradiation.  The study enrolled 268 patients randomized 1:1 to receive either SGX942 or placebo.  The primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group.  Despite this clinically meaningful improvement, the variability in the distribution of the data yielded a p-value that was not statistically significant.

    Other secondary endpoints supported the biological activity of dusquetide, including a statistically significant 50% reduction in the duration of SOM in the per-protocol population, which decreased from 18 days in the placebo group to 9 days in the SGX942 treatment group (p=0.049), consistent with the findings in the Phase 2 trial.  Similarly, incidence of SOM also followed this biological trend as seen in the Phase 2 study, decreasing by 16% in the SGX942 treatment group relative to the placebo group in the per-protocol population.  The per-protocol population was defined as the population receiving a minimum of 55 Gy radiation and at least 10 doses of study drug (placebo or SGX942) throughout the intended treatment period, with no major protocol deviations (e.g. breaks in study drug administration longer than 8 days between successive doses).  

    "We are obviously very disappointed with the unanticipated outcome of the study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Despite the fact that SGX942 demonstrated clinically meaningful reductions in oral mucositis consistent with the Phase 2 study, the Phase 3 trial did not achieve the statistically significant benefit we expected. Over the coming weeks, we will be analyzing the data to better determine why the study did not meet expectations.  If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from SGX942 therapy, we will certainly communicate our findings and explore follow-up discussions with the FDA and the EMA."  

    Dr. Schaber continued, "With approximately $20 million of cash and our non-dilutive government funding, we will evaluate strategic options as we continue to execute on the multiple development programs across our rare disease pipeline.  Most importantly, this will include the preparation of a New Drug Application for SGX301 in the treatment of cutaneous T-cell lymphoma, which demonstrated statistical significance in its pivotal Phase 3 clinical trial earlier this year, as well as continuing activities towards SGX301 U.S. commercialization where we expect peak annual sales to exceed $75 million."

    The Company will host a webcast and conference call today at 8:30 AM EST to review the top-line findings. 

    Conference Call, December 22, 2020 at 8:30 AM Eastern Time

    The Company will share information on its Phase 3 top-line results for its SGX942 program in oral mucositis.  A question and answer (Q&A) session with management will follow the presentations.  If you would like to ask a question during the Q&A, please submit your request via email to  at least 15 minutes prior to the scheduled start of the call.

    U.S. toll free: 1-866-652-5200

    International: 1-412-317-6060

    Please request to be entered into the Soligenix call.

    A transcript of the presentation will be archived for 30 days following the event.

    About Oral Mucositis

    Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the U.S. per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

    The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

    It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in HNC is a subpopulation of approximately 90,000 patients in the U.S., with a comparable number in Europe. Oral mucositis almost always occurs in patients with HNC treated with CRT and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

    In the pediatric population, head and neck cancer is a rarer occurrence and is caused by different underlying pathologies. The major types of HNC in children are lymphoma, sarcomas (including rhabdomyosarcomas), and neuroblastoma rather than squamous cell carcinoma, the major type of adult HNC cancers. Hematopoietic stem cell transplantation (HSCT), especially allogeneic transplantation with higher risk of oral mucositis, is more frequently used in the pediatric population than in adults when treating a number of primary tumor types, as seen in leukemia and lymphoma.  Both treatment of HNC and HSCT are associated with high risk of oral mucositis in the pediatric population.

    Oral mucositis remains an area of unmet medical need where there are currently no approved drug therapies in the context of any solid tissue tumors.  

    About the Phase 3 DOM-INNATE Study

    This multinational, placebo-controlled, randomized study enrolled 268 subjects with squamous cell carcinoma of the oral cavity and oropharynx, scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects were randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of CRT.  The primary endpoint for the study is the median duration of SOM, assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis is evaluated using the WHO (World Health Organization) Grading system. SOM is defined as a WHO Grade of ≥3.  A positive interim analysis was conducted in August 2019, resulting in the recommended addition of 35 subjects / group to the study to maintain 90% power. Subjects are being followed for an additional 12 months after the completion of treatment. Soligenix has been working with leading oncology centers internationally, a number of which participated in the Phase 2 study.

    About Dusquetide

    Dusquetide (the active ingredient in SGX942) is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory, anti-infective and tissue healing response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, including melioidosis.

    SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to CRT for HNC.

    SGX942 has received Fast Track Designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, as well as Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of SOM in HNC patients receiving CRT. In addition, products containing the same active ingredient, dusquetide, have been granted Fast Track Designation as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis and Orphan Drug Designations in the treatment of MAS and the treatment of acute radiation syndrome.

    Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has received partial funding from NIH for its oral mucositis clinical studies. The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study supported by a Phase II SBIR grant (#R44DE024032) award.

    In addition, a high level review of the IDR technology platform is available here.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class IDR technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

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  12. PRINCETON, N.J., Dec. 16, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has entered into a $20 million convertible debt financing agreement with Pontifax Medison Debt Financing (Pontifax), the healthcare-dedicated venture and debt fund of the Pontifax life science funds.

    "The access to less dilutive capital provided by this facility is designed to increase our financial flexibility as we continue to advance our rare disease pipeline, and build toward commercialization in the United States with SGX301 for the treatment of cutaneous T-cell…

    PRINCETON, N.J., Dec. 16, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has entered into a $20 million convertible debt financing agreement with Pontifax Medison Debt Financing (Pontifax), the healthcare-dedicated venture and debt fund of the Pontifax life science funds.

    "The access to less dilutive capital provided by this facility is designed to increase our financial flexibility as we continue to advance our rare disease pipeline, and build toward commercialization in the United States with SGX301 for the treatment of cutaneous T-cell lymphoma (CTCL) and SGX942 for the treatment of oral mucositis in head and neck cancer patients," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.

    "Pontifax is pleased to enter into this strategic financing partnership with Soligenix as it continues to advance its pipeline of clinically meaningful products for treating rare diseases," said Momi Karako, Partner at Pontifax. "Soligenix has deep expertise in development of products that treat diseases such as CTCL and oral mucositis in head and neck cancer patients, which is a perfect fit with our portfolio of transformative, cutting-edge life science companies."

    Under the terms of the agreement with Pontifax, Soligenix will have access to up to $20 million in convertible debt financing in three tranches, which will mature over a four and a half year period and have an interest-only period for the first two years. Upon the closing of this transaction, the Company has accessed the first tranche of $10 million, and has the option to draw the second tranche of $5 million at any time over the next 12 months and the third tranche of $5 million upon filing of the SGX301 new drug application, subject to certain conditions.

    Pontifax may elect to convert the outstanding loan drawn under the first two tranches into shares of Soligenix's common stock at any time prior to repayment at a conversion price of $4.10 per share. Soligenix also has the ability to force the conversion of the loan into shares of its common stock at a conversion price of $4.92 per share, subject to certain conditions.

    About Pontifax Ventures

    Founded in 2004, Pontifax is a healthcare-dedicated venture capital firm with over $775 million under management. It seeks transformative, cutting-edge life sciences technologies at all development stages. Its portfolio comprises of about 80 companies that develop breakthrough solutions to substantial unmet needs.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the HYBRYTE Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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  13. PRINCETON, N.J., Dec. 8, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has demonstrated extended protection with its heat stable ricin toxin vaccine, RiVax®. Mice, vaccinated twice on Days 1 and 21 were protected for at least 365 days against subsequent ricin challenge. These results demonstrate that the thermostabilized vaccine formulation is capable of eliciting enduring protection in mice. Coupled with previous demonstration of efficacy in mice and non-human primates (NHPs) as well as long-term thermostability (at least 1 year at…

    PRINCETON, N.J., Dec. 8, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has demonstrated extended protection with its heat stable ricin toxin vaccine, RiVax®. Mice, vaccinated twice on Days 1 and 21 were protected for at least 365 days against subsequent ricin challenge. These results demonstrate that the thermostabilized vaccine formulation is capable of eliciting enduring protection in mice. Coupled with previous demonstration of efficacy in mice and non-human primates (NHPs) as well as long-term thermostability (at least 1 year at 40°C or 104°F), these results reinforce the practicality of stockpiling and potentially utilizing the RiVax® vaccine in warfighters and civilian first responders without the complexities that arise for vaccines that require cold chain handling. This same thermostabilization approach is also being advanced in the development of Soligenix's CiVax™ vaccine for COVID-19.

    RiVax® is the Company's vaccine candidate for the prevention of death following exposure to a lethal dose of ricin toxin using a unique antigen that is completely devoid of the toxic activity of ricin.  Formulated by Soligenix to have enhanced thermostability, RiVax® has demonstrated up to 100% protection in mice and NHPs subsequently exposed to lethal doses of ricin toxin either systemically or by aerosol.  Most recently, mice have been shown to be protected from ricin challenge at 10 times the lethal dose for at least 12 months post-vaccination. 

    "These results continue to reinforce the convenience and practicality of the RiVax® vaccine," stated Dr. Oreola Donini, Chief Scientific Officer of Soligenix.  "This, and other ongoing work, has continued to corroborate the efficacy of RiVax® and will facilitate its potential approval."

    Approval for RiVax® will be pursued under the US Food and Drug Administration (FDA) "Animal Rule," which is applied to products where testing in clinical efficacy trials would be unethical.  In the case of a ricin toxin vaccine, clinical efficacy testing of the vaccine is unethical since it would require intentionally exposing humans to ricin toxin.  The Animal Rule is generally associated with the approval of medical countermeasures for biodefense purposes. The Animal Rule requires the evaluation of efficacy in animals (RiVax® has demonstrated up to 100% protection in NHPs exposed to lethal aerosolized ricin), safety in humans (the RiVax® antigen has been demonstrated to be well-tolerated in human Phase 1 clinical studies) and immunogenicity correlated between animal models and humans (biomarkers have been identified, see publication here).

    RiVax® studies are supported by a contract (# HHSN272201400039C) award of approximately $21.2 million from the National Institute of Allergy and Infectious Diseases (NIAID).  Non-dilutive funding for the development of RiVax® has exceeded $40 million to date.

    RiVax® has received Orphan Drug and Fast Track designations from the FDA, and, upon approval, has the potential to qualify for a biodefense Priority Review Voucher (PRV).  In addition, RiVax® has received Orphan Drug designation from the European Medicines Agency (EMA).

    About Ricin Toxin

    Ricin toxin is a lethal plant-derived toxin and is considered both a bioterrorism agent and a chemical warfare agent because of its stability and high potency, and the fact that it is readily extracted from by-products of castor oil production.  Ricin comes in many forms including powder, mist or pellet.  Ricin can also be dissolved in water and other liquids.  The US Centers for Disease Control and Prevention estimates that the lethal dose in humans is about the size of a grain of salt.  Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure.  Ricin is especially toxic when inhaled.  Ricin works by entering cells of the body and preventing the cells from making the proteins they need.  Without the proteins, cells die, which is eventually harmful to the entire body.

    There are currently no effective treatments for ricin poisoning.  The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used to vaccinate military personnel and civilian emergency responders at high risk of potential exposure in the event of a biological attack.

    About RiVax®

    RiVax® is Soligenix's proprietary heat stable recombinant subunit vaccine developed to protect against exposure to ricin toxin, the threat of which has been highlighted in the news with an envelope addressed to President Trump that was thought to contain this potent and potentially lethal toxin.  With RiVax®, Soligenix is a world leader in the area of ricin toxin vaccine research.

    RiVax® contains a genetically altered version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule which was originally invented at the University of Texas Southwestern.  Phase 1 clinical studies to date have demonstrated the safety of the antigen and adjuvant, as well as the generation of ricin neutralizing antibodies which are increased in the presence of the alum adjuvant.  In animal studies, the alum formulation of RiVax® also induced higher titers and longer-lasting antibodies than the adjuvant-free vaccine.  Vaccination with the thermostabilized alum-adjuvanted RiVax® formulation in a large animal model provided 100% protection (p<0.0001) against acute exposure to aerosolized ricin, the most lethal route of exposure for ricin.  The protected animals also had no signs of gross lung damage, a serious and enduring ramification with long-term consequences for survivors of ricin exposure.  These results are described in a publication available here.

    Heat stabilization of RiVax® is achieved with the Company's proprietary ThermoVax® technology, designed to eliminate the cold-chain production, distribution and storage logistics required for most vaccines.  The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations.  By employing ThermoVax® during the final formulation of RiVax®, the vaccine has demonstrated enhanced stability and the ability to withstand temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year. These results are described in a publication available here.

    The development of RiVax® has been funded through a series of grants from both the NIAID and the FDA and ongoing development is sponsored by NIAID contract #HHSN272201400039C. Non-dilutive funding for the development of RiVax® has exceeded $40 million to date.  RiVax® is being developed under the FDA "Animal Rule" and potentially would be added to the Strategic National Stockpile and dispensed in the event of a terrorist threat.  RiVax® has received orphan drug designation in the US and in Europe.

    As a new chemical entity, an FDA approved RiVax® vaccine has the potential to qualify for a biodefense PRV, which allows the holder accelerated review of a drug application.  Approved under the 21st Century Health Cures Act in late 2016, the biodefense PRV is awarded upon approval as a medical countermeasure when the active ingredient(s) have not been otherwise approved for use in any context.  PRVs are transferable and can be sold, with sales in recent years in excess of $100 million.  When redeemed, PRVs entitle the user to an accelerated review period of six months, saving a median of seven months' review time as calculated in 2009.  However, the FDA must be advised 90 days in advance of the use of the PRV and the use of a PRV is associated with an additional user fee ($2.1 million in 2020).

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the NIAID, the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-demonstrates-extended-protection-with-its-rivax-ricin-toxin-vaccine-301187774.html

    SOURCE Soligenix, Inc.

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  14. Soligenix Inc. (NASDAQ:SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, where it has demonstrated positive […]

    Soligenix Inc. (NASDAQ:SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell…

    Soligenix Inc. (NASDAQ:SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, where it has demonstrated positive […]

    Soligenix Inc. (NASDAQ:SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, where it has demonstrated positive and statistically significant results in its pivotal Phase 3 FLASH ("Fluorescent Light Activated Synthetic Hypericin") study. Its first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, has completed patient enrollment in its pivotal Phase 3 clinical trial, referred to as the DOM-INNATE ("Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity") study, and the company expects top-line final results read out by end of this year.   For more information, visit the company's website at www.soligenix.com.

    To view IBN's virtual coverage of the Fall Investor Summit, visit https://ibn.fm/InvestorSummitFall2020

    About InvestorBrandNetwork's Virtual Coverage

    The InvestorBrandNetwork ("IBN"), a multifaceted financial news and publishing company, is providing the online investment community with a custom-built portal that includes summaries on each of the publicly traded companies participating virtually at the Fall Investor Summit. In addition to enabling proficient evaluation of each company via one-click access to market research tools and helpful website links, IBN is once again using social media and syndicated articles to maximize the visibility of this month's Investor Summit.

    For more than a decade, IBN has provided real-time coverage for numerous global events and conferences through its various brands, social media accounts and investment newsletters. To further expand visibility of participating companies at these events, and to ensure another successful year for our many event collaborations in 2020, IBN's syndication partners have extended digital coverage to include individual broadcasts on financial websites and platforms visited by millions of investors daily.

    For more information, please visit https://www.InvestorBrandNetwork.com

    Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: http://IBN.fm/Disclaimer

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  15. NEW YORK, NY / ACCESSWIRE / November 12, 2020 / Soligenix, Inc. (NASDAQ:SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, will be presenting at this year's virtual Fall Investor Summit on November 16th-18th.

    The Fall Investor Summit will take place virtually, featuring 75 companies and over 300 institutional and retail investors.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light…

    NEW YORK, NY / ACCESSWIRE / November 12, 2020 / Soligenix, Inc. (NASDAQ:SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, will be presenting at this year's virtual Fall Investor Summit on November 16th-18th.

    The Fall Investor Summit will take place virtually, featuring 75 companies and over 300 institutional and retail investors.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    The Investor Summit (formerly MicroCap Conference) is an exclusive, independent conference dedicated to connecting smallcap and microcap companies with qualified investors.

    To register as a presenting company: please contact Brittney Blocker ()

    To request complimentary investor registration: please visit our website at www.investorsummitgroup.com

    News Compliments of ACCESSWIRE

    FOR MORE INFORMATION

    Please visit: www.investorsummitgroup.com

    Or, contact Brittney Blocker at

    SOURCE: Soligenix, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/615982/Soligenix-Inc-to-Present-at-the-virtual-Fall-Investor-Summit-on-November-16th-18th

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  16. PRINCETON, N.J., Nov. 12, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended September 30, 2020.

    "We continue to look to the future with our Specialized BioTherapeutics business segment," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the recent successful completion of our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 has demonstrated the potential to be a significant new treatment for early-stage…

    PRINCETON, N.J., Nov. 12, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended September 30, 2020.

    "We continue to look to the future with our Specialized BioTherapeutics business segment," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the recent successful completion of our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, SGX301 has demonstrated the potential to be a significant new treatment for early-stage cutaneous T-cell lymphoma (CTCL).  In the double-blind, placebo controlled Cycle 1 portion of the study, a statistically significant treatment response (p=0.04) was achieved in the primary endpoint after just 6 weeks of therapy.  This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycles at 12 weeks (Cycle 2) and 18 weeks (Cycle 3), reinforcing the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1.  With the study now concluded, we will begin preparing our new drug application for submission to the FDA.  We also continue to progress our pivotal Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) study for SGX942 (dusquetide), for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy.  With enrollment of 268 subjects completed, top-line final results continue to be expected before the end of the year."

    Dr. Schaber continued, "Under our Public Health Solutions business segment, supported by non-dilutive government funding, we continue to advance our work with the University of Hawaiʻi at Mānoa (UHM) and Hawaii Biotech Inc. on filovirus vaccines (protecting against viruses such as Ebola and Marburg) and the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19.  We recently announced publication of positive pre-clinical data from immunogenicity studies with CiVax™ (heat stable COVID-19 vaccine candidate), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the novel CoVaccine HT™ adjuvant in-licensed from BTG Specialty Pharmaceuticals (a division of Boston Scientific Corporation).  Our heat stable ricin vaccine, RiVax®, continues to be supported with a National Institute of Allergy and Infectious Disease contract award.  With over $11M in cash, not including our non-dilutive government funding, along with the at-the-market sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including final top-line results in our SGX942 Phase 3 clinical trial in oral mucositis."

    Soligenix Recent Accomplishments

    • On October 22, 2020, the Company announced the continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of the trial (Cycle 3), for a total of 6 months in the study, continued to significantly improve responses and remained safe and well-tolerated in its FLASH study. This data reinforces the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. SGX30l treatment in Cycle 3 further improved response rates, with 49% of patients electing to receive SGX301 for a total of 18 weeks demonstrating a 50% or greater reduction in their combined CAILS (Composite Assessment of Index Lesion Score) lesion score compared to 40% of patients demonstrating such a reduction after completing 12 weeks of SGX301 treatment in Cycle 2 (p=0.046). In addition, continued analysis of results has revealed that 12 weeks of SGX301 treatment (Cycle 2) is equally effective on both patch (response 37%, p=0.0009) and plaque (response 42%, p<0.0001) lesions of CTCL when compared to Cycle 1 placebo lesion responses. SGX301 continued to be very well tolerated, benefiting from the lack of hypericin circulation in the blood stream after targeted topical application to the lesions, as well as the use of visible light. To view this press release, please click here.



    • On September 15, 2020, the Company announced the publication of nonclinical results characterizing filovirus protein antigens (including for Ebola and Marburg viruses) and their thermostabilization. The article, authored by collaborators at the University of Colorado, University of Hawaiʻi at Mānoa (UHM) and Soligenix, is titled, "Preservation of Quaternary Structure in Thermostable, Lyophilized Filovirus Glycoprotein Vaccines: A Search for Stability-Indicating Assays" and has been accepted for publication in the Journal of Pharmaceutical Sciences. A copy of manuscript has been made available here. To view this press release, please click here.



    • On September 10, 2020, the Company conducted an Investor Webcast presentation on the use of its thermostabilized glycoprotein vaccine platform for the development of a COVID-19 vaccine, called CiVax™. To listen to this Webcast Event, please click here and to view the press release, please click here.

    Financial Results – Quarter Ended September 30, 2020

    Soligenix's revenues for the quarter ended September 30, 2020 were $0.6 million as compared to $1.3 million for the quarter ended September 30, 2019.  Revenues included payments on a contract in support of RiVax®, our ricin toxin vaccine candidate, grants received to support the development of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases, ThermoVax®, our thermostabilization technology, and the assessment of SGX942 safety in juvenile animals.

    Soligenix's basic net loss was $1.8 million, or ($0.06) per share, for the quarter ended September 30, 2020, as compared to $2.7 million, or ($0.14) per share, for the quarter ended September 30, 2019.  This decrease in net loss was primarily the result of decreased research and development spending due to the completion of the CTCL trial.

    Research and development expenses were $1.3 million as compared to $2.3 million for the quarters ended September 30, 2020 and 2019, respectively.  The decrease in research and development spending for the quarter ended September 30, 2020 was primarily attributable to the reduction in expense due to the completion of the CTCL trial.

    General and administrative expenses were $0.8 million for both the three months ended September 30, 2020 and 2019.

    As of September 30, 2020, the Company's cash position was approximately $11.3 million.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-recent-accomplishments-and-third-quarter-2020-financial-results-301171676.html

    SOURCE Soligenix, Inc.

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  17. PRINCETON, N.J., Nov. 10, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation at the upcoming virtual investor conferences below.

    • Virtual Fall Investor Summit held on November 16 through 18, 2020, with presentations, one-on-one meetings, round tables, and networking. The Soligenix presentation will be held on Tuesday, November 17 at 9:30AM ET. To view the live webcast, please visit https://www.webcaster4.com/Webcast/Page/2038/38404. For more…

    PRINCETON, N.J., Nov. 10, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation at the upcoming virtual investor conferences below.

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

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    SOURCE Soligenix, Inc.

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  18. PRINCETON, N.J., Oct. 22, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of the trial (Cycle 3), for a total of 6 months in the study, continued to significantly improve responses and remained safe and well-tolerated in its FLASH (Fluorescent Light Activated Synthetic Hypericin) study.  This data reinforces the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. SGX30l treatment in Cycle 3 further…

    PRINCETON, N.J., Oct. 22, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of the trial (Cycle 3), for a total of 6 months in the study, continued to significantly improve responses and remained safe and well-tolerated in its FLASH (Fluorescent Light Activated Synthetic Hypericin) study.  This data reinforces the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. SGX30l treatment in Cycle 3 further improved response rates, with 49% of patients electing to receive SGX301 for a total of 18 weeks demonstrating a 50% or greater reduction in their combined CAILS (Composite Assessment of Index Lesion Score) lesion score compared to 40% of patients demonstrating such a reduction after completing 12 weeks of SGX301 treatment in Cycle 2 (p=0.046).  In addition, continued analysis of results from the protocol mandated efficacy cycles (Cycles 1 and 2) of the study has revealed that 12 weeks of treatment (Cycle 2) with SGX301 is equally effective on both patch (response 37%, p=0.0009) and plaque (response 42%, p<0.0001) lesions of cutaneous T-cell lymphoma (CTCL) when compared to Cycle 1 placebo lesion responses, further demonstrating the unique benefits of the more deeply penetrating visible light activation of hypericin. SGX301 continued to be very well tolerated, benefiting from the lack of hypericin circulation in the blood stream after targeted topical application to the lesions, as well as the use of visible light.

    "Along with SGX301's rapid response time and safety profile, the patch and plaque data from the study are extremely compelling," stated Brian Poligone, MD, PhD, Lead Enrolling Investigator in the FLASH study and Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, USA.  "Current treatments for CTCL are generally less effective against plaques and deeper lesions, very similar to the problem observed in psoriasis.  The ability of SGX301 to target both patches and thicker plaques in CTCL is an important feature for this therapy and, if approved, will be of benefit to patients, regardless of their presentation.  These results are consistent with the positive findings highlighted in a recently reported case study of folliculotropic mycosis fungoides, a hard to treat variant of CTCL where lesions are associated with the hair follicles deep in the skin and more resistant to phototherapy."

    "On behalf of everyone at Soligenix, I would like to extend my sincere thanks to the patients, families, investigators, and advisors involved in the pivotal Phase 3 FLASH study," stated Richard Straube, MD, Chief Medical Officer of Soligenix.  "In treating CTCL, which is a chronic cancer with no cure, long-term safety is of paramount concern.  SGX301 treatment continues to demonstrate strong efficacy and a very benign safety profile, which is of significant benefit to patients living with this difficult disease.  Although the focus of the additional optional cycle was safety, we continue to see improvement in CTCL lesions with extended SGX301 treatment, building upon the robust efficacy signal in previous cycles.  The efficacy against both patch and plaque lesions, for example, is particularly encouraging and we believe provides another important differentiating feature from other therapies currently being used to treat early stage disease."

    "These results continue to strengthen our long-standing belief that SGX301 has the potential to be a valuable and life-changing therapy for patients suffering from CTCL, which is an orphan disease and area of unmet medical need," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  "With the study now concluding, we continue to thoroughly assess commercialization and/or partnership of SGX301 while in parallel preparing for filing the New Drug Application with FDA.  Despite the challenges imposed by the COVID-19 pandemic, 2020 continues to be a very impactful year for us as we now focus on our next near-term and potentially transformational catalyst - the announcement of top-line final results by year-end from our other pivotal Phase 3 study of SGX942 (dusquetide) for the treatment of oral mucositis in head and neck cancer patients."

    Soligenix previously announced positive top-line results when the FLASH study achieved statistical significance (p=0.04) in its primary endpoint over the first 6-week double-blind treatment cycle (Cycle 1) (available here).  The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo in Cycle 1.  After the subsequent additional 6-week treatment in the open-label Cycle 2, the response rate in patients receiving a total of 12 weeks treatment increased two and a half-fold (40% with p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment).  These highly statistically significant results confirm the benefit of continued SGX301 treatment in CTCL patients (press release available here).  Treatment responses were assessed at Week 8 (after 6 weeks of treatment) and at Week 16 (after 12 weeks of treatment).  A positive response was defined as an improvement of at least 50% in the CAILS for three index lesions evaluated.  Further analysis of the patients receiving SGX301 through 12 weeks has revealed that treatment of both patch and plaque lesions was equally effective.  Similar to the overall findings, the responses of individual lesions were statistically significantly improved after 12 weeks treatment relative to 6 weeks treatment with SGX301 or placebo.  Importantly, this improvement was seen equally for both patches (response 37%, p=0.0009) and plaques (response 42%, p<0.0001), a differentiating feature of SGX301 relative to other treatment modalities in CTCL.

    Cycle 3 of the study was designed as a compassionate use, optional, cycle where patients could elect to continue SGX301 treatment for an additional 6 weeks (up to a total of 18 weeks) for all their lesions.  Sixty-six percent (66%) of patients elected to continue into Cycle 3.  During this cycle, SGX301 was applied to multiple cancerous skin lesions on the body, maximizing the exposure to the drug.  Including Cycle 3 in the study enabled a more rigorous safety assessment in the context of extended and increased exposure to SGX301.  Similar to the overall findings, the responses of individual lesions after three cycles of treatment with SGX301 was statistically significant after Cycle 3 relative to outcomes after Cycles 1 and 2 (49% of all lesions responded with a CAILS score reduction of at least 50%, with a statistically significant change from end of Cycle 2 [p=0.0009] and compared to patients receiving placebo only in Cycle 1 [p<0.0001]).  Further, no synthetic hypericin was detected in the bloodstream of patients, minimizing safety concerns of drug effects outside of the tumor area. All safety data continues to indicate that SGX301 treatment is safe and well tolerated, in marked contrast to other available second-line and off-label therapies for CTCL.   

    About Cutaneous T-Cell Lymphoma (CTCL)

    CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.  Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin.  These malignant cells migrate to the skin where they form various lesions, typically beginning as patches that may progress to more difficult to treat raised plaques and tumors.  Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL and no FDA approved first-line treatment option.  Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

    CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually.

    About SGX301

    SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation.  The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later.  The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure.  Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients.  In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective.  SGX301 has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

    The Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consists of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received SGX301 treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving SGX301 achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). SGX301 treatment in the first cycle was safe and well tolerated.

    In the second open-label treatment cycle (Cycle 2), all patients received SGX301 treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of SGX301 treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of SGX301 treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes.  SGX301 continued to be safe and well tolerated. Additional analyses also indicated that SGX301 is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

    The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive SGX301 treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received SGX301 throughout all 3 cycles of treatment, 49% of them demonstrated a treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that SGX301 is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, SGX301 continued to be well tolerated despite extended and increased use of the product to treat multiple lesions. Follow-up visits are expected to be completed in 2020.   

    Overall safety of SGX301 is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period.  SGX301's mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects.  Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging.  Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available.  Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product.  SGX301 potentially represents the safest available efficacious treatment for CTCL.  With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues. 

    The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc. 

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-phase-3-flash-study-continues-to-demonstrate-positive-benefits-in-patients-with-cutaneous-t-cell-lymphoma-301157831.html

    SOURCE Soligenix, Inc.

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  19. PRINCETON, N.J., Oct. 8, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its President and Chief Executive Officer, Christopher J. Schaber, Ph.D., will deliver a corporate presentation at the BIO Investor Forum, held virtually October 13-15, 2020. The presentation will be available on-demand for conference attendees.

    For more information about the BIO Investor Forum, please visit the conference website.

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    About Soligenix, Inc.

    Soligenix is…

    PRINCETON, N.J., Oct. 8, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its President and Chief Executive Officer, Christopher J. Schaber, Ph.D., will deliver a corporate presentation at the BIO Investor Forum, held virtually October 13-15, 2020. The presentation will be available on-demand for conference attendees.

    For more information about the BIO Investor Forum, please visit the conference website.

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs targeting both filoviruses (such as Marburg and Ebola) and coronaviruses. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA), and the Defense Threat Reduction Agency (DTRA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-to-present-at-the-bio-investor-forum-301148702.html

    SOURCE Soligenix, Inc.

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  20. PRINCETON, N.J., Sept. 15, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of nonclinical results characterizing filovirus protein antigens (including for Ebola and Marburg viruses) and their thermostabilization.  The article, authored by collaborators at the University of Colorado, University of Hawaiʻi at Mānoa (UHM) and Soligenix, is titled, "Preservation of Quaternary Structure in Thermostable, Lyophilized Filovirus Glycoprotein Vaccines: A Search for Stability-Indicating Assays" and has been accepted for publication in the Journal

    PRINCETON, N.J., Sept. 15, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of nonclinical results characterizing filovirus protein antigens (including for Ebola and Marburg viruses) and their thermostabilization.  The article, authored by collaborators at the University of Colorado, University of Hawaiʻi at Mānoa (UHM) and Soligenix, is titled, "Preservation of Quaternary Structure in Thermostable, Lyophilized Filovirus Glycoprotein Vaccines: A Search for Stability-Indicating Assays" and has been accepted for publication in the Journal of Pharmaceutical Sciences. A copy of manuscript has been made available here.

    Under the Company's Public Health Solutions business segment, ongoing collaborations with Axel Lehrer, PhD, Associate Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UHM and Hawaii Biotech Inc. (HBI), as well as work conducted by Theodore Randolph, PhD, Professor, Center for Pharmaceutical Biotechnology, Department of Chemical and Biological Engineering at the University of Colorado, Boulder have demonstrated the feasibility of developing heat stable subunit protein vaccine formulations for filovirus vaccines.  Protective efficacy has been demonstrated in non-human primates against infection with Ebola virus, Sudan virus, and Marburg virus.  Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit).  These most recent results demonstrate the thermostabilization of three virus glycoproteins (from Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus), and the identification of key stability-indicating assays to further support mono-, bi- and tri-valent vaccine formulations. 

    "Filoviruses are endemic in areas of the world where the power supply can be uncertain, making a thermostable vaccine particularly valuable," stated Dr. Lehrer, "Our work to date has demonstrated not only the feasibility of rapid and efficient manufacturing, but also the applicability of thermostabilization and the potential for a broadly applicable and easily distributed vaccine.  With Marburg virus continuing to be an unmet medical need of priority to the US government, we are now focusing and accelerating evaluations of the Marburg virus vaccine specifically."

    "The continued advances in the filovirus program demonstrates the program's maturity and overall developability," noted Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix.  "The compatibility with thermostabilization, and the identification of key stability indicating assays, are both hallmarks of a potentially broadly applicable vaccine platform.  Using this platform, we also continue to accelerate our joint COVID-19 vaccine effort, called CiVax™, with Dr. Lehrer and look forward to further developments for both programs."

    About Filovirus Infection

    Ebola Virus Disease is caused by one of six species of Ebolavirus, four of which are known to cause disease in humans, including its best-known member, Zaire ebolavirus (Ebola virus).  All species of ebolavirus belong to the Filoviridae family, a family that further contains the equally human pathogenic Marburg virus.  Filoviruses are believed to be harbored in various animal species in Africa, particularly bats, although the specific reservoir host for many of these viruses is still unknown.  There have been several known Ebola and Marburg virus disease outbreaks since 1967, with the largest outbreak starting in 2014 in Western Africa, and involved over 26,000 confirmed/probable/suspected cases with an estimated death toll of over 11,000 people according to the Centers for Disease Control and Prevention (CDC), including some cases in Europe and the United States.

    Transmission of filoviruses requires direct contact with bodily fluids from an infected person or contact with infected animals.  The mortality rate from filovirus infections are extremely high, and can sometimes be affected by the quality of supportive care available with a focus on early initiation of treatment.  Resolution of the disease largely depends on the patient's own immune system.  There is no approved treatment for Ebola or Marburg although research into both has accelerated since the onset of the 2014 outbreak and significant progress has been made in advanced clinical testing of immunotherapeutics for Zaire ebolavirus. There is an approved vaccine, requiring storage at less than -60°C for Ebola virus (Zaire ebolavirus), but no protection is yet available for Marburg virus (Marburg marburgvirus) or Sudan virus (Sudan ebolavirus).

    About John A. Burns School of Medicine, University of Hawai'i at Manoa

    The University of Hawai'i at Manoa is one of the most ethnically diverse institutions of higher education.  Hawai'i's cultural diversity and geographical setting affords the JABSOM a unique research environment to excel in health disparity research.  JABSOM faculty bring external funding of about $40 million annually into Hawai'i.

    About Hawaii Biotech, Inc.

    Hawaii Biotech (HBI) is a privately held biotechnology company focused on the development of prophylactic vaccines for established and emerging infectious diseases and anti-toxin drugs for biological threats.  HBI has developed proprietary expertise in the production of recombinant proteins that have application to the manufacture of safe and effective vaccines, diagnostic kits, and as research tools.  HBI completed successful first-in-human Phase 1 clinical studies with both West Nile virus and dengue vaccines in healthy human subjects.  HBI has developed a product pipeline of recombinant subunit vaccines, including vaccine candidates for West Nile virus, tick-borne flavivirus, malaria, Crimean-Congo hemorrhagic fever, and Ebola.  The company is also continuing the development of small molecule anti-toxin drugs for anthrax and botulism. HBI, founded in Hawaii in 1982, is headquartered in Honolulu.  For more information, please visit: www.hibiotech.com.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs targeting both filoviruses (such as Marburg and Ebola) and coronaviruses. The development of our vaccine programs incorporates the use of  our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA), and the Defense Threat Reduction Agency (DTRA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-publication-demonstrating-thermostabilization-of-filovirus-vaccine-antigens-301130824.html

    SOURCE Soligenix, Inc.

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  21. PRINCETON, N.J., Sept. 10, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, released the presentation for its Investor Webcast event today from 4:00 – 5:00 pm Eastern Time on the use of its thermostabilized glycoprotein vaccine platform for the development of a COVID-19 vaccine, called CiVax™.

    The development of CiVax™ is based on the thermostabilized glycoprotein vaccine platform which Soligenix has been developing in collaboration with the University of Hawaiʻi at Mānoa, focused on multivalent thermostabilized vaccines for filovirus infections such as Ebola.

    The…

    PRINCETON, N.J., Sept. 10, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, released the presentation for its Investor Webcast event today from 4:00 – 5:00 pm Eastern Time on the use of its thermostabilized glycoprotein vaccine platform for the development of a COVID-19 vaccine, called CiVax™.

    The development of CiVax™ is based on the thermostabilized glycoprotein vaccine platform which Soligenix has been developing in collaboration with the University of Hawaiʻi at Mānoa, focused on multivalent thermostabilized vaccines for filovirus infections such as Ebola.

    The vaccine platform includes three essential components:

    1)   one or more protein antigens, specifically a viral surface glycoprotein, which mediates entry and fusion of the virus with host cells and is manufactured with a proprietary insect cell expression system coupled with protein-specific affinity purification;

    2)   an adjuvant (CoVaccine HT™ - licensed from BTG Specialty Pharmaceuticals ("BTG"), a division of Boston Scientific Corporation) which has been shown to enhance both cell mediated and humoral immunity; and

    3)   a formulation which enables thermostabilization of the resulting mixture, avoiding the need for cold chain storage and shipping.

    The resulting vaccine is broadly applicable, including to individuals often excluded from common viral vector vaccine approaches such as children, the elderly and the immunocompromised. These same components can now be applied to a COVID-19 vaccine, using well-defined surface glycoprotein(s) from one or more coronaviruses.  The protection of elderly and immunocompromised populations are particularly important in the context of COVID-19.

    Data with a prototype vaccine has confirmed the potential to elicit both strong cell mediated immunity as well as a balanced humoral (antibody) responses. Very strong neutralizing antibody responses, similar to those found in convalescent plasma, have also been shown in mice. These results have been released in a pre-print article available here. More recent studies have demonstrated that when utilizing a more complete Spike protein antigen (as intended in the final CiVax™ formulation) strong antibody responses are evident as soon as 7 days after the first vaccination, with rapid boosting as soon as 7 days after the second vaccination. At the same time, antibody responses and cell mediated immune responses have both demonstrated the desired Th1 bias.

    Conference Call Thursday, September 10 at 4:00 PM Eastern Time

    The Company will share information on its thermostabilized glycoprotein vaccine platform for the development of a COVID-19 vaccine on Thursday, September 10, 2020 during a webcast event. A question and answer (Q&A) session with the featured experts and management will follow the presentations. If you would like to ask a question during the Q&A, please submit your request via email to  at least 15 minutes prior to the scheduled start of the call.

    Live Event: https://www.webcaster4.com/Webcast/Page/2498/37323

    U.S. toll free: 1-866-652-5200

    International:   1-412-317-6060

    Please request to be entered into the Soligenix call.

    An audio recording and transcript of the presentation will be archived for 30 days following the event.

    The Investor Event will include presentations from the following:

    Dr. Axel Lehrer, Associate Professor, Department. of Tropical Medicine, Medical Microbiology and Pharmacology, University of Hawaiʻi at Mānoa, John A. Burns School of Medicine

    Dr. Oreola Donini, Chief Scientific Officer of Soligenix

    Mr. Dan Ring, Vice President, Business Development of Soligenix

    Dr. Christopher J Schaber, President and Chief Executive Officer of Soligenix

    Featured Expert Biographical Background 

    Axel Lehrer, PhD

    Axel Lehrer, Dr. rer. nat., Associate Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaiʻi at Mānoa. Dr. Lehrer has been researching vaccines since 2002 in both commercial and academic settings. He has primarily worked on developing vaccines for filoviruses such as Ebola virus, but also contributed to the development of flavivirus vaccines (Zika virus, Tick-borne encephalitis (TBE) virus, West Nile virus and Dengue virus). His research mostly employs recombinant viral subunits expressed and purified from an insect cell expression system. Dr. Lehrer's is trained in biochemistry, molecular biology, virology, as well as immunology and his research has received funding from NIH and other federal sources.

    About CiVax™

    CiVax™ is the Company's heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2.  Under the Company's Public Health Solutions business segment, ongoing collaborations with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UHM have demonstrated the feasibility of developing heat stable subunit filovirus vaccines, including hemorrhagic disease caused by Zaire ebolavirus, Sudan ebolavirus as well as Marburg marburgvirus, with both monovalent and bivalent vaccine combinations.  Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit).  In March 2020, Soligenix and its collaborators expanded the technology platform to assess compatibility with vaccine candidates targeting SARS-CoV-2, the cause of COVID-19.

    The vaccine platform includes three essential components:

    1)   a protein antigen, specifically a viral surface glycoprotein, which mediates entry and fusion of the virus with host cells and is manufactured with a proprietary insect cell expression system coupled with protein-specific affinity purification;

    2)   an adjuvant which has been shown to enhance both cell mediated and humoral immunity; and

    3)   a formulation which enables thermostabilization of the resulting mixture, avoiding the need for cold chain storage and shipping.

    The resulting vaccine is broadly applicable, including to individuals often excluded from common viral vector vaccine approaches such as children, the elderly and the immunocompromised.  The protection of elderly and immunocompromised populations are particularly important in the context of COVID-19. The ability to provide a thermostabilized, single vial vaccine, is particularly important in the context of rapid and broad vaccine distribution.

    These same components are now being applied to coronavirus vaccine, using the well-defined surface glycoprotein, known as the Spike protein, as the antigen. Pre-clinical work in mice with a prototype vaccine recently have been made available, demonstrating the ability of the CoVaccine adjuvant in combination with a prototype antigen, to:

    • stimulate immunity within 14 days after the first vaccination;
    • induce a balanced immune response with a significant Th1 component, believed to be critical to inducing immunity without the risk of aggravating disease pathology;
    • induce a neutralizing antibody response; and
    • induce a cell mediated immune response.

    Recently, pre-clinical studies with a more complete Spike protein (as intended in the final formulation) have demonstrated all the same attributes, including a rapid onset of immunogenicity within 7 days of the first vaccination.

    About Coronavirus Infection

    Coronavirus infections can cause a wide spectrum of disease in humans, ranging from a common cold to a more severe respiratory infection, such as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), which have a case mortality rate of approximately 10% and 30%, respectively.  Similar to filoviruses, coronaviruses also are endemic in wildlife populations and can be transmitted to humans with close contact.  The COVID-19 outbreak, caused by SARS-CoV-2, is the most recent example of a suspected species crossover seen with this virus family.  Although the case fatality rate of COVID-19 is still under investigation, COVID-19 has been declared a global pandemic by the World Health Organization.  The global impact of this emerging infection demonstrates the urgent need for robust technology platforms to rapidly develop new vaccines for novel diseases.  The only FDA sanctioned treatments for COVID-19 are available under "Emergency Use Authorization."   There is currently no approved vaccine.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma; our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942), for the treatment of oral mucositis in head and neck cancer; and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate; SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease; and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

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    SOURCE Soligenix, Inc.

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  22. PRINCETON, N.J., Sept. 9, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation at the upcoming virtual investor conferences below.

    • Cantor Virtual Global Healthcare Conference on Tuesday, September 15 at 1:20 PM Eastern Time. To view the presentation live, please go to https://www.webcaster4.com/Webcast/Page/2495/37223. The presentation will be archived there for 90 days. For more information about the Cantor Virtual Global Healthcare Conference…

    PRINCETON, N.J., Sept. 9, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation at the upcoming virtual investor conferences below.

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs targeting both filoviruses (such as Marburg and Ebola) and coronaviruses. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA), and the Defense Threat Reduction Agency (DTRA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-invited-to-present-at-upcoming-virtual-investor-conferences-301126133.html

    SOURCE Soligenix, Inc.

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  23. PRINCETON, N.J., Sept. 3, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it will be hosting an Investor Webcast Event Thursday, September 10, 2020, from 4:00 – 5:00 pm Eastern Time on the use of its thermostabilized glycoprotein vaccine platform for the development of a COVID-19 vaccine, called CiVax™.

    Utilizing a novel adjuvant, CoVaccine HT™, the platform has yielded a prototype vaccine with strong induction of both cell mediated and neutralizing antibody immunity in preclinical studies. More recent work with recombinant, affinity-purified…

    PRINCETON, N.J., Sept. 3, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it will be hosting an Investor Webcast Event Thursday, September 10, 2020, from 4:00 – 5:00 pm Eastern Time on the use of its thermostabilized glycoprotein vaccine platform for the development of a COVID-19 vaccine, called CiVax™.

    Utilizing a novel adjuvant, CoVaccine HT™, the platform has yielded a prototype vaccine with strong induction of both cell mediated and neutralizing antibody immunity in preclinical studies. More recent work with recombinant, affinity-purified SARS-CoV-2 Spike protein antigens have demonstrated similarly compelling data as well as an ability to induce a strong antibody response within 7 days of the initial vaccine dose. Combined with the previously demonstrated ability of this platform to produce heat stable vaccines at temperatures exceeding 100 degrees fahrenheit (40 degrees Celsius), which can be shipped and stored at ambient temperatures, as well as the accepted safety of protein vaccines also in higher-risk populations, such as the young, elderly and immunocompromised, the CiVax™ program has the potential to yield an easily distributed and broadly applicable vaccine to address both the immediate emergency of the COVID-19 pandemic and any potential need for future seasonal vaccinations. Preliminary results with the prototype vaccine are available at the following link: https://www.biorxiv.org/content/10.1101/2020.07.24.220715v1.

    Conference Call Thursday, September 10 at 4:00 pm Eastern Time

    The Company will share information on its thermostabilized glycoprotein vaccine platform for the development of a COVID-19 vaccine on Thursday, September 10, 2020 during a webcast event. A question and answer (Q&A) session with the featured experts and management will follow the presentations. If you would like to ask a question during the Q&A, please submit your request via email to  at least 15 minutes prior to the scheduled start of the call. For a more detailed technical response, you are encouraged to e-mail questions no later than September 8, 2020.

    Live Event: https://www.webcaster4.com/Webcast/Page/2498/37323

    U.S. toll free:    1-866-652-5200

    International:    1-412-317-6060

    Please request to be entered into the Soligenix call.

    An audio recording and transcript of the presentation will be archived for 30 days following the event.

    The Investor Event will include presentations from the following:

    Dr. Axel Lehrer, Associate Professor, Dept. of Tropical Medicine, University of Hawaiʻi at Mānoa, School of Medicine

    Dr. Oreola Donini, Chief Scientific Officer of Soligenix

    Mr. Dan Ring, Vice President, Business Development of Soligenix

    Dr. Christopher J Schaber, President and Chief Executive Officer of Soligenix

    Featured Expert Biographical Background 

    Axel Lehrer, PhD

    Axel Lehrer, Dr. rer. nat., Associate Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa (UHM). Dr. Lehrer has been researching vaccines since 2002 in both commercial and academic settings. He has primarily worked on developing vaccines for filoviruses such as Ebola virus, but also contributed to the development of flavivirus vaccines (Zika virus, Tick-borne encephalitis (TBE) virus, West Nile virus and Dengue virus). His research mostly employs recombinant viral subunits expressed and purified from an insect cell expression system. Dr. Lehrer's is trained in biochemistry, molecular biology, virology, as well as immunology and his research has received funding from NIH and other federal sources.

    About CiVax™

    CiVax™ is the Company's heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2.  Under the Company's Public Health Solutions business segment, ongoing collaborations with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UHM have demonstrated the feasibility of developing heat stable subunit filovirus vaccines, including hemorrhagic disease caused by Zaire ebolavirus, Sudan ebolavirus as well as Marburg marburgvirus, with both monovalent and bivalent vaccine combinations.  Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit).  In March 2020, Soligenix and its collaborators expanded the technology platform to assess compatibility with vaccine candidates targeting SARS-CoV-2, the cause of COVID-19.

    The vaccine platform includes three essential components:

    1)   a protein antigen, specifically a viral surface glycoprotein, which mediates entry and fusion of the virus with host cells and is manufactured with a proprietary insect cell expression system coupled with protein-specific affinity purification;

    2)   an adjuvant which has been shown to enhance both cell mediated and humoral immunity; and

    3)   a formulation which enables thermostabilization of the resulting mixture, avoiding the need for cold chain storage and shipping.

    The resulting vaccine is broadly applicable, including to individuals often excluded from common viral vector vaccine approaches such as children, the elderly and the immunocompromised.  The protection of elderly and immunocompromised populations are particularly important in the context of COVID-19. The ability to provide a thermostabilized, single vial vaccine, is particularly important in the context of rapid and broad vaccine distribution.

    These same components are now being applied to coronavirus vaccine, using the well-defined surface glycoprotein, known as the Spike protein, as the antigen. Pre-clinical work in mice with a prototype vaccine recently have been made available, demonstrating the ability of the CoVaccine adjuvant in combination with a prototype antigen, to:

    • stimulate immunity within 14 days after the first vaccination;
    • induce a balanced Th1 response, believed to be critical to inducing immunity without aggravating disease pathology;
    • induce a neutralizing antibody response; and
    • induce a cell mediated immune response.

    About Coronavirus Infection

    Coronavirus infections can cause a wide spectrum of disease in humans, ranging from a common cold to a more severe respiratory infection, such as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), which have a case mortality rate of approximately 10% and 30%, respectively.  Similar to filoviruses, coronaviruses also are endemic in wildlife populations and can be transmitted to humans with close contact.  The COVID-19 outbreak, caused by SARS-CoV-2, is the most recent example of a suspected species crossover seen with this virus family.  With more than 25 million cases and over 800,000 fatalities, COVID-19 has been declared a global pandemic by the World Health Organization.  The global impact of this emerging infection demonstrates the urgent need for robust technology platforms to rapidly develop new vaccines for novel diseases.  The only FDA sanctioned treatments for COVID-19 are available under "Emergency Use Authorization".   There is currently no approved vaccine in the US or EU, even though there is an intense global effort under way to develop vaccines using a variety of platforms.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma; our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942), for the treatment of oral mucositis in head and neck cancer; and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate; SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease; and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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  24. PRINCETON, N.J., Aug. 14, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended June 30, 2020.

    Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We continue to execute on our strategy with a number of positive accomplishments. Our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial continues to demonstrate SGX301's potential to be an important new treatment for early-stage cutaneous T-cell lymphoma (CTCL).  In the double-blind…

    PRINCETON, N.J., Aug. 14, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended June 30, 2020.

    Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We continue to execute on our strategy with a number of positive accomplishments. Our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial continues to demonstrate SGX301's potential to be an important new treatment for early-stage cutaneous T-cell lymphoma (CTCL).  In the double-blind, placebo controlled Cycle 1 portion of the study, a statistically significant treatment response (p=0.04) was achieved in the primary endpoint after 6 weeks of therapy.  This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycle, referred to as Cycle 2, with an additional 6 weeks of therapy (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment).  The optional, compassionate-use, treatment cycle (Cycle 3) and the subsequent 6-month follow-up is expected in the fourth quarter of 2020, with the majority of patients enrolled having elected to continue with this optional cycle of the study – a clear indication of their satisfaction.  We also continue to advance our pivotal Phase 3 clinical trial of SGX942 (dusquetide), referred to as the DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) study, for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy.  Following the positive recommendation received from the independent Data Monitoring Committee (DMC) and after taking a conservative approach to assessing the potential impact of COVID-19 on the study, we have successfully enrolled 268 subjects.   With enrollment completed, top-line results continue to be expected in the fourth quarter 2020."

    Dr. Schaber continued, "Under our Public Health Solutions business segment, we continue to advance our work with the University of Hawaiʻi at Mānoa (UHM) and Hawaii Biotech Inc. on filovirus vaccines (protecting against viruses such as Ebola and Marburg) and the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19.  We recently announced publication of positive pre-clinical data from immunogenicity studies with CiVax™ (heat stable COVID-19 vaccine candidate), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the CoVaccine HT™ adjuvant.  Our heat stable ricin vaccine, RiVax®, continues to be supported with a National Institute of Allergy and Infectious Disease contract award of $21.2 million.  With over $11M in cash, not including our non-dilutive government funding, along with the at-the-market sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including final top-line results in our SGX942 Phase 3 clinical trial in oral mucositis."

    Soligenix Recent Accomplishments

    • On July 28, 2020, the Company announced publication of pre-clinical immunogenicity studies for its CiVax™ program (heat stable COVID-19 vaccine candidate), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the CoVaccine adjuvant. The article, authored by collaborators at the UHM, is titled, "CoVaccine HT™ adjuvant potentiates robust immune responses to recombinant SARS-CoV-2 spike-S1 immunization," and has been submitted for peer-review to the journal npj Vaccines. An accelerated preprint of the manuscript has been made available here. To view this press release, please click here.
    • On July 20, 2020, the Company announced that it had issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber, highlighting important catalysts for the second half of 2020. To view this press release and letter, please click here.
    • On June 24, 2020, the Company announced that it had completed patient enrollment in its Phase 3 DOM-INNATE study for SGX942 (dusquetide) in the treatment of oral mucositis in HNC patients. The study successfully enrolled 268 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study's primary efficacy endpoint by an independent DMC. To view this press release, please click here.
    • On June 22, 2020, the Company announced that it would join the Russell Microcap® Index at the conclusion of the 2020 Russell indexes annual reconstitution, effective after the US market opens on June 29th, according to a final list of additions posted June 15th. To view this press release, please click here.

    Financial Results – Quarter Ended June 30, 2020

    Soligenix's revenues for the quarter ended June 30, 2020 were $0.5 million as compared to $1.4 million for the quarter ended June 30, 2019.  Revenues included payments on a contract in support of RiVax®, our ricin toxin vaccine candidate, grants received to support the development of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases, ThermoVax®, our thermostabilization technology, and the assessment of SGX942 safety in juvenile animals.

    Soligenix's basic net loss was $2.8 million, or ($0.10) per share, for the quarter ended June 30, 2020, as compared to $2.1 million, or ($0.12) per share, for the quarter ended June 30, 2019.  This increase in net loss was primarily the result of increased research and development spending primarily attributable to higher clinical trial site and patient fees for the pivotal Phase 3 clinical trials of SGX301 and SGX942.

    Research and development expenses were $2.2 million as compared to $1.9 million for the quarters ended June 30, 2020 and 2019, respectively.  The increase in research and development spending for the quarter ended June 30, 2020 was primarily attributable to the site and patient fees for the pivotal Phase 3 clinical trials of SGX301 and SGX942, compared to the same period in 2019.

    General and administrative expenses were $0.8 million for both the three months ended June 30, 2020 and 2019.

    As of June 30, 2020, the Company's cash position was approximately $11.2 million.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs targeting both filoviruses (such as Marburg and Ebola) and coronaviruses. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA), and the Defense Threat Reduction Agency (DTRA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. The Company cannot offer assurance as to any result from the arbitration against, or that it will recover any damages from, Emergent BioSolutions, Inc., Emergent Product Development Gaithersburg, Inc. and Emergent Manufacturing Operations Baltimore LLC.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

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  25. PRINCETON, N.J., July 28, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of pre-clinical immunogenicity studies for its CiVax™ program (heat stable COVID-19 vaccine), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the CoVaccine HT™ (CoVaccine) adjuvant.  The article, authored by collaborators at the University of Hawaiʻi at Mānoa (UHM), is titled, "CoVaccine HT™ adjuvant potentiates robust immune responses to recombinant SARS-CoV-2 spike-S1 immunization," and has been submitted…

    PRINCETON, N.J., July 28, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of pre-clinical immunogenicity studies for its CiVax™ program (heat stable COVID-19 vaccine), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the CoVaccine HT™ (CoVaccine) adjuvant.  The article, authored by collaborators at the University of Hawaiʻi at Mānoa (UHM), is titled, "CoVaccine HT™ adjuvant potentiates robust immune responses to recombinant SARS-CoV-2 spike-S1 immunization," and has been submitted for peer-review to the journal npj Vaccines. An accelerated preprint of the manuscript has been made available here.

    CiVax™ is the Company's heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2.  Ongoing collaborations with Axel Lehrer, PhD, Assistant Professor in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UHM have demonstrated the feasibility of developing a broadly immunogenic vaccine for COVID-19.  With significant research dedicated worldwide to the generation of COVID-19 vaccines, it is noteworthy that the essential attributes of a vaccine successful in controlling the ongoing pandemic are believed to include the ability to rapidly stimulate a balanced antibody response, including an enhanced Th1 response, which includes raising significant virus neutralizing antibodies and potent cell-mediated immunity, demonstrated by T-cell activation.  Previous work with the CoVaccine adjuvant, which Soligenix licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation, has indicated that CoVaccine has these critical characteristics.  In these results, Lehrer and his colleagues now demonstrate these attributes of CoVaccine, specifically in the context of SARS-CoV-2.  Moreover, these results, using a prototype antigen, also demonstrate a rapid onset of immunity with antibody responses detected within 14 days after the first vaccination.

    Many programs have been initiated seeking a vaccine for COVID-19, but the novelty of the virus and previous challenges developing potent vaccines for the related SARS-CoV (Severe Acute Respiratory Syndrome Coronavirus) and MERS-CoV (Middle East Respiratory Syndrome Coronavirus), suggest that a timely solution requires parallel approaches.  The total number of vaccine doses required to control the ongoing pandemic also suggests that multiple vaccines, based on different manufacturing platforms, will be necessary to efficiently vaccinate the worldwide population. Subunit vaccines are considered the gold standard for vaccine safety, but are relatively under-represented in fast-tracked COVID-19 vaccine candidates to date.  Unlike virally vectored vaccines, there is no limit to the number of times the adjuvant and antigen can be used and the typical safety profile of a subunit vaccine results in a vaccine that is suitable for immune compromised or elderly populations as well. In contrast, while RNA and DNA vaccines are rapid to manufacture, there is a lack of regulatory precedent (no RNA or DNA vaccine has been approved to date).

    "Our work to date has demonstrated not only the feasibility of rapid and efficient manufacturing of the required vaccine antigens, but also the potential for a broadly applicable and easily distributed vaccine," stated Dr. Lehrer.  "We are delighted with our earlier successes on development of filovirus and flavivirus vaccines with this platform.  The results in our latest manuscript confirm that the advantages of our vaccine platform with the CoVaccine adjuvant can also be realized in the context of SARS-CoV-2, while we continue our work to rapidly advance development of a heat stable subunit COVID-19 vaccine in collaboration with Soligenix."

    "We believe that creating a vaccine with enhanced stability at elevated temperatures that can obviate the costs and logistical burdens associated with cold chain storage and distribution has the potential to provide a distinct advantage over other COVID-19 vaccines currently in development and simplifies worldwide distribution," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  "Our approach appears to be unique in its use of a well-established, well-understood, and safe, subunit platform coupled with a novel adjuvant and a thermostabilizing formulation.  We are very encouraged with the latest results and look forward to continuing to advance development of CiVax™."

    About Coronavirus Infection

    Coronavirus infections can cause a wide spectrum of disease in humans, ranging from a common cold to a more severe respiratory infection, such as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), which have a case mortality rate of approximately 10% and 30%, respectively.  Similar to filoviruses, coronaviruses also are endemic in wildlife populations and can be transmitted to humans with close contact.  The COVID-19 outbreak, caused by SARS-CoV-2, is the most recent example of a suspected species crossover seen with this virus family.  Although the case fatality rate of COVID-19 is still under investigation, COVID-19 has been declared a global pandemic by the World Health Organization.  The global impact of this emerging infection demonstrates the urgent need for robust technology platforms to rapidly develop new vaccines for novel diseases.  The only FDA sanctioned treatments for COVID-19 are available under "Emergency Use Authorization."   There is currently no approved vaccine.

    About John A. Burns School of Medicine, University of Hawai'i at Manoa

    The John A. Burns School of Medicine (JABSOM) at the UHM is one of the leading medical education institutions in the United States.  For the last three years, JABSOM has been a leader in National Institutes of Health research awards among community-based public medical schools (i.e., public medical schools without a university hospital).  JABSOM has also been a leader in the rate of MD graduates (who are also residency trained in state) retained as practitioners in-state.  In addition, Hawai'i's cultural diversity and geographical setting affords JABSOM a unique research environment to excel in health disparity research. JABSOM faculty bring external funding of about $40 million annually into the state.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs targeting both filoviruses (such as Marburg and Ebola) and coronaviruses. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA), and the Defense Threat Reduction Agency (DTRA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

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  26. PRINCETON, N.J., July 20, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber.  The content of this letter is provided below.

    Dear Friends and Shareholders,

    I hope this letter finds you and your families safe and healthy.  A great deal has changed in the World since my last update earlier this year.  We are now living through a pandemic that is testing all of us both personally and professionally.  Like many life science companies, we are confronted with the challenge…

    PRINCETON, N.J., July 20, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber.  The content of this letter is provided below.

    Dear Friends and Shareholders,

    I hope this letter finds you and your families safe and healthy.  A great deal has changed in the World since my last update earlier this year.  We are now living through a pandemic that is testing all of us both personally and professionally.  Like many life science companies, we are confronted with the challenge of trying to predict the impact COVID-19 may have on our operations and public guidance moving forward.  As many of you are aware, we had taken a conservative approach with our Phase 3 clinical programs in order to maintain their statistical integrity during these unprecedented times; however, I am pleased to report that the negative impact of the pandemic on our studies was much less significant than initially anticipated and all timelines remain on-track.  Nonetheless, we will continue to remain vigilant and will report any challenges caused by the COVID-19 pandemic that may have a potential impact on our current guidance.

    We continue to execute on our strategy with a number of positive accomplishments.  In March, we announced positive data in our pivotal Phase 3 FLASH ("Fluorescent Light Activated Synthetic Hypericin") study with SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL).  In the double-blind, placebo-controlled portion of the study (Cycle 1), a statistically significant treatment response (p=0.04) was achieved in the primary endpoint after 6 weeks of therapy (press release available here).  This positive treatment response continued to dramatically improve with extended SGX301 treatment in the open-label treatment cycle, referred to as Cycle 2, with an additional 6 weeks of therapy (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment; press release available here).  Next up will be the extended safety results from the optional, compassionate-use, treatment cycle (Cycle 3) and the subsequent 6-month follow-up expected in the fourth quarter of 2020.  In Cycle 3, subjects that completed Cycles 1 and 2 had the option of continuing SGX301 treatment of up to all of their lesions for another 6 weeks.  I am happy to report that the majority of patients enrolled have elected to continue with this optional cycle of the study – a clear indication of their satisfaction.  This clinical trial success was a tremendous accomplishment for the company, and we are eagerly anticipating other important milestones during the remainder of 2020. 

    Our other pivotal Phase 3 clinical trial with SGX942 (dusquetide), referred to as the DOM-INNATE ("Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity") study, treating oral mucositis in patients with head and neck cancer, completed patient enrollment in June (press release available here).  The study successfully enrolled 268 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study's primary efficacy endpoint by an independent Data Monitoring Committee (DMC). As you may recall, the study enrollment was temporarily extended as we assessed the potential impact of COVID-19 on the study (e.g., patient treatment compliance and completion of necessary assessments).  With extra efforts by participating patients, physicians and clinical staff, we successfully reported that the negative impact of the pandemic on the overall study was much less than initially anticipated. With enrollment now completed, top-line results are expected in the fourth quarter of 2020.

    Under our Public Health Solutions business segment, we continue to advance our work with the University of Hawaiʻi at Mānoa (UH Mānoa) and Hawaii Biotech Inc. (HBI) on filovirus vaccines (protecting against viruses such as Ebola and Marburg).  We also extended this program to the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19 (recent conference presentation available here).  We continue to support our FDA Fast Tracked (press release available here) heat stable ricin vaccine, RiVax®, with a National Institute of Allergy and Infectious Disease contract award of $21.2 million

    With approximately $9 million in cash, not including our non-dilutive government funding, along with the at-the-market (ATM) sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including top-line results in our SGX942 Phase 3 clinical trial in oral mucositis.

    Corporate Highlights

    Since our last update in January, we have continued to focus on the quality execution of our multiple development programs in our rare disease pipeline, where we currently anticipate achieving multiple important milestones in the second half of 2020

    Specialized Biotherapeutics Business Segment

    We continue to advance our two pivotal Phase 3 clinical programs.

    1. On March 19, 2020, we announced positive preliminary top-line results for our pivotal Phase 3 FLASH trial evaluating SGX301 in the treatment of Stages IA, IB and IIA CTCL.  The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating a statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. 

    As Ellen Kim, MD, Director of the Dermatology Clinic, Perelman Center for Advanced Medicine and Lead Investigator of the FLASH study stated in the announcement, "This is an important outcome for patients suffering from CTCL.  SGX301 has successfully demonstrated efficacy in this challenging chronic cancer, with no safety concerns, making it a potentially preferred first-line option for the treatment of early stage CTCL, which is the large majority of patients suffering from this disease.  This successfully proves that the drug has biologic activity in combating this disease in a relatively short time window, with preliminary data suggesting that the improvement continues to increase with extended treatment.  In addition to the efficacy demonstrated, SGX301 was well-tolerated and its mechanism of action is not associated with DNA damage like other currently available therapies."

    On April 30, 2020, we announced that continued treatment with SGX301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40% (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment) in the open-label treatment cycle (referred to as Cycle 2) of the pivotal Phase 3 study for the treatment of early-stage CTCL.  These highly statistically significant results confirm the benefit of continued SGX301 treatment in CTCL patients. 

    As Ms. Susan Thornton, Chief Executive Officer of the Cutaneous Lymphoma Foundation, the largest patient advocacy organization for CTCL, noted in the announcement, "The availability of a safe, rapid-acting, treatment for CTCL is extremely important to patients.  From the patient perspective, you want a treatment that is safe and effective with the least amount of side effects.  Many of the therapies available today either don't work for all patients, don't work for long-periods of time, can't be used by some because of their concerning side effects, or are used off-label creating access issues.  As the leader of the patient organization and a patient myself, I know first-hand the importance of developing more therapies and options to support people living with this rare cancer."

    We are now awaiting the safety data from the optional (compassionate use) treatment cycle (Cycle 3) of the trial, in which patients could receive SGX301 treatment of up to all their lesions, as well as the 6-month safety follow-up once all treatment has ended.  Of note is that not only have the majority of patients enrolled elected to continue with this optional cycle of the study, but in an analysis of a subset of patients in Cycle 3, it was demonstrated that SGX301 is not systemically available, consistent with the general safety observed with this topical product to date.  Results from Cycle 3 and the subsequent 6-month follow-up are expected in the fourth quarter of 2020. 

    SGX301 has received Orphan Drug designation as well as Fast Track designation from the United States (US) Food and Drug Administration (FDA).  Additionally, SGX301 was granted Orphan Drug designation from the European Medicines Agency (EMA) and Promising Innovative Medicine (PIM) designation from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK).

    2. On June 24, 2020, we announced that we completed full enrollment of 268 patients randomized into the pivotal Phase 3 multinational, double-blind, placebo-controlled clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy (CRT).  With the positive interim analysis previously reported (press release available here), we look forward to final top-line results for the DOM-INNATE study in the fourth quarter of 2020.

    Dusquetide is a new chemical entity with a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response.  It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.  The Phase 2 data demonstrated a significant reduction in the duration of oral mucositis, as well as reduced infection rates, as published in 2016 in the Journal of Biotechnology (available here).  Long-term follow-up data from the Phase 2 trial, published in 2017 in Biotechnology Reports (available here), further indicated the safety and tolerability of SGX942 treatment, with a sustained trend towards reduced mortality and increased tumor resolution compared to placebo.  SGX942 has received Fast Track designation from the FDA for the treatment of oral mucositis as a result of CRT in HNC patients as well as PIM designation from the MHRA in the UK.

    Public Health Solutions Business Segment 

    We most recently announced exciting developments in the area of emerging infectious diseases.  In collaboration with UH Mānoa and HBI, we continue to advance development of filovirus vaccines (protecting against viruses such as Ebola and Marburg).  Working with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UH Mānoa, we have demonstrated the feasibility of developing heat stable subunit filovirus vaccines, including Ebola virus disease as well as Marburg virus disease, with both monovalent and bivalent vaccine combinations.  Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit).

    Formulation development work with the UH Mānoa on a trivalent thermostabilized Ebola vaccine is currently supported by a $700,000 sub-award over five years from NIAID.  The subunit vaccine offers broader coverage for differing filoviruses, including Ebola, Marburg and Sudan, and offers the potential for a simpler supply chain with no refrigerated conditions required.  Previous work demonstrating thermostabilization of the univalent vaccine has been recently published in the European Journal of Pharmaceutics and Biopharmaceutics (available here).  

    Expanding on our glycoprotein vaccine platform with UH Mānoa, we have also recently announced efforts to develop a safe, broadly applicable, subunit vaccine for treatment of COVID-19. Our COVID-19 vaccine candidate, CiVax™, utilizes a novel adjuvant, CoVaccine HT™, which we have exclusively licensed from BTG Specialty Pharmaceuticals ("BTG"), a division of Boston Scientific Corporation (NYSE:BSX), in the fields of coronavirus and pandemic flu (press release available here). Proof of concept studies in mice with the platform have already demonstrated strong potential COVID-19 immunogenicity. There are two components to the immune response – the antibody response and the cell-mediated response (involving T-cells); both of which can be activated by vaccines. Typically, vaccines are characterized by their ability to generate antibodies and particularly neutralizing antibodies (that is, antibodies that can prevent virus binding and entry, as well as marking the virus for destruction). Prototype studies with the CoVaccine adjuvant with a SARS-CoV-2 antigen has indicated that both types of immunity can be significantly enhanced.  Some of these results are available in a recent conference presentation (available here).  We will look to disclose more data as it becomes available.

    We continue to progress our heat stable ricin vaccine, RiVax®, with the support of up to $21.2 million over six years awarded by NIAID, where we have successfully identified biomarkers for RiVax® testing, as published in the journal Vaccine in 2018 (available here and more recently here), facilitating potential approval under the FDA Animal Rule.  The FDA Animal Rule is applied to products where testing in human clinical trials would be unethical, and, in the case of ricin toxin, fatal.  The Animal Rule combines safety studies in humans and efficacy testing in animals to facilitate approval.  Key to the application of the Animal Rule is the requirement to establish a correlation between the immune response observed in clinical trials in healthy volunteers with the immune response demonstrated in animal efficacy studies. 

    RiVax® has received Orphan Drug designation as well as Fast Track designation from the FDA, and, as a new chemical entity, upon approval in the US, has the potential to qualify for a biodefense Priority Review Voucher (PRV).  PRVs are transferable and can be sold, with sales in recent years of approximately $100 million.  Additionally, RiVax® was granted Orphan Drug designation from the EMA.  Recent events, including the news of an envelope addressed to President Trump that was thought to contain this potent and potentially lethal toxin, as well as a foiled bioattack with ricin in Germany, suggest that the RiVax® vaccine may be of increasing interest to multiple countries.

    Additional funding for dusquetide (active ingredient in SGX942) has also been obtained through a Defense Threat Reduction Agency (DTRA) subaward of approximately $600,000 over 3 years (access press release here).  These studies will further elucidate the therapeutic anti-infective action of dusquetide in animal models of biodefense-related infectious agents.

    Non-Dilutive Funding

    As noted above, we aggressively pursue non-dilutive funding sources to support our rare disease pipeline.  We have received two NIH SBIR grant awards totaling approximately $3 million for two of our biotherapeutics development programs.  We are also operating under government grant and contract awards of up to $22.5 million in our Public Health Solutions business segment to support RiVax® development, our collaboration with the UH Mānoa and HBI for the development of a trivalent thermostabilized Ebola vaccine, and the evaluation of dusquetide as a broad spectrum therapeutic for the treatment of bacterial infectious disease.  This non-dilutive funding to date has provided a meaningful offset to our development expenses while better positioning us to effectively manage our overall cash burn. 

    Balance Sheet and Capital

    As of June, we had approximately $9 million in cash.  In addition to the non-dilutive funding received to date, we also have an ATM instrument in place with B. Riley FBR, Inc. to judiciously supplement cash if/when the need arises and stock volume and price permit, such as to support the execution of certain CTCL pre-commercialization activities to potentially support a new drug application filing with the FDA.  With a solid balance sheet and the available resources, we currently do not contemplate a larger capital raise until after final top-line oral mucositis results are disclosed.  We also continue to have ongoing confidential business development discussions, which may lead to more favorable capital inflows, including the potential to receive additional non-dilutive funding.  Overall, we are mindful of dilution and will look at all future capital inflow initiatives in the most efficient and shareholder friendly manner as possible.

    One last note is our recent membership into the Russell Microcap® Index, which remains in place for one year and means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.  Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's US indexes.  For more information on the Russell Microcap® Index, go to the "Russell Reconstitution" section on the FTSE Russell website here.

    In closing, thank you for your interest and your ongoing support of Soligenix.  It continues to be a very exciting time in our life cycle and late stage pipeline.  We look forward to the second half of 2020 being as productive as the first half, with the potential for multiple near-term catalysts on the horizon as we further advance our development programs towards commercialization.  Best wishes!

    Dr. Christopher J. Schaber

    President and Chief Executive Officer

    Soligenix, Inc.

    July 20, 2020

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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    SOURCE Soligenix, Inc.

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  27. PRINCETON, N.J., June 24, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today it has completed patient enrollment in its Phase 3 DOM-INNATE ("Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity") study for SGX942 (dusquetide) in the treatment of oral mucositis (OM) in head and neck cancer (HNC) patients.  The study successfully enrolled 268 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study's primary efficacy endpoint by an independent Data Monitoring Committee (DMC…

    PRINCETON, N.J., June 24, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today it has completed patient enrollment in its Phase 3 DOM-INNATE ("Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity") study for SGX942 (dusquetide) in the treatment of oral mucositis (OM) in head and neck cancer (HNC) patients.  The study successfully enrolled 268 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study's primary efficacy endpoint by an independent Data Monitoring Committee (DMC).  With enrollment completed, top-line results are expected in the fourth quarter of 2020.

    SGX942 is a novel, first-in-class, Innate Defense Regulator (IDR) which both modulates inflammation and enhances anti-infective and tissue-healing pathways of the innate immune system.  Study enrollment was temporarily extended as Soligenix assessed the potential impact of COVID-19 on the study (e.g., patient treatment compliance and completion of necessary assessments).  With extra efforts by participating patients, physicians and clinical staff, the Company can now successfully report that the negative impact of the pandemic on the overall study was much less than initially anticipated.  The study remains on-track to provide top-line results before the end of 2020.   

    "We are pleased to have completed enrollment and look forward to the top-line results in the fourth quarter, particularly in light of the DMC recommendation at the interim analysis which observed a beneficial drug effect," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  "We continue to positively position this fast-tracked program for approval.  With approximately $8 million in cash as of the end of the first quarter, not including our non-dilutive government funding, along with the at-the-market sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including top-line results in the DOM-INNATE study.  As there is no FDA approved drug for the treatment of oral mucositis in head and neck cancer or other solid tumor settings, we believe SGX942 has the potential to be the first approved therapy to address this unmet medical need and dramatically improve the lives of patients undergoing chemoradiation therapy (CRT)."

    "SGX942 has the potential to have a significant impact on the lives of patients undergoing CRT for squamous cell carcinoma of the oral cavity and oropharynx," stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix.  "We would like to thank the DMC members, our esteemed medical advisory board and our dedicated clinical investigators for their efforts in the design and conduct of this important clinical trial, as well as all the subjects that are participating in the trial.  Our focus now is to complete the treatments for all subjects in both the US and Europe and to lock the study database, facilitating top-line results in the fourth quarter of 2020." 

    Based on the positive results demonstrated in the Phase 2 study of SGX942, the Phase 3 trial is a highly powered, double-blind, randomized, placebo-controlled, multicenter and multinational trial.  The primary endpoint for the study is the median duration of severe oral mucositis, assessed by oral examination at each treatment visit and then through six weeks following completion of CRT.  Oral mucositis is evaluated using the WHO (World Health Organization) Grading system.  Other secondary measures, including incidence of severe oral mucositis, incidence and duration of ulcerative oral mucositis, and incidence of infection will also be assessed at topline or during the 12-month follow-up. 

    A prospectively defined interim analysis was conducted in August 2019 by an independent DMC and was used to verify the underlying assumptions defining the required sample size of the study to maintain its rigorous 90% statistical power.  The DMC identified a beneficial SGX942 effect and accordingly adjusted the study sample size to approximately 260.  The DMC did not identify any safety concerns.  The interim recommendation is described in the August 2019 press release here.

    About Oral Mucositis

    Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

    The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

    It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in HNC is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe. Oral mucositis almost always occurs in patients with HNC treated with CRT and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

    In the pediatric population, head and neck cancer is a rarer occurrence and is caused by different underlying pathologies. The major types of HNC in children are lymphoma, sarcomas (including rhabdomyosarcomas), and neuroblastoma rather than squamous cell carcinoma, the major type of adult HNC cancers. Hematopoietic stem cell transplantation (HSCT), especially allogeneic transplantation with higher risk of oral mucositis, is more frequently used in the pediatric population than in adults when treating a number of primary tumor types, as seen in leukemia and lymphoma.  Both treatment of HNC and HSCT are associated with high risk of oral mucositis in the pediatric population.

    Oral mucositis remains an area of unmet medical need where there are currently no approved drug therapies in the context of any solid tissue tumors.

    About the Phase 3 DOM-INNATE Study

    This multinational, placebo-controlled, randomized study is targeted to enroll approximately 260 subjects with squamous cell carcinoma of the oral cavity and oropharynx, scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects are randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of CRT. The primary endpoint for the study is the median duration of severe oral mucositis, assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis is evaluated using the WHO (World Health Organization) Grading system. Severe oral mucositis is defined as a WHO Grade of ≥3. Subjects are to be followed for an additional 12 months after the completion of treatment. Soligenix has been working with leading oncology centers internationally, a number of which participated in the Phase 2 study.

    About Dusquetide

    Dusquetide (the active ingredient in SGX942) is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory, anti-infective and tissue healing response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, including melioidosis. 

    SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to CRT for HNC. Soligenix is working with leading oncology centers in the US and Europe to advance SGX942 in oral mucositis with the conduct of a pivotal Phase 3 clinical trial referred to as the "DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity).

    SGX942 has received Fast Track Designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, as well as Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of severe oral mucositis in HNC patients receiving CRT. In addition, products containing the same active ingredient, dusquetide, have been granted Fast Track Designation as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis and Orphan Drug Designations in the treatment of MAS and the treatment of acute radiation syndrome. 

    Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has received partial funding from NIH for its oral mucositis clinical studies. The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study being supported by a Phase II SBIR grant (#R44DE024032) award.

    In addition, a high level review of the IDR technology platform is available here.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy (including the outcome of the interim analysis) or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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    SOURCE Soligenix, Inc.

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  28. PRINCETON, N.J., June 22, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Company is set to join the Russell Microcap® Index at the conclusion of the 2020 Russell indexes annual reconstitution, effective after the US market opens on June 29th, according to a final list of additions posted June 15th.

    Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization…

    PRINCETON, N.J., June 22, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Company is set to join the Russell Microcap® Index at the conclusion of the 2020 Russell indexes annual reconstitution, effective after the US market opens on June 29th, according to a final list of additions posted June 15th.

    Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

    "We are pleased to be included in the Russell Microcap® Index," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We anticipate that our addition to the index will increase our visibility to the investment community as we continue to move forward with our programs. After observing a statistically significant treatment response in the double-blind, placebo controlled Cycle 1 portion of our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin), the trial continues to demonstrate highly statistically significant results and confirm SGX301's potential to be an important new treatment for early-stage cutaneous T-cell lymphoma. We also continue to advance our pivotal Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, where we anticipate top-line results in the fourth quarter of 2020."

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

    For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website here.

    About FTSE Russell

    FTSE Russell is a leading global index provider creating and managing a wide range of indexes, data and analytic solutions to meet client needs across asset classes, style and strategies.  Covering 98% of the investable market, FTSE Russell indexes offer a true picture of global markets, combined with the specialist knowledge gained from developing local benchmarks around the world.

    FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $16 trillion is currently benchmarked to FTSE Russell indexes.  For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives. FTSE Russell indexes also provide clients with tools for asset allocation, investment strategy analysis and risk management.

    A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on index innovation and customer partnership applying the highest industry standards and embracing the IOSCO Principles. FTSE Russell is wholly owned by London Stock Exchange Group.

    For more information, visit http://www.ftserussell.com.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

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  29. PRINCETON, N.J., June 9, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its Senior Vice President and Chief Scientific Officer, Oreola Donini, PhD, will deliver a presentation discussing Soligenix's vaccine efforts, including a COVID-19 vaccine development program, at the MedInvest Infectious Disease and Immunology Investor Conference, held virtually on June 15 and 16, 2020.

    Oral Presentation:

    Thermostabilized Protein Vaccines with Applications in Ricin Toxin, Filoviruses and Coronaviruses presented by Oreola Donini, PhD, Chief Scientific…

    PRINCETON, N.J., June 9, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its Senior Vice President and Chief Scientific Officer, Oreola Donini, PhD, will deliver a presentation discussing Soligenix's vaccine efforts, including a COVID-19 vaccine development program, at the MedInvest Infectious Disease and Immunology Investor Conference, held virtually on June 15 and 16, 2020.

    Oral Presentation:

    Thermostabilized Protein Vaccines with Applications in Ricin Toxin, Filoviruses and Coronaviruses presented by Oreola Donini, PhD, Chief Scientific Officer, Soligenix on June 16 at 2:30 PM EDT. A question and answer period will follow the presentation.

    A recording of the presentation will be available on the Soligenix website after June 16.

    For more information about the MedInvest Infectious Disease and Immunology Investor Conference, please refer to the conference website at https://www.medinvestconferences.com.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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  30. PRINCETON, N.J., May 15, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended March 31, 2020.

    Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "This has been a very rewarding year for us thus far. Our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial continues to demonstrate SGX301's potential to be an important new treatment for early-stage cutaneous T-cell lymphoma (CTCL).  In the double-blind, placebo controlled Cycle…

    PRINCETON, N.J., May 15, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended March 31, 2020.

    Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "This has been a very rewarding year for us thus far. Our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial continues to demonstrate SGX301's potential to be an important new treatment for early-stage cutaneous T-cell lymphoma (CTCL).  In the double-blind, placebo controlled Cycle 1 portion of the study, a statistically significant treatment response (p=0.04) was achieved in the primary endpoint after 6 weeks of therapy.  This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycle, referred to as Cycle 2, with an additional 6 weeks of therapy (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment).  We also continue to advance our pivotal Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy.  Following the positive recommendation received from the independent Data Monitoring Committee, we have successfully achieved our target of 260 patients randomized into the study; however, due to the uncertainty surrounding the coronavirus pandemic, we decided to enroll up to 25 additional patients into the study.  We are taking this cautious approach in order to maintain the statistical integrity of the trial, by accounting for patients that may potentially drop out of the study before completing their protocol required study treatment and evaluations.  Therefore, the study target to complete enrollment and provide top-line results has been revised to the fourth quarter 2020; however, this will continue to remain dependent on the medical and logistical challenges caused by the coronavirus showing a reasonable level of improvement in the relative near-term."

    Dr. Schaber continued, "Under our Public Health Solutions business segment, we continue to advance our work with University of Hawaiʻi at Mānoa (UH Mānoa) on filovirus vaccines (protecting against viruses such as Ebola and Marburg) and the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19.  We continue to support our heat stable ricin vaccine, RiVax®, with a National Institute of Allergy and Infectious Disease contract award of $21.2 million.  With over $8M in cash, not including our non-dilutive government funding, along with the at-the-market sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including top-line results in our SGX942 Phase 3 clinical trial in oral mucositis."

    Soligenix Recent Accomplishments

    • On May 11, 2020, the Company announced publication of immunogenicity studies for RiVax® identifying novel correlates of immune protection to facilitate potential approval under the United States Food and Drug Administration (FDA) "Animal Rule." The article, titled "A Multivariate Model Combining Endpoint and Epitope-specific Antibody Responses as a Correlate of Protection to Ricin Toxin," has been submitted to the peer-reviewed medical journal Vaccine and a preprint is available here. To view this press release, please click here.
    • On May 7, 2020, the Company announced that it had received approximately $840,000, net of transaction costs, in non-dilutive financing via the State of New Jersey's Technology Business Tax Certificate Transfer Program. To view this press release, please click here.
    • On April 30, 2020, the Company announced that continued treatment with SGX301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40% (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment) in Cycle 2 of its pivotal Phase 3 FLASH study for the treatment of early-stage CTCL. These highly statistically significant results confirm the benefit of continued SGX301 treatment in CTCL patients. To view this press release, please click here.
    • On April 16, 2020, the Company announced it had executed an agreement for the exclusive worldwide license of CoVaccine HT™, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation (NYSE:BSX), for the fields of pandemic flu and coronaviruses, including SARS-CoV-2, the cause of COVID-19. To view this press release, please click here. This collaboration further builds on the recently announced collaboration between the UH Mānoa and Soligenix to develop a SARS-CoV-2 vaccine (available here).
    • On April 6, 2020, the Company announced that the European patent office has granted the divisional patent application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 2932973). The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of CTCL. To view this press release, please click here.

    Financial Results – Quarter Ended March 31, 2020

    Soligenix's revenues for the quarter ended March 31, 2020 were $0.9 million as compared to $1.1 million for the quarter ended March 31, 2019.  Revenues included payments on a contract in support of RiVax®, our ricin toxin vaccine candidate, grants received to support the development of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases, ThermoVax®, our thermostabilization technology, and the assessment of SGX942 safety in juvenile animals.

    Soligenix's basic net loss was $7.6 million, or ($0.32) per share, for the quarter ended March 31, 2020, as compared to $1.6 million, or ($0.09) per share, for the quarter ended March 31, 2019.  This increase in net loss was primarily the result of the issuance of $5 million of common stock as a milestone payment triggered by the successful Phase 3 clinical trial of SGX301 for the treatment of CTCL and increased research and development spending. The number of shares of common stock issued as a milestone payment was calculated using an effective price of $2.56 per share, based upon a formula set forth in the applicable agreement.

    Research and development expenses were $2.7 million as compared to $1.6 million for the quarters ended March 31, 2020 and 2019, respectively.  The increase in research and development spending for the quarter ended March 31, 2020 was primarily attributable to the site and patient fees for the pivotal Phase 3 clinical trials of SGX301 and SGX942, compared to the same period in 2019.

    General and administrative expenses were $0.9 million for both the three months ended March 31, 2020 and 2019.

    As of March 31, 2020, the Company's cash position was approximately $7.2 million, not including the approximate $840,000 recently received from the State of New Jersey's Technology Business Tax Certificate Transfer Program.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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  31. PRINCETON, N.J., May 11, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of immunogenicity studies for RiVax® (heat stable ricin toxin vaccine) identifying novel correlates of immune protection to facilitate potential approval under the United States Food and Drug Administration (FDA) "Animal Rule."  The article, titled "A Multivariate Model Combining Endpoint and Epitope-specific Antibody Responses as a Correlate of Protection to Ricin Toxin," has been submitted to the peer-reviewed medical journal Vaccine and a preprint is available…

    PRINCETON, N.J., May 11, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of immunogenicity studies for RiVax® (heat stable ricin toxin vaccine) identifying novel correlates of immune protection to facilitate potential approval under the United States Food and Drug Administration (FDA) "Animal Rule."  The article, titled "A Multivariate Model Combining Endpoint and Epitope-specific Antibody Responses as a Correlate of Protection to Ricin Toxin," has been submitted to the peer-reviewed medical journal Vaccine and a preprint is available here.

    RiVax® is the Company's vaccine candidate for the prevention of death following exposure to a lethal dose of ricin toxin using a unique antigen that is completely devoid of the toxic activity of ricin.  Further formulated by Soligenix to have enhanced thermostability, RiVax® has demonstrated up to 100% protection in mice and non-human primates (NHPs) subsequently exposed to lethal doses of ricin toxin either systemically or by aerosol.  In studies conducted in collaboration with the laboratory of Dr. Nicholas Mantis, Research Scientist, Division of Infectious Diseases, Wadsworth Center, New York State Department of Health, species independent tests to evaluate the protective immunogenicity of the vaccine were developed.  These tests will facilitate potential approval of RiVax® under the FDA Animal Rule which requires the evaluation of efficacy in animals (RiVax® has demonstrated up to 100% protection in NHPs exposed to lethal aerosolized ricin), safety in humans (the RiVax® antigen has been demonstrated to be well-tolerated in human Phase 1 clinical studies) and immunogenicity correlated between animal models and humans.

    "These results continue to reinforce the link between the antibody response to the vaccination and the potency of the RiVax® vaccine," stated Dr. Oreola Donini, Chief Scientific Officer of Soligenix.  "This, and other ongoing work in our collaboration with Dr. Mantis and his team, has continued to corroborate the efficacy of RiVax® and will facilitate its potential approval."

    Approval for RiVax® will be pursued under the FDA "Animal Rule," which is applied to products where testing in clinical efficacy trials would be unethical.  In the case of a ricin toxin vaccine, clinical efficacy testing of the vaccine is unethical since it would require intentionally exposing humans to ricin toxin.  The Animal Rule is generally associated with the approval of medical countermeasures for biodefense purposes. 

    In addition to being protective and thermostable, RiVax® has demonstrated that a reduced number of vaccinations may establish protection, potentially utilizing only two doses instead of three. 

    RiVax® studies are supported by a contract (# HHSN272201400039C) award of up to $21.2 million from the National Institute of Allergy and Infectious Diseases (NIAID).  Non-dilutive funding for the development of RiVax® has exceeded $40 million to date.

    RiVax® has received Orphan Drug designations from both the FDA and European Medicines Agency (EMA) and, upon approval, has the potential to qualify for a biodefense Priority Review Voucher (PRV).

    About Ricin Toxin

    Ricin toxin is a lethal plant-derived toxin and potential biological weapon because of its stability and high potency, and the fact that it is readily extracted from by-products of castor oil production.  Ricin comes in many forms including powder, mist or pellet.  Ricin can also be dissolved in water and other liquids.  The US Centers for Disease Control and Prevention estimates that the lethal dose in humans is about the size of a grain of salt.  Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure.  Ricin is especially toxic when inhaled.  Ricin works by entering cells of the body and preventing the cells from making the proteins they need.  Without the proteins, cells die, which is eventually harmful to the entire body.

    There are currently no effective treatments for ricin poisoning.  The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used to vaccinate military personnel and civilian emergency responders at high risk of potential exposure in the event of a biological attack.

    About RiVax®

    RiVax® is Soligenix's proprietary heat stable recombinant subunit vaccine developed to protect against exposure to ricin toxin, the threat of which has been highlighted in the news with an envelope addressed to President Trump that was thought to contain this potent and potentially lethal toxin.  With RiVax®, Soligenix is a world leader in the area of ricin toxin vaccine research.

    RiVax® contains a genetically altered version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule which was originally invented at the University of Texas Southwestern.  Phase 1 clinical studies to date have demonstrated the safety of the antigen and adjuvant, as well as the generation of ricin neutralizing antibodies which are increased in the presence of the alum adjuvant.  In animal studies, the alum formulation of RiVax® also induced higher titers and longer-lasting antibodies than the adjuvant-free vaccine.  Vaccination with the thermostabilized alum-adjuvanted RiVax® formulation in a large animal model provided 100% protection (p<0.0001) against acute exposure to aerosolized ricin, the most lethal route of exposure for ricin.  The protected animals also had no signs of gross lung damage, a serious and enduring ramification with long-term consequences for survivors of ricin exposure.  These results are described in a publication available here.

    Heat stabilization of RiVax® is achieved with the Company's proprietary ThermoVax® technology, designed to eliminate the cold-chain production, distribution and storage logistics required for most vaccines.  The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations.  By employing ThermoVax® during the final formulation of RiVax®, the vaccine has demonstrated enhanced stability and the ability to withstand temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year. These results are described in a publication available here.

    The development of RiVax® has been funded through a series of grants from both the NIAID and the FDA and ongoing development is sponsored by NIAID contract #HHSN272201400039C. Non-dilutive funding for the development of RiVax® has exceeded $40 million to date.  RiVax® is being developed under the FDA "Animal Rule" and potentially would be added to the Strategic National Stockpile and dispensed in the event of a terrorist threat.  RiVax® has received orphan drug designation in the US and in Europe.

    As a new chemical entity, an FDA approved RiVax® vaccine has the potential to qualify for a biodefense PRV, which allows the holder accelerated review of a drug application.  Approved under the 21st Century Health Cures Act in late 2016, the biodefense PRV is awarded upon approval as a medical countermeasure when the active ingredient(s) have not been otherwise approved for use in any context.  PRVs are transferable and can be sold, with sales in recent years in excess of $100 million.  When redeemed, PRVs entitle the user to an accelerated review period of six months, saving a median of seven months' review time as calculated in 2009.  However, the FDA must be advised 90 days in advance of the use of the PRV and the use of a PRV is associated with an additional user fee ($2.1 million in 2020).

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-publication-of-correlates-of-immune-protection-for-the-rivax-ricin-toxin-vaccine-301056114.html

    SOURCE Soligenix, Inc.

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  32. PRINCETON, N.J., May 7, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received approximately $840,000, net of transaction costs, in non-dilutive financing via the state of New Jersey's Technology Business Tax Certificate Transfer Program. 

    This competitive program enables approved technology and biotechnology businesses to sell their unused Net Operating Loss (NOL) Carryovers and unused Research and Development (R&D) Tax Credits to unaffiliated, profitable corporate taxpayers in the state of New Jersey. This allows businesses with NOLs…

    PRINCETON, N.J., May 7, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received approximately $840,000, net of transaction costs, in non-dilutive financing via the state of New Jersey's Technology Business Tax Certificate Transfer Program. 

    This competitive program enables approved technology and biotechnology businesses to sell their unused Net Operating Loss (NOL) Carryovers and unused Research and Development (R&D) Tax Credits to unaffiliated, profitable corporate taxpayers in the state of New Jersey. This allows businesses with NOLs to turn their tax losses and credits into cash proceeds to fund additional R&D, purchase equipment and/or facilities, or cover other allowable expenditures. The New Jersey Economic Development Authority's (NJEDA) determines eligibility for the program, the New Jersey Division of Taxation determines the value of the available tax benefits (NOLs and R&D Tax Credits), and the New Jersey Commission on Science and Technology evaluates the technology and its viability. The state of New Jersey was the originator of this Program and the first state to implement and fund it. 

    "Receipt of this non-dilutive funding is a welcomed addition to our non-dilutive government grant and contract funding," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "This is our ninth year receiving NOL funding, which now totals approximately $5.6 million. We are, again, very thankful for NJEDA's continued support of its biotechnology industry."

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-receives-840-000-in-non-dilutive-funding-through-new-jersey-technology-business-tax-certificate-transfer-program-301054609.html

    SOURCE Soligenix, Inc.

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  33. PRINCETON, N.J., April 30, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that continued treatment with SGX301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40% (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment) in the open-label treatment cycle (referred to as Cycle 2) of its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early-stage cutaneous T-cell lymphoma (CTCL).  These highly statistically significant results confirm the benefit of continued SGX301 treatment in CTCL patients. 

    Soligenix previously announced positive top-line results when the study achieved statistical significance (p=0.04) in its primary endpoint over the first 6 week double-blind treatment cycle (referred to as Cycle 1) (available here).  The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo in Cycle 1.  After the subsequent additional 6-week treatment in the open-label Cycle 2, the response rate in patients receiving a total of 12 weeks treatment increased two and a half-fold.  Treatment responses for each cycle were assessed at Week 8 (after 6 weeks of treatment) and at Week 16 (after 12 weeks of treatment).  A positive response was defined as an improvement of at least 50% in the Composite Assessment of Index Lesion Score (CAILS) for three index lesions evaluated in both Cycles 1 and 2. The data continues to indicate that SGX301 is safe and well tolerated. 

    "As anticipated, the data continues to become more compelling with extended SGX301 treatment," stated Ellen Kim, MD, Director of the Dermatology Clinic, Perelman Center for Advanced Medicine and Lead Investigator of the FLASH study.  "This treatment response is comparable to other, less safe, treatment alternatives, showing a statistically significant response at just 6 weeks, which continues to significantly increase with more treatment.  The response rate at 12 weeks is similar to other therapies, some of which patients must take for more than a year.  In addition to the efficacy demonstrated, SGX301 remains well tolerated with a unique mechanism of action that is not associated with DNA damage like other currently available therapies.  I look forward to working with Soligenix to move this important new therapy forward with US Food and Drug Administration (FDA) so that patients may access it as soon as possible."

    "The availability of a safe, rapid-acting, treatment for CTCL is extremely important to patients," stated Ms. Susan Thornton, Chief Executive Officer of the Cutaneous Lymphoma Foundation, the largest patient advocacy organization for CTCL.  "From the patient perspective, you want a treatment that is safe and effective with the least amount of side effects.  Many of the therapies available today either don't work for all patients, don't work for long-periods of time, can't be used by some because of their concerning side effects, or are used off-label creating access issues.  As the leader of the patient organization and a patient myself, I know first-hand the importance of developing more therapies and options to support people living with this rare cancer."

    "On behalf of everyone at Soligenix, I would like to again extend my sincere appreciation to the patients, families, investigators, and advisors involved in the pivotal Phase 3 FLASH study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We are extremely pleased with the study results, which demonstrate successful continued treatment with SGX301 and reinforces its potential to be a valuable and life-changing new therapy for patients suffering from early-stage CTCL, which is an orphan disease and area of unmet medical need."

    About Cutaneous T-Cell Lymphoma (CTCL)

    CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.  Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin.  These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors.  Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.  Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

    CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually.

    About SGX301

    SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation.  The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later.  This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure.  Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients.  In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective.   SGX301 has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

    The Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consists of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 subjects received SGX301 treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving SGX301 achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). SGX301 treatment in the first cycle was safe and well tolerated.

    In the second open-label treatment cycle (Cycle 2), all patients received SGX301 treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of SGX301 treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of SGX301 treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes.  SGX301 continued to be safe and well tolerated.

    In the third (optional) treatment cycle (Cycle 3), all subjects could receive SGX301 treatment of all their lesions. Of note, the majority of patients enrolled have elected to continue with this optional cycle of the study. Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that SGX301 is not systemically available, consistent with the general safety of this topical product observed to date. Other secondary measures assessed are treatment response (including duration), degree of improvement, and time to relapse and safety. Results from Cycle 3 and the subsequent 6-month follow-up after completion of treatment will be further announced as the final patients continue to complete their designated visits. 

    Overall safety of SGX301 is a critical attribute of this treatment and will continue to be monitored throughout the additional treatment cycles and the 6-month follow-up period.  SGX301's mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects.  Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging.  Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available.  Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product.  SGX301 potentially represents the safest available efficacious treatment for CTCL.  With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues. 

    The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc. 

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

     

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    SOURCE Soligenix, Inc.

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  34. PRINCETON, N.J., April 16, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) ("Soligenix"), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has executed an agreement for the exclusive worldwide license of CoVaccine HT™, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals ("BTG"), a division of Boston Scientific Corporation (NYSE: BSX), for the fields of SARS-CoV-2, the cause of COVID-19 and pandemic flu. 

    CoVaccine HT is a novel adjuvant, which has been shown to enhance both cell-mediated and antibody-mediated immunity. Soligenix and its collaborators, including the University of Hawaiʻi at Mānoa and Dr…

    PRINCETON, N.J., April 16, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) ("Soligenix"), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has executed an agreement for the exclusive worldwide license of CoVaccine HT™, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals ("BTG"), a division of Boston Scientific Corporation (NYSE: BSX), for the fields of SARS-CoV-2, the cause of COVID-19 and pandemic flu. 

    CoVaccine HT is a novel adjuvant, which has been shown to enhance both cell-mediated and antibody-mediated immunity. Soligenix and its collaborators, including the University of Hawaiʻi at Mānoa and Dr. Axel Lehrer, have successfully demonstrated the utility of CoVaccine HT in the development of its heat stable filovirus vaccine program, with vaccine candidates against Ebola and Marburg virus disease. Given this previous success, CoVaccine HT will potentially be an important component of Soligenix's vaccine technology platform currently being assessed for use against coronaviruses including SARS-CoV-2, the cause of COVID-19.

    "BTG has a long track record of technological innovation in the production of antibodies for rescue medicines. We're pleased that, in the hands of Soligenix, CoVaccine HT could potentially play a role in helping to address the current pandemic," said Anthony Higham, President of BTG. 

    "We are very excited to include CoVaccine HT into our heat stable vaccine platform technology. It has the potential to provide a distinct advantage over other vaccines currently in development," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the rapid advancement of the vaccine platform, we feel the program is optimally poised to look at other viruses, including coronaviruses."

    The agreement was executed between Soligenix and Protherics Medicines Development, one of the companies that make up the BTG Specialty Pharmaceutical business, which owns the CoVaccine HT intellectual property. Terms of the deal are not being disclosed.

    About CoVaccine HT™ Adjuvant

    An adjuvant is a substance which enhances the immune response and so helps maximize the production of antibodies. The CoVaccine HT adjuvant is a sucrose fatty acid sulphate ester that increases both humoral and cell-mediated immune responses to experimental vaccines following intramuscular administration.

    About Coronavirus Infection

    Coronavirus infections can cause a wide spectrum of disease in humans, ranging from a common cold to a more severe respiratory infection such as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), which have a case mortality rate of approximately 10% and 30%, respectively. Similar to filoviruses, coronaviruses are also endemic in wildlife populations and can be transmitted to humans with close contact. The COVID-19 outbreak, caused by SARS-CoV-2, is the most recent example of species crossover seen with this virus family. Although the case fatality rate of COVID-19 is still under investigation, the global impact of this emerging infection demonstrates the need for a robust technology platform to rapidly develop new vaccines for novel diseases. There is currently no approved treatment for any coronavirus infection, nor any approved vaccine.

    About BTG Specialty Pharmaceuticals

    BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation, provides rescue medicines typically used in emergency rooms and intensive care units to treat patients for whom there are limited treatment options. BTG is dedicated to the development, manufacture, and commercialization of quality medicines that make a real difference to patients and their families. BTG's current portfolio of antidotes counteracts certain snake venoms and the toxicity associated with some heart and cancer medications. To learn more, please visit: btgsp.com. 

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials.  Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-exclusive-licensing-agreement-for-novel-vaccine-adjuvant-from-btg-specialty-pharmaceuticals-301041324.html

    SOURCE Soligenix, Inc.

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  35. PRINCETON, N.J., March 30, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the year ended December 31, 2019.

    Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We are extremely pleased to have achieved positive top-line results in our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial that demonstrates SGX301's potential to be an important new treatment for early stage cutaneous T-cell Lymphoma (CTCL).  Having demonstrated statistical…

    PRINCETON, N.J., March 30, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the year ended December 31, 2019.

    Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We are extremely pleased to have achieved positive top-line results in our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial that demonstrates SGX301's potential to be an important new treatment for early stage cutaneous T-cell Lymphoma (CTCL).  Having demonstrated statistical significance in the study's primary endpoint, we will now look to report results from the extended treatment portion of the trial, which we anticipate announcing in June 2020.  Following the positive recommendation received from the independent Data Monitoring Committee, we have successfully achieved our target of 260 patients randomized into the pivotal Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy; however, due to the uncertainty surrounding the coronavirus pandemic, we have decided to enroll approximately 25 additional patients into the study.  We are taking this cautious approach in order to maintain the statistical integrity of the trial, by accounting for patients that may potentially drop out of the study before completing their protocol required study treatment and evaluation.  Therefore, the study target to complete enrollment and provide top-line results is being revised from the second quarter of 2020 to the fourth quarter 2020; however, this will remain dependent on the medical and logistical challenges caused by the coronavirus showing a reasonable level of improvement in the relative near-term."

    Dr. Schaber continued, "Under our Public Health Solutions business segment, we continue to progress our heat stable ricin vaccine, RiVax®, with the support of a National Institute of Allergy and Infectious Disease contract award of up to $24.7 million.  We are also excited to advance our work with University of Hawaiʻi at Mānoa (UH Mānoa) beyond filovirus vaccines (protecting against viruses such as Ebola and Marburg) to the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19.  With over $7.5M in cash, not including our State and Federal funding, we anticipate having the cash resources sufficient to achieve multiple inflection points across our rare disease pipeline, including top-line results in our SGX942 Phase 3 clinical trial in oral mucositis."

    Soligenix Recent Accomplishments

    • On March 23, 2020, the Company announced that it expanded its research collaboration with UH Mānoa to investigate potential coronavirus vaccines. The Company and UH Mānoa are expanding the technology platform, developed as part of their filovirus program, to assess compatibility with coronaviruses including SARS-CoV-2, the cause of COVID-19. The resulting vaccines have the potential to be broadly applicable, including to individuals often excluded from common viral vector vaccine approaches such as children, the elderly and the immunocompromised. To view this press release, please click here.

    • On March 19, 2020, the Company announced positive preliminary top-line results for its pivotal Phase 3 FLASH trial evaluating SGX301 (synthetic hypericin) in the treatment of CTCL. The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. To view this press release, please click here.

    • On February 13, 2020, the Company announced that its RiVax® (heat stable ricin toxin vaccine) development program for prevention of ricin intoxication had received "Fast Track" designation from the FDA. To view this press release, please click here.

    • On February 3, 2020, the Company announced that its ongoing collaboration with the UH Mānoa and Hawaii Biotech Inc. had resulted in what the Company believes is a significant milestone in the development of heat stable filovirus vaccines, in which the platform has demonstrated feasible thermostable formulations and protection in non-human primate models with both monovalent and bivalent vaccine candidates in the three most deadly human pathogenic filoviruses (Ebola virus, Sudan virus and Marburg virus). To view this press release, please click here.

    • On February 3, 2020, the Company announced that the Japanese Patent Office had granted the patent titled "Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis." This allowance builds on similar intellectual property in the US, New Zealand, Australia and Singapore and patent applications pending in other jurisdictions worldwide. The new claims cover therapeutic use of dusquetide (active ingredient in SGX942) and related innate defense regulator (IDR) analogs, and add to composition of matter claims for dusquetide and related analogs that have been granted in the US and worldwide. To view this press release, please click here.

    • On January 14, 2020, the Company issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. To view this press release, please click here.

    • On December 18, 2019, the Company announced that it had received preliminary approval for a tax credit from the New Jersey Economic Development Authority's (NJEDA) New Jersey Technology Business Tax Certificate Transfer program. As a result, the Company anticipates being able to transfer this credit and receive approximately $850,000 in net proceeds. To view this press release, please click here.

    • On December 3, 2019, the Company announced it had completed patient enrollment in its Phase 3 FLASH study for SGX301 in the treatment of CTCL. The study successfully enrolled 169 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study's primary efficacy endpoint by an independent Data Monitoring Committee. To view this press release, please click here.

    Financial Results – Year Ended December 31, 2019

    Soligenix's revenues for the year ended December 31, 2019 were $4.6 million as compared to $5.2 million for the year ended December 31, 2018. Revenues included payments on a contract in support of RiVax®, in addition to the grants received to support the development of SGX301 for the treatment of CTCL and SGX942 for the treatment of oral mucositis in HNC.

    Soligenix's basic net loss was $9.4 million, or ($0.48) per share, for the year ended December 31, 2019, as compared to $8.9 million, or ($0.68) per share, for the year ended December 31, 2018.

    Research and development expenses were $8.1 million as compared to $6.8 million for the years ended December 31, 2019 and 2018, respectively. The increase in research and development spending for the year ended December 31, 2019 was primarily attributable to the expansion of the Phase 3 clinical trial of SGX942 as well as the ongoing Phase 3 clinical trial of SGX301, compared to the same period in 2018.

    General and administrative expenses were $3.4 million as compared to $3.0 million for the years ended December 31, 2019 and 2018, respectively.

    As of December 31, 2019, the Company's cash position was approximately $5.4 million.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials. Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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    SOURCE Soligenix, Inc.

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  36. PRINCETON, N.J., March 23, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its ongoing collaboration with the University of Hawaiʻi at Mānoa (UH Mānoa) is being expanded to assess potential coronavirus vaccines (including COVID-19).

    Under the Company's Public Health Solutions business segment, ongoing collaborations with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UH Mānoa have demonstrated the feasibility of developing heat stable subunit filovirus…

    PRINCETON, N.J., March 23, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its ongoing collaboration with the University of Hawaiʻi at Mānoa (UH Mānoa) is being expanded to assess potential coronavirus vaccines (including COVID-19).

    Under the Company's Public Health Solutions business segment, ongoing collaborations with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UH Mānoa have demonstrated the feasibility of developing heat stable subunit filovirus vaccines, including Ebola virus disease caused by either Zaire or Sudan ebolavirus variants, as well as Marburg virus disease, with both monovalent and bivalent vaccine combinations. Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit). Soligenix and its collaborators are expanding the technology platform to assess compatibility with coronaviruses including SARS-CoV-2, the cause of COVID-19.

    The vaccine platform includes three essential components:

    1)   a protein antigen, specifically a viral surface glycoprotein, which mediates entry and fusion of the virus with host cells and is manufactured with a proprietary insect cell expression system coupled with protein-specific affinity purification;
    2)   an adjuvant which has been shown to enhance both cell mediated and humoral immunity; and
    3)   a formulation which enables thermostabilization of the resulting mixture, avoiding the need for cold chain storage and shipping.

    The resulting vaccine is broadly applicable, including to individuals often excluded from common viral vector vaccine approaches such as children, the elderly and the immunocompromised. These same components can now be applied to coronavirus vaccine, using well-defined surface glycoprotein(s) from one or more coronaviruses, which will include key antigens expected to be protective for COVID-19.  The protection of elderly and immunocompromised populations are particularly important in the context of COVID-19.

    "Our work to date has demonstrated not only the feasibility of rapid and efficient manufacturing, but also the potential for a broadly applicable and easily distributed vaccine. We are delighted with our successes on development of filovirus and flavivirus vaccines using our platform and look forward to accelerated studies with the coronaviruses," stated Dr. Lehrer, Assistant Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology at the JABSOM. 

    "It is rewarding to see ongoing work by JABSOM investigators and collaborators expanding on successful research on filovirus vaccines (protecting against viruses such as Ebola and Marburg virus) that may help us make unique life-saving contributions during this difficult time in healthcare. The prospect of a science lab in Hawaiʻi helping develop a vaccine amid the COVID-19 pandemic is a testament to the importance of local research in Hawaiʻi," stated JABSOM Dean Jerris R. Hedges, MD, MS, MMM.

    "We believe that creating a vaccine with enhanced stability at elevated temperatures that can obviate the costs and logistical burdens associated with cold chain storage and distribution, has the potential to provide a distinct advantage over other vaccines currently in development and simplifies worldwide distribution," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the rapid advancement of the filovirus vaccine platform, we feel the program is optimally poised to look at other viruses and infections, including COVID-19."

    About Coronavirus Infection

    Coronavirus infections can cause a wide spectrum of disease in humans, ranging from a common cold to a more severe respiratory infection, such as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), which have a case mortality rate of approximately 10% and 30%, respectively.  Similar to filoviruses, coronaviruses also are endemic in wildlife populations and can be transmitted to humans with close contact. The COVID-19 outbreak, caused by SARS-COV-2, is the most recent example of species crossover seen with this virus family.  Although the case fatality rate of COVID-19 is still under investigation, COVID-19 has been declared a global pandemic by the World Health Organization.  The global impact of this emerging infection demonstrates the need for robust technology platforms to rapidly develop new vaccines for novel diseases. There is currently no approved treatment for any coronavirus infection, nor any approved vaccine.

    About John A. Burns School of Medicine, University of Hawai'i at Manoa

    The John A. Burns School of Medicine (JABSOM) at the University of Hawai'i at Mānoa is one of the leading medical education institutions in the United States.  For the last three years, JABSOM has been a leader in National Institutes of Health research awards among community-based public medical schools (i.e., public medical schools without a university hospital). JABSOM has also been a leader in the rate of MD graduates (who are also residency trained in state) retained as practitioners in-state. In addition, Hawai'i's cultural diversity and geographical setting affords JABSOM a unique research environment to excel in health disparity research. JABSOM faculty bring external funding of about $40 million annually into the state.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trial.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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    SOURCE Soligenix, Inc.

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  37. New York, New York--(Newsfile Corp. - March 20, 2020) - Soligenix, on Thursday, announced positive topline data for its lead CTCL drug candidate, SGX301. The published data demonstrated statistically significant efficacy results in treating this challenging and often debilitating chronic cancer. Additionally, this potentially transformative milestone for Soligenix (NASDAQ:SNGX) positions the company to explore strategic partnership and commercialization opportunities to take advantage of what is an expected $250 million drug market opportunity.

    The positive preliminary topline results in the pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial are the result of treating a study enrollment of 169 patients in a randomized…

    New York, New York--(Newsfile Corp. - March 20, 2020) - Soligenix, on Thursday, announced positive topline data for its lead CTCL drug candidate, SGX301. The published data demonstrated statistically significant efficacy results in treating this challenging and often debilitating chronic cancer. Additionally, this potentially transformative milestone for Soligenix (NASDAQ:SNGX) positions the company to explore strategic partnership and commercialization opportunities to take advantage of what is an expected $250 million drug market opportunity.

    The positive preliminary topline results in the pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial are the result of treating a study enrollment of 169 patients in a randomized 2:1 design to receive either SGX301 or a placebo. Of the 166 evaluable patients treated, a statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) met the primary endpoint assessment at 8 weeks for Cycle 1. Notably, the company announced that the preliminary evaluation of the open-label Cycle 2 results from the study suggests a significantly more robust response rate after 12 weeks of SGX301 treatment. Data from the 12-week cycle is expected to get released during June of 2020.

    Importantly, the SGX301 data demonstrate the drug's potential to fill an unmet medical need, qualify for priority review, and position Soligenix to leverage the drug's unique ability to serve as a preferred first-line option for the treatment of early-stage CTCL. Additionally, the drug was shown to be safe, well-tolerated, and its mechanism of action is not associated with DNA damage, a critical distinction from other currently available therapies.

    SGX301 Shows Statistical Significance in Treating CTCL

    A key takeaway from the topline data is that SGX301 showed a statistically significant improvement after just 6 weeks of treatment. Specifically, the data demonstrate that the drug has biologic activity in combating CTCL in a relatively short time window. Moreover, preliminary data from cycle 2 suggest that the drug's value extends during longer periods of treatment, with patients reportedly responding favorably in 35% after the 12-week cycle, compared to 16% in cycle 1.

    The Phase 3 FLASH trial enrolled 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL, and is designed to evaluate three treatment cycles, each of 8 weeks duration. Specifically, treatments were administered twice weekly for the first 6 weeks, and treatment response was determined at the end of the 8th week of each cycle.

    Data from the first double-blind treatment cycle included results from 116 subjects that received SGX301 treatment (0.25% synthetic hypericin), and from 50 patients that were provided placebo treatment of their index lesions. Of that group, a total of 16% of the patients receiving SGX301 achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04). Importantly, SGX301 treatment in the first cycle was safe and well-tolerated.

    Data from Cycle 2 is also impressive. During the open-label Cycle 2 treatment cycle, all patients received SGX301 treatment. Data from this cohort indicated preliminary results (from blinded data) that suggest more than a 35% response rate (inclusive of patients receiving both 12 weeks and 6 weeks of therapy), indicating the response increases with continued treatment. Results from Cycle 2 are expected to be announced in June 2020.

    The trial is further designed with a third (optional) treatment cycle (Cycle 3). In that group, all subjects could receive SGX301 treatment of all their lesions. A definite clue as to the performance of the drug is that the majority of patients enrolled have elected to continue with this optional cycle of the study. Again, extending the treatment beyond 8 weeks has demonstrated no safety concerns from continued use. The company is expected to release the results from Cycle 3 and the subsequent 6-month follow-up after completion of treatment and designated follow-up evaluations.

    SGX301 Can Fill A Substantial Unmet Medical Need

    CTCL has been particularly difficult to challenge, but the optimistic tone from several of the trial investigators during the topline data release conference call is extremely encouraging toward the drug building a path toward FDA approval.

    The disease itself is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Different than most NHLs, however, which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes normally programmed to migrate to the skin. The result of these cancerous cells migrating to the skin induces the formation of various lesions, often beginning as a rash and eventually progressing to raised plaques and tumors as the disease progresses. The visual effects are only one debilitating effect of the disease. The mortality rate from CTCL is more disturbing, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. For Soligenix, the opportunity to address this market can be substantial, as there is no cure for CTCL available to patients. In most cases, the current standard of care provides only temporary relief from CTCL lesions, with most lesions usually returning either in the same part of the body or in new areas.

    The CTCL treatment market can be a lucrative opportunity for Soligenix. Although CTCL constitutes a rare group of NHLs, occurring in roughly 4% of the approximate 700,000 individuals living with the disease, published studies and reports indicate that CTCL currently affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually. An NDA filing could come as early as the end of 2020 for this novel drug.

    It's The Differentiation That Makes SGX301 Unique

    Protection from the competition is another strength of the SGX301 platform. The differentiation that most separates SGX301 from current, mostly symptom-relieving treatments is its expected effectiveness and its route of administration. Dr. Richard Straube, Soligenix CMO, characterized SGX301 as a topically applied ointment which is activated by visible (not UV) light. Using non-UV light to activate the drug results in the release of superoxide that works in a non-mutative method of action to destroy lesion cells while preserving the surrounding healthy cells. Moreover, the fluorescent light source is entirely non-carcinogenic.

    The early topline success of the trial can be further attributed to an advantage of how SGX301 is administered to the patient. After all, of the 169 initially enrolled, to date, the majority have completed through to the optional Cycle 3. The relatively simple process begins when the patient first applies the proprietary ointment to the CTCL-caused lesions, usually at home the night before visiting their physician. The 18-24-hour lapse allows the lotion to be absorbed by the unwanted cancer cells before visiting the physician, who then exposes the lesions to a precisely controlled dose of safe fluorescent light for roughly five to seven minutes. This combination of ointment application and light exposure constitutes a single treatment.

    Beyond safe, however, SGX301 as a combination product with the fluorescent light has the potential to be a cost-effective treatment that demonstrates the ability to release free radicals, which induce apoptosis (programmed cell death) of the lesions. Importantly, and also a critical distinction from other treatments, is that the SGX301 data is showing that cancer cell death is NOT caused by DNA mutation. That distinction is essential in emphasizing that the hypericin is not a mutagenic agent. Moreover, the light source associated with the treatment is not carcinogenic. Additionally, collateral damage to healthy tissue is minimized by applying ointment only on the cancerous lesions themselves and encourages selective uptake of the drug preferentially by malignant T-cells.

    The much-anticipated topline data release did not disappoint on any level. Beyond the statistical significance in patient response compared to the placebo control, the longer-term benefits of treatment show even more therapeutic strength in treating the disease.

    And, equally important when it comes to getting drugs to market, Soligenix noted during the SGX301 conference call that they are positioned financially to see both the SGX301 trial and the SGX942 trial conclude later this year without the need to access the markets for additional funding.

    Money In The Bank Is Unique To Small-Cap Biotechs, SNGX Has it

    According to Dr. Chris Schaber, Soligenix CEO, the company holds approximately $7.6M in cash, not including the anticipated sale of its New Jersey net operating loss carryovers and United Kingdom tax incentive receivable of roughly $1 million. The company also has access to its non-dilutive government funding, which stands at approximately $25 million.

    The cash runway allows Soligenix the time to evaluate the potential need for a capital raise only after topline results from its Phase 3 study in oral mucositis is completed. Also, by not being forced early, or at all, to the capital markets to complete the trials, Soligenix is afforded the opportunity to more thoroughly assess commercialization and/or partnership of SGX301 in tandem with preparing for the New Drug Application submission to FDA.

    Undoubtedly, the topline data release from the SGX301 FLASH trial can be the first transformative moment for Soligenix. Combing compelling data that is supported by a capital position that allows the company to bargain from a place of strength regarding potential partnerships and commercialization deals, Soligenix is well-positioned to create substantial increases to shareholder value.

    Most certainly, the results released on Thursday support the company's long-standing belief that SGX301 has the potential to be a valuable therapy in the treatment of early-stage CTCL, which is an orphan disease and area of unmet medical need.

    And, as investors digest the compelling update from the SGX301 program, eyes, and attentions are also focused on the near-term data release for its oral mucositis treatment, SGX942, as well as from the opportunities presented from its Bio-defense programs. Data from each can contribute toward significant growth in the coming months, making Soligenix a multiple shots-on-goal investment opportunity.

    Based on the SGX301 news on Thursday, great things may be happening at Soligenix.

    Media Contact
    Ken Ellis

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  38. PRINCETON, N.J., March 19, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive preliminary top-line results for its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial evaluating SGX301 (Synthetic Hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1…

    PRINCETON, N.J., March 19, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive preliminary top-line results for its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial evaluating SGX301 (Synthetic Hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. In addition, preliminary assessment of the open-label Cycle 2 results suggest a significantly more robust response rate after 12 weeks of SGX301 treatment. These data are expected to be announced in June 2020.   

    "This is an important outcome for patients suffering from CTCL. SGX301 has successfully demonstrated efficacy in this challenging chronic cancer, with no safety concerns, making it a potentially preferred first-line option for the treatment of early stage CTCL, which is the large majority of patients suffering from this disease," stated Ellen Kim, MD, Director of the Dermatology Clinic, Perelman Center for Advanced Medicine and Lead Investigator of the FLASH study. "The treatment showed a statistically significant improvement after just 6 weeks of treatment. This successfully proves that the drug has biologic activity in combating this disease in a relatively short time window, with preliminary data suggesting that the improvement continues to increase with extended treatment. In addition to the efficacy demonstrated, SGX301 was well-tolerated and its mechanism of action is not associated with DNA damage like other currently available therapies."

    "On behalf of everyone at Soligenix, I would like to extend my sincere appreciation to the patients, families, investigators, and advisors involved in the pivotal Phase 3 FLASH study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We are extremely pleased with the results, which demonstrate successful treatment with SGX301 and reinforces its potential to be an important new treatment for early stage CTCL. We will now look to move as quickly as possible to complete a full analysis of the data for publication, as well as begin preparations for a robust discussion with the FDA regarding this important dataset."

    Dr. Schaber continued, "With approximately $7.6M in cash, not including the anticipated sale of our New Jersey net operating loss carryovers and United Kingdom tax incentive receivable of approximately $1.0M or our non-dilutive government funding, we will evaluate the potential need for a larger capital raise only after top-line results from our Phase 3 study in oral mucositis. This will afford us the opportunity to more thoroughly assess commercialization and/or partnership of SGX301 in tandem with preparing for the New Drug Application submission to FDA. These results support our long-standing belief that SGX301 has the potential to be a valuable therapy in the treatment of early stage CTCL, which is an orphan disease and area of unmet medical need."

    Conference Call Thursday, March 19 at 8:30 AM Eastern Time

    The Company will share trial results on Thursday, March 19, 2020 during an investor conference call. Investors may submit questions electronically at: at least 15 minutes prior to the scheduled start of the call.

    U.S. toll free:    1-866-652-5200
    International:    1-412-317-6060
    Please request to be entered into the Soligenix call.

    A transcript of the conference call will be archived for 30 days following the event.

    The Phase 3 FLASH trial enrolled 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consists of three treatment cycles, each of 8 weeks duration. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 subjects received SGX301 treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving SGX301 achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04). SGX301 treatment in the first cycle was safe and well tolerated. In the second open-label treatment cycle (Cycle 2), all patients received SGX301 treatment. Of note, preliminary results from blinded data to date suggest more than a 35% response rate (inclusive of patients receiving both 12 weeks and 6 weeks of therapy), indicating the response increases with continued treatment. Further independent review of lesion photographs may be conducted to provide for a more uniform confirmation of response. Results from Cycle 2 are expected to be announced in June 2020.

    In the third (optional) treatment cycle (Cycle 3), all subjects could receive SGX301 treatment of all their lesions. Of note, the majority of patients enrolled have elected to continue with this optional cycle of the study. Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that SGX301 is not systemically available, consistent with the general safety of this topical product observed to date. Results from Cycle 3 and the subsequent 6-month follow-up after completion of treatment will be further announced as the final patients continue to complete their designated visits.

    About Cutaneous T-Cell Lymphoma (CTCL)

    CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as a rash and eventually forming raised plaques and tumors as the disease progresses. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

    CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually. 

    About SGX301

    SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

    Based on the positive results demonstrated in the Phase 2 study of SGX301, the Phase 3 protocol is a highly powered, double-blind, randomized, placebo-controlled, multicenter trial targeted to enroll 160 evaluable subjects. The trial consists of three treatment cycles, each of 8 weeks duration. Treatments are administered twice weekly for the first 6 weeks and treatment response will be determined at the end of Week 8. In the first treatment cycle, 116 subjects received SGX301 and 50 subjects received placebo treatment of their index lesions. In the second cycle, all subjects received SGX301 treatment of their index lesions and in the third cycle all subjects could receive SGX301 treatment of all their lesions. Subjects are followed for an additional 6 months after the completion of treatment. The primary efficacy endpoint was assessed on the percent of patients in each of the two treatment groups (i.e., SGX301 and placebo) achieving a Partial or Complete Response (yes/no) of the treated lesions defined as a ≥ 50% reduction in the total Composite Assessment of Index Lesion Disease Severity (CAILS) score for three index lesions at the Cycle 1 evaluation visit (Week 8) compared to the total CAILS score at baseline. Assessment of the primary endpoint revealed that 16% patients receiving SGX301 responded (i.e., had ≥ 50% reduction in index lesion size) while only 4% receiving placebo responded (p=0.04). Preliminary results from blinded data to date suggest more than a 35% response rate (inclusive of patients receiving both 12 weeks and 6 weeks of therapy), indicating the response increases with continued treatment.

    Other secondary measures assessed are treatment response (including duration), degree of improvement, time to relapse and safety, and will be available as the subsequent cycles and follow-up visits are completed for all subjects.    

    Overall safety of SGX301 is a critical attribute of this treatment and will continue to be monitored throughout the additional treatment cycles and the 6-month follow-up period. SGX301's mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. SGX301 potentially represents the safest available efficacious treatment for CTCL. With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues. 

    The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc. 

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-positive-top-line-results-for-its-pivotal-phase-3-flash-trial-evaluating-sgx301-in-treatment-of-cutaneous-t-cell-lymphoma-301026468.html

    SOURCE Soligenix, Inc.

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  39. Soligenix, on Thursday February 27th, gave the market some more good news. This time the company highlighted data from its ongoing collaboration with the University of Hawai’i at Manoa (UHM) and Hawaii Biotech Inc. (HBI) that has resulted in what the Company believes is a significant milestone in the development of heat stable filovirus vaccines. According to the update, the platform has demonstrated feasible thermostable formulations and protection in non-human primate models with both monovalent and bivalent vaccine candidates in the three most deadly human pathogenic filoviruses (Ebola virus, Sudan virus and Marburg virus).

    Soligenix (NASDAQ:SNGX), in the release, pointed to its Public Health Solutions business segment, and its ongoing collaborations…

    Soligenix, on Thursday February 27th, gave the market some more good news. This time the company highlighted data from its ongoing collaboration with the University of Hawai’i at Manoa (UHM) and Hawaii Biotech Inc. (HBI) that has resulted in what the Company believes is a significant milestone in the development of heat stable filovirus vaccines. According to the update, the platform has demonstrated feasible thermostable formulations and protection in non-human primate models with both monovalent and bivalent vaccine candidates in the three most deadly human pathogenic filoviruses (Ebola virus, Sudan virus and Marburg virus).

    Soligenix (NASDAQ:SNGX), in the release, pointed to its Public Health Solutions business segment, and its ongoing collaborations with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UHM and HBI that have demonstrated the feasibility of developing heat stable subunit protein vaccines for filovirus. Specifically, protective efficacy has been demonstrated in non-human primates against infection with Ebola virus, Sudan virus, and Marburg virus. Additionally, protection has been achieved with both monovalent and bivalent vaccine combinations. Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit).

    The February 27th release further stated that Soligenix and its collaborators are now focusing specifically on accelerating development of a Marburg virus (MARV) vaccine, which is one of the most deadly viruses and has caused multiple disease outbreaks with significant mortality since the 1960s and for which there exists no approved vaccine or treatment.

    Commenting on the program developments, Chris Schaber, PhD,President and CEO of Soligenix, stated,“We believe that creating a vaccine with enhanced stability at elevated temperatures, which can obviate the costs and logistical burdens associated with cold chain storage and distribution, has the potential to provide a distinct advantage over other vaccines currently in development,” He added, “In concert with US government feedback, we will now look to focus specifically on Marburg virus.”

    The update, which comes as investors are eyeing the release of topline data for the company’s late-stage Phase 3 SGX301 trial, shows the added depth that Soligenix has in the pipeline that can target unmet medical needs as well as to provide heat-stabilization technology to meaningful and potentially urgent vaccine products.


    Video Link: https://www.youtube.com/embed/enIZbap_DVQ

    Eyes Focused On Q1 Topline Data Release For SGX301

    Aside from the good news on Thursday, investors also have their eyes trained on Soligenix with the imminent release of topline data after completing final enrollment for SGX301, a pivotal Phase 3 trial targeting the treatment of cutaneous T-cell lymphoma. A successful report may position the company for significant increases to shareholder value before the end of Q1 2020, and ultimately position the company to commercialize its first drug in a market that is estimated at a more than $200 million revenue opportunity.

    The Phase 3 (FLASH) clinical trial is focused on the potential benefits of Soligenix’s topical drug ointment SGX301, or synthetic hypericin, in the treatment of cutaneous T-cell lymphoma (CTCL). CTCL is a rare type of Non-Hodgkin’s Lymphoma that sits high on the list of conditions that has no current or effective drug treatment, pushing Soligenix to fill the demand to serve this unmet medical need. Further, a positive final data set from the SGX301 trial can position the drug to become the front-line standard of care option, replacing the often ineffective cancer treatments that involve the mutation of DNA, most of which are known to cause collateral damage, inclusive of skin damage, and even secondary cancers that must be treated again. Moreover, because there is no current front-line care nor cure for CTCL, doctors have been forced to focus purely on the management of the discomfort caused by the disease’s painful skin lesions.

    And, with interim data demonstrating encouraging results, SNGX’s SGX301 may be in the unique and sole position to offer a first-in-class method to manage this rare and uncomfortable disease.

    While investors embraced the news on Thursday of the continued progress in its Public Health Solutions business segment, the primary attention during the next 31 days will remain on SGX301 data. If that data can mimic interim data, it could become a transformative event for Soligenix.

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    To view the original version on ABNewswire visit: Soligenix Shows Pipeline Depth From Heat Stabilization Technology For Filovirus Vaccine Platform; Eyes Remain Focused On SGX301 Data Release

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  40. PRINCETON, N.J., Feb. 27, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its ongoing collaboration with the University of Hawai'i at Manoa (UHM) and Hawaii Biotech Inc. (HBI) has resulted in what the Company believes is a significant milestone in the development of heat stable filovirus vaccines, in which the platform has demonstrated feasible thermostable formulations and protection in non-human primate models with both monovalent and bivalent vaccine candidates in the three most deadly human pathogenic filoviruses (Ebola virus, Sudan virus…

    PRINCETON, N.J., Feb. 27, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its ongoing collaboration with the University of Hawai'i at Manoa (UHM) and Hawaii Biotech Inc. (HBI) has resulted in what the Company believes is a significant milestone in the development of heat stable filovirus vaccines, in which the platform has demonstrated feasible thermostable formulations and protection in non-human primate models with both monovalent and bivalent vaccine candidates in the three most deadly human pathogenic filoviruses (Ebola virus, Sudan virus and Marburg virus).

    Under the Company's Public Health Solutions business segment, ongoing collaborations with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UHM and HBI have demonstrated the feasibility of developing heat stable subunit protein vaccines for filovirus. Protective efficacy has been demonstrated in non-human primates against infection with Ebola virus, Sudan virus, and Marburg virus. Protection has been achieved with both monovalent and bivalent vaccine combinations. Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit). Soligenix and its collaborators are now focusing specifically on accelerating development of a Marburg virus (MARV) vaccine, which is one of the most deadly viruses and has caused multiple disease outbreaks with significant mortality since the 1960s and for which there exists no approved vaccine or treatment.  

    "Filoviruses are endemic in areas of the world where the power supply can be uncertain, making a thermostable vaccine particularly valuable," stated Dr. Lehrer, Assistant Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology at the JABSOM. "Our work to date has demonstrated not only the feasibility of rapid and efficient manufacturing, but also the potential for a broadly applicable and easily distributed vaccine. With Marburg virus continuing to be an unmet medical need of priority to the US government, we are now focusing and accelerating evaluations of the Marburg virus vaccine specifically."

    "We believe that creating a vaccine with enhanced stability at elevated temperatures, which can obviate the costs and logistical burdens associated with cold chain storage and distribution, has the potential to provide a distinct advantage over other vaccines currently in development," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "In concert with US government feedback, we will now look to focus specifically on Marburg virus."

    About Filovirus Infection

    Ebola Virus Disease is caused by one of five species of Ebolavirus, four of which cause disease in humans, including its best-known member, Zaire Ebolavirus (Ebola virus). All species of Ebolavirus belong to the Filoviridae family, a family that further contains the equally human pathogenic Marburg virus. The Ebola virus is believed to be harbored in various animal species in Africa, although the specific reservoir host is still unknown. There have been several known Ebola and Marburg virus disease outbreaks since 1967, with the largest outbreak starting in 2014 in Western Africa, and involved over 26,000 confirmed/probable/suspected cases with an estimated death toll of over 11,000 people according to the Centers for Disease Control and Prevention (CDC), including some cases in Europe and the United States.

    Transmission of filoviruses requires direct contact with bodily fluids from an infected person or contact with infected animals. The mortality rate from filovirus infections are extremely high, and can sometimes be affected by the quality of supportive care available with a focus on early initiation of treatment. Resolution of the disease largely depends on the patient's own immune system. There is no approved treatment for Ebola or Marburg although research into both has accelerated since the onset of the 2014 outbreak and significant progress has been made in advanced clinical testing of immunotherapeutics for Zaire ebolavirus. There is an approved vaccine, requiring storage at less than -60 °C for Ebola virus (Zaire ebolavirus), but no protection is yet available for Marburg virus (Marburg Marburgvirus) or Sudan virus (Sudan ebolavirus).

    About John A. Burns School of Medicine, University of Hawai'i at Manoa

    The University of Hawai'i at Manoa is one of the most ethnically diverse institutions of higher education. Hawai'i's cultural diversity and geographical setting affords the John A. Burns School of Medicine (JABSOM) a unique research environment to excel in health disparity research. JABSOM faculty bring external funding of about $40 million annually into Hawai'i.

    About Hawaii Biotech, Inc.

    Hawaii Biotech (HBI) is a privately held biotechnology company focused on the development of prophylactic vaccines for established and emerging infectious diseases and anti-toxin drugs for biological threats. HBI has developed proprietary expertise in the production of recombinant proteins that have application to the manufacture of safe and effective vaccines, diagnostic kits, and as research tools. HBI completed successful first-in-human Phase 1 clinical studies with both West Nile virus and dengue vaccines in healthy human subjects. HBI has developed a product pipeline of recombinant subunit vaccines, including vaccine candidates for West Nile virus, tick-borne flavivirus, malaria, Crimean-Congo hemorrhagic fever, and Ebola.  The company is also continuing the development of small molecule anti-toxin drugs for anthrax and botulism. HBI, founded in Hawaii in 1982, is headquartered in Honolulu. For more information, please visit: www.hibiotech.com.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy (including the outcome of the interim analysis) or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-successful-demonstration-of-heat-stabilization-for-filovirus-vaccine-platform-301012079.html

    SOURCE Soligenix, Inc.

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  41. PRINCETON, N.J., Feb. 13, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its RiVax® (heat stable ricin toxin vaccine) development program for prevention of ricin intoxication has received "Fast Track" designation from the US Food and Drug Administration (FDA).

    Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is intended to facilitate the development and expedite…

    PRINCETON, N.J., Feb. 13, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its RiVax® (heat stable ricin toxin vaccine) development program for prevention of ricin intoxication has received "Fast Track" designation from the US Food and Drug Administration (FDA).

    Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is intended to facilitate the development and expedite the review of new drugs and biologics. For instance, should events warrant, Soligenix will be eligible to submit a biologics license application (BLA) for RiVax® on a rolling basis, permitting the FDA to review sections of the BLA prior to receiving the complete submission. Additionally, BLAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.

    "We are very pleased to have been granted fast track designation from the FDA to go along with the orphan drug designation previously received," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We believe that the FDA's action in granting fast track designation validates the unmet medical need that currently exists for a vaccine providing protection against lethal ricin toxin exposure and for the potential key role RiVax® can serve as a part of the US Strategic National Stockpile."

    The development of RiVax® has been funded through a series of grants from both the National Institute of Allergy and Infectious Diseases (NIAID) and the FDA and ongoing development is sponsored by NIAID contract #HHSN272201400039C. Non-dilutive funding for the development of RiVax® has exceeded $40 million to date.

    About Ricin Toxin

    Ricin toxin is a lethal plant-derived toxin and potential biological weapon because of its stability and high potency, and the fact that it is readily extracted from by-products of castor oil production. Ricin comes in many forms including powder, mist or pellet. Ricin can also be dissolved in water and other liquids. The US Centers for Disease Control and Prevention estimates that the lethal dose in humans is about the size of a grain of salt. Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure. Ricin is especially toxic when inhaled. Ricin works by entering cells of the body and preventing the cells from making the proteins they need. Without the proteins, cells die, which is eventually harmful to the entire body.

    There are currently no effective treatments for ricin poisoning. The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used to vaccinate military personnel and civilian emergency responders at high risk of potential exposure in the event of a biological attack.

    About RiVax®

    RiVax® is Soligenix's proprietary heat stable recombinant subunit vaccine developed to protect against exposure to ricin toxin, the threat of which has been highlighted recently in the news with an envelope addressed to President Trump that was thought to contain this potent and potentially lethal toxin. With RiVax®, Soligenix is a world leader in the area of ricin toxin vaccine research.

    RiVax® contains a genetically altered version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule. A Phase 1A clinical trial was conducted with a formulation of RiVax® that did not contain an adjuvant. This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of RiVax® induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals.

    To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax® was subsequently formulated with an adjuvant of aluminum salts (known colloquially as alum) for a Phase 1B clinical trial. Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants. The results of the Phase 1B study indicated that alum-adjuvanted RiVax® was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax®. In animal studies, the alum formulation of RiVax® also induced higher titers and longer-lasting antibodies than the adjuvant-free vaccine. Vaccination with the thermostabilized alum-adjuvanted RiVax® formulation in a large animal model provided 100% protection (p<0.0001) against acute exposure to aerosolized ricin, the most lethal route of exposure for ricin. The protected animals also had no signs of gross lung damage, a serious and enduring ramification with long-term consequences for survivors of ricin exposure. These results are described in a publication available here.

    Heat stabilization of RiVax® is achieved with the Company's proprietary ThermoVax® technology, designed to eliminate the cold-chain production, distribution and storage logistics required for most vaccines. The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations. By employing ThermoVax® during the final formulation of RiVax®, the vaccine has demonstrated enhanced stability and the ability to withstand temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year. These results are described in a publication available here.

    The development of RiVax® has been funded through a series of grants from both the National Institute of Allergy and Infectious Diseases (NIAID) and the FDA and ongoing development is sponsored by NIAID contract #HHSN272201400039C. Non-dilutive funding for the development of RiVax® has exceeded $40 million to date. RiVax® is being developed under the FDA "Animal Rule" and potentially would be added to the Strategic National Stockpile and dispensed in the event of a terrorist threat. RiVax® has received orphan drug designation in the US and in Europe.

    As a new chemical entity, an FDA approved RiVax® vaccine has the potential to qualify for a biodefense Priority Review Voucher (PRV), which allows the holder accelerated review of a drug application. Approved under the 21st Century Health Cures Act in late 2016, the biodefense PRV is awarded upon approval as a medical countermeasure when the active ingredient(s) have not been otherwise approved for use in any context. PRVs are transferable and can be sold, with sales in recent years in excess of $100 million. When redeemed, PRVs entitle the user to an accelerated review period of six months, saving a median of seven months' review time as calculated in 2009. However, the FDA must be advised 90 days in advance of the use of the PRV and the use of a PRV is associated with an additional user fee ($2.1 million in 2020).

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/fda-grants-soligenix-fast-track-designation-for-rivax-in-the-prevention-of-ricin-poisoning-301004194.html

    SOURCE Soligenix, Inc.

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  42. PRINCETON, N.J., Feb. 11, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that Dr. Brian Poligone, clinical investigator and lead enroller in the pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study evaluating SGX301 in the treatment of early stage cutaneous T-cell lymphoma (CTCL), will present a patient case study from the trial.  The presentation will be given at the upcoming 4th World Congress of Cutaneous Lymphomas on February 12-14, in Barcelona, Spain.

    Oral Presentation:

    Response in a patient with refractory folliculotropic

    PRINCETON, N.J., Feb. 11, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that Dr. Brian Poligone, clinical investigator and lead enroller in the pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study evaluating SGX301 in the treatment of early stage cutaneous T-cell lymphoma (CTCL), will present a patient case study from the trial.  The presentation will be given at the upcoming 4th World Congress of Cutaneous Lymphomas on February 12-14, in Barcelona, Spain.

    Oral Presentation:

    Response in a patient with refractory folliculotropic mycosis fungoides to a topical hypericin ointment activated with fluorescent light presented by Brian Poligone, MD, PhD, an Investigator in the FLASH study and Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, USA, on February 13th, 2020 at 8:00 AM CET.  Abstract will be available on corporate website following the conference.

    Folliculotropic mycosis fungoides (FMF) is a type of CTCL that is very difficult to treat.  FMF is generally considered more severe and aggressive than other types of CTCL due to its greater risk of disease progression and worse prognosis.  Treatment usually includes early consideration of systemic therapies, as topical therapies are often not beneficial.  The presented case study focuses on a single patient with FMF who has completed the Phase 3 FLASH trial, including the open-label cycles and 6-month follow-up.  The patient had previously failed at least five therapies, including topical treatments, oral medications and phototherapy.  While in the study, the patient received at least 12 weeks of SGX301 treatment and experienced significant improvement, eventually leading to complete clearance of disease that has been sustained for at least 4 years.

    "I'm happy to be presenting this important case study at the world congress," stated Dr. Brian Poligone, Director of the Rochester Skin Lymphoma Group.  "This patient community needs safe, skin directed therapies to treat this difficult lymphoma and I'm very excited that SGX301 may be one such therapy.  I know I can speak for the other clinical study sites participating in the FLASH study, when I say, we are eager for the topline results this quarter."

    About the 4th World Congress of Cutaneous Lymphomas

    The 4th World Congress is designed to promote the exchange of scientific ideas and foster interactions between physicians, researchers and anyone engaged in the field of cutaneous lymphomas. The program will include discussions of basic, translational and clinical research and discuss new developments in the diagnosis, practice and management of cutaneous lymphomas. More information about the Congress is found here and the final programme is available here.

    About SGX301

    SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation.  The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later.  This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure.  Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p ≤ 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective:  58.3% compared to 8.3%, respectively.  

    The Phase 3 FLASH trial enrolled 169 patients with Stage IA, IB or IIA CTCL. Enrollment of the trial is completed and topline primary endpoint results are expected to be available in Q1 2020. The trial consists of three treatment cycles, each of 8 weeks duration.  Treatments are administered twice weekly for the first 6 weeks and treatment response is determined at the end of Week 8.  In the first treatment cycle, approximately 107 subjects receive SGX301 treatment (0.25% synthetic hypericin) and 53 receive placebo treatment of their index lesions.  In the second cycle, all subjects receive SGX301 treatment of their index lesions and in the third (optional) cycle all subjects receive SGX301 treatment of all their lesions.  Subjects are followed for an additional 6 months after the completion of treatment.  The majority of patients enrolled have elected to continue with the optional, open-label component of the study.  

    The Phase 3 CTCL clinical study was partially funded with this NCI Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

    SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

    About Cutaneous T-Cell Lymphoma (CTCL)

    CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.  Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin.  These malignant cells migrate to the skin where they form various lesions, typically beginning as a rash and eventually forming raised plaques and tumors as the disease progresses.  Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.  Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

    CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually. 

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy (including the outcome of the interim analysis) or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-announces-sgx301-patient-case-study-presentation-at-the-4th-world-congress-of-cutaneous-lymphomas-301002395.html

    SOURCE Soligenix, Inc.

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  43. PRINCETON, N.J., Feb. 3, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Japanese Patent Office has granted the patent titled "Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis."  This allowance builds on similar intellectual property in the United States (US), New Zealand, Australia and Singapore and patent applications pending in other jurisdictions worldwide.  The new claims cover therapeutic use of dusquetide (active ingredient in SGX942) and related innate defense regulator (IDR) analogs, and add to composition of…

    PRINCETON, N.J., Feb. 3, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Japanese Patent Office has granted the patent titled "Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis."  This allowance builds on similar intellectual property in the United States (US), New Zealand, Australia and Singapore and patent applications pending in other jurisdictions worldwide.  The new claims cover therapeutic use of dusquetide (active ingredient in SGX942) and related innate defense regulator (IDR) analogs, and add to composition of matter claims for dusquetide and related analogs that have been granted in the US and worldwide.  Dusquetide previously demonstrated positive results in a Phase 2 oral mucositis clinical trial and a pivotal Phase 3 study is ongoing, with a positive interim analysis completed in August 2019 and final topline results expected in Q2 2020. 

    Based on the positive and previously published Phase 2 results, the pivotal Phase 3 clinical trial is a highly powered, double-blind, randomized, placebo-controlled, multinational trial. The study, called DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity), is enrolling approximately 260 subjects with head and neck cancer (HNC) undergoing standard chemoradiation therapy (CRT) and who are therefore at high risk of developing severe oral mucositis.  Enrollment is ongoing in the US and across Europe with enrollment completion expected in Q1 2020 and final topline primary endpoint results anticipated in Q2 2020.

    "Soligenix continues to pursue broad patent coverage for its IDR technology, including dusquetide, first with composition of matter claims followed by therapeutic use claims in oral mucositis," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Having successfully pursued composition of matter claims in jurisdictions worldwide, we continue to pursue therapeutic use claims like those issued in the US previously and in Japan with this most recent patent. The therapeutic use claims are expected to be generally valid until 2034, which provides significant patent protection and life to dusquetide and our other IDRs.  This allowance is timely as we continue to have discussions with potential strategic partners and pursue all options to advance our pipeline and plan for commercial activities."

    About Oral Mucositis

    Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

    The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

    It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in HNC is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe. Oral mucositis almost always occurs in patients with HNC treated with CRT and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

    In the pediatric population, head and neck cancer is a rarer occurrence and is caused by different underlying pathologies. The major types of HNC in children are lymphoma, sarcomas (including rhabdomyosarcomas), and neuroblastoma rather than squamous cell carcinoma, the major type of adult HNC cancers. Hematopoietic stem cell transplantation (HSCT), especially allogeneic transplantation with higher risk of oral mucositis, is more frequently used in the pediatric population than in adults when treating a number of primary tumor types, as seen in leukemia and lymphoma.  Both treatment of HNC and HSCT are associated with high risk of oral mucositis in the pediatric population.

    Oral mucositis remains an area of unmet medical need where there are currently no approved drug therapies in the context of any solid tissue tumors.

    About Dusquetide

    Dusquetide (the active ingredient in SGX942) is an IDR, a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory, anti-infective and tissue healing response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, including melioidosis. 

    SGX942 has demonstrated safety and tolerability in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study (Study IDR-OM-01) in 111 patients with oral mucositis due to CRT for HNC, including potential long-term ancillary benefits. Soligenix is working with leading oncology centers in the US and Europe to advance SGX942 in oral mucositis with the conduct of a pivotal Phase 3 clinical trial (Study IDR-OM-02) referred to as the "DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity). The multinational, placebo-controlled, randomized Phase 3 study is targeted to enroll approximately 260 subjects with squamous cell carcinoma of the oral cavity and oropharynx, scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects are randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of CRT. The primary endpoint for the study is the median duration of severe oral mucositis, assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis is evaluated using the WHO (World Health Organization) Grading system. Severe oral mucositis is defined as a WHO Grade of ≥3. Subjects are to be followed for an additional 12 months after the completion of treatment. An interim analysis for this study has been completed and identified a promising signal.

    SGX942 has received Fast Track Designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, as well as Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of severe oral mucositis in HNC patients receiving CRT. In addition, products containing the same active ingredient, dusquetide, have been granted Fast Track Designation as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis and Orphan Drug Designations in the treatment of MAS and the treatment of acute radiation syndrome. 

    Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has received partial funding from NIH for its oral mucositis clinical studies. The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study being supported by a Phase II SBIR grant (#R44DE024032) award.

    In addition, a high level review of the IDR technology platform is available here.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy (including the outcome of the interim analysis) or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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    SOURCE Soligenix, Inc.

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  44. PRINCETON, N.J., Jan. 30, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation reviewing the Company's two Phase 3 clinical programs and pipeline at the 22nd Annual BIO CEO & Investor Conference in New York City, Tuesday, February 11, 2020 at 9:45 AM EST. The presentation will take place at the New York Marriott Marquis, Wilder Room, 4th Floor.

    "This is clearly an exciting time for Soligenix with final topline data for our Phase 3 cutaneous…

    PRINCETON, N.J., Jan. 30, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation reviewing the Company's two Phase 3 clinical programs and pipeline at the 22nd Annual BIO CEO & Investor Conference in New York City, Tuesday, February 11, 2020 at 9:45 AM EST. The presentation will take place at the New York Marriott Marquis, Wilder Room, 4th Floor.

    "This is clearly an exciting time for Soligenix with final topline data for our Phase 3 cutaneous T-cell lymphoma program expected this quarter followed by Phase 3 topline data in Oral Mucositis next quarter," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The BIO CEO conference comes at an opportune time as we continue to have ongoing discussions with potential strategic partners and pursue all options to advance our pipeline and plan for commercial activities. We also look forward to meeting directly with high caliber investment funds during the conference as well as potential pharmaceutical partners."

    If you are interested in arranging a one-on-one meeting, please contact .

    To access the Soligenix corporate presentation, please visit here

    For more information about the BIO CEO & Investor Conference, please refer to the conference website at https://www.bio.org/events/bio-ceo-investor-conference.

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy (including the outcome of the interim analysis) or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma.  Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-to-present-at-the-22nd-annual-bio-ceo--investor-conference-300995799.html

    SOURCE Soligenix, Inc.

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  45. PRINCETON, N.J., Jan. 14, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. The content of this letter is provided below.

    Dear Friends and Shareholders,

    Let me start by wishing you a Healthy and Happy New Year!  I wanted to take this opportunity to provide a corporate update, as well as some further guidance on our development programs moving forward. 

    It is truly an exciting time for the Company. As many of you are aware, we have a number of significant and potentially…

    PRINCETON, N.J., Jan. 14, 2020 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. The content of this letter is provided below.

    Dear Friends and Shareholders,

    Let me start by wishing you a Healthy and Happy New Year!  I wanted to take this opportunity to provide a corporate update, as well as some further guidance on our development programs moving forward. 

    It is truly an exciting time for the Company. As many of you are aware, we have a number of significant and potentially transformational events ahead of us this quarter and over the next six months.  Most notably, top-line final results are imminent from two pivotal Phase 3 clinical trials:

    1. SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL), where we have completed enrollment and expect top-line results in Q1 2020; and
    2. SGX942 (dusquetide) for the treatment of oral mucositis in head and neck cancer, where we expect to complete enrollment in Q1 2020 and report top-line results in Q2 2020.

    In addition, we continue to advance the development of our heat stable ricin toxin vaccine (RiVax®) with the financial support of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), while we also actively pursue additional non-dilutive funding to support our rare disease pipeline. 

    Corporate Highlights

    This past year we strengthened our commercial and business expertise, both at the Board level and with our senior management team, so that we may begin to position the company for the potential success of our Phase 3 clinical trials. 

    In July 2019, we announced the addition of Ms. Diane Parks to our Board of Directors (access press release here). Ms. Parks is an accomplished businesswoman and commercial executive with an extensive record of driving profitable growth for large pharmaceutical and biotech companies. With a successful career spanning more than 30 years, she served as Senior Vice President and Head of US Commercial for Kite Pharma, Inc. (acquired by Gilead Sciences, Inc. for $11.9B), as Vice President and Head of Global Marketing for Pharmacyclics, Inc. (acquired by Abbvie, Inc. for $21B), as Vice President of Sales for Amgen Inc., and as Senior Vice President, Specialty Biotherapeutics for Genentech, Inc. (acquired by Roche Holdings AG for $46.8B). As we look forward to potential product approval, we intend to leverage Ms. Park's extensive business and commercialization experience in launching novel drug therapies in orphan diseases and areas of high unmet medical need. We believe her expertise adds significantly to our already diverse and experienced Board of Directors and management team. 

    In September 2019, we announced the additions of Jonathan Guarino, CPA, as Senior Vice President and Chief Financial Officer (access press release here) and Daniel Ring, as Vice President, Business Development and Strategic Planning (access press release here). Both Jonathan and Dan come with extensive backgrounds in their respective disciplines, while also having experience working for commercial life science companies.

    As we look forward to 2020, we continue to evaluate with prospective partners a number of strategic alternatives including, but not limited to, merger, acquisition, partnership, alliance, co-development and/or co-commercialization licensing agreements.

    Specialized Biotherapeutics Business Segment

    We continue to make good progress in advancing our two pivotal Phase 3 clinical programs.

    1. We completed patient enrollment in our pivotal Phase 3 double-blind, placebo-controlled study in CTCL with SGX301 (synthetic hypericin) in December (access press release here) following the positive recommendation received from the independent Data Monitoring Committee (DMC) in October 2018 (access press release here). Everything remains on track and our focus is now to complete the treatments for all patients and to lock the study database shortly thereafter, facilitating top-line results in Q1 2020. 

      We remain encouraged by this development program as a potential front line treatment where there is currently an unmet medical need. You may recall that this trial, referred to as the "FLASH" study (Fluorescent Light Activated Synthetic Hypericin), aims to evaluate the response to SGX301 as a skin directed therapy to treat early stage CTCL. SGX301 has received Orphan Drug designation as well as Fast Track designation from the United States (US) Food and Drug Administration (FDA). Additionally, SGX301 was granted Orphan Drug designation from the European Medicines Agency (EMA) and Promising Innovative Medicine (PIM) designation from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK).

      Approximately 35 CTCL centers across the US, representing the major Key Opinion Leaders (KOLs) in this indication, are participating in this pivotal trial, which enrolled 169 subjects.  Although the trial begins with a double-blind, placebo-controlled portion (referred to as Cycle 1), all participants in the trial eventually receive active study drug (referred to as Cycle 2) and an optional portion of the trial is available to them to continue with SGX301 treatment (referred to as Cycle 3). We remain encouraged that the majority of patients have elected to continue with Cycle 3, the optional open-label portion of the study. We also continue to work closely with patient advocacy groups, such as the Cutaneous Lymphoma Foundation and the National Organization for Rare Disorders.

      The CTCL development program has received partial funding of approximately $1.5 million over two years from a Small Business Innovative Research (SBIR) grant awarded by the NIH's National Cancer Institute (NCI).

    2. We continue to actively enroll patients in a pivotal Phase 3 multinational, double-blind, placebo-controlled clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy (CRT). Since enrolling our first patient in December 2017 in a "controlled roll-out" of the study in the US to assure site adherence with the protocol design, we have expanded enrollment into Europe following the same controlled process. As we announced in August 2019 (access press release here), the DMC conducted an unblinded interim analysis with data from approximately 90 study subjects, including assessment of the study's primary efficacy endpoint. The DMC recommended that additional subjects be randomized into the trial to maintain the rigorous assumption of 90% statistical power for the primary efficacy endpoint. No safety concerns were reported by the DMC based on the interim analysis. Although we do not typically give specific enrollment numbers during the active conduct of our clinical trials, I am happy to say that we currently have over 220 of the 260 subjects required to complete enrollment in this study. Consistent with our public guidance, we currently expect to complete enrollment in Q1 2020, with final topline results in Q2 2020. 

    This trial, referred to as the "DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity), aims to evaluate the response of SGX942 in reducing the median duration of severe oral mucositis, in addition to other clinically meaningful measures, and incorporates feedback from the FDA as well as the EMA via the Scientific Advice process. Scientific Advice from the EMA indicated that a single, double-blind, placebo-controlled Phase 3 study, if successful, in conjunction with the positive results from the Phase 2 dose-ranging study, generally will be sufficient to support a marketing authorization application for potential licensure in Europe. SGX942 is the first Innate Defense Regulator in development for oral mucositis and has previously demonstrated positive results in a Phase 2 clinical trial. 

    Dusquetide is a new chemical entity with a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.  The Phase 2 data demonstrated a significant reduction in the duration of oral mucositis, as well as reduced infection rates, as published in 2016 in the Journal of Biotechnology (available here). Long-term follow-up data from the Phase 2 trial, published in 2017 in Biotechnology Reports (available here), further indicated the safety and tolerability of SGX942 treatment, with a sustained trend towards reduced mortality and increased tumor resolution compared to placebo. SGX942 has received Fast Track designation from the FDA for the treatment of oral mucositis as a result of CRT in HNC patients as well as PIM designation from the MHRA in the UK.

    Approximately 50 oncology centers in the US and Europe are actively participating in this pivotal, Phase 3 study, which is targeted to enroll 260 subjects with squamous cell carcinoma of the oral cavity and oropharynx who are scheduled to receive the standard treatment regimen with a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day and concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week.

    The oral mucositis development program has received partial funding of approximately $1.5 million over two years from an SBIR grant awarded by the NIH's National Institute of Dental and Craniofacial Research (NIDCR).

    Public Health Solutions Business Segment 

    We are advancing the development of our thermostabilized ricin toxin vaccine, RiVax®, with the support of up to $24.7 million over six years awarded by NIAID, where we have successfully identified biomarkers for RiVax® testing, as published in the journal Vaccine in 2018 (available here), facilitating potential approval under the FDA Animal Rule. The FDA Animal Rule is applied to products where testing in human clinical trials would be unethical, and in the case of ricin toxin, fatal. The Animal Rule combines safety studies in humans and efficacy testing in animals to facilitate approval. Key to the application of the Animal Rule is the requirement to establish a correlation between the immune response observed in clinical trials in healthy volunteers with the immune response demonstrated in animal efficacy studies.

    We recently initiated a third Phase 1C vaccine immunogenicity and safety study in healthy volunteers utilizing RiVax® (access press release here). This study is building upon the safety already demonstrated with the RiVax® antigen from the two previous Phase 1 clinical trials, but will look to test the product formulated with our proprietary heat stabilization technology (ThermoVax®). In parallel, additional efficacy studies in non-human primates are planned, enabling a larger database of biomarkers for correlation with human clinical results. In addition to being protective and thermostable, RiVax® has demonstrated that a reduced number of vaccinations may be required to establish protection, potentially utilizing only two doses instead of three, and both vaccine regimens are planned to be tested in future studies. 

    RiVax® has received Orphan Drug designations from both the FDA and EMA, and as a new chemical entity, upon approval in the US, has the potential to qualify for a biodefense Priority Review Voucher (PRV). PRVs are transferable and can be sold, with sales in recent years of approximately $100 million. Recent events, including the news of an envelope addressed to President Trump that was thought to contain this potent and potentially lethal toxin, as well as a foiled bioattack with ricin in Germany, suggest that the RiVax® vaccine may be of increasing interest to multiple countries.

    Formulation development work with the University of Hawai'i on a trivalent thermostabilized Ebola vaccine continues as planned with the support of a $700,000 sub-award over five years from NIAID.  The subunit vaccine offers broader coverage to different strains of Ebola, as well as Marburg virus, and offers the potential for a simpler chain of custody with no refrigerated conditions required. Previous work demonstrating thermostabilization of the univalent vaccine has been recently published in the European Journal of Pharmaceutics and Biopharmaceutics (available here).  

    Additional funding for dusquetide (active ingredient in SGX942) has also been obtained through a Defense Threat Reduction Agency (DTRA) subaward of approximately $600,000 over 3 years (access press release here). These studies will further elucidate the therapeutic anti-infective action of dusquetide in animal models of biodefense-related infectious agents.

    Non-Dilutive Funding

    As noted above, we aggressively pursue non-dilutive funding sources to support our rare disease pipeline. We have received two NIH SBIR grant awards totaling approximately $3 million for two of our biotherapeutics development programs. We are also operating under NIAID grant and contract awards of up to $25.4 million in our Public Health Solutions business segment to support RiVax® development, our collaboration with the University of Hawai'i at Manoa for the development of a trivalent thermostabilized Ebola vaccine and the evaluation of dusquetide as a broad spectrum therapeutic for the treatment of bacterial infectious disease. This non-dilutive funding continues to provide a meaningful offset to our development expenses while better positioning us to effectively manage our overall cash burn. Recently, we also received preliminary approval of a tax credit under the New Jersey Economic Development Authority's New Jersey Technology Business Tax Certificate Transfer program, which we anticipate being able to sell for approximately $850,000 in net proceeds (access press release here). 

    Balance Sheet and Capital

    As of January, we have over $6 million in cash. In addition to the non-dilutive funding received and anticipated in 2019, we also have an At-The-Market (ATM) instrument in place with B. Riley FBR, Inc. to judiciously supplement cash if/when the need arises and stock volume and price permit, such as to support the execution of certain CTCL pre-commercialization activities to potentially support a new drug application filing with the FDA. With this available funding, we currently do not contemplate a larger capital raise, until at the earliest, after final top-line CTCL results are disclosed. We also continue to have ongoing business development discussions, which may lead to more favorable capital inflows, including the potential to receive additional non-dilutive funding. Overall, we are mindful of dilution and will look at all future capital inflow initiatives in the most efficient and shareholder friendly manner as possible. 

    In closing, thank you for your interest and your continued support of Soligenix. It is a very exciting time in our life cycle. We look forward to a productive 2020 as we further advance our development programs towards potential commercialization. Best wishes!

    Dr. Christopher J. Schaber
    President and Chief Executive Officer
    Soligenix, Inc.
    January 14, 2020

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy (including the outcome of the interim analysis) or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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    SOURCE Soligenix, Inc.

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  46. PRINCETON, N.J., Dec. 18, 2019 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received preliminary approval for a tax credit from the New Jersey Economic Development Authority's (NJEDA) New Jersey Technology Business Tax Certificate Transfer program.  As a result, the Company anticipates being able to transfer this credit and receive approximately $850,000 in net proceeds.

    This competitive program enables approved technology and biotechnology businesses to sell their unused Net Operating Loss (NOL) Carryovers and unused Research and Development…

    PRINCETON, N.J., Dec. 18, 2019 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received preliminary approval for a tax credit from the New Jersey Economic Development Authority's (NJEDA) New Jersey Technology Business Tax Certificate Transfer program.  As a result, the Company anticipates being able to transfer this credit and receive approximately $850,000 in net proceeds.

    This competitive program enables approved technology and biotechnology businesses to sell their unused Net Operating Loss (NOL) Carryovers and unused Research and Development (R&D) Tax Credits to unaffiliated, profitable corporate taxpayers in the state of New Jersey. This allows businesses with NOLs to turn their tax losses and credits into cash proceeds to fund additional R&D, purchase equipment and/or facilities, or cover other allowable expenditures. The NJEDA determines eligibility for the program, the New Jersey Division of Taxation determines the value of the available tax benefits (NOLs and R&D Tax Credits), and the New Jersey Commission on Science and Technology evaluates the technology and its viability. The State of New Jersey was the originator of this program and the first state to implement and fund it. 

    "As we are always looking for non-dilutive ways to fund our company, we are once again very pleased with NJEDA's decision to support advancing biotechnology companies with the approval of our application in this year's program," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "This is our ninth year receiving NOL funding.  Over this time period, we have received approximately $5.7 million in non-dilutive NOL funding that has allowed us to advance our rare disease pipeline to where we are now approaching final data readout in two pivotal Phase 3 clinical trials.  The first study is SGX301 for the treatment of cutaneous T-cell lymphoma (CTCL), where enrollment is complete with topline results expected in the first quarter of 2020.  The second study is SGX942 for the treatment of oral mucositis in patients with head and neck cancer, where topline results are expected in the second quarter of 2020."  

    Dr. Schaber continued, "This program continues to be a welcomed and important addition to other significant non-dilutive funding we have been awarded from the Biomedical Advanced Research and Development Authority and the National Institutes of Health.  We are, again, very thankful for New Jersey's continued support of its biotechnology industry."

    About Soligenix, Inc.

    Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

    Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

    For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

    This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

    Cision View original content:http://www.prnewswire.com/news-releases/soligenix-to-receive-850-000-in-non-dilutive-funding-through-new-jersey-technology-business-tax-certificate-transfer-program-300976584.html

    SOURCE Soligenix, Inc.

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  47. New York, New York--(Newsfile Corp. - December 13, 2019) - This news release has been corrected to add legal disclaimers. As the end of the year's fourth quarter comes to a close, CEO3in60 highlights how Soligenix (NASDAQ:SNGX) has achieved multiple milestones across the company's core focus areas. Two treatments in development to treat rare diseases and/or areas of unmet medical need are currently in Phase 3 studies. Additionally, the Public Health Solutions arm has grown to operate under a multi-million-dollar contract with the National Institutes of Health (NIH).

    Cannot view this video? Visit:
    https://www.youtube.com/watch?v=QQoE_S91jYI

    Patient Enrollment Completed for SGX301 Phase 3 Study

    At the beginning of the month, Soligenix reached…

    New York, New York--(Newsfile Corp. - December 13, 2019) - This news release has been corrected to add legal disclaimers. As the end of the year's fourth quarter comes to a close, CEO3in60 highlights how Soligenix (NASDAQ:SNGX) has achieved multiple milestones across the company's core focus areas. Two treatments in development to treat rare diseases and/or areas of unmet medical need are currently in Phase 3 studies. Additionally, the Public Health Solutions arm has grown to operate under a multi-million-dollar contract with the National Institutes of Health (NIH).

    Cannot view this video? Visit:
    https://www.youtube.com/watch?v=QQoE_S91jYI

    Patient Enrollment Completed for SGX301 Phase 3 Study

    At the beginning of the month, Soligenix reached a new milestone by completing patient enrollment for its Phase 3 "Fluorescent Light Activated Synthetic Hypericin" (FLASH) study for SGX301 (synthetic hypericin), which is designed to treat cutaneous T-cell lymphoma (CTCL).

    169 subjects successfully enrolled in the study, which had previously received positive interim analysis from an independent Data Monitoring Committee (DMC) in October 2018. The committee recommended to continue enrolling patients, having observed a beneficial drug effect and further recommended to increase the trial sample size of the study in order to maintain its 90% statistical power, a rigorous standard for the industry. Additionally, the DMC did not note any safety concerns associated with the use of SGX301.

    With enrollment complete for this pivotal Phase 3 trial, top-line results are now expected in the first quarter of 2020. SGX301 is a priority program for Soligenix and this study will be used to support a marketing authorization or new drug filing with the US FDA.

    More About the SGX301 Clinical Trial

    SGX301 is a photodynamic therapy that treats cancerous skin lesions by applying a novel, first in class, synthetic hypericin topical ointment followed by activation of the drug with safe, visible fluorescent light. The treatment has the potential to be the first approved front line therapy for CTCL and is anticipated to minimize the risk of secondary malignancies associated with other photodynamic and chemo- therapies, many of which are currently not FDA approved.

    The Phase 3 trial design includes three distinct cycles of treatment:

    The first cycle is defined as treatment period for the primary endpoint in the trial. Cycle 1 is the randomized double-blind portion of the study with 2:1 SGX301: placebo randomization across 169 patients. The patients treat their 3 index lesions twice a week for 6 weeks, with escalating light exposure until a study defined maximum light exposure is reached. After a 2 week rest period, the size and characteristics of the 3 index lesions are assessed and the improvement in lesion scores for all 3 lesions are compared to the cumulative score for those same lesions at baseline. An improvement ≥50% is considered a successful response.

    The second cycle of the study is an unblinded portion. All patients treat their 3 index lesions with SGX301, using the same procedure as in Cycle 1. The lesions are characterized at the end (week 8) of the cycle.

    The third cycle of the study is also unblinded and is optional. In this cycle, patients can treat all their lesions with SGX301, using the same procedure as in Cycle 1.

    Following Cycle 3 (or Cycle 2 if the patients don't opt into Cycle 3), a six-month follow-up is undertaken.

    Phase 3 for SGX942

    Another promising treatment under development is SGX942, which is now actively enrolling in a Phase 3 clinical trial, following a positive interim analysis that was conducted by a DMC in August of 2019. The study is enrolling 260 patients in the US and Europe. Patient enrollment is expected to finish in the first quarter of the new year and expect to receive the trial's top line results by the second quarter 2020.

    SGX942 treats oral mucositis that develops in head and neck cancer patients receiving radiation and chemotherapy. oral mucositis is a side effect experienced by these cancer patients undergoing chemo-radiation. Oral mucositis inflames the mouth, throat, and GI tract, so severely that painful open ulcers develop that often times leaves patients unable to eat and drink. The symptoms can be so intense that patients may stop their cancer treatment just to gain temporary relief.

    SGX942 is a short 4-minute IV-infusion given in conjunction with the radiation and chemotherapy treatment. The anticipated result is that theSGX942 will modulate or reduce the severe inflammation, while healing the mouth quicker and reducing the high infection rates often associated with oral mucositis.

    Government Contracts in Public Health Initiatives

    Soligenix also operates a Public Health Solutions business segment, which is presently funded entirely by the government. Currently, the company is operating under about $28 million in government grants and contracts, predominantly with the NIH. The lead program currently in development, is a heat stable ricin vaccine, RiVax®, to prevent lethal ricin poisoning.

    These public health programs provide an offset to the company's overall cash burden, allowing Soligenix to manage its funds more effectively compared to other biotech companies.

    Soligenix is proud to end the year with multiple promising trials in progress and looks forward to contributing even more to the medical community in 2020.

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