1. NEW YORK, Sept. 15, 2021 /PRNewswire/ -- The damage done by the opioid epidemic has caused families grief and loss, but recent developments in the case against Purdue Pharma will see some restitution for the family. A potential $10 billion will be going toward fighting the opioid crisis that killed upward of 500,000 Americans in the past two decades. The Sackler family that owns Purdue Pharma will forfeit ownership of Purdue Pharma and pay $4.5 billion for the damage done by opioids like its best-selling Oxycontin. Fortunately, a new flock of companies is upending the traditional view of medicine by providing psychedelic treatments into their research and opening clinics to treat patients. Companies like Revitalist Lifestyle and Wellness Ltd.

    NEW YORK, Sept. 15, 2021 /PRNewswire/ -- The damage done by the opioid epidemic has caused families grief and loss, but recent developments in the case against Purdue Pharma will see some restitution for the family. A potential $10 billion will be going toward fighting the opioid crisis that killed upward of 500,000 Americans in the past two decades. The Sackler family that owns Purdue Pharma will forfeit ownership of Purdue Pharma and pay $4.5 billion for the damage done by opioids like its best-selling Oxycontin. Fortunately, a new flock of companies is upending the traditional view of medicine by providing psychedelic treatments into their research and opening clinics to treat patients. Companies like Revitalist Lifestyle and Wellness Ltd. (CSE:CALM), Atai Life Sciences N.V. (NASDAQ:ATAI), Cybin (NYSE:CYBN), Seelos Therapeutics, Inc. (NASDAQ:SEEL) and Tonix Pharmaceuticals (NASDAQ:TNXP) are researching, developing, and bringing to market new treatments in order to avoid the mistakes of the past.

    Revitalist Lifestyle and Wellness Ltd. (CSE:CALM) has just announced it has opened its fifth clinic in Raleigh, North Carolina. The city of Raleigh was chosen for its leading scholarly institutions and healthcare industry. With 14 treatment rooms, the clinic will have the ability to treat over 14,500 patients annually. The clinic will participate in advocacy programs working with Veterans Affairs and assisting veterans struggling with Post Traumatic Stress Disorder, Pain Syndromes, Major Depressive Disorder, and Suicidal Ideations gain greater access to care and is expected to generate approximately $7.1 million in revenue at full capacity.

    Revitalist will aim to bring its unique blend of comprehensive care and future-centric treatments provided by medical professionals, mental health experts, and chronic pain specialists. As the state ranks 21st in the country for the prevalence of mental illness, Revitalist's clinic is well-placed to serve the people of Raleigh and the surrounding communities in a more holistic and natural way.

    Revitalist now has a total of five clinics since opening the first in 2018. The company operates across the United States and will continue the expansion across the US is advancing its mission of bringing new, comprehensive care solutions to patients in both mental health care and pain management.   If you'd like to learn more about Revitalist Lifestyle and Wellness Ltd. (CSE:CALM), click here.

    Companies Taking a New Approach to Treatment and Avoiding the MIstakes of the Past

    Seelos Therapeutics, Inc. (NASDAQ:SEEL) is a clinical-stage biopharmaceutical company developing therapies for many central nervous system disorders and rare diseases. It is also advancing its mission and announced on January 27 that it had been selected as one of the 17 companies to be included in the world's first psychedelic Exchange Traded Fund (ETF). The fund has begun trading on the NEO exchange under the symbol PSYK. This opens the avenues for investors to gain exposure to the growing psychedelic market.

    Cybin (NYSE:CYBN) is the first for the sector to list on the NYSE, and is a validation for both the company and the industry. Cybin is currently developing a pipeline of psychedelic molecules for treating mental health conditions, including a proprietary formulation of psilocybin. This formulation is currently in phase 2 clinical trials.

    Atai Life Sciences (NASDAQ:ATAI) has a revolutionary digital therapeutic platform called Itrospect Digital Therapeutics. The company has announced it will begin a usability study of the app for support of standard of care ketamine therapy for patients with treatment-resistant depression. With digital health services growing in popularity and need, Atai is hoping to bring its app to more users to help treat mental illness in a more productive way without the need for addictive medications.

    Clinical-stage biopharmaceutical company Tonix Pharmaceuticals (NASDAQ:TNXP) has a large pipeline of innovative and proprietary therapeutics to address the needs of patients. The company also takes an approach that focuses on less addictive treatment. The company's portfolio includes small molecules and biologics to treat pain, neurologic, and psychiatric disorders, along with addiction disorders. The company will be a presenter at the H.C. Wainwright Global Investment Conference from September 13-15, and aims to bring investors awareness to the company through the conference.

    Companies are taking a good, long look at the damage done by companies like Purdue Pharma, and developing new treatments using psychedelics to provide better care for patients. Revitalist Lifestyle and Wellness Ltd. continues to move toward that goal by opening more clinics and bringing its services to more people across the country.

    DISCLAIMER: Microsmallcap.com (MSC) is the source of the Article and content set forth above.  References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. FN Media Group (FNM) is a third-party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated with MSC or any company mentioned herein. The commentary, views and opinions expressed in this release by MSC are solely those of MSC and are not shared by and do not reflect in any manner the views or opinions of FNM. Readers of this Article and content agree that they cannot and will not seek to hold liable MSC and FNM for any investment decisions by their readers or subscribers. MSC and FNM and their respective affiliated companies are a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.

     

     The Article and content related to the profiled company represent the personal and subjective views of the Author (MSC), and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author (MSC) has not independently verified or otherwise investigated all such information. None of the Author, MSC, FNM, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer's filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer's securities, including, but not limited to, the complete loss of your investment. FNM was not compensated by any public company mentioned herein to disseminate this press release but was compensated twenty five hundred dollars by MSC, a non-affiliated third party to distribute this release on behalf of Revitalist Lifestyle and Wellness Ltd.

     

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  2. TNX-1800 is a Live Virus Vaccine Designed to Elicit Durable T cell Immunity

    TNX-1800 is a Modified Version of Dr. Edward Jenner's Vaccine that Eradicated Smallpox, Engineered to Express SARS-CoV-2 Spike Protein

    In Animal Testing, TNX-1800 Protected Upper and Lower Airways After Challenge with SARS-CoV-2, Suggesting an Ability to Block Forward Transmission

    Phase 1 Trial of TNX-1800 for the Prevention of COVID-19 Expected to Start in the First Half of 2022

    CHATHAM, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it received the official written response from a Type B pre-Investigational New Drug (IND) meeting with…

    TNX-1800 is a Live Virus Vaccine Designed to Elicit Durable T cell Immunity

    TNX-1800 is a Modified Version of Dr. Edward Jenner's Vaccine that Eradicated Smallpox, Engineered to Express SARS-CoV-2 Spike Protein

    In Animal Testing, TNX-1800 Protected Upper and Lower Airways After Challenge with SARS-CoV-2, Suggesting an Ability to Block Forward Transmission

    Phase 1 Trial of TNX-1800 for the Prevention of COVID-19 Expected to Start in the First Half of 2022

    CHATHAM, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it received the official written response from a Type B pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-18001 (recombinant horsepox virus, live vaccine) as a potential SARS-CoV-2 vaccine to protect against COVID-19.

    Tonix believes the written response provides a path to agreements on the design of a Phase 1 study and the overall clinical development plan to qualify TNX-1800 as a vaccine to prevent COVID-19. Based on the response, the Company expects to begin a Phase 1 study in the first half of 2022.

    TNX-1800 is a live virus vaccine based on the horsepox viral vector platform designed to express the SARS-CoV-2 spike protein and to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. The horsepox virus is closely related to the vaccine developed by Dr. Edward Jenner more than 200 years ago that led to the eradication of smallpox.

    Seth Lederman, M.D., President and Chief Executive Officer of Tonix, stated, "The pre-IND meeting written response marks an important milestone in the development of TNX-1800. We have obtained FDA concurrence and clear guidance on the proposed manufacturing, nonclinical pharmacology and toxicology studies, and the Phase 1 clinical design." Dr. Lederman continued, "Operation Warp Speed (OWS) vaccines were available very rapidly and have made a huge contribution to the health of the U.S. population, but they have limitations, particularly in terms of the short duration of protection and the likely requirement for boosters. Concerns about durability of protection have led Pfizer and Moderna, the innovators of the two most widely used COVID-19 vaccines in U.S., to file or plan to file for approval of booster shots within eight months after the administration of each vaccine's second dose."

    "It's taken longer to develop live virus vaccines relative to the OWS vaccines," Dr. Lederman added, "but live virus vaccines for other viruses have proven to induce durable T cell immunity, prevent serious illness after infection and block forward transmission. These properties have been demonstrated with vaccines against smallpox, chickenpox, mumps, measles, and rubella, among others. We designed TNX-1800 as a potential single dose vaccine using a virus that is closely related to Dr. Jenner's vaccine, which provided long term, even lifetime T cell immunity to smallpox, prevented forward transmission of the smallpox virus, and eradicated that disease."

    Dr. Lederman continued, "Unlike smallpox, we do not expect COVID-19 to be eradicated because there are asymptomatic spreaders, a relatively long period when people are infectious before they become symptomatic and numerous animal reservoirs. Like Jenner's smallpox vaccine, we expect TNX-1800 can potentially be scaled up for manufacturing and will not require a costly and cumbersome cold chain for distribution and storage. We expect it will also be glass-sparing, with 100 doses filled per vial."

    "Many believe that after the COVID pandemic passes COVID will become endemic, and it will likely remain a long-term concern," Dr. Lederman added. "Because of this, we believe the need for new vaccine technologies will be ongoing and may lead to vaccines that are tailored to each person's health, genetics or age using precision medicine. Ultimately, a childhood vaccination like the MMR for measles, mumps and rubella with long lasting protection may be what's needed to control COVID in the future. Together with an expected strong and durable immune response, ability to manufacture at scale, store and ship in standard refrigeration, a live virus vaccine like TNX-1800 could become a global product."

    Anthony Macaluso, Ph.D., Executive Vice President of Strategic Development of Tonix, commented, "We previously reported the positive results of TNX-1800 in animals after a live SARS-CoV-2 challenge. Animals vaccinated with TNX-1800 had undetectable SARS-CoV-2 in their upper and lower airways six days after challenge with SARS-CoV-2. Animals vaccinated with TNX-1800 manifested both neutralizing antibodies and a ‘take', which is a skin reaction to horsepox vaccination that also serves as a validated biomarker of functional T cell immunity."

    Dr. Macaluso continued, "The 'take‘ is considered important because it is otherwise difficult and costly to measure the T cell response to a vaccine. Vaccines that elicit a strong T cell response, like horsepox and closely related vaccinia virus vaccine, have been established to provide long-term, durable immunity and to block forward transmission. In the successful campaign to eradicate smallpox, which was also spread by the respiratory route like COVID-19, the ‘take' was used as a biomarker for protective immunity. We believe the absence of detectable CoV-2 in the upper airways shows the potential for TNX-1800 to decrease shedding of virus and is consistent with decreased forward transmission."

    Dr. Lederman added, "The reliable durability of vaccine protection from the OWS vaccines is under review1, leading the makers of the two mRNA vaccines to take steps towards seeking approval of booster shots and setting up the possible need for boosters on a regular basis in the future. The U.S. government has pledged to make available booster shots for the mRNA vaccines available starting on September 20, pending FDA approval. The prospect of boosters poses a challenging and expensive public health policy implementation in the U.S. In contrast to the short duration of protection of the OWS COVID-19 vaccines, live virus vaccines typically provide decades or life-long protective immunity against those diseases. Live virus vaccines activate the immune system in ways that scientists do not completely understand and have not yet been able to recreate with other technologies."

    About TNX-18001

    TNX-1800 is a live modified horsepox virus vaccine for percutaneous administration that is designed to express the Spike protein of the SARS-CoV-2 virus and to elicit a predominant T cell response. TNX-1800 is based on a horsepox vector, which is a live replicating, attenuated virus that elicits a strong immune response. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials. Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor horsepox3-7. Relative to vaccinia, horsepox has substantially decreased virulence in mice7. Molecular analysis shows that horsepox is closer than modern vaccinia vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner, which protected against smallpox, a respiratory-transmitted disease caused by the orthopox virus, variola.4-7 Vaccine genome researchers have established the contemporaneous use of horsepox and horsepox-related viruses in the United States as smallpox vaccines in the 1860's, and found a remarkable degree of identity with the circa 1860 U.S. smallpox vaccine VK05 and the 1976 Mongolian horsepox isolate called MNR-76, upon which Tonix's TNX-801 is based.3,8-10 Tonix's proprietary horsepox vector is believed to be more closely related to Jenner's vaccinia vaccine than modern vaccinia vaccines, which appear to have evolved by deletions and mutations to a phenotype of larger plaque size in tissue culture and greater virulence in mice. The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate11. Tonix's TNX-1800 vaccine candidate is administered percutaneously using a two-pronged, or "bifurcated" needle. The major cutaneous reaction or "take" to vaccinia vaccine was described by Dr. Edward Jenner in 179612 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization's (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960's. The "take" is a measure of functional T cell immunity validated by the eradication of smallpox. Tonix reported that immunization with a single dose of TNX-1800 induced "takes" and neutralizing anti-SARS-CoV-2 antibodies in non-human primates. 13

    1TNX-1800 is in the pre-IND stage and has not been approved for any indication.

    2Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

    Statement. URL: www.cdc.gov/media/releases/2021/s0818-covid-19-booster-shots.html

    3Tulman ER, et al. (2006) J Virol. 80(18):9244-58.PMID:16940536

    4Qin et al. J. Virol. 89:1809 (2015).

    5Esparza E, et al Vaccine. (2017) 35(52):7222-7230.

    5Schrick L et al N Engl J Med (2017); 377:1491-1492

    7Noyce RS, et al. (2018) PLoS One. 13(1):e0188453

    8Brinkmann A et al, Genome Biology (2020) 21:286 https://doi.org/10.1186/s13059-020-02202-0

    9Duggan A et al. Genome Biology (2020) 21:175 https://doi.org/10.1186/s13059-020-02079-z

    10Esparza J et al. Vaccine. (2020); 38(30):4773-4779.

    11Trindale GS et al. Viruses (2016) (12). pii: E328. PMID:27973399

    12Jenner E. "An Inquiry Into the Causes and Effects of the Variole Vaccinae, a Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire and Known by the Name of the cow‐pox." London: Sampson Low, 1798.

    13Tonix Press Release: "Tonix Pharmaceuticals Reports Positive COVID-19 Vaccine Efficacy Results in Non-Human Primates Vaccinated with TNX-1800 and Challenged with Live SARS-CoV-2. URL: ir.tonixpharma.com/press-releases/detail/1255/tonix-pharmaceuticals-reports-positive-covid-19-vaccine"

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. TNX-35003 (sangivamycin) is a small molecule antiviral drug for COVID-19 in the pre-IND stage of development.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2TNX-1800 and TNX-801 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication.

    3TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505



    Primary Logo

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  3. CHATHAM, N.J., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will present at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13-15, 2021.

    Investors interested in arranging a virtual meeting with the Company's management during the conference should contact the H.C. Wainwright conference coordinator. A webcast of the presentation will be available on-demand beginning September 13, 2021 at 7:00 a.m. under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com. A webcast replay…

    CHATHAM, N.J., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will present at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13-15, 2021.

    Investors interested in arranging a virtual meeting with the Company's management during the conference should contact the H.C. Wainwright conference coordinator. A webcast of the presentation will be available on-demand beginning September 13, 2021 at 7:00 a.m. under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com. A webcast replay will be accessible for 90 days following the event.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. TNX-35003 (sangivamycin) is a small molecule antiviral drug for COVID-19 in the pre-IND stage of development.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    3TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke, an ICR Company

    peter.vozzo@westwicke.com

    (443) 213-0505



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  4. Company Plans to Submit an IND to Support a Phase 2 Clinical Trial of TNX-102 SL for the Treatment of Long COVID

    Long COVID Symptoms of Pain, Sleep Disturbance, Fatigue and Brain Fog Overlap with Symptoms of Fibromyalgia, for which TNX-102 SL is in Mid-Phase 3 Development

    Long COVID Afflicts More Than 30% of Patients Following Infection with SARS-CoV-2, the Virus that Causes COVID-19, and is Expected to be a Global Health Burden

    CHATHAM, N.J., Aug. 24, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it received the official minutes from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and…

    Company Plans to Submit an IND to Support a Phase 2 Clinical Trial of TNX-102 SL for the Treatment of Long COVID

    Long COVID Symptoms of Pain, Sleep Disturbance, Fatigue and Brain Fog Overlap with Symptoms of Fibromyalgia, for which TNX-102 SL is in Mid-Phase 3 Development

    Long COVID Afflicts More Than 30% of Patients Following Infection with SARS-CoV-2, the Virus that Causes COVID-19, and is Expected to be a Global Health Burden

    CHATHAM, N.J., Aug. 24, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it received the official minutes from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-102 SL1 (cyclobenzaprine HCl sublingual tablets) as a potential treatment for Long COVID Syndrome (Long COVID), which is now known officially as Post-Acute Sequelae of COVID-19 (PASC2). Tonix believes the minutes provide a path to agreement on the design of a Phase 2 study and the overall clinical development plan to qualify TNX-102 SL as an indicated treatment for a subset of patients affected by Long COVID. Based on the minutes, the Company is planning to submit the IND in the fourth quarter of 2021 to support a Phase 2 study for the management of a subset of Long COVID patients whose symptoms overlap with fibromyalgia.

    Seth Lederman, M.D., President and Chief Executive Officer of Tonix, stated, "Long COVID is a new, complex and heterogeneous disorder. Long COVID is a protracted syndrome experienced by many people following SARS-CoV-2 infection that can include a number of persistent disabling symptoms, including fatigue, widespread pain, sleep disturbance, brain fog or difficulty concentrating, arthralgias, diffuse myalgia, olfactory dysfunction, and headache.3 Our Phase 2 study will focus on Long COVID patients whose primary symptoms overlap with fibromyalgia, and, therefore, our Long COVID program leverages what we have learned about the pharmacodynamic activity of TNX-102 SL from more than 1,000 participants who have been or are enrolled in our fibromyalgia trials to date. Long COVID has been compared to fibromyalgia because of the common symptoms of sleep disturbance, persistent widespread pain, fatigue, and brain fog.4 Additionally, Long COVID, like fibromyalgia, is experienced by women at a rate approximately four times that of men.5 The 2003 SARS outbreak, due to an earlier coronavirus, was also described as causing a post-SARS syndrome similar to fibromyalgia.6"

    Gregory Sullivan, M.D., Chief Medical Officer of Tonix, commented, "Based on our positive fibromyalgia Phase 3 RELIEF study in which TNX-102 SL showed activity in addressing persistent pain, sleep disturbance, memory, fatigue and energy, we are hopeful that TNX-102 SL might provide a unique treatment opportunity for the symptoms of Long COVID in patients whose symptoms overlap with those of fibromyalgia. We believe the core symptoms of Long COVID, including fatigue, sleep disturbances, persistent pain and diffuse myalgia share an underlying pathogenesis with fibromyalgia."

    Dr. Lederman added, "TNX-102 SL is in mid-Phase 3 development for the treatment of fibromyalgia. The proposed mechanism of TNX-102 SL is to improve sleep quality. Since disturbed sleep is linked to exacerbation and chronicity of a number of pain, neuropsychiatric and addictive disorders, we plan to conduct clinical trials to determine whether TNX-102 SL improves sleep in certain of these other disorders in addition to Long COVID and fibromyalgia."

    About Long COVID or Post-Acute Sequelae of SARS-CoV-2 (PASC)

    Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. These individuals experience a constellation of symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 virus from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive impairment described as "brain fog" or memory disturbance, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.3 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as "long-haulers". Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.7 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID last December.8 While the vaccines available in the U.S. under Emergency Use Authorization have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID."

    About TNX-102 SL

    TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for fibromyalgia, PTSD, alcohol use disorder and agitation in Alzheimer's disease. The U.S. Patent and Trademark Office (USPTO) has issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in these patents are important elements of Tonix's proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18009, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8019, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. TNX-350010 (sangivamycin) is a small molecule antiviral drug for COVID-19 in the pre-IND stage of development.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Feb. 24, 2021 - White House COVID-19 Response Team press briefing; Feb 25, 2021 - policy brief from the World Health Organization on long COVID.

    3Nalbandian, Ani, et al. "Post-acute COVID-19 syndrome." Nature Medicine (2021): 1-15.

    4Clauw DJ, Häuser W, Cohen SP, Fitzcharles M-A. Considering the potential for an increase in chronic pain after the COVID-19 pandemic. Pain. 2020 Aug; 161(8): 1694–1697.

    5Cox, D. "Why are women more prone to long Covid?" The Guardian. 13 Jun 2021 https://www.theguardian.com/society/2021/jun/13/why-are-women-more-prone-to-long-covid

    6Moldofsky H, Patcai J. Chronic widespread musculoskeletal pain, fatigue, depression and disordered sleep in chronic post-SARS syndrome; a case-controlled study. BMC Neurol 2011;11:37.

    7Briggs, Andrew, and Anna Vassall. "Count the cost of disability caused by COVID-19." (2021): 502-505.

    8The NIH provision of Title III Health and Human Services, Division M--Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021. The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.

    9TNX-1800 and TNX-801 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication.

    10TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com 

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com 

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com 

    (443) 213-0505



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  5. Central Nervous System Pipeline Progressing with Two Phase 2 Studies (TNX-1300 and TNX-1900) and One Phase 3 Study (TNX-102 SL) Expected to Start This Year

    COVID-19 Pipeline Progressing with First-in-Human Trial of TNX-2100, a Novel in vivo Skin Test for COVID-19 T cell Immunity, Expected to Start This Year

    New Advanced Development Center, Currently Under Construction, and Planned Acquisition of Infectious Disease R&D Facility Will Expand Internal R&D and Manufacturing Capabilities for Vaccines and Antiviral Therapeutics, With Initial Focus on COVID-19

    At June 30, 2021, Cash and Cash Equivalents Totaled Approximately $166 Million

    CHATHAM, N.J., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix…

    Central Nervous System Pipeline Progressing with Two Phase 2 Studies (TNX-1300 and TNX-1900) and One Phase 3 Study (TNX-102 SL) Expected to Start This Year

    COVID-19 Pipeline Progressing with First-in-Human Trial of TNX-2100, a Novel in vivo Skin Test for COVID-19 T cell Immunity, Expected to Start This Year

    New Advanced Development Center, Currently Under Construction, and Planned Acquisition of Infectious Disease R&D Facility Will Expand Internal R&D and Manufacturing Capabilities for Vaccines and Antiviral Therapeutics, With Initial Focus on COVID-19

    At June 30, 2021, Cash and Cash Equivalents Totaled Approximately $166 Million

    CHATHAM, N.J., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the second quarter ended June 30, 2021 and provided an overview of recent operational highlights.

    "Our clinical, manufacturing, and regulatory teams are advancing four programs into clinical trials by the end of 2021," said Seth Lederman, M.D., President and Chief Executive Officer. "We look forward to initiating Phase 2 studies of TNX-1300 for cocaine intoxication and TNX-1900 for chronic migraine in the third and fourth quarters of 2021, respectively. We also expect to initiate a Phase 3 study of TNX-102 SL for PTSD outside of the U.S. and a first-in-human study of TNX-2100, a skin test diagnostic for COVID-19 T cell immunity, in the fourth quarter of 2021."

    Dr. Lederman continued, "We are expanding our R&D and manufacturing facilities. In July we announced an agreement to acquire an infectious disease research facility in Frederick, MD, and earlier this month we began construction on our Advanced Development Center (ADC) in New Bedford MA. We expect these facilities, coupled with our planned commercial scale manufacturing facility for vaccines in Hamilton, MT, will enable us to avoid future outsourcing bottlenecks and to work with greater efficiency in developing our programs for COVID-19, its variants, and other infectious diseases."

    Dr. Lederman added, "Recent reports of COVID-19 outbreaks in the U.S. and elsewhere, due primarily to the Delta variant, point to the urgent needs for more robust vaccines and more potent antiviral therapeutics. We believe the recent steps we have taken to strengthen our internal capabilities with company-controlled R&D and manufacturing facilities will accelerate our full pipeline of COVID-19 product candidates, which currently includes the TNX-1800 vaccine, TNX-3500 antiviral, TNX-2100 diagnostic, and TNX-102 SL for treating Long COVID."

    Recent Highlights—Key Product Candidates*

    Central Nervous System (CNS) Pipeline

    TNX-102 SL (cyclobenzaprine HCl sublingual tablets): small molecule for the management of fibromyalgia

    • In July 2021, Tonix announced that the RALLY study, the second Phase 3 trial of TNX-102 SL 5.6 mg for fibromyalgia, stopped enrolling new participants following recommendation from a pre-planned interim analysis by the Independent Data Monitoring Committee (IDMC). Based on interim analysis results of the first 50% of targeted participants (n=337), the IDMC recommended stopping the trial for futility as TNX-102 SL was unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall change from baseline in daily diary pain severity scores between those treated with TNX-102 SL 5.6 mg (2x 2.8 mg tablets) and those receiving placebo. Tonix remains blinded to the detailed interim analysis results and only received the recommendation made by the IDMC. Preliminary blinded safety data from these participants did not reveal any new safety signals, and the decision to discontinue enrolling new participants is not related to safety. The Company intends to continue studying those participants currently enrolled until completion and then proceed with a full analysis of the unblinded data, with the topline results expected to be reported in the fourth quarter of 2021, to determine the next steps in this program.

    TNX-102 SL for the treatment of Posttraumatic Stress Disorder (PTSD)

    • Tonix intends to meet with the U.S. Food and Drug Administration (FDA) to discuss potential new endpoints for the indication of treatment of PTSD in the third quarter of 2021. The Company also expects to begin enrolling a Phase 3 study of TNX-102 SL in police in Kenya in the fourth quarter of 2021.

    TNX-102 SL for the treatment of Long COVID Syndrome or Post-Acute Sequelae of COVID-19 (PASC)

    • The Company met with the FDA in the third quarter of 2021 to seek agreement on the design of a potential Phase 2 pivotal study and the overall clinical development plan for TNX-102 SL as an indicated treatment for Long COVID. Tonix expects to receive official minutes from this meeting in the third quarter of 2021.

    TNX-1300 (recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication

    • Tonix expects to initiate a Phase 2 open-label safety study in an emergency department setting to study TNX-1300 in the third quarter of 2021. Cocaine esterase is the most potent known catalyst for cocaine degradation. Results of a positive Phase 2 study of volunteer cocaine users in a controlled laboratory setting were reported prior to Tonix licensing the technology.

    TNX-1900 (intranasal potentiated oxytocin): small peptide for migraine, craniofacial pain, insulin resistance and related disorders

    • Tonix intends to submit an Investigational New Drug (IND) application to the FDA in the third quarter of 2021 and is targeting to start a Phase 2 study of TNX-1900 for the prophylactic treatment of chronic migraine in the U.S. in the fourth quarter of 2021. A Phase 2 trial under an investigator-initiated IND was completed in the U.S. using the TNX-1900 formulation prior to Tonix's acquisition of the program.

    TNX-601 CR (tianeptine oxalate and naloxone controlled-release tablets): small molecule for the treatment of major depressive disorder, PTSD and neurocognitive dysfunction associated with corticosteroid use.

    • Tonix previously completed a Phase 1 trial for formulation development outside of the U.S. Based on official minutes from a pre-IND meeting with the FDA, the Company expects to initiate a Phase 2 study for the treatment of depression in the first half of 2022, pending results of nonclinical toxicology studies and IND clearance.

    COVID-19 Pipeline

    TNX-1800 (live virus vaccine based on Tonix's horsepox virus vector, TNX-801): COVID-19 vaccine designed as a single-administration vaccine to elicit T cell immunity

    • A Phase 1 safety study using TNX-1800 in humans is anticipated to start in the first half of 2022, pending IND clearance from the FDA and the production of cGMP material. In March 2021, positive efficacy results from a study of TNX-1800 in which non-human primates were vaccinated with TNX-1800 and challenged with live SARS-CoV-2 were reported. TNX-1800 was found to induce protection against infection in both upper and lower airways, which suggests an ability to inhibit forward transmission. The Company believes these findings also demonstrate the flexibility of the horsepox vaccine platform, and its capability to be engineered to construct new vaccines to protect against other diseases of interest in military and civilian populations.

    TNX-2100 (diagnostic skin test): SARS-CoV-2 epitope peptide mixtures for intradermal administration to measure the delayed-type hypersensitivity (DTH) reaction to SARS-CoV-2

    • Tonix expects to initiate a first-in-human clinical study in the fourth quarter of 2021. TNX-2100, designed to measure functional in vivo T cell immunity to SARS-CoV-2, is a test comprising three different mixtures of synthetic peptides (TNX-2110, -2120 and -2130). Tonix's proposed skin test has the potential to serve as: 1) a biomarker for cellular (T-cell mediated) immunity and protective immunity; 2) a method to stratify participants in COVID-19 vaccine trials by immune status; 3) an endpoint in COVID-19 vaccine trials, and 4) a biomarker of durability of vaccine protection.

    TNX-3500 (sangivamycin): antiviral inhibitor of SARS-CoV-2 for the treatment of COVID-19 and potential other viral disorders

    • In April 2021, Tonix entered into an exclusive worldwide licensing agreement with OyaGen, Inc. to develop TNX-3500 (sangivamycin, formerly OYA1) for the treatment of COVID-19 and potentially other viral disorders. It has demonstrated broad-spectrum activity in laboratory-based assays against the coronaviruses SARS-CoV-2 and MERS-CoV. Tonix intends to conduct further nonclinical animal studies prior to submitting an IND and initiating a Phase 1 study.

    Immunology Pipeline

    TNX-1500 (anti-CD154 monoclonal antibody): third generation monoclonal antibody as first line monotherapy for preventing or treating organ transplant rejection and treating autoimmune disorders.

    • Tonix expects to start a Phase 1 study in the second half of 2022. In experiments at the Massachusetts General Hospital, a teaching hospital of Harvard Medical School, TNX-1500 product candidate is being studied as monotherapy or in combination with mycophenolate mofetil in heart and kidney organ transplants in non-human primates. Preliminary results from an ongoing experiment in heart transplants indicated that TNX-1500 appeared to have comparable efficacy to historical experiments using the chimeric mouse-human anti-CD40L monoclonal antibody (mAb) hu5c8 and no evidence of thrombosis has been observed.

    • *All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication.

    Recent Highlights—Facilities and Corporate

    • In August 2021, Tonix announced that it has commenced construction on its Advanced Development Center (ADC) for the development and manufacturing of Good Manufacturing Practice or GMP live-virus vaccines to support Phase 1 and 2 clinical trials. The facility is planned to be BSL-2 and expected to be operational in the first half of 2022. A groundbreaking ceremony held August 3, 2021 was attended by local, state, and federal officials, including U.S. Representative Bill Keating, Massachusetts Housing and Economic Development Secretary Mike Kennealy and New Bedford Mayor Jon Mitchell.
    • In July 2021, Tonix entered into a contingent non-binding Purchase and Sales Agreement in connection with an infectious disease R&D facility in Maryland, which is expected to provide internal capacity to discover and develop vaccines and antiviral drugs against COVID-19, its variants, and other infectious diseases. The BSL-2 facility, currently owned and operated by Tonix partner Southern Research, has housed research relating to Tonix's COVID-19 vaccine candidate, TNX-1800, and to Tonix's smallpox and monkeypox candidate, TNX-801. Tonix expects the transaction to close in the fourth quarter of 2021.
    • In June 2021, Tonix announced that plans were advancing to construct a commercial-scale manufacturing facility to develop and manufacture vaccines in Hamilton, Montana. Construction on the greenfield site is expected to start in 2022.
    • Tonix announced its addition to both the broad-market Russell 3000® index and the small-cap Russell 2000® Index as part of the annual reconstitution of the Russell stock indexes, which was effective after the market opened on June 28, 2021. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.
    • In July 2021, Tonix announced the appointment to its Board of Directors of Carolyn E. Taylor, who brings over 35 years of experience in corporate law, including 15 years as a partner at Covington & Burling LLP and six years as general counsel of two start-up companies.

    Recent Highlights--Financial

    As of June 30, 2021, Tonix had $165.7 million of cash and cash equivalents, compared to $77.1 million as of December 31, 2020.

    Cash used in operations was approximately $19.1 million for the three months ended June 30, 2021, compared to $10.1 million for the three months ended June 30, 2020. The increase in cash used in operations resulted primarily from an increase in research and development programs and general and administrative activities as defined below.

    Second Quarter 2021 Financial Results

    Research and development expenses for the second quarter of 2021 were $18.1 million, compared to $10.6 million for the same period in 2020. This increase is predominately due to increased non-clinical expenses of $7.1 million, manufacturing expenses of $2.7 million, employee-related expenses of $1.2 million and regulatory/legal expenses of $0.4 million offset by a decrease in clinical expenses of $4.1 million. We expect research and development expenses to increase during 2021 as we move our clinical development programs forward and continue to invest in our development pipeline.

    General and administrative expenses for the second quarter of 2021 were $5.4 million, compared to $3.6 million for the same period in 2020. The increase is primarily due to an increase in employee-related expenses of $1.1 million, an increase in investor relations/public relations expenses of $0.2 million, an increase in financial reporting expenses of $0.2 million and an increase in insurance premiums of $0.2 million.

    Net loss available to common stockholders was $23.6 million, or $0.07 per share, basic and diluted, for the second quarter of 2021, compared to net loss of $14.2 million, or $0.23 per share, basic and diluted, for the second quarter of 2020. The basic and diluted weighted average common shares outstanding for the second quarter of 2021 was 331,281,242, compared to 62,391,006 shares for the second quarter of 2020.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. TNX-35003 (sangivamycin) is a small molecule antiviral drug in the pre-IND stage of development.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2TNX-1800 and TNX-801 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication.

    3TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development of R&D facilities, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.



    TONIX PHARMACEUTICALS HOLDING CORP.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (In Thousands, Except Share and Per Share Amounts)
    (unaudited)
     
      Three Months Ended June 30,  Six Months Ended June 30,
      2021  2020  2021  2020
    COSTS AND EXPENSES:               
    Research and development $18,133  $10,571  $33,460  $15,247 
    General and administrative  5,429   3,621   10,838   6,242 
       23,562   14,192   44,298   21,489 
                    
    Operating Loss  (23,562)  (14,192)  (44,298)  (21,489)
                    
    Interest and other income, net  9   13   92   37 
                    
    Net loss  (23,553)  (14,179)  (44,206)  (21,452)
                    
    Warrant deemed dividend           451 
    Preferred stock deemed dividend           1,260 
                    
    Net loss available to common stockholders $(23,553) $(14,179) $(44,206) $(23,163)
                    
    Net loss per common share, basic and diluted $(0.07) $(0.23) $(0.14) $(0.54)
                    
    Weighted average common shares outstanding, basic and diluted  331,281,242   62,391,006   310,807,619   43,209,988 



    TONIX PHARMACEUTICALS HOLDING CORP.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (in thousands)
    (Unaudited)
     
     June 30, 2021

     December 31, 20201
    Assets    
    Cash and cash equivalents$165,719 $77,068
    Prepaid expenses and other 11,550  10,921
    Total current assets 177,269  87,989
    Other non-current assets 11,896  10,194
    Total assets$189,165 $98,183
         
    Liabilities and stockholders' equity  
    Total liabilities$8,672 $10,535
    Stockholders' equity 180,493  87,648
    Total liabilities and stockholders' equity$189,165 $98,183

    1The condensed consolidated balance sheets for the year ended December 31, 2020 has been derived from the audited financial statements but does not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505



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  6. CHATHAM, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it will hold a groundbreaking ceremony at the Company's planned 45,000 square foot clinical scale manufacturing facility in the New Bedford Business Park in Massachusetts on August 3, 2021 at 11:00 a.m. ET. The new facility is expected to house Tonix's Advanced Development Center (ADC) for accelerated research, development and analytical capabilities, as well as the production of clinical trial quality vaccines for infectious diseases, including COVID-19. The ceremony marks the formal start of site construction. Tonix expects the facility to be operational in…

    CHATHAM, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it will hold a groundbreaking ceremony at the Company's planned 45,000 square foot clinical scale manufacturing facility in the New Bedford Business Park in Massachusetts on August 3, 2021 at 11:00 a.m. ET. The new facility is expected to house Tonix's Advanced Development Center (ADC) for accelerated research, development and analytical capabilities, as well as the production of clinical trial quality vaccines for infectious diseases, including COVID-19. The ceremony marks the formal start of site construction. Tonix expects the facility to be operational in the first half of 2022.

    Plans for the ADC include single-use bioreactors and purification suites with equipment for Good Manufacturing Practice (GMP) production of vaccines for clinical trials, including when fully operational, the capability of producing sterile vaccines in glass bottles. The ADC is intended to be Biosafety Level 2 (BSL-2). At full capacity, the facility can employ up to 70 researchers, scientists, manufacturing and technical support staff.

    U. S. Representative Bill Keating is expected to attend the event, along with Massachusetts Housing and Economic Development Secretary, Mike Kennealy, the mayor of New Bedford, Jon Mitchell, and Seth Lederman, M.D., President and Chief Executive Officer of Tonix.

    "The South Coast is fast becoming a significant player in biotech in Massachusetts, and Tonix Pharmaceuticals' decision to open the Advanced Development Center within the New Bedford Business Park is a positive indicator of future economic growth throughout the region," said Congressman Bill Keating. "Tonix Pharmaceuticals is bringing good jobs to our region, and I look forward to watching their growth as the local economy continues to benefit from increased investment on the South Coast, including in South Coast Rail. The research, development, and manufacturing planned to take place in the new ADC has the potential to improve lives all over the world, and that is something we can all be proud of."

    "We welcome Tonix Pharmaceuticals to the New Bedford Business Park as they strive to develop important solutions that address the health challenges of today and tomorrow," said Jon Mitchell, mayor of the City of New Bedford.

    "The ADC is expected to greatly enhance our internal capacity for development activities, but, even more importantly, add a manufacturing capability for clinical trial quality vaccines. We at Tonix are grateful to the Town of Dartmouth for their support. We also thank the City of New Bedford for its cooperation with the Town of Dartmouth on this project," stated Dr. Lederman. "The initiation of construction is a significant milestone in ultimately adding to our competitive advantage in responding quickly to emerging infectious diseases utilizing our growing range of vaccine technologies and protein-based therapeutic platforms."

    The facility is located in the New Bedford Business Park in a section of the park that is located in the Town of Dartmouth, Massachusetts. The two municipalities work together to accommodate businesses located in the Dartmouth portion of the park as the roads are inaccessible through Dartmouth and municipal services are provided by the City of New Bedford.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. TNX-35003 (sangivamycin) is a small molecule antiviral drug in the pre-IND stage of development.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    3TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development and operation of the ADC, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



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  7. R&D Facility in Frederick, MD is Expected to Provide Internal Capacity to Discover and Develop Vaccines and Antiviral Drugs Against COVID-19, its Variants and Other Infectious Diseases

    Facility, Currently Owned and Operated by Tonix Partner Southern Research, has Housed Research Relating to Tonix's COVID-19 Vaccine Candidate, TNX-1800 and Smallpox and Monkeypox Vaccine Candidate, TNX-801

    CHATHAM, N.J., July 27, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the signing of a Purchase and Sale Agreement to acquire an approximately 48,000 square foot research and development (R&D) facility in Frederick, MD to support Tonix's expanding…

    R&D Facility in Frederick, MD is Expected to Provide Internal Capacity to Discover and Develop Vaccines and Antiviral Drugs Against COVID-19, its Variants and Other Infectious Diseases

    Facility, Currently Owned and Operated by Tonix Partner Southern Research, has Housed Research Relating to Tonix's COVID-19 Vaccine Candidate, TNX-1800 and Smallpox and Monkeypox Vaccine Candidate, TNX-801

    CHATHAM, N.J., July 27, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the signing of a Purchase and Sale Agreement to acquire an approximately 48,000 square foot research and development (R&D) facility in Frederick, MD to support Tonix's expanding infectious disease pipeline, including TNX-1800, a live replicating viral vaccine designed to protect against COVID-19, TNX-801, a live vaccine designed to protect against smallpox and monkeypox, and TNX-3500, a small molecule antiviral to inhibit replication of SARS-CoV-2.

    Tonix agreed to purchase the R&D facility from Southern Research, a research collaboration partner for TNX-1800 and TNX-801 development. The facility currently operates at biosafety level 2 (BSL-2) containment. Pending transfer and approval of relevant permits, Tonix expects the transaction to close and the facility to be operational in the fourth quarter of 2021. Southern Research plans to consolidate its research activities at its Birmingham, AL campus. Tonix and Southern Research plan to continue those aspects of their collaboration on the development of vaccines and antivirals that are ongoing at the Birmingham, AL campus.

    "The Fredrick facility will be a major expansion of our R&D capabilities," stated Seth Lederman, M.D., President and Chief Executive Officer of Tonix. "We believe this facility will ensure adequate resources and capacity to support and grow our pipeline of vaccines and antiviral therapeutics. In addition, we view control of in-house facilities as a strategic capability to ensure the speed and efficiency with which we can develop vaccines and antiviral products in the future against known, emerging or novel pathogens."

    Dr. Lederman continued, "While COVID-19 has the appearance of being controlled in certain geographic centers, reports of increasing infections in both unvaccinated and vaccinated individuals, primarily related to new variants, have led to new mask mandates and restrictions in parts of the U.S. as well as new lockdowns and other restrictions in Europe and elsewhere. These concerning trends point to an urgent need for more robust vaccine technology and better overall preparedness. The COVID-19 pandemic revealed weaknesses in the U.S. domestic capability to conduct infectious disease R&D and produce vaccines and therapeutics, particularly in the setting of an interrupted global supply chain. We believe our planned capabilities at the Frederick facility will provide greatly needed domestic resources. The facility is ideally located in Maryland's 'biotech corridor', which is rich in highly skilled talent, and is also close to the center of the U.S. biodefense research community."

    Josh Carpenter, PhD, Chief Executive Officer of Southern Research stated, "We are delighted that Tonix will be acquiring the Frederick research campus. This is another chapter in a robust partnership that will be made even stronger. We have enjoyed partnering with Tonix on TNX-1800 and TNX-801 vaccine projects and look forward to continued collaboration on these projects, as well as TNX-3500 with work performed at our Birmingham campus."

    Tonix's Fredrick R&D facility will complement its Advanced Development Center (ADC) being constructed in New Bedford, MA and the Commercial Manufacturing Center (CMC) that Tonix is planning in Hamilton, MT. The ADC will house laboratories dedicated to process analytical development and pilot manufacturing of its vaccine candidates. The CMC is expected to support commercial scale manufacturing of vaccine products.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. TNX-35003 (sangivamycin) is a small molecule antiviral drug in the pre-IND stage of development.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    3TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    About Southern Research

    Founded in 1941, Southern Research (SR) is an independent, 501(c)(3) nonprofit affiliated with the University of Alabama at Birmingham. SR is an applied scientific research organization with more than 400 scientists and engineers working across four divisions: CRO services, Drug Discovery, Energy Storage, and Engineering. SR has supported the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries. SR works on behalf of the National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Energy, NASA and other major aerospace firms, utility companies, and other external academic, industry and government agencies. SR pursues entrepreneurial and collaborative initiatives to develop and maintain a pipeline of intellectual property and innovative technologies that positively impact real-world problems. SR has numerous ongoing drug discovery programs, which encompass drug discovery programs to combat various forms of cancer, Alzheimer's, schizophrenia, opioid use disorder, human immunodeficiency virus, disease, Parkinson's, tuberculosis, influenza, and others. SR's strong history, which includes nearly 80 years of successful collaborations to solve complex problems, has led to the discovery of seven FDA-approved cancer drugs—a number rivaling any other U.S. research institute. Furthermore, experts at SR are well-equipped to assist with the challenging landscapes of drug design and development technologies and market viability. SR is headquartered in Birmingham, Alabama.

    Further information about SR can be found at https://southernresearch.org

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development of R&D facilities, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



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  8. RALLY Study Will Stop Enrolling New Participants Following Recommendation from an Interim Analysis Indicating Inadequate Separation from Placebo at Week-14 in the First 50% of Participants, Based on the Original Targeted Study Size

    Company Plans to Unblind and Report Topline Results in the Fourth Quarter of 2021 Following Completion of Study for Currently Enrolled Participants

    RALLY Study Follows Announcement in December 2020 of Positive Results from First Phase 3 Study, RELIEF, of TNX-102 SL 5.6 mg for the Management of Fibromyalgia

    CHATHAM, N.J., July 23, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that the Company has…

    RALLY Study Will Stop Enrolling New Participants Following Recommendation from an Interim Analysis Indicating Inadequate Separation from Placebo at Week-14 in the First 50% of Participants, Based on the Original Targeted Study Size

    Company Plans to Unblind and Report Topline Results in the Fourth Quarter of 2021 Following Completion of Study for Currently Enrolled Participants

    RALLY Study Follows Announcement in December 2020 of Positive Results from First Phase 3 Study, RELIEF, of TNX-102 SL 5.6 mg for the Management of Fibromyalgia

    CHATHAM, N.J., July 23, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that the Company has decided to stop enrollment in the Phase 3 RALLY study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia following an unblinded, pre-planned interim analysis by the Independent Data Monitoring Committee (IDMC) of the RALLY study. Based on interim analysis results of the first 50% (n=337) enrolled participants, the IDMC recommended stopping the trial for futility as TNX-102 SL is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall change from baseline in daily diary pain severity scores between those treated with TNX-102 SL 5.6 mg (2x 2.8 mg tablets) and those receiving placebo. Tonix remains blinded to the detailed interim analysis results and only received the recommendation made by the IDMC. Preliminary blinded safety data from these participants did not reveal any new safety signals, and the decision to discontinue enrolling new participants is not related to safety. The Company intends to continue studying those participants currently enrolled until completion and then proceed with a full analysis of the unblinded data, with the topline results expected to be reported in the fourth quarter of 2021, to determine the next steps in this program.

    "We are surprised and disappointed that the interim analysis did not support continued enrollment in this Phase 3 RALLY study, especially considering the previous Phase 3 RELIEF study, which had a similar design and achieved statistical significance on the primary endpoint. After the currently enrolled participants complete the study, we will proceed with a full analysis of the unblinded data from the study to determine the next steps in this program," commented Seth Lederman, M.D., President and Chief Executive Officer. "These results underscore the difficulty in managing and treating fibromyalgia. We thank the patients, caregivers and investigators who participated in the RALLY study."

    About the Phase 3 RALLY Study

    The RALLY study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets). The two-arm trial has enrolled 514 participants across approximately 40 U.S. sites. For the first two weeks of treatment, there is a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. After the first two weeks, all participants have the dose increased to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for 12 weeks. The primary endpoint is daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation.

    Additional details about the RALLY study are available at clinicaltrials.gov (NCT04508621).

    About Fibromyalgia

    Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

    About TNX-102 SL

    TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin-2A, alpha-1 adrenergic, histamine-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for fibromyalgia, PTSD, alcohol use disorder and agitation in Alzheimer's disease. The U.S. Patent and Trademark Office (USPTO) has issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in these patents are important elements of Tonix's proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to clinical trials, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



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  9. NEW YORK, July 19, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix), a clinical-stage biopharmaceutical company, today announced the appointment of Carolyn E. Taylor to its Board of Directors, effective as of July 16, 2021.

    Seth Lederman, M.D., President and Chief Executive Officer of Tonix commented, "We are pleased to welcome Carolyn E. Taylor to the Tonix Board. Ms. Taylor brings over 35 years of experience in corporate law, including 15 years as a partner at Covington & Burling LLP and six years as general counsel of two start-up companies. Her broad-based transactional experience will be invaluable to Tonix as we continue to grow the company. We look forward to the insights Ms. Taylor will bring to the…

    NEW YORK, July 19, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix), a clinical-stage biopharmaceutical company, today announced the appointment of Carolyn E. Taylor to its Board of Directors, effective as of July 16, 2021.

    Seth Lederman, M.D., President and Chief Executive Officer of Tonix commented, "We are pleased to welcome Carolyn E. Taylor to the Tonix Board. Ms. Taylor brings over 35 years of experience in corporate law, including 15 years as a partner at Covington & Burling LLP and six years as general counsel of two start-up companies. Her broad-based transactional experience will be invaluable to Tonix as we continue to grow the company. We look forward to the insights Ms. Taylor will bring to the Board."

    "It's a pleasure to join a company with a strong sense of purpose coupled with such a dedicated, experienced management team," said Ms. Taylor. "I look forward to collaborating with the management team and the other members of Tonix's Board as well as offering my perspective on Tonix's strategic initiatives."

    Ms. Taylor was a Partner at the Covington & Burling law firm for more than 15 years where she was a corporate attorney with a broad-based transactional practice. Ms. Taylor has also served as General Counsel of Strike Protocols, Inc. and Longitude, Inc.

    Ms. Taylor received a B.A., magna cum laude, from Brown University and a J.D. from Columbia Law School, where she was a Harlan Fiske Stone Scholar and the Developing Editor of the Columbia Law Review.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, with positive data from the Phase 3 RELIEF study reported in December 2020. The Company expects interim data from the second Phase 3 study, RALLY, in the third quarter of 2021 and topline data in the first quarter of 2022. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, inclusion in the Russell indexes, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



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  10. CHATHAM, N.J., June 28, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that Tonix was added to the broad-market Russell 3000® index and the small-cap Russell 2000® Index, effective after the U.S. market opens today, June 28, 2021, as part of the annual reconstitution of the Russell stock indexes.

    "Tonix is pleased to be included in the Russell indexes which reflects our positive achievements and growth over the past year," stated Seth Lederman, M.D., President and Chief Executive Officer of Tonix. "These indexes are widely followed and we look forward to a broader awareness of our Company as a result of this inclusion."

    Annual…

    CHATHAM, N.J., June 28, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that Tonix was added to the broad-market Russell 3000® index and the small-cap Russell 2000® Index, effective after the U.S. market opens today, June 28, 2021, as part of the annual reconstitution of the Russell stock indexes.

    "Tonix is pleased to be included in the Russell indexes which reflects our positive achievements and growth over the past year," stated Seth Lederman, M.D., President and Chief Executive Officer of Tonix. "These indexes are widely followed and we look forward to a broader awareness of our Company as a result of this inclusion."

    Annual reconstitution of the Russell indexes captures the 4,000 largest U.S. stocks as of May 7, 2021, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the small-cap Russell 2000® Index, as well as 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 $10.6 trillion in assets are benchmarked against Russell's US indexes1. Russell indexes are part of FTSE Russell, a leading global index provider.

    For more information on the Russell 3000® Index and Russell 2000® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

    1Source: FTSE Russell

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, with positive data from the Phase 3 RELIEF study reported in December 2020. The Company expects interim data from the second Phase 3 study, RALLY, in the third quarter of 2021 and topline data in the first quarter of 2022. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, inclusion in the Russell indexes, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



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  11. Long COVID Symptoms of Pain, Sleep Disturbance, Fatigue and Brain Fog Overlap with Symptoms of Fibromyalgia, for which TNX-102 SL is in Mid-Phase 3 Development

    Condition Afflicts More Than 30 Percent of Patients Post Infection with SARS-CoV-2, the Virus that Causes COVID-19

    Pre-IND Meeting with FDA Scheduled for Q3 2021

    CHATHAM, N.J., June 21, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it plans to develop TNX-102 SL (cyclobenzaprine HCl sublingual tablets) as a potential treatment for Long COVID Syndrome (Long COVID) which is now known officially as Post-Acute Sequelae of COVID-19 (PASC1). Tonix plans to meet with the…

    Long COVID Symptoms of Pain, Sleep Disturbance, Fatigue and Brain Fog Overlap with Symptoms of Fibromyalgia, for which TNX-102 SL is in Mid-Phase 3 Development

    Condition Afflicts More Than 30 Percent of Patients Post Infection with SARS-CoV-2, the Virus that Causes COVID-19

    Pre-IND Meeting with FDA Scheduled for Q3 2021

    CHATHAM, N.J., June 21, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it plans to develop TNX-102 SL (cyclobenzaprine HCl sublingual tablets) as a potential treatment for Long COVID Syndrome (Long COVID) which is now known officially as Post-Acute Sequelae of COVID-19 (PASC1). Tonix plans to meet with the U.S. Food and Drug Administration (FDA) in the third quarter of 2021 to seek agreement on the design of a potential Phase 2 pivotal study and the overall clinical development plan to qualify TNX-102 SL as an indicated treatment for Long COVID.

    Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID, or PASC. These individuals experience a constellation of symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 virus from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive impairment described as "brain fog", gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.2 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection.

    Seth Lederman, M.D., President and Chief Executive Officer of Tonix, stated, "We are excited to begin development of TNX-102 SL for the treatment of Long COVID because the program leverages what we have learned about the pharmacodynamic activity of TNX-102 SL from more than one thousand participants who have been or are enrolled in our fibromyalgia trials to date. Long COVID has been compared to fibromyalgia because of the common symptoms of sleep disturbance, persistent pain, fatigue, and brain fog.3 Additionally, Long COVID, like fibromyalgia, is experienced by women at a rate approximately four times that of men.4 The 2003 SARS outbreak that was due to an earlier coronavirus outbreak was also described as causing a post-SARS syndrome similar to fibromyalgia.5 Long COVID is a chronic disabling condition that is expected to result in a significant global economic burden.6 In response to the urgent need for therapies that address PASC, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID last December.7 While the vaccines available in the U.S. under Emergency Use Authorization have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of PASC."

    Gregory Sullivan, M.D., Chief Medical Officer of Tonix, commented, "We believe the core symptoms of Long COVID, including fatigue, sleep disturbances, and persistent pain, share an underlying pathogenesis with fibromyalgia. By improving sleep quality, we believe TNX-102 SL may improve the sleep disturbance of Long COVID and potentially also improve other symptoms of Long COVID. For example, TNX-102 SL showed activity in addressing persistent pain, sleep disturbance and fatigue in our fibromyalgia Phase 3 study.   In our double-blind clinical studies for both fibromyalgia and posttraumatic stress disorder (PTSD), TNX-102 SL showed robust activity in improving sleep quality starting within the first two weeks of treatment."

    Dr. Lederman added, "TNX-102 SL is in mid-Phase 3 development for the treatment of fibromyalgia, for which interim analysis results of the second potential pivotal study are expected in the third quarter of 2021, and topline results are expected in the first quarter of 2022. The proposed mechanism of TNX-102 SL is to improve sleep quality. Since disturbed sleep is linked to exacerbation and chronicity of a number of pain, neuropsychiatric and addictive disorders, we plan to conduct clinical trials to determine whether TNX-102 SL improves sleep in certain pain and neuropsychiatric disorders in addition to fibromyalgia. Tonix already has four active INDs for TNX-102 SL, including fibromyalgia, PTSD, agitation in Alzheimer's disease (AAD) and alcohol use disorder (AUD)."

    1Feb. 24, 2021 - White House COVID-19 Response Team press briefing; Feb 25, 2021 - policy brief from the World Health Organization on long COVID

    2Nalbandian, Ani, et al. "Post-acute COVID-19 syndrome." Nature Medicine (2021): 1-15.

    3Clauw DJ, Häuser W, Cohen SP, Fitzcharles M-A. Considering the potential for an increase in chronic pain after the COVID-19 pandemic. Pain. 2020 Aug; 161(8): 1694–1697.

    4Cox, D. "Why are women more prone to long Covid?" The Guardian. 13 Jun 2021 https://www.theguardian.com/society/2021/jun/13/why-are-women-more-prone-to-long-covid

    5Moldofsky H, Patcai J. Chronic widespread musculoskeletal pain, fatigue, depression and disordered sleep in chronic post-SARS syndrome; a case-controlled study. BMC Neurol 2011;11:37.

    6Briggs, Andrew, and Anna Vassall. "Count the cost of disability caused by COVID-19." (2021): 502-505.

    7The NIH provision of Title III Health and Human Services, Division M--Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021.  The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.

    About Long COVID or Post-Acute Sequelae of SARS-CoV-2 (PASC)

    Long COVID is a protracted syndrome experienced by some people following SARS-CoV-2 infection, that can include a number of persistent symptoms including fatigue, pain, sleep disturbance, brain fog or difficulty concentrating, arthralgias, olfactory dysfunction, and headache. Patients with Long COVID are sometimes referred to as "long-haulers."

    About TNX-102 SL

    TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for fibromyalgia, PTSD, alcohol use disorder and agitation in Alzheimer's disease. The U.S. Patent and Trademark Office (USPTO) has issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in these patents are important elements of Tonix's proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, with positive data from the Phase 3 RELIEF study reported in December 2020. The Company expects interim data from the second Phase 3 study, RALLY, in the third quarter of 2021 and topline data in the first quarter of 2022. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



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  12. CHATHAM, N.J., June 16, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will present at the Raymond James Human Health Innovation Conference on June 23, 2021, at 8:00 a.m. ET.

    Investors interested in arranging a virtual meeting with the Company's management during the conference should contact the Raymond James conference coordinator. A webcast of the presentation will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical…

    CHATHAM, N.J., June 16, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will present at the Raymond James Human Health Innovation Conference on June 23, 2021, at 8:00 a.m. ET.

    Investors interested in arranging a virtual meeting with the Company's management during the conference should contact the Raymond James conference coordinator. A webcast of the presentation will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, with positive data from the Phase 3 RELIEF study reported in December 2020. The Company expects interim data from the second Phase 3 study, RALLY, in the third quarter of 2021 and topline data in the first quarter of 2022. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke, an ICR Company

    peter.vozzo@westwicke.com

    (443) 213-0505



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  13. CHATHAM, N.J., June 10, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will participate in the BIO Digital Conference being held June 10-11 and 14-18, 2021.

    The Company's presentation will be made through the BIO Digital Conference website and available on demand to registered participants during the conference at https://www.bio.org/events/bio-digital/sessions?sessionTypes=25903. Following the conference, the presentation will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    About Tonix Pharmaceuticals

    CHATHAM, N.J., June 10, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will participate in the BIO Digital Conference being held June 10-11 and 14-18, 2021.

    The Company's presentation will be made through the BIO Digital Conference website and available on demand to registered participants during the conference at https://www.bio.org/events/bio-digital/sessions?sessionTypes=25903. Following the conference, the presentation will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, with positive data from the Phase 3 RELIEF study reported in December 2020. The Company expects interim data from the second Phase 3 study, RALLY, in the third quarter of 2021 and topline data in the first quarter of 2022. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication. 

    2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke, an ICR Company

    peter.vozzo@westwicke.com

    (443) 213-0505



    Primary Logo

    View Full Article Hide Full Article
  14. CHATHAM, N.J., June 03, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the poster presentation of positive results from its Phase 3 clinical study, RELIEF, of TNX-102 SL for the management of fibromyalgia. A copy of the poster will be made available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    The poster, titled, "Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Trial" shows that TNX-102 SL met its pre-specified primary endpoint…

    CHATHAM, N.J., June 03, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the poster presentation of positive results from its Phase 3 clinical study, RELIEF, of TNX-102 SL for the management of fibromyalgia. A copy of the poster will be made available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    The poster, titled, "Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Trial" shows that TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) and was associated with a higher rate than placebo of ≥30% pain responders in participants with fibromyalgia (p=0.006). TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints measuring improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific functional recovery. In addition, TNX-102 SL was well tolerated and was not associated with side-effects seen with other approved oral fibromyalgia treatments, including weight gain, insomnia, nausea or sexual dysfunction.

    "We believe the results of the Phase 3 RELIEF trial validate the mechanism that improved sleep quality can lead to syndromal effects on fibromyalgia, improving not only pain but also sleep and fatigue. The sublingual formulation of TNX-102 SL for transmucosal absorption showed promise at the 2.8 mg dose in prior fibromyalgia studies, but we believe RELIEF provides evidence that 5.6 mg is the right dose for this patient population," said Seth Lederman, M.D., President and Chief Executive Officer. "We expect interim analysis results for the confirmatory Phase 3 study, RALLY, in the third quarter of this year, followed by topline data in the first quarter of next year."

    About Fibromyalgia

    Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

    About TNX-102 SL

    TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for fibromyalgia, PTSD, alcohol use disorder and agitation in Alzheimer's disease. The U.S. Patent and Trademark Office (USPTO) has issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in these patents are important elements of Tonix's proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

    About the Phase 3 RELIEF Study

    The RELIEF study has been completed and TNX-102 SL achieved a statistically significant benefit as measured by the primary, prespecified endpoint of improvement over placebo in daily pain. The RELIEF study was a double-blind, randomized, placebo-controlled Phase 3 trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. The two-arm trial targeted enrollment of 470 participants, at approximately 40 U.S. sites. RELIEF completed final enrollment of 503 participants. The first two weeks of treatment were a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. After the first two weeks, all participants had the dose increased to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for 12 weeks. The primary endpoint was daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation.

    Additional details about the completed RELIEF study are available at clinicaltrials.gov (NCT04172831), and study results are detailed in the poster presentation at ASCP (available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com).

    About the Phase 3 RALLY Study

    The ongoing RALLY study is also a double-blind, randomized, placebo-controlled Phase 3 trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets). The trial design and endpoints are essentially the same as the RELIEF study; however, the RALLY study is targeting to enroll 200 more participants than the RELIEF study, for a total of 670 participants at approximately 40 U.S. sites. RALLY has already enrolled more than 335 participants for the interim cohort. RALLY will have a planned interim analysis based on the first approximately 335 recruited participants in which an independent data monitoring board (IDMB) will make recommendations to the company to stop early for success, continue as planned, add more participants, or stop for futility. The interim analysis results expected in the third quarter of 2021 followed by topline data in the first quarter of 2022.

    Additional details about the ongoing RALLY study are available at clinicaltrials.gov (NCT04508621).

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, with positive data from the Phase 3 RELIEF study reported in December 2020. The Company expects interim data from the second Phase 3 study, RALLY, in the third quarter of 2021 and topline data in the first quarter of 2022. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



    Primary Logo

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  15. CHATHAM, N.J., May 26, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company) a clinical-stage biopharmaceutical company, announced that it will present two posters at the 2021 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. The ASCP annual meeting is being held virtually June 1-4, 2021. Copies of the posters will be made available under the IR Events tab of the Investors section of the Tonix website at the times of the presentations at www.tonixpharma.com. Poster presentation details are as follows:

    Title Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind,

    CHATHAM, N.J., May 26, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company) a clinical-stage biopharmaceutical company, announced that it will present two posters at the 2021 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. The ASCP annual meeting is being held virtually June 1-4, 2021. Copies of the posters will be made available under the IR Events tab of the Investors section of the Tonix website at the times of the presentations at www.tonixpharma.com. Poster presentation details are as follows:

    Title Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Trial
    Session Poster Session I
    Date June 2, 2021
    Time 11:00 a.m. – 12:00 p.m. ET





    Title Effect of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) on PTSD Sleep-Dependent Emotional Memory Processing: Retrospective Analysis of Phase 2 and 3 Trial Results in Military-Related and Civilian PTSD
    Session Poster Session II
    Date June 3, 2021
    Time 10:00 a.m. – 11:00 a.m. ET

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, with positive data from the Phase 3 RELIEF study reported in December 2020. The Company expects interim data from the second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the first quarter of 2022. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending agreement from FDA on statistical analysis plan.

    3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



    Primary Logo

    View Full Article Hide Full Article
  16. CHATHAM, N.J., May 12, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company) a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present a company overview during the Q2 Investor Summit Virtual Conference on Monday, May 17, 2021 at 3:30 p.m. ET.

    Investors interested in arranging a virtual meeting with the Company's management during the conference should contact the Investor Summit conference coordinator. A webcast of the presentation will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a…

    CHATHAM, N.J., May 12, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company) a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present a company overview during the Q2 Investor Summit Virtual Conference on Monday, May 17, 2021 at 3:30 p.m. ET.

    Investors interested in arranging a virtual meeting with the Company's management during the conference should contact the Investor Summit conference coordinator. A webcast of the presentation will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, with positive data from the Phase 3 RELIEF study reported in December 2020. The Company expects interim data from the second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the first quarter of 2022. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending agreement from FDA on statistical analysis plan.

    3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



    Primary Logo

    View Full Article Hide Full Article
  17. Announced Positive Efficacy Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800

    Interim Analysis of Second Confirmatory Phase 3 Study in Fibromyalgia Expected in Third Quarter 2021

    Deep Pipeline Progressing with Three Central Nervous System (CNS) Programs Expected to Enter Phase 2 Trials This Year

    At March 31, 2021, Cash and Cash Equivalents Totaled Approximately $164 Million

    CHATHAM, N.J., May 10, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2021 and provided an overview of recent operational highlights.

    "Tonix possesses a deep pipeline of high-value programs…

    Announced Positive Efficacy Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800

    Interim Analysis of Second Confirmatory Phase 3 Study in Fibromyalgia Expected in Third Quarter 2021

    Deep Pipeline Progressing with Three Central Nervous System (CNS) Programs Expected to Enter Phase 2 Trials This Year

    At March 31, 2021, Cash and Cash Equivalents Totaled Approximately $164 Million

    CHATHAM, N.J., May 10, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2021 and provided an overview of recent operational highlights.

    "Tonix possesses a deep pipeline of high-value programs ranging from preclinical to mid-Phase 3 development, with three CNS programs poised to enter Phase 2 trials this year," said Seth Lederman, M.D., President and Chief Executive Officer. "Our strategy is to in-license, acquire or internally invent high impact therapeutic programs which we can validate, de-risk and advance in clinical development through potentially value-creating milestones. We believe successful Phase 2 and Phase 3 trials can be inflection points for program value."

    Dr. Lederman continued, "Our clinical, manufacturing, and regulatory teams are progressing programs across multiple modalities including small molecule drugs, synthetic peptides, biologics, monoclonal antibodies and live virus vaccines. The three CNS drug candidates we expect to enter Phase 2 trials this year include: TNX-1300, an E. coli produced biologic in development as an i.v. administered antidote for cocaine intoxication; TNX-1900, a synthetic peptide in development as an intranasally delivered therapeutic for the treatment of chronic migraine; and TNX-601 CR, a controlled release oral formulation in development for the treatment of major depressive disorder."

    "Our most advanced program is a confirmatory Phase 3 trial of TNX-102 SL for the management of fibromyalgia. We expect to report an interim analysis in the third quarter of this year and topline data in the first quarter of next year," continued Dr. Lederman. "We believe that if the topline results are positive, this study will support a New Drug Application, which we would expect to submit in 2022."

    Recent Highlights

    Research and Development*

    TNX-102 SL (cyclobenzaprine HCl sublingual tablets): small molecule product candidate for the management of fibromyalgia

    • In March 2021, 50 percent of the planned total number of participants had been randomized in the RALLY study, the second potentially pivotal Phase 3 trial of TNX-102 SL for fibromyalgia. The Company expects the results of an interim analysis1 in the third quarter of 2021, followed by topline results in the first quarter of 2022. Tonix expects to submit a New Drug Application (NDA) for TNX-102 SL for fibromyalgia to the U.S. Food and Drug Administration (FDA) in 2022, pending positive results from the second Phase 3 study.
    • In December 2020, TNX-102 SL met its pre-specified primary endpoint in the first Phase 3 study, RELIEF (p=0.01), significantly reducing daily pain compared to placebo in participants with fibromyalgia. Activity was also shown in key secondary endpoints of improving sleep, reducing fatigue, and improving overall fibromyalgia symptoms and function.

          TNX-102 SL for the management of PTSD

    • Tonix completed the Phase 3 RECOVERY trial and reported topline results in the fourth quarter of 2020 in which TNX-102 SL did not meet the primary efficacy endpoint. As a next step, we intend to meet with the FDA to discuss potential new endpoints for the indication of treatment of PTSD. We also expect to begin enrolling a Phase 3 PTSD study of TNX-102 SL in police in Kenya, in the third quarter of 2021.

    TNX-1800 (live attenuated vaccine based on Tonix's horsepox virus vector, TNX-801): COVID-19 vaccine candidate designed as a single-administration vaccine to elicit T cell immunity.

    • In March 2021, positive efficacy results from a study of TNX-1800 in which non-human primates were vaccinated with TNX-1800 and challenged with live SARS-CoV-2 were reported. TNX-1800 was found to induce protection against infection in both upper and lower airways, which suggests an ability to block forward transmission and stimulate long-term T cell immunity. The Company believes these findings also demonstrate the flexibility of the horsepox vaccine platform, TNX-801, and its capability to be tailored to other diseases of interest in military and civilian populations.
    • A Phase 1 safety study using TNX-1800 in humans is anticipated to start in the first half of 2022, pending Investigational New Drug (IND) clearance from the FDA and the production of GMP material.

    TNX-2100 (diagnostic skin test): SARS-CoV-2 epitope peptide mixtures for intradermal administration to measure the delayed-type hypersensitivity (DTH) reaction to SARS-CoV-2

    • TNX-2100, designed to measure functional, or meaningful, in vivo T cell immunity to SARS-CoV-2, is a test comprising three different mixtures of synthetic peptides (TNX-2110, -2120 and -2130). T cell immunity to SARS-CoV-2 persists longer than antibody immunity, is sometimes present in the absence of a measurable antibody response and is believed to provide an important element of protection against serious COVID-19 illness after infection with SARS-CoV-2.2-6 Tonix expects to initiate a first-in-human clinical study in the fourth quarter of 2021.
    • Tonix's proposed skin test has the potential to serve as: 1) a biomarker for cellular (T-cell mediated) immunity and protective immunity; 2) a method to stratify participants in COVID-19 vaccine trials by immune status; 3) an endpoint in COVID-19 vaccine trials, and 4) a biomarker of durability of vaccine protection.

    TNX-601 CR (tianeptine oxalate and naloxone controlled-release tablets): small molecule product candidate for treatment of major depressive disorder, PTSD and neurocognitive dysfunction associated with corticosteroid use.

    • Tonix received the official minutes from a Type B pre-IND meeting with the FDA on its development plan for TNX-601 CR for the treatment of major depressive disorder (MDD). Based on the official minutes, Tonix expects to submit the IND to conduct a human abuse potential study and meet with the FDA's controlled substances staff (CSS) to reach agreement on the details of the abuse potential study. Pending the results of ongoing nonclinical toxicology studies, Tonix expects to be in a position to initiate a Phase 2 study for the treatment of MDD in the fourth quarter of 2021.

    TNX-1900 (intranasal potentiated oxytocin): small peptide product candidate for migraine, craniofacial pain, insulin resistance and related disorders

    • Tonix intends to submit an IND application to the FDA in the third quarter of 2021 and is targeting to start a Phase 2 study of TNX-1900 for the prophylactic treatment of chronic migraine in the U.S. also in the third quarter of 2021. A Phase 2 trial under an investigator-initiated IND was completed in the U.S. using TNX-1900 prior to Tonix's acquisition of the program.

    TNX-2900 (novel formulation of intranasal potentiated oxytocin): small peptide product candidate for the treatment of Prader-Willi syndrome

    • Tonix entered into an agreement in February 2021 whereby the Company licensed technology using oxytocin-based therapeutics for the treatment of Prader-Willi syndrome from Inserm, the French National Institute of Health and Medical Research. The co-exclusive license allows Tonix to expand its intranasal potentiated oxytocin development program to a new indication. Tonix plans to submit applications to the FDA for Orphan Drug and Fast Track designations for TNX-2900.

    TNX-3500 (sangivamycin): antiviral inhibitor of SARS-CoV-2 for treatment of COVID-19 and potential other viral disorders

    • In April 2021, Tonix entered into an exclusive worldwide licensing agreement with OyaGen, Inc. to develop TNX-3500 (sangivamycin, formerly OYA1) for the treatment of COVID-19 and potentially other viral disorders. It has demonstrated broad-spectrum activity in laboratory-based assays against the coronaviruses SARS-CoV-2 and MERS-CoV. The active ingredient of TNX-3500 has been studied for safety in humans in prior studies on cancer patients at the U.S. National Cancer Institute but has not been approved for marketing in any jurisdiction. Tonix intends to conduct further preclinical studies this year.

    TNX-1300 (recombinant double mutant cocaine esterase): biologic product candidate for life-threatening cocaine intoxication

    • Cocaine esterase is the most potent known catalyst for cocaine degradation. Results of a positive Phase 2 study of volunteer cocaine users in a controlled laboratory setting were reported prior to Tonix licensing the technology. Tonix expects to initiate a Phase 2 open-label safety study in an emergency room setting to study TNX-1300 in the third quarter of 2021.

    TNX-1500 (anti-CD154 monoclonal antibody): third generation monoclonal antibody as a potential first line monotherapy for preventing or treating organ transplant rejection and treating autoimmune disorders.

    • In January 2021, Tonix entered into a second research collaboration with Harvard Medical School Teaching Hospital/Massachusetts General Hospital (MGH) in Boston for TNX-1500, a humanized monoclonal antibody (mAb) that targets the CD40-ligand for the prevention of organ transplant rejection. The new collaboration will focus on kidney transplantation, while an earlier collaboration with MGH is focused on heart transplantation. The Company expects to have TNX-1500 GMP material available in the third quarter of 2021.

    1Pending agreement from FDA on statistical analysis plan.

    2Dan, JM et al., Science. 2021. Jan 6 : eabf4063. Published online 2021 Jan 6. doi: 10.1126/science.abf4063

    3Le Bert, N. et al., J Exp Med. 2021 May 3; 218(5): e20202617. Published online 2021 Mar 1. doi: 10.1084/jem.20202617

    4Gaebler, C., et al. 2021. Nature. 10.1038/s41586-021-03207-w

    5Wang, Y., et al. 2020. J. Clin. Invest. 130:5235–5244. 10.1172/JCI138759

    6Rydyznski Moderbacher, et al., Cell. 2020 Nov 12; 183(4): 996–1012.e19. doi: 10.1016/j.cell.2020.09.038

    *All Tonix product candidates are investigational new drugs or biologics and have not been approved for any indication.

    Financial

    As of March 31, 2021, Tonix had $164.2 million of cash and cash equivalents, compared to $77.1 million as of December 31, 2020. During the first quarter of 2021, the Company raised gross proceeds of approximately $110 million from two previously announced securities purchase agreements. Cash used in operations was approximately $21.1 million for the first quarter ended March 31, 2021, compared to $9.3 million for the first quarter ended March 31, 2020. The increase in cash used in operations resulted primarily from an increase in research and development and general and administrative activities as defined below.

    First Quarter 2021 Financial Results

    Research and development expenses for the first quarter of 2021 were $15.3 million, compared to $4.7 million for the same period in 2020. This increase is predominately due to timing of milestones related to the Phase 3 RELIEF study and the initiation of a second Phase 3 study of TNX-102 SL for FM, RALLY, in the third quarter of 2020, as well as activities to prepare for initiation of Phase 2 clinical studies of TNX-1300, TNX-1900 and TNX-601 CR by the end of 2021. New activities related to the development of TNX-1800 as a potential COVID-19 vaccine, and increased spending related to our development pipeline also contributed to the increase.

    General and administrative expenses for the first quarter of 2021 were $5.4 million, compared to $2.6 million for the same period in 2020. The increase is primarily due to an increase in financial reporting expenses, patent prosecution and maintenance costs and an increase in salaries and headcount.

    Net loss available to common stockholders was $20.7 million, or $0.07 per share, basic and diluted, for the first quarter of 2021, compared to net loss of $9.0 million, or $0.37 per share, basic and diluted, for the first quarter of 2020. The basic and diluted weighted average common shares outstanding for the first quarter of 2021 was 290,106,510, compared to 24,028,970 shares for the first quarter of 2020.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, with positive data from the Phase 3 RELIEF study reported in December 2020. The Company expects interim data from the second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the first quarter of 2022. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending agreement from FDA on statistical analysis plan.

    3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.





    TONIX PHARMACEUTICALS HOLDING CORP.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In Thousands, Except Share and Per Share Amounts)

    (unaudited)

      Three Months Ended March 31, 
       2021   2020 
    COSTS AND EXPENSES:        
    Research and development $15,327  $4,676 
    General and administrative  5,409   2,621 
       20,736   7,297 
             
    Operating loss  (20,736)  (7,297)
             
    Interest and other income, net  83   24 
             
    Net loss  (20,653)  (7,273)
             
    Warrant deemed dividend  -   451 
    Preferred stock deemed dividend  -   1,260 
             
    Net loss available to common stockholders $(20,653) $(8,984)
             
    Net loss per common share, basic and diluted $(0.07) $(0.37)
             
    Weighted average common shares outstanding, basic and diluted  290,106,510   24,028,970 





    TONIX PHARMACEUTICALS HOLDING CORP.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

    (Audited)

     March 31, 20211 December 31, 20201
    Assets    
    Cash and cash equivalents$164,214 $77,068
    Prepaid expenses and other 8,951  10,921
    Total current assets 173,165  87,989
    Other non-current assets 10,356  10,194
    Total assets$183,521 $98,183
       
    Liabilities and stockholders' equity  
    Total liabilities$6,605 $10,535
    Stockholders' equity 176,916  87,648
    Total liabilities and stockholders' equity$183,521 $98,183

    The condensed consolidated balance sheets for the periods ended March 31, 2021 and December 31, 2020 have been derived from the audited financial statements but does not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.



    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com 

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com 

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com 

    (443) 213-0505



    Primary Logo

    View Full Article Hide Full Article
  18. NEW YORK, April 24, 2021 (GLOBE NEWSWIRE) -- FMW Media's "New to The Street" TV broadcast its no. 170 show today on Bloomberg Television at 6 PM EST. And, broadcasting its 1- hour show tomorrow, April 25, 2021, on NEWSMAX TV from 10-11AM EST.

    "New To The Street's" TV shows features the following Companies and their businesses:

    - Tonix Pharmaceuticals (NASDAQ:TNXP)
    - Global Cannabis Applications Corp. (OTC:FUAPF)
    - Healixa, Inc. (OTC:EMOR)
    - Finxflo Crypto (FXF)
    - Petproducts.com
    - Native Coin (N8V)

    Tonix Pharmaceuticals, Inc.'s (NASDAQ:TNXP) CEO, Seth Lederman, talks to "New To The Street" TV about their Company's agreement with OyaGen, Inc. to license an experimental COVID-19 antiviral drug TNX-3500 (formerly known as OYA1) –Broadcast…

    NEW YORK, April 24, 2021 (GLOBE NEWSWIRE) -- FMW Media's "New to The Street" TV broadcast its no. 170 show today on Bloomberg Television at 6 PM EST. And, broadcasting its 1- hour show tomorrow, April 25, 2021, on NEWSMAX TV from 10-11AM EST.

    "New To The Street's" TV shows features the following Companies and their businesses:

    - Tonix Pharmaceuticals (NASDAQ:TNXP)

    - Global Cannabis Applications Corp. (OTC:FUAPF)

    - Healixa, Inc. (OTC:EMOR)

    - Finxflo Crypto (FXF)

    - Petproducts.com

    - Native Coin (N8V)

    Tonix Pharmaceuticals, Inc.'s (NASDAQ:TNXP) CEO, Seth Lederman, talks to "New To The Street" TV about their Company's agreement with OyaGen, Inc. to license an experimental COVID-19 antiviral drug TNX-3500 (formerly known as OYA1) –Broadcast: Bloomberg TV and NEWSMAX TV.

    Brad Moore, CEO at Global Cannabis Application Corp – "GCAC" (OTC:FUAPF) talks on the show about their Company's new definitive three-year software licensing agreement with Herb Industries Ltd. – Broadcast: Bloomberg TV and NEWSMAX TV.

    "New To The Street" TV has CEO Ian Parker of Healixa, Inc. (OTC:EMOR) who talks about the pilot roll-out in selected metro areas of the "last mile" digital pharmacy, a globally recognized tech enabled system . Mr. Parker also talks, on the show, about their "Justice League" of healthcare professionals, now formalizing to work with Healixa, Inc. – Broadcast: Bloomberg TV and NEWSMAX TV.

    Cryptocurrency, Finxflo (FXF) CEO James Gillingham, provide the "New To The Street" TV viewers information about their "KYT" (Know Your Transaction). He explains how the "KYT" system works for trading and best price for crypto platforms - https://www.finxflo.com/.

    NEWSMAX TV- Broadcast- Sunday, April 25, 2021

    The "New toTheStreet's" TV, 1-hour show, Sunday, April 25, 2021 on NEWSMAX TV to feature PetProducts.com, an Al Simon, WEE WEE Pad inventor company, Pet Segment. Pet Products.com will be on regularly with tips and pet product news on "what's" happening in the pet industry- Broadcast: NEWSMAX TV.

    Also, on the 1-hour, "New To The Street's" NEWSMAX TV broadcast, cryptocurrency Native Coin (N8V). N8V's President Randy Williams discusses the goal of the Company to help the Native American tribes with commerce and bring out the invisibility of this sovereign cryptocurrency- Broadcast: NEWMAX TV.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of the central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsebox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox – www.tonixpharma.com

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending agreement from FDA on statistical analysis plan

    About Global Cannabis Applications Corp.



    Global Cannabis Applications Corp. is a global leader in designing, developing, SaaS licensing, and acquiring innovative data technologies for the medical cannabis industry. The Citizen Green and Efixii platforms are the world's first end-to-end - from patient to regulator - medical cannabis data solutions. They use six core technologies: mobile applications, artificial intelligence, RegTech, smart databases, Ethereum blockchain and GCAC smart rewards. These technologies transparently disclose cannabis chain-of-custody events, thereby enabling patients to provide crowd-sourced medical cannabis efficacy data. Driven by digital and cannabis industry experts, GCAC is focused on generating revenue from SaaS licensing its technology, and acquiring high-quality cannabis datasets that improve patient outcomes and become the world's largest cannabis efficacy data provider- https://cannappscorp.com

    About Healixa Inc.

    Healixa is a technology company with assets in both health tech and fintech. Healixa marries code and care to create exceptional experiences in health tech. The Company's people-first approach is designed to humanize care via purpose-driven ethical engineering practices, deploying simple solutions for complex global challenges. Healixa offers value-based tech solutions to enterprise partner channels across a broad range of industries including employer benefits, travel, pharma, logistics, and more.

    About Finxflo (FXF)

    Finxflo is a platform that focuses on the changing the cryptocurrency market through innovation. As the world's first hybrid DeFi/CeFI liquidity and protocol aggregator, Finxflo brings a one-stop solution for all crypotcurrency trades and investors. Using only one account with KYC (Know Your Client), our users are able to utilize liquidity from 25+ various CeFi and DeFi platforms through a single user interface. Finxflo blends all the upsides of DeFi and CeFi ecosystems to produce the ultimate product - https://www.finxflo.com/

    About Petproducts.com

    PetProducts.com has been the leading global directory for all things pet. We are now giving consumers direct access to the products they need. We provide a one-stop shop for products, research, and reviews. PetProducts.com works diligently to serve pet lovers who deeply care about their animals - https://www.petproducts.com/

    About NativeCoin (N8V)

    NativeCoin is a digital currency running on the Ethereum blockchain network and is specially made for Native American Tribes and their businesses. This Native American Sovereign Cryptocurrency is made to be used by Tribal casinos and other enterprises in the United States and around the world - https://native-coin.com/.

    About FMW Media

    FMW Media operates one of the longest-running U.S and International sponsored and Syndicated Nielsen Rated programming T.V. brands "New to the Street," and its blockchain show "Exploring The Block." Since 2009, these brands run biographical interview segment shows across major U.S. Television networks. The TV platforms reach over 540 million homes both in the US and international markets. FMW recently added Newsmax to its broadcasting platform with its first show broadcasted Sunday, December 27th. The NEWSMAX New to The Street show is syndicated on Sundays at 10 AM EST. FMW is also one of the nation's largest buyers of linear Television long and short form- https://www.newsmaxtv.com/Shows/New-to-the-Street

    https://www.newtothestreet.com/

    FMW Media Contact:

    Bryan Johnson

    +1 (631) 766-7462

    Bryan@NewToTheStreet.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ec766ce9-a2a0-44c1-86ec-433d6a52892f



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  19. CHATHAM, N.J., April 21, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company) a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, was invited to deliver a company presentation and participate in a panel at the 4th Annual Neuroscience Innovation Forum for Business Development, Licensing and Investment, hosted by Sachs Associates and taking place from April 28-30, 2021.

    Virtual Panel Details

    Title: Pain, Migraine & Addiction
    Date: Thursday, April 29, 2021
    Time: 11:45 a.m. – 12:45 p.m. ET

    The Company's presentation will be available on demand during the conference to registered conference participants through…

    CHATHAM, N.J., April 21, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company) a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, was invited to deliver a company presentation and participate in a panel at the 4th Annual Neuroscience Innovation Forum for Business Development, Licensing and Investment, hosted by Sachs Associates and taking place from April 28-30, 2021.

    Virtual Panel Details

    Title: Pain, Migraine & Addiction

    Date: Thursday, April 29, 2021

    Time: 11:45 a.m. – 12:45 p.m. ET

    The Company's presentation will be available on demand during the conference to registered conference participants through the Sachs Associates conference website. The presentation will be available subsequent to the conference under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the Phase 3 RELIEF trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth quarter of 2021. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending agreement from FDA on statistical analysis plan.

    3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



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  20. CHATHAM, N.J., April 19, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, and OyaGen, Inc. (OyaGen), a pre-clinical biotechnology research company, announced today an exclusive worldwide licensing agreement for an antiviral inhibitor of SARS-CoV-2, TNX-3500 (sangivamycin, formerly OYA1), for the treatment of COVID-19 and potentially other viral disorders. The active ingredient of TNX-3500 has been studied for safety in humans in prior studies on cancer patients at the U.S. National Cancer Institute but has not been approved for marketing in any jurisdiction.

    "We are excited to expand our pipeline and we look forward to developing TNX-3500 as a potential…

    CHATHAM, N.J., April 19, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, and OyaGen, Inc. (OyaGen), a pre-clinical biotechnology research company, announced today an exclusive worldwide licensing agreement for an antiviral inhibitor of SARS-CoV-2, TNX-3500 (sangivamycin, formerly OYA1), for the treatment of COVID-19 and potentially other viral disorders. The active ingredient of TNX-3500 has been studied for safety in humans in prior studies on cancer patients at the U.S. National Cancer Institute but has not been approved for marketing in any jurisdiction.

    "We are excited to expand our pipeline and we look forward to developing TNX-3500 as a potential treatment for COVID-19 and emerging variants," said Seth Lederman, M.D., Tonix's President and Chief Executive Officer. "TNX-3500 is in the pre-Investigational New Drug (IND) phase of development with encouraging early data from cell culture infectivity studies with SARS-CoV-2. We believe that its potency on SARS-CoV-2 inhibition in tissue culture and its tolerability in humans from prior studies suggests that TNX-3500 may qualify for expedited clinical development."

    Harold Smith, PhD, Chief Executive Officer and founder of OyaGen and professor of biochemistry and biophysics at the University of Rochester, School of Medicine and Dentistry said, "TNX-3500 has shown strong dose-dependent antiviral activity against live SARS-CoV-2 virus in cell culture infectivity studies. TNX-3500 was demonstrated to be approximately 65 times more potent in head to head comparisons at inhibiting SARS-CoV-2 than remdesivir, the active ingredient of Veklury®. In addition, combining TNX-3500 and remdesivir has demonstrated additive activity against SARS-CoV-2 in cell culture infectivity studies. These studies are from unpublished results from OyaGen's collaborative research with the National Institutes of Allergy and Infectious Diseases Integrated Research Facility (NIAID-IRF), part of the National Institutes of Health. TNX-3500 inhibits the replication of SARS-CoV-2 and may have other mechanisms of action that affect viral particle release from infected cells."

    Dr. Smith continued, "We're delighted to partner with Tonix on the development of TNX-3500 because we believe Tonix to be ideally capable to bring this program to the clinic and position it for worldwide commercialization in the rapidly evolving and highly competitive area of SARS-CoV-2 inhibitors."

    Under the terms of the agreement, Tonix has been granted an exclusive license from OyaGen for technology and patents related to TNX-3500 and other related compounds. Tonix will conduct further studies to test the safety and efficacy of TNX-3500 in treating COVID-19 as necessary to support regulatory approval.

    About TNX-3500

    TNX-3500 (sangivamycin) has demonstrated broad-spectrum antiviral activity in laboratory-based assays against the coronaviruses SARS-CoV-2 and MERS-CoV. Sangivamycin also demonstrated that it acts as a dual target specific antiviral against filoviruses such as Ebola virus in cell culture infectivity studies. TNX-3500 was studied in the U.S. at the National Cancer Institute (NCI), part of NIH, as an investigational new drug for treating cancer in the 1960s. Studies at that time demonstrated safety in nonhuman primates and human adults when dosed daily or weekly. TNX-3500 was demonstrated in studies in mice to persist in tissues for greater than 12 days following a single dose. Its long half-life in tissues suggests that a single dose or weekly dosing may be sufficient for antiviral treatments.

    About OyaGen, Inc.

    OyaGen is a privately held biotechnology company located in Rochester, New York. OyaGen is focused on the identification and early development of novel therapeutics for the treatment of viral diseases, such as those caused by HIV, coronavirus, and Ebola virus.

    Further information about OyaGen can be found at www.oyageninc.com.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth quarter of 2021. Tonix's immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, a live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending agreement from FDA on statistical analysis plan.

    3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Tonix Pharmaceuticals InquiriesOyaGen, Inc. Inquiries
      
    Jessica Morris (corporate)Kevin J. Phelps
    Tonix PharmaceuticalsCFO, OyaGen, Inc.
    investor.relations@tonixpharma.comkphelps@oyageninc.com
    (862) 904-8182(585) 820-5474
      
    Olipriya Das, Ph.D. (media) 
    Russo Partners 
    Olipriya.Das@russopartnersllc.com 
    (646) 942-5588 
      
    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505
     


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  21. CHATHAM, N.J., April 07, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company) a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present a company overview during the 20th Annual Needham Virtual Healthcare Conference on Wednesday, April 14, 2021 at 8:00 a.m. ET.

    Investors interested in arranging a virtual meeting with the Company's management during the conference should contact the Needham conference coordinator. A webcast of the presentation will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    Tonix Pharmaceuticals Holding Corp.

    CHATHAM, N.J., April 07, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company) a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present a company overview during the 20th Annual Needham Virtual Healthcare Conference on Wednesday, April 14, 2021 at 8:00 a.m. ET.

    Investors interested in arranging a virtual meeting with the Company's management during the conference should contact the Needham conference coordinator. A webcast of the presentation will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending agreement from FDA on statistical analysis plan.

    3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



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  22. CHATHAM, N.J., March 22, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has received the official minutes from a Type B pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) on its development plan for TNX-601 CR (tianeptine oxalate and naloxone controlled-release) tablet for the treatment of major depressive disorder (MDD). Tonix's TNX-601 CR is a novel oral formulation which is being developed as a potential treatment for MDD, posttraumatic stress disorder, and neurocognitive dysfunction associated with corticosteroid use. Tianeptine sodium (amorphous) immediate release (IR) has been…

    CHATHAM, N.J., March 22, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has received the official minutes from a Type B pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) on its development plan for TNX-601 CR (tianeptine oxalate and naloxone controlled-release) tablet for the treatment of major depressive disorder (MDD). Tonix's TNX-601 CR is a novel oral formulation which is being developed as a potential treatment for MDD, posttraumatic stress disorder, and neurocognitive dysfunction associated with corticosteroid use. Tianeptine sodium (amorphous) immediate release (IR) has been available in Europe and many countries in Asia and Latin America for the treatment of depression for more than three decades, first marketed in France in 1989.

    Based on the official minutes, Tonix expects to submit the IND to conduct a human abuse potential study and meet with FDA's controlled substances staff (CSS) to reach agreement on the details of the abuse potential study. Pending the results of the human abuse potential study and the results of ongoing nonclinical toxicology studies, Tonix expects to be in a position to initiate a Phase 2 study for the treatment of MDD in the fourth quarter of 2021.

    "We are pleased with the results of the FDA meeting on developing TNX-601 CR for the treatment of MDD and we look forward to advancing its clinical development," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. "Tianeptine products have been approved in Europe and other countries around the world and marketed as prescriptions drugs for treating depression for more than 3 decades. We believe that with respect to tianeptine, TNX-601 CR would meet the bioequivalence standard for daily dosing of these immediate release (IR) products. No tianeptine-containing product has been approved by the FDA. TNX-601 CR's proposed mechanism of action is distinct from any approved antidepressant in the U.S."

    "TNX-601 CR is designed for once daily dosing, which is believed to provide an adherence advantage relative to the three times per day dosing of the immediate-release sodium salt products available in Europe and other jurisdictions around the world," said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. "The efficacy of tianeptine sodium IR is comparable to both selective serotonin inhibitor (SSRI) and tricyclic antidepressants1,2 while being associated with a lower incidence of sexual dysfunction than either class3. And unlike SSRIs, tianeptine is not associated with adverse effects on libido4. Given tianetptine's unique metabolic pathway, we believe that TNX-601 CR has a reduced risk of drug-drug interactions compared to SSRIs5. Tianeptine's antidepressant activity is believed to relate to indirect modulation of the glutamatergic system. While it does not have measurable interactions with the NMDA, AMPA or kainate receptors, tianeptine is known to modulate AMPA receptor trafficking and to promote synaptic plasticity in the hippocampus under conditions of stress or corticosteroid use."

    Dr. Sullivan continued, "We are excited to bring to the clinic the discoveries and observations of the late Professor Bruce McEwen (1938-2020) of Rockefeller University in New York City who noted that tianeptine's ability in animal models, ‘to restore normal neuroplasticity… and to reverse stress-induced impairments in synaptic glutamate transmission… is crucial in virtually all key functions perturbed in depressed states'."6

    Tonix has added naloxone to the TNX-601 CR tablet as a deterrent to parenteral abuse, because tianeptine is a weak mu-opioid receptor agonist and has been linked to illicit misuse at much higher doses than those reported to be effective in the treatment of MDD7. In patients who were prescribed tianeptine for depression, the French Transparency Committee found an incidence of abuse of approximately 1 case per 1,000 patients treated8. Clinical trials have shown that cessation of a therapeutic course of tianeptine did not result in dependence or withdrawal symptoms following 6-weeks2,3,9–11, 3-months12, or 12-months13 of treatment. 

    1Jeon, H. J., et al. .J. Clin. Psychopharmacol. 2014, 34 (2), 218–225.

    2Emsley, R., et al. J. Clin. Psychiatry 2018, 79 (4)

    3Bonierbale M, et al. Curr Med Res Opin 2003, 19(2):114-124.

    4Costa e Silva, J. A., et al. Neuropsychobiology 1997, 35 (1), 24–29.

    5Wagstaff, A. J. et al. CNS Drugs 2001, 15 (3), 231–259.

    6McEwen, B. S., et al. Mol. Psychiatry 2010, 15 (3), 237–249.

    7Lauhan, R., et al. Psychosomatics 2018, 59 (6), 547–553.

    8Haute Authorite de Sante; Transparency Committee Opinion. Stablon 12.5 Mg, Coated Tablet, Re-Assessment of Actual Benefit at the Request of the Transparency Committee. December 5, 2012.

    9Guelfi, J. D., et al. Neuropsychobiology 1989, 22 (1), 41–48.

    10Invernizzi, G. et al., Neuropsychobiology 1994, 30 (2–3), 85–93.

    11Lepine, J. P., et al. Hum. Psychopharmacol. 2001, 16 (3), 219–227.

    12Guelfi, J. D. et al., Neuropsychobiology 1992, 25 (3), 140–148.

    13Lôo, H. et al., Br. J. Psychiatry. Suppl. 1992, No. 15, 61–65.

    About Depression

    According to the National Institute of Mental Health, depression affects approximately 17 million adults in the U.S.1 have had at least one major depressive episode, with approximately 2.5 million adults treated with adjunctive therapy.2,3 Depression is a condition characterized by symptoms such as a depressed mood or loss of interest or pleasure in daily activities most of the time for two weeks or more, accompanied by appetite changes, sleep disturbances, motor restlessness or retardation, loss of energy, feelings of worthlessness or excessive guilt, poor concentration, and suicidal thoughts and behaviors. These symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The majority of people who suffer from depression do not respond adequately to initial antidepressant therapy.4

    1National Institute of Mental Health. (2017). Major Depression. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml

    2IMS NSP, NPA, NDTI MAT-24-month data through Aug 2017.

    3PLOS One, Characterization of Treatment Resistant Depression Episodes in a Cohort of Patients from a US Commercial Claims Database, Oct 2013, Vol 8, Issue 10.

    4Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).

    About TNX-601 CR

    TNX-601 CR is a novel oral formulation of tianeptine oxalate designed for once-daily daytime dosing that is in the pre-IND (Investigational New Drug) stage of development for the treatment of MDD. Tianeptine sodium (amorphous) immediate release was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently there is no tianeptine-containing product approved in the U.S. and no controlled release tianeptine product approved in any jurisdiction. Tonix discovered a novel oxalate salt of tianeptine that may provide improved stability, consistency, and manufacturability compared to known forms of tianeptine. Tianeptine is believed to work in depression as a modulator of the glutamatergic system. Tianeptine modulates the glutamatergic system indirectly since it does not interact with NMDA, AMPA or kainate receptors. In animals, tianeptine has been shown to reverse the adverse neuroplastic changes that are observed during periods of stress and elevated corticosteroid exposure. Tianeptine and its MC5 metabolite are weak mu-opioid receptor (MOR) agonists. Tonix has added naloxone to the TNX-601 CR tablet as a deterrent to parenteral abuse as tianeptine has been linked to illicit misuse at much higher doses than the reported therapeutic dose in the treatment of MDD. Neither tianeptine nor MC5 have been shown to bind other neurotransmitter receptors. Tianeptine's reported pro-cognitive and anxiolytic effects as well as its ability to attenuate the neuropathological effects of excessive stress responses suggest that it may be used to treat post-traumatic stress disorder by a different mechanism of action than TNX-102 SL.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending agreement from FDA on statistical analysis plan.

    3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



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  23. CHATHAM, N.J., March 19, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 10,946,027 to the Company on March 16, 2021. Tianeptine oxalate is the active pharmaceutical ingredient of Tonix's development candidate, TNX-601 CR (tianeptine oxalate and naloxone controlled-release tablet). The new patent, "Tianeptine Oxalate Salts and Polymorphs," includes claims directed to pharmaceutical compositions comprising crystalline tianeptine oxalate salts, to methods of using those compositions to treat various disorders, and to methods of producing the oxalate salts. This patent…

    CHATHAM, N.J., March 19, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 10,946,027 to the Company on March 16, 2021. Tianeptine oxalate is the active pharmaceutical ingredient of Tonix's development candidate, TNX-601 CR (tianeptine oxalate and naloxone controlled-release tablet). The new patent, "Tianeptine Oxalate Salts and Polymorphs," includes claims directed to pharmaceutical compositions comprising crystalline tianeptine oxalate salts, to methods of using those compositions to treat various disorders, and to methods of producing the oxalate salts. This patent is expected to provide Tonix with U.S. market exclusivity until December 28, 2037, excluding any patent term extensions.

    Tonix's TNX-601 CR is a novel oral formulation of one of the claimed tianeptine oxalate salts, which is being developed as a potential treatment for major depressive disorder (MDD), posttraumatic stress disorder and neurocognitive dysfunction associated with corticosteroid use. Tianeptine sodium (amorphous) immediate release (IR) has been available in Europe for the treatment of depression for more than three decades, first marketed in France in 1989. Tianeptine sodium IR is also marketed in many countries in Asia and Latin America. No tianeptine-containing product has been approved by the U.S. Food and Drug Administration (FDA).

    TNX-601 CR is designed for once daily dosing, which is believed to provide an adherence advantage relative to the three times per day, or t.i.d. dosing, of the immediate-release tianeptine sodium salt products available in Europe and other jurisdictions around the world. The crystalline tianeptine oxalate of the patented compositions is believed to provide improved stability, consistency, and manufacturability as compared to the amorphous sodium salt.

    "We are pleased with the issuance of the new patent that protects pharmaceutical compositions and uses of salts of tianeptine oxalate," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. "We believe that the expected period of patent protection, together with the scope and term of our earlier U.S. patents directed to tianeptine and its salts, warrants the further development of tianeptine for the U.S. market. The mechanism of TNX-601 CR in treating depression is distinct from any other antidepressant available in the U.S."

    "The issuance of this patent is the fruit of Tonix's internal discovery efforts," said Siobhan Fogarty, Executive Vice President of Product Development of Tonix Pharmaceuticals. "We believe the physiochemical properties of the crystalline oxalate salt are superior to the amorphous sodium salt marketed in Europe and other parts of the world, and together with our controlled-release technology will provide a once-daily dosage product."

    Tianeptine indirectly modulates the glutamatergic pathway via altered AMPA and NMDA receptor neurotransmission, and plays a role in promoting brain neuroplasticity under conditions of stress or corticosteroid use. Tonix has added naloxone to the TNX-601 CR tablet as a deterrent to parenteral abuse, because tianeptine is a weak mu-opioid receptor agonist and has been linked to illicit misuse at much higher doses than those reported to be effective in the treatment of MDD.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 2021 and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR

    peter.vozzo@westwicke.com

    (443) 213-0505



    Primary Logo

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  24. Announced Positive Phase 3 RELIEF Study Results for TNX-102 SL 5.6 mg in Fibromyalgia

    Interim Analysis Results from Second Confirmatory Phase 3 Study, RALLY, Expected in Third Quarter 2021: Interim Cohort Enrolled

    Efficacy Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800, Expected in First Quarter 2021

    Phase 1 Safety Study in Humans of TNX-1800 Expected to Start in Second Half 2021

    At December 31, 2020, Cash and Cash Equivalents Totaled $77.1 Million; Approximately $110 Million in Gross Proceeds Raised Subsequent to Year-End

    CHATHAM, N.J., March 15, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results…

    Announced Positive Phase 3 RELIEF Study Results for TNX-102 SL 5.6 mg in Fibromyalgia

    Interim Analysis Results from Second Confirmatory Phase 3 Study, RALLY, Expected in Third Quarter 2021: Interim Cohort Enrolled

    Efficacy Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800, Expected in First Quarter 2021

    Phase 1 Safety Study in Humans of TNX-1800 Expected to Start in Second Half 2021

    At December 31, 2020, Cash and Cash Equivalents Totaled $77.1 Million; Approximately $110 Million in Gross Proceeds Raised Subsequent to Year-End

    CHATHAM, N.J., March 15, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2020, and provided an overview of recent operational highlights.

    "We continue to make progress across our development programs and are steadily advancing our diverse pipeline of CNS and immunology product candidates," said Seth Lederman, M.D., President and Chief Executive Officer. "In 2021, we expect to deliver on several important milestones. Following on the success of our first pivotal Phase 3 fibromyalgia study, RELIEF, we look forward to reporting interim and topline data from a second potentially pivotal Phase 3 fibromyalgia study, RALLY, this year. We recently reported that we achieved enrollment of the first 50 percent of participants in RALLY, which we expect will be the interim analysis cohort. We also expect to report preclinical efficacy data from our COVID-19 vaccine candidate this quarter and start a Phase 1 study in humans in the second half of this year. Finally, we expect to initiate new clinical trials this year for several other programs including a Phase 2 cocaine intoxication trial, Phase 2 migraine trial, and a proof-of-concept study for the skin test for COVID-19 exposure to measure T cell immunity."

    Recent Highlights

    Research and Development*

    TNX-102 SL (cyclobenzaprine HCl sublingual tablets): small molecule product candidate for management of fibromyalgia

    • TNX-102 SL is a non-opioid, centrally-acting analgesic, taken once daily at bedtime, being developed for the management of fibromyalgia. In December 2020, Tonix announced TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF study (p=0.01), significantly reducing daily pain compared to placebo in participants with fibromyalgia. Activity was also shown in key secondary endpoints of improving sleep, reducing fatigue, and improving overall fibromyalgia symptoms and function. The drug was generally well tolerated with no new safety signals observed. RELIEF was a 14-week randomized, double-blind, placebo-controlled trial of TNX-102 SL 5.6 mg that included 503 participants with fibromyalgia.
    • Tonix recently announced that 50 percent of the planned total number of participants have been randomized in the second potentially pivotal Phase 3 trial of TNX-102 SL for fibromyalgia, the RALLY study. Approximately 670 participants are targeted for enrollment for the full study. The Company expects the results of an interim analysis in the third quarter of 2021, followed by topline results in the fourth quarter of 2021. Following a second positive Phase 3 study, Tonix expects to submit a New Drug Application for TNX-102 SL for fibromyalgia to the U.S. Food and Drug Administration (FDA) in 2022.

    TNX-1800 (live attenuated vaccine based on Tonix's horsepox virus vector, TNX-801): COVID-19 vaccine candidate designed as a single-administration vaccine to elicit T cell immunity

    • In November 2020, the Company announced results following vaccination of non-human primates with TNX-1800 in COVID-19 models to measure safety and the immune response to the SARS-CoV-2 Spike protein. Data demonstrated that TNX-1800 at a low dose induces a strong immune response to SARS-CoV-2 in non-human primates, with all eight animals manifesting "takes", a skin reaction which is a validated biomarker of functional T cell immunity.
    • Efficacy results from a study of TNX-1800 in which non-human primates were vaccinated with TNX-1800 and challenged with live SARS-CoV-2 are expected in the first quarter of 2021.
    • A Phase 1 safety study using TNX-1800 in humans is anticipated to start in the second half of 2021, pending Investigational New Drug (IND) clearance from the FDA.

    TNX-2100 (diagnostic skin test): SARS-CoV-2 epitope peptide mixtures for intradermal administration to measure the delayed-type hypersensitivity (DTH) reaction to SARS-CoV-2

    • Based on guidance from the FDA the Company plans to file an IND in the second quarter of 2021 and initiate clinical trials in the second half of 2021. The Company has already manufactured peptides under cGMP. TNX-2100 is designed to measure functional, or meaningful, in vivo T cell immunity to SARS-CoV-2. T cell immunity to SARS-CoV-2 persists longer than antibody immunity, is sometimes present in the absence of a measurable antibody response and is believed to provide an important element of protection against serious COVID-19 illness after infection with SARS-CoV-2. TNX-2100 is a test comprising three different mixtures of synthetic peptides (TNX-2110, -2120 and -2130), which are designed to represent different protein components of the SARS-CoV-2 virus.
    • Tonix's proposed skin test has the potential to serve as: 1) a biomarker for cellular immunity and protective immunity; 2) a method to stratify participants in COVID-19 vaccine trials by immune status; 3) an endpoint in COVID-19 vaccine trials, and 4) a biomarker of durability of vaccine protection.

    TNX-1900 (intranasal potentiated oxytocin): small peptide product candidate for migraine, craniofacial pain, insulin resistance and related disorders

    • Tonix intends to submit an IND application to the FDA in the second quarter of 2021 and is targeting to start a Phase 2 study of TNX-1900 for the prophylactic treatment of chronic migraine in the U.S. in the third quarter of 2021. A Phase 2 trial under an investigator-initiated IND was completed in the U.S. using TNX-1900 prior to Tonix's acquisition of the program.

    • In June 2020, Tonix acquired the assets of Trigemina, Inc., including the rights to develop TNX-1900 for migraine and craniofacial pain. In December 2020, Tonix acquired an exclusive license to the University of Geneva's technology for using oxytocin to treat insulin resistance and related syndromes, including obesity. This license allows Tonix to expand its intranasal potentiated oxytocin development program into cardiometabolic syndromes, which include insulin resistance, impaired glucose tolerance, and obesity.

    TNX-2900 (novel formulation of intranasal potentiated oxytocin): small peptide product candidate for the treatment of Prader-Willi syndrome

    • In February 2021, Tonix announced an agreement whereby the Company has licensed technology using oxytocin-based therapeutics for the treatment of Prader-Willi syndrome from Inserm, the French National Institute of Health and Medical Research. The co-exclusive license allows Tonix to expand its intranasal potentiated oxytocin development program to a new indication.
    • Prader-Willi syndrome is an orphan disease that occurs in approximately one in 15,000 births, and is recognized as the most common genetic cause of life-threatening childhood obesity, affecting males and females with equal frequency and all races and ethnicities. There is currently no approved treatment for either the suckling (breastfeeding) deficit in infants or the obesity and hyperphagia in older children associated with Prader-Willi syndrome. Tonix plans to submit applications to the FDA for Orphan Drug and Fast Track designations for TNX-2900.

    TNX-1300 (recombinant double mutant cocaine esterase): biologic product candidate for life-threatening cocaine intoxication

    • Tonix expects to initiate a Phase 2 open-label safety study in an emergency room setting to study TNX-1300 in the second quarter of 2021. Results of a positive Phase 2 study of volunteer cocaine users in a controlled laboratory setting were reported prior to Tonix licensing the technology. Cocaine esterase is the most potent known catalyst for cocaine degradation.

    TNX-1500 (monoclonal antibody anti-CD154): third generation monoclonal antibody as a potential first line monotherapy for preventing or treating organ transplant rejection and treating autoimmune disorders

    • In January 2021, Tonix announced a second research collaboration with the Massachusetts General Hospital (MGH) in Boston to develop TNX-1500, a humanized monoclonal antibody (mAb) that targets the CD40-ligand for the prevention of organ transplant rejection. The new collaboration will focus on kidney transplantation, while an earlier collaboration with MGH is focused on heart transplantation. The Company expects to have TNX-1500 GMP material available in the third quarter of 2021.

          *All Tonix product candidates are investigational new drugs or biologics and have not been approved for any indication.

    Financial

    As of December 31, 2020, Tonix had $77.1 million of cash and cash equivalents, compared to $11.2 million as of December 31, 2019. Cash used in operations was approximately $48.6 million for the full year ended December 31, 2020, compared to $26.7 million for full year ended December 31, 2019. The increase in cash used in operations resulted principally from an increase in research and development and general and administrative activities as defined below.

    For the year ended December 31, 2020, net proceeds from financing activities were $123.1 million, predominantly from the sale of common stock and exercise of warrants. In January 2021, the Company sold 50,000,000 shares of common stock at $0.80 per share, priced at-the-market, for gross proceeds of approximately $40 million, and net proceeds of approximately $36.9 million, after deducting the underwriting discount and other offering expenses. In February 2021, the Company sold 58,333,334 shares of common stock at $1.20 per share in a registered direct public offering, priced at-the-market, for gross proceeds of approximately $70 million, and net proceeds of approximately $65.0 million, after deducting the underwriting discount and other offering expenses.

    Fourth Quarter 2020 Financial Results

    Research and development expenses for the fourth quarter of 2020 were $12.1 million, compared to $5.7 million for the same period in 2019. This increase is predominantly due to two Phase 3 studies ongoing during this time for TNX-102 SL for fibromyalgia as well as the development of potential COVID-19 vaccine candidate, TNX-1800, which was not in development in 2019.

    General and administrative expenses for the fourth quarter of 2020 were $4.9 million, compared to $3.0 million for the same period in 2019. The increase is primarily due to an increase in financial reporting expenses, patent prosecution and maintenance costs and an increase in headcount.

    Net loss available to common stockholders was $17.0 million, or $0.10 per share, basic and diluted, for the fourth quarter of 2020, compared to net loss of $11.2 million, or $2.86 per share, basic and diluted, for the fourth quarter of 2019. The basic and diluted weighted average common shares outstanding for the fourth quarter of 2020 was 163,873,489, compared to 3,912,800 shares for the fourth of 2019.

    Full Year 2020 Financial Results

    Research and development expenses for full year 2020 were $36.2 million, compared to $18.2 million for the same period in 2019. This increase is predominantly due to the timing of development milestones related to the Phase 3 RELIEF and RALLY studies in fibromyalgia in 2020, increased activities for the development of potential vaccine candidates, TNX-1800 and TNX-801 as well as the Trigemina asset acquisition.

    General and administrative expenses for full year 2020 were $14.4 million, compared to $10.6 million for the same period in 2019. The increase is primarily due to an increase in legal fees, patent prosecution and maintenance costs, financial reporting expenses and increased employee headcount.

    Net loss available to common stockholders was $52.2 million, or $0.55 per share, basic and diluted, for full year 2020, compared to net loss available to common stockholders of $31.1 million, or $19.33 per share, basic and diluted, for full year 2019. The basic and diluted weighted average common shares outstanding for full year 2020 was 94,591,715, compared to 1,608,568 shares for full year 2019.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending submission and agreement from FDA on statistical analysis plan.

    3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Tonix Pharmaceuticals Reports Fourth Quarter 2020 Financial Results

    TONIX PHARMACEUTICALS HOLDING CORP.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except share and per share amounts)

    (Unaudited)

     Full Year Ended

     Three Months Ended

     December 31, December 31,

     2020

     2019  

     2020 2019
    Costs and expenses               
    Research and development$36,157  $18,192  $12,097  $5,690 
    General and administrative 14,354   10,636   4,926   3,044 
    Total costs and expenses 50,511   28,828   17,023   8,734 
    Operating loss (50,511)  (28,828)  (17,023)  (8,734)
    Interest income, net 48   210   2   27 
    Net loss$(50,463) $(28,618) $(17,021) $(8,707)
    Warrant deemed dividend (451)  -   -   - 
    Preferred stock deemed dividend (1,260)  (2,474)  -   (2,474)
    Net loss available to common stockholders$(52,174) $(31,092) $(17,021) $(11,181)
    Net loss per common share, basic and diluted$(0.55) $(19.33) $(0.10) $(2.86)
    Weighted average common shares outstanding, basic and diluted 94,591,715   1,608,568   163,873,489   3,912,800 

    TONIX PHARMACEUTICALS HOLDING CORP.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

    (Audited)

     December 31, 20201

     December 31, 20191

    Assets     
    Cash and cash equivalents$77,068 $11,249
    Prepaid expenses and other 10,921  2,699
    Total current assets 87,989  13,948
    Other non-current assets 10,194  610
    Total assets$98,183 $14,558
          
    Liabilities and stockholders' equity     
    Total liabilities$10,535 $5,141
    Stockholders' equity 87,648  9,417
    Total liabilities and stockholders' equity$98,183 $14,558

    1The condensed consolidated balance sheets for the years ended December 31, 2020 and December 31, 2019 have been derived from the audited financial statements but does not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505



    Primary Logo

    View Full Article Hide Full Article
  25. Enrollment Continues in Phase 3 RALLY Study, with Interim Analysis of the First 50 Percent of Participants Expected Third Quarter 2021

    Topline Results of Approximately 670 Participants in RALLY Expected Fourth Quarter 2021

    Positive Topline Results from RELIEF, the First Phase 3 Study of TNX-102 SL for Management of Fibromyalgia, Previously Announced December 2020

    CHATHAM, N.J., March 15, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that 50 percent of the planned total number of participants have been randomized in the Phase 3 RALLY study (TNX-CY-F306) for the management of fibromyalgia. RALLY is the Company's second of…

    Enrollment Continues in Phase 3 RALLY Study, with Interim Analysis of the First 50 Percent of Participants Expected Third Quarter 2021

    Topline Results of Approximately 670 Participants in RALLY Expected Fourth Quarter 2021

    Positive Topline Results from RELIEF, the First Phase 3 Study of TNX-102 SL for Management of Fibromyalgia, Previously Announced December 2020

    CHATHAM, N.J., March 15, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that 50 percent of the planned total number of participants have been randomized in the Phase 3 RALLY study (TNX-CY-F306) for the management of fibromyalgia. RALLY is the Company's second of two potential pivotal Phase 3 studies of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid, centrally acting analgesic, taken daily at bedtime. The RALLY study utilizes the same protocol design as the Company's first positive Phase 3 study, RELIEF, but with an additional 200 patients.

    "We believe that achieving this milestone keeps us on plan for the anticipated release of interim results from RALLY in the third quarter and topline data in the fourth quarter of this year," said Tonix's President and Chief Executive Officer, Seth Lederman, M.D. "If the topline results are positive, we expect to be in a position to submit a New Drug Application (NDA) for TNX-102 SL for fibromyalgia to the U.S. Food and Drug Administration (FDA) in 2022."

    In December 2020, the Company reported positive topline results from the RELIEF study, its first Phase 3 study for TNX-102 SL 5.6 mg in fibromyalgia. In the RELIEF study, the 5.6 mg dose achieved statistically significant pain reduction over placebo at Week 14 (primary endpoint, p=0.01). In addition, TNX-102 SL was generally well tolerated with an adverse event profile comparable to prior studies, and no new safety signals observed.

    An interim analysis of the first 50 percent of randomized participants in the RALLY study will be conducted shortly after the 14-week treatment period has been completed by these participants. Pending approval of the interim statistical analysis plan by the FDA, results from the interim analysis are expected in the third quarter of 2021. The interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) which will review the unblinded data and make one of four recommendations: (1) stop the study for success; (2) continue to enroll the full study as planned; (3) continue to enroll with a specified increase in the total number of participants in the full study; or (4) stop the study for futility.

    About the Phase 3 RALLY Study

    The RALLY study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets). The two-arm trial is expected to enroll approximately 670 patients across approximately 40 U.S. sites. For the first two weeks of treatment, there is a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. After the first two weeks, all participants have the dose increased to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for 12 weeks. The primary endpoint is daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation.

    About Fibromyalgia

    Fibromyalgia is a chronic pain disorder that is thought to result from amplified sensory and pain signaling. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S, and physicians and patients report widespread dissatisfaction with currently marketed products. Common symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    TNX-102 SL is an investigational new drug and has not been approved for any indication.

    Pending submission and agreement from FDA on statistical analysis plan.

    TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505



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  26. CHATHAM, N.J., March 09, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company) a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will participate in the following upcoming virtual investor conferences.

    Event33rd Annual ROTH Conference
    DateMarch 16, 2021
      
    EventMaxim Emerging Growth Conference
    DateMarch 17-18, 2021
    PresentationAvailable on demand beginning March 17
      
    EventInvestor Summit
    DateMarch 23-25, 2021
    PresentationMarch 23 at 10:30 a.m. ET

    Webcasts of the Maxim and Investor Summit conferences presentations will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com

    CHATHAM, N.J., March 09, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company) a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will participate in the following upcoming virtual investor conferences.

    Event33rd Annual ROTH Conference
    DateMarch 16, 2021
      
    EventMaxim Emerging Growth Conference
    DateMarch 17-18, 2021
    PresentationAvailable on demand beginning March 17
      
    EventInvestor Summit
    DateMarch 23-25, 2021
    PresentationMarch 23 at 10:30 a.m. ET

    Webcasts of the Maxim and Investor Summit conferences presentations will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending submission and agreement from FDA on statistical analysis plan.

    3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505



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  27. CHATHAM, N.J., March 04, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Global Market. On March 3, 2021, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix's shares had a closing bid price at or above $1.00 per share for a minimum of 20 consecutive business days, Tonix's stock had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(a)(1), and the matter is now closed.

    Tonix

    CHATHAM, N.J., March 04, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Global Market. On March 3, 2021, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix's shares had a closing bid price at or above $1.00 per share for a minimum of 20 consecutive business days, Tonix's stock had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(a)(1), and the matter is now closed.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending submission and agreement from FDA on statistical analysis plan.

    3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505



    Primary Logo

    View Full Article Hide Full Article
  28. Expands Proprietary Uses of Tonix's Potentiated Oxytocin for Intranasal Administration

    Disorder Stunts Growth of Newborns and, Paradoxically, Can Cause Excessive Hunger During Childhood and Beyond

    CHATHAM, N.J., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement whereby Tonix has licensed technology using oxytocin-based therapeutics for the treatment of Prader-Willi syndrome and non-organic failure to thrive disease from Inserm. The licensing agreement has been negotiated and signed by Inserm Transfert, the private subsidiary of Inserm, on behalf of Inserm (the French National Institute of Health and Medical Research…

    Expands Proprietary Uses of Tonix's Potentiated Oxytocin for Intranasal Administration

    Disorder Stunts Growth of Newborns and, Paradoxically, Can Cause Excessive Hunger During Childhood and Beyond

    CHATHAM, N.J., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement whereby Tonix has licensed technology using oxytocin-based therapeutics for the treatment of Prader-Willi syndrome and non-organic failure to thrive disease from Inserm. The licensing agreement has been negotiated and signed by Inserm Transfert, the private subsidiary of Inserm, on behalf of Inserm (the French National Institute of Health and Medical Research), Aix-Marseille Université and Centre Hospitalier Universitaire of Toulouse.

    The co-exclusive license allows Tonix to expand its intranasal potentiated oxytocin development program to a new indication. The new program at Tonix has the designation TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. The patents covering the technology are expected to provide market exclusivity for the co-licensees in the U.S. and Europe through 2031, which exclusivity could be extended after marketing authorization by a Supplemental Protection Certificate in Europe or a Patent Term Extension in the U.S., independent of other Tonix-held patents covering the formulation and oxytocin potentiation technologies for intranasal administration.

    "Prader-Willi syndrome is a rare genetic disorder of failure to thrive in infancy and uncontrolled appetite and obesity in childhood and adulthood with no approved treatments available," said Tonix's President and Chief Executive Officer, Seth Lederman, M.D. "With the license from Inserm Transfert, we have the opportunity to expand our ongoing efforts with intranasal potentiated oxytocin to this new indication. Since Prader-Willi syndrome is an orphan disease that occurs in approximately one in 15,000 births, we plan at the appropriate time to submit an application to the U.S. Food and Drug Administration for Orphan Drug and Fast Track designations for TNX-2900."   

    Prader-Willi syndrome results in physical, mental and behavioral problems. A key feature of Prader-Willi syndrome in infants is a lack of suckling and poor muscle strength which leads to malnutrition and failure to thrive. However, paradoxically in children and adults, the key feature of Prader-Willi syndrome is a constant sense of hunger (hyperphagia), which leads to severe obesity. Intranasal oxytocin improves suckling in newborn animals but also suppresses feeding behaviors in adult animal models. Tonix's patented potentiated oxytocin formulation is believed to increase specificity for oxytocin receptors relative to vasopressin receptors as well as to enhance the potency of oxytocin.

    About Prader-Willi Syndrome

    Prader-Willi syndrome is recognized as the most common genetic cause of life-threatening childhood obesity1 and affects males and females with equal frequency and all races and ethnicities. The hallmarks of Prader-Willi syndrome are lack of suckling in infants and, in children and adults, severe hyperphagia, an overriding physiological drive to eat, leading to severe obesity and other complications associated with significant mortality. There is currently no approved treatment for either the suckling deficit in babies or the obesity and hyperphagia in older children associated with Prader-Willi syndrome.

    1Foundation for Prader-Willi Research (fpwr.org).

    About TNX-2900* and Tonix's Potentiated Oxytocin Platform

    TNX-2900 is based on Tonix's patented intranasal potentiated oxytocin formulation. Tonix is also developing a different intranasal formulation and device, designated TNX-1900, for prophylaxis of chronic migraine and for the treatment of insulin resistance and related conditions. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. It was originally approved by the U.S. Food and Drug Administration (FDA) as Pitocin®**, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor. An intranasal form of oxytocin was marketed in the U.S. by Novartis to assist in the production of breast milk as Syntocinon®*** (oxytocin nasal 40 units/ml), but the product was withdrawn, and the New Drug Application (NDA) has been discontinued. TNX-2900 and TNX-1900 are in the pre-Investigational New Drug (IND) stage and have not been approved for any indication.

    *TNX-2900 is an investigational new drug and has not been approved for any indication.

    **Pitocin® is a trademark of Par Pharmaceutical, Inc.

    ***Syntocinon® is a trademark of BGP Products Operations GmbH

    About TNX-1900* (Intranasal Potentiated Oxytocin)

    TNX-1900 is based on a proprietary potentiated formulation of oxytocin and is currently being developed as a candidate for prophylaxis of chronic migraine and for the treatment of insulin resistance and related conditions.

    TNX-1900 for Migraine: In clinical and preliminary research, it has been observed that low oxytocin levels in the body can lead to increase in headache frequency, and that increased oxytocin levels can relieve headaches. Oxytocin, when delivered via the nasal route, results in enhanced binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting transmission of pain signals. Intranasal oxytocin has been well tolerated in several clinical trials in adults and children. Intranasal oxytocin has been shown to block calcitonin gene-related peptide (CGRP) release in animals, a pathway known to be critical to the pathogenesis of migraine attacks. TNX-1900 is believed to interrupt pain signals at the trigeminal ganglia by suppressing electrical impulses, a potentially different activity than drugs that just block CGRP. Migraine attacks are caused, in part, by the release of CGRP from pain-sensing nerve cells that are part of the trigeminal system. Targeted delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects which could potentially occur with systemic CGRP antagonists. For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. Tonix believes targeted delivery of oxytocin could translate into selective blockade of CGRP release in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition. TNX-1900 is also believed to provide augmented analgesia in the treatment of pain, relative to oxytocin.

    TNX-1900 for Insulin Resistance: Tonix recently acquired the exclusive license to develop TNX-1900 for the treatment of insulin resistance and related conditions from the University of Geneva. The license allows Tonix to expand its intranasal potentiated oxytocin development program into cardiometabolic syndromes, which include insulin resistance, impaired glucose tolerance, obesity, diabetes management and related metabolic complications. The patents covering the technology are expected to provide Tonix market exclusivity in the U.S. and Europe through 2031 which exclusivity could be extended after marketing authorization by a Supplemental Protection Certificate in Europe or a Patent Term Extension in the U.S., independently of other Tonix-held patents covering the formulation and potentiation technologies related to TNX-1900. The University of Geneva technology is based on the discovery that oxytocin administration in an animal model of obesity improved lipid metabolism by increasing lipolysis and fatty acid-β-oxidation in adipose tissue accompanied by improvements in glucose intolerance and insulin resistance, independent of food intake1. A number of studies have shown that intranasal oxytocin has effects on insulin resistance and weight2-4,". Intranasal oxytocin has been reported to improve glucose homeostasis, improve pancreatic β-cell responsivity, decrease energy-induced and reward-induced eating, and support cognitive control of food choices.2-9 

    *TNX-1900 is an investigational new drug and has not been approved for any indication.

    1Deblon N, et al. (2011) PLoS ONE 6(9): e25565. doi:10.1371/journal.pone.0025565

    2Lawson EA. (2017) Nat Rev Endocrinol. 13(12):700-709. doi: 10.1038/nrendo.2017.115. PMID: 28960210

    3Olszewski PK, et al. (2017) Curr Opin Endocrinol Diabetes Obes. 24(5):320-325. doi: 10.1097/MED.0000000000000351. PMID: 28590323.

    4Ding C, et al. (2019) Obes Rev. 2019 Jan;20(1):22-40. doi: 10.1111/obr.12757. PMID: 30253045.

    5Lawson EA, et al. (2015) Obesity. 23:950–956. DOI: 10.1002/oby.21069 PMID: 25865294

    6Klement, J et al. (2017) Diabetes 66(2) 264-271; DOI: 10.2337/db16-0569

    7Ott V, et al. (2013) Diabetes. 62:3418–3425. DOI: 10.2337/db13-0663 PMID: 23835346

    8Thienel M, et al. (2016) Int J Obes. 40(11):1707-1714. DOI: 10.1038/ijo.2016.149 PMID: 27553712 

    9Striepens N, et al. (2016) Human Brain Mapp. 37(12):4276–4285. DOI: 10.1002/hbm.23308 PMID: 27381253

    About Inserm Transfert

    Inserm Transfert, the private subsidiary of the French National Institute of the Health and Medical Research (Inserm), is responsible for value creation of Inserm innovations in human health and promotes long-term technology transfers in line with international best practices. Inserm Transfert SA was founded in 2000, and manages, under a Public Service Management Contract (Délégation de Service Public), the entire promotion and transfer of knowledge emerging from the Inserm research laboratories to the industrial world, from invention disclosure to industrial partnerships and startups incorporation. Inserm Transfert also offers services relating to setting up and managing national, European and international projects, as well as supporting the technology transfer of clinical research and health data/databases. In 2009, Inserm Transfert and Inserm established an investment fund to finance proofs of concept. In 2005, Inserm Transfert Initiative, a dedicated seed money fund for life sciences, was created. Since 2017 a pathway for pre-entrepreneurship supports researchers/inventors that aspire to become involved in entrepreneurship. www.inserm-transfert.com

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the second quarter of 20212 and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending submission and agreement from FDA on statistical analysis plan.

    3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com 

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com 

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com 

    (443) 213-0505



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  29. CHATHAM, N.J., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will participate in the BIO CEO & Investor Digital Conference being held February 16-18, 2021.

    The Company's presentation will be made through the BIO CEO & Investor Digital Conference website and available on demand to registered participants during the conference at https://www.bio.org/events/bio-ceo-investor-digital-conference/company-presentations. Following the conference, the presentation will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com

    CHATHAM, N.J., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will participate in the BIO CEO & Investor Digital Conference being held February 16-18, 2021.

    The Company's presentation will be made through the BIO CEO & Investor Digital Conference website and available on demand to registered participants during the conference at https://www.bio.org/events/bio-ceo-investor-digital-conference/company-presentations. Following the conference, the presentation will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the second quarter of 20212 and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-18003, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1TNX-102 SL is an investigational new drug and has not been approved for any indication.

    2Pending submission and agreement from FDA on statistical analysis plan.

    3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke, an ICR Company

    peter.vozzo@westwicke.com

    (443) 213-0505



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  30. CHATHAM, N.J., Feb. 09, 2021 (GLOBE NEWSWIRE) -- TONIX PHARMACEUTICALS HOLDINGS CORP. (NASDAQ:TNXP) ("Tonix" or the "Company"), a clinical-stage biopharmaceutical company, today announced the closing of its previously announced registered direct offering, priced at-the-market, with gross proceeds of approximately $70.0 million before deducting fees and other estimated offering expenses. The Company sold 58,333,334 shares of common stock at $1.20 per share. 

    A.G.P./Alliance Global Partners acted as sole placement agent for the offering.

    This offering was made pursuant to effective shelf registration statements on Form S-3 (File No. 333-251500 and 333-237610) previously filed with and declared effective by the U.S. Securities and Exchange…

    CHATHAM, N.J., Feb. 09, 2021 (GLOBE NEWSWIRE) -- TONIX PHARMACEUTICALS HOLDINGS CORP. (NASDAQ:TNXP) ("Tonix" or the "Company"), a clinical-stage biopharmaceutical company, today announced the closing of its previously announced registered direct offering, priced at-the-market, with gross proceeds of approximately $70.0 million before deducting fees and other estimated offering expenses. The Company sold 58,333,334 shares of common stock at $1.20 per share. 

    A.G.P./Alliance Global Partners acted as sole placement agent for the offering.

    This offering was made pursuant to effective shelf registration statements on Form S-3 (File No. 333-251500 and 333-237610) previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A final prospectus relating to the offering was filed with the SEC on February 9, 2021 and is available on the SEC's website located at http://www.sec.gov. Copies of the prospectus supplement, together with the accompanying prospectuses, can be obtained at the SEC's website at www.sec.gov or from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, New York 10022 or by email at prospectus@allianceg.com.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL*, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the second quarter of 2021** and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800***, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801***, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    *TNX-102 SL is an investigational new drug and has not been approved for any indication.

    ** Pending submission and agreement from FDA on statistical analysis plan.

    ***TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward-Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, statements about the expected closing of the offering; anticipated gross proceeds from the offering; risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; substantial competition and other risks and uncertainties detailed in Tonix's Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission ("SEC") on March 24, 2020, as well as Tonix's subsequent periodic and current report filed with the SEC. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the SEC on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505



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  31. CHATHAM, N.J., Feb. 08, 2021 (GLOBE NEWSWIRE) -- TONIX PHARMACEUTICALS HOLDINGS CORP. (NASDAQ:TNXP) ("Tonix" or the "Company"), a clinical-stage biopharmaceutical company, today announced it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 58,333,334 shares of common stock, par value $0.001 per share at an offering price of $1.20 per share, pursuant to a registered direct offering, priced at-the-market under Nasdaq rules. The gross proceeds of the offering will be approximately $70 million before deducting fees and other estimated offering expenses. The closing of the registered direct offering is expected to take place on or about February 9, 2021, subject to the satisfaction of customary…

    CHATHAM, N.J., Feb. 08, 2021 (GLOBE NEWSWIRE) -- TONIX PHARMACEUTICALS HOLDINGS CORP. (NASDAQ:TNXP) ("Tonix" or the "Company"), a clinical-stage biopharmaceutical company, today announced it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 58,333,334 shares of common stock, par value $0.001 per share at an offering price of $1.20 per share, pursuant to a registered direct offering, priced at-the-market under Nasdaq rules. The gross proceeds of the offering will be approximately $70 million before deducting fees and other estimated offering expenses. The closing of the registered direct offering is expected to take place on or about February 9, 2021, subject to the satisfaction of customary closing conditions. 

    A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

    This offering was made pursuant to effective shelf registration statements on Form S-3 (File No. 333-251500 and 333-237610) previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC").  This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.  A prospectus supplement relating to the shares of common stock will be filed by Tonix with the SEC.  When available, copies of the prospectus supplement, together with the accompanying prospectuses, can be obtained at the SEC's website at www.sec.gov or from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, New York 10022 or by email at prospectus@allianceg.com.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL*, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the second quarter of 2021** and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800***, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801***, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    *TNX-102 SL is an investigational new drug and has not been approved for any indication.

    **Pending submission and agreement from FDA on statistical analysis plan.

    ***TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward-Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, statements about the expected closing of the offering; anticipated gross proceeds from the offering; risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; substantial competition and other risks and uncertainties detailed in Tonix's Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission ("SEC") on March 24, 2020, as well as Tonix's subsequent periodic and current report filed with the SEC. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the SEC on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505



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  32. Pre-IND Meeting Written Response from FDA Provides Guidance on Product Development and Clinical Testing Protocol

    Intradermal Test is Designed to Measure SARS-CoV-2 Specific Delayed Type Hypersensitivity (DTH), the Classic Method of Measuring T Cell Immunity to Tuberculosis and Other Pathogens

    Multiple Potential Uses Include Functional Measure of T Cell Immunity to SARS-CoV-2; Aid to COVID-19 Diagnosis and Public Health Surveillance; Endpoint for COVID-19 Vaccine Trials

    CHATHAM, N.J., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it has received the written response from the U.S. Food and Drug Administration (FDA) to…

    Pre-IND Meeting Written Response from FDA Provides Guidance on Product Development and Clinical Testing Protocol

    Intradermal Test is Designed to Measure SARS-CoV-2 Specific Delayed Type Hypersensitivity (DTH), the Classic Method of Measuring T Cell Immunity to Tuberculosis and Other Pathogens

    Multiple Potential Uses Include Functional Measure of T Cell Immunity to SARS-CoV-2; Aid to COVID-19 Diagnosis and Public Health Surveillance; Endpoint for COVID-19 Vaccine Trials

    CHATHAM, N.J., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it has received the written response from the U.S. Food and Drug Administration (FDA) to a Type B pre-investigational new drug (IND) meeting package describing its technology and plans to develop a diagnostic skin test, TNX-2100 (SARS-CoV-2 epitope peptide mixtures for intradermal administration), to measure the delayed-type hypersensitivity (DTH) reaction to SARS-CoV-2 (CoV-2), the virus that causes COVID-19.

    TNX-2100 is designed to measure T cell immunity to CoV-2. There currently is no standardized laboratory test available to measure T cell immune responses to CoV-2. T cell immunity to CoV-2 persists longer than antibody immunity, is sometimes present in the absence of a measurable antibody response and is believed to provide an important element of protection against serious COVID-19 illness after infection with CoV-2.

    "We believe TNX-2100 has the potential to measure T cell immunity to CoV-2 and therefore serve as an aid to COVID-19 diagnosis to support patient care, public health surveillance and vaccine trials," said Seth Lederman, M.D., Tonix's President and Chief Executive Officer. "Our proposed skin test has the potential to serve as: 1) a biomarker for cellular immunity and protective immunity; 2) a method to stratify participants in COVID-19 vaccine trials by immune status; 3) an endpoint in COVID-19 vaccine trials, and 4) a biomarker of durability of vaccine protection."

    The only currently available methods to detect T cell immunity to CoV-2 require expensive, multi-step sample preparation and in vitro T cell stimulation in highly specialized laboratories using methods that have not been amenable to standardization. When fully developed, the TNX-2100 skin test is expected to provide clinicians, patients, employers and public health officials with information of potential diagnostic, safety and predictive significance in a timely and cost-effective manner, including the durability of immune responses in vaccinated, convalescent and exposed individuals, clusters, workplaces and populations.

    TNX-2100 is a test comprising three different mixtures of synthetic peptides (TNX-2110, -2120 and -2130), which are designed to represent different protein components of the CoV-2 virus. TNX-2110 (CoV-2 multi-antigen peptides) represents multiple proteins from CoV-2. TNX-2120 (CoV-2 spike peptides) represents only the spike protein. TNX-2130 (CoV-2 non-spike peptides) represents non-spike proteins. Each of these three tests is expected to be administered as part of the same procedure, at separate locations on the forearm, and each is expected to elicit a DTH response after approximately 48 hours in individuals with pre-existing T cell immunity to peptides in that mixture. Individuals who have been infected by or exposed to CoV-2 would be expected to respond to all three mixtures. In contrast, a successfully vaccinated individual who has not been exposed or infected by CoV-2 would be expected to respond only to TNX-2120 (CoV-2 spike peptides), since the currently available vaccines only encode spike protein. In the planned clinical protocol for testing TNX-2100, positive skin test controls will be used to confirm that study participants have intact T cell immunity and are not immunodeficient.

    The test is designed to be administered in the same way as skin tests for tuberculosis, or TB, sold as Tubersol® or Aplisol® or generically as the Mantoux tuberculin purified protein derivative (PPD) test. A thin gauge needle is used to apply the three separate peptide mixtures into the skin, or intradermally, on the inner surface of the forearm between the wrist and the elbow. The test may be administered in a variety of settings: ranging from a doctor's office to a remote outpost without running water or in inclement or extreme weather. In a typical positive test, the skin surrounding the injection site is expected to become red, raised and hardened, or "indurated", after approximately 48 hours. Induration above a threshold level would signify a positive result and the diameter of the induration would indicate the amount of T cell immunity to the test peptides. DTH skin test responses are believed to reflect functional in vivo immunity. Clinical trials are expected to correlate skin test results with clinical history to inform estimates about the sensitivity and specificity of the test as a marker of T cell immunity in individuals pre- and post-COVID-19 vaccination, who are recovered from COVID-19, and some with active CoV-2 infection.

    "Based on guidance provided by FDA in their written response, we believe we have the information necessary to respond to queries and file the IND application in the second quarter of 2021," said Herbert Harris, M.D., Ph.D., Tonix's Executive Vice President for Translational Medicine. "The Company has manufactured peptides under current good manufacturing process or cGMP. We expect clinical trials of TNX-2100 can be initiated, upon FDA clearance of the IND application, in the second half of 2021."

    In parallel to developing TNX-2100 as a potential diagnostic tool, Tonix is developing TNX-1800, a live replicating vaccine for COVID-19 designed to elicit primarily T cell immunity. Tonix announced positive immune response data in non-human primates in the fourth quarter of 2020 and expects to release data from non-human primate studies involving challenge with SARS-CoV-2 in the first quarter of 2021.

    Tubersol® is a trademark of Sanofi Pasteur

    Aplisol® is a trademark of Par Pharmaceutical, Inc.

    About TNX-2100

    TNX-2100 is a diagnostic product candidate in the pre-Investigational New Drug (IND) stage and has not been approved for any indication. Discovered in 1882 by Robert Koch, the DTH reaction has been used for more than a century as a clinical test for T cell-mediated immune reactions1. In the 1940s, Landsteiner and Chase demonstrated that the reaction was mediated by the cellular and not the antibody arm of the immune system2. When small quantities of antigen are injected intradermally, a hallmark response is elicited which includes induration, swelling and monocytic infiltration into the site of the lesion within 24 to 48 hours. This reaction has been shown to be dependent on the presence of memory T cells. Both the CD4+ and CD8+ T cells have been shown to participate in this response. DTH skin tests have been commonly used to detect T cell responses to tuberculosis, fungal pathogens, and mumps virus.

    1Black CA. Delayed type hypersensitivity: current theories with an historic perspective. Dermatol Online J. 1999;5:7.

    2Landsteiner K, Chase MW. Studies on the sensitization of animals with simple chemical compounds: vii. Skin sensitization by intraperitoneal injections. J Exp Med. 1940;71:237.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL*, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data from a second Phase 3 study, RALLY, in the second quarter of 2021** and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800***, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801***, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    *TNX-102 SL is an investigational new drug and has not been approved for any indication.

    ** Pending submission and agreement from FDA on statistical analysis plan.

    ***TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505

     



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  33. GMP Production of TNX-1500 is Expected to be Available in the Third Quarter of 2021

    CHATHAM, N.J., Jan. 14, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the World Intellectual Property Organization has published a patent application filed under the Patent Cooperation Treaty covering TNX-1500, a humanized monoclonal antibody (mAb) directed against CD40-ligand, which is also known as CD154, T-BAM, 5c8 antigen, TRAP and gp39. The patent application is titled "Anti-CD154 Antibodies and Uses Thereof" and published under International Publication No. WO 2021/001458 A1. If claims are granted, a patent issuing from a national stage…

    GMP Production of TNX-1500 is Expected to be Available in the Third Quarter of 2021

    CHATHAM, N.J., Jan. 14, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the World Intellectual Property Organization has published a patent application filed under the Patent Cooperation Treaty covering TNX-1500, a humanized monoclonal antibody (mAb) directed against CD40-ligand, which is also known as CD154, T-BAM, 5c8 antigen, TRAP and gp39. The patent application is titled "Anti-CD154 Antibodies and Uses Thereof" and published under International Publication No. WO 2021/001458 A1. If claims are granted, a patent issuing from a national stage of this application could potentially provide U.S. patent coverage for the TNX-1500 composition of matter through 2040 excluding possible patent term extensions or patent term adjustments.

    Tonix's President and Chief Executive Officer, Seth Lederman, M.D. said, "Nearly 30 years ago my laboratory at Columbia University generated the first anti-CD40-ligand mAb (5c8), discovered and characterized human CD40-ligand and elucidated the molecular basis of T cell helper function1. Collaborating with a team at Biogen Inc., we determined the crystal structure of CD40-ligand2, developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Our studies and those of others generated a substantial body of evidence in humans and animals that indicates anti-CD40-ligand mAbs have the potential to be an important therapeutic option for preventing or treating transplant organ rejection and for treating autoimmune disorders."

    Dr. Lederman continued, "Despite the recognized promise of anti-CD40-ligand mAb therapy, first generation anti-CD40-ligand mAbs were limited because their crystallizable fragment (Fc) domain interacted with a cell surface receptor called FcγRII, which resulted in an increased risk of thrombosis. Second generation anti-CD40-ligand mAbs had dramatically reduced binding to FcγRII, but had other issues, including decreased efficacy3-5. TNX-1500 is a third generation anti-CD40-ligand mAb that has been designed by protein engineering to decrease FcγRII binding and the potential for thrombosis, while retaining efficacy. We believe TNX-1500 has the potential for treating and preventing organ transplant rejection and treating autoimmunity."

    TNX-1500 incorporates the antigen binding fragment (Fab) region of hu5c8, which has been extensively characterized including at the atomic level in complex with CD40-ligand6. The newly published patent application includes claims related to proprietary anti-human CD40-ligand mAbs that were engineered to have modified effector function, including TNX-1500, which have reduced potential for Fc binding to FcγRII. The patent application also claims uses of TNX-1500 for preventing and treating conditions, such as organ transplant rejection and autoimmune disorders.

    Dr. Lederman added, "We believe the development risk of TNX-1500 is mitigated by previous clinical data and extensive preclinical science with ruplizumab. We are developing the manufacturing processes for TNX-1500 and expect Good Manufacturing Practice (GMP) TNX-1500 to be available in the third quarter of 2021. There remains a significant need for new treatments with improved activity and tolerability to prevent or treat organ transplant rejection and to treat autoimmune conditions, including systemic lupus erythematosus, rheumatoid arthritis and multiple sclerosis."

    1 Lederman, S. et al. J. Exp. Med. 175:1091-1101 (1992)

    2 Karpusas, M et al., Structure 3:1031-1039 (1995)

    3 Waters J, Biocentury; October 26, (2018)

    4 NCT02273960; ClinicalTrials.gov; "Study to Evaluate Safety and Efficacy in Adult Subjects With ITP (ITP)"; results posted April 1, 2019, updated July 29, 2019 and accessed Jan 11, 2021

    5 Ferrant JL et al., International Immunol. (11):1583 (2004)

    6 Karpusas M, et al. Structure. 9(4):321-9. (2001)

    About CD40-Ligand

    CD40-ligand is a protein expressed on the surface of activated T lymphocytes that mediates T cell helper function. CD40-ligand is also known as CD154, the T cell-B cell activating molecule (T-BAM), TRAP and gp39. CD154 is a member of the Tumor Necrosis Factor (TNF) Super Family. No mAb against CD154 has been approved for commercial use anywhere in the world. Other TNF Super Family members have been successfully targeted by antagonist mAbs. Approved mAbs against TNFα include: infliximab (Remicade®), adalimumab (Humira®), certolizumab pegol (Cimzia®), and golimumab (Simponi®) for the treatment of certain autoimmune conditions. Also, etanercept (Enbrel®) is a TNFα antagonist receptor fusion protein. An approved mAb against RANKL (CD254) is denosumab (Prolia® or Xgeva®) for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.

    Remicade® and Simponi® are trademarks of Janssen; Humira® is a trademark of AbbVie Inc.; Cimzia® is a trademark of UCB S. A.; Enbrel®, Prolia® and Xgeva® are trademarks of Amgen Inc.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL*, is in mid-Phase 3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data for the Phase 3 RALLY study in the second quarter of 2021** and topline data in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800***, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801***, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    *TNX-102 SL is an investigational new drug and has not been approved for any indication.



    ** Pending submission and agreement from FDA on statistical analysis plan.

    ***TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com 

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com  

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com 

    (443) 213-0505



    Primary Logo

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  34. CHATHAM, N.J., Jan. 13, 2021 (GLOBE NEWSWIRE) -- TONIX PHARMACEUTICALS HOLDINGS CORP. (NASDAQ:TNXP) ("Tonix" or the "Company"), a clinical-stage biopharmaceutical company, today announced the closing of its previously announced registered direct offering, priced at-the-market, with gross proceeds of $40.0 million before deducting fees and other estimated offering expenses.

    The Company sold 50,000,000 shares of common stock at $0.80 per share. A.G.P./Alliance Global Partners acted as sole placement agent for the offering.

    This offering was made pursuant to effective shelf registration statements on Form S-3 (File No. 333-224586 and 333-237610) previously filed and declared effective by the U.S. Securities and Exchange Commission (the "SEC…

    CHATHAM, N.J., Jan. 13, 2021 (GLOBE NEWSWIRE) -- TONIX PHARMACEUTICALS HOLDINGS CORP. (NASDAQ:TNXP) ("Tonix" or the "Company"), a clinical-stage biopharmaceutical company, today announced the closing of its previously announced registered direct offering, priced at-the-market, with gross proceeds of $40.0 million before deducting fees and other estimated offering expenses.

    The Company sold 50,000,000 shares of common stock at $0.80 per share. A.G.P./Alliance Global Partners acted as sole placement agent for the offering.

    This offering was made pursuant to effective shelf registration statements on Form S-3 (File No. 333-224586 and 333-237610) previously filed and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A final prospectus relating to the offering was filed with the SEC on January 12, 2021 and is available on the SEC's website located at http://www.sec.gov. Copies of the prospectus supplement, together with the accompanying prospectuses, can be obtained at the SEC's website at www.sec.gov or from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, New York 10022 or by email at prospectus@allianceg.com.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL*, is in mid-Phase 3 development for the management of fibromyalgia since positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data for the Phase 3 RALLY study in the second quarter of 2021** and topline data in the Phase 3 RALLY study in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800***, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801***, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    *TNX-102 SL is an investigational new drug and has not been approved for any indication.

    ** Pending submission and agreement from the U.S. Food and Drug Administration (FDA) on the statistical analysis plan.

    ***TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward-Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, statements about the closing of the offering; gross proceeds from the offering; risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; substantial competition and other risks and uncertainties detailed in Tonix's Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission ("SEC") on March 24, 2020, as well as Tonix's subsequent periodic and current report filed with the SEC. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the SEC on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505



    Primary Logo

    View Full Article Hide Full Article
  35. Presentation Times and Weblinks Released for Over 60 Presenting Companies

    NEW YORK, NY / ACCESSWIRE / January 13, 2021 / Sidoti & Company, LLC has released the presentation schedule, with weblink click-throughs, for its two-day Winter 2021 Virtual Investor Conference, to take place Wednesday and Thursday, January 13-14, 2021. The links can also be found at www.sidoticonference.com/events.

    Sidoti & Co. Winter 2021 Microcap Conference - Virtual Agenda

    Day 1 - Wednesday, January 13, 2021

    8:30-9:00

    ****

    ****

    ****

    ****

    9:15-9:45

    Tonix Pharmaceuticals (TNXP)

    Circor International (CIR)

    Intelligent Systems
    (INS)

    ****

    10:00-10:30

    Protech Home Medical (PTQ.V)

    The Eastern Company (EML)

    Braemer Hotels & Resorts
    (BHR)

    SWM International (SWM)

    10:45-11:15

    VolitionRx Limited (VNRX)

    Presentation Times and Weblinks Released for Over 60 Presenting Companies

    NEW YORK, NY / ACCESSWIRE / January 13, 2021 / Sidoti & Company, LLC has released the presentation schedule, with weblink click-throughs, for its two-day Winter 2021 Virtual Investor Conference, to take place Wednesday and Thursday, January 13-14, 2021. The links can also be found at www.sidoticonference.com/events.

    Sidoti & Co. Winter 2021 Microcap Conference - Virtual Agenda

    Day 1 - Wednesday, January 13, 2021

    8:30-9:00

    ****

    ****

    ****

    ****

    9:15-9:45

    Tonix Pharmaceuticals (TNXP)

    Circor International (CIR)

    Intelligent Systems
    (INS)

    ****

    10:00-10:30

    Protech Home Medical (PTQ.V)

    The Eastern Company (EML)

    Braemer Hotels & Resorts
    (BHR)

    SWM International (SWM)

    10:45-11:15

    VolitionRx Limited (VNRX)

    Orion Group Holdings (ORN)

    Information Services Group (III)

    VSE Corporation (VSEC)

    11:30-12:00

    Otter Tail Corporation (OTTR)

    Culp, Inc. (CULP)

    Forrester Research (FORR)

    ****

    12:15-12:45

    Carriage Services, Inc. (CSV)

    ESCO Technologies Inc. (ESE)

    DHI Group, Inc.
    (DHX)

    Brady Corporation
    (BRC)

    1:00-1:30

    Hooker Furniture Corporation
    (HOFT)

    Quaker Houghton
    (KWR)

    ****

    ABM Industries (ABM)

    1:45-2:15

    Helius Medical Technologies, Inc. (HSDT)

    Balchem Corporation (BCPC)

    Mistras Group
    (MG)

    Charles River Associates (CRAI)

    2:30-3:00

    Safehold Inc. (SAFE)

    PyroGenesis Canada Inc

    BioSig Technologies, Inc. (BSGM)

    Willdan Group (WLDN)

    3:15-3:45

    SuRo Capital (SSSS)

    Powell Industries, Inc. (POWL)

    OneSoft Solutions Inc. (OSS.V)

    Heidrick & Struggles (HSII)

    4:00-4:30

    Axos Financial, Inc.
    (AX)

    Capstone Turbine Corporation (CPST)

    A10 Networks (ATEN)

    Resources Connection (RGP)

    1x1s Only

    (13th)

    Astec Industries (ASTE)

    CSW Industrials (CSWI)

    Heritage Insurance Holdings (HRTG)

    Kimball Electronics (KE)

    Matson, Inc. (MATX)

    Sidoti & Co. Winter 2021 Microcap Conference - Virtual Agenda

    Day 2 - Thursday, January 14, 2021

    8:30-9:00

    ****

    ****

    Golden Valley Mines Ltd. (GZZ.V)

    Eagle Bulk Shipping (EGLE)

    9:15-9:45

    International Seaways (INSW)

    Gibraltar Industries (ROCK)

    Comtech Telecommunications (CMTL)

    Osisko Gold Royalties (OR)

    10:00-10:30

    Matrix Service Company (MTRX)

    ****

    Luxfer Holdings PLC (LXFR)

    Unisys Corporation
    (UIS)

    10:45-11:15

    LeMaitre Vascular (LMAT)

    AAON Inc. (AAON)

    VersaBank (VB.TO)

    Good Natured Products (GDNP.V)

    11:30-12:00

    Varex Imaging Corp. (VREX)

    Apogee Enterprises (APOG)

    Civeo Corporation (CVEO)

    ****

    1x1s Only

    (14th)

    Commercial Vehicle Group (CVGI)

    Heritage Insurance Holdings (HRTG)

    Methode Electronics (MEI)

    Plexus Corp (PLXS)

    Quanex Building Products (NX)

    Please join our friends at Friedman LLP (www.friedmanllp.com) next week, for two valuable tax webinars: "Mapping out the New Stimulus Bill" on January 19th and "COVID-19 Impact on State Residency: Tax Opportunities & Pitfalls" on January 21st. To register please click here.

    About Sidoti
    For over two decades, Sidoti has been a premier provider of independent securities research focused specifically on small- and micro-cap companies and the institutions that invest their securities, with most of our coverage in the $100 million - $3 billion market cap range. Our approach affords companies and institutional clients a combination of high-quality research, a small-and micro- cap focused nationwide sales effort, broad access to corporate management teams, and extensive trading support. We serve 500+ institutional clients in the U.S., Canada and the U.K., including many leading managers of portfolios with $200 million to $2 billion of AUM. Sidoti promotes meaningful interaction between issuers and investors in the small- and micro-cap space through our conferences www.sidoticonference.com and the hundreds of non-deal roadshows we host each year.

    Contact
    Sidoti Events Team
    212-453-7031
    conference@sidoti.com

    SOURCE: Sidoti & Company, LLC



    View source version on accesswire.com:
    https://www.accesswire.com/624038/Sidoti-Virtual-Investor-Conference

    View Full Article Hide Full Article
  36. CHATHAM, N.J., Jan. 11, 2021 (GLOBE NEWSWIRE) -- TONIX PHARMACEUTICALS HOLDINGS CORP. (NASDAQ:TNXP) ("Tonix" or the "Company"), a clinical-stage biopharmaceutical company, today announced it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 50,000,000 shares of common stock, par value $0.001 per share at an offering price of $0.80 per share, pursuant to a registered direct offering, priced at-the-market under Nasdaq rules. The gross proceeds of the offering will be $40,000,000 before deducting fees and other estimated offering expenses. The closing of the registered direct offering is expected to take place on or about January 13, 2021, subject to the satisfaction of customary closing…

    CHATHAM, N.J., Jan. 11, 2021 (GLOBE NEWSWIRE) -- TONIX PHARMACEUTICALS HOLDINGS CORP. (NASDAQ:TNXP) ("Tonix" or the "Company"), a clinical-stage biopharmaceutical company, today announced it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 50,000,000 shares of common stock, par value $0.001 per share at an offering price of $0.80 per share, pursuant to a registered direct offering, priced at-the-market under Nasdaq rules. The gross proceeds of the offering will be $40,000,000 before deducting fees and other estimated offering expenses. The closing of the registered direct offering is expected to take place on or about January 13, 2021, subject to the satisfaction of customary closing conditions. 

    A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

    This offering was made pursuant to effective shelf registration statements on Form S-3 (File No. 333-224586 and 333-273610) previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC").  This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.  A prospectus supplement relating to the shares of common stock will be filed by Tonix with the SEC.  When available, copies of the prospectus supplement, together with the accompanying prospectuses, can be obtained at the SEC's website at www.sec.gov or from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, New York 10022 or by email at prospectus@allianceg.com.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL*, is in mid-Phase 3 development for the management of fibromyalgia since positive data on the RELIEF Phase 3 trial were recently reported. The Company expects interim data for the Phase 3 RALLY study in the second quarter of 2021** and topline data in the Phase 3 RALLY study in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800***, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801***, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    *TNX-102 SL is an investigational new drug and has not been approved for any indication.

    ** Pending submission and agreement from the U.S. Food and Drug Administration (FDA) on the statistical analysis plan.

    ***TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward-Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, statements about the expected closing of the offering; anticipated gross proceeds from the offering; risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; substantial competition and other risks and uncertainties detailed in Tonix's Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission ("SEC") on March 24, 2020, as well as Tonix's subsequent periodic and current report filed with the SEC. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the SEC on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505



    Primary Logo

    View Full Article Hide Full Article
  37. CHATHAM, N.J., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will present at four upcoming virtual conferences in January.

    EventH.C. Wainwright BioConnect Conference
    DateJanuary 11-14, 2021
    TimePresentation available on demand January 11-14, 2021
      
    EventBiotech Showcase 2021
    DateJanuary 11-15, 2021
    TimePresentation available on demand January 11-15, 2021
      
    EventSidoti Winter Virtual Investor Conference  
    DateWednesday, January 13, 2021  
    Time9:15 a.m. ET  
      
    EventICR Conference 2021  
    DateThursday, January 14, 2021  
    Time9:15 a.m. ET  

    Webcasts of the H.C…

    CHATHAM, N.J., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will present at four upcoming virtual conferences in January.

    EventH.C. Wainwright BioConnect Conference
    DateJanuary 11-14, 2021
    TimePresentation available on demand January 11-14, 2021
      
    EventBiotech Showcase 2021
    DateJanuary 11-15, 2021
    TimePresentation available on demand January 11-15, 2021
      
    EventSidoti Winter Virtual Investor Conference  
    DateWednesday, January 13, 2021  
    Time9:15 a.m. ET  
      
    EventICR Conference 2021  
    DateThursday, January 14, 2021  
    Time9:15 a.m. ET  

    Webcasts of the H.C. Wainwright, Sidoti and ICR conferences presentations will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL*, is in mid-Phase 3 development for the management of fibromyalgia since positive data on the RELIEF Phase 3 trial were recently reported. The Company expects topline data in the Phase 3 RALLY study in the fourth quarter of 2021.  The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800**, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801**, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    *TNX-102 SL is an investigational new drug and has not been approved for any indication.

    **TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke, an ICR Company

    peter.vozzo@westwicke.com

    (443) 213-0505



    Primary Logo

    View Full Article Hide Full Article
  38. Expands Ongoing Research Collaboration Between Tonix and MGH Studying TNX-1500 in Heart Transplantation

    TNX-1500 May Hold Potential in Treating Autoimmune Diseases Including Systemic Lupus Erythematosus, Rheumatoid Arthritis and Multiple Sclerosis

    CHATHAM, N.J., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the signing of a second research collaboration agreement with Massachusetts General Hospital (MGH), a teaching hospital of Harvard Medical School, to develop TNX-1500, a humanized monoclonal antibody (mAb) that targets the CD40-ligand (also known as CD154, T-BAM or 5c8 antigen1) for the prevention and treatment of…

    Expands Ongoing Research Collaboration Between Tonix and MGH Studying TNX-1500 in Heart Transplantation

    TNX-1500 May Hold Potential in Treating Autoimmune Diseases Including Systemic Lupus Erythematosus, Rheumatoid Arthritis and Multiple Sclerosis

    CHATHAM, N.J., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the signing of a second research collaboration agreement with Massachusetts General Hospital (MGH), a teaching hospital of Harvard Medical School, to develop TNX-1500, a humanized monoclonal antibody (mAb) that targets the CD40-ligand (also known as CD154, T-BAM or 5c8 antigen1) for the prevention and treatment of organ transplant rejection. Transplant organ rejection occurs when the immune system of the organ recipient attacks the new organ as if it was an infection or tumor. The new collaboration will focus on kidney transplantation, while an earlier collaboration with MGH is focused on heart transplantation.

    Transplantation experts led by Tatsuo Kawai, M.D., Ph.D., Surgical Director of the Living Donor Transplantation and Dialysis Access Program at MGH and Professor of Surgery at Harvard Medical School (HMS) will study TNX-1500 in kidney transplantation in a variety of models including non-human primates. The goal of the collaboration is to advance TNX-1500 as a potential first-in-class therapeutic to prevent and treat kidney transplant rejection.

    Dr. Kawai said, "Anti-CD40-ligand therapy has a unique activity in controlling the immune response to organ transplants.2 There remains a significant need for new treatments to reduce the toxicity of current treatments by more selectively suppressing immune responses or inducing specific tolerance to the transplanted organ. Anti-CD40-ligand has shown promise not only to effectively suppress rejection but also to facilitate ‘transplant tolerance' in multiple preclinical transplant models.6"

    The study of TNX-1500 in heart transplantation at MGH began last year under the direction of Richard N. Pierson III, M.D., scientific director of the Center for Transplantation Sciences in the Department of Surgery at MGH and Professor of Surgery HMS.

    Key Advances in Anti-CD40-Ligand Antibody Engineering Led to TNX-1500

    Tonix's President and Chief Executive Officer, Seth Lederman, M.D. said, "A substantial body of evidence in humans and animals indicates that mAbs targeting CD40-ligand have the potential to be an important therapeutic option for preventing or treating transplant organ rejection and as a treatment for autoimmune disorders. Despite the recognized promise of anti-CD40-ligand therapy, first generation anti-CD40- ligand mAbs were limited because their constant fragment (Fc) domain interacted with a receptor called FcγRII, which raised concerns over an increased risk of thrombosis. Second generation anti-CD40- ligand mAbs had dramatically reduced binding to FcγRII, but had other issues, including decreased efficacy5-7. TNX-1500 is a third generation anti-CD40- ligand mAb that has been designed by protein engineering to target CD40-ligand therapeutically, while potentially decreasing FcγRII binding and the potential for thrombosis."

    1 Lederman, S. & al. J. Exp. Med. 175:1091-1101 (1992)

    2 Kawai T, et al. Am J Transplant. 4(9):1391 (2004)

    3 OʼNeill NA, et al. Transplantation. 101(9): 2038 (2017)

    4 Zhang T, et al. Immunotherapy. 7(8):899 (2015)

    5 Waters J, Biocentury; October 26, (2018)

    6 NCT02273960; ClinicalTrials.gov; "Study to Evaluate Safety and Efficacy in Adult Subjects With ITP (ITP)"; results posted April 1, 2019, accessed July 29, 2019)

    7 Ferrant JL et al., International Immunol. (11):1583 (2004)

    About CD40-Ligand

    CD40-ligand is a protein expressed on the surface of activated T lymphocytes that mediates T cell helper function. CD40-ligand is also known as CD154, the T cell-B cell activating molecule (T-BAM), TRAP or gp39. CD40-ligand is a member of the Tumor Necrosis Factor (TNF) Super Family. Other TNF Super Family members have proven to be targets for antagonist mAbs. Licensed mAbs against TNFα include: infliximab (Remicade®), adalimumab (Humira®), certolizumab pegol (Cimzia®), and golimumab (Simponi®) for the treatment of certain autoimmune conditions. Also, etanercept (Enbrel®) is a TNFα antagonist receptor fusion protein. A licensed mAb against RANKL (CD254) is denosumab (Prolia® or Xgeva®) for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.

    Remicade® and Simponi® are trademarks of Janssen; Humira® is a trademark of AbbVie Inc.; Cimzia® is a trademark of UCB S. A.; Enbrel®, Prolia® and Xgeva® are trademarks of Amgen Inc.

    Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL*, is in mid-Phase 3 development for the management of fibromyalgia since positive data on the RELIEF Phase 3 trial were recently reported. The Company expects topline data in the Phase 3 RALLY study in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800**, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801**, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    *TNX-102 SL is an investigational new drug and has not been approved for any indication.

    **TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505



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  39. Hamilton, MT Facility Is Planned to Manufacture Vaccines at Commercial Scale, Including Vaccines Under Development for COVID-19

    CHATHAM, N.J., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has completed the purchase of an approximately 44-acre site in Hamilton, Montana, for the construction of a vaccine development and commercial scale manufacturing facility. In September 2020, Tonix completed the purchase of a 40,000 square foot facility in Massachusetts to house its new Advanced Development Center (ADC) for accelerated development and manufacturing of vaccines for clinical trials. Both the Montana and Massachusetts…

    Hamilton, MT Facility Is Planned to Manufacture Vaccines at Commercial Scale, Including Vaccines Under Development for COVID-19

    CHATHAM, N.J., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has completed the purchase of an approximately 44-acre site in Hamilton, Montana, for the construction of a vaccine development and commercial scale manufacturing facility. In September 2020, Tonix completed the purchase of a 40,000 square foot facility in Massachusetts to house its new Advanced Development Center (ADC) for accelerated development and manufacturing of vaccines for clinical trials. Both the Montana and Massachusetts facilities are intended to support the development and production of Tonix's vaccine candidates, which are led by modified horsepox vaccines, TNX-1800, a potential COVID-19 vaccine and TNX-801, a potential smallpox and monkeypox vaccine.

    "The COVID-19 pandemic exposed weaknesses in the U.S. domestic vaccine development and manufacturing capabilities," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. "Tonix seeks to be a leader in the re-domestication of American vaccine development and production. We believe it is critical to bring these capabilities and high-tech jobs back to the U.S. both to finish the fight against the COVID-19 pandemic and to prepare for potential future pandemics. After the pandemic, we believe it is likely that COVID-19 will become endemic. That means humans will have to co-exist with COVID-19 and it will be a constant threat that can only be managed by maintaining a vaccinated population. To manage COVID-19 in the future, we need a next-generation COVID-19 vaccine that can be part of the standard childhood immunizations, like MMR for mumps, measles and rubella. We expect that such a vaccine will be a live-virus vaccine, because of their potential to provide durable protection and block forward transmission."

    Dr, Lederman continued, "The planned Montana facility reflects our commitment to the development of our vaccines and, along with the recent announcement of our new ADC in Massachusetts, takes us a step closer to controlling and vertically integrating more of our development and manufacturing activities. While we applaud the recent successes and Emergency Use Authorizations of the first-generation COVID-19 vaccines, we believe that Tonix's live replicating viral vector vaccine technology in development remains an important initiative given all of the unanswered questions about those vaccines due to the novelty of their underlying technology and the expedited timelines allowed for emergency use authorization. Specifically, it is unknown whether the first-generation vaccines provide durable protection (for example a year after vaccination), protect against death, or block forward transmission. Tonix's lead COVID-19 vaccine candidate TNX-1800, is based on the backbone of the smallpox vaccine developed by Edward Jenner more than 200 years ago, which led to the eradication of smallpox. TNX-1800 has been designed to have several important features including one shot dosing, ability to elicit a ‘take' biomarker for T cell protection, stability during transport and storage, and scalability of manufacturing."

    U.S. Senators Jon Tester and Steve Daines and Governor-elect Greg Gianforte have shown broad support of Montana's bioscience industry.

    "Good news for Hamilton! It's great to see Montana leading in the bioscience industry which will help support Montana jobs and end our reliance on other countries for critical vaccines and prescription drugs," said Senator Steve Daines.

    Senator Jon Tester echoed the sentiment, noting, "Montanans are hard workers and I am pleased to see more manufacturing jobs come to our state. The growing bioscience industry in Montana is good for our economy and will improve our public health."

    Tonix joins the U.S. National Institutes of Health's Rocky Mountain Laboratories (RML) in Hamilton, which is an internationally recognized leader in vaccine development and virology research. GlaxoSmithKline (GSK) also has a vaccine manufacturing facility in Hamilton.

    "It's no surprise that the bioscience industry is thriving in Montana," said Governor-elect Gianforte. "We have an unmatched work ethic. We're problem solvers. And we do it all from one of the most beautiful places in the world."

    Tonix currently is developing potential COVID-19 vaccines based on two live viral vector platforms: horsepox and bovine parainfluenza (BPI) virus. Four potential COVID-19 vaccines in development are based on the horsepox vector and two potential vaccines based on the BPI vector. The Company's lead vaccine, TNX-1800, is based on the horsepox vector1. Horsepox is believed to be similar to the live attenuated single dose smallpox vaccine developed by Dr. Edward Jenner more than 200 years ago, which led to the eradication of smallpox: the only viral disease ever eradicated. Recently, it was shown that horsepox has 99.7% colinear identity with a circa 1860 U.S. smallpox vaccine2. TNX-1800 is expresses the SARS-CoV-2 spike protein after vaccination and is believed to elicit a predominantly T cell response which is expected to provide long term immunity and prevent forward transmission. Tonix expects to report efficacy data from animal challenge studies of TNX-1800 in the first quarter of 2021.

    About TNX-801*

    TNX-801 is a live virus vaccine based on synthesized horsepox1. Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor. Molecular analysis of archaic smallpox vaccines shows that horsepox is closer than modern smallpox vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner, including the recent report that horsepox shares 99.7% co-linear identity with a U.S. smallpox vaccine from circa 18602. The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate3. Relative to vaccinia, horsepox has substantially decreased virulence in mice1. Tonix's TNX-801 vaccine candidate is administered percutaneously using a two-pronged, or "bifurcated" needle. The major cutaneous reaction or "take" to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization's (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960's. The "take" is a measure of functional T cell immunity validated by the eradication of smallpox, a respiratory-transmitted disease caused by variola. Tonix's proprietary horsepox vector is believed to be more closely related to Jenner's vaccinia vaccine than modern vaccinia vaccines, which appear to have evolved by deletions and mutations to a phenotype of larger plaque size in tissue culture and greater virulence in mice. TNX-801 vaccinated macaques showed no overt clinical signs after monkeypox challenge4.

    About TNX-1800**

    TNX-1800 is a live modified horsepox virus vaccine for percutaneous administration that is designed to express the Spike protein of the SARS-CoV-2 virus and to elicit a predominant T cell response. TNX-1800 is based on a horsepox vector, which is a live replicating, attenuated virus that elicits a strong immune response. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice1. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials. Like TNX-801, Tonix's TNX-1800 vaccine candidate is administered percutaneously using a two-pronged, or "bifurcated" needle. Tonix recently reported that immunization with a single dose of TNX-1800 induced "takes" and neutralizing anti-SARS-CoV-2 antibodies in non-human primates.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL*** (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia since positive data on the RELIEF Phase 3 trial were recently reported. The Company expects topline data in the Phase 3 RALLY study in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800**, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    *TNX-801 is in the pre-IND stage and has not been approved for any indication.

    **TNX-1800 is in the pre-IND stage and has not been approved for any indication.

    ***TNX-102 SL is an investigational new drug and has not been approved for any indication.

    1Noyce RS, et al. (2018) PLoS One. 13(1):e0188453

    2Brinkmann A et al, (2020) Genome Biology 21:286 https://doi.org/10.1186/s13059-020-02202-0

    3Trindale GS et al. Viruses (2016) (12). pii: E328. PMID:27973399

    4Noyce, RS, et al. Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox* Presented as a poster at the American Society of Microbiology BioThreats Conference - January 29, 2020, Arlington, VA. (https://content.equisolve.net/tonixpharma/media/10929ac27f4fb5f5204f5cf41d59a121.pdf)

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts                                

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com  

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com 

    (443) 213-0505



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  40. CHATHAM, N.J., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement whereby Tonix has acquired the exclusive license to the University of Geneva's technology for using oxytocin to treat insulin resistance and related syndromes, including obesity, from privately held Katana Pharmaceuticals, Inc. This license allows Tonix to expand its intranasal potentiated oxytocin development program, TNX-1900, into cardiometabolic syndromes, which include insulin resistance, impaired glucose tolerance, and obesity. The patents covering the technology are expected to provide Tonix with freedom to operate in these indications as well…

    CHATHAM, N.J., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement whereby Tonix has acquired the exclusive license to the University of Geneva's technology for using oxytocin to treat insulin resistance and related syndromes, including obesity, from privately held Katana Pharmaceuticals, Inc. This license allows Tonix to expand its intranasal potentiated oxytocin development program, TNX-1900, into cardiometabolic syndromes, which include insulin resistance, impaired glucose tolerance, and obesity. The patents covering the technology are expected to provide Tonix with freedom to operate in these indications as well as market exclusivity in the U.S. and Europe through 2031, upon its approval, independently of other Tonix-held patents covering the formulation and potentiation technologies related to TNX-1900.

    The University of Geneva technology is based on the discovery that oxytocin administration in an animal model of obesity improved lipid metabolism by increasing lipolysis and fatty acid-β-oxidation in adipose tissue accompanied by improvements in glucose intolerance and insulin resistance, independent of food intake1.

    "The important new technology from University of Geneva will allow Tonix to develop intranasal oxytocin on a broader platform to treat both central nervous system (CNS) and cardiometabolic conditions. We believe that TNX-1900 has the potential to be a safe, natural, non-addictive, and easy to administer treatment alternative for a number of CNS disease states. Our lead indication for TNX-1900 is for the treatment of migraine," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals.

    "Subsequent to the University of Geneva inventions, a number of studies have shown that intranasal oxytocin has effects on insulin resistance and weight2-4," continued Dr. Lederman.  "Intranasal oxytocin has been reported to improve glucose homeostasis, improve pancreatic β-cell responsivity, decrease energy-induced and reward-induced eating, and support cognitive control of food choices.2-9 The effects of intranasal oxytocin on improving peripheral insulin sensitivity, pancreatic function and lipid metabolism encourage us to develop TNX-1900 as a potential therapeutic in obesity, insulin resistance, diabetes management and related metabolic complications." 

    In June 2020, Tonix acquired its potentiated oxytocin technology and development program from Trigemina, Inc., and assumed licenses for certain related technologies from Stanford University. TNX-1900 has demonstrated activity in several non-clinical studies in CNS disease models. In addition, prior to the acquisition from Trigemina, TNX-1900 was studied in the U.S. under a physician-requested Investigational New Drug Application .

    1Deblon N, et al. (2011) PLoS ONE 6(9): e25565. doi:10.1371/journal.pone.0025565

    2Lawson EA. (2017) Nat Rev Endocrinol. 13(12):700-709. doi: 10.1038/nrendo.2017.115. PMID: 28960210

    3Olszewski PK, et al. (2017) Curr Opin Endocrinol Diabetes Obes. 24(5):320-325. doi: 10.1097/MED.0000000000000351. PMID: 28590323.

    4Ding C, et al. (2019) Obes Rev. 2019 Jan;20(1):22-40. doi: 10.1111/obr.12757. PMID: 30253045.

    5Lawson EA, et al. (2015) Obesity. 23:950–956. DOI: 10.1002/oby.21069 PMID: 25865294

    6Klement, J et al. (2017) Diabetes 66(2) 264-271; DOI: 10.2337/db16-0569

    7Ott V, et al. (2013) Diabetes. 62:3418–3425. DOI: 10.2337/db13-0663 PMID: 23835346

    8Thienel M, et al. (2016) Int J Obes. 40(11):1707-1714. DOI: 10.1038/ijo.2016.149 PMID: 27553712 

    9Striepens N, et al. (2016) Human Brain Mapp. 37(12):4276–4285. DOI: 10.1002/hbm.23308 PMID: 27381253

    About TNX-1900 (Intranasal Potentiated Oxytocin)*

    TNX-1900, Tonix's proprietary intranasal oxytocin is currently being studied as a candidate for prophylaxis of chronic migraine. TNX-1900 is in the pre-Investigational New Drug (IND) stage and has not been approved for any indication. It is based on a proprietary formulation of oxytocin and is being developed first for the treatment of migraine. Oxytocin is a naturally-occurring human hormone that acts as a neurotransmitter in the brain. It is approved by the U.S. Food and Drug Administration (FDA) as Pitocin®, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor. An intranasal form of oxytocin was marketed in the U.S. by Novartis to assist in the production of breast milk as Syntocinon® (oxytocin nasal 40 units/ml), but the product was withdrawn and the New Drug Application (NDA) has been discontinued. In clinical and preliminary research, it has been observed that low oxytocin levels in the body can lead to increase in headache frequency, and that increased oxytocin levels can relieve headaches. Oxytocin, when delivered via the nasal route, results in enhanced binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting transmission of pain signals. Intranasal oxytocin has been well tolerated in several clinical trials in adults and children. Intranasal oxytocin has been shown to block calcitonin gene-related peptide (CGRP) release in animals, a pathway known to be critical to the pathogenesis of migraine attacks. TNX-1900 is believed to interrupt pain signals at the trigeminal ganglia by suppressing electrical impulses, a potentially different activity than drugs that just block CGRP. Migraine attacks are caused, in part, by the release of CGRP from pain-sensing nerve cells that are part of the trigeminal system. Targeted delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects which could potentially occur with systemic CGRP antagonists. For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. Tonix believes targeted delivery of oxytocin could translate into selective blockade of CGRP release in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition.

    *TNX-1900 is in the pre-IND phase and has not been approved for any indication.

    Pitocin® is a trademark of Par Pharmaceutical, Inc.

    Syntocinon® is a trademark of BGP Products Operations GmbH

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL**, is in mid-Phase 3 development for the management of fibromyalgia since positive data on the RELIEF Phase 3 trial were recently reported. The Company expects topline data for a 2nd Phase 3 study, RALLY, in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800***, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    **TNX-102 SL is an investigational new drug and has not been approved for any indication.

    ***TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts                                

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505



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  41. Primary Endpoint For Full Cohort of Enrolled Participants Did Not Achieve Statistical Significance (P=0.343), Consistent with Previously Reported Interim Analysis 

    Encouraging Activity of TNX-102 SL Observed in Secondary Endpoints: Clinical Global Impression – Severity (P=0.024), Patient Global Impression of Change (P=0.007) and PROMIS Sleep Disturbance (P=0.055)

    Participants were 94% Civilian PTSD and 79% Female: Global Impression and Sleep Results Similar to Prior Studies of TNX-102 SL in Predominantly Male, Military-Related PTSD Studies

    TNX-102 SL Generally Well Tolerated; No New Safety Signals Observed: No Change in Weight or Blood Pressure

    Total CAPS-5 Decreased by 58% in Treatment Group and 49% in Placebo Group

    Planning Development

    Primary Endpoint For Full Cohort of Enrolled Participants Did Not Achieve Statistical Significance (P=0.343), Consistent with Previously Reported Interim Analysis 

    Encouraging Activity of TNX-102 SL Observed in Secondary Endpoints: Clinical Global Impression – Severity (P=0.024), Patient Global Impression of Change (P=0.007) and PROMIS Sleep Disturbance (P=0.055)

    Participants were 94% Civilian PTSD and 79% Female: Global Impression and Sleep Results Similar to Prior Studies of TNX-102 SL in Predominantly Male, Military-Related PTSD Studies

    TNX-102 SL Generally Well Tolerated; No New Safety Signals Observed: No Change in Weight or Blood Pressure

    Total CAPS-5 Decreased by 58% in Treatment Group and 49% in Placebo Group

    Planning Development of TNX-102 SL for Treatment of PTSD Sleep Disturbance Indication, Pending FDA Discussion

    CHATHAM, N.J., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced topline results from its Phase 3 RECOVERY study1 of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the treatment of civilian and military-related posttraumatic stress disorder (PTSD). The RECOVERY study did not achieve statistical significance in the prespecified primary efficacy endpoint of change from baseline to Week 12 in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) between TNX-102 SL and placebo (p=0.343) (Table 1). In the primary analysis, TNX-102 SL subjects achieved a 20.7 unit reduction in CAPS-5 versus 18.5 units for placebo. TNX-102 SL separated from placebo in the first key secondary endpoint, Clinical Global Impression – Severity (CGI-S) scale (p=0.024) (Table 1) and in the Patient Global Impression of Change (PGIC), (p=0.007). TNX-102 SL also trended for improvement on the PROMIS Sleep Disturbance scale (p=0.055), consistent with the proposed mechanism of targeting the PTSD sleep disturbance (Table 1). Among completers, there was a 58% observed mean reduction in symptoms in the active group compared to 49% in the placebo group, as measured by CAPS-5 total. TNX-102 SL is generally well tolerated and no new safety signals were observed.

    "As expected from the futility result at the interim analysis in the first quarter of 2020, TNX-102 SL did not separate on the primary endpoint of CAPS-5 at Week 12," said Seth Lederman, M.D., President and Chief Executive Officer. "Given the complexity of PTSD as a syndrome and the demonstrated potential of TNX-102 SL to improve sleep quality in PTSD, we plan to meet with the U.S. Food and Drug Administration (FDA) to discuss a proposed new indication: TNX-102 SL for the treatment of sleep disturbance associated with PTSD. Sleep disturbance is a core symptom of PTSD and believed to play roles in onset, consolidation and chronicity. Treating sleep disturbance is recognized as a clinically valid approach for addressing global improvement in PTSD2-5. This new direction is supported by consistent results observed from all three registration-quality studies of TNX-102 SL in PTSD (nearly 800 participants randomized across three placebo-controlled trials) showing trends or nominal benefits in treating sleep disturbance, global improvement by patient self-rating or by clinician-rating. These results included female-predominant, civilian PTSD in RECOVERY and male-predominant, military-related PTSD in the Phase 2 AtEase6 and Phase 3 HONOR7 studies. The FDA-approved insomnia drugs of the benzodiazepine or non-benzodiazepine classes are DEA-Schedule IV, have not been shown useful in PTSD and have the potential to impair sleep-dependent memory processing at high doses or when combined with alcohol."

    Greg Sullivan, M.D., Chief Medical Officer, said, "We are encouraged by TNX-102 SL's activity on the sleep disturbance in PTSD and on the clinician-rated and patient self-rated global measures of clinical improvement, CGI-S and PGIC, in this predominantly female and civilian PTSD sample. Pending discussion with the FDA, we intend to pursue TNX-102 SL as a treatment for the sleep disturbance that is integral to the development and maintenance of PTSD. PTSD is a memory processing disorder, and adequate quality and quantity of deep slow wave sleep and rapid eye-movement sleep are known to be important for emotional memory processing necessary for recovery from trauma. Although treatment of the PTSD sleep disturbance would be a new indication, instruments like sleep quality assessments can be validated by patient- and clinician-perception of global improvement. Therefore, the discriminatory power of CGI-S and PGIC on TNX-102 SL's activity in PTSD support such a development. TNX-102 SL is mechanistically distinct from the two FDA approved PTSD drugs; both are SSRIs, and neither target the sleep disturbance.

    Dr. Sullivan continued, "We are also encouraged by the tolerability profile that has been expanded by the RECOVERY study. TNX-102 SL treatment was not associated with weight gain or sexual side effects, and TNX-102 SL treatment notably trended towards improvement of female sexual function in RECOVERY (Table 3). This tolerability profile has the potential to differentiate TNX-102 SL from the reported tolerability of the two SSRIs that are FDA-approved for PTSD."

    "Tonix has worked diligently to develop a treatment for PTSD, a serious and disabling condition affecting nearly 12 million civilian and veteran adults in the U.S.," said Dr. Lederman. "The demographics of the RECOVERY study participants, 94% civilians and 79% female, largely reflect the real-world metrics of those living with PTSD in which the vast majority are civilians and, among diagnosed civilians, approximately two-thirds are female. We are grateful for the contributions from all our study participants and their families in helping advance this program."

    Table 1. RECOVERY study: Primary and Secondary Efficacy Endpoints

     TNX-102 SL (N=80)Placebo (N=83)TNX-102 SL v. Placebo
    Wk 12 Outcome MeasureLS MeanSELS MeanSELSMDSE95% CIp-value*ES
    CAPS-5 CFB#-20.71.97-18.51.9-2.22.3-6.7, 2.30.3430.15
    CGI-S score CFB-20.18-1.50.17-0.50.22-0.9, -0.10.0240.36
    PGIC score2.30.162.80.16-0.50.19-0.9, -0.10.0070.43
    PROMIS SD T-score CFB-131.57-9.41.51-3.51.82-7.1, 0.10.0550.30
    CAPS-5 item E6/SD CFB-1.30.19-0.90.19-0.40.23-0.8, 0.10.0860.28

    Abbreviations: CAPS-5 = Clinician-Administered PTSD Scale; CFB = change from baseline; CGI-S = Clinical Global Impression – Severity; CI = confidence interval; ES = effect size; LS = least squares; LSMD = least squares mean difference; N = number; PGIC = Patient Global Impression of Change; PROMIS = Patient-Reported Outcomes Measurement Information System; SD = sleep disturbance; SE = standard error; Wk = week.

    # Primary efficacy endpoint

    *All secondary p-values are descriptive

    Table 2. RECOVERY study: Changes in Weight, Blood Pressure and Heart Rate Between Baseline and Last Assessment

     TNX-102 SL (N=80)Placebo (N=84)
    Change in Outcome MeasureMean95% CIMean95% CI
    Weight (kg)0.03-0.48, 0.540.58-0.01, 1.16
    Systolic blood pressure (mmHg)1.8-0.8, 4.51.3-1.4, 4.0
    Diastolic blood pressure (mmHg)1.5-0.5, 3.5-0.2-2.3, 1.9
    Heart rate (beats per minute)1.8-1.0, 4.51.5-1.1, 4.0

    Abbreviations: CI = confidence interval;N = number

    Table 3. RECOVERY study: Changes in Sexual Functioning Questionnaire Short Form

     TNX-102 SL (N=65)Placebo (N=64)TNX-102 SL v. Placebo
    Wk 12 Outcome MeasureLS MeanSELS MeanSELSMDSE95% CIp-value**ES
    CSFQ-14 CFB* (female)4.60.842.40.862.21.21-0.2, 4.60.070.32

    *higher score on CSFQ-14 indicates better sexual functioning

    ** p-value is descriptive

    Abbreviations: CSFQ-14 = Changes in Sexual Functioning Questionnaire short form: CI = confidence interval; ES = effect size; LS = least squares; LSMD = least squares mean difference; N = number; SE = standard error; Wk = week.

    RECOVERY STUDY

    The RECOVERY study was a double-blind, randomized, placebo-controlled, adaptive design study evaluating the efficacy and safety of TNX-102 SL 5.6 mg over 12 weeks of treatment for civilian and military-related PTSD. The study enrolled 192 participants across 29 clinical sites in the U.S. Enrollment was restricted to individuals with PTSD who experienced an index trauma within nine years of screening. The primary efficacy endpoint was the mean change from baseline in the severity of PTSD symptoms as measured by the CAPS-5 between those treated with TNX-102 SL 5.6 mg and those receiving placebo.

    Interim Analysis

    A pre-specified interim analysis (IA) was conducted by an unblinded Independent Data Monitoring Committee (IDMC) after half the target population was enrolled and evaluable in Q1 2020. The Company announced it stopped enrollment in RECOVERY following a non-binding recommendation to stop the trial for futility by the IDMC (N=112; IA modified Intent-to-Treat (mITT) population). The Company chose to discontinue new enrollment but continue all currently enrolled participants at that time to completion. The IDMC decision to discontinue enrollment in the study was not related to safety of TNX-102 SL; the blinded safety data from the IA did not reveal any serious and unexpected adverse events.

    Full cohort topline analysis:

    In the full cohort topline analysis, 163 of the 192 participants enrolled were included in the modified mITT population. TNX-102 SL did not achieve statistical significance in the prespecified primary efficacy endpoint of change from baseline in CAPS-5 (p=0.343; Table 1). The CAPS-5 is a standardized structured clinical interview and serves as the standard in research for measuring the symptom severity of PTSD, although it was developed as a diagnostic instrument. The CAPS-5 assesses 20 items by rating severity (a function of intensity and frequency of each symptom) on a 5 point Likert scale (0-4), so the total scores range from 0 to 80. Earlier versions of the CAPS, which assessed 17 items from the DSM-IV or earlier by recording intensity and frequency as separate 5 point Likert scales (total score range 0 to 136), were used to support the approval of the two currently marketed PTSD treatments.

    TNX-102 SL separated from placebo in the first key secondary endpoint, CGI-S scale, by LS mean (SE) of -0.5 units (p=0.024) (Table 1). The CGI-S measures how clinicians rate the severity of PTSD in study participants over the preceding week and is not tied to any theoretical construct of disease recovery such as the assumptions inherent in the CAPS-5 items. Previous studies of TNX-102 SL, AtEase and HONOR, used the Clinical global impression of improvement (CGI-I), which is similar to CGI-S, but is based on a "lookback" to patient baseline, rather than 7 days.

    TNX-102 SL also separated from placebo in the PGIC analyzed as a continuous measure with a least squares mean difference (standard error) -0.5 (0.19), p=0.007 by Mixed Models Repeated Measures (MMRM). Similarly to previous TNX-102 SL studies (AtEase and HONOR), in RECOVERY TNX-102 SL separated in the PGIC by responder analysis, with TNX-102 SL treatment resulting in 51.3% responders relative to 34.9% on placebo, odds ratio 1.88 [1.00, 3.54], p=0.049 by Cochran-Mantel-Haenszel test. The PGIC measures how study participants themselves rate how they feel; it is not tied to any theoretical construct of disease recovery such as the assumptions inherent in the CAPS-5 items.

    Dr. Sullivan said, "In RECOVERY, the placebo response elicited on CAPS-5 was more pronounced than that reported by CGI-S and PGIC. Similar results were observed in our two previous studies. The high levels of PTSD symptom improvement of placebo-treated trial participants detected by CAPS, was not reported by the patients themselves as measured by PGIC, nor by the clinicians by CGI-S in the RECOVERY study or by CGI-I in the AtEase or HONOR studies. We believe that the high levels of CAPS-5 improvement in the placebo groups of these trials do not correspond to the clinical challenges of treating moderate-to severe PTSD patients in practice, which suggests a measurement problem. Although we devoted significant efforts to CAPS-5 rater-training, certification and monitoring, the CAPS-5 data from these studies have not tracked the patient and clinician perceptions of global improvement, which are typically anchors for observable units of improvement on disease symptom-specific scales."

    Effects of TNX-102 SL on Sleep Quality

    Similar to prior studies, TNX-102 SL at 5.6 mg in RECOVERY demonstrated trends on measures of sleep quality including the PROMIS Sleep Disturbance inventory, which at Week 12 showed a least squares (LS) mean difference (SE) from placebo of -3.5 (1.82), p=0.055 (Table 1). Although the early stop of enrollment due to the interim analysis outcome resulted in an underpowered sample size for detecting effects on sleep at p<0.05, the effect size of 0.30 on PROMIS SD suggests significant effects might have been detected by the originally planned sample of N=250. Similarly, the CAPS-5 sleep item E6 showed TNX-102 SL trended towards improvement over placebo by LS mean difference (SE) of -0.4 (0.23), p=0.086, with an effect size of 0.28. Mechanistically, TNX-102 SL is considered to improve PTSD through pharmacodynamic effects on CNS receptors that mediate sleep quality, and, as a result, improve sleep-dependent emotional memory processing necessary to recovery from PTSD. Replication of the effects on sleep in the predominantly civilian PTSD sample of RECOVERY along with the patient and clinician rated global improvement suggests this mechanism is also operational in a mostly female sample with non-military PTSD.

    Female Sexual Dysfunction (Changes in Sexual Functioning Questionnaire Short Form)

    The Changes in Sexual Functioning Questionnaire Short Form (CSFQ-14), which has female and male versions, was administered at baseline and Week 12 in RECOVERY. In female participants, the TNX-102 SL group (N=65) trended for greater improvement in CSFQ-14 total score compared with placebo (N=64), with a Least Squares Mean Difference (LSMD) of 2.2 units, p=0.070 (Table 3). The number of male subjects in the study in the TNX-102 SL group (N=15) and placebo group (N=19) precluded meaningful statistical comparison. These results suggest TNX-102 SL may potentially improve sexual functioning in females with PTSD, which contrasts with the approved drugs for PTSD which can have impairing effects on sexual functioning.

    Safety and Tolerability

    TNX-102 SL was well-tolerated and the adverse events reported were similar to those seen in prior TNX-102 SL studies (Table 4). There were three participants with serious adverse events (SAEs) reported during the study: two in the placebo group and one in the active group (osteomyelitis of left great toe). None were deemed related to study drug. Administration site reactions were similar in profile to prior studies with TNX-102 SL, with oral numbness (hypoaesthesia) at the highest rate, 29.2% in the TNX-102 SL arm versus 1.1% in the placebo arm. These oral sensory adverse events (AE), oral numbness, oral tingling, and tongue discomfort were always temporally-related to dosing and tended to be rated as mild and transient (<60 min) in the majority of cases. And only one of these oral sensory AEs lead to study discontinuation (in a participant who took only one dose and reported oral numbness, nausea, and emesis). Systemic AEs at a rate of ≥ 5% in the TNX-102 SL group were dry mouth (8.3 v. 3.3%) and upper respiratory tract infections (5.2 v. 4.4%). Discontinuations due to AE were at a rate of 6.3% in the TNX-102 SL group versus 2.2% on placebo. The safety population had an overall completion rate of 65.8%, which was numerically higher in the placebo group (70.3%) than in the TNX-102 SL 5.6 mg group (61.5%). No new safety signals were observed.

    Table 2. Treatment Emergent Adverse Events at Rate of ≥ 5% in the TNX-102 SL Group

      TNX-102 SL (N=96) Placebo (N=91) Overall (N=187)
    Administration Site Reactions N % N % N %
    Oral numbness 28 29.2 1 1.1 29 15.5
    Oral tingling 7 7.3 1 1.1 8 4.3
    Tongue discomfort 5 5.2 0 0.0 5 2.7
    Systemic Adverse Events N % N % N %
    Dry Mouth 8 8.3 3 3.3 11 5.9
    Upper respiratory tract infection 5 5.2 4 4.4 9 4.8
                 

    About TNX-102 SL

    TNX-102 SL is a proprietary sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin-2A, alpha-1 adrenergic, histamine-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for fibromyalgia, PTSD, alcohol use disorder and agitation in Alzheimer's disease. TNX-102 SL recently showed a statistically significant improvement in the pre-specified primary pain endpoint in a Phase 3 study of fibromyalgia, called RELIEF (F304). A confirmatory Phase 3 trial, called RALLY is currently enrolling. Topline data from RALLY are expected in the fourth quarter of 2021. The U.S. Patent and Trademark Office has issued a patent (U.S. Patent No. 9,636,408) protecting the composition and manufacture of the unique formulation. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix's proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9,636,408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020.

    About Posttraumatic Stress Disorder (PTSD)

    PTSD can develop from witnessing or experiencing a traumatic event in which there was the severe threat of, or actual occurrence of, grave physical harm or death. PTSD affects approximately 12 million Americans and is a chronic and severely debilitating condition in which patients re-experience the horrific traumas that resulted in the condition in the forms of intrusive memories, flashbacks, and nightmares. PTSD typically is characterized by disrupted sleep, anxiety, agitation, avoidance, emotional numbness and estrangement from family and friends, guilt or negative beliefs about self, and sometimes is associated with clinical depression and suicidal thinking. Individuals who suffer from PTSD usually have significant impairment in social functioning, occupational disability, and an overall poor quality of life. PTSD is sometimes associated with substance abuse and unpredictable violent or suicidal behaviors.

    Additional details about the RECOVERY study are available at clinicaltrials.gov (NCT03841773)

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL*, is in mid-Phase 3 development for the management of fibromyalgia since positive data on the RELIEF Phase 3 trial were recently reported. The Company expects topline data in the Phase 3 RALLY study in the fourth quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800**, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801**, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

    1ClinicalTrials.gov Identifier: NCT02277704

    2ClinicalTrials.gov Identifier: NCT03668041

    3Germain, A et al, Current Opinion in Psychology 2017, 14:84–89, http://dx.doi.org/10.1016/j.copsyc.2016.12.004

    4Krystal J et al, Biological Psychiatry 2017; 82:e51–e59, http://dx.doi.org/10.1016/j.biopsych.2017.03.007



    5
    Bajor, LA et al., Harv Rev Psychiatry 2011;19:240–258, http://dx.doi.org/10.3109/10673229.2011.614483

    6ClinicalTrials.gov Identifier: NCT03841773

    7ClinicalTrials.gov Identifier: NCT03062540

    *TNX-102 SL is an investigational new drug and has not been approved for any indication.

    **TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505 



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  42. New 5.6 mg Dose Achieved Statistically Significant Pain Reduction Over Placebo at Week 14 (Primary Endpoint, p=0.01)

    TNX-102 SL Generally Well Tolerated with Adverse Event Profile Comparable to Prior Studies; No New Safety Signals Observed

    Approximately 90% of Those Affected by Fibromyalgia are Women; 95% of Participants in the RELIEF Study were Women

    Company to Host Conference Call Today at 8:30 a.m. EST

    CHATHAM, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that TNX-102 SL (cyclobenzaprine HCl sublingual tablets) met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo…

    New 5.6 mg Dose Achieved Statistically Significant Pain Reduction Over Placebo at Week 14 (Primary Endpoint, p=0.01)

    TNX-102 SL Generally Well Tolerated with Adverse Event Profile Comparable to Prior Studies; No New Safety Signals Observed

    Approximately 90% of Those Affected by Fibromyalgia are Women; 95% of Participants in the RELIEF Study were Women

    Company to Host Conference Call Today at 8:30 a.m. EST

    CHATHAM, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that TNX-102 SL (cyclobenzaprine HCl sublingual tablets) met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.01) in participants with fibromyalgia in the Phase 3 RELIEF study (Table 1). TNX-102 SL is a novel, non-opioid, centrally-acting analgesic, taken once daily at bedtime, being developed for the management of fibromyalgia. RELIEF was a 14-week randomized, double-blind, placebo-controlled trial of TNX-102 SL 5.6 mg, in which 503 participants with fibromyalgia were randomized in a 1:1 ratio across 39 U.S. sites. All participants received one tablet of TNX-102 SL (2.8 mg) or placebo for the first two weeks, which was increased to two tablets of TNX-102 SL (5.6 mg) or placebo for the remaining 12 weeks.

    "Tonix is dedicated to improving the lives of the millions suffering from fibromyalgia, approximately 90% of whom are female, and the results of the RELIEF trial bring new hope to this community," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. "TNX-102 SL at 5.6 mg showed statistically significant and clinically meaningful improvement on the primary endpoint of reducing daily pain, as well as showed activity in key secondary endpoints of improving sleep and reducing fatigue. One of the biggest challenges in drug development is finding a dose that balances efficacy and tolerability. We are pleased with the consistent effects of TNX-102 SL 5.6 mg on the primary endpoint of daily pain as well as the tolerability of this dose in the RELIEF study. We are also pleased at the activity shown on all of the fibromyalgia specific, pre-specified secondary endpoints. We look forward to the results of the currently enrolling, second potential pivotal Phase 3 study, RALLY, for which we expect to report topline data in the second half of 2021. Based on the long term safety exposure data we have already collected, the mature stage of our Good Manufacturing Practice (GMP) manufacturing processes and the established product stability at 36 months, we believe that upon achieving positive results from the currently enrolling RALLY study, we may potentially be in a position to submit a New Drug Application (NDA) for TNX-102 SL for fibromyalgia to the U.S. Food and Drug Administration (FDA) in 2022. Additionally, we believe that our commercial manufacturing is on track to supply the U.S. market in 2022."

    Table 1. Results of Primary and Secondary Endpoints

          
    Outcome Measure at Week 14 Intent-to-Treat Analysis P-value1 
    Primary Endpoint     
    Daily Pain Diary, NRS Mean Change (Primary Analysis)2 0.010* 
          
    Key Secondary Endpoints     
    Non-specific     
    Patient Global Impression of Change Proportion "Much" or "Very Much Improved" 0.058 (LR) 
          
    Fibromyalgia Syndrome-Related     
    FIQ-R Symptom Domain Mean Change 0.007# 
    FIQ-R Function Domain Mean Change 0.009# 
    PROMIS Fatigue Mean Change 0.018# 
    Daily Sleep Quality Diary, NRS Mean Change <0.001# 
    PROMIS Sleep Disturbance Mean Change <0.001# 
      
    Abbreviations: FIQ-R = Fibromyalgia Impact Questionnaire - Revised; PROMIS = Patient-Reported Outcomes Measurement Information System; LR = Logistic Regression (missing data considered non-responders); 
    NRS = Numeric Rating Scale 
    * statistically significant at p<0.0452    
    # nominally significant at p<0.0452    
      
    1Analysis by Mixed Model Repeated Measures with Multiple Imputation unless otherwise indicated. 
    2Primary endpoint analysis for FDA approvals of Cymbalta® and Lyrica® in fibromyalgia.

      

    "These results support the proposed mechanism in which TNX-102 SL targets disturbed sleep in fibromyalgia and that improved sleep quality leads to improvement of fibromyalgia at the syndromal level," continued Dr. Lederman. "The sleep disorder specific to fibromyalgia has been called ‘non-restorative' sleep. Dr. Harvey Moldofsky, Professor emeritus of Psychiatry and Medicine at the University of Toronto, founding Director of the University of Toronto Center for Sleep and Chronobiology, and Member of the Tonix Scientific Advisory Board, first recognized the central role of non-restorative sleep in the pathogenesis of fibromyalgia3,4. Our program is based on the subsequent pioneering work of Dr. Iredell W. Iglehart III, Assistant Professor of Medicine, part-time, Division of Rheumatology, Johns Hopkins School of Medicine, and Member of the Tonix Scientific Advisory Board, who recognized that a sleep-focused cyclobenzaprine treatment protocol had the potential to target non-restorative sleep and lead to improvement of fibromyalgia at the syndromal level5. Transforming this treatment paradigm into a potential product with the clinical activity described in the RELIEF study depended on the invention of the Protectic® and Angstro® technologies. These technologies are integral to TNX-102 SL, which is a sublingual tablet designed for transmucosal delivery of cyclobenzaprine with distinctive pharmacokinetic properties that include bypassing first-pass hepatic metabolism.  Teams led by Giorgio Reiner at APR Applied Pharma Research S.A. and Professor Marino Nebuloni and Patrizia Colombo at Redox Analytical Science Srl invented and developed these underlying technologies in collaboration with Tonix."

    "I'm pleased that TNX-102 SL has demonstrated statistically significant treatment effects on fibromyalgia pain," said Dr. Harvey Moldofsky.  "These results validate the mechanism that improving sleep quality can lead to syndromal effects on fibromyalgia.  The sublingual formulation of TNX-102 SL for transmucosal absorption showed promise at the 2.8 mg dose in two prior studies, but now that the 5.6 mg dose has shown consistent efficacy, we are encouraged in the outcome of future studies."

    "TNX-102 SL has the potential to be a new non-addictive, non-opiate analgesic for the management of fibromyalgia which is particularly important given that fibromyalgia is a chronic pain condition," said Gregory Sullivan, M.D., Chief Medical Officer of Tonix. "Approximately one third of fibromyalgia patients resort to opiates out of desperation and because of dissatisfaction with available therapies. Cyclobenzaprine, the active ingredient of TNX-102 SL, has no recognized potential for addiction. Based on our previous discussions with FDA, we expect to submit an NDA without new addiction liability studies. TNX-102 SL could potentially offer fibromyalgia patients, who have multiple disabling fibromyalgia symptoms, a first-line monotherapy with broad symptom relief, and the compliance advantage of being administered once-a-day (at bedtime)."

    3Moldofsky H et al, Psychosom Med 1975;37:341-51.

    4Moldofsky H and Scarisbrick P. Psychosom Med 1976;38:35-44.

    5Iglehart IW. 2003; US Patent 6,541,523.

    SUMMARY OF TOPLINE RESULTS OF THE RELIEF STUDY

    The RELIEF study included a pre-specified interim analysis that was conducted in September 2020. Due to the inclusion of the potential to stop for success for this interim analysis, positive results required a two sided p-value of 0.0452 for both primary and secondary endpoints. Based on interim results, the independent data monitoring committee (IDMC) made the non-binding recommendation that the trial continue to completion with the addition of 210 participants to the original sample size of 470 participants, which was the maximum number of participants that could be added under the interim statistical analysis plan. Given this information, the Company decided to complete the study with the 503 enrolled participants and not to add additional participants. The first cohort of the study was enrolled between December 2019 and April 2020 at a time when the COVID-19 pandemic struck the U.S. Due to the pandemic, the Company modified the protocol in accordance with FDA guidelines to ensure patient safety and minimize risk in enrolling the first cohort. The modification allowed sites to conduct remote study visits for select cases in which the COVID-19 pandemic made on-site visits unsafe or otherwise not possible. The second cohort was enrolled between last week of April and July 2020 and, by this time, the sites' COVID-19-related safety procedures for participants' attendance at clinic visits had become routine. At the time of the interim analysis in September 2020, there were only 15 participants still active in the study, all of whom completed their last visit by the end of October 2020.

    In analyzing the efficacy endpoints, a sequential test procedure was applied to the primary and six key secondary efficacy endpoints such that each endpoint had to meet statistical significance (below a two-sided 0.0452 p-value) in order for the subsequent endpoints to be considered for statistical significance.

    The RELIEF study achieved statistical significance on the pre-specified primary efficacy endpoint: change from baseline in the weekly average of daily diary pain severity numerical rating scale (NRS) scores for TNX-102 SL 5.6 mg (LS mean [SE]: -1.9 [0.12] units) versus placebo (-1.5 [0.12] units), analyzed by mixed model repeated measures with multiple imputation (LS mean [SE] difference: -0.4 [0.16] units, p=0.010, Table 1).

    The statistically significant improvement in pain is further substantiated when diary pain was analyzed by another standard statistical approach, a 30 percent responder analysis, with 46.8% on active and 34.9% on placebo having a 30 percent or greater reduction in pain (logistic regression; odds ratio [95% CI]: 1.67 [1.16, 2.40]; p=0.006).

    The key secondary efficacy endpoints, in sequential order, were: (1) Patient Global Impression of Change (PGIC) (responder analysis); (2) FIQ-R symptom domain score (mean change); (3) FIQ-R function domain score (mean change); (4) PROMIS Sleep Disturbance instrument T-score (mean change); (5) PROMIS Fatigue instrument T-score (mean change); and (6) daily diary NRS assessment of sleep quality (mean change). The responder analysis of PGIC trended for a greater proportion of responders (rating of "very much improved" or "much improved" at Week 14) to TNX-102 SL of 37.5% compared with placebo of 29.4% , but the result did not achieve statistical significance (logistic regression; odds ratio [95% CI]: 1.44 [0.99, 2.10]; p=0.058). Therefore, because of the sequential test waterfall, the remaining key secondary endpoints only could be considered nominally significant at best.

    "The results on Patient Global Impression of Change or PGIC were unexpected based on results from the prior studies. PGIC is a general measure of patient self-assessed benefit that is not tied to any specific symptom of fibromyalgia. In two prior studies of TNX-102 SL at 2.8 mg in fibromyalgia, PGIC met statistical significance in both. We speculate that the ongoing COVID-19 pandemic might have affected the participants' sense of well-being and confounded the PGIC measure," said Dr. Sullivan. "The five other key secondary endpoints all resulted in nominal p-values of less than 0.02."

    Consistent with the proposed mechanism that TNX-102 SL acts in fibromyalgia through improving sleep quality, TNX-102 SL showed nominal improvement of sleep by several measures. For the daily diary sleep quality ratings, TNX-102 SL (-2.0 [0.12] units) compared to placebo (-1.5 [0.12] units) was nominally significant (LS mean difference: -0.6 [0.17] units; p<0.001). For the PROMIS Sleep Disturbance instrument, TNX-102 SL was also nominally significant over placebo on T-scores (LS mean difference: -2.9 [0.82] units; p<0.001). The effect sizes on the diary sleep ratings and PROMIS Sleep Disturbance instrument were 0.31 and 0.32, respectively. Fatigue is another cardinal symptom of fibromyalgia. TNX-102 SL showed nominal improvement over placebo on the PROMIS Fatigue instrument T-scores (-1.8 [0.76] units; p=0.018).

    The syndromal activity of TNX-102 SL was studied by the Fibromyalgia Impact Questionnaire – Revised (FIQ-R). TNX-102 SL showed nominal improvement over placebo in both the symptom domain (-4.3 [1.60] units; p=0.007) and function domain (-4.4 [1.69] units; p=0.009).

    SAFETY RESULTS OF THE PHASE 3 RELIEF STUDY

    In the RELIEF study, TNX-102 SL was similarly well tolerated as in Phase 2 BESTFIT and Phase 3 AFFIRM studies which both studied TNX-102 SL at a lower dose of 2.8 mg daily. There were no new safety signals observed in the RELIEF study at the 5.6 mg daily dose. Among participants randomized to the TNX-102 SL and placebo arms, 82.3% and 83.5%, respectively, completed the 14-week dosing period. As expected based on prior TNX-102 SL studies, administration site reactions are the most commonly reported adverse events and were higher in the TNX-102 SL treatment group, including rates of tongue/mouth numbness , pain/discomfort of tongue/mouth, taste impairment, and tongue/mouth tingling (Table 2). Tongue/mouth numbness or tingling and taste impairment were local effects nearly always temporally related to dose administration and transiently expressed (<60 minutes) in most occurrences. The only systemic treatment-emergent adverse events that occurred at a rate of 5.0% or greater in either arm was somnolence/sedation at 5.6% in the TNX-102 SL arm, which was consistent with known side effects of marketed oral cyclobenzaprine. Adverse events resulted in premature study discontinuation in 8.9%of those who received TNX-102 SL compared with 3.9%of placebo recipients. There were a total of 7 serious adverse events in the study, none of which were deemed related to investigational product; 5 in placebo arm, and 2 in TNX-102 SL arm. Of the 2 in the TNX-102 SL arm, one was a motor vehicle accident with multiple bone fractures, and the other was a pneumonia secondary to an infection.

    Table 2. Treatment-Emergent Adverse Events at Rate of 5% or Greater in Either Treatment Arm

      TNX-102 SL (N=248) Placebo (N=255) Total (N=503)
    Administration Site Reactions N % N % N %
    Oral numbness 43 17.3 2 0.8 45 8.9
    Oral pain/discomfort 29 11.7 5 2.0 34 6.8
    Taste impairment 16 6.5 1 0.4 17 3.4
     Oral tingling 14 5.6 1 0.4 15 3.0
    Systemic      
    Adverse Events N % N % N %
    Somnolence/Sedation 14 5.6 3 1.2 17 3.4

    Conference Call Information

    Tonix Pharmaceuticals will host a live conference call and webcast with slides today at 8:30 a.m. Eastern Time to discuss the topline results of this clinical trial. The call can be accessed by dialing (866) 896-2215 (U.S. and Canada) or (617) 401-8110 (international) and referencing conference ID 9045217. Callers should dial in approximately 10 minutes prior to the start of the call. A question and answer session with the Tonix management team will follow the company's remarks. Individuals can participate in an interactive Q&A session by submitting pertinent questions via the webcast platform. To access the live webcast or the replay, visit the investor page of the Company's website at https://ir.tonixpharma.com/ir-events. The webcast will be recorded and available on the Company's website for 90 days.

    About Fibromyalgia

    Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

    About TNX-102 SL

    TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin-2A, alpha-1 adrenergic, histamine-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for fibromyalgia, PTSD, alcohol use disorder and agitation in Alzheimer's disease. The U.S. Patent and Trademark Office (USPTO) has issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in these patents are important elements of Tonix's proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

    About the Phase 3 RELIEF and RALLY Studies

    The RELIEF and RALLY studies are double-blind, randomized, placebo-controlled phase 3 trials designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets). The two-arm trials each targeted enrolling 470 participants at approximately 40 U.S. sites. For the first two weeks of treatment, there is a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. After the first two weeks, all participants have the dose increased to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for 12 weeks. The primary endpoint is daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation.

    Additional details about the completed RELIEF study are available at clinicaltrials.gov (NCT04172831).

    Additional details about the ongoing RALLY study are available at clinicaltrials.gov (NCT04508621).

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. In addition to fibromyalgia, Tonix's lead CNS candidate, TNX-102 SL**, is in development for the treatment of PTSD, agitation in Alzheimer's disease (AAD) and alcohol use disorder (AUD). The PTSD program is in Phase 3 development, while AAD and AUD are Phase 2 ready. The AAD program has FDA Fast Track designation. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and which has FDA Breakthrough Therapy designation. TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. Tonix's preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    About APR Applied Pharma Research s.a.

    APR is an independent pharma company headquartered in Switzerland with subsidiaries in Italy and Germany focused, since more than 25 years, in the development and commercialization of products intended to improve the quality of life of patients and families affected with rare or debilitating diseases. APR leverages many years of experience in developing patented drug delivery technologies, which are then applied to develop innovative therapeutic solutions.

    Further information about APR Applied Pharma Research can be found at www.apr.ch

    About Redox - Analytical Science srl

    Redox is an independent CRO company headquartered in Monza- Italy with R&D activities and customer analytical support to pharmaceutical companies for more than 30 years. From more than 25 years the analytical activities have been certified by national and international agencies (European Medicines Agency, the Italian Medicines Agency (AIFA), FDA, and etc). One of the main activities is the development of new drug products in order to improve the pharmaceutical actions and at the same time improve the stability and reducing the cost of the new drug substance. Several unique and sophisticated analytical techniques and equipment are used in support to research and development strategies with the focus to reach the best and effective pharmaceutical formulation in a short time frame. More than 30 professional people are dedicated to our efforts and many projects are ongoing in collaboration with the pharmaceutical industry as well as with Italian and international Universities.

    Further information about Redox can be found at www.labredox.com

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

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  43. Findings Published in the Current Issue of the Journal Genome Biology

    Horsepox is the Vector for Tonix's Experimental TNX-1800 COVID-19 Vaccine

    Horsepox Has Been Used as a Smallpox Vaccine Since at Least the 1860's

    Smallpox is the Only Viral Disease Ever Eradicated

    CHATHAM, N.J., Dec. 04, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that independent researchers reported 99.7% colinear identity between a circa 1860 U.S. smallpox vaccine and horsepox virus. Tonix's TNX-801 is a horsepox-based live virus vaccine being developed as a potential vaccine to prevent smallpox and monkeypox. Tonix's TNX-801 is also the vector…

    Findings Published in the Current Issue of the Journal Genome Biology

    Horsepox is the Vector for Tonix's Experimental TNX-1800 COVID-19 Vaccine

    Horsepox Has Been Used as a Smallpox Vaccine Since at Least the 1860's

    Smallpox is the Only Viral Disease Ever Eradicated

    CHATHAM, N.J., Dec. 04, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that independent researchers reported 99.7% colinear identity between a circa 1860 U.S. smallpox vaccine and horsepox virus. Tonix's TNX-801 is a horsepox-based live virus vaccine being developed as a potential vaccine to prevent smallpox and monkeypox. Tonix's TNX-801 is also the vector on which Tonix's COVID-19 experimental vaccine is based. Tonix was not involved in the research reported.

    The publication in the Journal Genome Biology, entitled "Re-assembly of 19th-century smallpox vaccine genomes reveals the contemporaneous use of horsepox and horsepox-related viruses in the United States"1 analyzed sequences of U.S. smallpox vaccines that had been published recently by a different group also in Genome Biology, entitled "The origins and genomic diversity of American Civil War Era smallpox vaccine strains"2.   The first paper applied modern techniques of sequencing old DNA to smallpox vaccine specimens stored in the Mütter Museum in Philadelphia, and identified that vaccines with horsepox core viral sequences were used in the 1860's and referenced sequence information from several vaccines that the authors posted in GenBank, the National Institute of Health genetic sequence database. The new report re-assembled certain genomes from the GenBank sequences associated with the first paper and found a remarkable degree of identity with the circa 1860 U.S. smallpox vaccine VK05 and the 1976 Mongolian horspox isolate called MNR-76. Tonix's TNX-801 was synthesized3 based on the sequence of the Mongolian horsepox isolate MNR-764.

    "The extent of colinear identity, approximately 99.7%, is remarkable between the circa 1860 U.S. smallpox vaccine VK05 and the 1976 Mongolian horsepox genome," said, José Esparza, MD, PhD, Adjunct Professor at the Institute of Human Virology, School of Medicine of the University of Maryland, who was an author of the Genome Biology letter. "This finding indicates that a true horsepox virus was used as a smallpox vaccine in the U.S. in the 1860's.  It is astonishing that there are so few differences between these viruses despite the separation of their isolation by over 100 years and from different continents."

    "This recent discovery is another step in establishing that what is called 'horsepox‘ today was used to vaccinate against smallpox in the 19th century," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. "Dr. Edward Jenner invented vaccination in 1798 and the procedure was called vaccination because the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox. ‘Cow' is ‘vacca' in Latin. However, Dr. Jenner suspected that cowpox originated from horsepox.5 Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination' from the Latin ‘equus' which means ‘horse'. Equination and vaccination were practiced side-by-side in Europe6. Several years ago, we recognized that the 2006 genome sequence of the 1976 Mongolian horsepox4 may be more like the vaccines that Jenner used than modern vaccinia vaccines, because the modern vaccinia vaccines appear to have undergone both divergent and convergent evolution since Jenner's time. To recreate a vaccine similar to Jenner's, together with scientists at the University of Alberta, Canada, we synthesized3 a live horsepox virus based on the 1976 Mongolian horsepox virus sequence and we are developing it as a potential vaccine for smallpox and monkeypox, called TNX-801. Horsepox is also the vector for our COVID-19 vaccine, TNX-1800, which has been modified to direct the expression of CoV-2 spike protein."

    "The new findings are particularly significant, because they confirm that horsepox has been used as a safe and effective smallpox vaccine since at least 1860, and probably since Edward Jenner's time in 1798," continued Dr. Lederman. "The new report confirms that modern 'vaccinia'-based smallpox vaccines from around the world have lost, apparently convergently, two genomic segments in evolution: an 11 Kilobase (kB) segment on the left side and a 6 kB Segment on the right side relative to the progenitor horsepox-like vaccines. The presence of these genetic elements in horsepox may contribute to the decreased virulence of horsepox relative to vaccinia in mice and the smaller plaque size in tissue culture. Later, after approximately 1875, when vaccinia propagation was moved from ‘arm to arm' to growth on cows in ‘vaccine farms'8, the core viral sequences of modern vaccinia vaccines appear to have diverged away from the horsepox core viral sequences. A standard for modern vaccine development and manufacturing is to make a ‘master virus bank' and tie vaccine production to the exact properties of the original master virus bank. Edward Jenner did not keep a master virus bank, because his work pre-dated understanding of viruses by more than 100 years. However, the recent work on sequencing and analyzing archaic smallpox vaccines gives us a clearer understanding of the structure and features of Jenner's vaccines. The more we learn, the more we are led to believe that Jenner's vaccinia was either horsepox or more like horsepox than modern vaccinia vaccines."

    The recent report is the latest in a series from a team composed by Dr. Esparza, Clarissa R Damaso, PhD at the Carlos Chagas Filho Biophisics Institute of the Federal University of Rio de Janeiro, Brazil, and Andreas Nitsche, Ph.D. at the Robert Koch Institute in Berlin, Germany. They have previously reported7 that the core viral sequence of a 1902 U.S. smallpox vaccine manufactured by Mulford, a vaccine manufacturer subsequently acquired by Merck, was closely related to the Mongolian horsepox MNR-76 on which TNX-801 is based. The latest report shows that the circa 1860 VK05 vaccine also contains a high degree of colinear identity through the ends of the viruses, including regions where all previously characterized smallpox vaccines including Mulford 1902 contained deletions of approximately 11 kB on the left side and 6 kB on the right side.

    Dr. Lederman continued, "Smallpox was eradicated using single-dose live replicating vaccines that induce durable T cell immunity, prevent serious illness after infection and block forward transmission. Our hope and our goal is to produce vaccines that will provide long term immunity with a single dose using a proven technology that can be readily scaled up for manufacturing and that does not require a costly and cumbersome cold chain for distribution and storage."

    About TNX-801*

    TNX-801 is a live virus vaccine based on synthesized horsepox3,4. Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor. Molecular analysis suggests that TNX-801 has relatively "complete" left and right inverted terminal repeats (ITRs) while different vaccinia isolates have a variety of deletions adjacent to the left and right ITRs including a characteristic approximately 11 kB deletion on the left side and an approximately 6 kB deletion on the right side. Therefore, TNX-801 has additional genes, relative to vaccinia vaccines, that may play roles in host immune interactions and one or more of such proteins may serve as antigens for protective immunity. Molecular analysis also shows that horsepox is closer than modern vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner3,4,5,7,8. The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate10. Relative to vaccinia, horsepox has substantially decreased virulence in mice3. Tonix's TNX-801 vaccine candidate is administered percutaneously using a two-pronged, or "bifurcated" needle. The major cutaneous reaction or "take" to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization's (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960's. The "take" is a measure of functional T cell immunity validated by the eradication of smallpox, a respiratory-transmitted disease caused by variola. Tonix's proprietary horsepox vector is believed to be more closely related to Jenner's vaccinia vaccine than modern vaccinia vaccines, which appear to have evolved by deletions and mutations to a phenotype of larger plaque size in tissue culture and greater virulence in mice. TNX-801 vaccinated macaques showed no overt clinical signs after monkeypox challenge11.

    About TNX-1800**

    TNX-1800 is a live modified horsepox virus vaccine for percutaneous administration that is designed to express the Spike protein of the SARS-CoV-2 virus and to elicit a predominant T cell response. TNX-1800 is based on a horsepox vector, which is a live replicating, attenuated virus that elicits a strong immune response. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice3. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials. Like TNX-801, Tonix's TNX-1800 vaccine candidate is administered percutaneously using a two-pronged, or "bifurcated" needle. Tonix recently reported that immunization with a single dose of TNX-1800 induced "takes" and neutralizing anti-SARS-CoV-2 antibodies in non-human primates.

    *TNX-801 is in the pre-IND stage and has not been approved for any indication.

    **TNX-1800 is in the pre-IND stage and has not been approved for any indication.

    1Brinkmann A et al, Genome Biology (2020) 21:286 https://doi.org/10.1186/s13059-020-02202-0

    2Duggan A et al. Genome Biology (2020) 21:175 https://doi.org/10.1186/s13059-020-02079-z

    3Noyce RS, et al. (2018) PLoS One. 13(1):e0188453

    4Tulman ER, et al. (2006) J Virol. 80(18):9244-58.PMID:16940536

    5Jenner E. "An Inquiry Into the Causes and Effects of the Variole Vaccinae, a Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire and Known by the Name of the cow‐pox." London: Sampson Low, 1798.

    6Esparza E, et al Vaccine. (2017) 35(52):7222-7230.

    7Schrick L et al N Engl J Med (2017); 377:1491-1492

    8Esparza J et al. Vaccine. (2020); 38(30):4773-4779.

    9Qin et al. J. Virol. 89:1809 (2015).

    10Trindale GS et al. Viruses (2016) (12). pii: E328. PMID:27973399

    11Noyce, RS, et al. Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox* Presented as a poster at the American Society of Microbiology BioThreats Conference - January 29, 2020, Arlington, VA. (https://content.equisolve.net/tonixpharma/media/10929ac27f4fb5f5204f5cf41d59a121.pdf)

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year and the first quarter of 2021. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19 but using bovine parainfluenza as the vector. Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects topline data in the Phase 3 RELIEF study in the fourth quarter of 2020. Tonix is also currently enrolling participants in the Phase 3 RALLY study for the management of fibromyalgia using TNX-102 SL, and the results are expected in second half of 2021. TNX-102 SL is also in development for PTSD, agitation in Alzheimer's disease (AAD) and alcohol use disorder (AUD). The PTSD program is in Phase 3 development, while AAD and AUD are Phase 2 ready. The AAD program has FDA Fast Track designation. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505

     



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  44. Anti-SARS-CoV-2 Neutralizing Antibodies Elicited in All Eight TNX-1800 Vaccinated Animals

    Skin Reaction or "Take," a Validated Biomarker of Functional T cell Immunity, Elicited in All Eight TNX-1800 Vaccinated Animals

    CHATHAM, N.J., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced preliminary results following vaccination of non-human primates with TNX-1800 (modified horsepox virus, live vaccine), a live attenuated COVID-19 vaccine candidate engineered to express the SARS-CoV-2 (CoV-2) spike protein after vaccination. The research is part of an ongoing collaboration between Southern Research Institute, the University of…

    Anti-SARS-CoV-2 Neutralizing Antibodies Elicited in All Eight TNX-1800 Vaccinated Animals

    Skin Reaction or "Take," a Validated Biomarker of Functional T cell Immunity, Elicited in All Eight TNX-1800 Vaccinated Animals

    CHATHAM, N.J., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced preliminary results following vaccination of non-human primates with TNX-1800 (modified horsepox virus, live vaccine), a live attenuated COVID-19 vaccine candidate engineered to express the SARS-CoV-2 (CoV-2) spike protein after vaccination. The research is part of an ongoing collaboration between Southern Research Institute, the University of Alberta and Tonix.

    "We are pleased that all eight animals vaccinated with TNX-1800 manifested "takes", a skin reaction which is a validated biomarker of functional T cell immunity, and that vaccination was associated with neutralizing antibodies in each case," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. "‘Take' has a long history as a validated biomarker for T cell immunity. 'Take‘ is important because it is otherwise difficult and costly to measure the T cell response to a vaccine. Vaccines that elicit a strong T cell response, like horsepox and closely related vaccinia, have been established to provide long-term, durable immunity and to block forward transmission. Single dose horsepox and vaccinia vaccination led to the eradication of smallpox, which, like CoV-2, is transmitted by the respiratory route. In the successful campaign to eradicate smallpox, 'take‘ was used as a biomarker for protective immunity."

    Dr. Lederman continued, "Our hope and our goal is to produce a vaccine that will provide long term immunity with a single dose using a proven technology that can be readily scaled up for manufacturing and that does not require a costly and cumbersome cold chain for distribution and storage. These results encourage us to advance TNX-1800 to human Phase 1 trials in 2021, when we expect to have Good Manufacturing Practice, or cGMP, quality TNX-1800 available. We have previously announced that our manufacturing partner is FUJIFILM Diosynth Biotechnologies."

    Key features and results:

    • STUDY DESIGN: This on-going study of non-human primates compares TNX-1800 (modified horsepox virus encoding CoV-2 spike protein) to TNX-801 (horsepox virus, live vaccine) at two doses. A control group received a placebo. Each of these five groups (TNX-1800 high and low dose; TNX-801 high and low dose and placebo) includes four animals.
    • NEUTRALIZING ANTI-CoV-2 ANTIBODIES: At day 14 after a single vaccination, all eight of the TNX-1800 vaccinated animals made anti-CoV-2 neutralizing antibodies (≥1:40 titer) and, as expected, none of the eight TNX-801 vaccinated control animals, or any of the four animals in the placebo group, made anti-CoV-2 neutralizing antibodies (≤1:10 titer). The level of neutralizing anti-CoV-2 antibody production was similar between the low and high dose TNX-1800 groups ((1 x 106 Plaque Forming Units [PFU]) and 3 x 106 PFU, respectively).
    • TOLERABILITY:TNX-1800 and TNX-801 were well tolerated at both doses.                
    • SKIN TAKE BIOMARKER: Further, as an expected additional outcome, all 16 animals vaccinated with either dose of TNX-1800 or the control TNX-801 manifested a "take", or cutaneous response, signaling that the horsepox vector elicited a strong T cell immune response.
    • DOSE: These results support the expectation that TNX-1800 at the low dose of 1 x 106 PFU is an appropriate dose for a one-shot vaccine in humans, and indicate that 100 doses per vial is the target format for commercialization, which is suited to manufacturing and distribution at large scale.
    • CONCLUSIONS: Together, these data show that TNX-1800 induces a strong immune response to CoV-2 in non-human primates. These data confirm that "take" is a biomarker of a strong immunological response to TNX-1800's vector, horsepox virus vaccine, and also indicate that "take" is predictive of a neutralizing antibody response to TNX-1800's cargo COVID-19 antigen, which is the CoV-2 spike protein.
    • NEXT PHASE: In the second phase of the study, the TNX-1800 vaccinated and control animals will be challenged with CoV-2. Results are expected in the first quarter of 2021.

    About TNX-1800

    TNX-1800 is a live modified horsepox virus vaccine for percutaneous administration that is designed to express the Spike protein of the SARS-CoV-2 virus and to elicit a predominant T cell response. Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor. Tonix's TNX-1800 vaccine candidate is administered percutaneously using a two-pronged, or "bifurcated" needle. TNX-1800 is based on a horsepox vector, which is a live replicating, attenuated virus that elicits a strong immune response. The major cutaneous reaction or "take" to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization's (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960's. The "take" is a measure of functional T cell immunity validated by the eradication of smallpox, a respiratory-transmitted disease caused by variola. Tonix's proprietary horsepox vector is believed to be more closely related to Jenner's vaccinia vaccine than modern vaccinia vaccines, which appear to have evolved by deletions and mutations to a phenotype of larger plaque size in tissue culture and greater virulence in mice. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice1. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials.

    1Noyce RS, et al. (2018) PLoS One. 13(1):e0188453

    About Southern Research

    Founded in 1941, Southern Research (SR) is an independent, 501(c)(3) nonprofit, scientific research organization with more than 400 scientists and engineers working across three divisions: Drug Discovery, Drug Development, and Engineering. SR has supported the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries. SR works on behalf of the National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Energy, NASA and other major aerospace firms, utility companies, and other external academic, industry and government agencies. SR pursues entrepreneurial and collaborative initiatives to develop and maintain a pipeline of intellectual property and innovative technologies that positively impact real-world problems. SR has numerous ongoing drug discovery programs, which encompass drug discovery programs to combat various forms of cancer, Alzheimer's, schizophrenia, opioid use disorder, human immunodeficiency virus, disease, Parkinson's, tuberculosis, influenza, and others. SR's strong history, which includes over 75 years of successful collaborations to solve complex problems, has led to the discovery of seven FDA-approved cancer drugs—a number rivaling any other U.S. research institute. Furthermore, experts at SR are well-equipped to assist with the challenging landscapes of drug design and development technologies and market viability. SR is headquartered in Birmingham, Alabama with additional laboratories and offices in Frederick, Maryland.

    Further information about SR can be found at https://southernresearch.org/

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year and the first quarter of 2021. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.. Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19 but using bovine parainfluenza as the vector. Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects topline data in the Phase 3 RELIEF study in the fourth quarter of 2020. Tonix is also currently enrolling participants in the Phase 3 RALLY study for the management of fibromyalgia using TNX-102 SL, and the results are expected in second half of 2021. TNX-102 SL is also in development for PTSD, agitation in Alzheimer's disease (AAD) and alcohol use disorder (AUD). The PTSD program is in Phase 3 development, while AAD and AUD are Phase 2 ready The AAD program has FDA Fast Track designation. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Contacts                                

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com 

    (443) 213-0505



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  45. Increasing Placebo Responses in PTSD Drug Trials Raise Questions About Current Methods of Measuring or Analyzing PTSD Symptom Change Over Time

    The U.S. 21st Century Cures Act Provides Direction on New Statistical Analyses Using Simulations

    Tonix Plans to Study TNX-102 SL in a New Phase 3 PTSD Trial in Kenya

    CHATHAM, N.J., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, outlined a new statistical method to analyze future Posttraumatic Stress Disorder (PTSD) drug studies and presented a retrospective analysis using the new method…

    Increasing Placebo Responses in PTSD Drug Trials Raise Questions About Current Methods of Measuring or Analyzing PTSD Symptom Change Over Time

    The U.S. 21st Century Cures Act Provides Direction on New Statistical Analyses Using Simulations

    Tonix Plans to Study TNX-102 SL in a New Phase 3 PTSD Trial in Kenya

    CHATHAM, N.J., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, outlined a new statistical method to analyze future Posttraumatic Stress Disorder (PTSD) drug studies and presented a retrospective analysis using the new method of the Phase 3 HONOR study (P301) of TNX-102 SL (cyclobenzaprine HCl sublingual tablets), for the treatment of military-related PTSD at the 3rd Annual Neuropsychiatric Drug Development Summit today.

    "The paradox that confounds modern PTSD studies is that the placebo response has increased over time, even as we and others have striven to improve study methods and data quality," said Dr. Lederman.   "In many studies, the placebo response has increased to the point where it has become very difficult for the treatment arm to be successful in a randomized placebo-controlled PTSD clinical trial. The measurements of PTSD placebo improvement in randomized clinical trials using the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) are inconsistent with what is known about the natural history of PTSD. In real world settings, PTSD patients do not dramatically improve without treatment like they appear to do in randomized clinical trials. Therefore, an opportunity and need exist to improve upon the measurement of PTSD symptoms in trials or the analysis of the data from trials. The 2017 21st Century Cures Act provides direction to the U.S. Food and Drug Administration (FDA) and to sponsors that new data analyses and particularly simulations should be used to improve clinical trial design and data analysis."

    The proposed new statistical method, called Randomization Honoring Non-Parametric Combination of Tests (RHNPCOT), was applied to a retrospective analysis of the Phase 3 HONOR study and showed a nominal p-value of 0.03 compared to the p-value of the prospective primary analysis of 0.6 in TNX-102 SL's treatment benefit at Week 12 as measured by change from baseline in the CAPS-5.

    Dr. Lederman added, "The RHNPCOT statistical method addresses key goals of the 21st Century Cures Act as a potential path forward in PTSD drug development and testing. It respects the actual randomization method of the study, preserves information from the 20 distinct items of the CAPS-5, efficiently uses data, and brings the analysis of CAPS-5 more into line with the patient self-reported outcome measure, Patient Global Impression of Change (PGIC). The PGIC has particular importance because it measures how study participants themselves rate how they feel and because it is not tied to any theoretical disease construct.   We have requested that FDA consider RHNPCOT as an exploratory outcome in our completed, but still blinded Phase 3 RECOVERY (P302) PTSD study. We expect to unblind the RECOVERY study before year end. Exploratory analysis of RECOVERY by RHNPCOT will provide additional information about the utility of the method. We plan to propose RHNPCOT as a primary analysis for future PTSD studies."

    In other psychiatric conditions, the placebo response is growing faster in the U.S. than in other countries1,2. Tonix is planning a Phase 3 PTSD study of TNX-102 SL in Kenya, expected to initiate in the third quarter of 2021, and will focus on studying police. The primary site for this multi-center study is Moi University School of Medicine in Eldoret, Kenya. The study was planned and the agreements negotiated when Dr. Lukoye Atwoli was Professor and Dean at Moi University School of Medicine. Dr. Atwoli was the principal investigator of the planned study before being recently recruited to be Dean of Aga Khan University Medical College East Africa based in Nairobi, the Capital of Kenya.

    Dr. Atwoli, now Professor of Psychiatry and Dean at Aga Khan University Medical College stated, "We in Kenya are very excited to be setting up the plans for a clinical trial to evaluate a treatment for PTSD in our region. This kind of research is not common in our part of the world. We believe there are opportunities to improve care in our population, but also to bolster the ability of our young researchers to carry out that kind of work. We are grateful to Tonix for supporting us and look forward to a long-term collaboration."

    Dr. Lederman stated, "PTSD knows no borders. We are impressed with the clinical trial capabilities at Moi University and several other sites in Kenya. We look forward to working with Dr. Atwoli and other experts to perform a study of TNX-102 SL on PTSD in Kenyan police."

    An archived replay of Dr. Lederman's presentation will be available on the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    About the 3rd Neuropsychiatric Drug Development Summit

    The 3rd Annual Neuropsychiatric Drug Development Summit focuses on unravelling the complexities of developing clinically transformative neuropsychiatric drugs.   With an emphasis on depressive disorders, schizophrenia, addiction and PTSD, this meeting provides a platform for thought leaders to have open reflections and share competitive knowledge.   The meeting will put the spotlight on innovations in clinical trial design, defining better clinical endpoints and the emergence of the next generation of anti-psychotics.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year and the first quarter of 2021. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19, but using bovine parainfluenza as the vector. Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects topline data in the Phase 3 RELIEF study in the fourth quarter of 2020. Tonix is also currently enrolling participants in the Phase 3 RALLY study for the management of fibromyalgia using TNX-102 SL, and the results are expected in second half of 2021. TNX-102 SL is also in development for PTSD, agitation in Alzheimer's disease (AAD) and alcohol use disorder (AUD). The PTSD program is in Phase 3 development while AAD and AUD are Phase 2 ready. The AAD program has FDA Fast Track designation. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    1Gopalakrishnan, M et al. J Clin Psychiatry. 2020; 81(2):19r12960

    2Laughren, TP J Clin Psychiatry. 2020; 81(2):19com13110

    *TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505

    Primary Logo

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  46. NEW YORK, NY / ACCESSWIRE / November 12, 2020 / Tonix Pharmaceuticals (NASDAQ:TNXP), a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering, 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 Tonix Pharmaceuticals

    Tonix is a clinical-stage biopharmaceutical company focused on small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology…

    NEW YORK, NY / ACCESSWIRE / November 12, 2020 / Tonix Pharmaceuticals (NASDAQ:TNXP), a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering, 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 Tonix Pharmaceuticals

    Tonix is a clinical-stage biopharmaceutical company focused on small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates.

    Tonix's lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response, with data expected from preclinical studies of TNX-1800 in 4Q'20.

    Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia with expected results from an interim analysis in September 2020 and topline data in the fourth quarter of 2020.

    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 (brittney@investorsummitgroup.com)

    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 brittney@investorsummitgroup.com

    SOURCE: Tonix Pharmaceuticals



    View source version on accesswire.com:
    https://www.accesswire.com/615988/Tonix-Pharmaceuticals-to-Present-at-the-virtual-Fall-Investor-Summit-on-November-16th-18th

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  47. CHATHAM, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, has been invited to present at three upcoming virtual investor conferences in November.

    Details are as follows:

    EventVirtual Fall Investor Summit
    DateNovember 16, 2020
    Time1:30 p.m. ET
      
    EventSidoti Virtual Microcap Conference
    DateNovember 19, 2020
    Time8:30 a.m. ET
      
    EventA.G.P Virtual Healthcare Symposium  
    DateNovember 19, 2020  
    DetailsPanel discussion moderated by A.G.P. analyst, Jim Molloy  
    Panel TitleThe Next Wave in COVID-19 Vaccines and Treatments  

    A live webcast and subsequent archived…

    CHATHAM, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, has been invited to present at three upcoming virtual investor conferences in November.

    Details are as follows:

    EventVirtual Fall Investor Summit
    DateNovember 16, 2020
    Time1:30 p.m. ET
      
    EventSidoti Virtual Microcap Conference
    DateNovember 19, 2020
    Time8:30 a.m. ET
      
    EventA.G.P Virtual Healthcare Symposium  
    DateNovember 19, 2020  
    DetailsPanel discussion moderated by A.G.P. analyst, Jim Molloy  
    Panel TitleThe Next Wave in COVID-19 Vaccines and Treatments  

    A live webcast and subsequent archived recording of the Company's participation in the Virtual Fall Investor Summit and the Sidoti Virtual Microcap Conference will be available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19, but using bovine parainfluenza as the vector. Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects topline data in the Phase 3 RELIEF study in the fourth quarter of 2020. Tonix is also currently enrolling participants in the Phase 3 RALLY study for the management of fibromyalgia using TNX-102 SL, and the results are expected in second half of 2021. TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). Both programs are Phase 2 ready, and the AAD program has FDA Fast Track designation. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505

    Primary Logo

    View Full Article Hide Full Article
  48. CHATHAM, N.J., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will be an invited speaker at the 3rd Annual Neuropsychiatric Drug Development Summit being held virtually November 10-12, 2020.

    Details of Dr. Lederman's presentation are as follows:

    Event3rd Annual Neuropsychiatric Drug Development Summit
    DateNovember 12, 2020
    Time11:55 a.m. ET
    TopicDeveloping a PTSD Therapeutic - Phase 3 Clinical Development

    An archived replay of Dr. Lederman's presentation will be available on the IR Events tab of the Investors section of the Tonix website…

    CHATHAM, N.J., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will be an invited speaker at the 3rd Annual Neuropsychiatric Drug Development Summit being held virtually November 10-12, 2020.

    Details of Dr. Lederman's presentation are as follows:

    Event3rd Annual Neuropsychiatric Drug Development Summit
    DateNovember 12, 2020
    Time11:55 a.m. ET
    TopicDeveloping a PTSD Therapeutic - Phase 3 Clinical Development

    An archived replay of Dr. Lederman's presentation will be available on the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com following the conference.

    About the 3rd Neuropsychiatric Drug Development Summit

    The 3rd Annual Neuropsychiatric Drug Development Summit focuses on unravelling the complexities of developing clinically transformative neuropsychiatric drugs.   With an emphasis on depressive disorders, schizophrenia, addiction and PTSD, this meeting provides a platform for thought leaders to have open reflections and share competitive knowledge.   The meeting will put the spotlight on innovations in clinical trial design, defining better clinical endpoints and the emergence of the next generation of anti-psychotics.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19, but using bovine parainfluenza as the vector. Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects topline data in the Phase 3 RELIEF study in the fourth quarter of 2020. Tonix is also currently enrolling participants in the Phase 3 RALLY study for the management of fibromyalgia using TNX-102 SL, and the results are expected in second half of 2021. TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). Both programs are Phase 2 ready, and the AAD program has FDA Fast Track designation. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals

    investor.relations@tonixpharma.com

    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners

    Olipriya.Das@russopartnersllc.com

    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke

    peter.vozzo@westwicke.com

    (443) 213-0505

    Primary Logo

    View Full Article Hide Full Article
  49. Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800, Expected in Fourth Quarter 2020

    Phase 1 Safety Study in Humans of TNX-1800 Expected to be Initiated in 2021

    CHATHAM, N.J., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the third quarter ended September 30, 2020, and provided an overview of recent operational highlights.

    "This is an exciting time for Tonix as we advance TNX-1800, our COVID-19 vaccine candidate, and expect to report our first data from animal studies before year end," said Seth Lederman, M.D., President and Chief Executive Officer. "In 2021, we anticipate initiation…

    Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800, Expected in Fourth Quarter 2020

    Phase 1 Safety Study in Humans of TNX-1800 Expected to be Initiated in 2021

    CHATHAM, N.J., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the third quarter ended September 30, 2020, and provided an overview of recent operational highlights.

    "This is an exciting time for Tonix as we advance TNX-1800, our COVID-19 vaccine candidate, and expect to report our first data from animal studies before year end," said Seth Lederman, M.D., President and Chief Executive Officer. "In 2021, we anticipate initiation of a Phase 1 study in humans. TNX-1800 is a live replicating vaccine based on our proprietary horsepox vector system and is designed to elicit a strong and durable T cell response in addition to antibody response to SARS-CoV-2 (CoV-2), the virus that causes COVID-19."

    Recent Highlights

    Research and Development

    TNX-1800 (live attenuated vaccine based on Tonix's horsepox virus vector): COVID-19 vaccine candidate designed as a single-administration vaccine to elicit T cell immunity

    • Data from small animal and non-human primate studies of TNX-1800 in COVID-19 models to measure safety and the immune response to the CoV-2 Spike protein are expected in the fourth quarter of 2020.
    • Data from small animal and non-human primate studies of TNX-1800 to measure efficacy in CoV-2 challenge studies are expected in the first quarter of 2021.

    COV-LOGIC, observational study: COVID-19 research collaboration with Southern Research

    • In September, Tonix announced that the first healthy volunteer was enrolled in the observational COV-LOGIC study, a multi-cohort sample collection study of T cell and antibody immune responses to CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19.  The research is part of an ongoing and broader collaboration between Tonix and Southern Research to develop and conduct animal testing of Tonix's COVID-19 vaccine candidate TNX-1800.
    • Data are expected in the first half of 2021.

    PRECISION, observational study: COVID-19 research collaboration with Columbia University

    • In October, Tonix announced enrollment of the first participant in the observational PRECISION study, designed to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to CoV-2. The research is designed to provide detailed immune responses to COVID-19 and to provide a foundation upon which to target vaccines and therapeutics to appropriate individuals using precision medicine.
    • Data are expected in 2021.

    TNX-2300 (live attenuated vaccine based on bovine parainfluenza virus): COVID-19 vaccine candidate in partnership with Kansas State University – platform designed to elicit T cell immunity by co-stimulation with CD40-ligand

    • In July, Tonix entered into a research and exclusive license option agreement with Kansas State University to develop a vaccine candidate for the prevention of COVID-19 that utilizes a novel live virus vaccine vector platform and the CD40-ligand, also known as CD154 or 5c8 antigen, to stimulate T cell immunity.
    • Data from small animals to measure efficacy in challenge studies using CoV-2 are expected in the second quarter of 2021.

    TNX-102 SL (cyclobenzaprine HCl sublingual tablets): small molecule product candidate for management of fibromyalgia

    • In September, following results from a pre-planned interim analysis, Tonix announced plans to complete the Phase 3 RELIEF study with the 503 enrolled participants and to report topline results in the fourth quarter of 2020.  The independent data monitoring committee (IDMC) made the non-binding recommendation that the trial continue to completion with the addition of 210 participants to the original sample size of 470 participants, which is the maximum number of participants that could be added under the interim statistical analysis plan.



    • Tonix is enrolling in a second potentially pivotal Phase 3 trial of TNX-102 SL for fibromyalgia, the RALLY study, and expects results in the second half of 2021.

    TNX-1900 (novel formulation of intranasal oxytocin): small peptide product candidate for migraine and craniofacial pain

    • In July, preclinical results of TNX-1900 (oxytocin formulation for intranasal delivery) were presented in a poster at the American Academy of Neurology's first-ever Sports Concussion Conference. The title of the poster was "Intranasal (IN) Oxytocin Relieves Pain and Depressive Behavior in a Rodent Model of Mild Traumatic Brain Injury (TBI)."  The research was sponsored by Trigemina, Inc. In June, Tonix acquired the assets of Trigemina including certain rights to the data described on the poster. 



    • Tonix intends to submit an Investigational New Drug (IND) application for this program to the U.S. Food and Drug Administration (FDA) in the first quarter of 2021 and is targeting to start a Phase 2 study of TNX-1900 for the prophylactic treatment of chronic migraine in the U.S. in the second quarter of 2021. A Phase 2 trial under an investigator-initiated IND has been completed in the U.S. using TNX-1900.

    TNX-1300 (cocaine esterase): biologic product candidate for cocaine intoxication

    • Tonix expects to initiate a Phase 2 open-label safety study in an emergency room setting to study TNX-1300 in the first quarter of 2021.  Results of a positive Phase 2 study of volunteer cocaine users in a controlled setting were reported prior to Tonix licensing the technology.

    Advanced Development Center for process and analytical development

    • In September 2020, Tonix completed the purchase of an approximately 40,000 square foot facility in Massachusetts to enable accelerated development and manufacturing of vaccines, including vaccines for COVID-19. Tonix expects the facility to be operational within 24 months with single-use bioreactors and purification suites with equipment for Good Manufacturing Practice (GMP) production of vaccines for clinical trials, including when fully operational the capability of producing sterile vaccines in glass vials 

    New Corporate Headquarters

    • In the third quarter, Tonix relocated its corporate headquarters to Chatham, N.J. Within the U.S., Tonix also maintains offices in New York, Massachusetts and California.

    Financial

    Third Quarter 2020 Financial Results

    As of September 30, 2020, Tonix had $55.7 million of cash and cash equivalents, compared to $11.2 million as of December 31, 2019. Cash used in operations was approximately $15.3 million for the three months ended September 30, 2020, compared to $6.6 million for the three months ended September 30, 2019.

    Research and development expenses for the third quarter of 2020 were $8.8 million, compared to $5.1 million for the same period in 2019. This increase is predominantly due to the timing of development milestones related to the Phase 3 RELIEF and RALLY studies in fibromyalgia in 2020, as well as increased activities for the development of potential vaccine candidates, TNX-1800 and TNX-801.

    General and administrative expenses for the third quarter of 2020 were $3.2 million, compared to $2.8 million for the same period in 2019. The increase is primarily due to an increase in financial reporting expenses and non-cash compensation expense.    

    Net loss was $12.0 million, or $0.09 per share, for the third quarter of 2020, compared to net loss of $7.8 million, or $5.69 per share, for the third quarter of 2019. The weighted average common shares outstanding, basic and diluted, for the third quarter of 2020 was 127,199,834, compared to 1,377,857 shares for the third quarter of 2019.

    As of November 6, 2020, the Company has an aggregate of 156,585,050 shares of common stock outstanding.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. Tonix is also developing TNX-2300* and TNX-2600*, live replicating vaccine candidates for the prevention of COVID-19, but using bovine parainfluenza as the vector. Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects topline data in the Phase 3 RELIEF study in the fourth quarter of 2020. Tonix is also currently enrolling participants in the Phase 3 RALLY study for the management of fibromyalgia using TNX-102 SL, and the results are expected in second half of 2021. TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). Both programs are Phase 2 ready, and the AAD program has FDA Fast Track designation. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801, TNX-2300, TNX-2600, TNX-1300, TNX-1500 and TNX-1700 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL, TNX-601 CR, TNX-1600 and TNX-1900 are investigational new drugs and have not been approved for any indication.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.



    Tonix Pharmaceuticals Reports Third Quarter 2020 Financial Results

    TONIX PHARMACEUTICALS HOLDING CORP.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except share and per share amounts)

    (Unaudited)

     Three Months Ended



              September 30,
    Nine Months Ended



               September 30,
     2020 2019 2020 2019
    Costs and expenses       
    Research and development$8,813 $5,052 $24,060   $12,502
    General and administrative        3,186       2,839         9,428            7,592
    Total costs and expenses     11,999       7,891       33,488          20,094
    Operating loss   (11,999)     (7,891)     (33,488)        (20,094)
    Interest income, net              9            53               46               183
    Net loss$(11,990)  $(7,838) $(33,442) $(19,911)
    Warrant deemed dividend          -           -            (451)              -
    Preferred stock deemed dividend