TNXP Tonix Pharmaceuticals Holding Corp.

0.72
-0.01  -1%
Previous Close 0.73
Open 0.73
52 Week Low 0.51
52 Week High 2.12
Market Cap $236,667,666
Shares 330,541,433
Float 330,310,520
Enterprise Value $76,887,351
Volume 4,865,395
Av. Daily Volume 10,280,729
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Upcoming Catalysts

Drug Stage Catalyst Date
Tonmya (TNX-102 SL)
Fibromyalgia
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Tonmya (TNX-102 SL)
Alcohol Use Disorder
Phase 2
Phase 2
Phase 2 ready.
Tonmya (TNX-102 SL)
Post-traumatic stress disorder (PTSD)
Phase 3
Phase 3
Phase 3 trial halted due to insufficient efficacy - July 27, 2018.
TNX-1800
COVID-19 vaccine
Phase 1
Phase 1
Phase 1 trial to be initiated 1H 2022.
TNX-1300
Cocaine intoxication
Phase 2
Phase 2
Phase 2 trial to be initiated 3Q 2021.
TNX-1900
Migraine
Phase 2
Phase 2
Phase 2 trial to be initiated 3Q 2021.
Tonmya (TNX-102 SL)
Post-traumatic stress disorder (PTSD)
Phase 3
Phase 3
Phase 3 enrolment to be stopped due to futility - February 5, 2020. Top-line data confirmed primary endpoint was not met - December 21, 2020.
TNX-201
Episodic tension-type headache
Phase 2
Phase 2
Phase 2 data released February 2016 did not meet primary endpoint

Latest News

  1. 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



    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners



    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR



    (443) 213-0505



    Primary Logo

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  2. 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



    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners



    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR



    (443) 213-0505



    Primary Logo

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  3. 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



    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners



    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR



    (443) 213-0505



    Primary Logo

    View Full Article Hide Full Article
  4. 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



    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners



    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR



    (443) 213-0505



    Primary Logo

    View Full Article Hide Full Article
  5. 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



    (862) 904-8182

    Olipriya Das, Ph.D. (media)

    Russo Partners



    (646) 942-5588

    Peter Vozzo (investors)

    Westwicke/ICR



    (443) 213-0505



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