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Tonix Pharmaceuticals Announces Oral Presentation and Poster at the 5th International Congress on Controversies in Fibromyalgia

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On March 23, 2023, Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at the 5th International Congress on Controversies in Fibromyalgia. The presentation will cover the efficacy and safety of TNX-102 SL for fibromyalgia, based on results from the randomized RELIEF trial. It is scheduled for March 30, 2023, at 5:10 p.m. CEST in Vienna, Austria. Additionally, a poster presentation will accompany the oral presentation. The company’s abstract will be published in a special issue of Clinical and Experimental Rheumatology. Tonix is focused on developing novel therapeutics, with interim data for TNX-102 SL expected in Q2 2023.

Positive
  • CEO Seth Lederman to present at a prominent fibromyalgia conference.
  • Presentation includes data from the randomized RELIEF trial for TNX-102 SL, showcasing product efficacy.
  • The abstract will be published in a peer-reviewed journal, enhancing visibility and credibility.
  • Interim data for TNX-102 SL expected in Q2 2023, indicating progress in clinical development.
Negative
  • None.

CHATHAM, N.J., March 23, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will deliver an oral presentation and the Company will present a poster at the 5th International Congress on Controversies in Fibromyalgia being held March 30-31, 2023 at the Austria Trend Hotel Savoyen Vienna, Vienna, Austria.

Copies of the Company’s presentation and poster will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. In addition to the presentation, the Company’s submitted abstract will be published in an online supplement to the journal Clinical and Experimental Rheumatology in a special issue on Fibromyalgia. Additional meeting information can be found on the International Congress on Controversies in Fibromyalgia website here.

Oral Presentation Details
  
Topic:Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia: Results from the Randomized, Placebo Controlled RELIEF Trial
  
Location:Austria Trend Hotel Savoyen Vienna, Vienna, Austria
  
Date:Thursday March 30, 2023
  
Time:5:10 p.m. CEST
  
Poster Presentation Details
  
Title:Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia: Results from the Randomized, Placebo Controlled RELIEF Trial
  
Location:Austria Trend Hotel Savoyen Vienna, Vienna, Austria
  
Date/Time:On display through duration of conference March 30-31, 2023


Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s 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 with interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition, for which a Phase 2 study was initiated in the third quarter of 2022. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is currently enrolling with interim data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation of tianeptine being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900, a class of broad-spectrum small molecule oral antivirals.

*All of Tonix’s product candidates are investigational new drugs or 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 the 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505


FAQ

What is the focus of Tonix Pharmaceuticals (TNXP)?

Tonix Pharmaceuticals focuses on developing therapeutics for various conditions, including fibromyalgia and Long COVID.

When will the presentation on TNX-102 SL take place?

The presentation will occur on March 30, 2023, at 5:10 p.m. CEST.

Where is the 5th International Congress on Controversies in Fibromyalgia being held?

The congress is being held at the Austria Trend Hotel Savoyen Vienna in Austria.

What is TNX-102 SL used for?

TNX-102 SL is being developed for the treatment of fibromyalgia.

What is the RELIEF trial?

The RELIEF trial is a randomized, placebo-controlled study assessing the efficacy and safety of TNX-102 SL for fibromyalgia.

Tonix Pharmaceuticals Holding Corp.

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