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Tonix Pharmaceuticals to Present at the Alliance Global Partners (A.G.P) Healthcare Company Showcase

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Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will participate virtually in a fireside chat at the A.G.P. Healthcare Company Showcase on May 21, 2024, at 9:00 a.m. ET.

The presentation will be live webcast and available for replay on the Tonix website.

Tonix is a biopharmaceutical company focused on developing therapeutics for CNS disorders, including submitting a New Drug Application (NDA) for Tonmya in the second half of 2024.

Other key products in their portfolio include TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection and autoimmune diseases. Tonix also markets Zembrace SymTouch and Tosymra for acute migraine treatment.

Positive
  • CEO Seth Lederman's participation in A.G.P. Healthcare Showcase may enhance visibility and investor interest in TNXP.
  • Live webcast and replay availability provide wider access to the company's presentation.
  • Upcoming NDA submission for Tonmya in 2024, supported by two significant Phase 3 studies, could be a major milestone.
  • TNX-1300 has Breakthrough Therapy designation, potentially accelerating its market entry.
  • Commercial products Zembrace SymTouch and Tosymra already marketed, providing revenue streams.
Negative
  • Tonmya, despite nearing NDA submission, has not yet been approved for any indication.
  • All product development candidates are still investigational, implying ongoing expenses without guaranteed returns.
  • The company's portfolio includes high-risk areas like CNS disorders and rare diseases, which often face significant regulatory and clinical hurdles.

CHATHAM, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Seth Lederman, M.D., Chief Executive Officer, will participate virtually in a fireside chat at A.G.P.’s Healthcare Company Showcase on Tuesday, May 21, 2024, at 9:00 a.m. ET.

A live webcast of the presentation can be found here.   A replay of the presentation will also be available under the IR Events tab of the Tonix website at www.tonixpharma.com following the event.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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 rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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; risks related to the failure to successfully market any of our products; 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience 
kdodge@lavoiehealthscience.com 
(978) 360-3151


FAQ

What will Tonix Pharmaceuticals discuss at the A.G.P. Healthcare Company Showcase?

CEO Seth Lederman will participate in a fireside chat to discuss the company's developments.

When is Tonix Pharmaceuticals' presentation at the A.G.P. Healthcare Company Showcase?

The presentation is scheduled for May 21, 2024, at 9:00 a.m. ET.

Where can I watch Tonix Pharmaceuticals' presentation at the A.G.P. Healthcare Company Showcase?

A live webcast will be available, with a replay accessible on the Tonix website.

What is Tonix Pharmaceuticals' stock symbol?

Tonix Pharmaceuticals is listed on Nasdaq under the symbol TNXP.

What are the key products in Tonix Pharmaceuticals' pipeline?

Key products include Tonmya for fibromyalgia, TNX-1300 for cocaine intoxication, and TNX-1500 for organ transplant rejection and autoimmune diseases.

When will Tonix Pharmaceuticals submit the NDA for Tonmya?

The NDA submission for Tonmya is planned for the second half of 2024.

What commercial products does Tonix Pharmaceuticals market?

Tonix markets Zembrace SymTouch and Tosymra for the treatment of acute migraine.

Tonix Pharmaceuticals Holding Corp.

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CHATHAM