Tonix Pharmaceuticals to Present at the Summer 2024 Virtual Investor Summit

Rhea-AI Summary

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will present at the Summer 2024 Virtual Investor Summit on August 20, 2024, at 11:00 a.m. ET. The presentation will be available via webcast on the company's website. Tonix is a fully-integrated biopharmaceutical company with marketed products and a development pipeline focused on central nervous system (CNS) disorders.

Key highlights include:

• Plans to submit a New Drug Application (NDA) for TNX-102 SL for fibromyalgia management in the second half of 2024
• FDA Fast Track designation for TNX-102 SL
• Development of TNX-1300 for cocaine intoxication with Breakthrough Therapy designation
• Immunology portfolio including TNX-1500 for organ transplant rejection and autoimmune diseases
• Commercial products: Zembrace SymTouch and Tosymra for acute migraine treatment

CHATHAM, N.J., Aug. 13, 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., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the Summer 2024 Virtual Investor Summit on Tuesday, August 20, 2024, at 11:00 a.m. ET.

Investors interested in arranging a meeting with the Company’s management virtually 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 Tonix website at www.tonixpharma.com.

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 TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. 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.

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

When is Tonix Pharmaceuticals (TNXP) presenting at the Summer 2024 Virtual Investor Summit?

Tonix Pharmaceuticals (TNXP) is presenting at the Summer 2024 Virtual Investor Summit on Tuesday, August 20, 2024, at 11:00 a.m. ET.

What is the main focus of Tonix Pharmaceuticals' (TNXP) development portfolio?

Tonix Pharmaceuticals' (TNXP) development portfolio is primarily focused on central nervous system (CNS) disorders.

When does Tonix Pharmaceuticals (TNXP) plan to submit a New Drug Application for TNX-102 SL?

Tonix Pharmaceuticals (TNXP) plans to submit a New Drug Application (NDA) to the FDA for TNX-102 SL in the second half of 2024.

What designation has the FDA granted to Tonix Pharmaceuticals' (TNXP) TNX-102 SL?

The FDA has granted Fast Track designation to Tonix Pharmaceuticals' (TNXP) TNX-102 SL for the management of fibromyalgia.

What are the marketed products of Tonix Pharmaceuticals (TNXP)?

Tonix Pharmaceuticals (TNXP) markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg for the treatment of acute migraine in adults.