Tonix Pharmaceuticals to Present at Two Upcoming January Investor Conferences

Rhea-AI Summary

Tonix Pharmaceuticals (TNXP) has announced its participation in two major investor conferences this January. CEO Seth Lederman will present at the 8th Annual Neuroscience Innovation Forum on January 12, 2025, delivering a company presentation at 11:15 a.m. PT and participating in a panel on neuropsychiatric treatments at 1:15 p.m. PT. Additionally, he will present at the 2025 Biotech Showcase on January 14, 2025, at 10:00 a.m. PT.

The company recently submitted an NDA for TNX-102 SL for fibromyalgia management, with a PDUFA date of August 15, 2025. Tonix's pipeline includes TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. They recently secured a DoD contract worth up to $34 million for developing TNX-4200, an antiviral agent. Their commercial subsidiary, Tonix Medicines, markets Zembrace SymTouch and Tosymra for acute migraine treatment.

CHATHAM, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Tonix management will present and host investor meetings at the following January investor conferences:

8^th Annual Neuroscience Innovation Forum by Sachs Associates

Company Presentation
Presenter:	Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals
Date:	Sunday, January 12, 2025
Place:	Marines Memorial Club, San Francisco, Calif.
Time:	11:15 a.m. PT
Room:	Track A – Room Rosenberg

Panel
Participant:	Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals
Title:	Revolutionizing Neuropsychiatric Treatments: Novel Approaches Panel
Date:	Sunday, January 12, 2025
Place:	Marines Memorial Club, San Francisco, Calif.
Time:	1:15 p.m. PT

2025 Biotech Showcase
Presenter:	Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals
Date:	Tuesday, January 14, 2025
Place:	Hilton San Francisco Union Square, San Francisco, Calif.
Time:	10:00 a.m. PT
Room:	Yosemite C (Ballroom level)

Investors interested in arranging a meeting with the Company's management during these conferences should contact the respective conference coordinators. Replays of both webcasts of the Company’s presentations at the Neuroscience Innovation Forum and the 2025 Biotech Showcase will be available under the IR Events tab of the Tonix website at www.tonixpharma.com following each presentation.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing approval. The FDA has also 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 and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the U.S. National Institute of Drug Abuse and Addiction. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified 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, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. 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; their efficacy and safety have not been established 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 Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

FAQ

When is the PDUFA date for Tonix's (TNXP) fibromyalgia drug TNX-102 SL?

The PDUFA date for Tonix's TNX-102 SL is August 15, 2025, when the FDA is expected to make a decision on marketing approval for fibromyalgia management.

What is the value of TNXP's new Department of Defense contract for TNX-4200?

Tonix Pharmaceuticals secured a contract with the DoD's Defense Threat Reduction Agency worth up to $34 million over five years to develop TNX-4200, a broad-spectrum antiviral agent.

When and where will TNXP present at the 2025 Biotech Showcase?

Tonix will present at the 2025 Biotech Showcase on Tuesday, January 14, 2025, at 10:00 a.m. PT at the Hilton San Francisco Union Square in the Yosemite C room.

What are the key products in TNXP's commercial portfolio?

Tonix Medicines, the commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg for acute migraine treatment in adults.

What is the status of TNXP's TNX-1300 drug development?

TNX-1300 is a biologic in Phase 2 development designed to treat cocaine intoxication. It has received FDA Breakthrough Therapy designation and is supported by a grant from the U.S. National Institute of Drug Abuse and Addiction.