Tonix Pharmaceuticals Announces Presentation at the 2024 BIO International Convention

Rhea-AI Summary

Tonix Pharmaceuticals announced that Chief Operating Officer Jessica Morris will present at the 2024 BIO International Convention in San Diego on June 4, 2024. The presentation will discuss statistically significant Phase 3 results of Tonmya™ for fibromyalgia management, with a New Drug Application (NDA) to the FDA planned for the second half of 2024. Tonix focuses on central nervous system (CNS) disorders, including treatments for acute stress reaction and Long COVID. The company's immunology portfolio targets organ transplant rejection and autoimmune diseases. Tonix markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment.

Positive

• Statistically significant Phase 3 results for Tonmya™ in fibromyalgia management.
• NDA submission for Tonmya™ planned for the second half of 2024.
• Tonix has a diverse pipeline targeting CNS disorders and immunology.
• Tonix’s commercial subsidiary markets FDA-approved acute migraine treatments (Zembrace® SymTouch® and Tosymra®).

Negative

• Tonmya™ has not yet been approved by the FDA.
• Pending NDA submission introduces regulatory approval risks.
• No details provided on financial performance or revenue.

Insights

Medical Research Analyst

Tonix Pharmaceuticals' announcement regarding the statistically significant Phase 3 results for Tonmya™ in the management of fibromyalgia is noteworthy for its potential implications. Fibromyalgia is a chronic condition causing widespread pain, which currently has limited treatment options. The successful completion of Phase 3 trials is a critical milestone because it indicates the drug's efficacy and safety in a larger patient population. The upcoming NDA submission to the FDA suggests Tonmya™ could soon be available to patients, pending approval, which would address a significant unmet need. For investors, this progress signals that the company is on track with its development timeline and an FDA approval could substantially enhance revenue streams and market position.

Financial Analyst

The completion of Phase 3 trials and the upcoming NDA submission for Tonmya™ significantly de-risks Tonix Pharmaceuticals' pipeline. Successful Phase 3 outcomes often lead to higher valuation due to anticipated future revenue from the new drug. If Tonmya™ gains FDA approval, it could open up a substantial market, given the prevalence of fibromyalgia. Moreover, the FDA's conditional acceptance of the tradename suggests regulatory processes are well underway. However, investors should also consider the costs associated with bringing a new drug to market, including manufacturing, marketing and distribution expenses. Long-term profitability will depend on these factors as well as market acceptance and competition.

Presentation to highlight statistically significant Phase 3 results of Tonmya™ for the management of fibromyalgia

New Drug Application (NDA) submission to the FDA on track for the second half of 2024

CHATHAM, N.J., May 28, 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, today announced that Jessica Morris, Chief Operating Officer, will present at the 2024 BIO International Convention being held June 3-6, 2024 in San Diego, Calif. The presentation will take place on Tuesday, June 4, 2024 at 10:45 a.m. PT in Theater 1 at the San Diego Convention Center.

To schedule a meeting with the Company’s management at the convention, please submit a meeting request through the BIO One-on-One Partnering™ system or contact brandon.weiner@westwicke.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 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 are the key highlights of Tonix Pharmaceuticals' presentation at the 2024 BIO International Convention?

The presentation will feature statistically significant Phase 3 results for Tonmya™ in fibromyalgia management.

When is the NDA submission for Tonmya™ expected?

Tonix plans to submit the NDA in the second half of 2024.

What products does Tonix Pharmaceuticals market?

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

What is the focus of Tonix Pharmaceuticals' development portfolio?

Tonix focuses on CNS disorders, including fibromyalgia, acute stress reaction, and Long COVID, as well as immunology for organ transplant rejection and autoimmune diseases.

Where and when is Tonix Pharmaceuticals presenting at the 2024 BIO International Convention?

Tonix will present on June 4, 2024, at 10:45 a.m. PT in Theater 1 at the San Diego Convention Center.