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Tonix Pharmaceuticals Announces Presentation at BIO-Europe Spring

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Tonix Pharmaceuticals Holding Corp. reported positive results from the second Phase 3 trial of Tonmya™ for fibromyalgia management. The company plans to submit a New Drug Application (NDA) to the FDA in the second half of 2024. In Japan, China, and most European countries, cyclobenzaprine is considered a New Chemical Entity. Tonix CEO will present at the 2024 BIO-Europe Spring Convention in Barcelona, Spain.
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The announcement of Tonix Pharmaceuticals' second positive Phase 3 trial results for Tonmya™ is a critical milestone in the drug's development pathway. The successful completion of a Phase 3 trial typically precedes a New Drug Application (NDA), indicating a significant step towards commercialization. As such, this news is likely to be closely monitored by investors and industry analysts for its potential to impact the company's revenue and market share. The planned NDA submission in the second half of 2024 sets a clear timeline for investors, potentially influencing the company's stock valuation. Investors should, however, be cautious of the inherent risks in drug development, including regulatory setbacks or unforeseen adverse effects that could emerge.

The designation of cyclobenzaprine as a New Chemical Entity (NCE) in Japan, China and most European countries implies exclusivity benefits that could provide Tonix with market protection and an opportunity to capitalize on first-mover advantage upon approval. This status could lead to a longer period of market exclusivity, preventing generic competition and potentially allowing for a higher pricing strategy. However, gaining NCE status also means that Tonix will need to navigate various international regulatory landscapes, which can be complex and time-consuming. Stakeholders should consider the implications of these regulatory challenges and the associated costs when evaluating the company's long-term growth potential.

Fibromyalgia is a chronic condition characterized by widespread pain and fatigue, affecting a significant patient population globally. The positive trial results for Tonmya™ suggest that the drug could meet an unmet medical need, providing relief for patients who have limited treatment options. From a market perspective, this could translate into a robust demand for Tonmya™, should it receive FDA approval. The success of the drug in the market will depend on factors such as efficacy, safety profile, pricing and the competitive landscape. Additionally, the company's ability to effectively market and distribute the drug will be crucial in capturing and sustaining market share.

Tonix recently reported results from second positive Phase 3 trial of Tonmya™ for the management of fibromyalgia

In the U.S., New Drug Application (NDA) submission to the FDA planned for the second half of 2024

In Japan, China and most countries in Europe cyclobenzaprine is a New Chemical Entity

CHATHAM, N.J., March 12, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2024 BIO-Europe Spring Convention being held March 18-20, 2024 in Barcelona, Spain. The presentation will take place on Tuesday, March 19, 2024 at 10:45 a.m. CET in Room 133/134 of the CCIB Barcelona.

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.

About Tonmya* (also known as TNX-102 SL)

Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.

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

Tonix Pharmaceuticals Holding Corp.*

Tonix is a 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 Tonmya, a product candidate for which two positive 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 with 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, 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.

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

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039


FAQ

What did Tonix Pharmaceuticals Holding Corp. report regarding Tonmya™?

Tonix reported positive results from the second Phase 3 trial of Tonmya™ for fibromyalgia management.

When does Tonix plan to submit a New Drug Application (NDA) to the FDA?

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

Where is the 2024 BIO-Europe Spring Convention being held?

The 2024 BIO-Europe Spring Convention is being held in Barcelona, Spain.

When will Tonix CEO present at the convention?

The Tonix CEO will present at the convention on Tuesday, March 19, 2024, at 10:45 a.m. CET.

How can one schedule a meeting with Tonix Pharmaceuticals Holding Corp. management at the convention?

To schedule a meeting with the company's management, one can submit a meeting request through the BIO One-on-One Partnering™ system or contact brandon.weiner@westwicke.com.

Tonix Pharmaceuticals Holding Corp.

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About TNXP

tonix is developing innovative pharmaceutical products to address major public health challenges. in addition to tonmya for ptsd, tonix is developing tnx-601 (tianeptine oxalate), a clinical candidate at pre-ind (investigational new drug) application stage, designed as a daytime treatment for ptsd and tnx-801, a live synthetic version of horsepox virus, at the pre-ind application stage, to be developed as a potential smallpox-preventing vaccine. further information about tonix can be found at www.tonixpharma.com.