Tonix Pharmaceuticals to Present Poster at IASP 2024 World Pain Congress

Tonix Pharmaceuticals Holding Corp., a fully integrated biopharmaceutical company listed on Nasdaq under the ticker TNXP, has announced a significant breakthrough in their treatment for fibromyalgia. Tonix's product candidate, Tonmya™ (TNX-102 SL), has shown statistically significant results in Phase 3 clinical trials for managing fibromyalgia, particularly in alleviating pain and improving sleep quality. The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024.

Tonix has been granted Fast Track Designation by the FDA for Tonmya™, which expedites the review process for drugs that treat serious conditions and fill an unmet medical need. This designation underscores the potential impact of Tonmya™ on fibromyalgia management, a condition characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory, and mood issues.

The company will present detailed findings from their Phase 3 RESILIENT trial at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain. The event will take place from August 5-9 in Amsterdam, Netherlands. Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, will present the poster titled "Targeting Fibromyalgia Non-Restorative Sleep with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl): Results of the Positive Phase 3 RESILIENT Trial Consistent with Syndromic Improvement." The presentation is scheduled for August 7, 2024, at 3:15 p.m. CEST. Following the conference, the poster will be available on Tonix's website.

Tonix Pharmaceuticals is dedicated to discovering, developing, licensing, and commercializing therapeutic solutions for various medical conditions, primarily focusing on central nervous system (CNS) disorders. In addition to fibromyalgia, the company's CNS portfolio includes TNX-1300, a biologic designed to treat cocaine intoxication, which has received Breakthrough Therapy designation.

Moreover, Tonix is advancing its immunology development portfolio, targeting organ transplant rejection, autoimmunity, and cancer. Notably, TNX-1500, a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154), is being developed to prevent allograft rejection and treat autoimmune diseases.

Tonix's commercial subsidiary, Tonix Medicines, markets Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray), both aimed at treating acute migraine in adults. These marketed products bolster the company's presence in the pharmaceutical market and provide valuable experience in commercializing therapeutic products.

The company's progress with Tonmya™ signifies a notable advancement in fibromyalgia treatment, offering hope to patients suffering from this chronic condition. By focusing on both pain relief and improvement in sleep quality, Tonix aims to address two critical aspects of fibromyalgia that significantly impact patients' quality of life.

In summary, Tonix Pharmaceuticals is making substantial strides in developing innovative treatments for various medical conditions, with a particular emphasis on CNS disorders. The promising results from the Phase 3 trials of Tonmya™ for fibromyalgia, combined with the FDA Fast Track Designation, position the company well for its upcoming NDA submission. As the company continues to advance its diverse portfolio, it remains committed to alleviating human suffering and improving patient outcomes across multiple therapeutic areas.

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