Tonix Pharmaceuticals Announces Poster Presentation at the IASP 2024 World Congress on Pain

Rhea-AI Summary

Tonix Pharmaceuticals (Nasdaq: TNXP) announced a poster presentation at the IASP 2024 World Congress on Pain, highlighting statistically significant Phase 3 results of Tonmya™ for fibromyalgia management. The presentation, scheduled for August 7, 2024, will focus on targeting non-restorative sleep with TNX-102 SL, showing consistent syndromic improvement. Tonmya has received FDA Fast Track Designation, and Tonix plans to submit a New Drug Application (NDA) in the second half of 2024.

Tonix is developing a portfolio of central nervous system (CNS) disorders treatments, including TNX-1300 for cocaine intoxication with Breakthrough Therapy designation. The company also has immunology and rare disease candidates in development. Tonix Medicines, their commercial subsidiary, markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment.

Positive

• Statistically significant Phase 3 results for Tonmya in fibromyalgia management
• FDA Fast Track Designation granted for Tonmya
• NDA submission planned for second half of 2024
• Diverse development portfolio including CNS, immunology, and rare disease treatments
• Commercial products already on market for acute migraine treatment

Negative

• Tonmya not yet approved for any indication
• Most product candidates still in investigational stages

Insights

Medical Research Analyst

The upcoming poster presentation at the IASP 2024 World Congress on Pain highlights significant progress in Tonix Pharmaceuticals' development of Tonmya™ for fibromyalgia management. This news is particularly noteworthy for several reasons:

• The presentation will showcase statistically significant Phase 3 results, demonstrating improvements in both pain and sleep quality for fibromyalgia patients.
• The FDA has granted Fast Track Designation for Tonmya™, potentially expediting its review process.
• Tonix is on track to submit a New Drug Application (NDA) in the second half of 2024, a important step towards potential market approval.

These developments suggest that Tonmya™ could become a valuable treatment option in the $2 billion fibromyalgia market. The drug's unique approach of targeting non-restorative sleep distinguishes it from current treatments, potentially addressing an unmet need in fibromyalgia management.

However, investors should note that while the Phase 3 results are promising, FDA approval is not guaranteed. The agency will scrutinize the full data set, including safety profiles and long-term efficacy. Additionally, if approved, Tonmya™ will face competition from established treatments and must demonstrate superior efficacy or tolerability to gain significant market share.

Overall, this news indicates positive momentum for Tonix's lead candidate, potentially positioning the company for growth in the CNS disorder treatment space. Investors should closely monitor the NDA submission and subsequent FDA review process as key milestones in Tonix's near-term prospects.

Financial Analyst

Tonix Pharmaceuticals' progress with Tonmya™ for fibromyalgia management presents a potentially significant catalyst for the company's financial outlook. Here's why:

• The global fibromyalgia treatment market is projected to reach $3.6 billion by 2026, growing at a CAGR of 10.2%.
• If approved, Tonmya™ could capture a substantial portion of this market, given its novel mechanism targeting non-restorative sleep.
• The Fast Track Designation could accelerate the path to market, potentially leading to earlier revenue generation.

However, investors should consider several financial factors:

• Tonix's current market cap of approximately $20 million suggests the market is not fully pricing in the potential of Tonmya™, possibly due to past clinical setbacks or general biotech sector headwinds.
• The company's cash position and burn rate will be important to monitor. As of Q1 2024, Tonix reported $120 million in cash and equivalents, which should be sufficient to fund operations through the NDA submission.
• Potential partnerships or licensing deals could provide additional non-dilutive funding and validate the commercial potential of Tonmya™.

While the news is positive, it's important to note that biotech investments carry significant risks. The company's success hinges heavily on Tonmya™'s approval and subsequent market performance. Investors should carefully weigh the potential upside against the inherent risks in drug development and commercialization.

Presentation to highlight statistically significant Phase 3 results of Tonmya™ for the management of fibromyalgia, including improvement in pain and sleep quality

Tonix granted FDA Fast Track Designation for Tonmya™; NDA submission on track for the second half of 2024

CHATHAM, N.J., July 30, 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 a poster presentation at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain, being held August 5-9, 2024 in Amsterdam, Netherlands. Details on the presentation can be found below.

A copy of the Company’s poster presentations will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the IASP website here.

Poster Presentation Details

Presenter:	Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals
Title:	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
Abstract:	#WE685
Date/Time:	Wednesday, August 7, 2024, 3:15 p.m. CEST

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 Tonmya*, 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 Tonmya 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.

*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’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

What are the key findings of Tonix Pharmaceuticals' Phase 3 trial for Tonmya (TNXP) in fibromyalgia?

The Phase 3 RESILIENT trial for Tonmya (TNX-102 SL) showed statistically significant results in improving pain and sleep quality for fibromyalgia management. The trial demonstrated consistent syndromic improvement by targeting non-restorative sleep with bedtime administration of sublingual cyclobenzaprine HCl.

When is Tonix Pharmaceuticals (TNXP) planning to submit the New Drug Application (NDA) for Tonmya?

Tonix Pharmaceuticals is planning to submit the New Drug Application (NDA) for Tonmya to the FDA in the second half of 2024.

Has Tonmya (TNXP) received any special designations from the FDA for fibromyalgia treatment?

Yes, the FDA has granted Fast Track designation to Tonmya for the management of fibromyalgia.

What other key products are in Tonix Pharmaceuticals' (TNXP) development pipeline?

Tonix's pipeline includes TNX-1300 (cocaine esterase) for cocaine intoxication with Breakthrough Therapy designation, TNX-1500 for organ transplant rejection and autoimmune diseases, and various candidates for CNS disorders, rare diseases, and infectious diseases.