Tonix Pharmaceuticals Announces Two Oral Presentations and One Poster Presentation Involving TNX-1500 (Fc-modified humanized anti-CD40L mAb) at the American Transplant Congress 2024

Rhea-AI Summary

Tonix Pharmaceuticals (Nasdaq: TNXP) announced two oral and one poster presentation at the American Transplant Congress 2024, showcasing research on TNX-1500, a humanized monoclonal antibody targeting CD40-ligand for organ transplant rejection. These presentations, led by researchers from Massachusetts General Hospital, will cover novel approaches and protocols in immunosuppression and immune tolerance. The presentations are scheduled for June 3-4, 2024, at the Pennsylvania Convention Center. Tonix aims to submit a New Drug Application for Tonmya for fibromyalgia in H2 2024 and is also developing treatments for CNS disorders, autoimmunity, and rare diseases.

Positive

• Tonix Pharmaceuticals is presenting significant research findings at a major scientific conference, indicating active engagement in cutting-edge research.
• The presentations at the American Transplant Congress 2024 may increase interest and credibility in TNX-1500, potentially boosting investor confidence.
• Tonix plans to submit an NDA for Tonmya in the second half of 2024, showing progress in their product pipeline.
• TNX-1500 is being developed for critical applications such as organ transplant rejection and autoimmune diseases, targeting high-need medical areas.
• Tonix's diverse development portfolio includes treatments for CNS disorders, rare diseases, and infectious diseases, indicating a broad and robust pipeline.

Negative

• There is no mention of immediate financial gains or new revenue streams from the TNX-1500 presentations, which may concern short-term investors.
• The presented data involves early-stage research, which might not translate into immediate clinical or commercial success.
• The success of Tonix's product candidates, including TNX-1500, hinges on future clinical trial results and regulatory approvals, presenting inherent risks.

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital

CHATHAM, N.J., May 29, 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 two oral presentations and a poster presentation at the American Transplant Congress 2024, being held June 1-5, 2024 at the Pennsylvania Convention Center, Philadelphia, Pa. Details on each presentation can be found below.

Copies 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 American Transplant Congress website here.

Oral Presentations Details
Presenter:		Kohei Kinoshita, M.D., Center for Transplantation Sciences, Massachusetts General Hospital
Title:		Combined Blockade of the CD154 and CD28 Co-Stimulation Pathways Attenuates Pathogenic Alloimmunity and Prolongs Survival in Cynomolgus Cardiac Allografts
Location:		109-AB‚ Level 1
Abstract:		860
Date/Time:		Tuesday, June 4, 2024, 9:45 a.m. ET
Presenter:		Ikechukwu Ileka, M.D., Massachusetts General Hospital and Harvard Medical School
Title:		Extended Survival of 9- and 10-Gene-Edited Pig Heart Xenografts with Ischemia Minimization and CD154 Costimulation Blockade-Based Immunosuppression
Location:		114 - Nutter Theater‚ Level 1
Abstract:		932
Date/Time:		Tuesday, June 4, 2024, 10:15 a.m. ET
Poster Presentations Details
Presenter:		Ikechukwu Ileka, M.D., Massachusetts General Hospital and Harvard Medical School
Title:		Experience with a Novel Delayed Immune Tolerance Protocol in Nonhuman Primates Based on Anti-CD154, Anti-CD2, and Anti-CD28
Location:		Poster Hall‚ Exhibit Hall A‚ Level 2
Abstract:		C086
Date/Time:		Monday, June 3, 2024, 9:15 a.m. ET

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 did Tonix Pharmaceuticals present at the American Transplant Congress 2024?

Tonix Pharmaceuticals presented two oral and one poster presentation on TNX-1500, focusing on novel immunosuppression and immune tolerance protocols.

When and where were the presentations on TNX-1500 conducted?

The presentations were conducted at the American Transplant Congress 2024, held from June 1-5, 2024, at the Pennsylvania Convention Center, Philadelphia.

Who led the research on TNX-1500 presented by Tonix Pharmaceuticals?

The research was led by faculty members from the Center for Transplantation Sciences, Massachusetts General Hospital.

What is TNX-1500 developed for?

TNX-1500 is developed for the prevention of organ transplant rejection and the treatment of autoimmune diseases.

When does Tonix Pharmaceuticals plan to submit an NDA for Tonmya?

Tonix Pharmaceuticals plans to submit an NDA for Tonmya in the second half of 2024.