Tonix Pharmaceuticals Advances Lyme Disease Prevention Program with TNX-4800 Development Update

Tonix Pharmaceuticals Holding Corp. provided program updates on TNX-4800, a long-acting human monoclonal antibody designed for seasonal prophylaxis against Lyme disease. The investigational product targets the outer surface protein A of Borrelia burgdorferi, the bacterium that causes Lyme disease. According to the company, TNX-4800 is being developed as a once-yearly subcutaneous administration intended to provide protection throughout the U.S. tick season. The development addresses a significant unmet medical need, as there are currently no FDA-approved vaccines or prophylactics for Lyme disease.

The company plans to meet with the FDA in 2026 to discuss Phase 2/3 development options, including the potential use of a controlled human infection model. Tonix expects to have GMP-manufactured investigational product available for testing in early 2027. This development timeline positions TNX-4800 as a potential breakthrough in Lyme disease prevention, particularly as Lyme disease cases continue to increase across the United States. The company's infectious disease portfolio includes multiple development candidates, with TNX-4800 representing a Phase 2-ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease.

Tonix Pharmaceuticals operates as a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. The company markets FDA-approved TONMYA, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, which represents the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. Additional marketed products include two treatments for acute migraine in adults: Zembrace SymTouch and Tosymra. The company's development portfolio focuses on central nervous system disorders, immunology, immuno-oncology, rare disease and infectious disease.

The company's immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2-ready Fc-modified humanized monoclonal antibody targeting CD40-ligand. Tonix's rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome. The infectious disease portfolio extends beyond Lyme disease to include TNX-801, a vaccine in development for mpox and smallpox. Additionally, TNX-4200 represents a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections, developed under a contract with the U.S. Department of Defense's Defense Threat Reduction Agency for up to $34 million over five years. Tonix owns and operates a state-of-the-art infectious disease research facility in Frederick, Maryland, supporting these development efforts.

Investors seeking additional information about Tonix Pharmaceuticals can access the company's newsroom at https://ibn.fm/TNXP. The press release was distributed through InvestorWire, a specialized communications platform that provides advanced wire-grade press release syndication services as part of the Dynamic Brand Portfolio at IBN. InvestorWire delivers access to wire solutions, article and editorial syndication to thousands of outlets, enhanced press release services, social media distribution, and tailored corporate communications solutions. More information about these services is available at https://www.InvestorWire.com. All content provided through InvestorWire is subject to the terms of use and disclaimers published on their website at https://www.InvestorWire.com/Disclaimer.