Tonix Pharmaceuticals (NASDAQ: TNXP) announced it received official minutes from a Type C meeting with the U.S. Food and Drug Administration supporting plans for an adaptive Phase 2 field study of TNX-4800, its long-acting anti-OspA monoclonal antibody candidate designed to prevent Lyme disease. The planned randomized, placebo-controlled study is expected to enroll approximately 3,300 adults over two Lyme disease seasons to evaluate prevention through six months after dosing, with manufacturing of investigational product on track for delivery to study sites in the first quarter of 2027. Tonix said TNX-4800 is being developed as a seasonal immunopreventative administered as two subcutaneous injections three months apart, with the potential to provide protection throughout the U.S. Lyme disease season.

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Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA(TM) (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace(R) SymTouch(R) and Tosymra(R). Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection.

Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

NOTE TO INVESTORS: The latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP

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