Tonix Pharmaceuticals Holding Corp. 8K

Tonix Pharmaceuticals obtained FDA Type C meeting minutes showing agreement on the design and timing of a large adaptive Phase 2 field trial of its Lyme disease prophylactic antibody TNX-4800, enabling a planned trial start in early 2027.

Tonix Pharmaceuticals Holding Corp. announced that it received official minutes from a Type C meeting with the U.S. Food and Drug Administration confirming alignment on key elements of the design for an adaptive, randomized, placebo-controlled Phase 2 field study of TNX-4800, its long-acting anti-OspA monoclonal antibody for prevention of Lyme disease in U.S. adults; the study is expected to start in the first quarter of 2027, enroll approximately 3,300 high‑risk adults over two Lyme seasons (with potential extension into 2029), use primary and secondary efficacy endpoints based on Lyme disease prevention through six and three months after first dose, and assess safety over 52 weeks, supporting Tonix’s strategy to position TNX-4800 as a seasonal prophylactic alternative to vaccination with patent protection and anticipated biologic exclusivity if approved.

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1430306

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8K

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sec

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0001493152-26-035741

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6