Alignment with FDA on key elements of the study design support planned start of the Phase 2 study in the first quarter of 2027

Long-acting monoclonal antibody TNX-4800 is a rapidly acting alternative to vaccination against Lyme disease with potential advantages in efficacy and tolerability over vaccines in development

BERKELEY HEIGHTS, N.J., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial-stage biotechnology company, today announced the receipt of official minutes from the Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the Company’s plans for an adaptive Phase 2 field study of TNX-4800 (human anti-outer-surface protein A [OspA] monoclonal antibody [mAb]) to prevent Lyme disease in adults in the U.S. OspA on immature Borrelia bacteria in the midgut of infected deer ticks is a validated target for Lyme disease prevention previously targeted by vaccines.1-3 TNX-4800 is a potential seasonal immunopreventative alternative to vaccination and is Fc-modified for extended half-life and duration of protection.