Tonix Pharmaceuticals Holding Corp. 8K

Tonix Pharmaceuticals used this Form 8‑K exhibit to update investors on preclinical and Phase 1 results for its Lyme disease prevention antibody TNX‑4800 and to outline regulatory and Phase 2 trial plans targeted for 2026–2027.

Tonix Pharmaceuticals Holding Corp. furnished an investor presentation on its investigational product TNX‑4800, a long‑acting, bactericidal human monoclonal antibody licensed from UMass Chan Medical School and designed to prevent Lyme disease, highlighting preclinical data, completion of a Phase 1 clinical trial showing favorable safety, tolerability, pharmacokinetics and immunogenicity, and outlining plans for a Type C FDA meeting in early third quarter 2026 and an adaptive, randomized, placebo-controlled Phase 2 field study in Lyme-endemic U.S. populations targeted for 2027, supported by ongoing GMP manufacturing preparations. The presentation also situates TNX‑4800 within Tonix’s broader pipeline and provides background information and safety disclosure for its approved fibromyalgia product, TONMYA.

Filing Facts

CIK

1430306

Ticker

-

Form

8K

Source Type

sec

Accession

0001999371-26-010790

Alert Tier

6