AN2 Therapeutics, Inc. 8-K

What Happened
On June 4, 2026 AN2 Therapeutics announced positive results from two studies of its oral CPSF3 inhibitor AN2-502998 for chronic Chagas disease. In a 28‑day nonhuman primate (NHP) study in naturally infected macaques, 100% of treated animals achieved parasite elimination at exposures the company says are attainable in humans, with elimination durable through four months after treatment. In a Phase 1 first‑in‑human study (NCT07024589) of single ascending doses and 10‑day multiple ascending doses in healthy volunteers, AN2‑502998 was generally well tolerated with no dose‑limiting toxicities and human plasma exposures met or exceeded the NHP efficacy thresholds. The press release was furnished as Exhibit 99.1 to the Form 8‑K.

Key Details

• Date: June 4, 2026; 28‑day NHP efficacy study used macaques with naturally acquired chronic T. cruzi infection.
• NHP results: 100% parasite elimination at target exposures; clearance sustained through four months post‑treatment; no drug‑related adverse events reported.
• Phase 1 results: single and multiple ascending oral doses (10 days) in healthy adults—no dose‑limiting toxicities; human PK achieved exposures at/above NHP efficacy thresholds.
• Market/context: Company notes ~10 million infected worldwide (300,000+ in U.S.); AN2-502998 could be eligible for an FDA Tropical Disease Priority Review Voucher and AN2 is working with DNDi on access plans.

Why It Matters
These results address two key early development risks: preclinical efficacy in a disease‑relevant animal model (naturally infected NHPs) and human pharmacokinetics/tolerability that reach the NHP efficacy levels. For investors, this supports AN2’s plan to advance AN2‑502998 toward Phase 2 (including collaboration with DNDi) and highlights a potentially large underserved market with no FDA‑approved adult treatments. The filing also includes the company’s forward‑looking caution: NHP/Phase 1 results do not guarantee safety or efficacy in patients and regulatory approval remains uncertain.