{"url_path":"/sec/antx/8-k/2026-06-04/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-04","source_url":"https://www.sec.gov/Archives/edgar/data/1880438/0001193125-26-257430-index.html","accession_number":"0001193125-26-257430","cik":"0001880438","ticker":"ANTX","issuer_name":"AN2 Therapeutics, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1880438/0001193125-26-257430-index.html","primary_entity_key":"0001880438","primary_entity_name":"AN2 Therapeutics, Inc."},"word_count":879,"has_tables":true,"body_markdown":"Item 8.01.\n\nOther Events.\n\nKey Findings: 28-Day Nonhuman Primate (NHP) Study\n\nThe NHP efficacy study evaluated AN2-502998 administered for 28 days in macaques with naturally-acquired, chronic T. cruzi infection, contracted via triatomine (kissing bug) vectors in their natural habitats, the same vector that transmits the parasite to humans. The Chagas disease vector is increasingly prevalent across the southern half of the U.S. The Company believes that efficacy in naturally infected NHPs is the most clinically relevant predictor of efficacy for human chronic Chagas disease.\n\n \n\n•\n \n\n100% of treated animals achieved parasite elimination at target exposures attainable in humans.\n\n \n\n•\n \n\nElimination of parasitemia in treated animals was durable and maintained through four months following the end of treatment.\n\n \n\n•\n \n\nParasitemia was evaluated using an enhanced PCR method with improved sensitivity and robustness.\n\n \n\n•\n \n\nAN2-502998 was well tolerated with no drug-related adverse events.\n\n \n\n•\n \n\nAN2-502998 is the only compound to have demonstrated curative activity in NHPs with long-term, naturally acquired T. cruzi infection.\n\nKey Findings: Phase 1 First-in-Human Study\n\nThe Phase 1 FIH study (NCT07024589) evaluated single ascending oral doses of AN2-502998 and then multiple ascending doses administered over 10 days in healthy adult volunteers:\n\n \n\n•\n \n\nAN2-502998 was generally well tolerated with no dose-limiting toxicities.\n\n \n\n•\n \n\nHuman PK was well characterized; plasma exposures at or above NHP efficacy thresholds were achieved.\n\nOverview of Chagas Disease\n\nChagas disease (also known as American trypanosomiasis) is caused by the parasite T. cruzi. Over 300,000 people are estimated to be infected in the U.S., 200,000 across Europe and Japan, and about 10 million worldwide. Left untreated, chronic T. cruzi infection is lifelong and can be life threatening. The parasite T. cruzi silently damages the heart and digestive system, with approximately 20-30% of people developing serious cardiac damage resulting in heart failure, stroke, or sudden death. There are no FDA-approved treatments for adults with Chagas disease.\n\nChagas Disease Opportunity\n\nThe Company believes that Chagas disease represents a potential multi-billion-dollar global market opportunity globally, given its large and readily treatable patient population. Well-established risk profiles including country of birth, travel history, and exposure to triatomine vectors enable targeted, cost-effective screening, and low-cost diagnostics are widely available. The commercial profile of Chagas disease therapeutics shares key structural characteristics with that of other large infectious disease markets, most notably hepatitis C, for which accessible diagnostics, defined risk populations, high urgency to treat, and broad insurance coverage transformed a historically underdiagnosed condition into a substantial market. In parallel, through its work with the Drugs for Neglected Diseases initiative (“DNDi”), the Company is committed to ensuring global access to AN2-502998, should it eventually be approved, in Chagas-endemic developing regions. AN2-502998, if approved, would also be eligible for an FDA Tropical Disease Priority Review Voucher.\n\nForward-Looking Statements\n\nThis Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions. Forward-looking statements expressed or implied in this report include, but are not limited to, statements regarding: NHP study data as a predictor of efficacy outcomes in human trials; market size and sales potential; the commercial profile of Chagas disease therapeutics; advancement of AN2-502998 into Phase 2 in collaboration with DNDi; the predictivity of data; eligibility for priority review; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives, and intentions, are not guarantees of future performance, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2’s ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2’s clinical trials and investigator-initiated clinical trials; AN2’s ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary, or expected results; the ability of particular preclinical models in non-human primates to predict safety and efficacy in humans; significant adverse events, toxicities, or other undesirable side effects associated with AN2’s product candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; AN2’s ability to obtain, maintain, or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading “Risk Factors” in AN2’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (“SEC”). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this report are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law."}