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AN2 Therapeutics Moves Blood-Cancer Trial Start to Fourth Quarter

The Tip Desk · October 17, 2026 · 3 min read

The drug developer reported $79.9 million in cash and investments and still expects three Phase 2 programs to be underway by year-end.

AN2 Therapeutics, Inc. (ANTX), a clinical-stage biopharmaceutical company, pushed the planned start of its polycythemia vera trial into the fourth quarter after maintaining a third-quarter target in its two preceding updates. The company attributed the revised enrollment schedule to an expansion of the epetraborole study, adding U.S. and Australian sites to a program originally planned to begin in India.

The change followed a pre-IND meeting with the U.S. Food and Drug Administration. AN2 expects to submit its investigational new drug application in the third quarter of 2026 and begin enrollment in the fourth quarter. The company plans to open with a sentinel cohort receiving a subtherapeutic dose, allowing investigators to assess the drug’s pharmacokinetics and safety in patients with the blood cancer before proceeding to the main evaluation.

The timetable also moved the earliest expected data beyond this year. In March and May, AN2 had anticipated periodic readouts beginning as early as the fourth quarter of 2026; it now anticipates Part 1 data periodically throughout 2027. Following successful completion of the sentinel cohort, a safety monitoring committee would advise on doses for the open-label, single-arm study. That evaluation is designed to run for 28 weeks and assess hematocrit control and reductions in phlebotomy frequency.

Epetraborole’s other clinical program progressed from patient screening, which began in March, to ongoing enrollment in an investigator-initiated Phase 2 trial for M. abscessus lung disease. The 84-patient study was being led by Dr. Kevin Winthrop with other investigators at U.S. sites. AN2 expects topline results in late 2027, subject to enrollment progress, and positive results could inform the design of a subsequent pivotal trial.

The company also reported the Chagas disease results that had been pending in its May update. In June, AN2 announced that 28 days of AN2-502998 treatment produced 100% parasitic elimination in non-human primates with naturally acquired chronic infection, at target exposures attainable in humans. In the Phase 1 human study, the compound was generally well tolerated at exposure levels consistent with the animal efficacy thresholds. Those findings support a Phase 2 proof-of-concept study in adults with chronic Chagas disease, which AN2 expects to initiate in late 2026.

Research spending rose alongside those development activities. Second-quarter research and development expenses were $6.0 million, compared with $3.2 million a year earlier. The increase reflected manufacturing and controls work, consulting and outside services, preclinical research, clinical trials and miscellaneous expenses, partly offset by lower personnel costs. General and administrative expenses were $2.9 million; lower professional services and personnel expenses reduced that category.

The quarterly net loss widened to $8.2 million from $6.5 million a year earlier. AN2 reported a loss of $0.18 a share, with weighted-average shares outstanding of about 44.8 million. Interest income was $0.7 million. Lower average cash and investment balances and lower interest rates reduced interest income.

Beyond the clinical programs, AN2 had declared an ENPP1 development candidate for solid tumors earlier in the year. Its research priorities included oncology and bone disorders, initially targeting ENPP1 and PI3Kα, where AN2 believes its boron chemistry could offer advantages. The company expects to advance a second development candidate by the end of 2026.

AN2 ended June with cash and investments supporting that development agenda. Its existing resources are projected to sustain operations into 2029 under its current operating plan, covering the period in which AN2 expects the blood-cancer readouts and late-2027 lung-disease results.

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