On May 11, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics derived from its boron chemistry platform, reported financial results for the first quarter ended March 31, 2026.
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"This was an important quarter for AN2 as we announced an exciting new program in polycythemia vera that is planned to enter Phase 2 development in the third quarter of 2026. This program is supported by what we believe is a robust package of epetraborole preclinical and clinical enabling data. We commenced an investigator-initiated Phase 2 study in M. abscessus lung disease, completed dosing in a Phase 1 study for our Chagas disease program, and declared our ENPP1 candidate for the treatment of solid tumors, as well as strengthened our balance sheet," said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. "Looking ahead, we expect to advance three programs into Phase 2 development this year and report multiple data readouts within our cash runway into 2029. I couldn’t be more excited about our progress and the potential to substantially improve the lives of patients across our diverse portfolio that is enabled by our boron chemistry pipeline."
First Quarter & Recent Business Updates:
Polycythemia vera
Advancing oral epetraborole into a Phase 2 trial for polycythemia vera
In March 2026, the Company outlined plans to expand the development of oral epetraborole into a Phase 2 proof-of-concept clinical study in adults with phlebotomy-dependent polycythemia vera (PV). PV is a blood cancer characterized by overproduction of red blood cells in the bone marrow. This overproduction increases hematocrit, which can lead to serious medical complications, including arterial and venous thromboembolic events. If untreated, PV can be life-threatening. Despite available therapies, such as burdensome periodic therapeutic phlebotomies, many patients experience uncontrolled hematocrit levels and persistent symptoms, requiring long-term management to maintain adequate disease control. PV is estimated to affect approximately 155,000 people in the U.S.
The Company is proceeding through the regulatory process and plans to initiate the Phase 2 clinical trial in the third quarter of 2026. Subject to regulatory clearance and enrollment progress, the Company expects to provide periodic data readouts beginning as early as the fourth quarter of 2026 and throughout 2027.
M. abscessus complex lung disease
Commenced Phase 2 investigator-initiated clinical trial of epetraborole in patients with M. abscessus lung disease
Building on the microbiological and safety data from AN2’s prior non-tuberculous mycobacterial (NTM) study, the Company believes that epetraborole has the potential to address a critical unmet need in M. abscessus lung disease, one of the most difficult-to-treat NTM infections and one for which no FDA-approved therapy exists. M. abscessus lung disease is a serious NTM infection requiring prolonged therapy, initially often with IV-only antibiotics. People affected by this illness face limited, burdensome treatment options and high rates of morbidity and 5-year mortality. NTM lung disease represents a growing global health concern. It is estimated that approximately 120,000–150,000 people in the U.S. are living with NTM lung disease, of which 10-15% are caused by M. abscessus.
The Company is supporting an investigator-initiated trial and anticipates that data from this study, if positive, could provide clinical proof-of-concept in M. abscessus lung disease and thereby inform the design of a subsequent pivotal trial. Patient screening commenced in March 2026. The multicenter, randomized, double-blind, placebo-controlled, prospective clinical study is being led by Dr. Kevin Winthrop, Professor of Public Health and Infectious Diseases at the Oregon Health and Sciences University, in conjunction with other investigators across an estimated 10-15 sites in the U.S. The Company anticipates reporting topline results in late 2027, subject to regulatory clearance and enrollment progress.
Chagas disease
Oral AN2-502998: Phase 1 first-in-human clinical trial and non-human primate data expected 2Q/2026; Phase 2 proof-of-concept study planned to initiate in 2026 pending results of Phase 1 study
In March 2026, the Company completed dosing all cohorts in the Phase 1 first-in-human trial of oral AN2-502998, an investigational, boron-based small molecule in development for the treatment of chronic Chagas disease, or American trypanosomiasis. In the second quarter of 2026, the Company anticipates reporting Phase 1 data from this study, as well as results from a non-human primate (NHP) study that tested the curative potential of AN2-502998 with a 28-day dosing duration. AN2-502998 is the only compound of which the Company is aware to have demonstrated curative activity in preclinical studies across multiple species, including in NHPs with long-term, naturally acquired, chronic infections caused by diverse T. cruzi genetic types. Because NHP infections are naturally acquired in the environment, these efficacy data may be more predictive of efficacy in human clinical trials than other animal models. The Company expects to initiate a Phase 2 proof-of-concept study in adults with chronic Chagas disease later in 2026, pending results of the Phase 1 study.
Boron chemistry pipeline
Declared ENPP1 candidate for the potential treatment of solid tumors
The Company is prioritizing targets in oncology and bone disorders for which boron chemistry may offer a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties, and intellectual property, including initially ENPP1 and PI3Kα. The unique binding modes of boron-containing compounds enable the discovery of inhibitors with high ligand efficiency against targets considered undruggable or difficult to access with traditional chemistry approaches. Boron chemistry has produced first-in-class molecules against a number of targets including CPSF3 (AN2-502998 and acoziborole) and LeuRS (epetraborole, ganfeborole and tavaborole). The Company has discovered preclinical compounds with profiles that are sub-nanomolar, highly selective and characterized by excellent oral pharmacokinetics. The Company recently declared its ENPP1 candidate for the treatment of solid tumors, marking an important step in transitioning the program from early research into development.
Selected First Quarter Financial Results
Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $6.7 million, compared to $7.7 million for the same period during 2025 due to decreased chemistry manufacturing and controls (CMC) expenses, primarily due to decreased expenses related to completion of CMC activities in certain programs, and license fees. These decreases were partially offset by increases in personnel-related expenses, clinical trial expenses, consulting and outside services, and facilities and other expenses.
General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 and the same period during 2025 were $3.8 million.
Interest Income: Interest income for the first quarter of 2026 was $0.5 million, compared to $0.9 million for the same period during 2025 due to lower average cash, cash equivalents and investment balances and lower interest rates in 2026 as compared to 2025.
Net Loss: Net loss for the first quarter of 2026 was $10.0 million, compared to $10.6 million for the same period during 2025.
Cash Position: The Company had cash, cash equivalents and investments of $85.3 million at March 31, 2026. In March 2026, AN2 raised gross proceeds of $40.0 million through a private placement, before deducting placement agent fees and other expenses. The Company projects that existing cash, cash equivalents, and investments will sustain operations into 2029 under the current operating plan.
(Press release, AN2 Therapeutics, MAY 11, 2026, View Source [SID1234665428])