AN2 Therapeutics Q1 2024 Financial Results and Recent Highlights

AN2 Therapeutics, Inc., a biopharmaceutical company specializing in rare and chronic infectious diseases, has announced its financial results for the first quarter of 2024. The company is developing solutions for diseases with significant unmet medical needs. Their primary candidate, epetraborole, is being tested as a treatment for nontuberculous mycobacteria (NTM) lung disease, a severe condition caused by mycobacteria that can lead to irreversible lung damage and potentially be fatal.

The company provided updates on its pivotal Phase 2/3 clinical trial (EBO-301) targeting treatment-refractory Mycobacterium avium Complex (TR-MAC). Currently, the trial is comparing epetraborole, combined with a background regimen, against a placebo in patients suffering from TR-MAC lung disease. AN2 Therapeutics paused new patient enrollments for the Phase 3 segment of the trial in February 2024 to review additional data. However, the 97 patients already enrolled continue to receive treatment as per the existing protocol.

The pause in Phase 3 enrollment was prompted by an analysis of blinded aggregate data from the ongoing Phase 2 study. This analysis revealed a possibly lower than anticipated efficacy. The patient demographics indicated a highly refractory population with significant resistance to background regimens, chronic NTM lung disease, and high levels of cavitary disease. The study also includes patients who are unresponsive to Arikayce, the only FDA-approved treatment for refractory NTM due to MAC. Importantly, the decision to pause was not related to safety concerns.

The company expects to release topline data from Phase 2 in August 2024. The decision to resume Phase 3 enrollments will be made after reviewing the unblinded Phase 2 data and consulting with the FDA.

Financially, AN2 Therapeutics reported that research and development (R&D) expenses for Q1 2024 increased to $14.7 million from $12.0 million in the same period in 2023. This rise is attributed to higher clinical trial expenses, personnel costs, consulting fees, and other costs, partially offset by reduced chemistry manufacturing and controls expenses and lower research study costs. General and administrative (G&A) expenses decreased to $3.6 million from $4.1 million, largely due to reduced professional services and insurance costs, although there was an increase in personnel expenses.

Other income, net for Q1 2024 was $1.7 million, up from $0.7 million in Q1 2023, driven by higher interest and investment income. The net loss for the first quarter of 2024 was $16.6 million, compared to a $15.3 million loss in the same period the previous year.

As of March 31, 2024, AN2 Therapeutics reported cash, cash equivalents, and investments totaling $118.1 million. This financial position places the company in a favorable situation to continue its research and development activities.

AN2 Therapeutics continues to focus on developing epetraborole, aiming to address the needs of patients with TR-MAC lung disease. The upcoming Phase 2 data will be pivotal in determining the future direction of the treatment and the potential for resuming Phase 3 patient enrollment, contingent upon discussions with the FDA. The company's financial health ensures it has the resources needed to advance its clinical trials and sustain its operations.