AN2 Therapeutics Reports $51.3 Million Net Loss for Fiscal Year 2024, Restructures Workforce

AN2 Therapeutics, Inc. has reported a net loss of $51.3 million for the fiscal year ending December 31, 2024, a decrease from the $64.7 million loss recorded in 2023. The company's accumulated deficit now stands at $205.8 million. Total operating expenses for 2024 were $56.8 million, down 18% from $69.6 million in the previous year, primarily due to reduced research and development costs associated with the termination of the Phase 2/3 clinical trial for its lead candidate, epetraborole, in treatment-refractory Mycobacterium avium complex (MAC) lung disease. Research and development expenses decreased by 26% to $40.5 million, while general and administrative expenses slightly declined to $14.1 million.

In terms of strategic developments, AN2 Therapeutics has made significant progress with its clinical pipeline. The company recently announced topline results from the Phase 2 portion of the EBO-301 study, which evaluated epetraborole in patients with treatment-refractory MAC lung disease. The study met its primary objective of validating a novel patient-reported outcome tool, showing a clinical response rate of 39.5% in the epetraborole group compared to 25.0% in the placebo group. However, a key secondary endpoint, sputum culture conversion, did not show significant differences between treatment arms. Following these results, the company has submitted an amended statistical analysis plan to the FDA, proposing a new primary efficacy endpoint for the Phase 3 portion of the trial.

Operationally, AN2 Therapeutics has undergone a restructuring, reducing its workforce by approximately 50% to extend its operating capital. This restructuring resulted in $2.2 million in severance and related charges. As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $88.6 million, which it believes will be sufficient to fund operations for at least the next 12 months. The company has also engaged in various funding activities, including an underwritten offering that raised $70 million in August 2023 and an at-the-market equity offering that generated $19.1 million in June 2023.

Looking ahead, AN2 Therapeutics plans to continue advancing its product candidates, including epetraborole for acute melioidosis and AN2-502998 for chronic Chagas disease. The company anticipates initiating a Phase 1 study for AN2-502998 in 2025 and aims to release top-line Phase 3 data for epetraborole in the second quarter of 2025. The company remains focused on leveraging its boron chemistry platform to address unmet medical needs in infectious diseases and oncology, while also navigating the complexities of regulatory approvals and market competition.