Company: ANTX
Filing Date: 2025-03-25
Form Type: 10-K
Source: 0000950170-25-044366
Chunk: 52

Company: AN2 Therapeutics, Inc.
Filing Date: 2025-03-25
Form: 10-K
Item: Item 1A
Chunk 52
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 from the Phase 2 portion of EBO-301, our Phase 2/3 clinical trial evaluating epetraborole in patients with treatment-refractory MAC lung disease. Although the Phase 2 part of the study met its primary objective in demonstrating the potential validation of a novel patient-reported outcome (“PRO”) tool and a non-significant, but numerically higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs. placebo + OBR (25.0%; treatment difference 13.9%, p=0.19), sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs. 10.0% placebo + OBR; treatment difference 3.4%, p=0.64). Given these topline results, we decided to close out the Phase 3 portion of the trial and commence a review of data to help inform further development. Although we believe that to date our ongoing data review supports the continued development of epetraborole in patients with treatment-refractory MAC lung disease, it is possible that we will determine to defer or discontinue development of epetraborole in NTM, whether due to further FDA feedback or otherwise.

Failure to obtain regulatory approval for our product candidates in the United States or other territories will prevent us from commercializing and marketing such product candidates. The success of our product candidates will depend on several additional factors, including:

•successful and timely completion of preclinical and nonclinical studies and requisite clinical trials;

•performing preclinical studies and clinical trials in compliance with the FDA or any comparable regulatory authority requirements;

•receipt of regulatory approvals from applicable regulatory authorities;

•the ability to manufacture sufficient quantity of product for development, clinical trials or potential commercialization;

•obtaining regulatory approvals with labeling for sufficiently broad patient populations and indications, without unduly restrictive distribution limitations or safety warnings, such as black box warnings or a Risk Evaluation and Mitigation Strategies ("REMS") program;

•obtaining and maintaining patent, trademark and trade secret protection, and regulatory exclusivity for our product candidates;

•making and retaining sufficient and reliable arrangements with third parties for manufacturing capabilities;

•launching commercial sales of products, if and when approved;

•acceptance of our therapies, if and when approved, by physicians, patients and third-party payors;

•competing effectively with other therapies;

•obtaining and maintaining healthcare coverage