Company: ANTX
Filing Date: 2025-03-25
Form Type: 10-K
Source: 0000950170-25-044366
Chunk: 68

Company: AN2 Therapeutics, Inc.
Filing Date: 2025-03-25
Form: 10-K
Item: Item 1A
Chunk 68
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 the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for commercial success.

Even if we obtain approvals from the FDA or other comparable regulatory agencies and are able to initiate commercialization of any of our product candidates, such product candidates may not achieve market acceptance among physicians, patients and third-party payors and, ultimately, may not be commercially successful. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

•the safety, tolerability, efficacy and ease of use of a once-a-day oral dose and other potential advantages compared to alternative treatments;

•the potential and perceived advantages and disadvantages of the product candidates, including cost and clinical benefit relative to alternative treatments;

•the convenience and ease of once-a-day oral administration compared to alternative treatments (e.g., inhaled drug through nebulizer);

•the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

•acceptance by physicians, patients, payor-formularies and treatment facilities and parties responsible for coverage and reimbursement of the product; 

•the availability of coverage and adequate reimbursement by third-party payors, including government authorities;

•our ability to manufacture the product candidates in sufficient quantities and yields;

•the strength and effectiveness of marketing and distribution support;

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•the prevalence and severity of any side effects;

•limitations or warnings, including distribution or use restrictions, contained in the product’s approved labeling or an approved REMS;

•whether the product is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy for particular infections;

•whether the product is safe, tolerable and efficacious when used in combination therapy with the current multi-drug standard of care regimen;

•the approval of other new products for the same indications;

•the timing of market introduction of the approved product as well as competitive products; and

•the emergence of bacterial resistance to the product.

If the market size of any product candidate that obtains regulatory approval is significantly smaller than we anticipate, it may not achieve market acceptance or commercial success. This could significantly and negatively impact our business, financial condition, results of operations and growth prospects.

We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

The development and commercialization of new drug products is highly competitive. We face competition from major multi-national pharmaceutical companies, biotechnology companies, specialty pharmaceutical companies and generic