Company: PHAT
Filing Date: 2025-03-06
Form Type: 10-K
Source: 0000950170-25-034183
Chunk: 150

Company: Phathom Pharmaceuticals, Inc.
Filing Date: 2025-03-06
Form: 10-K
Item: Item 1A
Chunk 150
---
 candidates. The success of vonoprazan for future indications and our product candidates will depend on several additional factors, including:

•completing clinical trials that demonstrate their efficacy and safety;

•receiving marketing approvals from applicable regulatory authorities;

•completing any post-marketing studies required by applicable regulatory authorities;

•maintaining adequate commercial manufacturing capabilities;

•maintaining successful commercial sales, marketing and distribution operations;

•the prevalence and severity of adverse events experienced with vonoprazan and our future product candidates;

•acceptance of VOQUEZNA and our future product candidates by patients, the medical community and third-party payers;

•a continued acceptable safety profile following approval;

•obtaining and maintaining healthcare coverage and adequate reimbursement for VOQUEZNA and our future product candidates;

•competing effectively with other therapies, including with respect to the sales and marketing of our product candidates, if approved; and

•qualifying for, maintaining, enforcing and defending our intellectual property rights and claims.

 Many of these factors are beyond our control, including the time needed to adequately complete clinical testing, the regulatory submission process, potential threats to our intellectual property rights and changes in the competitive landscape. It is possible that no new indications for vonoprazan and no future product candidates will ever obtain regulatory approval even if we expend substantial time and resources seeking such approval. If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully complete clinical trials, obtain regulatory approval or, if 

60

approved, commercialize additional vonoprazan indications or any other product candidates, which would materially harm our business, financial condition and results of operations.

Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and the results of preclinical studies and early clinical trials are not necessarily predictive of future results.

Clinical drug development is expensive and can take many years to complete, and its outcome is inherently uncertain. Even if we believe the results of our clinical trials are positive, obtaining regulatory approval may not occur on a timely basis, if at all. The results from clinical trials or preclinical studies of a product candidate may not predict the results of later clinical trials of the product candidate, and interim results of a clinical trial are not necessarily indicative of final results. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy characteristics despite having progressed through preclinical studies and initial clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered