Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 63

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 63
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0 and the approval may be for a narrower indication than we seek.

We
cannot commercialize a compound until the appropriate regulatory authorities have reviewed and approved the compound. Even if
CC8464, CT2000 and CT3000 meet their respective safety and efficacy endpoints in clinical trials, the regulatory authorities may
not complete their review processes in a timely manner, or we may not be able to obtain regulatory approval. Additional delays
may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval. In
addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative
action, or changes in regulatory authority policy during the period of product development, clinical trials and the review process.

Regulatory
authorities also may approve a compound for more limited indications than requested or they may impose significant limitations
in the form of narrow indications, warnings or a post-approval safety monitoring program. These regulatory authorities may require
precautions or contra-indications with respect to conditions of use or they may grant approval subject to the performance of costly
post-marketing clinical trials. In addition, regulatory authorities may not approve the labeling claims that are necessary or
desirable for the successful commercialization of CC8464, CT2000 and CT3000. Any of the foregoing scenarios could materially harm
the commercial prospects for CC8464, CT2000 and CT3000 and materially and adversely affect our business, financial condition,
results of operations and prospects as CC8464 is our only compound in clinical development and CT2000 and CT3000 have not yet
entered pre-clinical trials.

CC8464,
CT2000 and CT3000 may cause undesirable side effects or have other properties that could delay or prevent its regulatory approval,
limit the commercial potential or result in significant negative consequences following any potential marketing approval.

Our
Phase 1 clinical trials have shown that CC8464 can lead to rashes. In addition to this side effect and possibly others caused
by CC8464, the administration process or related procedures also can cause adverse side effects. If any such adverse events occur,
our clinical trials could be suspended or terminated. If in the future we are unable to demonstrate that such adverse events were
caused by the administration process or related procedures, the FDA, the European Commission, the EMA or other regulatory authorities
could order us to cease further development of, or deny approval of, CC8464 for any or all targeted indications. Even if we