Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 252

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 252
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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 can
demonstrate that any serious adverse events are not product-related, such occurrences could affect patient recruitment or the
ability of enrolled patients to complete the trial. Moreover, if we elect, or are required, to delay, suspend or terminate any
clinical trial of CC8464, the commercial prospects of such compound may be harmed and our ability to generate revenues from this
compound may be delayed or eliminated. Any of these occurrences may harm our ability to develop other product candidates, and
may harm our business, financial condition and prospects significantly. As CC8464 is our only compound in clinical development,
any setback may have a significant negative effect on our business.

37 

Additionally,
if CC8464 receives marketing approval, the FDA could require us to adopt