Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 249

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 249
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 or future studies and clinical trials. CC8464
is our only compound in clinical development and advancing a different compound would require substantial time and resources as
well as being subject to the same risks and uncertainties as described here for CC8464.

There
is no guarantee that results of our potential future clinical trials will be positive or that we will be able to complete this
or any potential future clinical trials on the anticipated timelines or at all. Furthermore, research and discoveries by us or
others may identify serious adverse events, undesirable side effects or other unexpected properties of our current and future
compounds, including CC8464, that could delay, prevent or cause the withdrawal of regulatory approval, limit the commercial potential,
or result in significant negative consequences following marketing approval.

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 future compound for more limited indications than requested or they may impose significant limitations
in the form of narrow indications, warnings or 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. Any of the foregoing scenarios could materially harm the commercial
prospects for CC8464 and materially and adversely affect our business, financial condition, results of operations and prospects.

35 

We
may encounter substantial delays in our pre-clinical and clinical trials, or we may fail to demonstrate safety and efficacy to
the satisfaction of applicable regulatory authorities.

Before
obtaining marketing approval from regulatory authorities for the sale of our drug candidates, CC8464, CT2000 and CT3000 included,
we must conduct extensive clinical trials to demonstrate the safety and efficacy of the drug candidate for its intended indications.
Clinical trials are expensive, time consuming and uncertain as to outcome. We cannot guarantee that any clinical trials will be
conducted as planned or completed on schedule, if