Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 60

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 60
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 medical community and third-party payors.

If
we fail in one or more of these factors, we could experience significant delays or an inability to successfully commercialize
CT3000, which would materially harm our business. If we do not receive regulatory approvals for CT3000, our business, financial
condition, results of operations and prospects could be materially and adversely affected. Advancing a different compound than
CT3000 towards clinical development would take substantial time and resources and be subject to the same risks as described here
for CT3000.

CC8464
is in early-stage development, and there is no guarantee that the results from prior clinical and preclinical studies will be
indicative of our ability to complete or the results to be obtained in the current 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