Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 251

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 251
---

    authorities withdraw, or suspend, their approval of the drug or impose restrictions on its distribution;

    ●
    be subject to the
    addition of labeling statements, such as warnings or contraindications;

    ●
    be sued; or

36 

    ●
    experience damage
    to our reputation.

As
CC8464 is our only compound in clinical development, any setback may have a significant negative effect on our business.

Our
drug development costs will increase if we experience delays in testing or obtaining marketing approvals. We do not know whether
any of our preclinical studies or clinical trials will begin as planned, need to be restructured or be completed on schedule,
if at all.

We,
the FDA or an Institutional Review Board may suspend our clinical trials at any time if it appears that we or our collaborators
are failing to conduct a trial in accordance with regulatory requirements, including the FDA’s current GCP, regulations,
that we are exposing participants to unacceptable health risks, or if the FDA finds deficiencies in our IND applications or the
conduct of these trials. Therefore, we cannot predict with any certainty the schedule for commencement and completion of future
clinical trials. If we experience delays in the commencement or completion of our clinical trials, or if we terminate a clinical
trial prior to completion, the commercial prospects of our drug candidates could be negatively impacted, and our ability to generate
revenues from our drug candidates may be delayed. As CC8464 is our only compound in clinical development, any setback may have
a significant negative effect on our business.

Even
if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize
CC8464, CT2000 and CT3000 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