Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 62

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 62
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 clinical trials are inconclusive or if there are safety concerns or serious adverse events associated with
our drug candidates, we may:

    ●
    be delayed in obtaining
    marketing approval, if at all, or be required to conduct additional confirmatory safety and/or efficacy studies causing additional
    expenses;

    ●
    obtain approval
    for indications or patient populations that are not as broad as intended or desired;

    ●
    obtain approval
    with labeling that includes significant use or distribution restrictions or safety warnings;

    ●
    be subject to additional
    post-marketing testing requirements;

    ●
    be required to perform
    additional clinical trials to support approval or be subject to additional post-marketing testing requirements;

    ●
    have regulatory
    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 CT300