Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 7

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 7
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ic efficacy and toxicology in two in vivo models, which will be followed
                                         by a POC trial in patients. We expect the human POC trials for this ophthalmic formulation
                                         of CT2000 to start in the second quarter 2025.

●Develop
                                         CT3000 for the treatment of post-surgical pain. Based on its pre-clinical profile,
                                         and the target validation, if approved by the FDA, we believe that CT3000 has the potential
                                         to become a drug for treatment of acute post operative surgical pain for knee and shoulder
                                         surgery where nerve blocks are appropriate, potentially delivering meaningful clinical
                                         benefits over the currently available standard of care.

    ●
    Advance the
    development of CC8464 towards FDA approval for treating EM and iSFN. Based on its pre-clinical profile, the target
    validation and trends seen with other NaV1.7 blockers in clinical studies, if approved by the FDA, we believe that CC8464
    has the potential to become a drug for treatment of EM and iSFN patients, potentially delivering meaningful clinical benefits
    over the currently available standard of care.

    ●
    Leverage our
    differentiated research and discovery approach to expand our pipeline. We plan to build a pipeline of potential pain
    blockers acting against sodium-channels related to NaV1.7. Pain modulation is complex, and a multitude of physiological mechanisms
    are involved in transmitting pain signals. Other than NaV1.7, we believe that several related sodium channels, e.g., NaV1.8
    or NaV1.9, may be involved in pain sensation. While NaV1.7 is the most validated pain receptor, we believe that blockers against
    other sodium channels may complement CC8464, CT2000 and CT3000 as our primary pain blocking candidates.

    ●
    Build a leading,
    fully integrated pharmaceutical company to maximize the clinical impact and value of our pipeline and deliver value to stockholders.
    We plan to build an experienced team to rapidly advance compounds in a capital-efficient manner. We intend to retain
    the commercialization rights to our lead compounds; however, we may opportunistically enter into strategic collaborations
    in certain geographic or clinical settings to maximize the value of our pipeline.

While
CT2000 and CT3000 are the focus of our efforts, we may also allocate future resources towards the discovery and development of
other compounds that could potentially