Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 53

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 53
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, licensing arrangements, government grants and the IPO (from which we raised net proceeds of approximately $5.7
million, after deducting underwriting discounts, commissions and other offering expenses). Our ability to achieve significant
profitability depends on our ability to successfully complete the development of, and obtain the regulatory approvals necessary
to commercialize, CC8464, CT2000, CT3000 and/or additional compounds. We expect that it will take several years, if ever, before
we have a commercialized compound. The net losses we incur may fluctuate significantly from quarter to quarter.

30 

If
we are required by the FDA, the EMA, or other international regulatory authorities to which we may be subject, to perform studies
in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of CC8464,
CT2000, CT3000 and/or other future compounds, our expenses could increase and revenue could be further delayed. We anticipate
that our expenses will increase substantially if, and as, we:

    ●
    continue our research
    and the clinical development of CC8464, CT2000 and CT3000;

    ●
        
    launch
human proof of concept of CT2000 for the treatment of eye pain;

    ●
    conduct
CMC and develop GMP formulations and human proof of concept of CT3000 for the treatment of post-surgical pain;

    ●
    initiate additional
    clinical trials and preclinical studies for any additional compounds that we may pursue in the future;

    ●
    prepare an NDA for
    filing with the FDA, a marketing authorization application, and approvals in certain other countries;

    ●
    oversee the manufacturing
    of material for clinical trials or potential commercial sales;

    ●
    develop a portfolio
    of compounds;

    ●
    establish a business
    development operation to in- our out-license certain assets;

    ●
    establish a sales,
    marketing and distribution infrastructure to commercialize any compound for which we may obtain marketing approval;

    ●
    develop, maintain,
    expand, protect and enforce our intellectual property rights portfolio; and/or

    ●
    acquire or in-license
    other compounds and technologies.

To
become and remain profitable, we must develop and eventually commercialize one or more compounds with significant market potential.
This will require us to be successful in a range of challenging activities, including completing the clinical trials, developing
and