Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 264

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 264
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 terms, if at all. If any future
collaborators do not commit sufficient resources to commercialize our products, or we are unable to develop the necessary capabilities
on our own, we will be unable to generate sufficient product revenue to sustain our business. We compete with many companies that
currently have extensive, experienced and well-funded medical affairs, marketing and sales operations to recruit, hire, train
and retain marketing and sales personnel. We also face competition in our search for third parties to assist us with the sales
and marketing efforts of our compounds. Without an internal team or the support of a third party to perform marketing and sales
functions, we may be unable to compete successfully against these more established companies.

Our
efforts to educate the medical community and third-party payors on the benefits of our compounds may require significant resources
and may never be successful. Such efforts may require more resources than are typically required due to the complexity and uniqueness
of our potential products. If any of our compounds are approved but fails to achieve market acceptance among physicians, patients
or third-party payors, we will not be able to generate significant revenues from such product, which could have a material adverse
effect on our business, financial condition, results of operations and prospects.

If
the market opportunities for CC8464, CT2000, CT3000 or our future compounds are smaller than we believe they are, our revenues
may be adversely impacted, and our business may suffer.

We
are currently focusing our research and product development efforts on CC8464 for the management of EM and iSFN, CT2000 for acute
and chronic eye pain, CT3000 for post-surgical pain and, potentially, other fields of neuropathic pain. Our understanding of both
the number of people who have EM or iSFN, as well as the subset of people with either disease who have the potential to benefit
from treatment with CC8464, are based on estimates in published literature. Similarly, our understanding of the number of people
who could benefit from treatment with CT2000 and CT3000, are based on estimates in published literature. These estimates may prove
to be incorrect and new studies may reduce the estimated incidence or prevalence of this disease. The number of patients in the
United States, the European Union and elsewhere may turn out to be lower than expected or these patients may not be otherwise
amenable to treatment with CC8464, CT2000 and CT3000 or may become increasingly difficult to identify and