Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 256

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 256
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 to adapt to changes in existing requirements or the adoption of new requirements or
policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained
and we may not achieve or sustain profitability, which would materially and adversely affect our business, financial condition,
results of operations and prospects.

39 

Even
if we obtain and maintain approval for CC8464, CT2000 and CT3000 from the FDA, we may never obtain approval for them outside of
the United States, which would limit our market opportunities and adversely affect our business.

Approval
of a compound in the United States by the FDA does not ensure approval of such compound by regulatory authorities in other countries
or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other
foreign countries or by the FDA. Sales of CC8464, CT2000 and CT3000 or other future compounds outside of the United States will
be subject to foreign regulatory requirements governing clinical trials and marketing approval. Even if the FDA grants marketing
approval for a compound, comparable regulatory authorities of foreign countries also must approve the manufacturing and marketing
of the compound in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative
review periods different from, and more onerous than, those in the United States, including additional preclinical studies or
clinical trials. In many countries outside the United States, a compound must be approved for reimbursement before it can be approved
for sale in that country. In some cases, the price that we intend to charge for our compounds, if approved, is also subject to
approval. We intend to submit a marketing authorization application to the EMA for approval of CC8464, CT2000 and CT3000 in the
European Union, but obtaining such approval from the European Commission following the opinion of the EMA is a lengthy and expensive
process. Even if a compound is approved, the FDA or the European Commission, as the case may be, may limit the indications for
which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming
additional clinical trials or reporting as conditions of approval. Regulatory authorities in countries outside of the United States
and the European Union also have requirements for approval of compounds with which we must comply prior to marketing in those
countries. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant
delays, difficulties and costs for us and could delay or prevent the