Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 67

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 67
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Any
government investigation of alleged violations of law could require us to expend significant time and resources in response and
could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize
CC8464, CT2000 and CT3000 and adversely affect our business, financial condition, results of operations and prospects.

The
FDA’s policies, and those of equivalent foreign regulatory agencies, may change and additional government regulations may
be enacted that could prevent, limit or delay regulatory approval of CC8464, CT2000 and CT3000. We cannot predict the likelihood,
nature or extent of government regulation that may arise from future legislation or administrative action, either in the United
States or abroad. If we are slow or unable 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