Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 68

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 68
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 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 introduction of our compounds in certain countries.

Further,
clinical trials conducted in one country may not be accepted by regulatory authorities in other countries. Also, regulatory approval
for any of our compounds may be withdrawn. If we fail to comply with the regulatory requirements, our target market will be reduced
and our ability to realize the full market potential of CC8464, CT2000, CT3000 or our future compounds will be harmed and our
business, financial condition, results of operations and prospects will be adversely affected.

While
we plan to apply for orphan drug designation for CC8464 in the future, it may not effectively protect us from competition, and
we may be unable to obtain similar designations for our future compounds. For instance, if our competitors are able to obtain
orphan drug exclusivity for products that constitute the same drug and treat the same indications as our lead compounds before
us, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of
time. To date, we have not submitted an application for orphan drug designation.

In
connection with the application for one of our two lead compounds, CC8464, for the treatment of EM and iSFN, we also plan to seek
orphan drug designation from the FDA. As of the date of this Report, we have not submitted an application for orphan drug designation
for CC8464. Under the Orphan Drug Act of 1983, the FDA may designate a compound as an orphan drug if it is intended to treat a
rare disease or condition, which is generally defined as having a patient population of fewer than 200,000 individuals in the
United States, or a patient population greater than 200,000 in the United States