Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 257

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 257
---
 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for any of our compounds may be withdrawn.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 where there is no reasonable expectation that
the cost of developing the drug will be recovered from sales in the United States.

Generally,
if a compound with an orphan drug designation receives the first marketing approval for the indication for which it has such designation,
the product is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application
for a product that constitutes the same drug treating the same indication for that marketing exclusivity period, except in limited
circumstances. If another sponsor receives such approval before we do (regardless of our orphan drug designation), we will be
precluded from receiving marketing approval for our product for the applicable exclusivity period. The applicable period is seven
years in the United States.

40 

Even