Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 309

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 309
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 expect to launch the Phase 2a POC study following the dose
escalation study and EM pilot study, to assess the potential efficacy of CC8464 in iSFN patients. Both of iSFN and EM are orphan
indications for which we plan to apply for orphan drug designations. The orphan indication may decrease the scope of the ultimate
development program that is necessary for approval and is associated with a marketing exclusivity period from the FDA along with
some tax advantages.

Though
the Phase 2a POC study design has not yet been completed, the study will take approximately twelve months after it is initiated.
The primary endpoint will be the amount of pain experienced from iSFN with secondary endpoints including other measurements like
pain relief and neuropathy scores. The final design may change based on feedback from regulatory authorities or information learned
during the dose escalation trial.

The
potential population for EM in the United States is estimated to be between 5,000 and 50,000 patients and the potential population
for ISFN in the United States is estimated to be between 20,000 and 80,000 patients. In both instances, we expect patients would
potentially take our drug for the remainder of their lives, and given the lack of good therapeutic alternatives, we expect to
have a robust, ongoing, and durable market.

The
Phase 2a results will have significance beyond EM and iSFN and provide important insights about NaV1.7 as a potential target to
find novel pain medications as an alternative to opioids, the continuing primary standard of care in analgesics. We believe that
positive results from the Phase 2a study could not only act as support for CC8464’s potential in EM and iSFN but may also
provide guidance of its potential for other indications of peripheral neuropathic pain.

71 

We
may further expand our pipeline with other internal or external compounds in the future, but all other internally discovered compounds
are pre-clinical.

Benuvia
Spray Formulations: In addition to our NaV1.7 programs set forth above, on December 23, 2023, we entered into an exclusive
licensing agreement (the “Benuvia License Agreement”) with Benuvia for a sublingual formulation of a Diclofenac spray
for the treatment of acute pain, a Rizatriptan intranasal spray formulation and an Ondansetron sublingual spray formulation (collect