Company: PTHS
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001753926-25-001326
Chunk: 123

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 123
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 amount of pain experienced, and the secondary endpoint is a determination if
CC8464 reduces the frequency of EM flares.

Pelthos
is currently working on the development of the Phase 2a POC plan and expects 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 Pelthos plans 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, Pelthos expects patients
would potentially take its drug for the remainder of their lives, and given the lack of good therapeutic alternatives, Pelthos
expects 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. Pelthos believes
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.  

Pelthos
may further expand its 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