Company: PTHS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001753926-25-000790
Chunk: 37

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 1
Chunk 37
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 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, Channel expects patients
would potentially take its drug for the remainder of their lives, and given the lack of good therapeutic alternatives, Channel
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. Channel 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.  

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

26

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
(collectively, the “Spray Formulations”). The Spray Formulations diversify our pipeline of non-opioid pain treatment
therapies, while adding therapeutic options for related conditions. The sublingual formulation of a Diclofenac spray for the treatment
of acute pain (the “Diclofenac Spray Formulation”) is patented and has started clinical development in human volunteers.
Preliminary pharmacokinetics suggest that this formulation may have a faster onset of action than oral Diclofenac tablets. Diclofenac
is an NSAID that is also marketed under additional brand names including Voltaren and Cataflam in its pill form. A single Phase
1 trial of the Diclofenac Spray Formulation was completed in 24 healthy volunteers wherein a single dose of 50mg diclofenac-potassium
was