Company: PTHS
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001753926-25-001326
Chunk: 118

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 118
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 to the exclusion of the original programs, on
the commercialization of Zelsuvmi.

27 

Our
pre-Merger programs selectively target the sodium ion-channel known as “NaV1.7”, which has been genetically validated
as a pain receptor in human physiology. A NaV1.7 blocker is a chemical entity that modulates the structure of the sodium-channel
in a way to prevent the transmission of pain perception to the central nervous system (“CNS”). The goal of the pre-Merger
programs is to develop a novel and proprietary class of NaV blockers that target the body’s peripheral nervous system.

There
are three pre-Merger programs developing pain treatment therapeutics, all of which are based on the same proprietary molecule,
as follows:

Eye
Pain: Based on a novel formulation of CC8464, its Eye Pain program, titled CT2000, is for the potential treatment of both
acute and chronic eye pain. NaV1.7 channels are present on the cornea, making it a viable biological target for treating eye pain.
Eye pain may occur with various conditions, including severe dry eye disease, trauma and surgery. Existing therapies for eye pain
(such as steroids, topical non-steroidal anti-inflammatory agents, lubricants, local anesthetics) are limited in their effectiveness
and/or limited in the duration that they may be prescribed because of safety issues. Pelthos intends to explore the viability
of developing CT2000 as a topical agent for the relief of eye pain. A potential advantage of this approach is that topical administration
of CT2000 is unlikely to lead to any hypersensitivity or skin reactions, like what was noted with systemic administration of CC8464,
because the systemic absorption from a topical administration would be extremely limited. Pelthos has developed topical ophthalmic
formulations and are pursuing trial plans as set forth below.

Current
options for the treatment of ocular pain center on the use of corticosteroids and non-steroidal anti-inflammatory drug (“NSAID”)
based therapeutics. These options suffer from sight-threatening complications such as Glaucoma and corneal melting, thus there
is a large unmet need for other approaches. As an example of the potential patient population, Pelthos estimates that there are
approximately 5 million cases of corneal abrasions per year in the United States. In addition, other potential indications associated
with eye pain include:

    ●
    severe dry