Company: PTHS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001753926-25-001764
Chunk: 76

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 1
Chunk 76
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 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 these programs is to develop a novel and proprietary class of NaV
blockers that target the body’s peripheral nervous system.

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

45

Eye
Pain (Phase1-2a ready): Based on a novel formulation of CC8464, our 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. The Company 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. The
Company has completed two animal efficacy studies and has successfully completed a pivotal IND enabling ophthalmic toxicology
studies as a precursor to launching a Phase 1a/2b human proof of concept study.

Depot
Program (Pre-Clinical): Based on several novel formulations of CC8464, the Company’s most recently launched program,
titled CT3000, is for the potential treatment of post operative pain with the use of nerve blocks. Examples would include knee
surgery or shoulder surgery. Existing therapies for nerve blocks lead to neuromuscular blockade which prevents movement following
surgery. Doctors often want patients to move soon after surgery to avoid complications such as blood clots. A NaV1.7 inhibitor
used for nerve blocks may provide good analgesia but will not lead to neuromuscular blockade that prevents movement like other
local anesthetics. The Company will periodically review the timing and budget related to the commencement of toxicology and CMC
work and a