Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 1177

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 6
Chunk 1177
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ulations 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, we estimate 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 eye,

    ●
    side effects from
    photorefractive keratectomy (PRK) and pterygium surgery,

    ●
    second eye cataract
    surgery,

    ●
    neuropathic corneal
    pain, and

    ●
    severe uveitis and
    severe iritis/scleritis.

As
NaV1.7 channels are present on the cornea and is a viable biological target for treating eye pain, we believe that we have a sound
scientific basis for our ability to treat a multitude of eye pain indications. We have successfully developed an eye drop formulation
and have determined that the eye drops are well tolerated by animals. We have completed animal efficacy studies and are in the
process of running toxicology studies on animals. We expect to announce the efficacy and toxicology results by April 2025.

Following
the animal studies, if successful, we intend to move into POC studies in humans. We plan to conduct the POC study in Australia
to avail ourselves of a 43.5% tax credit for clinical expenses incurred in Australia and, on January 9, 2023, established an Australian
subsidiary through which the work will be conducted. We are planning to conduct the  POC in a clinic in Brisbane, Australia
and are in the process of contracting the services to perform such trial. 

Depot
Program: 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