Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 558

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1C
Chunk 558
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 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. 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 has successfully developed a number of formulations and in December 2024, announced that it achieved its endpoints in
two pre-clinical in vivo models of the Company’s nerve block formulations for acute pain, showing material improvement over
the existing standard of care, bupivacaine, in both efficacy and duration.

The
Company performed a thermal hyperalgesia test in rodents with a placebo arm, bupivacaine arm and four arms of the main formulations
of the Company’s molecule. The Company also performed a mechanical allodynia test in rodents with the same arms as above.
For both models, the drugs were administered as a sciatic nerve block. All four Company formulations showed a