Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 932

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 4
Chunk 932
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 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 depot effect in
excess of four days, an improvement over bupivacaine, the current standard of care.

69 

The
results of the thermal hyperalgesia results are shown in the chart below. After thirty minutes, three of the four formulations
showed materially better efficacy than bupivacaine, with each of the three being statistically superior to placebo for more than
two days longer than bupivacaine. One of the formulations remained statistically superior to placebo for more than four days.
Further, as NaV1.7 does not have an impact on mobility, this approach may offer a better option for post-surgical physical therapy
as current nerve block therapies cause temporary paralysis in the affected area.

Similarly
for the mechanical allodynia test results, three of