Company: PTHS
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001753926-25-001326
Chunk: 120

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 120
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urther improve when dosed over several days). The results after 1 day of dosing CT2000 are summarized in the following graph: 

Following
the animal studies, if successful, Pelthos intends to move into proof-of-concept (“POC”) studies in humans. Pelthos
plans to conduct the POC study in Australia to avail itself of the streamlined regulatory structure and 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. Pelthos is planning to conduct the POC in a clinic in Brisbane, Australia and is in the process of contracting
the services to perform a trial in patients suffering from pain associated with dry-eye disease.

29 

Depot
Program: Based on several novel formulations of CC8464, Pelthos’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.

Pelthos
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 Pelthos’s nerve block formulations for acute pain, showing material improvement over the existing standard
of care, bupivacaine, in both efficacy and duration.

Pelthos
performed a thermal hyperalgesia test in rodents with a placebo arm, bupivacaine arm and four arms of the main formulations of
Pelthos’s molecule. Pelthos 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.

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 bupiv