Company: PTHS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001753926-25-000790
Chunk: 34

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 1
Chunk 34
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Program: Based on several novel formulations of CC8464, Channel’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.

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

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

24

Similarly
for the mechanical allodynia test results, three of the four formulations showed statistically better efficacy for a longer duration
of time than bupivacaine. The mechanical allodynia test is shorter in duration, reflecting the subject’s innate swift recovery
rate to surgical incisions. Nonetheless, the results mirrored the successful results set forth with the thermal hyperalgesia test.

Following
the close of the Merger, Channel will review the