Company: PTHS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001753926-25-000790
Chunk: 70

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 2
Chunk 70
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 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 timing and budget related to the commencement of toxicology and CMC work and
a subsequent human POC trial. 

Neuropathic
Pain: CC8464 is being developed to address certain types of neuropathic pain. The chemical characteristics of CC8464 restrict
its entry into the CNS and limit its effect to the NaV1.7 channels in the peripheral nervous system, which consists of the nerves
outside the brain and spinal cord. Activation of other channels in the CNS can result in side effects, including addiction and
other centrally mediated adverse effects. Since CC8464 is designed to not penetrate the CNS it is highly unlikely to produce CNS
mediated side effects including euphoria or addiction. Based on its characteristics, preclinical studies (described below) and
the Phase 1 studies Channel has completed to date, Channel believes that CC8464, if approved, could become an attractive option
for