Company: PTHS
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001753926-25-001326
Chunk: 121

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 121
---
acaine, 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 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.

30 

Following
the close of the Merger, Pelthos 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 Pelthos has completed to date, Pelthos believes that CC8464, if approved, could become an attractive option
for both patients and physicians as a treatment for moderate-to-severe pain in Erythromelalgia (“EM”) and idiopathic
small fiber neuropathy (“iSFN”).

Pelthos
conducted four Phase 1 trials with 207 patients. The results showed that CC8464 has a good overall tolerability and demonstrated
no liver or renal toxicity, no central nervous system changes and no cardiovascular findings but may cause skin rashes in certain
patients. The occurrence of skin rashes is not uncommon with the class of molecules to which CC8464 belongs and the rashes were
successfully treated in all cases with topical steroids and/or topical antih