Company: PTHS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001753926-25-001764
Chunk: 77

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 1
Chunk 77
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 subsequent human POC trial, but has no immediate plans to do so.

Neuropathic
Pain (Pre-Clinical): 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,
and the Phase 1 studies completed to date, the Company 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 and idiopathic small fiber neuropathy.
The Company will periodically review the timing and budget related to the commencement of toxicology and CMC work and a subsequent
human POC trial, but has no immediate plans to do so.

ZELSUVMI
Commercial Strategy

The
Company has launched and is focused on the commercialization of ZELSUVMI and is continuing to support its sales, marketing and
commercial team to detail ZELSUVMI.

Commercial
Background

ZELSUVMI
is the first FDA-approved at-home prescription medication indicated for the treatment of molluscum contagiosum in patients one
year of age and older that can administered by patients, parents and caregivers. As a prescription, ZELSUVMI will generally be
covered under patients’ pharmacy benefit, differentiating it from procedural reimbursement for cantharidin and cryotherapy.
Pediatricians, pediatric dermatologists, dermatologists and infectious disease specialists will be the target prescribers.

Pediatricians
diagnose the majority of molluscum contagiosum infections, and the Company believes many patients have not been treated due, in
part, to a lack of FDA approved prescription treatment options that can be administered outside of medical settings. The Company
believes that pediatricians will be key to expanding the market, increasing peak sales, and sales and marketing efficiency. The
Company will seek to position ZELSUVMI as the preferred first line therapy among pediatricians. The Company believes ZELSUVMI
will enhance and complement current non-prescription treatment options