Company: PTHS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001753926-25-001764
Chunk: 73

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 1
Chunk 73
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 and pediatric patients one year of age and older. ZELSUVMI is the first FDA approved topically applied nitric oxide
releasing agent indicated for the treatment of molluscum contagiosum in people ages one year and older and the first and only
prescription medication FDA approved for use in non-medical settings that can be safely applied by patients, parents and caregivers.
Molluscum contagiosum is a highly contagious viral skin infection that primarily affects children, immunocompromised adults and
sexually active persons. The Company estimates that molluscum contagiosum infections afflict an approximately 17 million people
of all ages in the United States.

ZELSUVMI
was developed using the proprietary nitric oxide-based technology platform, NITRICIL. ZELSUVMI’s mechanism of action against
molluscum contagiosum is unknown. In vitro studies of ZELSUVMI’s active ingredient, berdazimer sodium, have demonstrated
(i) anti-pox virus activity on vaccinia virus, which is often used as a surrogate for molluscum contagiosum virus; and (ii) reduced
early gene expression of molluscum contagiosum virus proteins. ZELSUVMI’s final Phase 3 clinical study included 891 enrolled
patients treated with ZELSUVMI and demonstrated statistically significant and clinically meaningful efficacy results on both primary
and secondary endpoints, a greater reduction in lesions at every measurement point, and favorable safety results during the 12-week
duration.

The
Company’s market research and feedback to date indicate physicians have highly favorable opinions about ZELSUVMI’s
clinical efficacy, safety, and practicality as the first and only topical medication indicated for molluscum contagiosum that
does not require in-office administration by a healthcare provider. The Company believes that ZELSUVMI is likely to complement
or represent a differing treatment regimen of current procedural treatments administered in medical settings such as cryosurgery,
cantharidin application and curettage.

The
Company has an exclusive license to use the NITRICIL Technology Platform as necessary to manufacture ZELSUVMI, as set forth in
the license agreement between the Company and Ligand. The Company believes that the NITRICIL platform’s ability to deploy
nitric oxide in a solid form, on demand and in localized formulations allows the potential to improve patient outcomes in a variety
of diseases. The Company’s achievement of an FDA approval for ZELSUVMI has validated the NITRIC