Company: PTHS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001753926-25-001764
Chunk: 74

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 1
Chunk 74
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IL technology platform’s
ability to achieve stable, tunable and druggable delivery of nitric oxide on therapeutically and commercially important targets
such as molluscum contagiosum.

Molluscum
Contagiosum

Molluscum
contagiosum is caused by a poxvirus and is a common skin infection seen by dermatologists, pediatric dermatologists, and pediatricians,
with a prevalence estimated by management to be 17 million people in the United States and an annual incidence estimated by management
to be 3-6 million. According to the Centers for Disease Control and Prevention (“CDC”), molluscum contagiosum infections
are contagious and spread to others through contact with infected persons or contaminated objects such as towels, toys, furniture,
swimming pools, and other surfaces. Children are the most vulnerable to molluscum contagiosum infections as are adults with weakened
immune systems. In addition, molluscum contagiosum can be sexually transmitted.

44

Molluscum
contagiosum infections present with raised, skin-colored or red bumps that can appear anywhere on the body, including the face,
hands, trunk, genitals, back of the knees, armpits, and other sensitive areas. People with molluscum contagiosum may suffer discomfort
from itching, secondary bacterial infections, as well as immense social stigma from having visible molluscum contagiosum lesions
which typically last for months or for years. Left untreated, molluscum contagiosum lesions may persist an average of 13 months,
with reports of cases remaining unresolved for up to five years. The symptoms of molluscum contagiosum can cause anxiety, and
parents frequently seek treatment due to its highly contagious nature and its impact on physical appearance.

Manufacturing
Facility and NITRICIL Platform

The
Company currently leases its primary operating facility, including 19,265 square feet of laboratory, cGMP manufacturing, warehouse,
storage and office space in Durham, North Carolina. The lease, dated January 18, 2021, as amended, has an initial term expiring
in 2032, with an option to extend the term of the lease for a period of 5 years. This bespoke purpose-built facility was constructed
to serve as the primary berdazimer sodium API manufacturing site. Berdazimer sodium is the API that is the backbone of the NITRICIL
platform technology. Different concentrations of berdazimer sodium and different