Company: PTHS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001753926-25-001764
Chunk: 79

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 1
Chunk 79
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 strategic social media advertising, sharing impactful patient testimonials,
and leveraging trusted influence partnerships. For example, in early October 2025, the Company launched “Moms Against Molluscum”
movement, a movement to unite mothers, parents, and other caregivers navigating molluscum contagiosum. The Moms Against Molluscum
movement encourages people managing this highly contagious skin infection to visit MomsAgainstMolluscum.com to share their stories
and access information about new treatment options, including ZELSUVMI.

Market
Access Strategy

The
Company’s cross functional, payer and reimbursement account team is actively prioritizing and ensuring that the process
of accessing ZELSUVMI is seamless, affordable, and easy with everything our patient customers will need, from step-by-step instructions
to co-pay cards for eligible patients, to maximize the probability of having a positive outcome from using the Company’s
product regardless of whatever distributor they prefer to access ZELSUVMI. The Company’s is focused on certain channels,
including commercial, Medicaid and Managed Medicaid and the use of co-pay cards and coupons for eligible patients for commercially
insured patients to ease access regardless of the channel utilized.

Manufacturing
and Supply Chain

Background

Berdazimer
sodium is the API that is the critical component of the NITRICIL platform technology. The Company believes different concentrations
of berdazimer sodium and different formulations of the finished drug product may be used to develop additional product candidates
for other diseases or conditions. For example, ZELSUVMI (berdazimer) topical gel, 10.3%, which has been approved by the FDA, is
one product and indication that has met the regulatory requirements for commercialization. The Company believes the NITIRCIL technology
platform could generate other potential product candidates that could be further developed, and, pursuant to the MSA with Ligand,
the Company may produce API for such other uses.

The
supply chain includes the procurement of raw materials, the conversion of raw materials into API, and the conversion of API to
finished product. The Company’s process, as described in more detail below, is effectively as follows:

●Procurement
                                         of underlying raw materials, such as nitric oxide gas;

●Conversion
                                         of raw materials into API, including allocated overhead, fixed and variable costs;

●Shipment
                                         of API to a third-party contract manufacturing organization (“CMO”);

●Conversion
                                         of API into finished product, ZELSUVMI, at