Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 7

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 7
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 oxide’s naturally occurring anti-viral, anti-bacterial, anti-fungal, and immunomodulatory
potential mechanisms of action in an effort to treat a range of diseases. Nitric oxide plays a vital role in the natural immune
system response against microbial pathogens and is a critical regulator of inflammation. The technology’s ability to harness
nitric oxide and its multiple potential mechanisms of action has enabled the creation of a platform with the potential to generate
differentiated product candidates. The two key components of the nitric oxide platform are the proprietary NITRICIL technology,
which drives the creation of macromolecular New Chemical Entities, and formulation science, both of which are used to tune product
candidates for specific targeted indications.

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 NITRICIL technology platform’s ability to achieve stable, tunable and druggable delivery of nitric oxide
on therapeutically and commercially important targets such as molluscum contagiosum. 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.

Berdazimer sodium is the Active Pharmaceutical Ingredient (“API”) that is the backbone of the NITRICIL
platform technology, including ZELSUVMI. Different concentrations of berdazimer sodium and different formulations of the finished
drug product are what differentiates potential treatment options for various indications. The Company believes the NITIRCIL technology
platform has many other potential product candidates that could be further developed. To date, clinical work has been performed
in various indications, including, but not limited to, acne (SB204), atopic dermatitis and psoriasis (SB414), tinea pedis and
onychomycosis (SB208) and external genital warts (SB207), the rights to which are owned by Ligand.

Licensing and Other Agreements

Ligand

On March 24, 2025, the
Company assigned its IP portfolio related to the Novan acquisition, including the NITRICIL technology, to Ligand and entered into
an exclusive license and sublicense agreement with Ligand, pursuant to which Ligand licensed to the Company the intellectual property