Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 8

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 8
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 treat pain.

CC8464’s
FDA Orphan Drug Designation

We
are considering submitting a request to the FDA for Orphan Drug Designation for EM and iSFN, which could lead to approval for
such designation. Orphan Drug Designation provides for a seven-year window of exclusivity and potential 25% tax credit on qualified
clinical trials, as well as reduced FDA review periods and regulatory fees. We may apply for similar designations in additional
jurisdictions, including India, Japan and Mexico, as well as additional regulatory classifications, such as FDA Breakthrough Therapy
designation, that confer an advantage during development. As of the date of this Report, we have not submitted an application
for orphan drug designation for CC8464.

5 

CC8464,
CT2000 and CT3000 Manufacturing

We
plan to manufacture the clinical and eventual commercial supply through Clinical Manufacturing Organizations (“CMOs”)
in the U.S. and potentially other jurisdictions. We do not produce drug substances in house. External CMOs have produced enough
CC8464 drug substance to conduct the dose escalation trial, prepare the eye pain formulation, conduct the eye pain toxicology
trial and potentially, to conducts the Phase 2 proof of concept for neuropathic pain and acute and chronic eye pain.

We
have rights to two proprietary methods to produce CC8464. We have not yet decided which production process we will use for subsequent
clinical trials and eventual commercial supply, but both appear suitable for further use and optimization. Both manufacturing
processes employ common methods of organic synthesis used in the production drug substance. We do not intend to file patents for
these processes but will keep the detailed protocols (e.g., the selected crystallization solvent or the particular salt) as trade
secrets.

The
Company has developed the formulation for the eye drops associated with the eye pain treatment therapy and depot injections associated
with the nerve block therapy and are in the early stages of determining our manufacturing strategy. We expect to pursue a similar
strategy to have CT2000 and CT3000 manufactured by CMOs.

Intellectual
Property

Protection of our intellectual property
is an important part of our business. We seek patent protection in the United States and in other countries for our inventions
and discoveries, and we develop and protect our key know-how and trade secrets relating to our platform technology and the products
we are developing using our platform.

We have adopted a strategy of seeking patent protection in the United States and in other