Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 9

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 9
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 jurisdictions globally that we deem appropriate with respect to certain of our technologies relating to our products and process.  We have been granted a patent in the United States directed to the composition of matter and use of our lead compound, CC8464. We have also obtained patents in France, Japan, India in Mexico, Israel and South Korea. Our U.S. patent for CC8464 will expire in 2035. In addition, we have an additional pending patent application in India.

We
have pending patent applications for each of CT2000 ophthalmic formulation and CT3000 injectable formulations, and for the treatment
of pain. 

Granted
U.S. Patent 9,855,234 is directed to the diclofenac spray formulation and will expire in April of 2036. The Ondansetron Spray
Formulation is covered by U.S. Patent 9,566,233 and U.S. Patent 10,172,833. Both patents are composition-of-matter patents that
will expire in May 2034 and August 2036, respectively. The U.S. and international patents relating to the Rizatriptan Spray Formulation
have either expired or have been abandoned.

In
addition to patents and licenses, we rely on trade secrets and know-how to develop and maintain technologies and methods that
provide us a meaningful competitive advantage. However, trade secrets can be difficult to defend and maintain. We seek to protect
our proprietary technology and processes, and maintain ownership of certain technologies, in part, through confidentiality agreements
and invention assignment agreements with our employees, consultants and commercial partners.

Our
Competition

The
biotechnology and pharmaceutical industries are highly competitive. Several pharmaceutical companies that are developing molecules
that modulate NaV (including NaV1.7 and NaV1.8) activities or address pain through other methods of action and therefore have
the potential to mitigate eye, post-surgical and EM and iSFN pain. These companies and new entrants may potentially compete with
our products in the future with novel delivery technologies. Competition in this space will remain strong and we do not know if
we will be successful in obtaining orphan designation from the FDA for CC8464, encounter challenges to our issued patents and
continue to advance CC8464, C2000 and CT3000 through clinical development towards approval.

6 

In
connection with the Company’s initial public offering (the “IPO”), we entered into a side letter with Chromoc