Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 73

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 73
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to use third-party intellectual property, it could adversely affect our ability to commercialize our technologies, products or
services, as well as harm our competitive business position and our business prospects.

Rizatriptan
is an off-patent branded generic that can be manufactured and sold by other pharmaceutical manufacturers, which may increase the
competition we face and reduce our ability to diversify our pipeline of non-opioid pain treatment therapies, while adding therapeutic
options for related conditions under the Benuvia License Agreement.

Rizatriptan
is an off-patent branded generic pharmaceutical and is currently not protected by intellectual property rights. As a result, other
pharmaceutical companies may sell products similar to the Rizatriptan Spray Formulation at a lower cost, and this might result
in a commensurate loss in expected sales or require us to lower our prices to compete. If other pharmaceutical companies sell
products that are similar to the Rizatriptan Spray Formulation, we may face additional competition and our business and profitability
may be adversely affected, and our ability diversifying our pipeline of non-opioid pain treatment therapies, while adding therapeutic
options for related conditions under the Benuvia License Agreement may be reduced.

Risks
Related to Manufacturing

Delays
in obtaining regulatory approvals of the process and facilities needed to manufacture CC8464, CT2000, CT3000 or any of our other
compounds or disruptions in our manufacturing process may delay or disrupt our product development and commercialization efforts.

Before
we can begin to commercially manufacture CC8464, CT2000, CT3000 or any of our other compounds, whether in a third-party facility
or in our own facility, if established, we must pass a pre-approval inspection of our manufacturing facility by the FDA. A manufacturing
authorization must also be obtained from the appropriate regulatory authorities. The timeframe required for us to obtain such
approvals is uncertain. To obtain approval, we will need to ensure that all our processes, methods and equipment are compliant
with cGMP, and perform extensive audits of vendors, contract laboratories and suppliers. If any of our vendors, contract laboratories
or suppliers is found to be out of compliance with cGMP, we may experience delays or disruptions in manufacturing while we work
with these third parties to remedy the violation or while we work to identify suitable replacement vendors. The cGMP requirements
govern quality control of the manufacturing process and documentation policies and procedures. In complying with