Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 262

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 262
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 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 cGMP, we will
be obligated to expend time, money and effort in production, record keeping and quality control to assure that the product meets
applicable specifications and other requirements. If we fail to comply with these requirements, we would be subject to possible
regulatory action and may not be permitted to sell any compound that we may develop.

In
addition, the manufacturing process used to produce our existing compounds is complex, novel and has not been validated for commercial
use. To produce enough quantities of our existing compounds for future clinical trials and initial U.S. commercial demand, we
will need to increase the scale of our manufacturing process. We employ multiple steps to control our manufacturing process to
assure that the process works and that CC8464