Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 74

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 74
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 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, CT2000 and CT3000 are made strictly and consistently in compliance with the process.
Problems with, or deviations from, the manufacturing process, even if minor, could result in product defects or manufacturing
failures that result in lot failures, product recalls, product liability claims or insufficient inventory. We may encounter problems
achieving adequate quantities and quality of clinical-grade materials that meet FDA, EMA or other applicable standards or specifications
with consistent and acceptable production yields and costs.

43 

Any
contamination in our manufacturing process, shortages of raw materials or failure of any of our key suppliers to deliver necessary
components could result in delays in our clinical development or marketing schedules.

Given
the nature of sterile product manufacturing, there is a risk of contamination. Any contamination could materially adversely affect
our ability to produce CC8464, CT2000 and CT3000 on schedule and could, therefore, harm our results of operations and cause reputational
damage.

Some
of the raw materials required in our manufacturing process may be derived from biologic sources. Such raw materials are difficult
to procure and may be subject to contamination or recall. A material shortage, contamination, recall or restriction on the use
of biologically derived substances in the manufacture of CC8464, CT2000 and CT3000 could adversely impact or disrupt the commercial
manufacturing or the production of clinical material, which could materially and adversely affect our development timelines and
our business, financial condition, results of operations and prospects.

Risks
Related to Commercialization of Our Compounds

If
we are unable to expand our market development capabilities or enter into agreements with third parties to market and sell our
compounds, we may be unable to generate any revenue.

We
currently do not