Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 50

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 50
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 raw materials
and finished API and drug products, we have limited ability to control the process or timing of their testing work. Additionally,
if the results do not meet specifications, then obtaining additional raw materials may jeopardize our or our CMOs’ ability
to manufacture API and/or drug product, the start or overall conduct of preclinical studies and clinical trials, the timing of
regulatory submissions, or the commercialization of our products and any future product candidates, if approved. We and our CMOs
currently engage third parties to perform analytical tests to ensure the API and drug product meets quality specifications. The
analytical equipment used by us or our CMOs to perform these tests must be maintained, qualified, calibrated and operational. If
there are testing execution delays, equipment problems or if the results of the analytical testing do not meet our quality specifications,
then manufacturing additional API or drug product may increase costs and may jeopardize our or our CMOs’ ability to manufacture
API and/or drug product, which may cause delays in the start or overall conduct of preclinical studies and clinical trials, the
submission of regulatory filings, or the commercialization of our products and any future product candidates.

Our business involves the use of hazardous materials and we and our third-party suppliers and manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.

Our manufacturing activities and the manufacturing
activities of our third-party suppliers and manufacturers, involve the controlled storage, use and disposal of hazardous materials.
Further, our manufactured drug substances and drug products may be considered hazardous materials under applicable laws and regulations.
Our manufacturing activities, whether conducted by us or our third-party suppliers and manufacturers, like all manufacturing processes
that utilize hazardous materials, including those under high pressures, must be properly controlled to avoid unintended reactions
or other accidents that could cause injury or damage to personnel, equipment or property. We and our manufacturers and suppliers
are subject to laws and regulations governing the use, manufacture, storage, transportation, handling and disposal of these hazardous
materials, and our failure to manage the use, manufacture, storage, transportation, handling or disposal of hazardous materials
could subject us to significant costs or future liabilities. In some cases, these hazardous materials and various wastes resulting
from their use are transported and stored at our suppliers’ or manufacturers’ facilities pending use and disposal.
We and our suppliers and manufacturers cannot completely eliminate the risk of contamination, which could cause an interruption
of our commercialization efforts, research and development efforts and business