Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 120

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 120
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 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 LNHC’s or its 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 LNHC’s products and any future product candidates, if approved. LNHC and its CMOs currently engage third parties to perform analytical tests to ensure the API and drug product meets quality specifications. The analytical equipment used by LNHC or its 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 LNHC’s quality specifications, then manufacturing additional API or drug product may increase costs and may jeopardize LNHC’s or its 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 LNHC’s products and any future product candidates.

LNHC’s business involves the use of hazardous materials and LNHC and its third-party suppliers and manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how it does business.

LNHC’s manufacturing activities and the manufacturing activities of LNHC’s third-party suppliers and manufacturers, involve the controlled storage, use and disposal of hazardous materials. Further, LNHC’s manufactured drug substances and drug products may be considered hazardous materials under applicable laws and regulations. LNHC’s manufacturing activities, whether conducted by it or its 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. LNHC and its manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage, transportation, handling and disposal of these hazardous materials, and its failure to manage the use, manufacture, storage, transportation, handling or disposal of hazardous materials could subject it to significant costs or future liabilities. In some cases, these hazardous materials and various wastes resulting from their use are transported and stored at LNHC’s suppliers’ or manufacturers’ facilities pending use and disposal. LNHC and its suppliers and manufacturers cannot completely eliminate the risk of contamination, which could cause an interruption of LNHC’s commercialization efforts, research and development efforts and business