Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 117

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 117
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 accordance with LNHC’s expectations, misappropriation of LNHC’s proprietary information, including trade secrets and know-how, or any termination by these third parties of their arrangements with LNHC, which, in each case, could be the result of one or many factors outside of LNHC’s control, could delay or prevent the manufacture or commercialization of LNHC’s products, disrupt LNHC’s operations or cause reputational harm to LNHC. In addition, except for the terms and conditions specified in LNHC’s contractual arrangements with its contract manufacturers, LNHC has no control over the ability of its contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of LNHC’s API or drug products or if it withdraws any such approval in the future, LNHC may need to find alternative manufacturing facilities, which would significantly impact LNHC’s ability to develop, obtain regulatory approval for, market and sell its products and potential product candidates. LNHC is required to identify the supplier(s) of all the raw materials for its products, including ZELSUVMI, in its applications with the FDA. To the extent practicable, LNHC’s attempts to identify more than one supplier in each drug application. However, some products and raw materials are available only from a single source and, in some of its drug applications, only one supplier of products and raw materials has been identified, even in instances where multiple sources exist. To the extent any difficulties experienced by LNHC’s suppliers cannot be resolved within a reasonable time and at reasonable cost, or if raw materials for a particular product become unavailable from an approved supplier and LNHC is required to qualify a new supplier with the FDA, its profit margins and market share for the affected product could decrease and LNHC’s development and sales and marketing efforts could be delayed or negatively impacted.

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LNHC has never produced at a commercial scale any products that utilize the NITRICIL technology, and any delay or disruptions in the on-going qualification of manufacturing facilities and process or in the manufacture of LNHC’s (i) API, including berdazimer sodium, the API of LNHC’s ZELSUVMI product, or (ii) potential future clinical trial materials or commercial supplies of any other potentially approved product candidates utilizing the NITRICIL technology, could adversely affect LNHC’s development and commercialization timelines and results or result in increased costs or in LNHC breaching its obligations to others