Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 119

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 119
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 requirements on commercially reasonable terms and in compliance with cGMP or other regulatory requirements could adversely affect its business in a number of ways, including:

| • | an inability to meet commercial demands; |

| • | an inability to initiate or complete clinical trials in a timely manner; |

| • | delays in submitting regulatory applications, or receiving regulatory approvals; |

| • | subjecting third-party manufacturing facilities to additional inspections by regulatory authorities; and |

| • | requirements to cease development or to recall product batches. |

In addition, LNHC may be unable to establish additional long-term supply agreements with third-party manufacturers or to do so on acceptable terms, which increases the risk of failing to timely obtain sufficient quantities of its products or any future product candidates or such quantities at an acceptable cost, which would have a material adverse impact on LNHC’s financial position. There are risks associated with scaling up manufacturing to commercial volumes including, among others, cost overruns, technical or other problems with process scale-up, process reproducibility, stability issues, lot consistency and timely availability of raw materials. There is no assurance that LNHC’s manufacturers will be successful in establishing a larger-scale commercial manufacturing process for ZELSUVMI that achieves LNHC’s objectives for manufacturing capacity and cost of goods, in a timely manner, or at all. Unexpected results in the analysis of raw materials, the API or drug product or problems with the execution of or quality systems supporting the analytical testing work, whether conducted internally or by third-party service providers, could adversely affect LNHC’s development and commercialization timelines and result in increased costs of potential development programs initiated by LNHC. Third parties engaged directly by LNHC or by its API and drug product contract manufacturing organizations (“CMOs”), test all of the raw materials and finished API and drug products. It is a regulatory requirement that raw materials are tested and there are a limited number of suppliers for testing these raw materials. There may be a need to assess alternate suppliers to prevent a possible disruption of the supply of these raw materials for the manufacture of API or drug product. Additionally, the analytical equipment used by these third parties must be maintained and operational. Except for the terms established within LNHC’s or its CMOs’ contracts with the third parties responsible for testing raw materials and finished API and drug products, LNHC has 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