Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 116

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 116
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 | withdrawal of clinical trial participants; |

| • | significant costs to defend the related litigation; |

| • | substantial monetary awards paid to trial participants or patients; |

| • | reduced resources of management to pursue LNHC’s business strategy; and |

| • | the inability to commercialize any products that LNHC may develop. |

LNHC’s parent, Ligand, currently holds product liability insurance that covers its clinical trials up to a $15.0 million annual limit. LNHC may need to secure additional product liability insurance coverage following commencement of LNHC’s commercialization activities for ZELSUVMI for the treatment of molluscum

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contagiosum and may need to further increase its insurance coverage if it initiates clinical trials or expands commercialization activities for its product candidates that obtain regulatory approval. Insurance coverage is increasingly expensive. LNHC may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

### Risks Related to LNHC’s Operations and Manufacturing
**Delays or disruptions in LNHC’s supply chain and manufacturing of LNHC’s products, including ZELSUVMI, and potential product candidates could adversely affect LNHC’s sales and marketing efforts and LNHC’s development and commercialization timelines and could result in increased costs or in LNHC breaching its obligations to others.

LNHC’s ability to make, move, and sell its products is critical to its success. Damage or disruption to LNHC’s supply chain, including third-party manufacturing, assembly or transportation and distribution capabilities, due to weather, including any potential effects of climate change, natural disaster, fire or explosion, terrorism, pandemics (such as the COVID-19 pandemic), strikes, tariffs, government action, inflation, war or other reasons beyond LNHC’s control or the control of its suppliers and business partners, could impair LNHC’s ability to manufacture or sell its products. Failure to take adequate steps to mitigate the likelihood or potential impact of such events, or to effectively manage such events if they occur, particularly where LNHC’s product is sourced from a single supplier or location, could adversely affect LNHC’s business or financial results. Any interruption or failure by LNHC’s suppliers, distributors and other partners to meet their obligations on schedule or in 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