Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 136

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 136
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 reasonable terms.

Many of the third parties with whom LNHC may contract may also have relationships with other commercial entities, including LNHC’s competitors, for whom they may also be conducting clinical trials or other drug development activities that could harm LNHC’s competitive position. If the third parties conducting LNHC’s preclinical studies or clinical trials do not perform their contractual duties or obligations, experience work stoppages, do not meet expected deadlines, terminate their agreements with LNHC or need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to LNHC’s clinical trial protocols, GLPs or GCPs, or for any other reason, LNHC may need to enter into new arrangements with alternative third parties. This could be difficult, costly or impossible, and LNHC’s preclinical studies or clinical trials may need to be extended, delayed, terminated or repeated. As a result, LNHC may not be able to obtain regulatory approval in a timely fashion, or at all, for the applicable future product candidate, its financial results and the commercial prospects for its product candidates would be harmed, its costs could increase, and its ability to generate revenues could be delayed.

In addition, principal investigators for LNHC’s clinical trials may serve as scientific advisors or consultants to LNHC from time to time and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the interpretation of the trial, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection by the FDA of any NDA LNHC submits. Any such delay or rejection could prevent it from commercializing its future product candidates.

LNHC’s employees, independent contractors, principal investigators, CMOs, CROs, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could expose it to liability and hurt its reputation.

LNHC is exposed to the risk that its employees, independent contractors, principal investigators, CMOs, CROs, consultants, commercial partners and vendors may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless or negligent conduct or disclosure of unauthorized activities to**

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LNHC that