Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 126

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 126
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 prospects significantly. In addition, many of the factors that cause, or lead to, the termination suspension of, or a delay in the commencement or completion of, clinical trials may also ultimately lead to the denial of regulatory approval of a potential product candidate. Any resulting delays to LNHC’s clinical trials could shorten any period during which it may have the exclusive right to commercialize its future product candidates. In such cases, its competitors may be able to bring products to market before LNHC, and the commercial viability of its future product candidates could be significantly reduced. Any of these occurrences may harm LNHC’s business, financial condition and prospects. Use of ZELSUVMI and any future product candidates could be associated with adverse side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause LNHC to suspend or discontinue clinical trials, abandon a product candidate, limit the commercial profile of ZELSUVMI or any other approved product or result in other significant negative consequences that could severely harm LNHC’s business, prospects, operating results and financial condition. Results of any clinical trials LNHC may conduct could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by LNHC product candidates, whether used alone or in combination with other therapies, could cause LNHC or regulatory authorities to interrupt, delay or halt clinical trials or lead to the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities, or, if for any approved products, result in a more restrictive label and other post-approval requirements.

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Any treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or could result in potential product liability claims. Any of these occurrences may harm LNHC’s business, financial condition and prospects significantly. If any of LNHC’s future product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with other approved products or investigational drugs, LNHC may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. If such significant adverse events or other side effects are observed in any clinical trials LNHC may choose to conduct, such events could lead LNHC, the FDA, other comparable regulatory authorities or an institutional review board to suspend clinical trials, including due to a belief