Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 123

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 123
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 not guarantee regulatory approval. The FDA or other comparable foreign regulatory authorities may require that LNHC conduct additional studies or clinical trials, provide additional data, take additional manufacturing steps, or require other conditions before they will reconsider or approve any New Drug Application (“NDA”), supplemental NDA (“sNDA”) or any

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comparable marketing application. If the FDA or other comparable foreign regulatory authorities require additional studies, clinical trials or data beyond those LNHC may contemplate, LNHC would incur increased costs and delays in the regulatory approval process, which may require expending more resources than LNHC has available. It is possible that LNHC’s potential product candidates will never obtain regulatory approval, even if LNHC expends substantial time and resources seeking such approval. If LNHC does not achieve one or more of these factors in a timely manner or at all, it could experience significant delays or an inability to successfully commercialize any potential future product candidates, which would harm its business. Clinical product development involves a lengthy and expensive process, with an uncertain outcome. LNHC may incur additional costs or experience delays in completing, or ultimately be unable to complete, potential development and commercialization of any future product candidates. The risk of failure for product candidates is high. If LNHC were to acquire or otherwise develop future product candidates, it would be impossible to predict when or if any of LNHC’s future product candidates would prove effective or safe in humans or would receive regulatory approval. Before obtaining regulatory approval from regulatory authorities for the sale of any potential future product candidate, LNHC may be required to complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of its product candidates in humans. Before LNHC could initiate such clinical trials for any product candidates, it would be required to submit the results of preclinical studies to the FDA or comparable foreign regulatory authorities along with other information, including information about product candidate chemistry, manufacturing and controls and its proposed clinical trial protocol, as part of an Investigational New Drug Application (“IND”) or similar regulatory submission. The FDA or comparable foreign regulatory authorities may require LNHC to conduct additional preclinical studies for any product candidate before it allows LNHC to initiate clinical trials under any IND or similar regulatory submission, which may lead to delays and increase the costs of any such preclinical development programs. If initiated, clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. A failure of one or more clinical trials could occur at any stage