Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 131

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 131
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 evidence from well-controlled clinical trials, and to the satisfaction of the FDA or foreign regulatory agencies, that such product candidates are safe and effective for their intended uses. Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if LNHC believes the nonclinical or clinical data for its product candidates are promising, such data may not be sufficient to support approval by the FDA and other regulatory authorities. The FDA may also require that LNHC conduct additional nonclinical studies or clinical trials for LNHC’s product candidates either prior to or after approval, or it may object to elements of LNHC’s clinical development program. Of the large number of products in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized. The lengthy approval or marketing authorization process as well as the unpredictability of future clinical trial results may result in LNHC’s failing to obtain regulatory approval or marketing authorization to market LNHC’s product candidates, which would significantly harm LNHC’s business, financial condition, results of operations and prospects. The FDA or comparable foreign regulatory authorities can delay, limit or deny approval of a product candidate for many reasons, including:

| • | such authorities may disagree with the design or execution of LNHC’s clinical trials; |

| • | negative or ambiguous results from clinical trials or results may not meet the level of statistical significance or persuasiveness required by the FDA or comparable foreign regulatory agencies for approval; |

| • | serious and unexpected drug-related side effects may be experienced by participants in clinical trials or by individuals using drugs similar to the applicable product candidates; |

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| • | the population studied in clinical trials may not be sufficiently broad or representative to assure safety in the full population for which LNHC may seek approval; |

| • | such authorities may not accept clinical data from trials that are conducted at clinical facilities or in countries where the standard of care is potentially different from that of their own country; |

| • | LNHC be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; |

| • | such authorities may disagree with LNHC’s interpretation of data from preclinical studies or clinical trials; |

| • | such authorities may not agree that the data collected from clinical trials are acceptable or sufficient to support the submission of an NDA, sNDA or other submission or to obtain regulatory approval in the U.S. or elsewhere, and such authorities may impose requirements for additional preclinical studies or clinical trials; |

| • | such