Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 57

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 57
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 approval from regulatory authorities for the sale of Channel’s drug candidates, CC8464, CT2000 and CT3000 included, it must conduct extensive clinical trials to demonstrate the safety and efficacy of the drug candidate for its intended indications. Clinical trials are expensive, time consuming and uncertain as to outcome. Channel cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage of testing. Events that may prevent successful or timely completion of clinical development include:

| • | delays in reaching a consensus with regulatory authorities on trial design; |

| • | delays in opening sites and recruiting suitable patients to participate in its clinical trials; |

| • | imposition of a clinical hold by regulatory authorities as a result of a serious adverse event or concerns with a class of drug candidates, or after an inspection of its clinical trial operations or trial sites; |

| • | delays in having patients complete participation in a trial or return for post-treatment follow-up; |

| • | occurrence of serious adverse events associated with the drug candidate that are viewed to outweigh its potential benefits; or |

| • | changes in regulatory requirements and guidance that require amending or submitting new clinical protocols. |

In addition, if Channel has to make manufacturing or formulation changes to CC8464, CT2000 and CT3000, it would need to conduct additional studies to bridge its modified compound to earlier versions. Clinical trial delays could also shorten any periods during which it may have the exclusive right to commercialize CC8464, CT2000, and CT3000, or allow its competitors to bring products to market before it does, which could limit its potential revenue or impair its ability to successfully commercialize CC8464, CT2000 and CT3000 and may harm its business, financial condition, results of operations and prospects. Any delays, setbacks or failures in its clinical trials could materially and adversely affect its business, financial condition, results of operations and prospects. Additionally, if the results of Channel’s clinical trials are inconclusive or if there are safety concerns or serious adverse events associated with our drug candidates, it may:

| • | be delayed in obtaining marketing approval, if at all, or be required to conduct additional confirmatory safety and/or efficacy studies causing additional expenses; |

| • | obtain approval for indications or patient populations that are not as broad as intended or desired; |

| • | obtain approval with labeling that includes significant use or distribution restrictions or safety warnings; |

| •