Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 60

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 60
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 may harm its business, financial condition and prospects significantly. As CC8464 is Channel’s only compound in clinical development, any setback may have a significant negative effect on its business. Additionally, if CC8464 receives marketing approval, the FDA could require Channel to adopt a post-approval safety monitoring program to ensure that the benefits outweigh its risks, which may include, among other things, a medication guide outlining the risks of the product for distribution to patients and a communication plan to health care practitioners. Furthermore, if Channel or others later identify undesirable side effects caused by CC8464, several potentially significant negative consequences could result, including:

| • | regulatory authorities may suspend or withdraw approvals of such compound; |

| • | regulatory authorities may require additional warnings on the label; |

| • | Channel may be required to change the way a compound is administered or conduct additional clinical trials; |

| • | Channel could be sued and held liable for harm caused to patients; and |

| • | Channel’s reputation may suffer. |

Any of these events could prevent Channel from achieving or maintaining market acceptance of CC8464 and could significantly harm its business, financial condition, results of operations and prospects. Additionally, other regulatory regimes in other geographies, such as the European Union, India and Japan, where Channel is initially targeting its products, may impose similar conditions or post-monitoring requirements as a result of such findings. Channel has yet to begin evaluating CT2000 and CT3000 in humans to determine if it has any side effects, but could face similar or other issues, including but not limited to the disclosures set forth above for CC8464 with respect to FDA approval, ongoing monitoring programs and label requirements. CC8464, CT2000 and CT3000 are based on specific modes of administration (dose escalation regime, eye drops and injection, respectively), which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval. The clinical trial requirements of the FDA, EMA and other regulatory authorities and the criteria these regulators use to determine the safety and efficacy of a compound vary substantially according to the type, complexity, novelty and intended use and market of such compounds. The regulatory approval process for novel compounds such as Channel can be more expensive and take longer than for other, better known or more extensively studied compounds. Regulatory requirements governing pain medication products have been changing as side effects and the addictive nature of opioids became more apparent. The regulatory framework for pain medications has been tightened and these changes may affect Channel’s programs and its commercial potential despite