Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 298

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 298
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 of acute post operative surgical pain for knee and shoulder surgery where nerve blocks are appropriate, potentially delivering meaningful clinical benefits over the currently available standard of care. |

| • | Advance the development of CC8464 towards FDA approval for treating EM and iSFN.Based on its pre-clinical profile, the target validation and trends seen with other NaV1.7 blockers in clinical studies, if approved by the FDA, Channel believes that CC8464 has the potential to become a drug for treatment of EM and iSFN patients, potentially delivering meaningful clinical benefits over the currently available standard of care. |

| • | Leverage Channel’s differentiated research and discovery approach to expand its pipeline.Channel plans to build a pipeline of potential pain blockers acting against sodium-channels related to NaV1.7. Pain modulation is complex, and a multitude of physiological mechanisms are involved in transmitting pain signals. Other than NaV1.7, Channel believes that several related sodium channels, e.g., NaV1.8 or NaV1.9, may be involved in pain sensation. While NaV1.7 is the most validated pain receptor, Channel believes that blockers against other sodium channels may complement CC8464, CT2000 and CT3000 as its primary pain blocking candidates. |

| • | Build a leading, fully integrated pharmaceutical company to maximize the clinical impact and value of Channel’s pipeline and deliver value to stockholders.Channel plans to build an experienced team to rapidly advance compounds in a capital-efficient manner. Channel intends to retain the commercialization rights to its lead compounds; however, Channel may opportunistically enter into strategic collaborations in certain geographic or clinical settings to maximize the value of its pipeline. |

While CT2000 and CT3000 are the focus of its efforts, Channel may also allocate future resources towards the discovery and development of other compounds that could potentially treat pain. CC8464’s FDA Orphan Drug Designation Channel is considering submitting a request to the FDA for Orphan Drug Designation for EM and iSFN, which could lead to approval for such designation. Orphan Drug Designation provides for a seven-year window of exclusivity and potential 25% tax credit on qualified clinical trials, as well as reduced FDA review periods and regulatory fees. Channel may apply for similar designations in additional jurisdictions, including India, Japan and Mexico, as well as additional regulatory classifications, such as FDA Breakthrough Therapy designation, that confer an advantage during development. As of the date of this information statement, Channel has not submitted an application for