Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 299

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 299
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 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 orphan drug designation for CC8464. CC8464, CT2000 and CT3000 Manufacturing Channel plans to manufacture the clinical and eventual commercial supply through Clinical Manufacturing Organizations (“CMOs”) in the U.S. and potentially other jurisdictions. Channel does not produce drug substances in house. External CMOs have produced enough CC8464 drug substance to conduct the dose escalation trial, prepare the eye pain formulation, conduct the eye pain toxicology trial and potentially, to conducts the Phase 2 proof of concept for neuropathic pain and acute and chronic eye pain. Channel has rights to two proprietary methods to produce CC8464. Channel has not yet decided which production process Channel will use for subsequent clinical trials and eventual commercial supply, but both appear suitable for further use and optimization. Both manufacturing processes employ common methods of organic synthesis used in the production of drug substance.