Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 299

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 299
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 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. Channel does not intend to file patents for these processes but will keep the detailed protocols (e.g., the selected crystallization solvent or the particular salt) as trade secrets. Channel has developed the formulation for the eye drops associated with the eye pain treatment therapy and depot injections associated with the nerve block therapy and are in the early stages of determining its manufacturing strategy. Channel expects to pursue a similar strategy to have CT2000 and CT3000 manufactured by CMOs.

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#### Intellectual Property
Protection of Channel’s intellectual property is an important part of its business. Channel seeks patent protection in the United States and in other countries for its inventions and discoveries, and Channel develops and protects its key know-how and trade secrets relating to its platform technology and the products Channel is developing using its platform.

Channel has adopted a strategy of seeking patent protection in the United States and in other jurisdictions globally that Channel deems appropriate with respect to certain of its technologies relating to its products and process. Channel has been granted a patent in the United States directed to the composition of matter and use of its lead compound, CC8464. Channel has also obtained patents in France, Japan, India in Mexico, Israel and South Korea. Its U.S. patent for CC8464 will expire in 2035. In addition, Channel has an additional pending patent application in India.

Channel has pending patent applications for each of CT2000 ophthalmic formulation and CT3000 injectable formulations, and for the treatment of pain.

Granted U.S. Patent 9,855,234 is directed to the diclofenac spray formulation and will expire in April of 2036. The O