Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 67

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 67
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 and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any compound that it may develop. Competitors also may obtain FDA or other regulatory approval for their products more rapidly or earlier than Channel may obtain approval for Channel’s, which could result in Channel’s competitors establishing a strong market position before it is able to enter the market. Additionally, technologies developed by Channel’s competitors may render CC8464, CT2000 and CT3000 uneconomical or obsolete, and it may not be successful in marketing CC8464, CT2000 and CT3000 against competitors.

In addition, as a result of the expiration or successful challenge of our patent rights, Channel could face more litigation with respect to the validity and/or scope of patents relating to its competitors’ products. The availability of products of Channel’s competitors could limit the demand, and the price Channel is able to charge, for any compound that Channel may develop and commercialize.

On December 23, 2023, Channel entered into the Benuvia License Agreement. Channel is dependent on the Benuvia License Agreement, and the termination of the Benuvia License Agreement could have an adverse effect on our business.

On December 23, 2023, Channel entered into an exclusive licensing agreement (the “Benuvia License Agreement”) with Benuvia Operations LLC (“Benuvia”) for the Diclofenac Spray Formulation, the Rizatriptan Intranasal Formulation and the Ondansetron Spray Formulation (collectively, the “Spray Formulations”), diversifying its pipeline of non-opioid pain treatment therapies, while adding therapeutic options for related conditions. The Diclofenac Spray Formulation is patented and has started clinical development in human volunteers. Preliminary pharmacokinetics suggest that this formulation may have a faster onset of action than oral Diclofenac tablets. Diclofenac is an NSAID that is also marketed under additional brand names including Voltaren and Cataflam in its pill form. Rizatriptan, whose brand name is Maxalt, is used for the acute treatment of migraines as a pill. Ondansetron is an anti-emetic that is available in oral and intravenous form. Under the terms of the Benuvia License Agreement, Benuvia will be responsible for the manufacturing and supply of the Spray Formulations, but Channel will have exclusive, worldwide rights to develop, commercialize