Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 303

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 303
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 New York Action, plus disgorgement of all compensation previously paid or accrued to Mr. Kopfli by Channel.

By Order dated October 3, 2024, the court in the New York Action awarded Channel a default judgment against Mr. Kopfli and Chromocell Holdings on all claims and ordered an assessment of damages against Mr. Kopfli and Chromocell Holdings (to be held at a date to be determined). As of December 31, 2024, Channel has removed the accrual of $363,091 in compensation expenses and recorded a gain on default judgement in the same amount.

#### Parexel Claim
On July 31, 2024, Channel received a demand letter from an attorney representing Parexel International (IRL) Limited (“Parexel”). The letter, which was addressed to both Channel and Chromocell Holdings, purports to be a notice of default of the Promissory Note between Chromocell Holdings and Parexel (the “Promissory Note”) and seeks the payment of allegedly unpaid principal in the amount of $682,551.49 plus interest exceeding $177,000. Channel denies that it is liable for any of the amounts sought by Parexel; Channel is not a party to the Promissory Note and does not believe it is liable for any amounts allegedly due thereunder. Channel intends to defend itself vigorously in the matter.

#### Government Regulation
The FDA and other regulatory authorities at federal, state and local levels, as well as outside the United States, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, recordkeeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs and biologics. Channel, along with its vendors, Clinical Research Organizations (“CRO”), clinical investigators, clinical trial sites and contract manufacturing organizations, will be required to navigate the various preclinical, clinical, manufacturing and commercial approval requirements of the governing regulatory agencies of the countries in which Channel wishes to

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conduct studies or seek marketing approval of compounds. The process of obtaining regulatory approvals of drugs and biologics and ensuring subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. In the United States where Channel is initially focusing its drug commercialization, Channel believes compounds,