Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 12

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 12
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 3, 2024, the court in the New York Action awarded the Company 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, the Company 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, the Company received a demand letter from an attorney representing Parexel International (IRL) Limited (“Parexel”).
 The letter, which was addressed to both the Company 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 plus interest exceeding $177,000.  The Company denies that it
is liable for any of the amounts sought by Parexel; the Company is not a party to the Promissory Note and does
not believe it is liable for any amounts allegedly due thereunder.  The Company 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. We, along with our 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 we wish to 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 we are initially focusing our drug commercialization, we believe