Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 1186

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 6
Chunk 1186
---
ac 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.
By a number of clinical measures it is thought to be superior to Sumatriptan. A sublingual formulation of Rizatriptan may potentially
have a faster onset of action than an oral form and may be easier to tolerate than swallowing a pill when patients are experiencing
nausea as a result of the migraine headache. Ondansetron is an anti-emetic that is available in oral and intravenous form. An
Ondansetron sublingual spray formulation may potentially have a faster onset of action than an oral form and may be easier to
tolerate than swallowing a pill when patients are experiencing nausea. Under the terms of the Benuvia License Agreement, Benuvia
will be responsible for the manufacturing and supply of the Spray Formulations, but we will have exclusive, worldwide rights to
develop, commercialize and distribute the Spray Formulations.

In
connection with the Benuvia License Agreement, we agreed to pay Benuvia a six and one-half percent (6.5%) royalty on net sales
of the Spray Formulations for a period of up to 15 years from the date of the first commercial sale of any of the Spray Formulations.
In addition, on December 23, 2023, we entered into a stock issuance agreement with Benuvia pursuant to which we issued to Benuvia
384,226 shares of our Common Stock, which may be offered and sold pursuant to the resale prospectus which forms a part of the
Registration Statement.

While
we currently do not have strategy and development plans for the Spray Formulations licensed from Benuvia, beginning in the first
quarter of 2025, we plan to develop clinical programs for each of the Spray Formulations, determine the labelling strategy that
would be obtained from completion of these programs and discuss with the FDA the requirements for bringing each of the Spray Formulations
to market. We anticipate bringing the Spray Formulations to market through the FDA 505(b)(2) regulatory pathway for new drug applications;
however, the exact details will require further consultation with the FDA.

74 

Going
Concern

For
the years ended December 31, 2024 and 2023, we