Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 489

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1B
Chunk 489
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23, 2023, we entered into the Benuvia License Agreement for the Spray Formulations, diversifying our 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. 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 and we will purchase the Spray Formulations exclusively
from Benuvia, pursuant to the Benuvia Supply Agreement. The initial sale price per unit for each Spray Formulation payable by
us to Benuvia pursuant to the Benuvia Supply Agreement shall be subject to good faith negotiations; provided that the initial
price for each Spray Formulation and the price for each Spray Formulation during the term of the Benuvia License Agreement in
no event shall be less than Benuvia’s cost of manufacturing the respective Spray Formulation plus a gross margin to Benuvia.
The price for each Spray Formulation shall be subject to an annual increase in amounts equal to the percentage change in the Producer
Price Index, Pharmaceutical Preparations as published by the U.S. Department of Labor, Bureau of Labor Statistics.

Under
the terms of the Benuvia License Agreement, we obtained exclusive, worldwide rights to develop, commercialize