Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 1182

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 6
Chunk 1182
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 of Diclofenac Spray Formulation resulted
in lower systemic exposure to Diclofenac than the oral dose of 50mg diclofenac-potassium which means that an additional Phase
I pharmacokinetic study exploring additional higher doses of the sublingual diclofenac spray will likely be necessary to determine
the appropriate dose.

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. Both Rizatriptan and Sumatriptan belong to a family of tryptamine-based medications named “triptans”
that work as serotonin 1A receptor (or 5-HT1A-receptor) agonists and are indicated for the treatment of migraine. An intranasal
spray formulation of Rizatriptan (the “Rizatriptan 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 as a result of the
migraine headache. According to a study that was reported in 2001, Rizatriptan has a higher bioavailability and a more rapid onset
of action which may be responsible for better results in resolving migraines as well as better results in patients reporting that
they are “pain free” after 2 hours. Both Sumatriptan and Rizatriptan are competitors for the same indication, though
neither are widely marketed because they are generic drugs.

Ondansetron
is an anti-emetic that is available in oral and intravenous form. An Ondansetron sublingual spray formulation (the “Ondansetron
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.

We
currently do not have strategy and development plans for the Spray Formulations licensed from Benuvia. 

Background

We
were incorporated in Delaware on March 19, 2021. On August 10, 2022, we entered into the Contribution Agreement