Company: PTHS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001753926-25-001764
Chunk: 114

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 1
Chunk 114
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 Spray Formulation may have a faster onset of analgesia; however, additional trials
may be needed to confirm this effect. Additionally, the initial pharmacokinetic study demonstrated that a 25mg dose 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.

65

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 the Company will have exclusive, worldwide rights to develop, commercialize and distribute
the Spray Formulations.

The Company currently does not have strategy
or development plans for the Spray Formulations