Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 6

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 6
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”
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.

4 

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.

Our
Strategy

We
are a clinical-stage pharmaceutical company focused on non-opioid pain blockers in the NaV space. Our development programs are
initially designed to address the underlying condition and mitigate the pain associated with neuropathic pain and eye pain. The
key elements of our strategy to achieve our mission are:

●Develop
                                         CT2000 for the treatment of eye pain. According to a presentation at the Association
                                         for Research in Vision and Ophthalmology, with the abstract published in the publication,
                                         Investigative Ophthalmology and Visual Science in June 2020, NaV1.7 receptor is present
                                         on the cornea and as such, is a viable biological target for treating eye pain. We have
                                         developed a number of topical ophthalmic formulation of CT2000 that are being evaluated
                                         for ophthalm