Company: PTHS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001753926-25-000790
Chunk: 42

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 1
Chunk 42
---
 2024 in the matter Alexandra Wood (Canada) Inc v. Chromocell Corp., Index No. 651735/2024. AWI subsequently
transferred 173,000 shares of Chromocell Holding’s shares of Common Stock that it received such that AWI now owns 574,187
shares of the Common Stock originally issued to Chromocell Holdings in connection with the Contribution Agreement.

28

Trends
and Other Factors Affecting Our Business

On
December 23, 2023, we entered into an exclusive licensing agreement (the “Benuvia License Agreement”) with Benuvia
Operations LLC (“Benuvia”) for the Diclofenac Spray Formulation (as defined below), an intranasal spray formulation
of Rizatriptan and an Ondansetron sublingual spray formulation (collectively, the “Spray Formulations”), diversifying
our pipeline of non-opioid pain treatment therapies, while adding therapeutic options for related conditions. The sublingual formulation
of a Diclofenac spray for the treatment of acute pain (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