Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 72

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 72
---
 Agreement. We are dependent on the Benuvia License Agreement, and the termination
of the Benuvia License Agreement could have an adverse effect on our business.

On
December 23, 2023, we entered into the Benuvia License Agreement for the Diclofenac Spray Formulation, the Rizatriptan Spray Formulation
and the Ondansetron Spray Formulation, 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. Ondansetron is an anti-emetic that is available
in oral and intravenous form. 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. If we breach the Benuvia License Agreement, Benuvia may be able to terminate it, and as a result of this termination,
our business could be negatively impacted.

42 

If
Benuvia does not properly maintain or enforce the intellectual property underlying the Benuvia License Agreement, our competitive
position and business prospects could be harmed. Benuvia may also seek to terminate our license.

We
are a party to the Benuvia License Agreement. To this end, we are dependent on our license with Benuvia. Our success will depend
in part on the ability of Benuvia to obtain, maintain and enforce its licensed intellectual property. Benuvia may not successfully
prosecute any applications for or maintain intellectual property to which we have licenses, may determine not to pursue litigation
against other companies that are infringing such intellectual property, or may pursue such litigation less aggressively than we
would. Without protection for the intellectual property we license, other companies might be able to offer similar products for
sale, which could adversely affect our competitive business position and harm our business prospects. If we lose any of our right