Company: PTHS
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001753926-25-001764
Chunk: 113

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 1
Chunk 113
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 and damages the TBC Landlord may suffer
as a result of any default by the Company under the TBC Lease.

Contract Manufacturing Agreement

In February 2025, LNHC entered into a non-exclusive
Contract Management Agreement with Orion to manufacture and assemble various components related to the ZELSUVMI commercial drug
product, including the final fill/finish process and product packaging. This agreement has an initial period of five years, with
automatic two-year renewal periods thereafter, unless a notice of non-renewal is provided by either party. This commercial supply
agreement includes customary terms governing the manufacture of the ZELSUVMI drug product, including but not limited to, a quality
agreement governing the manufacture and quality control of the drug product, required periodic forecasting and demand planning/production
scheduling, periodic non-binding, and binding purchase commitments, including minimums, and pricing and cost parameters.

Benuvia License Agreement

On December 23, 2023, the Company entered
into an exclusive licensing agreement (the “Benuvia License Agreement”) with Benuvia for a sublingual formulation of
a Diclofenac spray for the treatment of acute pain, a Rizatriptan intranasal spray formulation and an Ondansetron sublingual spray
formulation (collectively, the “Spray Formulations”). The Spray Formulations diversify 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. A single Phase 1 trial of the Diclofenac Spray Formulation was completed in 24 healthy volunteers wherein a single dose of
50mg diclofenac-potassium was compared to 25 mg of Diclofenac Spray Formulation. In this trial, the blood plasma concentrations
of Diclofenac rose more quickly with the Diclofenac Spray Formulation than with the diclofenac administered orally by approximately
15 minutes. This suggests that the Diclofenac