Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 91

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 91
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applications related to various aspects of pain management and opioid sparing technology. Because patent applications can take
many years to issue, may be confidential for 18 months or more after filing, and can be revised before and after issuance, there
may be issued patents and patent applications now pending which may later result in issued patents that third-party asserts are
infringed by the manufacture, use, sale, or importation of our products. The biotechnology and pharmaceutical industries are characterized
by extensive and complex litigation regarding patents and other intellectual property rights. Our competitors or other third parties
may assert infringement claims against us, alleging that our therapeutics, manufacturing methods, formulations or administration
methods are covered by their patents. Moreover, we may face patent infringement claims from non-practicing entities that have
no relevant product revenue, and against whom our patent portfolio may therefore have no deterrent effect.

Third
parties may initiate legal or administrative proceedings attacking the validity of our patents protecting CC8464, CT2000, CT3000
and future compounds the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

We
may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property
rights with respect to CC8464, CT2000, CT3000 or any future compounds, or related technologies, including, for example, interference
proceedings, post grant review challenges, and inter partes review before the USPTO. For example, a third party may bring
an inter partes review challenging our patents and any future patent that may be granted to us. Such proceedings often
are used as a tactic by defendants in a patent litigation suit to threaten a patentee’s patents, both asserted in the litigation
and unasserted. Thus, a competitor, either in response to litigation initiated by us or in the ordinary course, may threaten the
validity, enforceability, and breadth of our patents which could have a negative impact on our business and render our patents
or other intellectual property rights ineffective or insufficient to prevent competition.

Instituting
and defending against patent and other types of intellectual property litigation and administrative proceedings could cause us
to spend substantial resources, distract our personnel from their normal responsibilities, and have uncertain outcomes. 

Patent
and other types of intellectual property litigation and administrative proceedings can involve complex factual and legal questions,
and their outcomes are uncertain. A finding of infringement could prevent us from manufacturing and commercializing our technologies,
including