Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 54

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 54
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 be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. Additionally, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending itself or asserting our rights, those actions could have a significant impact on our business and financial results, including, without limitation, the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, reputational harm, diminished profits and future earnings, and curtailment of our operations.

Risks Related to Intellectual Property

We rely on in-licenses from third parties. If we lose these rights, our business will be materially and adversely affected, our ability to develop improvements to our technology platform may be negatively and substantially impacted, and if disputes arise, we may be subjected to future litigation, as well as the potential loss of or limitations on our ability to incorporate the technology covered by these license agreements.

On March 24, 2025, LNHC assigned its IP
portfolio related to the Novan acquisition, including the NITRICIL technology, to Ligand and entered into an exclusive license
and sublicense agreement with Ligand, pursuant to which Ligand licensed to LNHC the intellectual property rights necessary to make,
use, sell or offer to sell ZELSUVMI for the treatment of molluscum contagiosum in humans worldwide, except for Japan. This license
agreement imposes various diligence, milestone payment, royalty, insurance, and other obligations on us, while also granting us
the rights to certain patents related to our products. We are substantially dependent on the in-licenses of ZELSUVMI and other
intellectual property to conduct our business.

In spite of our efforts to comply with
our obligations under our in-license agreements, our licensors might conclude that we have materially breached our obligations
under our license agreements and might therefore, including in connection with any aforementioned disputes, terminate the relevant
license agreement, thereby removing or limiting our ability to develop and commercialize technology covered by these license agreements.
If any such in-license is terminated, or if the licensed patents fail to provide the intended exclusivity, competitors or other
third parties might have the freedom to market or develop technologies similar to ours.

In some circumstances, we may not have the right to