Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 164

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 164
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 vulnerabilities. Additionally, federal and state consumer protection laws are increasingly being applied by FTC and states’ attorneys general to regulate the collection, use, storage, and disclosure of personal or personally identifiable information, through websites or otherwise, and to regulate the presentation of website content.

Compliance with applicable data privacy and security laws, rules and regulations could require LNHC to take on more onerous obligations in its contracts, require LNHC to engage in costly compliance exercises, restrict its ability to collect, use and disclose data, or in some cases, impact LNHC’s or its partners’ ability to operate in certain jurisdictions. Each of these constantly evolving laws can be subject to varying interpretations, and may conflict with one another or other legal obligations with which LNHC must comply. Any failure or perceived failure by LNHC or its employees, representatives, contractors, consultants, collaborators, or other third parties comply with any such laws, rules, or regulations, or adequately address privacy and security concerns, even if unfounded, could result in government investigations and/or enforcement actions, fines, civil or criminal penalties, private litigation or adverse publicity that could adversely affect LNHC’s business, financial condition and results of operations.

If plaintiffs bring product liability lawsuits against LNHC or its partners, LNHC or its partners may incur substantial liabilities and may be required to limit commercialization of LNHC’s approved products and product candidates.

As is common in LNHC’s industry, LNHC and its partners face an inherent risk of product liability as a result of the clinical testing of LNHC’s product candidates in clinical trials and face an even greater risk for commercialized products. Although LNHC is not currently a party to product liability litigation, if LNHC is sued, it may be held liable if any product or product candidate it develops causes injury or is found otherwise unsuitable during product testing, manufacturing, marketing or sale. Regardless of merit or eventual outcome, liability claims may result in decreased demand for any product candidates, partnered products or products that LNHC may develop, injury to LNHC’s reputation, discontinuation of clinical trials, costs to defend litigation, substantial monetary awards to clinical trial participants or patients, loss of revenue and product recall or withdrawal from the market and the inability to commercialize any products that LNHC develops. LNHC’s parent, Ligand, has product liability insurance that covers its clinical trials up to a $15.0 million annual limit. LNHC’s insurance coverage may not be sufficient to cover all of LNHC’s product liability-related expenses or losses and may not cover