Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 54

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 54
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 is appropriate for our stage of development and may need to obtain higher levels prior to marketing any of our product candidates, if approved. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have an adverse effect on our business and financial condition. Also, our insurance policies may have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.

We may be sued if any of our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing, or sale post-approval. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability, or a breach of warranties. Claims could also be asserted under state consumer protection laws. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit testing and commercialization of our products. Even successful defense would require significant financial and management resources.

Liability claims, regardless of their merit or outcome, could significantly impact our operations. Such claims may delay the development of our product candidates, like JOTROL™, and prompt investigations by the FDA, EMA, or other regulatory authorities into the safety and effectiveness of our products, manufacturing processes, facilities, or marketing programs. They could lead to decreased or disrupted demand, damage our reputation, and cause the withdrawal of clinical trial participants, hindering our ability to continue trials. Defending litigation would incur substantial costs, divert management’s attention, and strain our resources. Claims could result in significant monetary awards to trial participants or patients, necessitate product recalls, withdrawals, or restrictions on labeling, marketing, or promotion, and lead to revenue loss. Furthermore, such claims could exhaust available insurance and capital resources, ultimately jeopardizing our ability to commercialize our products.

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Risks Related