Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 53

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 53
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 both in the United States and internationally, on the extent to which the costs of such product candidates will be covered and reimbursed by third-party payors. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize an adequate return on our investment. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may not successfully commercialize any product candidate for which we obtain marketing approval.

There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the United States, reimbursement decisions are often led by the Centers for Medicare & Medicaid Services (CMS), with private payors frequently following CMS’s lead. However, coverage decisions can vary among payors, and the process for obtaining coverage is often time-consuming, costly, and requires substantial scientific and clinical support. Increasingly, third-party payors demand discounts and scrutinize pricing, medical necessity, and cost effectiveness, which may result in delays or limitations in coverage, formulary restrictions, and the need for additional studies. Even with these efforts, our products may not be deemed medically necessary or cost effective, and there is no assurance that adequate reimbursement will be available.

Outside the United States, commercialization is subject to extensive price controls and market regulations, particularly in Europe and other countries with national health systems. Pricing negotiations can be lengthy, and product prices are generally lower than in the United States. Additional foreign price controls or regulatory changes could further limit the prices we can charge, potentially reducing reimbursement and revenue. If we cannot secure or maintain adequate coverage and reimbursement for our product candidates, adoption and sales may be adversely affected, and even if favorable terms are achieved initially, future changes in policies or rates could negatively impact our ability to market or sell approved products.

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Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage, such inability could have an adverse effect on our business and financial condition. If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.

Our business exposes us to significant product liability risks inherent in the development, testing, manufacturing and marketing of therapeutic treatments. We currently have product liability insurance that we believe