Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 63

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 63
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 lowering the cost of healthcare. These and any further changes in the law or regulatory framework that reduce our revenue or increase our costs could also have a material and adverse effect on our business, financial condition and results of operations.

We expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our product candidates. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for biotechnology products. We cannot be sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition, increased scrutiny by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.

We are subject to extensive regulation for privacy and personal information under US and foreign law and failure to comply could have a material adverse effect on our Company

The regulatory framework for privacy and personal information security issues worldwide is rapidly evolving and is likely to remain uncertain for the foreseeable future. The U.S. federal and various state, local and foreign government bodies and agencies have adopted or are considering adopting laws and regulations limiting, or laws and regulations regarding, the collection, distribution, use, disclosure, storage, security and other processing of personal information.

In the European Union, the General Data Protection Regulation (GDPR) imposes substantial obligations and severe penalties for non-compliance, with its reach extending beyond the EU. The invalidation of the EU-U.S. Privacy Shield and ongoing questions about the use of Standard Contractual Clauses have complicated data transfers between the EU and the U.S., potentially increasing operational costs and restrictions. Brexit has introduced further uncertainty regarding UK data protection laws, as the UK is now treated as a third country under the GDPR. The evolving regulatory environment in both the UK and EU may increase compliance risks and costs for our business, particularly concerning cross-border data transfers and ongoing alignment of privacy standards.

In the United States, there are a broad variety of data protection laws and regulations that may apply to our activities