Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 51

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 51
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 prospects.

Even if JOTROL™ is approved for the treatment of Parkinson’s Disease or other indications, it may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

Even if JOTROL™ receives regulatory approval for the treatment of Parkinson’s Disease or other indications, it may not gain adequate market acceptance among physicians, patients, third-party payors and others in the medical community, we may not generate or derive sufficient revenue from that product candidate and our financial results could be negatively impacted. The market acceptance of our approved product candidates, such as JOTROL™, will depend on several key factors. The efficacy and safety profile demonstrated in clinical trials compared to alternative treatments will be critical, as will the timing of market entry relative to competing products. The specific clinical indications approved, along with any regulatory restrictions like boxed warnings, contraindications, or risk evaluation and mitigation strategies, could impact acceptance, especially if competitors face fewer restrictions. The perceived advantages, cost relative to other treatments, and suitability for combination therapies will also influence adoption. Convenience and ease of administration, as well as the willingness of patients, caregivers, and physicians to embrace novel therapies, will play significant roles. Securing coverage and adequate reimbursement from third-party payors, including government authorities, is essential, as is patients’ willingness to pay out-of-pocket if coverage is lacking. Effective sales and marketing efforts, support from key opinion leaders and patient advocacy groups, and avoiding unfavorable publicity will further drive acceptance. Finally, the approval of other therapies for the same indications could challenge our product candidates’ market position.

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The patient population suffering from MPS I, Friedreich’s ataxia, and MELAS is small and has not been established with precision. If the actual number of patients is smaller than we estimate, our revenue and ability to achieve profitability may be adversely affected. Because the target patient populations of our programs are small and the addressable patient population may be even smaller, we must be able to successfully identify patients and capture a significant market share to achieve profitability and growth.

MPS I, Friedreich’s ataxia, and MELAS are rare, genetic neuromuscular disorders. We estimate that MPS I occurs in approximately one in every 100,000 live births and that the patient population is approximately 2,000 to 3,000 in the United States and approximately 4,000 in Europe. Friedreich’s ataxia has a higher incidence of approximately 1 in