Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 39

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 39
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OTROL™. We have several pre-clinical trials and one completed Phase I clinical trial to evaluate the safety and tolerability of JOTROL™ in healthy volunteers. We are preparing for Phase II clinical trials. This will be our first clinical efficacy trial, and JOTROL™ has not previously been tested in humans with a specific disease although we can rely on data that exist for resveratrol. The reason for this is that once JOTROL™ is ingested the formulation excipients will be separated and it is only the active resveratrol that will be circulating in blood plasma. JOTROL™ will require additional clinical development, expansion of manufacturing capabilities, marketing approval from government regulators, substantial investment and significant marketing efforts to obtain established distributors before we can generate any revenues from product sales. We are not permitted to market or promote JOTROL™, or any other product candidate, before we receive marketing approval from the FDA and comparable foreign regulatory authorities, and we may never receive such marketing approvals.

The success of JOTROL™ depends on multiple factors. Timely completion of ongoing clinical trials, along with the initiation, enrollment, and completion of additional trials, is critical. Establishing and maintaining relationships with contract research organizations and clinical sites will support JOTROL™’s development. The frequency and severity of adverse events in trials, as well as demonstrating efficacy, safety, and tolerability satisfactory to the FDA, EMA, or other regulatory authorities, are essential for securing timely marketing approvals. Post-approval commitments, maintaining supply arrangements with third-party manufacturers, and obtaining robust patent, trade secret, and regulatory exclusivity protections both in the U.S. and globally are also vital. Protecting our intellectual property, expanding JOTROL™’s indications, and finding partners to manage commercialization will drive success. Following approval, achieving a successful commercial launch, maintaining an acceptable safety profile, and gaining acceptance from patients, the medical community, and third-party payors—especially given JOTROL™’s novel nature—will be key. Additionally, accurately assessing the market size and patient demographics, while competing effectively with other therapies, will significantly impact JOTROL™’s commercial viability.

We do not have control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any future collaborator. If we are not successful with respect to one or more of these factors in a timely manner or at all