Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 40

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 40
---
, we could experience significant delays or an inability to successfully commercialize JOTROL™, which would materially harm our business. If we do not receive marketing approvals for JOTROL™, we may not be able to continue our operations.

In addition to JOTROL™, our prospects depend in part upon discovering, developing and commercializing product candidates in future programs, which may fail or suffer delays that adversely affect their commercial viability.

Our future operating results are dependent on our ability to successfully develop, obtain regulatory approval for and commercialize product candidates from our research programs, in addition to our lead product candidate, JOTROL™. However, research and development related to novel therapeutics is inherently risky. A product candidate can unexpectedly fail at any stage of preclinical and/or clinical development. The historical failure rate for product candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards of medical care and other unpredictable variables. The results from preclinical testing or early clinical trials of a product candidate may not be predictive of the results that will be obtained in later stage clinical trials of the product candidate.

The success of our future product candidates hinges on several key factors. We must generate sufficient data to justify starting or continuing clinical trials and secure regulatory approval to initiate them. Contracting with the right parties to conduct these trials, successfully enrolling patients, and completing trials on time are critical. Additionally, we need to ensure the timely manufacture of adequate quantities of product candidates for clinical use while minimizing adverse events during trials.

Even if we successfully discover and advance any other product candidates into clinical development, their success will be subject to all of the clinical, regulatory and commercial risks described elsewhere in this “ Risk Factors” section. Accordingly, we cannot assure you that we will ever be able to discover, develop, obtain regulatory approval of, commercialize or generate significant revenue from any product candidates.

| 22 |

Clinical drug development involves a lengthy and expensive process with an uncertain outcome. The clinical trials of our product candidate may not demonstrate safety and efficacy to the satisfaction of the FDA, EMA or other comparable foreign regulatory authorities or otherwise produce positive results and the results of preclinical studies and early clinical trials may not be predictive of future results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

Our lead product candidate, JOTROL™, is entering into Phase II clinical trials after completing a Phase I clinical trial in March 2021 and its risk of failure is