Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 164

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 164
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 which there is an unmet medical
need and have a “clinically meaningful” outcome. Drugs that are eligible for this pathway must be reasonably likely to improve
a surrogate endpoint if a standard endpoint would require long-term evaluation. If given conditional approval, the sponsor must conduct
post-marketing clinical trials to ensure endpoints are met. If the standard endpoints are not met, the FDA can withdraw approval.

Breakthrough Therapy

This designation is designed
to expedite the development and review of drugs that are intended to treat serious conditions and preliminary clinical evidence indicates
that the drug may demonstrate substantial improvement over available therapies on clinically significant endpoints.

There is, however, no guarantee
that an accelerated pathway will lead to an accelerated FDA review and that a pediatric approval leads to a PRV. Additionally, there can
be no guarantee that the Company can be successful in its plans under any FDA pathway.

Research Agreement

On July 1, 2022, the Company
entered into a research agreement with the University of Miami to conduct a preclinical study to evaluate the effect of JOTROL™
in Parkinson’s Disease models. The cost of the research agreement activities, paid by the Company, was $72,844. The study was completed
in February of 2023.

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Asian Business Development Activities

We have entered into service
agreements in the areas of CMC, regulatory affairs and clinical trial management with companies with operations in South-East Asia. These
agreements are with companies that, we believe, have the knowledge and network in the South-East Asian market. The agreements are further
described in the section “Other Material Agreements”. In addition, we are in active negotiations with Dominant Treasure Health
(“DTH”), a BVI company. DTH has demonstrated to us, through several company introductions, that they have business relationships,
either directly or through affiliates, with many Southeast Asian pharmaceutical companies as well as companies involved in distribution
and sales of TCM, Traditional Chinese Medicine. We are therefore planning to engage DTH in active business development in China, Malaysia
and Singapore as soon as we have financing in place for their engagement. DTH has already introduced us to 3 Chinese companies, Beimei
Pharma, http://en.beimeiyaoye.com, that specializes in pediatric medications, Sichuan Kelun Pharmaceutical Co., Ltd., a publicly traded
company that is part of the Kelun Industrial Group, https://www.kelun.com/, and Tianjin Pharmaceuticals,