Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 162

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 162
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 Society,
UMDF, www.umdf.org, and the EveryLife Foundation in USA. However, formal relationships with such organizations may never come to fruition.

We have been approached by
several large and mid-size pharmaceutical companies discussing future collaborations once we have more clinical data available. We will
try to utilize this interest by out-licensing primarily in the Asian territories while waiting to conduct out-licensing in the USA and
Europe until after Phase II results are obtained.

We have participated in several
industry trade shows, such as Biotech Showcase, BIO USA, LSX World, World Orphan Congress, World Symposium for LSD, BIO Hong Kong 2023
and many others. We plan to continue to participate in those conferences as well as conferences targeting presentations by publicly traded
companies.

Operation and Organization

We are, and plan to stay,
primarily a virtual organization utilizing partnership arrangements for certain functions including but not limited to our R&D, clinical
trial work, regulatory affairs and product manufacturing. A core organization is in place and will be expanded handling Strategy, Project
Management, Clinical Trial Management, Regulatory Affairs, Finance and Business Development. We believe that our core management team
structure has proven experience in utilizing outside resources which allows us to efficiently execute several programs simultaneously
in what we believe to be a very cost-effective way.

Regulatory Approval

Our management, Scientific
Board of Advisors and business advisors have extensive experience in regulatory affairs and clinical development of product candidates
for the treatment of rare diseases, Parkinson’s Disease and Alzheimer’s disease. The overall regulatory approval process for
product candidates for the treatment of rare diseases are generally conducted with a smaller number of patients in clinical trials and
over a shorter amount of time than more prevalent diseases. There is a documented pathway to get accelerated FDA approval for a rare disease
indication if there is no existing treatment for the indication, if a product shows efficacy and has a good safety profile. There is also
a possibility of receiving a Priority Review Voucher (“PRV”) from the FDA upon approval in pediatric population in a rare
disease. One or more of our programs, such as MPS-I, will be targeting pediatric patients. The voucher entitles the bearer to regulatory
review in about six months rather than the standard ten months. The FDA awards a voucher following approval of a treatment for a neglected
disease, rare pediatric disease, or medical countermeasure. Two drugs can receive priority review for each voucher: the drug winning a
voucher for a neglected or rare pediatric