Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 150

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 150
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 expected within
12 months of first dosing.

JNS108 Mild Cognitive Impairment/Early Alzheimer’s Disease

The Company had previously
conducted studies which used JOTROL™ in our applications for investigating treatment of various segments of Alzheimer’s
disease of which MCI/early AD is the initial target.

The National Institute on
Aging (“NIA”) financed the Company’s Phase I study with $1.76 million through grant 1R44AG067907-01A1. Since there
were unanticipated higher costs, mostly due to Covid-19 related additional procedures during the Phase I trial, a supplemental grant
of $233,281 was submitted to the NIA in December of 2021. We were awarded the supplemental grant on April 7, 2022. In April 2021, we
submitted our first grant application to the NIA for full funding of a Phase II trial in MCI and early Alzheimer’s disease. The
Phase II trial was designed to focus on 3 areas: (1) safety and tolerability; (2) pharmacokinetics and pharmacodynamics, measuring of
responses from 2 different doses versus a placebo; and (3) measuring of effect on multiple biomarkers related to the disease. The application
was not accepted, but we were encouraged by the NIA to refine our application and submit again. We have since submitted 3 grant applications,
with budgets of $20 million or higher, to the NIA for full funding of such Phase II trial but none of those applications were successful.
The NIA scientific review of our Alzheimer’s Phase II trial grant application shows a total score of 47 which is our best score
so far. A score of 40 or below is necessary for being considered for funding. After discussions with the NIA, we have decided to apply,
in September of 2024, for a much smaller grant, $2.5 million, for a proof of concept study focusing on JOTROL™’s effect
on validated biomarkers. In May 2025, the Company announced that it will not receive this grant. The Company intends to use the biomarker
data that it obtains from the Phase IIa clinical trial for Parkinsons Disease and reapply for a grant next year, but we still may never
receive any future grants or cost savings.

Early-stage Alzheimer’s (MCI)

Later stages of Alzheimer’s
are very difficult to reverse and therefore it is important to start treatment of Alzheimer’s