Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 155

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 155
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 FDA on August 16, 2017.

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The MCRI study is widely published,
Eppie M. Yiu et al., and below is a summary table of the results including the demonstrated issue with gastro-intestinal side effects
at a higher dose.

The p-value (or probability
value) is used to determine if the outcome of an experiment is statistically significant. A low p-value means that there is a very low
likelihood that this outcome was a result of luck or is a random occurrence. A high p-value means that assuming the null hypothesis is
true, this outcome was very likely. Generally, a p value less than 0.05 (or 5% odds of the event being random) is regarded as statistically
significant. The lower the P value, the less chance that the comparison is a random outcome. The FDA follows these accepted measures of
statistical probability in the evaluation of significant results in preclinical experimental outcomes and for clinical trials. In general,
if a primary endpoint in a Phase III/Pivotal trial gets a p-value below 0.05 there is a good possibility, unless there are simultaneous
safety issues, that a product may receive approval from the FDA.

The below graph representing
results of two different doses of resveratrol in the same patient population. Comparisons are made from the patients’ baseline
and was not placebo controlled. There is a clear difference between the 1 gram daily dosing versus the 5 gram daily dosing in p-values
in all areas measured. There is also a clear difference in adverse events, primarily GI related between the 2 doses. This clearly demonstrates
that the significantly higher dose is effective while the lower dose is not. However, it also shows that the high dose of the regular
resveratrol administered cause unacceptable high gastro-intestinal side effects. Therefore, we believe that our JOTROL™
product in a Phase II/II trial will replicate the positive outcomes without any severe gastro-intestinal side effects.

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JNS102 Phase II trial for Mucopolysaccharidosis Type 1 (“MPS Type I” or “MPS-I”)

JNS102 is utilizing JOTROL™
for the treatment of Lysosomal Storage disease areas whereas MPS Type I is the first target.

MPS-I is divided into three
subtypes based on severity of symptoms. All three types result from an absence or insufficient levels of the enzyme alpha-L-iduronid