NASDAQ: JUNS
JUPITER NEUROSCIENCES, INC.CIK 0001679628 · Health Care · SIC 2834 · Pharmaceutical Preparations
This Business section, along with other sections of this Annual Report on Form 10-K, includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research,… About this business →
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Latest financial statements
From 10-Q filed May 14, 2026 (period ending Mar 31, 2026). SEC XBRL (companyfacts) — not generated by the model.
Consolidated Statements of Operations (Unaudited)
| Description | Q1 ended Mar 31, 2026 | Q3 ended Sep 30, 2025 |
|---|---|---|
| Revenue: | ||
| Total revenue / net sales | 0.02 | |
| Cost of revenue / cost of sales | — | |
| Gross profit | 0.01 | |
| Operating expenses: | ||
| Research and development | 0.4 | 0.8 |
| General and administrative | 1.6 | 1.5 |
| Selling, general and administrative | 1.6 | |
| Total operating expenses | 2.0 | 2.3 |
| Operating income | (2.0) | (2.3) |
| Interest expense | 0.1 | — |
| Other income/(expense), net | (0.10) | 0.01 |
| Net income | (2.1) | (2.3) |
| Basic earnings per share | (0.06) | (0.07) |
| Diluted earnings per share | (0.06) | (0.07) |
Consolidated Balance Sheets (Unaudited)
| Description | Mar 31, 2026 | Dec 31, 2025 |
|---|---|---|
| Current assets: | ||
| Cash and equivalents | 2.4 | 3.8 |
| Inventories | 0.1 | 0.2 |
| Prepaid expenses and other current assets | 0.1 | 0.1 |
| Other current assets | 0.8 | 0.8 |
| Total current assets | 3.4 | 4.8 |
| Operating lease right-of-use assets, net | 0.01 | 0.02 |
| Deferred income taxes and other assets | — | — |
| Other long-term assets | 0.5 | 0.7 |
| TOTAL ASSETS | 3.9 | 5.6 |
| Current liabilities: | ||
| Current portion of operating lease liabilities | 0.01 | 0.02 |
| Other current liabilities | 6.7 | 7.4 |
| Total current liabilities | 6.7 | 7.4 |
| Total liabilities | 6.7 | 7.4 |
| Shareholders' equity: | ||
| Common stock | — | — |
| Capital in excess of stated value | 33.9 | 32.8 |
| Retained earnings (deficit) | (36.7) | (34.7) |
| Total shareholders' equity | (2.8) | (1.8) |
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 3.9 | 5.6 |
Consolidated Statements of Cash Flows (Unaudited)
| Description | Q1 ended Mar 31, 2026 | Nine months ended Sep 30, 2025 |
|---|---|---|
| Operating Activities: | ||
| Net cash from operating activities | (1.4) | (3.0) |
| Financing Activities: | ||
| Net cash from financing activities | 0.01 | |
| Net increase/(decrease) in cash | (1.4) | (3.0) |
Amounts in millions USD; EPS as reported. Line labels are presentation-friendly mappings of filer XBRL tags — not a re-audit of the full statements. Use EDGAR for interactive notes and detail. Interactive statements & notes on EDGAR ↗
About JUPITER NEUROSCIENCES, INC.
Source: Item 1 (Business) from the 10-K filed April 1, 2026. Description as filed by the company with the SEC.
ITEM 1. BUSINESS
This Business section, along with
other sections of this Annual Report on Form 10-K, includes statistical and other industry and market data that we obtained from industry
publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and
studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee
the accuracy or completeness of such information. While we believe that these industry publications and third-party research, surveys
and studies are reliable, we have not independently verified such data and we do not make any representation as to the accuracy of the
information. Unless the context otherwise requires, “JNS,” “we,” “us,” “our,” or the
“Company” refers to Jupiter Neurosciences, Inc., a Delaware corporation.
Overview
Jupiter Neurosciences, Inc. (the
“Company,” “we” or “us”) is a clinical stage research and development company focused on
developing treatments for neuroinflammation through our unique resveratrol platform. Our platform product, JOTROL™, is an
enhanced oral formulation of resveratrol, which has many potential indications. In the larger disease areas, we are primarily
targeting Parkinson’s Disease. We are presently in the process of conducting a Phase IIa clinical trial in Parkinson’s
Disease.
In March 2025, the Company unveiled a new strategic
initiative to introduce Nugevia — a consumer-oriented product line dedicated to longevity and wellness. This initiative aims
to meet the rising demand for wellness solutions by developing nutritional products that support both consumer health and wellness.
The Company completed the formulations and initial sales through direct-to-consumer (“DTC”) social media began in the
second half of the year.
Read full description ↓
In December 2024, we received gross proceeds of $11
million in a registered public offering (the “Public Offering”) of 2,750,000 shares of our common stock, par value $0.0001 per share (“common stock”) at a price of $4.00 per share for gross proceeds of $11 million before deducting
underwriting discounts and other related expenses. In connection with the Public Offering, the Company’s common stock was
registered under Section 12(b) of the Exchange Act and began trading on The Nasdaq Capital Market under the symbol
“JUNS.”
The Company was incorporated in January 2016 under Delaware
law under the name of Jupiter Orphan Therapeutics, Inc. On August 30, 2021, the Company filed a Certificate of Amendment with the State
of Delaware to change its name to Jupiter Neurosciences, Inc.
Business Overview
Jupiter
Neurosciences, Inc. is a clinical stage research and development pharmaceutical company located in Jupiter, Florida. The Company is
advancing a therapeutic pipeline targeting central nervous system (“CNS”) disorders and rare diseases, while also
expanding into the consumer market with its Nugevia™ product line. Both efforts are powered by JOTROL™, Jupiter’s
proprietary, enhanced resveratrol formulation that has demonstrated potential for significantly improved bioavailability in an FDA
regulated Phase I study. The Company’s therapeutic development pipeline is focused broadly on CNS disorders, presently with a
Phase IIa clinical study in Parkinson’s disease. The Company’s Nugevia product line brings cutting edge science to the
supplement space, supporting mental clarity, skin health, and mitochondrial function.
The
Company completed preclinical studies at the University of Miami for Parkinson’s Disease in 2021. These studies used a
validated mouse model to mimic human disease characteristics. JOTROL™ demonstrated consistent improvements in motor
coordination, endurance, and strength across multiple endpoints in a validated Parkinson’s disease model, with statistically
significant benefits versus untreated disease controls. The promising results have led the Company to initiate a Phase IIa
clinical trial for Parkinson’s Disease, which received final IND approval by the FDA in November of 2025 and is expected to
start in the second quarter of 2026, with results anticipated 12 months later. The Company also aims to investigate other CNS
indications, such as Mild Cognitive Impairment (“MCI”) and Alzheimer’s disease, following the Parkinson’s
study.
The Company
believes, based on pre-clinical and clinical studies, that high doses of resveratrol are necessary for potential therapeutic
effects. Currently available resveratrol products cannot reach these levels without causing severe gastrointestinal side effects.
Human studies evaluating resveratrol in Alzheimer’s patients (Turner et al 2015) and Friedreich’s Ataxia patients (Yu et
al 2015) indicate the concentration of resveratrol at its peak (CMax) measured in blood plasma should be 300 ng/ml
or higher for a potential therapeutic effect. A Phase 1 study with 500mg of resveratrol as a maximum dose in the JOTROL™
formulation showed levels of resveratrol exceeding 800 ng/ml without generating any severe adverse events (AAPS Open 2022).
Resveratrol was shown in the Turner Alzheimer’s study to cross the blood-brain barrier, possibly indicating a potential for
positive effects on oxidative stress and inflammation. Subsequent analysis published in Molecular Science 2025 (Mousa et al) further
indicates that resveratrol may have an impact on neurodegeneration and neuroinflammation in Alzheimer’s patients.
Over the past
two years, JOTROL™ has garnered significant interest from Asian organizations. This interest is partly due to resveratrol’s
use in Asian herbal medicines, recent patent approvals in Hong Kong and China, and China’s list of rare disease indications where
JOTROL™ could be applicable. Additionally, recent publications in the Journal of Alzheimer’s Disease and AAPS Open, along
with the projected growth of the Traditional Chinese Medicine market, have contributed to this interest.
The Company has
entered service agreements with firms in Hong Kong to accelerate product development in Southeast Asia. These agreements aim to leverage
local expertise and networks to facilitate market entry and potential out-licensing deals. The Company entered into an agreement with
Dominant Treasure Health to expand its business development in China, Malaysia, and Singapore, aiming to penetrate the large and challenging
Asian market.
In March 2025, the Company unveiled
a new strategic initiative to introduce Nugevia—a consumer-oriented product line dedicated to longevity and wellness. This
initiative aims to meet the rising demand for scientifically backed wellness solutions by developing nutritional products that
support both longevity and health span. Positioned within a rapidly growing global industry expected to reach $8 trillion by 2030,
Nugevia products will leverage Jupiter’s proprietary JOTROL™ technology, a resveratrol-based platform that is designed
to deliver an increase in the bioavailability profile of resveratrol.
1
The first
products under the Nugevia brand, focusing on supporting longevity and health span are available for sale and shipments began in the
fourth quarter of 2025 through a DTC model. The products are:
●
Nugevia GLO (“GLO”),
which helps promote and support cellular functions and skin vitality;
●
Nugevia MND (“MND”), which supports cognitive resilience; and
●
Nugevia PWR (“PWR”), which helps support mitochondrial function, which is a key for sustained growth and performance.
The three debut
formulations—GLO, MND, and PWR—are designed to support wellness and longevity through intelligent stacking of synergistic ingredients,
all enhanced for optimal absorption via the JOTROL™ system.
The Company plans
to market these products in the U.S. and internationally.
Nugevia’s
launch is a pivotal move to monetize Jupiter’s proprietary science, support ongoing clinical trials, and capture a share of the
booming longevity market.
The Company operates through two segments:
(i) the sale of premium nutritional supplements under the Nugevia brand, and (ii) pharmaceutical operations centered on the development
of drug candidates.
Resveratrol
Resveratrol, a natural antioxidant compound found in foods like red grapes and berries, has been studied for over
50 years by academic institutions as well as by small and large pharmaceutical companies. The multi-functional mechanisms of resveratrol
are well documented in over 20,000 scientific publications. Several of these publications, including a summary paper by AY Berman et al,
published in Precision Oncology 2017, point to the issue of the poor bioavailability that has stopped medical utilization of regular resveratrol
and never received regulatory approval for any indication. We believe the Phase I study we have conducted indicates that we have resolved
the poor bioavailability issue with JOTROL™.
2
Based upon available scientific
literature, it appears that resveratrol is an activator of SIRT1, one of the mammalian forms of the sirtuin family of proteins.
SIRT1 deacetylates histones and nonhistone proteins including transcription factors. The SIRT1-regulated pathway is believed to
affect metabolism, stress resistance, cell survival, cellular senescence, inflammation/immune function, endothelial functions, and
circadian rhythms. Resveratrol has been documented in scientific literature to activate SIRT1, NrF2, NLRP3 inflammasomes and have an
epigenetic mechanism, and therefore, is predicted to benefit diseases affected by abnormal metabolic control, inflammation, and cell
cycle defects. Nonetheless, the administration of currently available resveratrol poses a major challenge for the
pharmaceutical industry, due to its poor solubility and bioavailability, as well as severe gastro-intestinal side effects when taken
at effective dose levels (over 2,000 mg daily).
JOTROL™
JOTROL™ was developed together
with our technology partner Aquanova, headquartered in Darmstadt, Germany. JOTROL™ is formulated with a unique patented
micellar technology that is projected to increase the bioavailability profile of resveratrol. Manufacturing technology transfers
were completed in 2017, and manufacturing procedures and clinical trial supply manufacturing have been completed at Catalent
Pharmaceutical Services, Inc. (“Catalent”), St Petersburg, Florida. Catalent has also completed the manufacturing of the clinical trial supplies for our Phase IIa trial in Parkinson’s Disease.
JOTROL™ is a micellar non-aqueous
solution of resveratrol delivered in a softgel capsule. Each capsule includes 100mg of resveratrol. Pre-clinical trials in mice and rats
were conducted comparing JOTROL™ to micronized resveratrol, labeled to have the highest bioavailability in the nutritional market,
to demonstrate that we could achieve a significantly higher bioavailability. A Phase I dose finding pharmacokinetic (“PK”)
study in healthy volunteers was completed during the first half of 2021. The study results met our targeted goals.
The
Phase I study demonstrated JOTROL™’s potential for higher bioavailability compared to resveratrol used in earlier
clinical trials (e.g., Turner, MCI/Early Alzheimer’s Disease trial and Yui et al., Friedreich’s ataxia trial). The
results of this Phase 1 study were published in the Journal of Alzheimer’s diseases and AAPS Open in February 2022. Subject to
additional discussions with and approval from FDA, we hope to use the results of this study as a cross-reference for other
indications to allow JOTROL™ to be tested in Phase II and Phase III clinical trials. FDA accepted this cross-reference in the
approval of the IND application for the Parkinson’s Phase IIa trial. The Company has not discussed the use of
cross-referencing in this manner with the FDA or other comparable regulatory authorities for any other indications, and FDA (or any
comparable regulatory authorities) may preclude us from the use of cross-referencing with respect to the results of this study. As a
result, we are presently unable to rely on potential cross-referencing other than the already cleared Phase II a Parkinson’s
study.
JOTROL™ Intellectual Property and License Agreement
We hold an exclusive global license
dated from Aquanova for micellar technologies to develop, manufacture, and sell JOTROL on the terms set forth in the license
agreement. Our Chief Scientific Officer (“CSO”), Marshall Hayward, and Aquanova’s founder, former CEO, and lead
scientist, Darius Benham, invented JOTROL™. The patent is co-owned by Aquanova and us, with the application assigned to
Aquanova. Filed in Germany on January 29, 2017, the patent (PCT/EP2017/O51659) expires in 2036 and is granted in the USA, Japan,
China, Hong Kong, and specific European countries. The patent covers a solubilization product with resveratrol, polysorbate 80 and
20, MCT, and tocopherols for pharmaceutical use. It includes claims on formulation specifics, micelle size, turbidity, and treatment
applications for diseases like Alzheimer’s and diabetes. The product is available in various capsule forms and is administered
orally.
Our license agreement with Aquanova is
vital, as JOTROL™ is our primary product. Losing this agreement would delay our plans and force us to seek similar licenses, if
available, adversely affecting our business. The agreement grants us worldwide exclusivity to utilize granted and pending patents. Effective
from September 15, 2016, it lasts until patent expiration or ten years after the first commercial sale. We paid an upfront fee of $20,000
and an annual license fee of $75,000 until the first product approval. Milestone payments of $200,000 are due per territory upon regulatory
approval, with royalties set at 5% of net sales. Each party has the option, within 180 days of a US Marketing approval, to demand that
the Company pay a one-time payment of $3 million for reduced royalties of 1.25%. Termination can occur due to material breach or insolvency,
with specific provisions for retaining licenses. Recent amendments include a Debt Forgiveness and Exchange Agreement on December 1, 2021,
where $225,000 of debt was forgiven in exchange for $125,000 cash, a $100,000 promissory note, and stock options.
The Company relies on trade secret
protection and contractual confidentiality obligations to safeguard certain proprietary know-how related to JOTROL™. The Company
also asserts common law trademark rights in the JOTROL™ name. In January 2025, the Company filed an intent-to-use trademark application
with the U.S. Patent and Trademark Office
3
Product Pipeline
The Company’s pharmaceutical product
pipeline is built around its proprietary platform product, JOTROL™ an enhanced oral formulation of resveratrol. Resveratrol, a natural
compound is optimized in JOTROL™, which is being evaluated to better understand its therapeutic benefits and its potential relevance
to biological pathways of interest, including those involving oxidative stress, inflammation and mitochondrial issues linked to neurological
conditions. The Company has designated the different indications with project numbers, JNS101 - JNS115. The same JOTROL™ product
is planned to be used in all indications although the number of capsules might vary and be indication specific and may be impacted by
regulatory requirements and other factors not known to us at this time.
The pipeline chart above shows the indications
that we presently are prioritizing and is subject to the availability of financing as further discussed in the “Risk Factors” section.
The validity of our product pipeline represented
above relies on the assumptions drawing upon previous preclinical and clinical data conducted by third parties. This data is available
either via public domain or under agreements with our key partners. The Company has not discussed with the FDA its ability to rely on
and reference data from previous third-party trials, such as the Phase II trial in MCI/early Alzheimer’s disease, conducted by Georgetown
University.
Our top priorities are advancing our
clinical studies for JNS115 for Parkinson’s Disease followed by JNS108 for MCI/early Alzheimer’s Disease. We executed all
CMC, regulatory, and preparations with investigators including IND approval by FDA for our JNS115 Phase IIa trial and estimate that
first dosing of patients will occur in the second quarter of 2026. We are also exploring clinical trials of JOTROL for other indications,
including rare diseases. Based on the FDA’s approval to use our Phase I study in support of the IND for our Phase IIa Parkinson’s
study, we believe there may be potential to cross-reference the Phase I data for additional indications in the future. However, we have
not discussed this cross-referencing for any other indication with FDA, and we may be precluded from relying on cross-referencing other
than in the Phase IIa Parkinson’s study.
JNS115 Parkinson’s Disease
We will be utilizing JOTROL™ for investigating
a treatment for Parkinson’s Disease (PD).
People are usually more familiar
with the motor symptoms of Parkinson’s disease (PD), which are noticeable and used by doctors for diagnosis. The three cardinal
motor symptoms are stiffness (rigidity), slowness (bradykinesia), and resting tremors. Stiffness involves muscle rigidity detected during
examination, while slowness refers to decreased spontaneous and voluntary movement, such as slower walking or reduced facial expression.
Resting tremor is an involuntary shaking that occurs when a limb is relaxed and disappears during movement.
Non-motor symptoms, often called
the “invisible” symptoms, can affect almost every body system and vary in severity. These symptoms can significantly impact
quality of life and include autonomic dysfunctions like constipation, low blood pressure, sexual problems, sweating issues, and urinary
problems. While available therapies can treat some symptoms, there is an urgent need for better treatments to improve quality of life
and slow disease progression. Approved medications for motor symptoms include dopamine replacement therapy (levodopa/carbidopa), adenosine
receptor antagonists, amantadine, anticholinergic medications, COMT inhibitors, decarboxylase inhibitors, dopamine agonists, and MAO-B
inhibitors. Researchers are increasingly recognizing the debilitating nature of non-motor symptoms and are working on new therapies,
while doctors manage these symptoms with current treatments.
4
Upcoming Phase IIa study in Parkinson’s Disease patients
The Company has engaged Zina
Biopharmaceuticals to assist with study design, FDA communications, including submission, of an Investigational New Drug (IND)
application and to manage the execution of the trial. Catalent has been engaged to manufacture the JOTROL™ clinical trial
supplies pursuant to the Manufacturing Agreement between Company and Catalent dated September 16, 2020, under which Catalent is to
provide the Company with clinical batches of JOTROL™ using a softgel formulation, which will be for active and placebo batches
for the Parkinson’s disease study. The study design is described below and has received final IND approval by the FDA. The Company expects
to start the clinical trial in the second quarter of 2026 and have the first study results available twelve months thereafter.
The multicenter, randomized,
double-blind, placebo-controlled study involves approximately 30 participants across three centers in the US. Participants are randomly
assigned to one of three groups to receive either a placebo or JOTROL™ at doses of 200 mg or 400 mg daily for three months. The
study aims to explore JOTROL™’s potential to improve energy metabolism in Parkinson’s Disease. An optional biomarker
sub-study will assess cerebrospinal fluid, requiring additional patient consent. Each patient will be involved in the study for approximately
four to five months, while the overall study including all subsequent analyses will span approximately two years, with initial results
expected within twelve 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.
Because 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. We are planning to submit the next grant application after we have the results from
our Phase IIa study in Parkinson’s patients as several biomarkers from that trial may apply to
Alzheimer’s patients as well. However, there can be no assurance that the results of this Phase IIa study will be positive or
that NIA will approve any future grant application.
Early-stage Alzheimer’s (mild)
Later stages of Alzheimer’s are
very difficult to reverse and therefore it is important to start treatment of Alzheimer’s in the earliest possible stage so the
individuals can continue living normal lives and maintain their independence.
In the early stage of Alzheimer’s,
a person may function independently. He or she may still drive, work, and participate in social activities. Despite this, the person may
feel as if he or she is having memory lapses, such as forgetting familiar words or the location of everyday objects.
Symptoms may not be widely apparent at
this stage, but family and close friends may take notice and a doctor would be able to identify symptoms using certain diagnostic tools.
Common difficulties include finding the right word or name, remembering names when meeting new people, and performing tasks in social
or work settings. People may also forget material they just read, lose or misplace valuable objects, and experience increased trouble
with planning or organizing.
This is the Alzheimer’s disease
patient category that we plan to include in our grant application for a proposed Phase II clinical trial with the final objective of showing
that JOTROL™ has the potential of slowing and/or possibly stopping the progression of this disease, subject to FDA’s review
of the clinical trial and the protocol. The effect of JOTROL™ treatment, in the potential Phase II trial, will primarily be measured
through several biomarkers.
Economic burden of Alzheimer’s disease on society
in USA is generating a very large opportunity
According to Alzheimer’s Association’s
2020 annual report Alzheimer’s disease has impacted 5.7 million Americans and that it costs the US $277 billion each year, excluding
the cost of “unpaid time and effort of the people, mostly women, who are caring for spouses, parents, siblings, and friends with
dementia.” The Association explained, “In 2017, 16 million Americans provided an estimated 18.4 billion hours of unpaid care
in the form of physical, emotional and financial support - a contribution to the nation valued at $232.1 billion.” Any product that
delays the onset of severe Alzheimer’s disease should represent significant savings to society.
5
Proposed JNS108 Phase II Clinical Trial for MCI/early
Alzheimer’s Disease
Subject to FDA’s review and
approval, the Phase II trial will be built on utilizing published information from the earlier Turner et al Phase II trial,
completed in 2015 with 119 patients with early Alzheimer’s disease who were treated with 4 different doses of resveratrol. The
study was conducted by Professor Raymond Turner, MD, Ph.D. at Georgetown University, a member of our Scientific Advisory Board, as
the Principal Investigator. Dr. Turner is the Principal Investigator of our proposed Phase II trial. The study tried 500mg, 1000mg,
1500mg and 2000mg daily doses with each dose taken by the patients over 13 weeks. Only the highest dose of 2000mg (2 X 1g per day)
showed positive results on biomarkers which lead to the conclusion that this study was most likely underdosed for achieving the best
therapeutic effect. Pharmacokinetic analysis showed that the average C-Max of resveratrol in the blood on the highest dose was 181 ng/ml, which
is far from the target of 300ng/ml that we believe is needed for reaching therapeutic effect.
Our
team of scientists in the Alzheimer’s field, Professors Raymond Turner, MD, Ph.D. and Charbel Moussa, Ph.D. from Georgetown
University and Li-Huei Tsai, Ph.D. from MIT have assisted in designing our Phase II a study to address and explore biomarkers. We believe these trial results can guide us to a follow-on studies that might
generate meaningful outcomes for MCI/early Alzheimer’s disease patients. The Company has not discussed its ability to rely on
and reference the Phase II trial conducted by Georgetown with the FDA nor has it discussed the design of the planned study in MCI
patients with the FDA.
Proposed JOTROL™ MCI Phase II Study
In the future, the Company hopes to
pursue a phase II, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of JOTROL™ (micellar
resveratrol solubilization formulation) in early Alzheimer’s disease (“AD”) patients. If the study and protocol is
approved by FDA, approximately 105 patients would be enrolled at study centers across the United States. Patients would be
randomized into one of two active treatment arms to receive JOTROL™ 200 mg BID or JOTROL™ 500 mg BID or to a placebo
group. We hypothesize that this proposed study would support JOTROL™ safety and tolerability in
individuals with MCI/early AD.
Objectives
Primary Objective:
●
To determine the safety and efficacy of JOTROL™ (200 mg resveratrol BID and 500 mg resveratrol BID) for neuroinflammation and biomarkers of MCI/early AD.
●
To assess safety and tolerability of JOTROL™ in AD-MCI patients by monitoring adverse events (AEs) and serious adverse events (“SAEs”) and assessing their relationship to the study drug. Tolerability will be measured by subjects’ ability to remain on treatment. Overall tolerability of the drug will be defined as fewer than 25% discontinuations due to drug-related AEs and SAEs
●
A first efficacy indicator will be stabilization of Abeta 40/42.
Secondary Objectives:
●
To assess population pharmacokinetics (“Population PK”) in the ITT population
●
To measure the effect of JOTROL™ on biochemical markers for AD, neurodegeneration, vascular damage, metabolic effects, and neuroinflammation
●
To determine the effects of JOTROL™ on whole-brain and regional brain atrophy
●
To measure the effects of JOTROL™ on functional MRI measures
●
To assess cognitive effects of JOTROL™
●
To examine the influence of Apolipoprotein E genotyping on both biomarker and cognitive endpoints
6
Endpoints
Primary Endpoint:
●
Assessment of safety/tolerability by monitoring AEs and SAEs, assessing their potential relationship to the study drug and Abeta 40/42
Secondary Endpoints:
●
Levels of AD relevant biomarkers
●
Volumetric MRI and Cortical Disarray Measurement
●
Additional experimental biomarkers as stated in protocol, such as those for neuroinflammation
Study Population: Approximately
105 male or female subjects between 55 and 85 years of age with a diagnosis of MCI/early AD will be enrolled. MCI/early AD patients should
be amyloid positive with an AD/MCI clinical diagnosis.
Phase: Phase II Description of
Sites/Facilities Enrolling Participants: Approximately 8 study centers in the USA. Study sites will be determined by competitive selection
of interested and eligible ADCS sites - with experienced study coordinators, raters, and site PIs.
Description of Study Intervention:
Subjects will be randomized 1:1:1 to receive 500 mg bid (1g/day) resveratrol as JOTROL™; or 200 mg bid (400mg/day) resveratrol as
JOTROL™; or placebo.
Participant Duration: Treatment
phase will be 6 months with a one month follow up safety visit and safety monitoring over a 6-month period to ensure that patients have
no long-lasting treatment related effects.
Rare Orphan Diseases
Proposed JNS102 Phase II trial for
Mucopolysaccharidosis Type 1 (“MPS Type I” or “MPS-I”)
JNS102 is investigating JOTROL™ for
the potential 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-iduronidase. Children who
have parents with MPS-I will carry the defective gene.
MPS-I patients are presently treated with
an Enzyme Replacement Therapy (“ERT”) named Aldurazyme. This requires a weekly infusion of 4 hours per event and costs over
$500,000 per year per patient. The ERT is effective in significantly prolonging life. However, since the ERT does not penetrate the blood
brain barrier, ears, eyes, or joints, it leaves the patients with a gradually worsening quality of life including loss of hearing, blindness
and severe arthritis.
JNS102 is targeting the specific areas that ERT cannot treat,
with JOTROL™.
Proposed JNS102 Phase II Clinical Trial
1.
Preclinical studies conducted at University of Miami in MPS-I mice results showed that a high dose of resveratrol increased the alpha-L-iduronidase which is the critical enzyme that is too low in these patients.
2.
IND application for Phase I study
was approved by the FDA.
3.
Final study details and start to be determined by consultation with the FDA and supportive additional financing.
4.
Primary endpoint:
●
Safety, tolerability and PK/PD values
5.
Secondary endpoints to include (subject to FDA acceptance)
i.
Improvement in 6-minute walk distance
ii.
Forced vital capacity
iii.
Biomarkers, such as alpha-L-iduronidase levels
iv.
MPS-I validated pain survey
JNS107 clinical trial for MELAS Syndrome
JNS107 is investigating
JOTROL™ as a product candidate to treat MELAS Syndrome.
MELAS (Mitochondrial Encephalopathy, Lactic
Acidosis, and Stroke-like episodes) syndrome is a rare disorder that begins in childhood, usually between two and fifteen years of age,
and mostly affects the nervous system and muscles. The most common early symptoms are seizures, recurrent headaches, loss of appetite,
and recurrent vomiting. Stroke-like episodes with temporary muscle weakness on one side of the body (hemiparesis) may also occur and this
can lead to altered consciousness, vision and hearing loss, loss of motor skills, and intellectual disability. MELAS is caused by mutations
in mitochondrial DNA. Pre-clinical trials performed with mice at University of Miami showed that JOTROL™ increased mitochondrial
biogenesis in the liver with 70% and in the brain with 30%.
7
While symptoms of MELAS syndrome usually
begin between the ages of two and fifteen years, delayed onset cases have also been reported in people aged fifteen to forty years and
older. In approximately 75% of cases, onset of the disorder occurs before the age of 20 years. Symptoms and physical findings associated
with MELAS syndrome vary greatly among affected individuals. The distinguishing feature in MELAS syndrome is the recurrence of stroke-like
episodes. It is currently thought that the deficiency of a compound called nitric oxide in the small blood vessels of the brain may be
responsible for the stroke-like episodes. Short stature and hearing loss may be present and fatigue and difficulty tolerating exercise
may be early symptoms.
MELAS syndrome is a rare disorder that
affects males and females in equal numbers. Although rare, MELAS syndrome is probably the most common type of mitochondrial myopathy caused
by mutations in mtDNA. Some researchers believe that mitochondrial myopathies may go unrecognized and underdiagnosed in the general population,
making it difficult to determine the true frequency of disorders like MELAS syndrome.
Opportunity for JNS107
The potential market for JOTROL™
in the USA includes approximately 80,000 patients1. With a projected treatment cost for MELAS syndrome of $75,000 per patient
annually, treating 50,000 patients could generate around $3.75 billion per year. Furthermore, successful clinical trial results may extend
JOTROL™’s applicability to other mitochondrial diseases, potentially expanding its market impact. There is no assurance that
JOTROL™ will obtain regulatory approval to treat MELAS syndrome or any other mitochondrial diseases.
Competition
The following is an overview of JNS’s
competitors in the pharmaceutical industry. Many companies, including the largest pharma companies in the world, are competitors in some
of the disease areas for which we are developing treatments for through our various projects. We will compete with both small and large
companies in each indication we are pursuing.
There are a multiple of companies, both
smaller biotech’s as well as large pharmaceutical companies, that are working on solutions for the same indications that we are
pursuing. There is no assurance that we will be able to compete with these companies even if our product is approved in an indication.
Parkinson’s Disease
Despite the availability of FDA-approved
treatments for Parkinson’s disease, no breakthrough therapies have emerged recently to halt disease progression. The most commonly
prescribed treatment is levodopa/carbidopa, which has been used since the late 1960s. Levodopa is absorbed in the intestine and converted
to dopamine in the brain, addressing the dopamine deficiency in Parkinson’s patients. Carbidopa prevents premature conversion of
levodopa to dopamine outside the brain, reducing side effects like nausea. This combination is available in various forms, including pills,
dissolvable tablets, and a gel infused directly into the intestine.
Levodopa/carbidopa significantly improves
motor symptoms in most patients, especially those with mild symptoms, and remains effective over time. However, as Parkinson’s progresses,
dosage adjustments may be necessary. Initial side effects can include nausea and vomiting, which can be mitigated by taking the medication
with a small snack or adding extra carbidopa. Other side effects may include drowsiness, low blood pressure, and hallucinations. Despite
these challenges, levodopa/carbidopa remains a cornerstone in managing Parkinson’s symptoms.
Alzheimer’s Disease
Several companies are actively developing
treatments for Alzheimer’s disease, each with unique approaches and challenges. Biogen’s Aduhelm, an IV infusion targeting
amyloid-beta plaques, has faced reimbursement issues despite FDA approval, leading to low market penetration and market withdrawal. Eli
Lilly’s donanemab, targeting a modified form of beta amyloid, recently received FDA approval and is priced at $32,000 annually.
It has shown promise in early Alzheimer’s patients and is undergoing further trials. Cognition Therapeutics is developing CT1812,
an orally dosed molecule in Phase II, supported by significant NIA grants.
Anavex Life Sciences is advancing Anavex
2-73, a Phase III candidate from their SIGMACEPTOR™ platform, targeting CNS conditions with genomic precision. Eisai and Biogen’s
Leqembi has received traditional FDA approval, potentially expanding Medicare coverage. Priced at $26,000 per year, Leqembi has shown
benefits for early-stage Alzheimer’s patients. Despite these advancements, the competitive landscape remains dynamic, with the possibility
of other companies emerging with successful treatment
Rare Diseases
There are several companies that are targeting
the same rare diseases as us. Below is a description of a selection of those companies that we see as our closest competitors. However,
it is possible that another company, that is not listed below, could have a successful product approved before us and have a more effective
treatment.
In the MPS-I space, several companies
offer competitive products to Jupiter. Sanofi Genzyme’s Aldurazyme has been the standard enzyme replacement therapy for nearly 20
years. RegenexBio is developing RGX-111, a gene therapy designed to deliver a functional copy of the IDUA gene to the central nervous
system. Sigilon Therapeutics, Inc. is working on SIG-005, which uses a genetically modified human cell line to express the IDUA enzyme,
with an Investigation New Drug (“IND”) application for Phase I submitted to the FDA. Additionally, Sangamo Therapeutics, Inc.
is exploring gene editing products, although no positive results have been published yet. These developments represent significant competition
in the treatment of MPS-I.
1
https://pmc.ncbi.nlm.nih.gov/articles/PMC8993002/
8
In the treatment of MELAS, several products
present competition to Jupiter’s offerings. Cyclerion Therapeutics is advancing CY643, currently in Phase 1B, which evaluates safety
and its impact on mitochondrial dysfunction and cognition. Abliva AB is developing KL1333, which has been granted orphan drug designation
in both the United States and Europe. This product has been tested in healthy volunteers and patients, with a registrational Phase II/III
study initiated in December 2022. These developments underscore the competitive landscape in the search for effective MELAS treatments.
Competitive Advantages
We believe that we are positioned to outperform
competitors in the pharmaceutical industry for the following reasons:
●
We believe that the focus on a new
product based on resveratrol with potentially higher bioavailability, JOTROL™, will enable us to explore its use for several
research pathways and indications, subject to FDA’s review and approval. Whether such path is viable would depend on
regulatory submissions and data generated in pre-clinical and clinical trials. We believe that this enables us to have several
opportunities to obtain regulatory approval in case we are able to show efficacy and safety acceptable to regulatory agencies for
one or more of our targeted indications.
●
JOTROL™ is an oral product based on a natural compound. Oral delivery of medications is a physician and patient preferred treatment compared with injections and infusions and we expect that our product will have an attractive and affordable price point for reimbursors and patients.
●
We are building a close relationship with key opinion leaders (“KOLs”) and patient organizations to facilitate a better understanding of patient needs and thereby design trials targeting solutions to those needs as long as these targets are acceptable to the FDA.
●
The natural product resveratrol is well studied with over 20,000 scientific publications to date. Published scientific papers, such as AY Berman et al, indicate that a highly bioavailable product generating less GI side effects may have application in a number of indications.
●
Based upon available scientific literature, it appears that resveratrol is an activator of SIRT1, one of the mammalian forms of the sirtuin family of proteins. SIRT1 deacetylates histones and nonhistone proteins including transcription factors. The SIRT1-regulated pathway affects metabolism, stress resistance, cell survival, cellular senescence, inflammation/immune function, endothelial functions, and circadian rhythms. Resveratrol has been documented in scientific literature to activate SIRT1, NrF2, NLR3P inflammasomes and have an epigenetic mechanism and therefore is predicted to benefit diseases affected by abnormal metabolic control, inflammation, and cell cycle defects. Nonetheless, resveratrol application is a major challenge, due to its poor solubility and bioavailability, as well as severe gastro-intestinal side effects when taken at high dose levels (over 2,000 mg daily). In this context, studies have proposed that structural changes in the resveratrol molecule, including glycosylation, alkylation, halogenation, hydroxylation, methylation, and prenylation could lead to the development of derivatives with enhanced bioavailability and pharmacological activity. Resveratrol has never been developed with all the necessary steps to achieve an approval as a pharmaceutical product because of severe gastro-intestinal side effects. This means that we need to take JOTROL™ through the full regulatory NDA requirement to obtain marketing approval. We were able to receive, through a confidential agreement from a major pharmaceutical company, chronic toxicology studies performed with resveratrol, in two different species, that was referenced in our approved Phase I IND application submitted to the FDA. The study was conducted by Charles River Laboratories.
●
Possible out-licensing for Asian markets is being considered as it may reduce risk and cost of product development in those markets that requires confirming trials in an Asian population, while generating income through milestones and royalty agreements, see “—Asian Business Development Activities” regarding further developments and strategy in the Asian market.
9
Marketing and Commercialization Plan for Therapeutic Drug
Candidates
The Company may consider out-licensing
JOTROL™ for pharmaceutical uses to one or more companies that have such commercialization capability in place. We may consider at
any time a complete exit through any proposed acquisition of our company. In case no acceptable M&A offer is presented, and in the
event we were able to obtain FDA regulatory approval for JOTROL™ we might consider marketing and distributing JOTROL™ in the
USA for the rare disease market only and have companies with large sales organizations distribute our product for larger indications.
All international distributions would most likely be out-licensed.
The marketing and sales of orphan drugs
can be relatively fast and effective. We believe, based on discussions with organizations such as the EveryLife Foundation an approval
of a drug for a rare disease is efficiently communicated through social media to KOLs, patient advocacy groups and directly to patients,
which may reduce marketing costs.
We have been approached by several large
and mid-size pharmaceutical companies discussing interest in future collaborations once we have more clinical data available for JOTROL™.
We will try to utilize this interest for 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.
Government Regulation
Regulatory Approval of our Drug Product Candidates
The FDA and comparable regulatory authorities
in state and local jurisdictions impose substantial and burdensome requirements upon companies involved in the clinical development, manufacture,
marketing, and distribution of drug products. These regulatory authorities and other federal, state, and local entities regulate the research
and development, testing, manufacture, quality control, safety, effectiveness, labeling, storage, documentation and record keeping, approval,
advertising and promotion, distribution, post-approval monitoring and reporting, and export and import of our drug candidates.
10
In the United States, the FDA regulates drugs under the Federal
Food, Drug, and Cosmetic Act (the “FDCA”), and its implementing regulations. The process of obtaining regulatory approvals
and compliance with applicable federal, state, local and foreign statutes and regulations requires the expenditure of substantial time
and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval
process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal
to approve pending New Drug Applications (“NDAs”), withdrawal of an approval, imposition of a clinical hold, issuance of warning
letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of
government contracts, restitution, disgorgement or civil or criminal penalties. The process required by the FDA before a drug may be marketed
in the United States generally involves the following, among other things:
● completion of pre-clinical laboratory tests, animal studies
and formulation studies in compliance with the FDA’s good laboratory practice (“GLP”) regulations;
● submission to the FDA of an IND application, which must become
effective before human clinical trials may begin;
● independent Institutional Review Board (“IRB”) approval;
● performance of adequate and well-controlled human clinical trials
in accordance with good clinical practices (“GCPs”) requirements to establish the safety and efficacy of the proposed drug
product for each indication;
● demonstration that the API and finished drug product are manufactured
under current good manufacturing conditions and meet all applicable standards of identity, strength, quality, and purity;
● submission to the FDA of an NDA;
● satisfactory completion of an FDA advisory committee review,
if applicable;
● FDA review and approval of the NDA, including consideration
of the views of any FDA advisory committee, prior to commercial marketing, promotion or sale of the drug in the United States; and
● compliance with any post-approval requirements, including the
potential requirement to implement a Risk Evaluation and Mitigation Strategy (REMS) or to conduct a post-approval study.
Pre-clinical studies
Before testing any drug product candidate in humans, the product
candidate must undergo rigorous pre-clinical testing. The pre-clinical developmental stage generally involves laboratory evaluations of
drug chemistry, formulation, and stability, and studies to evaluate toxicity in animals, to assess the potential for adverse events (AEs)
and, sometimes, to establish a rationale for therapeutic use. The conduct of pre-clinical studies is subject to federal regulations and
requirements. An IND sponsor must submit the results of the pre-clinical studies, together with manufacturing information, analytical
data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND.
An IND is a request for authorization from the FDA to ship
an investigational product and then administer it to humans for clinical research and must be allowed to proceed by the FDA before human
clinical trials may begin. An IND typically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions
before that time related to one or more proposed clinical trials and places the trial on clinical hold. In such a case, the IND sponsor
and the FDA must resolve any outstanding concerns before the clinical trial can begin. Thus, submission of an IND does not guarantee that
FDA will allow human clinical trials to commence.
Clinical trials
The clinical-trials stage of development involves the administration
of the investigational product to healthy volunteers or patients under the supervision of qualified clinical trial investigators, generally
experienced physicians, in accordance with GCPs, which includes the requirement that all research patients provide their informed consent
for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives
of the clinical trial, dosing procedures and regimens, subject inclusion and exclusion criteria and the parameters to be used to monitor
subject safety and assess efficacy of the investigational product. Each protocol, and any subsequent amendments to the protocol, typically
must be submitted to the FDA as part of the IND. Moreover, each clinical trial must be reviewed and approved by an IRB for each institution
where the clinical trial will be conducted. The IRB also approves the informed consent form that must be provided to each clinical trial
subject or his or her legal representative and must monitor the clinical trial until completed. Human clinical trials are typically conducted
in three sequential phases, which are summarized below at a high level:
● Phase I clinical trials generally involve a small number of healthy volunteers
or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. The main purpose
of Phase I clinical trials is to assess the metabolism, pharmacologic action, side effect tolerability and safety of the drug.
● Phase II clinical trials involve studies in disease-affected patients to determine
the dose required to produce the desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information
is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted.
● Phase III clinical trials generally involve a larger number of patients at multiple
sites and are designed to provide the data necessary to demonstrate the safety and effectiveness of the product for its intended use,
and to provide an adequate basis for product approval. These trials may include comparisons with placebo and/or other comparator treatments.
The duration of treatment is often extended to mimic the actual use of a product during marketing.
11
FDA Marketing Approval
Assuming successful completion of required clinical testing,
the results of the pre-clinical studies and clinical trials, together with detailed information relating to the product’s chemistry,
manufacture, quality controls, and proposed labeling, are submitted to FDA as part of an NDA requesting approval to market the product
for one or more indications. In most cases, the submission of an NDA is subject to a substantial application user fee.
The length of the review process may vary but typically takes
around twelve months from the date the NDA is submitted to FDA. FDA conducts a preliminary review of all NDAs to determine whether they
are sufficiently complete to permit substantive review by FDA before accepting them for “filing.” FDA may request additional
information from the NDA applicant rather than accept an NDA for filing. If this occurs, the NDA will typically need to be resubmitted
with the additional information requested by FDA. The resubmitted application is also subject to review before FDA accepts it for filing.
Once an NDA submission is accepted for filing, the FDA begins a detailed substantive review. FDA reviews an NDA to determine, among other
things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged, or held meets
standards designed to assure the product’s continued safety, quality and purity. Under the current guidelines in effect in the
Prescription Drug User Fee Act (PDUFA), the FDA has a goal to review and act on the submission within ten months from the completion
of the preliminary review of a standard NDA for a new molecular entity.
After evaluating the NDA and all related information, including
FDA advisory committee recommendation, if any, and any inspection reports regarding the manufacturing facilities and clinical trial sites,
FDA may issue an approval letter, or, in some cases, a complete response letter. A complete response letter generally contains a statement
of specific conditions that must be met to secure final approval and may require additional clinical trials or pre-clinical studies in
order for FDA to reconsider the application. Even with submission of this additional information, FDA ultimately may decide that the
application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction,
the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing
information for a specific indication(s).
Regulatory
Approval of Rare Diseases
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 obtain 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 an 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 receive FDA’s review of drug or biological product applications in 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,
upon the treatment meeting the statutory thresholds for such award. The voucher is transferable, and a subsequent holder may use it to
obtain priority review for its own qualifying application.
There
are four specific expedited development pathways that may be applicable to a rare disease indication. We will be evaluating and most
likely applying for one or more of these when we get closer in the FDA approval process. These include the following pathways for the
indications that it is targeting: (1) Priority Review (2) Fast Track (3) Accelerated Approval Pathway and (4) Breakthrough therapy.
Priority
Review
Priority
Review was authorized in 1992 by PDUFA which created the two-tiered FDA drug review system (standard versus priority). A product candidate
is eligible for priority review if it treats a serious or life-threatening condition and, if approved, would provide a significant improvement
in safety and effectiveness compared to available therapies. A Priority Review designation means that the goal for the FDA to review
an application is six months, rather than the standard review of 10 months under the PDUFA goals. The FDA determines if a drug receives
a standard or priority review, although sponsors may request a priority review.
Fast
Track
Product
candidates intended to treat a serious or life-threatening condition and show the potential to an unmet medical need may receive a Fast
track designation. The purpose of this designation is to help make important new drugs available to patients earlier. Any drug being
developed to treat or prevent a condition with no current therapy is directed at an unmet need. If there are available therapies, the
new drug must demonstrate advantages, such as:
1.
Show
superior effectiveness, effect on serious outcomes or improved effect on serious outcomes;
2.
Avoid
serious side effects of the available therapy;
3.
Decrease
clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment; and
4.
Address
an emerging or anticipated public health need
Fast
Track designation should typically be requested at the time of the IND or after, and no later than the pre-BLA or pre-NDA meeting. Once
in the Fast Track pathway, there are typically more frequent meetings with the FDA to discuss the development plan and appropriate data
needed to support drug approval. The fast track designation may be withdrawn by FDA if it believes that the designation is no longer
supported by data that emerges during the clinical trial process. Drugs in the Fast Track pathway are also eligible for accelerated approval
and priority review if relevant criteria are met.
Accelerated
Approval Pathway
Authorized
in 1992 and updated in 2012, this pathway is available for a drug for a serious or life-threatening illness that provides meaningful
therapeutic benefit to patients over existing treatments based upon a surrogate endpoint that is reasonably likely to predict clinical
benefit. The FDA may also grant accelerated approval for such a condition when the product has an effect on an intermediate clinical
endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, or IMM, and that is reasonably likely to
predict an effect on IMM or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the
availability or lack of alternative treatments. If approved based on the accelerated approval pathway, the FDA may require the sponsor
to conduct post-marketing confirmatory clinical trials to ensure that the drug provides the anticipated clinical benefits. If this requirement
is not met, the FDA can withdraw its approval. In addition, promotional materials for product candidates approved under the accelerated
approval pathway are subject to prior review by FDA.
Breakthrough
Therapy
To
qualify for the breakthrough therapy program, product candidates must be intended to treat a serious or life-threatening condition and
preliminary clinical evidence must indicate that such product candidates may demonstrate substantial improvement on one or more clinically
significant endpoints over existing therapies.
However,
there is no guarantee that any designation for an accelerated pathway will lead to an accelerated FDA review or that a pediatric approval
leads to grant of a PRV. Additionally, there can be no guarantee that the Company can be successful in its plans under any FDA review
pathway.
Disclosure
of Clinical Trial Information
Sponsors
of clinical trials of FDA-regulated products, including drugs, are required to register and disclose certain clinical trial information.
Information related to the product, patient population, phase of investigation, study sites and investigators, and other aspects of the
clinical trial is then made public as part of the registration. Sponsors are also obligated to discuss the results of their clinical
trials after completion. Disclosure of the results of any such clinical trials can be delayed in certain circumstances for an extended
period of time after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding
the progress of development programs.
12
Post-Approval Requirements
Even if an NDA is approved, a product will be subject to certain
post-approval requirements. For example, the FDA closely regulates the post-approval marketing and promotion of drugs, including standards
and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and
promotional activities involving the internet. Drugs may be marketed only for the approved indications and in accordance with the provisions
of the approved labeling.
Failure to comply with the applicable FDA post-marketing requirements
may subject manufacturers and distributors to administrative or judicial sanctions. These sanctions could include, among other things,
warning letters, product seizures, total or partial suspension of production or distribution, injunctions, civil money penalties, fines,
restitution, disgorgement, or civil or criminal penalties. Further, the FDA has authority to issue mandatory recalls for medical devices
and biologics, and we may need to undertake a voluntary recall for any of our products that may receive regulatory approval.
Regulation Outside the United States
In order to market any product outside of the U.S., we must
also comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding quality, safety and efficacy
and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of drug products. Whether
or not a product obtains FDA approval for a product, we would still need to obtain the necessary approvals by the comparable foreign regulatory
authorities before we could commence clinical trials or marketing of any product in those countries or jurisdictions. The approval process
ultimately varies between countries and jurisdictions and can involve additional product testing and additional administrative review
periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer than that required
to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure
or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others.
Government Regulation of Dietary Supplements
The Dietary Supplement Health and Education Act of 1994 (DSHEA),
amended the FDCA to establish a new framework governing the composition, safety, labeling, manufacturing and marketing of dietary supplements.
Generally, under DSHEA, dietary ingredients (e.g., vitamins; minerals; amino acids; or dietary substances for use by humans to supplement
diet by increasing total dietary intake; or any concentrate, metabolite, constituent, extract or combination of any of the above) that
were marketed in the United States prior to October 15, 1994 as a dietary supplement may be used in dietary supplements without notifying
the FDA. “New” dietary ingredients (i.e., dietary ingredients that were “not marketed in the United States before October
15, 1994”) must be the subject of a new dietary ingredient notification submitted to the FDA unless the ingredient has been present
in the food supply as an article used for food without being chemically altered. A new dietary ingredient notification must provide the
FDA evidence of a “history of use or other evidence of safety” establishing that use of the dietary ingredient “will
reasonably be expected to be safe.” A new dietary ingredient notification must be submitted to the FDA at least 75 days before introducing
the product into interstate commerce. The FDA may determine that a new dietary ingredient notification does not provide an adequate basis
to conclude that a dietary ingredient is reasonably expected to be safe. In addition, manufacturers of dietary supplements must ensure
that ingredients in their products that are not defined as dietary ingredients comply with all the requirements applicable to conventional
foods. For example, fillers and other constituents of the product must be approved as food additives or must be deemed generally recognized
as safe for the conditions of use in order to be sold.
The FDA generally prohibits the marketing of a dietary supplement
with a “disease claim,” including claims that the product is intended to treat, cure, mitigate or prevent disease or other
health-related conditions, unless the claim constitutes a permissible “health claim” under FDA regulations and guidance. Statements
of “nutritional support,” including so-called “structure/function claims,” may be permitted on labeling for dietary
supplements, subject to certain requirements being met. Such statements may describe how a particular dietary ingredient affects the structure,
function or general well-being of the body, or the mechanism of action by which a dietary ingredient may affect the structure, function
or well-being of the body, but they may not state that a dietary supplement will reduce the risk or incidence of a disease unless such
claim has been reviewed and approved by the FDA. A company that uses a statement of nutritional support in labeling must possess scientific
evidence substantiating the statement as truthful and not misleading. FDA must be notified of any such statements no later than thirty
days after first marketing the product with the certification that the company possesses the necessary evidence to substantiate any such
statements and must be accompanied by an FDA mandated label disclaimer that “This statement has not been evaluated by the FDA. This
product is not intended to diagnose, treat, cure or prevent any disease.”
In addition, the FDA has published detailed current Good Manufacturing
Practice (cGMP), regulations that govern the manufacturing, packaging, and labeling of dietary supplements. The cGMP regulations, among
other things, impose recordkeeping requirements on manufacturers and require dietary supplements to be of appropriate potency, purity
and identity. The cGMP requirements are in effect for all dietary supplement manufacturers, and the FDA conducts inspections of dietary
supplement manufacturers pursuant to these requirements. The FDA has broad authority to enforce the provisions of federal law applicable
to dietary supplements, including, among other things, the authority to issue a public warning or notice of violation letter to a company,
publicize information about illegal products, detain or seize products intended for import, require the reporting of serious adverse events,
require a recall of illegal or unsafe products from the market, and request the Department of Justice initiate a seizure action, an injunction
action or a criminal prosecution in the United States courts for violative conduct.
13
Nugevia Brand
The Company launched Nugevia, a premium
line of longevity and performance supplements to support mental clarity and skin vitality. The Nugevia brand targets
the growing consumer demand for wellness solutions, leveraging Jupiter’s proprietary JOTROL™ technology—a
resveratrol-based platform that is designed to provide higher bioavailability of resveratrol.
Nugevia’s initial product line features
three core formulations, each targeting a major aspect of health and longevity:
Product Name
Focus Area
Target Consumer Benefit
GLO
Skin beauty
Support skin beauty and healthy appearance
MND
Cognitive performance
Support mental clarity, cognitive
resilience
PWR
Mitochondrial and physical health
Maintain energy, endurance, muscle recovery
Nugevia’s formulations are
built on Jupiter’s patented JOTROL™ micellar delivery platform, which has shown potential for significantly enhanced
bioavailability and serves as the foundation for the company’s clinical-stage CNS investigational therapies. The debut
products—GLO, MND, and PWR—are formulated to support cellular resilience through synergistic ingredient combinations,
all optimized for absorption via the JOTROL™ system.
Market Positioning and Opportunities
The Nugevia brand will enter the
nutraceutical market as a premium longevity and performance supplement line, capitalizing on a global industry projected to reach $8
trillion by 2030. Powered by JOTROL™, a patented resveratrol-based platform that is designed to provide greater
bioavailability than standard resveratrol, Nugevia targets health-conscious consumers seeking science-backed solutions for
mitochondrial and physical health, mental clarity, and skin vitality. Products like PWR and GLO address key market
segments—dietary supplements and functional foods—driven by rising health awareness, an aging population, and a shift
toward preventive healthcare. The DTC model positions Nugevia to capture high-margin revenue in a competitive but growing market,
leveraging clinical-grade credibility to stand out in a competitive market.
Challenges and Competitive Landscape
The supplement market is fueled by increasing
lifestyle-related disorders and demand for natural ingredients. However, Nugevia faces challenges including regulatory hurdles, complex
product approvals, and competition from established players offering similar products. Consumer skepticism about resveratrol’s
historical bioavailability issues and the need for robust scientific validation could impact adoption. Nugevia’s use of JOTROL™
alongside ingredients like NovaSOL® Astaxanthin and CoQ10 aims to address these concerns, while strategic partnerships with Aquanova
and endorsements from figures like Annika Sörenstam and Chris Webber enhance brand trust. Success will hinge on overcoming market
saturation and proving efficacy to stand out in a crowded field.
Marketing
The Company will employ a digital-first
marketing strategy, leveraging a DTC e-commerce platform to reach health-conscious consumers seeking clinically validated wellness solutions.
The Company has appointed Annika Sörenstam, a Hall of Fame golfer with over 95 tournament victories, as Nugevia’s first brand
ambassador, enhancing brand credibility and aligning with the product’s focus on performance, focus, and longevity. In addition,
the Company has partnered with Chris Webber, five-time NBA All-Star and Hall of Fame inductee, as the Company’s second official
brand ambassador for Nugevia. Marketing efforts also include tailored campaigns for international markets, with service partners in Hong
Kong developing a specific program for Southeast Asia to address regional consumer preferences.
The initial launch in the USA
utilized a DTC model, with the Nugevia website serving as the primary sales platform. Following this, the Company aims to
expand distribution to Europe, the Middle East, and Southeast Asia through regional partnerships, capitalizing on the global demand
for longevity solutions. By combining cutting-edge science, strategic marketing, and a robust manufacturing
process, Nugevia is poised to capture a significant share of the longevity market while supporting Jupiter’s long-term mission
to advance treatments for CNS disorders.
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Competitors
The longevity and wellness market, driven
by increasing demand for health span extension, is highly competitive, with Nugevia facing established players like ChromaDex (offering
NAD+ precursors like Tru-Niagen), Novos (targeting aging hallmarks with products like NOVOS Core), Timeline’s urolithin A supplements
and Tally Health (providing personalized longevity supplements and biological age testing). Larger competitors, including Nestle Health
Science (with multiple brands and products), Amway (through Nutrilite’s Healthy Aging Solution), and L’Oreal (via its Longevity
Integrative Science initiative), are also expanding into this space, intensifying competition. Nugevia’s differentiation lies in
its proprietary JOTROL™ technology, which supports higher plasma concentrations (approximately 300 ng/ml) and effective
CNS delivery, positioning it as a premium offering.
Brands like NOVOS, Blueprint, and Perpetua.Life
offer formulas that combine resveratrol with other scientifically backed longevity compounds (e.g., NMN, quercetin, CoQ10, fisetin)
for synergistic effects. In addition, advanced delivery systems such as Liposomal and micellar technologies are widely used by many companies
to enhance the absorption of key actives, similar to Nugevia’s approach, purity and clinical validation. Furthermore, companies
such as ProHealth, Renue By Science, and Decode Age, who offer similar longevity supplements and sell their products online directly to
consumers, emphasize ingredient purity, bioavailability, multi-ingredient formulations and evidence-based dosing, which is appealing to
the target health-conscious consumers seeking credible, science-backed longevity solutions.
Manufacturing
Nugevia products will be manufactured
by Aquanova in Germany. The manufacturing process has several steps, which are: (a) ingredient combinations are manufactured as a liquid
solution by Aquanova in Germany, (b) the liquid solutions are shipped to GMP-certified facility in California for encapsulation into softgels
and (c) finished products are sent in bulk to a final packing and fulfillment center, which ships directly to customers. While all steps
except the initial solution preparation can be handled by U.S. suppliers, changing the first step would require a separate agreement with
Aquanova.
The FDA requires that dietary
supplement manufacturers comply with Current Good Manufacturing Practices (“cGMP”) under 21 CFR Part 111, ensuring
product safety, quality, and accurate labeling. Jupiter must verify that its manufacturing partners, including those involved in
producing JOTROL™ or sourcing ingredients like CoQ10, meet these standards. Non-compliance, such as contamination or
inconsistent ingredient potency, could lead to product recalls, enforcement actions, fines, or reputational damage. Any lapses in quality control could undermine consumer trust and weaken its
competitive edge in the $451.7 billion nutraceutical market.
Compliance with U.S. FDA Regulations
In the United States, Nugevia
products, classified as dietary supplements, fall under the Dietary Supplement Health and Education Act (DSHEA) of 1994, enforced by
the FDA. The FDA requires that all health claims be substantiated with credible scientific evidence, and any claims related to
Nugevia’s benefits—such as mitochondrial support, mental clarity, or skin vitality—must avoid implying treatment
or prevention of diseases, which would classify the products as drugs subject to stricter pre-market approval. Non-compliance, such
as misleading labeling or unsubstantiated claims, could result in warning letters, product seizures, or injunctions. Additionally,
Jupiter must ensure that JOTROL™, its proprietary resveratrol delivery system, complies with FDA’s New Dietary
Ingredient (NDI) notification requirements if deemed novel, a process that can take months and negatively impact the Company’s
ability to sell Nugevia products.
International Regulatory Variations
Global expansion introduces regulatory
complexities. In the European Union, the European Food Safety Authority (EFSA) oversees nutraceuticals under the Novel Food Regulation
(EU) 2015/2283. If JOTROL™ or other ingredients like NovaSOL® Astaxanthin are considered novel foods (not consumed in the EU
before May 15, 1997), Jupiter must submit a detailed safety dossier, a costly and time-intensive process that could delay market entry.
In markets like China or Japan, stringent pre-market approvals and ingredient restrictions may require reformulation or additional clinical
studies. Failure to navigate these variations could limit Nugevia’s global reach or result in costly reformulations, impacting Jupiter’s
revenue projections.
Post-Market Surveillance and Adverse Event Reporting
Nugevia products are subject
to post-market surveillance, particularly in the U.S., where manufacturers must report serious adverse events to the FDA within 15 days
under DSHEA. Even rare side effects linked to resveratrol or other ingredients like astaxanthin could trigger investigations, negative
publicity, or product withdrawals. Jupiter must establish robust adverse event reporting systems and ensure transparency to mitigate legal
and reputational risks. Failure to comply could lead to regulatory scrutiny, consumer lawsuits, or loss of market confidence, particularly
given past skepticism about resveratrol’s safety and efficacy at high doses.
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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 Southeast Asia. These agreements
are with companies that, we believe, have the knowledge and network in the Southeast Asian market. The agreements are further described
in the section “Other Material Agreements”. In addition, we are in active negotiations with Dominant Treasure Health Company
Limited (“Dominant Treasure”), a BVI company. Dominant Treasure 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 Dominant Treasure
in active business development in China, Malaysia and Singapore as soon as we have financing in place for their engagement. Dominant Treasure
has already introduced us to three 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, https://en.pharm.com.cn/, that advocates the corporate core values of “Love, Integrity and Power”.
TCM products are run in a separate division within Tianjin. The Asian market is very large and hard to penetrate for a small company and
we believe that our strategy with these agreements have the possibility to accelerate an out-licensing deal in the Southeast Asian territories.
However, there are no assurances that this approach will be successful.
Our rationale for the strong approach
into the Southeast Asian market is:
●
Background: Asian countries are not accepting pharmaceutical products to be sold without clinical trial approvals based on trials conducted in an Asian population.
●
The Company’s strategy is to partner with organizations in the territory that can execute much more efficiently than trying to manage the process from USA.
●
We have already received interest for our JOTROL™ product in the Asian market since resveratrol is listed as a Traditional Chinese Medicine.
●
The need for a set up that can service this market is imperative for success.
●
Strategic collaboration agreements have been executed to facilitate an expedited execution of an out-licensing agreement with one or more Chinese or other Southeast Asian pharmaceutical companies.
●
The Company is too small, both financially as well as internal manpower, to manage developments in the territory.
●
The Company has historically faced financial constraints that have, at times, limited its ability to fulfill certain commitments and complete clinical studies on its planned timeline.
●
By utilizing equity as service payments, the company believes that it can get projects finalized without any significant cash outflow.
●
The service agreements are therefore designed to be a win for both parties, assuming an increase in equity value, in case clinical studies and out-licensing activities will be successful in the territory.
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Other Material Agreements
The agreement with a major pharmaceutical
company, restricted by confidentiality, grants us data access to resveratrol toxicology studies through a letter of reference. Executed
on May 2, 2017, it can only be terminated due to a material breach and there is no time limit on access to this study. The studies were
conducted at Charles River Laboratories, and there are no payments associated with this agreement.
On December 15, 2024, the Company entered
into a Strategic Services Agreement (the “Dominant Treasure Agreement”) with Dominant Treasure Health Company Limited (“Dominant
Treasure”). Pursuant to the terms of the Dominant Treasure Agreement, Dominant Treasure agreed to provide certain services to the
Company to assist the Company in accelerating the development and distribution of the Company’s products in the Southeast Asian
market. In exchange for Dominant Treasure’s services pursuant to the Dominant Treasure Agreement, the Company agreed to pay Dominant
Treasure a one-time payment of $2,300,000 to be delivered after the closing of a minimum of $10,000,000 in gross proceeds from a public
offering. In addition, if Dominant Treasure is involved in generating negotiations and conclusion of a distribution agreement for the
Company in the countries of China (including Hong Kong), Singapore and Malaysia, the Company will pay Dominant Treasure a success fee
of 5% of any upfront and/or milestone payments to be received by the Company. If such distribution agreement includes a royalty payment
to the Company, Dominant Treasure will receive 5% of such royalty payment. The Dominant Treasure Agreement has a term of 36 months and
may be terminated at any time upon mutual agreement of the parties.
Service Agreements - Southeast Asia
On June 3, 2024, the Company entered into
three service agreements to expand in Southeast Asia; a CRO Services Agreement with Optimize Wellness Limited providing clinical trial
guidance in China, Malaysia, and Singapore, a Regulatory Services Agreement with Regis Healthcare Group Limited providing regulatory strategy
and guidance, and a Product Services Agreement with Longevity Technology Group Limited providing manufacturing guidance. Each of the 3
service agreements has a 3-year term and was paid for with an upfront issuance of 1,162,500 shares of common stock with a fair market
value of $1.33 per share (3,487,500 in the aggregate, with an aggregate fair market value of $4,638,375) as pre-payment for three years
of services, which were registered for resale as part of the initial public offering.
Legal Proceedings
From time to time, we are involved in
various legal proceedings arising from the normal course of business activities. We are not presently a party to any litigation the outcome
of which, we believe, if determined adversely to us, would individually or taken together have a material adverse effect on our business,
operating results, cash flows or financial condition.
Facilities
Our corporate headquarters are located at 1001 North US Hwy
1, Suite 504, Jupiter, Florida 33477, where we lease approximately 1,206 rentable square feet of office space. This lease expires on May
31, 2026. Terms of the office lease provide for a base rent payment of $4,258 per month and a share of the building’s operating
expenses, such as taxes and maintenance, of $600 per month. In September 2021, we added an additional office located at 127 Main Street,
Boston, Massachusetts 02129 for 120 rentable square feet of office space for our Boston-based employees and scientist to utilize as necessary.
We believe that these facilities are adequate for our current
and near-term future needs.
Employees
As of December 31, 2025, we had a total
of five full-time employees, two full-time consultants, three part-time consultants, and our six Scientific Advisory Board members. Of
these, three were primarily engaged in research or product development and clinical activities.
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