What changed in this filing

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Item 1. Business

2026-04-01 compared with 2025-03-28 · 1017 added, 701 removed, 48 unchanged (97% of the section changed)

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.

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

Unless the context otherwise requires, “JNS,” “we,” “us,” “our,” or the

“Company” refers to Jupiter Neurosciences, Inc., a Delaware corporation.

Jupiter Neurosciences, Inc.

“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

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.

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

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

Neurosciences, Inc.

(the “Company,” “we” or “us”) is a clinical stage research and development company.

We have developed a unique resveratrol platform product primarily targeting treatment of neuro-inflammation.

Our platform product, JOTROL,

an enhanced oral formulation of resveratrol, has many potential indications of use for rare diseases.

In the larger disease areas, we

are primarily targeting Parkinson’s Disease and Mild Cognitive Impairment/early Alzheimer’s disease.

December 2024, we received gross proceeds of $11 million in a registered public offering (“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 deducing 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.”

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.

Company’s platform product, JOTROL, is an enhanced orally administered resveratrol formulation designed and intended to deliver

therapeutically relevant, safe levels of resveratrol.

This platform has many potential indications of use for rare diseases, which include

Mucopolysaccharidoses Type 1, Friedreich’s ataxia and MELAS.

In the larger disease areas, we are primarily targeting Parkinson’s

Disease and Mild Cognitive Impairment/early Alzheimer’s disease.

available resveratrol products are associated with severe gastrointestinal (GI) side effects at the dose levels we believe are needed

for therapeutic effect.

Our belief, that a high dose of resveratrol is needed for therapeutic effects, is based on available scientific

literature, preclinical trial results conducted in mice and rats, and previously conducted human trials with resveratrol.

that JOTROL, based on the results from our Phase I clinical trial conducted at the University of Miami and completed in 2021 (“Miami

Clinical Trial”), has the potential to deliver a therapeutically effective dose of resveratrol in the blood stream without causing

any severe side effects.

Based on our own preclinical studies we believe that resveratrol has the ability to cross the blood-brain barrier.

In studies conducted in Friedreich’s ataxia (FA) and Alzheimer’s disease (AD) patients, JOTROL resulted in positive effects

on oxidative stress, inflammation, and mitochondrial function.

present primary target for the Company is treatment of Parkinson’s Disease (PD).

The Company completed preclinical activities in

a validated mouse model of Parkinson’s Disease (PD) at the University of Miami in 2021.

See our “Clinical Studies”.

The model of Parkinson’s Disease that was used in this clinical trial mimics many aspects of the disease utilizing a unilateral

injection of a neurotoxin precursor that elicits nigral cell loss, striatal dopamine loss and behavior deficits similar to physiological

characteristics of human disease.

We believe that results from this clinical trial indicate that Parkinson’s Disease might be the

best target for treatment and financial opportunity among the multiple indications where JOTROL might play a role.

The Company is now

in process to start its first Phase II trial in a patient population.

This will be a Phase IIa study conducted with the assistance of

Zina Biopharmaceuticals that is led by Dr.

Charbel Moussa, MBBS,Ph.D.

The study is expected to start in the third quarter of 2025 and

have results available approximately 12 months thereafter.

The trial design and outcomes are further described in this section, see JNS115.

are also targeting the treatment of MCI/early Alzheimer’s Disease.

We received funding of $2.2 million from the National Institute

of Aging (“NIA”) in in 2020 and 2022 from a grant application for a Phase 1 study for Mild Cognitive Impairment/ Alzheimer’.

In the NIA scientific review summary statement of our Phase I study application, it is stated that the NIA is looking forward to a Phase

II study with an enhanced resveratrol product, based on the earlier study results from the well published Turner et al.

We presently have a pending grant application, $16.5 Million, for a Phase II trial in MCI/early Alzheimer’s Disease with

This is an application for a 3-year Phase II trial that is expected to be completed with approximately 100 patients that have

Mild Cognitive Impairment.

The award will be decided in May 2025.

There is no guarantee that the application will be approved, and the

trial will be put on hold if an approval is not rewarded to the Company.

A draft of the final study design is not yet determined but

a draft synopsis is described in “Item 1.

Business - “ of this Annual Report on Form 10-K.

have over the past three years received a strong interest in JOTROL from various Asian organizations.

We believe that this interest has

been triggered, in part, because resveratrol is becoming commonly used in Asian herbal medicines as a therapeutic strategy as described

in available scientific literature published by PubMed Central:

PMC7498443 (September 2020);

(ii) Hong Kong’s and China’s

recent approval of the patent for JOTROL;

(iii) China releasing a list of approximately 120 rare disease indications issued jointly by

five national bodies, including the National Health Commission, Ministry of Science and Technology, Ministry of Industry and Information

Technology, State Drug Administration, and State Administration of Traditional Chinese Medicine (May 2018), that we believe JOTROL can

be applicable as a treatment for MPS-1 and MELAS in this population;

(iv) recent publications regarding JOTROL in the Journal of Alzheimer’s

Disease and AAPS Open (Journal of Alzheimer’s Disease 86 (2022) 173–190 February 2022;

Kemper et al.

AAPS Open June 2022);

and (v) the projected increase of the TCM market due to several factors which of one is reformulation of existing compounds.

recently entered into service agreements in the areas of Business Development, CMC (Chemistry, Manufacturing, and Controls), regulatory

affairs and clinical trial management.

These agreements are with companies that, we believe, have the knowledge and network in the South-East

Asian market to accelerate steps that is needed to have a product that can have treatment value in the territory.

The agreements are

further described in the section “Activities in Asia”.

March 2025, the Company announced that it had entered into a partnership with Aquanova AG to develop a series of nutritional products

targeting longevity, aging and Healthspan.

The first three products, which will focus on the concept of “Beauty from Within”,

are slated to hit the market in the third quarter of 2025 through a Direct-to-Consumer model.

The Company will form a wholly-owned subsidiary

to focus on the consumer market, and will market its products on a to-be-developed website targeting the US market, along with social

media marketing.

Internationally, the Company is focusing on partners who can market and accelerate sales, with an initial focus on the

Asian region.

has been studied for over 50 years by academic institutions as well as by small and large pharmaceutical companies.

multi-functional mechanisms of resveratrol are well documented in over 14,000 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

We believe the Phase I study we have conducted indicates that we have resolved the poor bioavailability issue with

upon available scientific literature, it appears that resveratrol is an activator of SIRT1, one of the mammalian forms of the sirtuin

family of proteins.

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.

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

believes, based on pre-clinical and clinical studies, that high doses of resveratrol are necessary for potential therapeutic

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.

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.

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;

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.

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, 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™.

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

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 for the pharmaceutical industry, due to its poor solubility and bioavailability,

as well as adverse effects, such as severe gastro-intestinal side effects when taken at effective dose levels (over 2,000 mg daily).

Resveratrol has never before been developed with all the necessary steps to achieve an approval as a pharmaceutical product since the

existing natural supplements cannot provide high enough levels of resveratrol in blood plasma to be able to provide a therapeutically

effective dose without generating severe gastro-intestinal side effects.

This means that we need to take JOTROL through the full regulatory

NDA (New Drug Application) requirement to obtain a prescription marketing approval in the USA.

was developed together with our technology partner Aquanova AG, Darmstadt, Germany.

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™ 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 has been completed at Catalent Pharmaceutical

Services, Inc., St Petersburg, Florida.

Catalent is also in process to manufacture the clinical trial supplies for our Phase IIa trial

in Parkinson’s Disease.

is a micellar non-aqueous solution of resveratrol delivered in a softgel capsule.

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.

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.

Summary details of these studies are

included in “Item 1.

Business” of this Annual Report on Form 10-K.

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”)

1 unchanged sentence

The study results met our targeted goals.

The results from this

study will be used as a cross-reference for all indications where JOTROL will be used in Phase II and Phase III clinical trials.

Phase I results and the FDA guidance of cross-referencing is further described in “Item 1.

Business” of this Annual Report

on Form 10-K.

The Company has not discussed the use of cross-referencing in this manner with the FDA or other comparable regulatory authorities.

Intellectual Property and License Agreement

hold an exclusive global license from Aquanova AG for micellar technologies to develop, manufacture, and sell JOTROL Our CSO, Marshall

Hayward, and Aquanova’s lead scientist, Darius Benham, invented JOTROL.

The patent is co-owned by Aquanova AG and us, with the

application assigned to Aquanova AG.

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.

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).

results of this Phase 1 study were published in the Journal of Alzheimer’s diseases and AAPS Open in February 2022.

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.

result, we are presently unable to rely on potential cross-referencing other than the already cleared Phase II a Parkinson’s

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

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

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

1 unchanged sentence

The product is available in various capsule forms and is administered

license agreement with Aquanova AG is vital, as JOTROL is our primary product.

Losing this agreement would delay our plans and force

us to seek similar licenses, adversely affecting our business.

The agreement grants us worldwide exclusivity to utilize granted and pending

Effective from September 15, 2016, it lasts until patent expiration or ten years after the first commercial sale.

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.

There is an option to pay $3 million for reduced royalties

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.

As of December 31, 2024, $75,000 in accrued license fees are recorded in accounts payable.

Company’s product pipeline is built arounds proprietary platform product, JOTROL an enhanced oral formulation of resveratrol.

a natural compound is optimized in JOTROL to deliver therapeutically effective doses safety, aiming to address 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.

pipeline chart above shows the indications that we presently are prioritizing.

However, JNS101 is an additional indication that we believe

will be of interest to perform a clinical trial in at a later stage.

product pipeline represented above assume drawing upon previous preclinical and clinical data conducted by third parties.

available either via public domain or under agreements with our key partner which are further described in “Item 1.

of this Annual Report on Form 10-K.

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.

top priorities are advancing our clinical studies for JNS115 for Parkinson’s Disease and JNS 1 08 for MCI/early Alzheimer’s

We have started the work with the JNS115 Phase IIa trial and estimate that first dosing of a patients will occur in Q3 of 2025.

If we receive funding from the NHI, we will start our clinical trial for MCI/Early Alzheimer’s Disease later this year.

have not set any timeline for starting clinical trials for rare diseases.

We may work with other strategic partners on these clinical

Parkinson’s Disease

will be utilizing JOTROL in our application for investigating a treatment for Parkinson’s Disease (PD).

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.

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.

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™.

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

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

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

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.

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.

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

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

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.

Phase 2a study in Parkinson’s Disease patients

Company has engaged Zina Biopharmaceuticals to assist with study design, FDA communications including IND and manage the execution

of the trial.

Catalent has been engaged to manufacture the JOTROL clinical trial supplies.

The preliminary study design is described

below and is subject to final IND approval by the FDA.

The Company expects to start the clinical trial in the third quarter of 2025 and have the first study results available within 12 months thereafter.

are sponsoring a Phase 2a clinical trial to evaluate the safety, tolerability, and pharmacokinetics of Resveratrol (JOTROLTM) in individuals

with Parkinson’s Disease.

This 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 200mg or 400mg daily for three months.

The study aims to explore JOTROL’s potential to improve energy metabolism in Parkinson’s

An optional biomarker sub-study will assess cerebrospinal fluid, requiring additional consent.

Each participant will be involved

for 4-5 months, with the entire study lasting two years.

First readout of results are expected within 12 months of first dosing.

Mild Cognitive Impairment/early Alzheimer’s Disease

will be utilizing JOTROL in our applications for investigating treatment of various segments of Alzheimer’s disease of which MCI/early

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.

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

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.

If any NIA grant application is successful, we will have the funding to conduct a Phase II trial in MCI/early

Alzheimer’s Disease.

Our failure to obtain such a grant will most likely result in delays of this project and the need to raise

additional capital.

Alzheimer’s (mild)

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.

the early stage of Alzheimer’s, a person may function independently.

He or she may still drive, work and be participate in social

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.

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.

is the Alzheimer’s disease patient category that we will include in our 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.

The effect of JOTROL treatment,

in the Phase II trial, will primarily be measured through several biomarkers.

burden of Alzheimer’s disease on society in USA is generating a very large opportunity

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 a significant

savings to society.

Phase II Clinical Trial for MCI/early Alzheimer’s Disease

Institute on Aging (“NIA”) financed our 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.

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 Mild Cognitive Impairment (MCI) and early Alzheimer’s

The Phase II trial was designed to focus on 3 areas:

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.

trial was designed to focus on 3 areas:

(1) safety and tolerability;

2) pharmacokinetics and pharmacodynamics, measuring

of responses from 2 different doses vs.

(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

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

The final study design is not yet determined but a draft synopsis is described below.

There is however no guarantee that we

will ever receive NIA grant funding for this project.

A delay or rejection of this funding will cause a delay in this program and most

likely requiring additional financing.

proposed Phase II trial is 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

at Georgetown University, a member of our Scientific Advisory Board, as the Principal Investigator.

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.

PK 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

on the recent Scientific Review received from NIA.

Our team of scientists in the Alzheimer’s field, Professors Raymond Turner,

application was not accepted, but we were encouraged by the NIA to refine our application and submit again.

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.

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.

study was conducted by Professor Raymond Turner, MD, Ph.D.

at Georgetown University, a member of our Scientific Advisory Board, as

the Principal Investigator.

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.

team of scientists in the Alzheimer’s field, Professors Raymond Turner, MD, Ph.D.

and Charbel Moussa, Ph.D.

from Georgetown University, Rudolph Tanzi, Ph.D.

Harvard and Li-Huei Tsai, Ph.D.

MIT are assisting

in designing our POC study to address and explore several biomarkers and areas where the trial results can guide us to a follow-on Phase

II trial, if approved to do so by the FDA, that might generate meaningful outcomes for MCI/early AD 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

POC study in MCI patients with the FDA.

JOTROL MCI Phase II Study

SYNOPSIS Title:

A phase II, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of JOTROL (micellar

resveratrol solubilisation formulation) in early Alzheimer’s Disease (AD) patients Study Description:

This study seeks to assess

the safety and efficacy of JOTROL (resveratrol) in patients with MCI/early AD.

Approximately 105 patients will be enrolled at study centers

across the United States.

Patients will 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 JOTROL will be safe and tolerable in individuals with MCI/early AD.

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.

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

We hypothesize that this proposed study would support JOTROL™ safety and tolerability in

individuals with MCI/early AD.

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.

tolerability of the drug will be defined as fewer than 25% discontinuations due to drug-related

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

measure the effect of JOTROL on biochemical markers for AD, neurodegeneration, vascular damage, metabolic effects, and neuroinflammation

determine the effects of JOTROL on whole-brain and regional brain atrophy

measure the effects of JOTROL on functional MRI measures

assess cognitive effects of JOTROL

examine the influence of Apolipoprotein E genotyping on both biomarker and cognitive endpoints

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

Primary Endpoint:

of safety/tolerability by monitoring AEs and SAEs, assessing their potential relationship to the study drug and Abeta 40/42.

of AD relevant biomarkers

MRI and Cortical Disarray Measurement

experimental biomarkers as stated in protocol, such as those for neuroinflammation

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 II Description of Sites/Facilities Enrolling Participants:

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 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

of Study Intervention:

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;

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.

Orphan Diseases

Friedreich’s ataxia direct to Phase II

is a project utilizing JOTROL, specifically designed to treat Friedreich’s Ataxia.

Ataxia (FA) is a rare inherited disease that causes damage to the nervous system as well as mobility dysfunctions.

FA usually begins

in childhood and leads to impaired muscle coordination (ataxia) which worsens over time.

It is caused by a defect (mutation) in a gene

Friedreich’s ataxia is recessive, meaning it only occurs in someone who inherits two defective copies of the gene,

one from each parent.

Although rare, FA is the most common form of hereditary ataxia, affecting about 1 in 50,000 people in the United

EU5 (5 largest European countries) alone has approximately the same amount of FA patients as there are in USA.

2014 Murdoch Children’s Research Institute (MCRI) conducted a clinical trial in 27 human subjects where 24 completed the study,

resulting in that a high daily dose (5 grams) of nutritional grade trans-resveratrol had statistically different positive results, see

p-values for 5 g daily dosing in the table below, on established Friedreich’s Ataxia measurements.

Key markers, such as FARS Score

and measurements of hearing and speech parameters were included in these positive results.

The results indicate that an effective dose

of resveratrol is expected to be a meaningful treatment for patients with Friedreich’s Ataxia.

The data from the MCRI study was

used in pre-IND meetings with the FDA discussing our Phase II study and was also referenced in our application for orphan drug designation

The ODD, request #17-5978, was granted to us by the FDA on August 16, 2017.

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.

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.

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 1gram daily dosing vs 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

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.

we believe that our JOTROL product in a Phase II/II trial will replicate the positive outcomes without any severe gastro-intestinal

side effects.

Phase II trial for Mucopolysaccharidosis Type 1 (MPS I)

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

I is divided into three subtypes based on severity of symptoms.

All three types result from an absence of, or insufficient levels of,

the enzyme alpha-L-iduronidase.

Children who have parents with MPS I will carry the defective gene.

I patients are presently treated with an Enzyme Replacement Therapy (ERT) named Aldurazyme.

This requires a weekly infusion of 4 hours

per event and cost 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 and Joints, it leaves the patients with a gradually worsening quality of life including

loss of hearing, blindness and severe arthritis.

is targeting the specific areas that ERT cannot treat, with JOTROL™ treatment.

Phase II Clinical Trial

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.

application for Phase I study was approved by the FDA and the clinical trial is completed.

Results documented in the section JOTROL

Phase I Pharmacokinetic (“PK”) and Safety Study .

study details and start to be determined by consultation with the FDA and supportive additional financing.

tolerability and PK/PD values

endpoints to include (subject to FDA acceptance)

in 6-minute walk distance

vital capacity

such as alpha-L-iduronidase levels

I validated pain survey

Phase II trial for MELAS Syndrome

is utilizing JOTROL as the product to treat MELAS Syndrome.

(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

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%, which is expected to lead to an

increase in the mitochondria levels in MELAS patients and thereby show positive patient outcomes.

of MELAS syndrome usually begin between the ages of two and fifteen years, but delayed onset cases have also been reported in people

aged fifteen to forty years and older.

In approximately 75 percent 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.

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.

potential market for JOTROL in the USA includes approximately 80,000 patients.

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.

following is an overview of JNS’s competitors.

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.

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

gets approved in an indication.

the availability of FDA-approved treatments for Parkinson’s Disease, no breakthrough therapies have emerged recently to halt disease

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.

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.

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.

companies are actively developing treatments for Alzheimer’s disease, each with unique approaches and challenges.

Aduhelm, an IV infusion targeting amyloid-beta plaques, has faced reimbursement issues despite FDA approval, leading to low market penetration.

Eli Lilly’s donanemab, targeting a modified form of beta amyloid, recently received FDA approval and is priced at $32,000 annually.

or 200 mg bid (400mg/day) resveratrol as

Participant Duration :

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.

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

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.

IND application for Phase I study

was approved by the FDA.

Final study details and start to be determined by consultation with the FDA and supportive additional financing.

Primary endpoint:

Safety, tolerability and PK/PD values

Secondary endpoints to include (subject to FDA acceptance)

Improvement in 6-minute walk distance

Forced vital capacity

Biomarkers, such as alpha-L-iduronidase levels

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%.

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

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

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 patients 1 .

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.

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

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.

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.

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.

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an orally dosed molecule in Phase II, supported by significant NIA grants.

Life Sciences is advancing Anavex 2-73, a Phase III candidate from their SIGMACEPTOR™ platform, targeting CNS conditions with genomic

Eisai and Biogen’s Leqembi, approved by a panel of experts, is expected to receive traditional FDA approval, potentially

expanding Medicare coverage.

Priced at $26,000 per year, Leqembi has shown benefits for early-stage Alzheimer’s patients.

these advancements, the competitive landscape remains dynamic, with the possibility of other companies emerging with successful treatment

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, can potentially have a successful

product approved before us and have a more effective treatment.

the MPS-1 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.

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.

it is possible that another company, that is not listed below, could have a successful product approved before us and have a more effective

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

RegenexBio is developing RGX-111, a gene therapy designed to deliver a functional copy of the IDUA gene to the central nervous

Sigilon Therapeutics, Inc.

is working on SIG-005, which uses a genetically modified human cell

line to express the IDUA enzyme, with an IND application for Phase I submitted to the FDA.

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.

exploring gene editing products, although no positive results have been published yet.

is exploring gene editing products, although no positive results have been published yet.

These developments represent significant competition

in the treatment of MPS-1.

the treatment of Friedreich’s Ataxia, several products compete with Jupiter’s offerings.

Reata Pharmaceuticals’ Omaveloxolone,

branded as SKYCLARYS, received approval in 2023 following successful Phase II and pivotal trials.

Despite its effectiveness, Jupiter

anticipates conducting future studies in Europe and Australia due to market competition in the USA, especially after Biogen’s acquisition

Minoryx Therapeutics has completed a Phase II trial for MIN-102, a selective PPAR gamma agonist, showing promise in this space.

Additionally, Larimar Therapeutics is developing CTI-1601, a recombinant fusion protein intended to deliver human frataxin to mitochondria,

currently in Phase I trials.

These advancements highlight the competitive landscape in Friedreich’s Ataxia treatment.

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 2/3 study initiated in December 2022.

These developments underscore the competitive landscape

in the search for effective MELAS treatments.

believe that we are positioned to outperform competitors for the following reasons:

believe that the focus on a new product based on resveratrol with higher bioavailability, JOTROL, will enable us to utilize the same

product for several indications, subject to FDA’s approval.

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

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.

are building a close relationship with Key Opinion Leaders (KOL’s) 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.

natural product resveratrol is well studied with over 14,000 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

upon available scientific literature, it appears that resveratrol is an activator of SIRT1, one of the mammalian forms of the sirtuin

family of proteins.

in the treatment of MPS-I.

https://pmc.ncbi.nlm.nih.gov/articles/PMC8993002/

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

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 for the pharmaceutical industry, due to its poor solubility and bioavailability,

as well as adverse effects, such as severe gastro-intestinal side effects when taken at effective 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

Resveratrol has never been developed with all the necessary steps to achieve an approval as a pharmaceutical product since

the existing natural supplements cannot provide high enough levels of resveratrol in blood plasma to be able to provide a therapeutically

effective dose without generating severe gastro-intestinal side effects.

This means that we need to take JOTROL through the full regulatory

NDA (New Drug Application) requirement to obtain a marketing approval.

We were able to receive, through a confidential agreement from

a major pharmaceutical company, a chronic toxicology study performed with resveratrol, in two different species, that was referenced

in our approved Phase I IND application submitted to the FDA.

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.

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.

and Commercialization Plan

March 2025, the Company announced that it had entered into a partnership with Aquanova AG to develop a series of nutritional products

targeting longevity, aging and Healthspan.

The first three products, which will focus on the concept of “Beauty from Within”,

are slated to hit the market in the third quarter of 2025 through a Direct-to-Consumer model.

The Company will focus on the consumer

market, and will market its products on a to-be-developed website targeting the US market, along with social media marketing.

Internationally,

the Company is focusing on partners who can market and accelerate sales, with an initial focus on the Asian region.

addition, we may also consider out-license JOTROL to one or more companies that has such commercialization capability in place.

consider at any time a complete exit through any proposed acquisition of our company.

In case no acceptable M&A offer is presented

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 the larger indications.

All international distributions will most likely be out licensed.

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 Key Opinion Leaders

(KOL), patient advocacy groups and directly to patients, which may reduce marketing costs.

are already using information regarding our development progress through KOL’s and the respective patient organizations that exist

for each indication.

We have also initiated a collaboration with several patient organizations such as the FARA organization, www.curefa.org,

the National MPS Society, UMDF, www.umdf.org, and the EveryLife Foundation in USA.

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 the Asian territories while waiting to conduct out-licensing

in USA and Europe until after Phase II results are obtained.

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.

and Organization

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.

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.

Marketing and Commercialization Plan for Therapeutic Drug

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

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.

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;

● 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.

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).

Approval of Rare Diseases

management, Scientific Board of Advisors and business advisors have extensive experience in regulatory affairs and clinical development

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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 an approval in pediatric population

in a rare disease.

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 regulatory review in about six months rather than the standard ten months.

The Food and Drug Administration (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 disease, and the drug using a voucher for another

The voucher may be sold.

For example, a small company might win a voucher for developing a drug for a neglected disease and

sell the voucher to a large company for use on a commercial disease.

are four specific approval pathways applicable for 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:

entitles the bearer to receive FDA’s review of drug or biological product applications in six months rather than the standard ten

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.

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.

Review was authorized in 1992 by the Prescription Drug User Fee Act (PDUFA) which created the two-tiered FDA drug review system (standard

This pathway shortens application review from 10 months (standard) to 6 months (priority).

The FDA determines if a drug

receives a standard or priority review, although sponsors may request a priority review.

Priority review is granted if a new drug would

result in a significant improvement in safety and effectiveness compared to existing therapies.

for the treatment of serious conditions that address an unmet medical need receive an expedited review.

The purpose of this pathway is

to get important new drugs to patent earlier, for conditions such as Alzheimer’s disease, epilepsy, depression, and multiple sclerosis.

Any drug being developed to treat or prevent a condition with no current therapy is prioritized.

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.

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:

superior efficacy;

new drug must demonstrate advantages, such as:

superior effectiveness, effect on serious outcomes or improved effect on serious outcomes;

serious side effects of the available therapy;

clinically significant toxicity of an available therapy;

clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment;

an emerging or anticipated public health need

Track designation should come at the time of submission and be requested by the manufacturer, although it can be requested at any time

in the approval process.

Once in the Fast Track pathway, there are more frequent meetings with the FDA to discuss the development plan

and appropriate data needed to support drug approval.

Drugs in the Fast Track pathway are also eligible for accelerated approval and

priority review if relevant criteria are met.

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.

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.

Approval Pathway

in 1992 and updated in 2012, this pathway is applied to new therapies that treat serious or life- threatening conditions for which there

is an unmet medical need and have a “clinically meaningful” outcome.

Drugs that are eligible for this pathway must be reasonably

likely to improve a surrogate endpoint if a standard endpoint would require long-term evaluation.

If given conditional approval, the

sponsor must conduct post-marketing clinical trials to ensure endpoints are met.

If the standard endpoints are not met, the FDA can withdraw

designation is designed to expedite the development and review of drugs that are intended to treat serious conditions and preliminary

clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on clinically significant

is however no guarantee that an accelerated pathway will lead to an accelerated FDA review and that a pediatric approval leads to a PRV.

Additionally, there can be no guarantee that the Company can be successful in its plans under any FDA pathway.

July 1, 2022, the Company entered into a research agreement with the University of Miami to conduct a preclinical study to evaluate the

effect of JOTROL in Parkinson’s Disease models.

The cost of the research agreement activities, to be paid by the Company, is $72,844.

The Company owns any intellectual property generated from the research.

The agreement is for 1 year from the start date, July 1, 2022.

Either the Company or the University of Miami may terminate this agreement upon thirty (30) days written notice for any reason.

event of such termination, both the Company and the University of Miami shall take all reasonable steps to cancel further costs in connection

with this agreement.

The Company and the University of Miami will be entitled to reimbursement for costs and non-cancelable obligations

incurred prior to effective day of the termination, not to exceed the total amount of the project.

Business Development Activities

have recently agreed to service agreements in the areas of CMC (Chemistry, Manufacturing, and Controls), regulatory affairs and clinical

trial management with companies with operations in SE Asia.

These agreements are with companies that, we believe, have the knowledge

and network in the South-East Asian market.

The agreements are further described in the section “Other Material Agreements”.

In addition, we are in active negotiations with Dominant Treasure Health (“DTH”), a BVI company.

DTH has demonstrated to

us, through several company introductions, that they have business relationships, either directly or through affiliates, with many South-East

Asian pharmaceutical companies as well as companies involved in distribution and sales of TCM, Traditional Chinese Medicine.

We are therefore

planning to engage DTH in active business development in China, Malaysia and Singapore as soon as we have financing in place for their

DTH has already introduced us to 3 Chinese companies, Beimei Pharma, http://en.beimeiyaoye.com, that specializes in pediatric

medications, Sichuan Kelun Pharmaceutical Co., ltd, a publicly traded company that is part of the Kelun Industrial Group, https://www.kelun.com/,

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

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.

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.

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

of Clinical Trial Information

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.

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.

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

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;

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

“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

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.

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.

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.

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:

Target Consumer Benefit

Support skin beauty and healthy appearance

Cognitive performance

Support mental clarity, cognitive

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.

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.

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.

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.

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.

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

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 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

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

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.

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 South-East Asian

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.

rationale for the strong approach into the South-East Asian market is:

Asian countries are not accepting pharmaceutical products to be sold without clinical trial approvals based on trials conducted in an

Asian population

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.

have already received interest for our JOTROL product in the Asian market since resveratrol is listed as a Traditional Chinese

need for a set up that can service this market is imperative for success.

collaboration agreements have been executed to facilitate an expedited execution of an out-licensing agreement with one or

more Chinese or other SE Asian pharmaceutical companies.

Company is too small, both financially as well as internal manpower, to manage developments in the territory.

Company has a history of poor financial status and not being able to fulfill commitments and finalize clinical studies.

utilizing equity as service payments, the company believes that it can get projects finalized without any significant cash outflow.

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.

Material Agreements

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.

The studies were conducted

at Charles River Laboratories, and there are no payments associated with this agreement.

Agreements – South-East Asia

June 3, 2024, the Company entered into three service agreements to expand in South-East 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 three service agreements were paid for with an upfront issuance of 1,162,500 shares

of common stock, which were registered for resale as part of the initial public offering, and have a term of three years.

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 Company’s desire to get its

products developed and distributed 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.

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 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

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.

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.

Our rationale for the strong approach

into the Southeast Asian market is:

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.

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.

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

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

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

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.

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

Terms of the office lease provide for a base rent payment of $3,783

per month and a share of the building’s operating expenses, such as taxes and maintenance, of $476 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.

believe that these facilities are adequate for our current and near-term future needs.

of December 31, 2024, we had a total of four full-time employees, two full-time consultants, one part-time consultant,

and our six Scientific Advisory Board members.

Of these, three were primarily engaged in research or product development and clinical

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.

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.

these, three were primarily engaged in research or product development and clinical activities.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business