JUPITER NEUROSCIENCES, INC.

This Business section, along with other sections of this Annual Report on Form 10-K, includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe that these industry publications and third-party research, surveys and studies are reliable, we have not independently verified such data and we do not make any representation as to the accuracy of the information. Unless the context otherwise requires, “JNS,” “we,” “us,” “our,” or the “Company” refers to Jupiter Neurosciences, Inc., a Delaware corporation.

Overview

Jupiter Neurosciences, Inc. (the “Company,” “we” or “us”) is a clinical stage research and development company focused on developing treatments for neuroinflammation through our unique resveratrol platform. Our platform product, JOTROL™, is an enhanced oral formulation of resveratrol, which has many potential indications. In the larger disease areas, we are primarily targeting Parkinson’s Disease. We are presently in the process of conducting a Phase IIa clinical trial in Parkinson’s Disease.

In March 2025, the Company unveiled a new strategic initiative to introduce Nugevia — a consumer-oriented product line dedicated to longevity and wellness. This initiative aims to meet the rising demand for wellness solutions by developing nutritional products that support both consumer health and wellness. The Company completed the formulations and initial sales through direct-to-consumer (“DTC”) social media began in the second half of the year.

In December 2024, we received gross proceeds of $11 million in a registered public offering (the “Public Offering”) of 2,750,000 shares of our common stock, par value $0.0001 per share (“common stock”) at a price of $4.00 per share for gross proceeds of $11 million before deducting underwriting discounts and other related expenses. In connection with the Public Offering, the Company’s common stock was registered under Section 12(b) of the Exchange Act and began trading on The Nasdaq Capital Market under the symbol “JUNS.”

The Company was incorporated in January 2016 under Delaware law under the name of Jupiter Orphan Therapeutics, Inc. On August 30, 2021, the Company filed a Certificate of Amendment with the State of Delaware to change its name to Jupiter Neurosciences, Inc.

Business Overview

Jupiter Neurosciences, Inc. is a clinical stage research and development pharmaceutical company located in Jupiter, Florida. The Company is advancing a therapeutic pipeline targeting central nervous system (“CNS”) disorders and rare diseases, while also expanding into the consumer market with its Nugevia™ product line. Both efforts are powered by JOTROL™, Jupiter’s proprietary, enhanced resveratrol formulation that has demonstrated potential for significantly improved bioavailability in an FDA regulated Phase I study. The Company’s therapeutic development pipeline is focused broadly on CNS disorders, presently with a Phase IIa clinical study in Parkinson’s disease. The Company’s Nugevia product line brings cutting edge science to the supplement space, supporting mental clarity, skin health, and mitochondrial function.

The Company completed preclinical studies at the University of Miami for Parkinson’s Disease in 2021. These studies used a validated mouse model to mimic human disease characteristics. JOTROL™ demonstrated consistent improvements in motor coordination, endurance, and strength across multiple endpoints in a validated Parkinson’s disease model, with statistically significant benefits versus untreated disease controls. The promising results have led the Company to initiate a Phase IIa clinical trial for Parkinson’s Disease, which received final IND approval by the FDA in November of 2025 and is expected to start in the second quarter of 2026, with results anticipated 12 months later. The Company also aims to investigate other CNS indications, such as Mild Cognitive Impairment (“MCI”) and Alzheimer’s disease, following the Parkinson’s study.

The Company believes, based on pre-clinical and clinical studies, that high doses of resveratrol are necessary for potential therapeutic effects. Currently available resveratrol products cannot reach these levels without causing severe gastrointestinal side effects. Human studies evaluating resveratrol in Alzheimer’s patients (Turner et al 2015) and Friedreich’s Ataxia patients (Yu et al 2015) indicate the concentration of resveratrol at its peak (CMax) measured in blood plasma should be 300 ng/ml or higher for a potential therapeutic effect. A Phase 1 study with 500mg of resveratrol as a maximum dose in the JOTROL™ formulation showed levels of resveratrol exceeding 800 ng/ml without generating any severe adverse events (AAPS Open 2022). Resveratrol was shown in the Turner Alzheimer’s study to cross the blood-brain barrier, possibly indicating a potential for positive effects on oxidative stress and inflammation. Subsequent analysis published in Molecular Science 2025 (Mousa et al) further indicates that resveratrol may have an impact on neurodegeneration and neuroinflammation in Alzheimer’s patients.

Over the past two years, JOTROL™ has garnered significant interest from Asian organizations. This interest is partly due to resveratrol’s use in Asian herbal medicines, recent patent approvals in Hong Kong and China, and China’s list of rare disease indications where JOTROL™ could be applicable. Additionally, recent publications in the Journal of Alzheimer’s Disease and AAPS Open, along with the projected growth of the Traditional Chinese Medicine market, have contributed to this interest.

The Company has entered service agreements with firms in Hong Kong to accelerate product development in Southeast Asia. These agreements aim to leverage local expertise and networks to facilitate market entry and potential out-licensing deals. The Company entered into an agreement with Dominant Treasure Health to expand its business development in China, Malaysia, and Singapore, aiming to penetrate the large and challenging Asian market.

In March 2025, the Company unveiled a new strategic initiative to introduce Nugevia—a consumer-oriented product line dedicated to longevity and wellness. This initiative aims to meet the rising demand for scientifically backed wellness solutions by developing nutritional products that support both longevity and health span. Positioned within a rapidly growing global industry expected to reach $8 trillion by 2030, Nugevia products will leverage Jupiter’s proprietary JOTROL™ technology, a resveratrol-based platform that is designed to deliver an increase in the bioavailability profile of resveratrol.

The first products under the Nugevia brand, focusing on supporting longevity and health span are available for sale and shipments began in the fourth quarter of 2025 through a DTC model. The products are:

The three debut formulations—GLO, MND, and PWR—are designed to support wellness and longevity through intelligent stacking of synergistic ingredients, all enhanced for optimal absorption via the JOTROL™ system.

The Company plans to market these products in the U.S. and internationally.

Nugevia’s launch is a pivotal move to monetize Jupiter’s proprietary science, support ongoing clinical trials, and capture a share of the booming longevity market.

The Company operates through two segments: (i) the sale of premium nutritional supplements under the Nugevia brand, and (ii) pharmaceutical operations centered on the development of drug candidates.

Resveratrol

Resveratrol, a natural antioxidant compound found in foods like red grapes and berries, has been studied for over 50 years by academic institutions as well as by small and large pharmaceutical companies. The multi-functional mechanisms of resveratrol are well documented in over 20,000 scientific publications. Several of these publications, including a summary paper by AY Berman et al, published in Precision Oncology 2017, point to the issue of the poor bioavailability that has stopped medical utilization of regular resveratrol and never received regulatory approval for any indication. We believe the Phase I study we have conducted indicates that we have resolved the poor bioavailability issue with JOTROL™.

Based upon available scientific literature, it appears that resveratrol is an activator of SIRT1, one of the mammalian forms of the sirtuin family of proteins. SIRT1 deacetylates histones and nonhistone proteins including transcription factors. The SIRT1-regulated pathway is believed to affect metabolism, stress resistance, cell survival, cellular senescence, inflammation/immune function, endothelial functions, and circadian rhythms. Resveratrol has been documented in scientific literature to activate SIRT1, NrF2, NLRP3 inflammasomes and have an epigenetic mechanism, and therefore, is predicted to benefit diseases affected by abnormal metabolic control, inflammation, and cell cycle defects. Nonetheless, the administration of currently available resveratrol poses a major challenge for the pharmaceutical industry, due to its poor solubility and bioavailability, as well as severe gastro-intestinal side effects when taken at effective dose levels (over 2,000 mg daily).

JOTROL™

JOTROL™ was developed together with our technology partner Aquanova, headquartered in Darmstadt, Germany. JOTROL™ is formulated with a unique patented micellar technology that is projected to increase the bioavailability profile of resveratrol. Manufacturing technology transfers were completed in 2017, and manufacturing procedures and clinical trial supply manufacturing have been completed at Catalent Pharmaceutical Services, Inc. (“Catalent”), St Petersburg, Florida. Catalent has also completed the manufacturing of the clinical trial supplies for our Phase IIa trial in Parkinson’s Disease.

JOTROL™ is a micellar non-aqueous solution of resveratrol delivered in a softgel capsule. Each capsule includes 100mg of resveratrol. Pre-clinical trials in mice and rats were conducted comparing JOTROL™ to micronized resveratrol, labeled to have the highest bioavailability in the nutritional market, to demonstrate that we could achieve a significantly higher bioavailability. A Phase I dose finding pharmacokinetic (“PK”) study in healthy volunteers was completed during the first half of 2021. The study results met our targeted goals.

The Phase I study demonstrated JOTROL™’s potential for higher bioavailability compared to resveratrol used in earlier clinical trials (e.g., Turner, MCI/Early Alzheimer’s Disease trial and Yui et al., Friedreich’s ataxia trial). The results of this Phase 1 study were published in the Journal of Alzheimer’s diseases and AAPS Open in February 2022. Subject to additional discussions with and approval from FDA, we hope to use the results of this study as a cross-reference for other indications to allow JOTROL™ to be tested in Phase II and Phase III clinical trials. FDA accepted this cross-reference in the approval of the IND application for the Parkinson’s Phase IIa trial. The Company has not discussed the use of cross-referencing in this manner with the FDA or other comparable regulatory authorities for any other indications, and FDA (or any comparable regulatory authorities) may preclude us from the use of cross-referencing with respect to the results of this study. As a result, we are presently unable to rely on potential cross-referencing other than the already cleared Phase II a Parkinson’s study.

JOTROL™ Intellectual Property and License Agreement

We hold an exclusive global license dated from Aquanova for micellar technologies to develop, manufacture, and sell JOTROL on the terms set forth in the license agreement. Our Chief Scientific Officer (“CSO”), Marshall Hayward, and Aquanova’s founder, former CEO, and lead scientist, Darius Benham, invented JOTROL™. The patent is co-owned by Aquanova and us, with the application assigned to Aquanova. Filed in Germany on January 29, 2017, the patent (PCT/EP2017/O51659) expires in 2036 and is granted in the USA, Japan, China, Hong Kong, and specific European countries. The patent covers a solubilization product with resveratrol, polysorbate 80 and 20, MCT, and tocopherols for pharmaceutical use. It includes claims on formulation specifics, micelle size, turbidity, and treatment applications for diseases like Alzheimer’s and diabetes. The product is available in various capsule forms and is administered orally.

Our license agreement with Aquanova is vital, as JOTROL™ is our primary product. Losing this agreement would delay our plans and force us to seek similar licenses, if available, adversely affecting our business. The agreement grants us worldwide exclusivity to utilize granted and pending patents. Effective from September 15, 2016, it lasts until patent expiration or ten years after the first commercial sale. We paid an upfront fee of $20,000 and an annual license fee of $75,000 until the first product approval. Milestone payments of $200,000 are due per territory upon regulatory approval, with royalties set at 5% of net sales. Each party has the option, within 180 days of a US Marketing approval, to demand that the Company pay a one-time payment of $3 million for reduced royalties of 1.25%. Termination can occur due to material breach or insolvency, with specific provisions for retaining licenses. Recent amendments include a Debt Forgiveness and Exchange Agreement on December 1, 2021, where $225,000 of debt was forgiven in exchange for $125,000 cash, a $100,000 promissory note, and stock options.

The Company relies on trade secret protection and contractual confidentiality obligations to safeguard certain proprietary know-how related to JOTROL™. The Company also asserts common law trademark rights in the JOTROL™ name. In January 2025, the Company filed an intent-to-use trademark application with the U.S. Patent and Trademark Office

Product Pipeline

The Company’s pharmaceutical product pipeline is built around its proprietary platform product, JOTROL™ an enhanced oral formulation of resveratrol. Resveratrol, a natural compound is optimized in JOTROL™, which is being evaluated to better understand its therapeutic benefits and its potential relevance to biological pathways of interest, including those involving oxidative stress, inflammation and mitochondrial issues linked to neurological conditions. The Company has designated the different indications with project numbers, JNS101 - JNS115. The same JOTROL™ product is planned to be used in all indications although the number of capsules might vary and be indication specific and may be impacted by regulatory requirements and other factors not known to us at this time.

The pipeline chart above shows the indications that we presently are prioritizing and is subject to the availability of financing as further discussed in the “Risk Factors” section.

The validity of our product pipeline represented above relies on the assumptions drawing upon previous preclinical and clinical data conducted by third parties. This data is available either via public domain or under agreements with our key partners. The Company has not discussed with the FDA its ability to rely on and reference data from previous third-party trials, such as the Phase II trial in MCI/early Alzheimer’s disease, conducted by Georgetown University.

Our top priorities are advancing our clinical studies for JNS115 for Parkinson’s Disease followed by JNS108 for MCI/early Alzheimer’s Disease. We executed all CMC, regulatory, and preparations with investigators including IND approval by FDA for our JNS115 Phase IIa trial and estimate that first dosing of patients will occur in the second quarter of 2026. We are also exploring clinical trials of JOTROL for other indications, including rare diseases. Based on the FDA’s approval to use our Phase I study in support of the IND for our Phase IIa Parkinson’s study, we believe there may be potential to cross-reference the Phase I data for additional indications in the future. However, we have not discussed this cross-referencing for any other indication with FDA, and we may be precluded from relying on cross-referencing other than in the Phase IIa Parkinson’s study.

JNS115 Parkinson’s Disease

We will be utilizing JOTROL™ for investigating a treatment for Parkinson’s Disease (PD).

People are usually more familiar with the motor symptoms of Parkinson’s disease (PD), which are noticeable and used by doctors for diagnosis. The three cardinal motor symptoms are stiffness (rigidity), slowness (bradykinesia), and resting tremors. Stiffness involves muscle rigidity detected during examination, while slowness refers to decreased spontaneous and voluntary movement, such as slower walking or reduced facial expression. Resting tremor is an involuntary shaking that occurs when a limb is relaxed and disappears during movement.

Non-motor symptoms, often called the “invisible” symptoms, can affect almost every body system and vary in severity. These symptoms can significantly impact quality of life and include autonomic dysfunctions like constipation, low blood pressure, sexual problems, sweating issues, and urinary problems. While available therapies can treat some symptoms, there is an urgent need for better treatments to improve quality of life and slow disease progression. Approved medications for motor symptoms include dopamine replacement therapy (levodopa/carbidopa), adenosine receptor antagonists, amantadine, anticholinergic medications, COMT inhibitors, decarboxylase inhibitors, dopamine agonists, and MAO-B inhibitors. Researchers are increasingly recognizing the debilitating nature of non-motor symptoms and are working on new therapies, while doctors manage these symptoms with current treatments.

Upcoming Phase IIa study in Parkinson’s Disease patients

The Company has engaged Zina Biopharmaceuticals to assist with study design, FDA communications, including submission, of an Investigational New Drug (IND) application and to manage the execution of the trial. Catalent has been engaged to manufacture the JOTROL™ clinical trial supplies pursuant to the Manufacturing Agreement between Company and Catalent dated September 16, 2020, under which Catalent is to provide the Company with clinical batches of JOTROL™ using a softgel formulation, which will be for active and placebo batches for the Parkinson’s disease study. The study design is described below and has received final IND approval by the FDA. The Company expects to start the clinical trial in the second quarter of 2026 and have the first study results available twelve months thereafter.

The multicenter, randomized, double-blind, placebo-controlled study involves approximately 30 participants across three centers in the US. Participants are randomly assigned to one of three groups to receive either a placebo or JOTROL™ at doses of 200 mg or 400 mg daily for three months. The study aims to explore JOTROL™’s potential to improve energy metabolism in Parkinson’s Disease. An optional biomarker sub-study will assess cerebrospinal fluid, requiring additional patient consent. Each patient will be involved in the study for approximately four to five months, while the overall study including all subsequent analyses will span approximately two years, with initial results expected within twelve months of first dosing.

JNS108 Mild Cognitive Impairment/early Alzheimer’s Disease

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

The National Institute on Aging (“NIA”) financed the Company’s Phase I study with $1.76 million through grant 1R44AG067907-01A1. Because there were unanticipated higher costs, mostly due to COVID-19 related additional procedures during the Phase I trial, a supplemental grant of $233,281 was submitted to the NIA in December of 2021. We were awarded the supplemental grant on April 7, 2022.

In April 2021, we submitted our first grant application to the NIA for full funding of a Phase II trial in MCI and early Alzheimer’s disease. The Phase II trial was designed to focus on 3 areas: (1) safety and tolerability; (2) pharmacokinetics and pharmacodynamics, measuring of responses from 2 different doses versus a placebo; and (3) measuring of effect on multiple biomarkers related to the disease. The application was not accepted, but we were encouraged by the NIA to refine our application and submit again. We have since submitted 3 grant applications, with budgets of $20 million or higher, to the NIA for full funding of such Phase II trial but none of those applications were successful. We are planning to submit the next grant application after we have the results from our Phase IIa study in Parkinson’s patients as several biomarkers from that trial may apply to Alzheimer’s patients as well. However, there can be no assurance that the results of this Phase IIa study will be positive or that NIA will approve any future grant application.

Early-stage Alzheimer’s (mild)

Later stages of Alzheimer’s are very difficult to reverse and therefore it is important to start treatment of Alzheimer’s in the earliest possible stage so the individuals can continue living normal lives and maintain their independence.

In the early stage of Alzheimer’s, a person may function independently. He or she may still drive, work, and participate in social activities. Despite this, the person may feel as if he or she is having memory lapses, such as forgetting familiar words or the location of everyday objects.

Symptoms may not be widely apparent at this stage, but family and close friends may take notice and a doctor would be able to identify symptoms using certain diagnostic tools. Common difficulties include finding the right word or name, remembering names when meeting new people, and performing tasks in social or work settings. People may also forget material they just read, lose or misplace valuable objects, and experience increased trouble with planning or organizing.

This is the Alzheimer’s disease patient category that we plan to include in our grant application for a proposed Phase II clinical trial with the final objective of showing that JOTROL™ has the potential of slowing and/or possibly stopping the progression of this disease, subject to FDA’s review of the clinical trial and the protocol. The effect of JOTROL™ treatment, in the potential Phase II trial, will primarily be measured through several biomarkers.

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

According to Alzheimer’s Association’s 2020 annual report Alzheimer’s disease has impacted 5.7 million Americans and that it costs the US $277 billion each year, excluding the cost of “unpaid time and effort of the people, mostly women, who are caring for spouses, parents, siblings, and friends with dementia.” The Association explained, “In 2017, 16 million Americans provided an estimated 18.4 billion hours of unpaid care in the form of physical, emotional and financial support - a contribution to the nation valued at $232.1 billion.” Any product that delays the onset of severe Alzheimer’s disease should represent significant savings to society.

Proposed JNS108 Phase II Clinical Trial for MCI/early Alzheimer’s Disease

Subject to FDA’s review and approval, the Phase II trial will be built on utilizing published information from the earlier Turner et al Phase II trial, completed in 2015 with 119 patients with early Alzheimer’s disease who were treated with 4 different doses of resveratrol. The study was conducted by Professor Raymond Turner, MD, Ph.D. at Georgetown University, a member of our Scientific Advisory Board, as the Principal Investigator. Dr. Turner is the Principal Investigator of our proposed Phase II trial. The study tried 500mg, 1000mg, 1500mg and 2000mg daily doses with each dose taken by the patients over 13 weeks. Only the highest dose of 2000mg (2 X 1g per day) showed positive results on biomarkers which lead to the conclusion that this study was most likely underdosed for achieving the best therapeutic effect. Pharmacokinetic analysis showed that the average C-Max of resveratrol in the blood on the highest dose was 181 ng/ml, which is far from the target of 300ng/ml that we believe is needed for reaching therapeutic effect.

Our team of scientists in the Alzheimer’s field, Professors Raymond Turner, MD, Ph.D. and Charbel Moussa, Ph.D. from Georgetown University and Li-Huei Tsai, Ph.D. from MIT have assisted in designing our Phase II a study to address and explore biomarkers. We believe these trial results can guide us to a follow-on studies that might generate meaningful outcomes for MCI/early Alzheimer’s disease patients. The Company has not discussed its ability to rely on and reference the Phase II trial conducted by Georgetown with the FDA nor has it discussed the design of the planned study in MCI patients with the FDA.

Proposed JOTROL™ MCI Phase II Study

In the future, the Company hopes to pursue a phase II, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of JOTROL™ (micellar resveratrol solubilization formulation) in early Alzheimer’s disease (“AD”) patients. If the study and protocol is approved by FDA, approximately 105 patients would be enrolled at study centers across the United States. Patients would be randomized into one of two active treatment arms to receive JOTROL™ 200 mg BID or JOTROL™ 500 mg BID or to a placebo group. We hypothesize that this proposed study would support JOTROL™ safety and tolerability in individuals with MCI/early AD.

Objectives

Primary Objective:

Secondary Objectives:

Endpoints

Primary Endpoint:

Secondary Endpoints:

Study Population: Approximately 105 male or female subjects between 55 and 85 years of age with a diagnosis of MCI/early AD will be enrolled. MCI/early AD patients should be amyloid positive with an AD/MCI clinical diagnosis.

Phase: Phase II Description of Sites/Facilities Enrolling Participants: Approximately 8 study centers in the USA. Study sites will be determined by competitive selection of interested and eligible ADCS sites - with experienced study coordinators, raters, and site PIs.

Description of Study Intervention: Subjects will be randomized 1:1:1 to receive 500 mg bid (1g/day) resveratrol as JOTROL™; or 200 mg bid (400mg/day) resveratrol as JOTROL™; or placebo.

Participant Duration: Treatment phase will be 6 months with a one month follow up safety visit and safety monitoring over a 6-month period to ensure that patients have no long-lasting treatment related effects.

Rare Orphan Diseases

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

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

MPS-I is divided into three subtypes based on severity of symptoms. All three types result from an absence or insufficient levels of the enzyme alpha-L-iduronidase. Children who have parents with MPS-I will carry the defective gene.

MPS-I patients are presently treated with an Enzyme Replacement Therapy (“ERT”) named Aldurazyme. This requires a weekly infusion of 4 hours per event and costs over $500,000 per year per patient. The ERT is effective in significantly prolonging life. However, since the ERT does not penetrate the blood brain barrier, ears, eyes, or joints, it leaves the patients with a gradually worsening quality of life including loss of hearing, blindness and severe arthritis.

JNS102 is targeting the specific areas that ERT cannot treat, with JOTROL™.

Proposed JNS102 Phase II Clinical Trial

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 older. In approximately 75% of cases, onset of the disorder occurs before the age of 20 years. Symptoms and physical findings associated with MELAS syndrome vary greatly among affected individuals. The distinguishing feature in MELAS syndrome is the recurrence of stroke-like episodes. It is currently thought that the deficiency of a compound called nitric oxide in the small blood vessels of the brain may be responsible for the stroke-like episodes. Short stature and hearing loss may be present and fatigue and difficulty tolerating exercise may be early symptoms.

MELAS syndrome is a rare disorder that affects males and females in equal numbers. Although rare, MELAS syndrome is probably the most common type of mitochondrial myopathy caused by mutations in mtDNA. Some researchers believe that mitochondrial myopathies may go unrecognized and underdiagnosed in the general population, making it difficult to determine the true frequency of disorders like MELAS syndrome.

Opportunity for JNS107

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

Competition

The following is an overview of JNS’s competitors in the pharmaceutical industry. Many companies, including the largest pharma companies in the world, are competitors in some of the disease areas for which we are developing treatments for through our various projects. We will compete with both small and large companies in each indication we are pursuing.

There are a multiple of companies, both smaller biotech’s as well as large pharmaceutical companies, that are working on solutions for the same indications that we are pursuing. There is no assurance that we will be able to compete with these companies even if our product is approved in an indication.

Parkinson’s Disease

Despite the availability of FDA-approved treatments for Parkinson’s disease, no breakthrough therapies have emerged recently to halt disease progression. The most commonly prescribed treatment is levodopa/carbidopa, which has been used since the late 1960s. Levodopa is absorbed in the intestine and converted to dopamine in the brain, addressing the dopamine deficiency in Parkinson’s patients. Carbidopa prevents premature conversion of levodopa to dopamine outside the brain, reducing side effects like nausea. This combination is available in various forms, including pills, dissolvable tablets, and a gel infused directly into the intestine.

Levodopa/carbidopa significantly improves motor symptoms in most patients, especially those with mild symptoms, and remains effective over time. However, as Parkinson’s progresses, dosage adjustments may be necessary. Initial side effects can include nausea and vomiting, which can be mitigated by taking the medication with a small snack or adding extra carbidopa. Other side effects may include drowsiness, low blood pressure, and hallucinations. Despite these challenges, levodopa/carbidopa remains a cornerstone in managing Parkinson’s symptoms.

Alzheimer’s Disease

Several companies are actively developing treatments for Alzheimer’s disease, each with unique approaches and challenges. Biogen’s Aduhelm, an IV infusion targeting amyloid-beta plaques, has faced reimbursement issues despite FDA approval, leading to low market penetration and market withdrawal. Eli Lilly’s donanemab, targeting a modified form of beta amyloid, recently received FDA approval and is priced at $32,000 annually. It has shown promise in early Alzheimer’s patients and is undergoing further trials. Cognition Therapeutics is developing CT1812, an orally dosed molecule in Phase II, supported by significant NIA grants.

Anavex Life Sciences is advancing Anavex 2-73, a Phase III candidate from their SIGMACEPTOR™ platform, targeting CNS conditions with genomic precision. Eisai and Biogen’s Leqembi has received traditional FDA approval, potentially expanding Medicare coverage. Priced at $26,000 per year, Leqembi has shown benefits for early-stage Alzheimer’s patients. Despite these advancements, the competitive landscape remains dynamic, with the possibility of other companies emerging with successful treatment

Rare Diseases

There are several companies that are targeting the same rare diseases as us. Below is a description of a selection of those companies that we see as our closest competitors. However, it is possible that another company, that is not listed below, could have a successful product approved before us and have a more effective treatment.

In the MPS-I space, several companies offer competitive products to Jupiter. Sanofi Genzyme’s Aldurazyme has been the standard enzyme replacement therapy for nearly 20 years. RegenexBio is developing RGX-111, a gene therapy designed to deliver a functional copy of the IDUA gene to the central nervous system. Sigilon Therapeutics, Inc. is working on SIG-005, which uses a genetically modified human cell line to express the IDUA enzyme, with an Investigation New Drug (“IND”) application for Phase I submitted to the FDA. Additionally, Sangamo Therapeutics, Inc. is exploring gene editing products, although no positive results have been published yet. These developments represent significant competition in the treatment of MPS-I.

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

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:

Marketing and Commercialization Plan for Therapeutic Drug Candidates

The Company may consider out-licensing JOTROL™ for pharmaceutical uses to one or more companies that have such commercialization capability in place. We may consider at any time a complete exit through any proposed acquisition of our company. In case no acceptable M&A offer is presented, and in the event we were able to obtain FDA regulatory approval for JOTROL™ we might consider marketing and distributing JOTROL™ in the USA for the rare disease market only and have companies with large sales organizations distribute our product for larger indications. All international distributions would most likely be out-licensed.

The marketing and sales of orphan drugs can be relatively fast and effective. We believe, based on discussions with organizations such as the EveryLife Foundation an approval of a drug for a rare disease is efficiently communicated through social media to KOLs, patient advocacy groups and directly to patients, which may reduce marketing costs.

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

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

Operation and Organization

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

Government Regulation

Regulatory Approval of our Drug Product Candidates

The FDA and comparable regulatory authorities in state and local jurisdictions impose substantial and burdensome requirements upon companies involved in the clinical development, manufacture, marketing, and distribution of drug products. These regulatory authorities and other federal, state, and local entities regulate the research and development, testing, manufacture, quality control, safety, effectiveness, labeling, storage, documentation and record keeping, approval, advertising and promotion, distribution, post-approval monitoring and reporting, and export and import of our drug candidates.

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:

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:

FDA Marketing Approval

Assuming successful completion of required clinical testing, the results of the pre-clinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, quality controls, and proposed labeling, are submitted to FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of an NDA is subject to a substantial application user fee.

The length of the review process may vary but typically takes around twelve months from the date the NDA is submitted to FDA. FDA conducts a preliminary review of all NDAs to determine whether they are sufficiently complete to permit substantive review by FDA before accepting them for “filing.” FDA may request additional information from the NDA applicant rather than accept an NDA for filing. If this occurs, the NDA will typically need to be resubmitted with the additional information requested by FDA. The resubmitted application is also subject to review before FDA accepts it for filing. Once an NDA submission is accepted for filing, the FDA begins a detailed substantive review. FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged, or held meets standards designed to assure the product’s continued safety, quality and purity. Under the current guidelines in effect in the Prescription Drug User Fee Act (PDUFA), the FDA has a goal to review and act on the submission within ten months from the completion of the preliminary review of a standard NDA for a new molecular entity.

After evaluating the NDA and all related information, including FDA advisory committee recommendation, if any, and any inspection reports regarding the manufacturing facilities and clinical trial sites, FDA may issue an approval letter, or, in some cases, a complete response letter. A complete response letter generally contains a statement of specific conditions that must be met to secure final approval and may require additional clinical trials or pre-clinical studies in order for FDA to reconsider the application. Even with submission of this additional information, FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for a specific indication(s).

Regulatory Approval of Rare Diseases

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

There are four specific expedited development pathways that may be applicable to a rare disease indication. We will be evaluating and most likely applying for one or more of these when we get closer in the FDA approval process. These include the following pathways for the indications that it is targeting: (1) Priority Review (2) Fast Track (3) Accelerated Approval Pathway and (4) Breakthrough therapy.

Priority Review

Priority Review was authorized in 1992 by PDUFA which created the two-tiered FDA drug review system (standard versus priority). A product candidate is eligible for priority review if it treats a serious or life-threatening condition and, if approved, would provide a significant improvement in safety and effectiveness compared to available therapies. A Priority Review designation means that the goal for the FDA to review an application is six months, rather than the standard review of 10 months under the PDUFA goals. The FDA determines if a drug receives a standard or priority review, although sponsors may request a priority review.

Fast Track

Product candidates intended to treat a serious or life-threatening condition and show the potential to an unmet medical need may receive a Fast track designation. The purpose of this designation is to help make important new drugs available to patients earlier. Any drug being developed to treat or prevent a condition with no current therapy is directed at an unmet need. If there are available therapies, the new drug must demonstrate advantages, such as:

Fast Track designation should typically be requested at the time of the IND or after, and no later than the pre-BLA or pre-NDA meeting. Once in the Fast Track pathway, there are typically more frequent meetings with the FDA to discuss the development plan and appropriate data needed to support drug approval. The fast track designation may be withdrawn by FDA if it believes that the designation is no longer supported by data that emerges during the clinical trial process. Drugs in the Fast Track pathway are also eligible for accelerated approval and priority review if relevant criteria are met.

Accelerated Approval Pathway

Authorized in 1992 and updated in 2012, this pathway is available for a drug for a serious or life-threatening illness that provides meaningful therapeutic benefit to patients over existing treatments based upon a surrogate endpoint that is reasonably likely to predict clinical benefit. The FDA may also grant accelerated approval for such a condition when the product has an effect on an intermediate clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, or IMM, and that is reasonably likely to predict an effect on IMM or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. If approved based on the accelerated approval pathway, the FDA may require the sponsor to conduct post-marketing confirmatory clinical trials to ensure that the drug provides the anticipated clinical benefits. If this requirement is not met, the FDA can withdraw its approval. In addition, promotional materials for product candidates approved under the accelerated approval pathway are subject to prior review by FDA.

Breakthrough Therapy

To qualify for the breakthrough therapy program, product candidates must be intended to treat a serious or life-threatening condition and preliminary clinical evidence must indicate that such product candidates may demonstrate substantial improvement on one or more clinically significant endpoints over existing therapies.

However, there is no guarantee that any designation for an accelerated pathway will lead to an accelerated FDA review or that a pediatric approval leads to grant of a PRV. Additionally, there can be no guarantee that the Company can be successful in its plans under any FDA review pathway.

Disclosure of Clinical Trial Information

Sponsors of clinical trials of FDA-regulated products, including drugs, are required to register and disclose certain clinical trial information. Information related to the product, patient population, phase of investigation, study sites and investigators, and other aspects of the clinical trial is then made public as part of the registration. Sponsors are also obligated to discuss the results of their clinical trials after completion. Disclosure of the results of any such clinical trials can be delayed in certain circumstances for an extended period of time after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.

Post-Approval Requirements

Even if an NDA is approved, a product will be subject to certain post-approval requirements. For example, the FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the internet. Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved labeling.

Failure to comply with the applicable FDA post-marketing requirements may subject manufacturers and distributors to administrative or judicial sanctions. These sanctions could include, among other things, warning letters, product seizures, total or partial suspension of production or distribution, injunctions, civil money penalties, fines, restitution, disgorgement, or civil or criminal penalties. Further, the FDA has authority to issue mandatory recalls for medical devices and biologics, and we may need to undertake a voluntary recall for any of our products that may receive regulatory approval.

Regulation Outside the United States

In order to market any product outside of the U.S., we must also comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of drug products. Whether or not a product obtains FDA approval for a product, we would still need to obtain the necessary approvals by the comparable foreign regulatory authorities before we could commence clinical trials or marketing of any product in those countries or jurisdictions. The approval process ultimately varies between countries and jurisdictions and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others.

Government Regulation of Dietary Supplements

The Dietary Supplement Health and Education Act of 1994 (DSHEA), amended the FDCA to establish a new framework governing the composition, safety, labeling, manufacturing and marketing of dietary supplements. Generally, under DSHEA, dietary ingredients (e.g., vitamins; minerals; amino acids; or dietary substances for use by humans to supplement diet by increasing total dietary intake; or any concentrate, metabolite, constituent, extract or combination of any of the above) that were marketed in the United States prior to October 15, 1994 as a dietary supplement may be used in dietary supplements without notifying the FDA. “New” dietary ingredients (i.e., dietary ingredients that were “not marketed in the United States before October 15, 1994”) must be the subject of a new dietary ingredient notification submitted to the FDA unless the ingredient has been present in the food supply as an article used for food without being chemically altered. A new dietary ingredient notification must provide the FDA evidence of a “history of use or other evidence of safety” establishing that use of the dietary ingredient “will reasonably be expected to be safe.” A new dietary ingredient notification must be submitted to the FDA at least 75 days before introducing the product into interstate commerce. The FDA may determine that a new dietary ingredient notification does not provide an adequate basis to conclude that a dietary ingredient is reasonably expected to be safe. In addition, manufacturers of dietary supplements must ensure that ingredients in their products that are not defined as dietary ingredients comply with all the requirements applicable to conventional foods. For example, fillers and other constituents of the product must be approved as food additives or must be deemed generally recognized as safe for the conditions of use in order to be sold.

The FDA generally prohibits the marketing of a dietary supplement with a “disease claim,” including claims that the product is intended to treat, cure, mitigate or prevent disease or other health-related conditions, unless the claim constitutes a permissible “health claim” under FDA regulations and guidance. Statements of “nutritional support,” including so-called “structure/function claims,” may be permitted on labeling for dietary supplements, subject to certain requirements being met. Such statements may describe how a particular dietary ingredient affects the structure, function or general well-being of the body, or the mechanism of action by which a dietary ingredient may affect the structure, function or well-being of the body, but they may not state that a dietary supplement will reduce the risk or incidence of a disease unless such claim has been reviewed and approved by the FDA. A company that uses a statement of nutritional support in labeling must possess scientific evidence substantiating the statement as truthful and not misleading. FDA must be notified of any such statements no later than thirty days after first marketing the product with the certification that the company possesses the necessary evidence to substantiate any such statements and must be accompanied by an FDA mandated label disclaimer that “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.”

In addition, the FDA has published detailed current Good Manufacturing Practice (cGMP), regulations that govern the manufacturing, packaging, and labeling of dietary supplements. The cGMP regulations, among other things, impose recordkeeping requirements on manufacturers and require dietary supplements to be of appropriate potency, purity and identity. The cGMP requirements are in effect for all dietary supplement manufacturers, and the FDA conducts inspections of dietary supplement manufacturers pursuant to these requirements. The FDA has broad authority to enforce the provisions of federal law applicable to dietary supplements, including, among other things, the authority to issue a public warning or notice of violation letter to a company, publicize information about illegal products, detain or seize products intended for import, require the reporting of serious adverse events, require a recall of illegal or unsafe products from the market, and request the Department of Justice initiate a seizure action, an injunction action or a criminal prosecution in the United States courts for violative conduct.

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:

Nugevia’s formulations are built on Jupiter’s patented JOTROL™ micellar delivery platform, which has shown potential for significantly enhanced bioavailability and serves as the foundation for the company’s clinical-stage CNS investigational therapies. The debut products—GLO, MND, and PWR—are formulated to support cellular resilience through synergistic ingredient combinations, all optimized for absorption via the JOTROL™ system.

Market Positioning and Opportunities

The Nugevia brand will enter the nutraceutical market as a premium longevity and performance supplement line, capitalizing on a global industry projected to reach $8 trillion by 2030. Powered by JOTROL™, a patented resveratrol-based platform that is designed to provide greater bioavailability than standard resveratrol, Nugevia targets health-conscious consumers seeking science-backed solutions for mitochondrial and physical health, mental clarity, and skin vitality. Products like PWR and GLO address key market segments—dietary supplements and functional foods—driven by rising health awareness, an aging population, and a shift toward preventive healthcare. The DTC model positions Nugevia to capture high-margin revenue in a competitive but growing market, leveraging clinical-grade credibility to stand out in a competitive market.

Challenges and Competitive Landscape

The supplement market is fueled by increasing lifestyle-related disorders and demand for natural ingredients. However, Nugevia faces challenges including regulatory hurdles, complex product approvals, and competition from established players offering similar products. Consumer skepticism about resveratrol’s historical bioavailability issues and the need for robust scientific validation could impact adoption. Nugevia’s use of JOTROL™ alongside ingredients like NovaSOL® Astaxanthin and CoQ10 aims to address these concerns, while strategic partnerships with Aquanova and endorsements from figures like Annika Sörenstam and Chris Webber enhance brand trust. Success will hinge on overcoming market saturation and proving efficacy to stand out in a crowded field.

Marketing

The Company will employ a digital-first marketing strategy, leveraging a DTC e-commerce platform to reach health-conscious consumers seeking clinically validated wellness solutions. The Company has appointed Annika Sörenstam, a Hall of Fame golfer with over 95 tournament victories, as Nugevia’s first brand ambassador, enhancing brand credibility and aligning with the product’s focus on performance, focus, and longevity. In addition, the Company has partnered with Chris Webber, five-time NBA All-Star and Hall of Fame inductee, as the Company’s second official brand ambassador for Nugevia. Marketing efforts also include tailored campaigns for international markets, with service partners in Hong Kong developing a specific program for Southeast Asia to address regional consumer preferences.

The initial launch in the USA utilized a DTC model, with the Nugevia website serving as the primary sales platform. Following this, the Company aims to expand distribution to Europe, the Middle East, and Southeast Asia through regional partnerships, capitalizing on the global demand for longevity solutions. By combining cutting-edge science, strategic marketing, and a robust manufacturing process, Nugevia is poised to capture a significant share of the longevity market while supporting Jupiter’s long-term mission to advance treatments for CNS disorders.

Competitors

The longevity and wellness market, driven by increasing demand for health span extension, is highly competitive, with Nugevia facing established players like ChromaDex (offering NAD+ precursors like Tru-Niagen), Novos (targeting aging hallmarks with products like NOVOS Core), Timeline’s urolithin A supplements and Tally Health (providing personalized longevity supplements and biological age testing). Larger competitors, including Nestle Health Science (with multiple brands and products), Amway (through Nutrilite’s Healthy Aging Solution), and L’Oreal (via its Longevity Integrative Science initiative), are also expanding into this space, intensifying competition. Nugevia’s differentiation lies in its proprietary JOTROL™ technology, which supports higher plasma concentrations (approximately 300 ng/ml) and effective CNS delivery, positioning it as a premium offering.

Brands like NOVOS, Blueprint, and Perpetua.Life offer formulas that combine resveratrol with other scientifically backed longevity compounds (e.g., NMN, quercetin, CoQ10, fisetin) for synergistic effects. In addition, advanced delivery systems such as Liposomal and micellar technologies are widely used by many companies to enhance the absorption of key actives, similar to Nugevia’s approach, purity and clinical validation. Furthermore, companies such as ProHealth, Renue By Science, and Decode Age, who offer similar longevity supplements and sell their products online directly to consumers, emphasize ingredient purity, bioavailability, multi-ingredient formulations and evidence-based dosing, which is appealing to the target health-conscious consumers seeking credible, science-backed longevity solutions.

Manufacturing

Nugevia products will be manufactured by Aquanova in Germany. The manufacturing process has several steps, which are: (a) ingredient combinations are manufactured as a liquid solution by Aquanova in Germany, (b) the liquid solutions are shipped to GMP-certified facility in California for encapsulation into softgels and (c) finished products are sent in bulk to a final packing and fulfillment center, which ships directly to customers. While all steps except the initial solution preparation can be handled by U.S. suppliers, changing the first step would require a separate agreement with Aquanova.

The FDA requires that dietary supplement manufacturers comply with Current Good Manufacturing Practices (“cGMP”) under 21 CFR Part 111, ensuring product safety, quality, and accurate labeling. Jupiter must verify that its manufacturing partners, including those involved in producing JOTROL™ or sourcing ingredients like CoQ10, meet these standards. Non-compliance, such as contamination or inconsistent ingredient potency, could lead to product recalls, enforcement actions, fines, or reputational damage. Any lapses in quality control could undermine consumer trust and weaken its competitive edge in the $451.7 billion nutraceutical market.

Compliance with U.S. FDA Regulations

In the United States, Nugevia products, classified as dietary supplements, fall under the Dietary Supplement Health and Education Act (DSHEA) of 1994, enforced by the FDA. The FDA requires that all health claims be substantiated with credible scientific evidence, and any claims related to Nugevia’s benefits—such as mitochondrial support, mental clarity, or skin vitality—must avoid implying treatment or prevention of diseases, which would classify the products as drugs subject to stricter pre-market approval. Non-compliance, such as misleading labeling or unsubstantiated claims, could result in warning letters, product seizures, or injunctions. Additionally, Jupiter must ensure that JOTROL™, its proprietary resveratrol delivery system, complies with FDA’s New Dietary Ingredient (NDI) notification requirements if deemed novel, a process that can take months and negatively impact the Company’s ability to sell Nugevia products.

International Regulatory Variations

Global expansion introduces regulatory complexities. In the European Union, the European Food Safety Authority (EFSA) oversees nutraceuticals under the Novel Food Regulation (EU) 2015/2283. If JOTROL™ or other ingredients like NovaSOL® Astaxanthin are considered novel foods (not consumed in the EU before May 15, 1997), Jupiter must submit a detailed safety dossier, a costly and time-intensive process that could delay market entry. In markets like China or Japan, stringent pre-market approvals and ingredient restrictions may require reformulation or additional clinical studies. Failure to navigate these variations could limit Nugevia’s global reach or result in costly reformulations, impacting Jupiter’s revenue projections.

Post-Market Surveillance and Adverse Event Reporting

Nugevia products are subject to post-market surveillance, particularly in the U.S., where manufacturers must report serious adverse events to the FDA within 15 days under DSHEA. Even rare side effects linked to resveratrol or other ingredients like astaxanthin could trigger investigations, negative publicity, or product withdrawals. Jupiter must establish robust adverse event reporting systems and ensure transparency to mitigate legal and reputational risks. Failure to comply could lead to regulatory scrutiny, consumer lawsuits, or loss of market confidence, particularly given past skepticism about resveratrol’s safety and efficacy at high doses.

Asian Business Development Activities

We have entered into service agreements in the areas of CMC, regulatory affairs and clinical trial management with companies with operations in Southeast Asia. These agreements are with companies that, we believe, have the knowledge and network in the Southeast Asian market. The agreements are further described in the section “Other Material Agreements”. In addition, we are in active negotiations with Dominant Treasure Health Company Limited (“Dominant Treasure”), a BVI company. Dominant Treasure has demonstrated to us, through several company introductions, that they have business relationships, either directly or through affiliates, with many Southeast Asian pharmaceutical companies as well as companies involved in distribution and sales of TCM, Traditional Chinese Medicine. We are therefore planning to engage Dominant Treasure in active business development in China, Malaysia and Singapore as soon as we have financing in place for their engagement. Dominant Treasure has already introduced us to three Chinese companies, Beimei Pharma, http://en.beimeiyaoye.com, that specializes in pediatric medications, Sichuan Kelun Pharmaceutical Co., Ltd., a publicly traded company that is part of the Kelun Industrial Group, https://www.kelun.com/, and Tianjin Pharmaceuticals, https://en.pharm.com.cn/, that advocates the corporate core values of “Love, Integrity and Power”. TCM products are run in a separate division within Tianjin. The Asian market is very large and hard to penetrate for a small company and we believe that our strategy with these agreements have the possibility to accelerate an out-licensing deal in the Southeast Asian territories. However, there are no assurances that this approach will be successful.

Our rationale for the strong approach into the Southeast Asian market is:

Other Material Agreements

The agreement with a major pharmaceutical company, restricted by confidentiality, grants us data access to resveratrol toxicology studies through a letter of reference. Executed on May 2, 2017, it can only be terminated due to a material breach and there is no time limit on access to this study. The studies were conducted at Charles River Laboratories, and there are no payments associated with this agreement.

On December 15, 2024, the Company entered into a Strategic Services Agreement (the “Dominant Treasure Agreement”) with Dominant Treasure Health Company Limited (“Dominant Treasure”). Pursuant to the terms of the Dominant Treasure Agreement, Dominant Treasure agreed to provide certain services to the Company to assist the Company in accelerating the development and distribution of the Company’s products in the Southeast Asian market. In exchange for Dominant Treasure’s services pursuant to the Dominant Treasure Agreement, the Company agreed to pay Dominant Treasure a one-time payment of $2,300,000 to be delivered after the closing of a minimum of $10,000,000 in gross proceeds from a public offering. In addition, if Dominant Treasure is involved in generating negotiations and conclusion of a distribution agreement for the Company in the countries of China (including Hong Kong), Singapore and Malaysia, the Company will pay Dominant Treasure a success fee of 5% of any upfront and/or milestone payments to be received by the Company. If such distribution agreement includes a royalty payment to the Company, Dominant Treasure will receive 5% of such royalty payment. The Dominant Treasure Agreement has a term of 36 months and may be terminated at any time upon mutual agreement of the parties.

Service Agreements - Southeast Asia

On June 3, 2024, the Company entered into three service agreements to expand in Southeast Asia; a CRO Services Agreement with Optimize Wellness Limited providing clinical trial guidance in China, Malaysia, and Singapore, a Regulatory Services Agreement with Regis Healthcare Group Limited providing regulatory strategy and guidance, and a Product Services Agreement with Longevity Technology Group Limited providing manufacturing guidance. Each of the 3 service agreements has a 3-year term and was paid for with an upfront issuance of 1,162,500 shares of common stock with a fair market value of $1.33 per share (3,487,500 in the aggregate, with an aggregate fair market value of $4,638,375) as pre-payment for three years of services, which were registered for resale as part of the initial public offering.

Legal Proceedings

From time to time, we are involved in various legal proceedings arising from the normal course of business activities. We are not presently a party to any litigation the outcome of which, we believe, if determined adversely to us, would individually or taken together have a material adverse effect on our business, operating results, cash flows or financial condition.

Facilities

Our corporate headquarters are located at 1001 North US Hwy 1, Suite 504, Jupiter, Florida 33477, where we lease approximately 1,206 rentable square feet of office space. This lease expires on May 31, 2026. Terms of the office lease provide for a base rent payment of $4,258 per month and a share of the building’s operating expenses, such as taxes and maintenance, of $600 per month. In September 2021, we added an additional office located at 127 Main Street, Boston, Massachusetts 02129 for 120 rentable square feet of office space for our Boston-based employees and scientist to utilize as necessary.

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

Employees

As of December 31, 2025, we had a total of five full-time employees, two full-time consultants, three part-time consultants, and our six Scientific Advisory Board members. Of these, three were primarily engaged in research or product development and clinical activities.