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What changed in JUPITER NEUROSCIENCES, INC.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of JUPITER NEUROSCIENCES, INC.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+771 added−634 removedSource: 10-K (2026-04-01) vs 10-K (2025-03-28)

Top changes in JUPITER NEUROSCIENCES, INC.'s 2025 10-K

771 paragraphs added · 634 removed · 372 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

97 edited+121 added−66 removed29 unchanged
Biggest changeOverall 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 6 ● 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 Endpoints: Primary Endpoint: ● Assessment of safety/tolerability by monitoring AEs and SAEs, assessing their potential relationship to the study drug and Abeta 40/42.
Biggest changeSecondary Objectives: ● To assess population pharmacokinetics (“Population PK”) in the ITT population ● To measure the effect of JOTROL™ on biochemical markers for AD, neurodegeneration, vascular damage, metabolic effects, and neuroinflammation ● To determine the effects of JOTROL™ on whole-brain and regional brain atrophy ● To measure the effects of JOTROL™ on functional MRI measures ● To assess cognitive effects of JOTROL™ ● To examine the influence of Apolipoprotein E genotyping on both biomarker and cognitive endpoints 6 Endpoints Primary Endpoint: ● Assessment of safety/tolerability by monitoring AEs and SAEs, assessing their potential relationship to the study drug and Abeta 40/42 Secondary Endpoints: ● Levels of AD relevant biomarkers ● Volumetric MRI and Cortical Disarray Measurement ● Additional experimental biomarkers as stated in protocol, such as those for neuroinflammation Study Population : Approximately 105 male or female subjects between 55 and 85 years of age with a diagnosis of MCI/early AD will be enrolled.
Regulatory Approval 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.
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.
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. Eli Lilly’s donanemab, targeting a modified form of beta amyloid, recently received FDA approval and is priced at $32,000 annually.
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.
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 gets approved in an indication.
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.
He or she may still drive, work and be 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.
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.
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 parties.
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.
We 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.
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.
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. JNS102 is targeting the specific areas that ERT cannot treat, with JOTROL™ treatment.
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™.
Objectives: 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. ● Primary Objective: ○ 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.
Objectives Primary Objective : ● To determine the safety and efficacy of JOTROL™ (200 mg resveratrol BID and 500 mg resveratrol BID) for neuroinflammation and biomarkers of MCI/early AD. ● To assess safety and tolerability of JOTROL™ in AD-MCI patients by monitoring adverse events (AEs) and serious adverse events (“SAEs”) and assessing their relationship to the study drug.
Since there were unanticipated higher costs, mostly due to Covid-19 related additional procedures during the Phase I trial, a supplemental grant of $233,281 was submitted to the NIA in December of 2021. We were awarded the supplemental grant on April 7, 2022.
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.
The effect of JOTROL treatment, in the Phase II trial, will primarily be measured through several biomarkers.
The effect of JOTROL™ treatment, in the potential Phase II trial, will primarily be measured through several biomarkers.
In 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 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.
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 vs. 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.
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.
JNS102 Phase II Clinical Trial 1. Preclinical studies conducted at University of Miami in MPS I mice results showed that a high dose of resveratrol increased the alpha-L-iduronidase which is the critical enzyme that is too low in these patients. 2. IND application for Phase I study was approved by the FDA and the clinical trial is completed.
Proposed JNS102 Phase II Clinical Trial 1. Preclinical studies conducted at University of Miami in MPS-I mice results showed that a high dose of resveratrol increased the alpha-L-iduronidase which is the critical enzyme that is too low in these patients. 2. IND application for Phase I study was approved by the FDA. 3.
Recent Agreements – South-East Asia On 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.
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.
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.
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.
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.
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 disease.
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.
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 engagement.
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.
Researchers are increasingly recognizing the debilitating nature of non-motor symptoms and are working on new therapies, while doctors manage these symptoms with current treatments. 4 Upcoming Phase 2a study in Parkinson’s Disease patients The Company has engaged Zina Biopharmaceuticals to assist with study design, FDA communications including IND and manage the execution of the trial.
Researchers are increasingly recognizing the debilitating nature of non-motor symptoms and are working on new therapies, while doctors manage these symptoms with current treatments. 4 Upcoming Phase IIa study in Parkinson’s Disease patients The Company has engaged Zina Biopharmaceuticals to assist with study design, FDA communications, including submission, of an Investigational New Drug (IND) application and to manage the execution of the trial.
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.
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.
Our rationale for the strong approach into the South-East Asian market is: Background: Asian countries are not accepting pharmaceutical products to be sold without clinical trial approvals based on trials conducted in an Asian population ● The Company’s strategy is to partner with organizations in the territory that can execute much more efficiently than trying to manage the process from USA. ● We have already received interest for our JOTROL product in the Asian market since resveratrol is listed as a Traditional Chinese Medicine. ● The need for a set up that can service this market is imperative for success. ● Strategic collaboration agreements have been executed to facilitate an expedited execution of an out-licensing agreement with one or more Chinese or other SE Asian pharmaceutical companies. ● The Company is too small, both financially as well as internal manpower, to manage developments in the territory. ● The Company has a history of poor financial status and not being able to fulfill commitments and finalize clinical studies. ● 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. 14 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.
Our rationale for the strong approach into the Southeast Asian market is: ● Background: Asian countries are not accepting pharmaceutical products to be sold without clinical trial approvals based on trials conducted in an Asian population. ● The Company’s strategy is to partner with organizations in the territory that can execute much more efficiently than trying to manage the process from USA. ● We have already received interest for our JOTROL™ product in the Asian market since resveratrol is listed as a Traditional Chinese Medicine. ● The need for a set up that can service this market is imperative for success. ● Strategic collaboration agreements have been executed to facilitate an expedited execution of an out-licensing agreement with one or more Chinese or other Southeast Asian pharmaceutical companies. ● The Company is too small, both financially as well as internal manpower, to manage developments in the territory. ● The Company has historically faced financial constraints that have, at times, limited its ability to fulfill certain commitments and complete clinical studies on its planned timeline. ● By utilizing equity as service payments, the company believes that it can get projects finalized without any significant cash outflow. ● The service agreements are therefore designed to be a win for both parties, assuming an increase in equity value, in case clinical studies and out-licensing activities will be successful in the territory. 16 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.
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.
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.
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 Disease. An optional biomarker sub-study will assess cerebrospinal fluid, requiring additional consent.
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.
Employees As 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 activities. 15
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. 17
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 territories. However, there are no assurances that this approach will be successful.
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.
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/, 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.
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”.
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.
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.
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).
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).
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 effect. Based on the recent Scientific Review received from NIA.
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.
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.
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.
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.
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.
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.
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.
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 a significant savings to society. 5 JNS108 Phase II Clinical Trial for MCI/early Alzheimer’s Disease National Institute on Aging (“NIA”) financed our Phase I study with $1.76 million through grant 1R44AG067907-01A1.
Economic burden of Alzheimer’s disease on society in USA is generating a very large opportunity According to Alzheimer’s Association’s 2020 annual report Alzheimer’s disease has impacted 5.7 million Americans and that it costs the US $277 billion each year, excluding the cost of “unpaid time and effort of the people, mostly women, who are caring for spouses, parents, siblings, and friends with dementia.” The Association explained, “In 2017, 16 million Americans provided an estimated 18.4 billion hours of unpaid care in the form of physical, emotional and financial support - a contribution to the nation valued at $232.1 billion.” Any product that delays the onset of severe Alzheimer’s disease should represent significant savings to society. 5 Proposed JNS108 Phase II Clinical Trial for MCI/early Alzheimer’s Disease Subject to FDA’s review and approval, the Phase II trial will be built on utilizing published information from the earlier Turner et al Phase II trial, completed in 2015 with 119 patients with early Alzheimer’s disease who were treated with 4 different doses of resveratrol.
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. The marketing and sales of orphan drugs can be relatively fast and effective.
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.
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.
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.
Resveratrol Resveratrol 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 14,000 scientific publications.
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.
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.
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.
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 cost over $500,000 per year per patient.
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 study was conducted by Charles River Laboratories. 11 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.
The study was conducted by Charles River Laboratories. ● Possible out-licensing for Asian markets is being considered as it may reduce risk and cost of product development in those markets that requires confirming trials in an Asian population, while generating income through milestones and royalty agreements, see “—Asian Business Development Activities” regarding further developments and strategy in the Asian market. 9 Marketing and Commercialization Plan for Therapeutic Drug Candidates The Company may consider out-licensing JOTROL™ for pharmaceutical uses to one or more companies that have such commercialization capability in place.
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. 9 Competition The following is an overview of JNS’s competitors.
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.
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 JNS101 Friedreich’s ataxia direct to Phase II JNS101 is a project utilizing JOTROL, specifically designed to treat Friedreich’s Ataxia.
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.
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 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.
We have since submitted 3 grant applications, with budgets of $20 million or higher, to the NIA for full funding of such Phase II trial but none of those applications were successful. The NIA scientific review of our Alzheimer’s Phase II trial grant application shows a total score of 47 which is our best score so far.
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.
Proposed JOTROL MCI Phase II Study 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.
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.
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.
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.
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.
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.
Results documented in the section JOTROL Phase I Pharmacokinetic (“PK”) and Safety Study . 3. Final study details and start to be determined by consultation with the FDA and supportive additional financing. 8 4. Primary endpoint: Safety, tolerability and PK/PD values 5. Secondary endpoints to include (subject to FDA acceptance) i. Improvement in 6-minute walk distance ii.
Final study details and start to be determined by consultation with the FDA and supportive additional financing. 4. Primary endpoint: ● Safety, tolerability and PK/PD values 5. Secondary endpoints to include (subject to FDA acceptance) i. Improvement in 6-minute walk distance ii. Forced vital capacity iii. Biomarkers, such as alpha-L-iduronidase levels iv.
These developments underscore the competitive landscape in the search for effective MELAS treatments. Competitive Advantages We believe that we are positioned to outperform competitors for the following reasons: We 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.
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.
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.
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 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. The natural product resveratrol is well studied with over 14,000 scientific publications to date.
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.
(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.
(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.
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.
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.
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.
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.
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).
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.
Our 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.
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.
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.
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.
JNS102 Phase II trial for Mucopolysaccharidosis Type 1 (MPS I) JNS102 is utilizing JOTROL for the treatment of Lysosomal Storage disease areas whereas MPS Type I is the first target. MPS I is divided into three subtypes based on severity of symptoms. All three types result from an absence of, or insufficient levels of, the enzyme alpha-L-iduronidase.
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.
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 and JNS 1 08 for MCI/early Alzheimer’s Disease.
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.
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.
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.
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.
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.
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. JOTROL is a micellar non-aqueous solution of resveratrol delivered in a softgel capsule.
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.
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 AG is vital, as JOTROL is our primary product.
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.
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.
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.
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. There is an option to pay $3 million for reduced royalties of 1.25%.
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.
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.
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.
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.
Drugs in the Fast Track pathway are also eligible for accelerated approval and priority review if relevant criteria are met.
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.
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.
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.
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.
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.
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.
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. In 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.
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.
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.
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.
There is however no guarantee that an accelerated pathway will lead to an accelerated FDA review and that a pediatric approval leads to a PRV.
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.
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 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.
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.
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.
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.
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 The Company’s platform product, JOTROL, is an enhanced orally administered resveratrol formulation designed and intended to deliver therapeutically relevant, safe levels of resveratrol.
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.
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.
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™.
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 IND application for Phase I submitted to the FDA.
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.
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.
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).
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.
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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeRule 12b-2 of the Exchange Act defines a “smaller reporting company” as an issuer that is not an investment company, an asset-backed issuer, or a majority-owned subsidiary of a parent that is not a smaller reporting company and that: ● had a public float of less than $250 million as of the last business day of its most recently completed second fiscal quarter, computed by multiplying the aggregate worldwide number of shares of its voting and non-voting common equity held by non-affiliates by the price at which the common equity was last sold, or the average of the bid and asked prices of common equity, in the principal market for the common equity; or ● in the case of an initial registration statement under the Securities Act, or the Exchange Act of 1934, as amended, which we refer to as the Exchange Act, for shares of its common equity, had a public float of less than $250 million as of a date within 30 days of the date of the filing of the registration statement, computed by multiplying the aggregate worldwide number of such shares held by non-affiliates before the registration plus, in the case of a Securities Act registration statement, the number of such shares included in the registration statement by the estimated public offering price of the shares; or ● in the case of an issuer whose public float as calculated under paragraph (1) or (2) of this definition was zero or whose public float was less than $700 million, had annual revenues of less than $100 million during the most recently completed fiscal year for which audited financial statements are available.
Biggest changeWe qualify as a “smaller reporting company” under Rule 12b-2 of the Exchange Act, defined as an issuer (not an investment company, asset-backed issuer, or majority-owned subsidiary of a non-smaller reporting company parent) with either: a public float of less than $250 million as of the last business day of its most recently completed second fiscal quarter, or, for initial registration statements, a public float of less than $250 million within 30 days of filing, or annual revenues of less than $100 million with a public float of zero or less than $700 million for the most recent fiscal year with audited financial statements.
As a result of all of these factors, our competitors may succeed in obtaining approval from the FDA, EMA or other comparable foreign regulatory authorities or in discovering, developing and commercializing products in our field before we do.
As a result of all these factors, our competitors may succeed in obtaining approval from the FDA, EMA or other comparable foreign regulatory authorities or in discovering, developing and commercializing products in our field before we do.
Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties may be approved for the same condition.
Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because drugs with different active moieties may be approved for the same condition.
We may seek an accelerated approval pathway for our one or more of our product candidates.
We may seek an accelerated approval pathway for one or more of our product candidates.
In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.
In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.
Restrictions under applicable federal and state healthcare laws and regulations may include the following: ● the federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid; 46 ● the federal false claims laws, including the civil False Claims Act, which can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties laws, prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; ● the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and their implementing regulations, also imposes obligations, including mandatory contractual terms, on covered entities, which are health plans, healthcare clearinghouses, and certain health care providers, as those terms are defined by HIPAA, and their respective business associates and their subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to CMS information regarding payments and other transfers of value to physicians, defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals as well as information regarding ownership and investment interests held by physicians and their immediate family members.
Restrictions under applicable federal and state healthcare laws and regulations may include the following: ● the federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid; ● the federal false claims laws, including the civil False Claims Act, which can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties laws, prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; ● the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and their implementing regulations, also imposes obligations, including mandatory contractual terms, on covered entities, which are health plans, healthcare clearinghouses, and certain health care providers, as those terms are defined by HIPAA, and their respective business associates and their subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to CMS information regarding payments and other transfers of value to physicians, defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals as well as information regarding ownership and investment interests held by physicians and their immediate family members.
For example, it could: ● make it more difficult for us to satisfy our obligations with respect to our indebtedness and any failure to comply with the obligations of any of our debt instruments, including financial and other restrictive covenants, could result in an event of default under the debt instruments; ● make us more vulnerable to adverse changes in general economic, industry and competitive conditions and adverse changes in government regulation; ● require us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing the availability of our cash flows to fund working capital, capital expenditures, acquisitions and other general corporate purposes; 22 ● limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate; ● place us at a competitive disadvantage compared to our competitors that have less debt; and ● limit our ability to borrow additional amounts for working capital, capital expenditures, acquisitions, debt service requirements, execution of our business strategy or other purposes.
For example, it could: ● make it more difficult for us to satisfy our obligations with respect to our indebtedness and any failure to comply with the obligations of any of our debt instruments, including financial and other restrictive covenants, could result in an event of default under the debt instruments; ● make us more vulnerable to adverse changes in general economic, industry and competitive conditions and adverse changes in government regulation; ● require us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing the availability of our cash flows to fund working capital, capital expenditures, acquisitions and other general corporate purposes; ● limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate; ● place us at a competitive disadvantage compared to our competitors that have less debt; and ● limit our ability to borrow additional amounts for working capital, capital expenditures, acquisitions, debt service requirements, execution of our business strategy or other purposes.
We cannot assure you that our data protection efforts and our investment in information technology, or the efforts or investments of CROs, consultants or other third parties, will prevent significant breakdowns or breaches in systems or other cyber incidents that cause loss, destruction, unavailability, alteration or dissemination of, or damage or unauthorized access to, our data and other data processed or maintained on our behalf or other assets that could have a material adverse effect upon our reputation, business, operations or financial condition.
We cannot assure you that our data protection efforts and our investment in information technology, or the efforts or investments of CROs, CDMOs, consultants or other third parties, will prevent significant breakdowns or breaches in systems or other cyber incidents that cause loss, destruction, unavailability, alteration or dissemination of, or damage or unauthorized access to, our data and other data processed or maintained on our behalf or other assets that could have a material adverse effect upon our reputation, business, operations or financial condition.
The degree of market acceptance of any of our approved product candidates will depend on a number of factors, including: ● the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments; ● the timing of market introduction of the product candidates as well as competitive products; 34 ● the clinical indications for which a product candidate is approved; ● restrictions on the use of product candidates in the labeling approved by regulatory authorities, such as boxed warnings or contraindications in labeling, or a risk evaluation and mitigation strategy, if any, which may not be required of alternative treatments and competitor products; ● the potential and perceived advantages of our product candidates over alternative treatments; ● the cost of treatment in relation to alternative treatments; ● the availability of an approved product candidate for use as a combination therapy; ● relative convenience and ease of administration; ● the willingness of the target patient population or their caregivers to try new therapies and of physicians to prescribe these therapies; ● the availability of coverage and adequate reimbursement by third-party payors, including government authorities; ● patients’ willingness to pay for these therapies in the absence of such coverage and adequate reimbursement; ● the effectiveness of sales and marketing efforts; ● support from KOLs and patient advocacy groups; ● unfavorable publicity relating to our product candidates; and ● the approval of other new therapies for the same indications.
The degree of market acceptance of any of our approved product candidates will depend on a number of factors, including: ● the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments; ● the timing of market introduction of the product candidates as well as competitive products; 33 ● the clinical indications for which a product candidate is approved; ● restrictions on the use of product candidates in the labeling approved by regulatory authorities, such as boxed warnings or contraindications in labeling, or a risk evaluation and mitigation strategy, if any, which may not be required of alternative treatments and competitor products; ● the potential and perceived advantages of our product candidates over alternative treatments; ● the cost of treatment in relation to alternative treatments; ● the availability of an approved product candidate for use as a combination therapy; ● relative convenience and ease of administration; ● the willingness of the target patient population or their caregivers to try new therapies and of physicians to prescribe these therapies; ● the availability of coverage and adequate reimbursement by third-party payors, including government authorities; ● patients’ willingness to pay for these therapies in the absence of such coverage and adequate reimbursement; ● the effectiveness of sales and marketing efforts; ● support from KOLs and patient advocacy groups; ● unfavorable publicity relating to our product candidates; and ● the approval of other new therapies for the same indications.
Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete.
Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. 20 Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete.
Even if management finds such controls to be effective, our independent registered public accounting firm may decline to attest to the effectiveness of such internal controls and issue a qualified report. 77 We believe we will be considered a smaller reporting company and will be exempt from certain disclosure requirements, which could make our Common Stock less attractive to potential investors.
Even if management finds such controls to be effective, our independent registered public accounting firm may decline to attest to the effectiveness of such internal controls and issue a qualified report. We believe we will be considered a smaller reporting company and will be exempt from certain disclosure requirements, which could make our Common Stock less attractive to potential investors.
Due to this lack of predictability, we may not have the resources necessary to meet regulatory requirements and successfully complete a potentially protracted, expensive and wide-ranging approval process for commercialization of product candidates for rare diseases. Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight.
Due to this lack of predictability, we may not have the resources necessary to meet regulatory requirements and successfully complete a potentially protracted, expensive and wide-ranging approval process for commercialization of product candidates for rare diseases. 38 Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight.
Our pending and future patent applications and those of our licensor may not result in patents being issued which protect our product candidates or which effectively prevent others from commercializing competitive product candidates. Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance.
Our pending and future patent applications and those of our licensor may not result in patents being issued which protect our product candidates or which effectively prevent others from commercializing competitive product candidates. 53 Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance.
In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, results of operations, financial condition and prospects. We may in the future pursue invalidity proceedings with respect to third-party patents.
In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, results of operations, financial condition and prospects. 55 We may in the future pursue invalidity proceedings with respect to third-party patents.
Our product candidates may cause serious adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.
Our product candidates may cause serious adverse events, toxicities or other undesirable side effects when used alone or in combination with approved products or investigational new drugs that may result in a safety or risk profile that could prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.
Further, even if we obtain significant market share for our product candidates, because the potential target populations are very small, we may never achieve profitability despite obtaining such significant market share. Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
Further, even if we obtain significant market share for our product candidates, because the potential target populations are very small, we may never achieve profitability despite obtaining such significant market share. 34 Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
If we do not adequately address these risks and difficulties or successfully make such a transition, our business will suffer. We have not generated any revenue from product sales to date, have incurred significant net losses since our inception, and expect to continue to incur significant net losses for the foreseeable future.
If we do not adequately address these risks and difficulties or successfully make such a transition, our business will suffer. We have not generated any meaningful revenue from product sales to date, have incurred significant net losses since our inception, and expect to continue to incur significant net losses for the foreseeable future.
Furthermore, even if we are able to enroll a sufficient number of patients for our clinical trials, we may have difficulty maintaining participation in our clinical trials through the treatment and any follow-up periods. We have limited resources and are currently focusing the majority of our efforts on developing JOTROL for particular indications.
Furthermore, even if we are able to enroll a sufficient number of patients for our clinical trials, we may have difficulty maintaining participation in our clinical trials through the treatment and any follow-up periods. 30 We have limited resources and are currently focusing the majority of our efforts on developing JOTROL™ for particular indications.
Furthermore, the failure of any of our product candidates to demonstrate safety and efficacy in any clinical trial could negatively impact the perception of our other product candidates and/or cause the FDA or other regulatory authorities to require additional testing before approving any of our product candidates. 26 We have experienced delays in completing our clinical trial and may experience additional delays in initiating or completing additional clinical trials.
Furthermore, the failure of any of our product candidates to demonstrate safety and efficacy in any clinical trial could negatively impact the perception of our other product candidates and/or cause the FDA or other regulatory authorities to require additional testing before approving any of our product candidates. 26 We have experienced delays in completing our clinical trial research and may experience additional delays in initiating or completing additional clinical trials.
We can give no assurance at what time, if ever, our common stock will not be classified as a “penny stock” in the future. If the benefits of any proposed acquisition do not meet the expectations of investors, stockholders or financial analysts, the market price of our Common Stock may decline.
We can give no assurance at what time, if ever, our common stock will not be classified as a “penny stock” in the future. 66 If the benefits of any proposed acquisition do not meet the expectations of investors, stockholders or financial analysts, the market price of our Common Stock may decline.
We are developing a novel biologically active small molecule for neurological disorders. As a result, there is uncertainty as to the safety profile of the product candidates we are developing. In addition, our product candidates may be used in combination with certain other therapies which may have undesirable side effects.
We are developing a novel biologically active small molecule for neurological disorders. As a result, there is uncertainty as to the safety profile of the product candidates we are developing. In addition, our product candidates could be used in combination with certain other therapies which may have undesirable side effects.
Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case. We may not be able to protect our intellectual property rights throughout the world.
Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case. 57 We may not be able to protect our intellectual property rights throughout the world.
While our common stock is not currently considered “penny stock” since it is listed on the Nasdaq Capital Market, if we are unable to maintain that listing and our common stock is no longer listed on the Nasdaq Capital Market, unless we maintain a per-share price above $5.00, our common stock will become “penny stock.” These rules impose additional sales practice requirements on broker-dealers that recommend the purchase or sale of penny stocks to persons other than those who qualify as “established customers” or “accredited investors.” For example, broker-dealers must determine the appropriateness for non-qualifying persons of investments in penny stocks.
While our common stock is not currently considered “penny stock” since it is listed on the Nasdaq, if we are unable to maintain that listing and our common stock is no longer listed on the Nasdaq, unless we maintain a per-share price above $5.00, our common stock will become “penny stock.” These rules impose additional sales practice requirements on broker-dealers that recommend the purchase or sale of penny stocks to persons other than those who qualify as “established customers” or “accredited investors.” For example, broker-dealers must determine the appropriateness for non-qualifying persons of investments in penny stocks.
We also could become subject to investigations by the Commission or other regulatory authorities, which could require additional financial and management resources. As an emerging growth company, our auditor will not be required to attest to the effectiveness of our internal controls.
We also could become subject to investigations by the Commission or other regulatory authorities, which could require additional financial and management resources 67 As an emerging growth company, our auditor will not be required to attest to the effectiveness of our internal controls.
Any decreased use of our products or limitation on our ability to export or sell our products would likely adversely affect our business. Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.
Any decreased use of our products or limitation on our ability to export or sell our products would likely adversely affect our business. 47 Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.
These requirements may restrict the ability of broker-dealers to sell our common stock and may affect your ability to resell our common stock. 75 Many brokerage firms will discourage or refrain from recommending investments in penny stocks. Most institutional investors will not invest in penny stocks.
These requirements may restrict the ability of broker-dealers to sell our common stock and may affect your ability to resell our common stock. Many brokerage firms will discourage or refrain from recommending investments in penny stocks. Most institutional investors will not invest in penny stocks.
Patient enrollment for our current or any future clinical trials may be affected by other factors, including: ● size and nature of the patient population; ● perceived risks and benefits of novel, unproven approaches; ● severity of the disease under investigation; ● availability and efficacy of approved drugs for the disease under investigation; ● patient eligibility criteria for the trial in question as defined in the protocol; ● perceived risks and benefits of the product candidates under study; ● clinicians’ and patients’ perceptions as to the potential advantages of the product candidates being studied in relation to other available therapies, including any new products that may be approved or other product candidates being investigated for the indications we are investigating; ● patient referral practices of physicians; ● the ability to monitor patients adequately during and after treatment; ● the activities of key opinion leaders (KOLs) and patient advocacy groups; ● proximity and availability of clinical trial sites for prospective patients; and ● the risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may have an advanced disease, will not survive the full terms of the clinical trials.
Patient enrollment for our current or any future clinical trials may be affected by other factors, including: ● size and nature of the patient population; ● perceived risks and benefits of novel, unproven approaches; ● severity of the disease under investigation; ● availability and efficacy of approved drugs for the disease under investigation; ● patient eligibility criteria for the trial in question as defined in the protocol; ● perceived risks and benefits of the product candidates under study; ● clinicians’ and patients’ perceptions as to the potential advantages of the product candidates being studied in relation to other available therapies, including any new products that may be approved or other product candidates being investigated for the indications we are investigating; ● patient referral practices of physicians; ● the ability to monitor patients adequately during and after treatment; ● the activities of KOLs and patient advocacy groups; ● proximity and availability of clinical trial sites for prospective patients; and ● the risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may have an advanced disease, will not survive the full terms of the clinical trials.
We have patent applications, in addition to the in-licensed patent from Aquanova AG, that were generated through the use of U.S. government funding or grants, and may acquire or license in the future intellectual property rights that have been generated through the use of U.S. government funding or grants.
We have patent applications, in addition to the in-licensed patent from Aquanova, that were generated through the use of U.S. government funding or grants, and may acquire or license in the future intellectual property rights that have been generated through the use of U.S. government funding or grants.
Due to the lack of precedent, broad discretion of regulatory authorities, and a multitude of unique factors that impact the regulatory approval process, the likelihood of the approval of any of our product candidates that target rare diseases, such as MPS I, Friedreich’s ataxia, and MELAS is uncertain, and we may not be able to anticipate, prepare for or satisfy requests or requirements from regulatory authorities, including completing and submitting planned Investigational New Drug (IND) and new drug applications (NDA) for our product candidates, in a timely manner, or at all.
Due to the lack of precedent, broad discretion of regulatory authorities, and a multitude of unique factors that impact the regulatory approval process, the likelihood of the approval of any product candidates that target rare diseases, such as MPS I and MELAS is uncertain, and we may not be able to anticipate, prepare for or satisfy requests or requirements from regulatory authorities, including completing and submitting planned Investigational New Drug (IND) and new drug applications (NDA) for our product candidates, in a timely manner, or at all.
The impact of these lawsuits as well as legislative, executive, and administrative actions of the Biden administration on us and the pharmaceutical industry as a whole is unclear. 43 At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
The impact of these lawsuits as well as legislative, executive, and administrative actions of the Biden administration on us and the pharmaceutical industry as a whole is unclear. 42 At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
Section 7.4 of our amended and restated bylaws provides that “[i]f any action is brought by any party against another party, relating to or arising out of these Bylaws, or the enforcement hereof, the prevailing party shall be entitled to recover from the other party reasonable attorneys’ fees, costs and expenses incurred in connection with the prosecution or defense of such action.” Our amended and restated bylaws provide that for this section, the term “attorneys’ fees” or “attorneys’ fees and costs” means the fees and expenses of counsel to the Company and any other parties asserting a claim subject to Section 7.4 of the amended and restated bylaws, which may include printing, photocopying, duplicating and other expenses, air freight charges, and fees billed for law clerks, paralegals and other persons not admitted to the bar but performing services under the supervision of an attorney, and the costs and fees incurred in connection with the enforcement or collection of any judgment obtained in any such proceeding.
Section 7.4 of our amended and restated bylaws provides that “if any action is brought by any party against another party, relating to or arising out of these Bylaws, or the enforcement hereof, the prevailing party shall be entitled to recover from the other party reasonable attorneys’ fees, costs and expenses incurred in connection with the prosecution or defense of such action.” Our amended and restated bylaws provide that for this section, the term “attorneys’ fees” or “attorneys’ fees and costs” means the fees and expenses of counsel to the Company and any other parties asserting a claim subject to Section 7.4 of the amended and restated bylaws, which may include printing, photocopying, duplicating and other expenses, air freight charges, and fees billed for law clerks, paralegals and other persons not admitted to the bar but performing services under the supervision of an attorney, and the costs and fees incurred in connection with the enforcement or collection of any judgment obtained in any such proceeding.
We may not be successful in our efforts to develop our proprietary drug delivery platform to build a pipeline of indications. A key element of our strategy is to leverage our proprietary drug delivery platform and our ability to expand our pipeline of indications.
We may not be successful in our efforts to develop our proprietary drug delivery platform, JOTROL™, to build a pipeline of indications. A key element of our strategy is to leverage our proprietary drug delivery platform and our ability to expand our pipeline of indications.
If we are unable to compete effectively, our opportunity to generate revenue from the sale of our products we may develop, if approved, could be adversely affected. 32 Interim, topline and preliminary data from our clinical trials that we announce or publish may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
If we are unable to compete effectively, our opportunity to generate revenue from the sale of our products we may develop, if approved, could be adversely affected. 31 Interim, topline and preliminary data from our clinical trials that we announce or publish may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
Additionally, any party who brings an action, and the party against whom such action is brought under Section 7.4 of our amended and restated bylaws, which could include, but is not limited to former and current shareholders, Company directors, officers, affiliates, legal counsel, expert witnesses and other parties, would be able to recover fees under this provision.
Additionally, any party who brings an action, and the party against whom such action is brought under Section 7.4 of our amended and restated bylaws, which could include, but is not limited to former and current stockholders, Company directors, officers, affiliates, legal counsel, expert witnesses and other parties, would be able to recover fees under this provision.
If we are unable to successfully commercialize our approved product candidates, either on our own or through collaborations with one or more third parties, our future product revenue will suffer, and we may incur significant additional losses. 50 In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
If we are unable to successfully commercialize our approved product candidates, either on our own or through collaborations with one or more third parties, our future product revenue will suffer, and we may incur significant additional losses. 48 In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
Our certificate of incorporation provide that we will indemnify and hold harmless our officers and directors against claims arising from our activities, to the maximum extent permitted by Delaware law. If we were called upon to perform under our indemnification obligations, then the portion of our assets expended for such purpose would reduce the amount otherwise available for our business.
Our certificate of incorporation provides that we will indemnify and hold harmless our officers and directors against claims arising from our activities, to the maximum extent permitted by Delaware law. If we were called upon to perform under our indemnification obligations, then the portion of our assets expended for such purpose would reduce the amount otherwise available for our business.
The certificate of incorporation, as amended, and amended and restated bylaws provides that state or federal court located within the state of Delaware will be the sole and exclusive forum for substantially all disputes between us and our shareholders, which could limit its stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.
The certificate of incorporation, as amended, and amended and restated bylaws provides that state or federal court located within the state of Delaware will be the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit its stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.
If any of these events occur, we may be forced to abandon our development efforts for a program or programs, which would have a material adverse effect on our business and could potentially cause us to cease operations. 33 We may develop JOTROL and potentially other programs in combination with other therapies, which would expose us to additional risks.
If any of these events occur, we may be forced to abandon our development efforts for a program or programs, which would have a material adverse effect on our business and could potentially cause us to cease operations. 32 We may develop JOTROL™ and potentially other programs in combination with other therapies, which would expose us to additional risks.
Any party who brings an action, and the party against whom such action is brought under Section 7.4 of our amended and restated bylaws, which could include, but is not limited to former and current shareholders, Company directors, officers, affiliates, legal counsel, expert witnesses and other parties, are subject to this provision.
Any party who brings an action, and the party against whom such action is brought under Section 7.4 of our amended and restated bylaws, which could include, but is not limited to former and current stockholders, Company directors, officers, affiliates, legal counsel, expert witnesses and other parties, are subject to this provision.
Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available. In addition, we may report interim analyses of only certain endpoints rather than all endpoints.
Topline data also remains subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available. In addition, we may report interim analyses of only certain endpoints rather than all endpoints.
We may also discover that the half-life of our product candidates renders them unsuitable for the therapeutic applications we have chosen. As a result, we cannot assure you that any clinical trials that we conduct will demonstrate consistent or adequate efficacy and safety to support marketing approval.
We may also discover that the half-life of our product candidates renders them unsuitable for the therapeutic applications we have chosen. As a result, we cannot assure you that any clinical trials that we conduct will demonstrate consistent or adequate efficacy and safety that is necessary to support marketing approval.
Even if we receive accelerated approval from the FDA, if our confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA may seek to withdraw accelerated approval. Where possible, we plan to pursue accelerated development strategies in areas of high unmet need.
Even if we receive an accelerated development designation from the FDA, if our confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA may seek to withdraw accelerated approval. Where possible, we plan to pursue accelerated development strategies in areas of high unmet need.
Because the target patient populations of our programs are small and the addressable patient population may be even smaller, we must be able to successfully identify patients and capture a significant market share to achieve profitability and growth. MPS I, Friedreich’s ataxia, and MELAS are rare, genetic neuromuscular disorders.
Because the target patient populations of our programs are small and the addressable patient population may be even smaller, we must be able to successfully identify patients and capture a significant market share to achieve profitability and growth. MPS I and MELAS are rare, genetic neuromuscular disorders.
If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.
If we or a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.
Our expenses could increase beyond expectations if we are required by the FDA, the European Medicines Agency (EMA) or other regulatory agencies to perform clinical trials or preclinical studies in addition to those that we currently anticipate. Other unanticipated costs may also arise.
Our expenses could increase beyond expectations if we are required by the FDA, the European Medicines Agency (the “EMA”) or other regulatory agencies to perform clinical trials or preclinical studies in addition to those that we currently anticipate. Other unanticipated costs may also arise.
The success of JOTROL will depend on several factors, including the following: ● the successful and timely completion of our clinical trials of JOTROL; 24 ● the initiation and successful patient enrollment and completion of additional clinical trials of JOTROL on a timely basis; ● maintaining and establishing relationships with CROs and clinical sites for the clinical development of JOTROL; ● the frequency and severity of adverse events in clinical trials; ● demonstrating efficacy, safety and tolerability profiles that are satisfactory to the FDA, EMA or any comparable foreign regulatory authority for marketing approval; ● the timely receipt of marketing approvals for JOTROL from applicable regulatory authorities; ● the extent of any required post-marketing approval commitments to applicable regulatory authorities; ● the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers for clinical development and, if approved, commercialization of JOTROL; ● obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; ● protecting our rights in our intellectual property portfolio; ● our ability to expand JOTROL into multiple indications; ● our ability to find partners handling all aspects of commercialization; ● the successful launch of commercial sales following any marketing approval; ● a continued acceptable safety profile following any marketing approval; ● the actual market-size, ability to identify patients and the demographics of patients eligible for our product candidates, which may be different than expected; ● commercial acceptance by patients, the medical community and third-party payors, particularly since the product candidates we develop may be novel; and ● our ability to compete with other therapies.
We are not permitted to market or promote JOTROL™, or any other product candidate, before we receive marketing approval from the FDA and comparable foreign regulatory authorities, and we may never receive such marketing approvals. 24 The success of JOTROL™ will depend on several factors, including the following: ● the successful and timely completion of our clinical trials of JOTROL™; ● the initiation and successful patient enrollment and completion of additional clinical trials of JOTROL™ on a timely basis; ● maintaining and establishing relationships with CROs and clinical sites for the clinical development of JOTROL™; ● the frequency and severity of adverse events in clinical trials; ● demonstrating efficacy, safety and tolerability profiles that are satisfactory to the FDA, EMA or any comparable foreign regulatory authority for marketing approval; ● the timely receipt of any marketing approvals for JOTROL™ from applicable regulatory authorities; ● the extent of any required post-marketing approval commitments to applicable regulatory authorities; ● the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers for clinical development and, if approved, commercialization of JOTROL™; ● obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; ● protecting our rights in our intellectual property portfolio; ● our ability to expand JOTROL™ into multiple indications; ● our ability to find partners handling all aspects of commercialization; ● the successful launch of commercial sales following any marketing approval; ● a continued acceptable safety profile following any marketing approval; ● the actual market-size, ability to identify patients and the demographics of patients eligible for our product candidates, which may be different than expected; ● commercial acceptance by patients, the medical community and third-party payors, particularly since the product candidates we develop may be novel; and ● our ability to compete with other therapies.
If we are unable to obtain such approval, we may be required to conduct additional preclinical studies or clinical trials beyond those that we contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals.
If we are unable to obtain such designations, we may be required to conduct additional preclinical studies or clinical trials beyond those that we contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals.
These current or future laws and regulations may impair our research, development or commercialization efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions. 48 Our business activities may be subject to the U.S.
These current or future laws and regulations may impair our research, development or commercialization efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions. 46 Our business activities may be subject to the U.S.
Our commercial success depends in part on our ability to obtain and maintain patent protection and trade secret protection for our product candidates, proprietary technologies and their uses as well as our ability to operate without infringing upon the proprietary rights of others.
Our commercial success depends in part on our ability to obtain and maintain patent protection and trade secret protection for JOTROL™ and other product candidates, proprietary technologies and their uses as well as our ability to operate without infringing upon the proprietary rights of others.
We have entered into a license agreement with Aquanova AG, a German company, pursuant to which we have acquired the exclusive right to certain patents and patent applications in micellar technologies that revolutionizes the bioavailability profile of resveratrol to treat certain rare diseases and Alzheimer’s disease by eliminating the severe gastro-intestinal side effects experienced at effective dose levels of resveratrol.
We have entered into a license agreement with Aquanova pursuant to which we have acquired the exclusive right to certain patents and patent applications in micellar technologies that revolutionizes the bioavailability profile of resveratrol to treat certain rare diseases and Alzheimer’s disease by eliminating the severe gastro-intestinal side effects experienced at effective dose levels of resveratrol.
The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses. 52 A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses. 50 A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other data.
Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinical, clinical or other data.
In addition, shareholders who do bring a claim in the state or federal court in the State of Delaware could face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near Delaware.
In addition, stockholders who do bring a claim in the state or federal court in the State of Delaware could face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near Delaware.
Although no third-party has asserted a claim of patent infringement against us as of the date of this prospectus, others may hold proprietary rights that could prevent our product candidates from being marketed. These claims could be alleged to cover JOTROL in certain treatment indications.
Although no third-party has asserted a claim of patent infringement against us as of the date of this Annual Report, others may hold proprietary rights that could prevent our product candidates from being marketed. These claims could be alleged to cover JOTROL™ in certain treatment indications.
The acceptance of study data by the FDA, EMA or other comparable foreign regulatory authority from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions.
The acceptance of study data by the FDA, EMA or other comparable foreign regulatory authorities from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions.
We currently plan to initiate a Phase II clinical trial with JOTROL in patients with Parkinson’s Disease, establish a presence in South-East Asia through service agreements and advancing the manufacturing of JOTROL clinical trial supplies. in support of activities leading up to clinical trials in targeted indications.
We currently plan to initiate a Phase II clinical trial with JOTROL™ in patients with Parkinson’s Disease, establish a presence in Southeast Asia through service agreements and advancing the manufacturing of JOTROL™ clinical trial supplies. in support of activities leading up to clinical trials in targeted indications.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected. We intend to use registered or unregistered trademarks or trade names to brand and market ourselves and our products.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected. We intend to use registered or unregistered trademarks for JOTROL™ and Nugevia, to brand and market ourselves and our products.
Additionally, this provision in Section 7.4 of our amended and restated bylaws could discourage shareholder lawsuits that might otherwise benefit the Company and its shareholders. THE FEE SHIFTING PROVISION CONTAINED IN THE AMENDED AND RESTATED BYLAWS IS NOT INTENDED TO BE DEEMED A WAIVER BY ANY HOLDER OF COMMON STOCK OF THE COMPANY’S COMPLIANCE WITH THE U.S.
Additionally, this provision in Section 7.4 of our amended and restated bylaws could discourage stockholder lawsuits that might otherwise benefit the Company and its stockholders. THE FEE SHIFTING PROVISION CONTAINED IN THE AMENDED AND RESTATED BYLAWS IS NOT INTENDED TO BE DEEMED A WAIVER BY ANY HOLDER OF COMMON STOCK OF THE COMPANY’S COMPLIANCE WITH THE U.S.
If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
If a prolonged government shutdown or personnel reduction occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest.
Our trademarks applications for JOTROL™ and Nugevia, may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest.
These requirements include submissions of safety and other post-marketing information and reports, registration, as well as on-going compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval.
These requirements include submissions of safety and other post-marketing information and reports, registration, as well as on-going compliance with cGMP regulations and GCPs for any clinical trials that we conduct post-approval.
For example, in recent years, including in 2018 and 2019, the U.S. government shut down several times and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical employees and stop critical activities.
For example, in recent years, the U.S. government shut down several times and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical employees and stop critical activities.
If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.
I f we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.
The patient population suffering from MPS I, Friedreich’s ataxia, and MELAS is small and has not been established with precision. If the actual number of patients is smaller than we estimate, our revenue and ability to achieve profitability may be adversely affected.
The patient population suffering from MPS I and MELAS syndrome is small and has not been established with precision. If the actual number of patients is smaller than we estimate, our potential revenue and ability to achieve profitability may be adversely affected.
As of December 31, 2024, we had a total of four full-time employees, two full-time consultants and one part-time consultant, plus our six Scientific Advisory Board members. Of these, three were primarily engaged in research or product development and clinical activities.
As of December 31, 2025, we had a total of five full-time employees, two full-time consultants and one part-time consultant, plus our six Scientific Advisory Board members. Of these, three were primarily engaged in research or product development and clinical activities.
As of December 31, 2024, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned approximately 77% our common stock. These stockholders, acting together, may be able to control matters requiring stockholder approval.
As of December 31, 2025, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned approximately 59% of our common stock. These stockholders, acting together, may be able to control matters requiring stockholder approval.
Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
Further, in our operations as a public company, future government shutdowns or personnel reductions could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
This reliance on third parties increases the risk that we will not have sufficient quality and quantities of our product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
This reliance on Aquanova and Catalent increases the risk that we will not have sufficient quality and quantities of our product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
The state or federal court of the State of Delaware may also reach different judgments or results than would other courts, including courts where a shareholder would otherwise choose to bring the action, and such judgments or results may be more favorable to us than to our shareholders.
The state or federal court of the State of Delaware may also reach different judgments or results than would other courts, including courts where a stockholder would otherwise choose to bring the action, and such judgments or results may be more favorable to us than to our stockholders.
We have entered into Service Agreements with the Asian Partners with respect to services to be provided by the Asian Partners to us in Asia for the development of our product in the South-East Asian territory immediately following the completion of the public offering, the shares issued by us in advance for the specific services could have a material negative impact on our business, financial condition and operating results in case the Asian Partners’ will not perform the services per the agreements.
We have entered into Service Agreements with the Asian Partners with respect to services to be provided by the Asian Partners to us in Asia for the clinical development of JOTROL™ in the Southeast Asian territory immediately following the completion of the initial public offering; the shares issued by us in advance for the specific services could have a material negative impact on our business, financial condition and operating results in case the Asian Partners’ will not perform the services per the agreements.
From time to time, certain of our stockholders may be eligible to sell all or some of their shares of common stock by means of ordinary brokerage transactions in the open market pursuant to Rule 144 promulgated under the Securities Act, subject to certain limitations.
Shares eligible for future sale may adversely affect the market. From time to time, certain of our stockholders may be eligible to sell all or some of their shares of common stock by means of ordinary brokerage transactions in the open market pursuant to Rule 144 promulgated under the Securities Act, subject to certain limitations.
Risks Related to the Discovery, Development and Commercialization of Our Product Candidate We are substantially dependent on the success of our lead product candidate, JOTROL, which will be undergoing Phase II clinical trials.
Risks Related to the Discovery, Development and Commercialization of Our Product Candidate We are substantially dependent on the success of our lead product candidate, JOTROL ™ , which will be undergoing Phase II clinical trials, subject to FDA’s review and agreement.
If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts. As of December 31, 2024, we had $3,769,510 in cash.
If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts. As of December 31, 2025, we had $3,789,342 in cash.
We commenced operations in January 2016, have no products approved for commercial sale and have not generated any revenue. We initiated and completed our Phase I clinical trial for our sole product candidate, JOTROL, in March 2021.
We commenced operations in January 2016, have no prescription or therapeutic products approved for commercial sale and have not generated any revenue through our pharmaceutical operations. We initiated and completed our Phase I clinical trial for our sole product candidate, JOTROL™, in March 2021.
In addition, the FDA has the authority to require a Risk Evaluation and Mitigation Strategy (REMS) plan as part of approving an NDA, or after approval, which may impose further requirements or restrictions on the distribution or use of an approved drug.
In addition, the FDA has the authority to require a REMS plan as part of approving an NDA, or after approval, which may impose further requirements or restrictions on the distribution or use of an approved drug.
Beginning in 2022, reporting obligations with respect to covered recipients will be expanded to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse midwives for payments and transfers of value made during the previous year; and ● analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance regulations promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures, or drug pricing; state and local laws that require the registration of pharmaceutical sales and medical representatives; state laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Beginning in 2022, reporting obligations with respect to covered recipients will be expanded to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse midwives for payments and transfers of value made during the previous year; and ● analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance regulations promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures, or drug pricing; state and local laws that require the registration of pharmaceutical sales and medical representatives; state laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. 45 Efforts to ensure that our current and future business arrangements with third parties will comply with applicable healthcare and data privacy laws and regulations will involve substantial ongoing costs, and may require us to undertake or implement additional policies or measures.
The regulatory approval processes for product candidates that target rare diseases, including MPS I, Friedreich’s ataxia, and MELAS are uncertain.
The regulatory approval processes for any product candidates that target rare diseases, including MPS I and MELAS are uncertain.
We have not undertaken a systematic analysis of the potential consequences to our business and financial results from a major flood, blizzard, fire, earthquake, power loss, terrorist activity, pandemics or other disasters and do not have a recovery plan for such disasters.
Our facilities are located in Jupiter, Florida. We have not undertaken a systematic analysis of the potential consequences to our business and financial results from a major flood, blizzard, fire, earthquake, power loss, terrorist activity, pandemics or other disasters and do not have a recovery plan for such disasters.
If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
If we fail to comply with our obligations in the agreements under which we license intellectual property rights from Aquanova or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business. Disputes with our licensor.
We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
We may have to pay any amount awarded by a court or negotiated in a settlement that exceeds our coverage limitations or that is not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe have no t identified risks from known cybersecurity threats, including as a result of any prior cybersecurity incidents, that have materially affected or are reasonably likely to materially affect us, including our operations, business strategy, results of operations, or financial condition. 80 Cybersecurity Governance Our executive management team, along with our managed information technology service provider , is responsible for assessing and managing risks from cybersecurity threats to the Company, including our Confidential Information and Critical Systems.
Biggest changeWe have no t identified risks from known cybersecurity threats, including as a result of any prior cybersecurity incidents, that have materially affected or are reasonably likely to materially affect us, including our operations, business strategy, results of operations, or financial condition. 69 Cybersecurity Governance Our executive management team, along with our managed information technology service provider , is responsible for assessing and managing risks from cybersecurity threats to the Company, including our Confidential Information and Critical Systems .

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeTerms 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.
Biggest changeTerms 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.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeThe results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 81 PART II
Biggest changeThe results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 70 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeRecent Sales of Unregistered Securities Name Date Type Type of Award Quantity Price A consultant January 24, 2024 Granted Non-qualified Stock Option; Common Stock 180,000 $ 1.33 Dana Eschenburg Perez, our former Chief Financial Officer March 15, 2024 Granted Non-qualified Stock Option; Restricted Stock 7,500 $ 1.33 Dana Eschenburg Perez, our former Chief Financial Officer March 15, 2024 Granted Non-qualified Stock Option; Common Stock 49,605 $ 1.33 A consultant April 17, 2024 Granted Non-qualified Stock Option; Common Stock 67,500 $ 1.33 The above issuances/sales were made pursuant to an exemption from registration as set forth in Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D promulgated under the Securities Act. 82 Purchases of Equity Securities by the Issuer and Affiliated Purchasers None.
Biggest changeRecent Sales of Unregistered Securities Name Date Type Type of Award Quantity Price A service provider April 23, 2025 Granted Common Stock 78,186 $ 0.64 A service provider April 23, 2025 Granted Common Stock 25,000 $ 0.64 The above issuances/sales were made pursuant to an exemption from registration as set forth in Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D promulgated under the Securities Act.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is listed on The Nasdaq Capital Market and its stock symbol is “JUNS.” The closing price of our common stock on The Nasdaq Capital Market on March 28, 2025 was $0.70.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is listed on The Nasdaq Capital Market and its stock symbol is “JUNS.” The closing price of our common stock on The Nasdaq Capital Market on March 30, 2026 was $0.3248.
Holders As of March 28, 2025, there were 33,103,860 shares of common stock issued and outstanding, and we had approximately 31 holders of record of our common stock. The number of record holders does not include beneficial owners of common stock whose shares are held in the names of banks, brokers, nominees or other fiduciaries.
Holders As of March 31, 2026, there were 36,281,252 shares of common stock issued and outstanding, and we had approximately 29 holders of record of our common stock. The number of record holders does not include beneficial owners of common stock whose shares are held in the names of banks, brokers, nominees or other fiduciaries.
Transfer Agent The Company’s transfer agent is Equiniti Trust Company. The transfer agent’s address is 1110 Centre Pointe Curve, Suite 101, Mendota Heights, Minnesota 55120, and its telephone number is (800) 401-1957. ITEM 6. [RESERVED]
Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. Transfer Agent The Company’s transfer agent is Equiniti Trust Company. The transfer agent’s address is 1110 Centre Pointe Curve, Suite 101, Mendota Heights, Minnesota 55120, and its telephone number is (800) 401-1957. 71 ITEM 6. [RESERVED]
As of March 28, 2025, there were 2,139,240 shares available for issuance under the 2023 Plan.
As of March 31, 2026, there were 5,250,000 shares available for issuance under the 2025 Plan.
Added
As of March 31, 2026, there were 1,047,135 shares available for issuance under the 2023 Plan. The Board of Directors and stockholders of the Company approved the 2025 Equity Incentive Plan (the “2025 Plan”) on December 19, 2025.
Added
Under the 2025 Plan, 5,250,000 shares of common stock are authorized for issuance to employees, directors and independent contractors (except those performing services in connection with the offer or sale of the Company’s securities in a capital raising transaction, or promoting or maintaining a market for the Company’s securities) of the Company or its subsidiaries.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

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Biggest changeItem 6. [Reserved] 83 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 83 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 92 Item 8. Financial Statements and Supplementary Data 93 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 93 Item 9A. Controls and Procedures 93 Item 9B.
Biggest changeItem 6. [Reserved] 72 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 72 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 81 Item 8. Financial Statements and Supplementary Data 82 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 82 Item 9A. Controls and Procedures 82 Item 9B.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeIn exchange for the forgiveness of the accrued bonuses the Company issued an aggregate of 289,294 stock options with an exercise price of $1.33 and an aggregate of 218,703 restricted stock units with a grant date value of $1.33 in exchange for the aggregate forgiveness of compensation in the amount of $583,213. 90 On March 15, 2024, a former executive agreed to forgive $100,000 of accrued compensation in exchange for 49,605 options to purchase common stock and 7,500 restricted stock units, The options to purchase common stock have a strike price of $1.33.
Biggest changeOn March 15, 2024, a former executive agreed to forgive $100,000 of accrued compensation in exchange for 49,605 options to purchase common stock and 7,500 restricted stock units, The options to purchase common stock have a strike price of $1.33. The option had a grant date fair value of $50,000.
Therefore, the principal amount of the note was increased to $1,377,778 and the exchange debt follows the requirements of Note II. In addition, the Holder agreed to extend the note maturity date to August 11, 2024. The note shall be designated as a 10% original issue discount secured note (“Senior Secured Note”) moving forward.
Therefore, the principal amount of the note was increased to $1,377,778 and the exchange debt follows the requirements of Note II. In addition, the Holder agreed to extend the note maturity date to August 11, 2024. The note shall be designated as a 10% original issue discount secured note (“Senior Secured Note”) moving forward.
The Senior Secured Note and interest will become due and payable upon the earliest of the maturity date or upon the occurrence of a qualified event. The note is recorded on the balance sheet under note payable.
The Senior Secured Note and interest will become due and payable upon the earliest of the maturity date or upon the occurrence of a qualified event. The note is recorded on the balance sheet under note payable.
On April 29, 2024, the Company, the Holder of the Note II and the CEO entered into an amendment in which the CEO agrees to exchange 685,867 shares issued to the Holder in exchange for his related party notes that accrued interest at 3% that are due from the Company in an aggregate principal amount of $266,667 and the Holder agreed to forfeit all rights to all additional future shares from the Company that would of become due upon a qualified offering as well as the conversion option.
On April 29, 2024, the Company, the Holder of the Note II and the CEO entered into an amendment in which the CEO agreed to exchange 685,867 shares issued to the Holder in exchange for his related party notes that accrued interest at 3% that are due from the Company in an aggregate principal amount of $266,667 and the Holder agreed to forfeit all rights to all additional future shares from the Company that would of become due upon a qualified offering as well as the conversion option.
We anticipate that we will need to raise substantial additional capital, the requirements of which will depend on many factors, including: ● the scope, rate of progress and costs of our drug delivery, preclinical development activities, laboratory testing and clinical trials for our drug candidate; ● the number and scope of clinical programs we decide to pursue; ● the scope and costs of manufacturing development and commercial manufacturing activities; ● the extent to which we acquire or in-license other drug candidate and technologies; ● the cost, timing and outcome of regulatory review of our drug candidate; ● the cost and timing of establishing sales and marketing capabilities, if our drug candidate receives marketing approval; ● the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; ● our ability to establish and maintain collaborations on favorable terms, if at all; ● our efforts to enhance operational systems and our ability to attract, hire and retain qualified personnel, including personnel to support the development of our drug candidate; ● the costs associated with being a public company; and ● the cost associated with commercializing our drug candidate, if it receives marketing approval. 85 If we raise additional funds by issuing equity securities, our stockholders may experience dilution.
We anticipate that we will need to raise substantial additional capital, the requirements of which will depend on many factors, including: ● the scope, rate of progress and costs of our drug delivery, preclinical development activities, laboratory testing and clinical trials for our drug candidate; ● the number and scope of clinical programs we decide to pursue; ● the scope and costs of manufacturing development and commercial manufacturing activities; ● the extent to which we acquire or in-license other drug candidate and technologies; ● the cost, timing and outcome of regulatory review of our drug candidate; ● the cost and timing of establishing sales and marketing capabilities, if our drug candidate receives marketing approval; ● the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; ● our ability to establish and maintain collaborations on favorable terms, if at all; ● our efforts to enhance operational systems and our ability to attract, hire and retain qualified personnel, including personnel to support the development of our drug candidate; ● the costs associated with being a public company; and ● the cost associated with commercializing our drug candidate, if it receives marketing approval. 74 If we raise additional funds by issuing equity securities, our stockholders may experience dilution.
The Company sold 2,750,000 shares of its Common Stock to the underwriters and yielded proceeds of $9,725,213, net of underwriters and other fees of $1,274,787. Critical Accounting Policies Basis of Presentation The financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”).
The Company sold 2,750,000 shares of its Common Stock to the underwriters and yielded proceeds of $9,725,213, net of underwriters and other fees of $1,274,787. 80 Critical Accounting Policies Basis of Presentation The financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”).
Convertible Notes with Embedded Derivative Liabilities The Company has entered into convertible notes, some of which contain variable conversion options, whereby the outstanding principal and accrued interest may be converted, by the holder, into shares of common stock at a fixed discount to the price of the common stock at or around the time of conversion upon certain trigger events.
Convertible Notes with and without Embedded Derivative Liabilities The Company has entered into convertible notes, some of which contain variable conversion options, whereby the outstanding principal and accrued interest may be converted, by the holder, into shares of common stock at a fixed discount to the price of the common stock at or around the time of conversion upon certain trigger events.
In connection with the issuance of the Note, the Company issued 514,403 shares of common stock to the holder with a fair market value of $2.16 per share (aggregate value of $1,111,111) as additional consideration for the holder lending $1,000,000 to the Company. The 514,403 shares have a relatively fair value of $310,000.
The Shares . In connection with the issuance of Note II, the Company issued 514,403 shares of common stock to the holder with a fair market value of $2.16 per share (aggregate value of $1,111,111) as additional consideration for the holder lending $1,000,000 to the Company. The 514,403 shares have a relatively fair value of $310,000.
GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates, and those estimates may be material.
GAAP requires management to make estimates and assumptions that materially affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates, and those estimates may be material.
Until the Company has consummated a Qualified Offering which results in a listing of the common stock onto a national securities exchange, if the Company engages in any future financing transactions with a third-party investor, if the holder determines that the terms of the subsequent investment are preferable in any respect to the terms of the securities of the Company issued to the Holder pursuant to the terms of the Purchase Agreement, the holder will have the right to amend and restate such securities to include the preferable term or terms. 89 Notes Payable, related party The Company’s Chief Executive Officer (CEO) has loaned the Company working capital since inception.
Until the Company has consummated a Qualified Offering which results in a listing of the common stock onto a national securities exchange, if the Company engages in any future financing transactions with a third-party investor, if the holder determines that the terms of the subsequent investment are preferable in any respect to the terms of the securities of the Company issued to the Holder pursuant to the terms of the Purchase Agreement, the holder will have the right to amend and restate such securities to include the preferable term or terms. 78 Notes Payable, related party The Company’s Chief Executive Officer (CEO) has loaned the Company working capital since inception.
On April 29, 2024, the Company, the Holder of the Note II and the CEO entered into an amendment in which the CEO agrees to exchange 685,869 shares issued to the Holder in exchange for his related party notes that accrued interest at 3% that are due from the Company in an aggregate principal amount of $266,667 and the Holder agreed to forfeit all rights to all additional future shares from the Company that would of become due upon a qualified offering and the conversion feature of the note.
On April 29, 2024, the Company, the Holder of the Note II and the CEO entered into an amendment in which the CEO agreed to exchange 685,869 shares issued to the Holder in exchange for his related party notes that accrued interest at 3% that are due from the Company in an aggregate principal amount of $266,667 and the Holder agreed to forfeit all rights to all additional future shares from the Company that would have become due upon a qualified offering and the conversion feature of the note.
The company believes these agreements to be favorable for both parties based on the cash position of the company and the need for these activities to be executed and enabling the possibility of a one or more out-licensing agreements in the territory. 86 Contractual obligations We do not have any long-term capital lease obligations, operating lease obligations or long-term liabilities, except as follows: On April 30, 2021, the Company executed a lease agreement for office space in Jupiter, Florida.
The Company believes these agreements to be favorable for both parties based on the cash position of the company and the need for these activities to be executed and enabling the possibility of a one or more out-licensing agreements in the territory. 75 Contractual obligations We do not have any long-term capital lease obligations, operating lease obligations or long-term liabilities, except as follows: On April 30, 2021, the Company executed a lease agreement for office space in Jupiter, Florida.
The aggregate principal amount of the Note is $1,111,111, and the Company received gross proceeds of $1,000,000 after giving effect to the original issue discount of 10%. The Note bears interest at a rate of 10% per year, payable monthly in arrears, and mature 12 months from issuance.
The Note . The aggregate principal amount of the Note is $1,111,111, and the Company received gross proceeds of $1,000,000 after giving effect to the original issue discount of 10%. The Note bore interest at a rate of 10% per year, payable monthly in arrears, and mature 12 months from issuance.
Pursuant to the terms of the Purchase Agreement, on April 11, 2022, the Company received aggregate gross proceeds of $1,000,000 and issued (i) a 10% Original Issue Discount Senior Secured Convertible Note in the principal amount of $1,111,111.11 (the “Note”) and (ii) 514,403 shares of common stock, par value $0.0001 per share (the “Shares”), of the Company. The Note .
Pursuant to the terms of the Purchase Agreement, on April 11, 2022, the Company received aggregate gross proceeds of $1,000,000 and issued (i) a 10% Original Issue Discount Senior Secured Convertible Note in the principal amount of $1,111,111.11 (the “Note” or “Note II”) and (ii) 514,403 shares of common stock, par value $0.0001 per share (the “Shares”), of the Company.
The Asian market is very large and hard to penetrate for a small company and we believe that our strategy with these agreements is cost effective and have the possibility to accelerate an out-licensing deal in the South-East Asian territories. However, there are no assurances that this approach will be successful.
The Asian market is very large and hard to penetrate for a small company and we believe that our strategy with these agreements is cost effective and 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.
Cash Flows for the Years Ended December 31, 2024 and 2023 The following table shows a summary of our cash flows for the years ended December 31, 2024 and 2023.
Cash Flows for the Years Ended December 31, 2025 and 2024 The following table shows a summary of our cash flows for the years ended December 31, 2025 and 2024.
Significant estimates during the years ended December 31, 2024 and 2023, respectively, include valuation of stock-based compensation, uncertain tax positions, and the valuation allowance on deferred tax assets. Research and Development Research and development costs are expensed as incurred.
Significant estimates during the years ended December 31, 2025 and 2024, respectively, include valuation of stock-based compensation, uncertain tax positions, valuation of debt instruments, and the valuation allowance on deferred tax assets. Research and Development Research and development costs are expensed as incurred.
We do not participate in transactions that create relationships with unconsolidated entities or financial partnerships, often referred to as variable interest entities, which would have been established for the purpose of facilitating off-balance sheet arrangements.
Off-balance sheet financing arrangements We have no obligations, assets or liabilities which would be considered off-balance sheet arrangements. We do not participate in transactions that create relationships with unconsolidated entities or financial partnerships, often referred to as variable interest entities, which would have been established for the purpose of facilitating off-balance sheet arrangements.
In 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 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 at a price of $4.00 per share for gross proceeds of $11 million before deducting underwriting discounts and other related expenses.
Loss (Gain) on Change in Fair Value of Derivative Liability As of December 31, 2024 and 2023 and at each quarter end during these years, the variable conversion options embedded in our convertible notes were marked to market, and the change in fair value of the derivative was recorded as a (loss)/gain of $(53,257) and $148,751, in the years ended December 31, 2024 and 2023, respectively.
Loss on Change in Fair Value of Derivative Liability As of December 31, 2024 and at each quarter end during the year, the variable conversion options embedded in our convertible notes were marked to market, and the change in fair value of the derivative was recorded as a loss of $53,257.
Since inception, we have incurred net losses and negative cash flows from operations. On December 31, 2024, we had an accumulated deficit of $26,022,129. Historically, we have financed our operations primarily by selling common stock and convertible debt.
Since inception, we have incurred net losses and negative cash flows from operations. On December 31, 2025, we had an accumulated deficit of $34,667,026. Historically, we have financed our operations primarily by selling common stock and convertible debt.
See “Risk Factors—We have a history of operating losses, our management has concluded that factors raise substantial doubt about our ability to continue as a going concern and our auditor has included an explanatory paragraph relating to our ability to continue as a going concern in its audit report for the fiscal years ended December 31, 2024 and 2023.
See “Risk Factors—We have a history of operating losses, our management has concluded that factors raise substantial doubt about our ability to continue as a going concern and our auditor has included an explanatory paragraph relating to our ability to continue as a going concern in its audit report for the fiscal years ended December 31, 2025 and 2024.” Results of Operations Year Ended December 31, 2025 Compared to Year Ended December 31, 2024 Revenue There was net revenue of $21,796 during the year ended December 31, 2025.
The option had a grant date fair value of $50,000. The Company recorded a gain on the forgiveness of accrued compensation in the amount of $40,000. As of December 31, 2024 and 2023, $64,105 and $67,750, respectively, was due to a Company wholly owned by the Company’s Chief Financial Officer, who also is an option holder.
The Company recorded a gain on the forgiveness of accrued compensation in the amount of $40,000. As of December 31, 2025 and 2024, $64,105 was due to a Company wholly owned by the Company’s Chief Financial Officer, who also is an option holder, respectively. The amount is included in accrued compensation on the Company’s balance sheets.
See “Risk Factors—We have a history of operating losses, our management has concluded that factors raise substantial doubt about our ability to continue as a going concern and our auditor has included an explanatory paragraph relating to our ability to continue as a going concern in its audit report for the fiscal years ended December 31, 2024 and 2023.
See “Risk Factors—We have a history of operating losses, our management has concluded that factors raise substantial doubt about our ability to continue as a going concern and our auditor has included an explanatory paragraph relating to our ability to continue as a going concern in its audit report for the fiscal years ended December 31, 2025 and 2024.” Our failure to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategies.
This resulted in a gain/(loss) on extinguishment of debt in the years ended December 31, 2024 and 2023 of $857,723 and $(887,946), respectively. 84 Liquidity and Capital Resources; Plan of Operations As of December 31, 2024, we had cash and cash equivalents of $3,769,510. Our cash equivalents are held in high yield savings account.
This resulted in a gain on extinguishment of debt in the year ended December 31, 2024 of $857,723. Liquidity and Capital Resources; Plan of Operations As of December 31, 2025, we had cash and cash equivalents of $3,789,342. Our cash equivalents are held in high yield savings account.
For awards subject to time-based vesting, the Company recognized stock-based compensation expense, on a straight-line basis over the requisite service period, which is generally the vesting term of the award. As of December 31, 2024 and 2023, stock-based compensation expenses totaled $1,840,908 and $1,198,579, respectively.
For awards subject to time-based vesting, the Company recognized stock-based compensation expense, on a straight-line basis over the requisite service period, which is generally the vesting term of the award. As of December 31, 2025 and 2024, stock-based compensation expenses totaled $2,418,516 and $1,840,908, respectively, and includes expenses associated with shares issued to service providers and warrant holders.
Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties. Unless the context otherwise requires, “JNS,” “we,” “us,” “our,” or the “Company” refers to Jupiter Neurosciences, Inc. Business Overview We are a clinical stage research and development company. We have developed a unique resveratrol platform product primarily targeting treatment of neuro-inflammation.
Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties. Unless the context otherwise requires, “JNS,” “we,” “us,” “our,” or the “Company” refers to Jupiter Neurosciences, Inc. Business Overview Jupiter Neurosciences, Inc. is a clinical stage research and development pharmaceutical company located in Jupiter, Florida.
Gain (Loss) on Extinguishment of Debt During the years ended 2024 and 2023, the Senior Secured Convertible Note was amended several times with materially different economics thus requiring for the recording of debt as an extinguishment and re-recording the debt with the amended terms.
These notes were fully paid off in the year ended December 31, 2024. Gain on Extinguishment of Debt During the year ended 2024, the Senior Secured Convertible Note was amended several times with materially different economics and subsequently paid off, thus requiring for the recording of debt as an extinguishment and re-recording the debt with the amended terms.
The balance of the loans to the CEO as of December 31, 2024 and 2023 was $146,432 and $358,479, respectively. The loan is due on demand and accrues interest at 3% per year.
The balance of the loans to the CEO as of December 31, 2024 was $146,432. The loan was due on demand and accrues interest at 3% per year. Accrued interest relating to the loan was $1,064 as of December 31, 2024, and is included in accrued interest on the accompanying 2024 balance sheets.
Net Cash Used in Investing Activities: No net cash was provided by or used in investing activities during the years ended December 31, 2024 and 2023. Net Cash Provided by Financing Activities: Net cash provided by financing activities for the year ended December 31, 2024 increased by $7,207,036 from the year ended December 31, 2023.
Net Cash Used in Investing Activities: No net cash was provided by or used in investing activities during the years ended December 31, 2025 and 2024.
Other Related Party Transactions Accrued compensation includes partially accrued salaries to executives since inception. Since inception, executive salaries have been paid in cash when the Company’s cash flow has permitted such payment. During 2020, the Company began paying salaries at 50% of the respective employment agreements. As of September 2021, the Company began paying full salaries.
Other Related Party Transactions Accrued compensation includes partially accrued salaries to executives since inception. Since inception, executive salaries have been paid in cash when the Company’s cash flow has permitted such payment.
This accounting treatment requires that the carrying amount of any derivatives be recorded at fair value at issuance and marked-to-market at each balance sheet date.
The Company evaluates all its financial instruments to determine if those contracts or any potential embedded components of those contracts qualify as derivatives. This accounting treatment requires that the carrying amount of any derivatives be recorded at fair value at issuance and marked-to-market at each balance sheet date.
There is substantial doubt regarding our ability to continue as a going concern as a result of our historical recurring losses and negative cash flows from operations as well as our dependence on private equity and financings.
As noted in our financial statements, as of December 31, 2025 and 2024, we had an accumulated deficit of $34,667,026 and $26,022,129, respectively. There is substantial doubt regarding our ability to continue as a going concern as a result of our historical recurring losses and negative cash flows from operations as well as our dependence on private equity and financings.
Fixed annual rent amounts are as follows: Lease Period Annual Fixed Rent 6/1/2021-5/31/2022 $ 45,396 6/1/2022-5/31/2023 $ 46,758 6/1/2023-5/31/2024 $ 48,158 6/1/2024-5/31/2025 $ 49,608 6/ l/2025-5/31/2026 $ 51,096 Senior Secured Note On April 11, 2022, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with an accredited investor for the sale of the Company’s convertible notes.
Fixed annual rent amounts are as follows: Lease Period Annual Fixed Rent 6/1/2021-5/31/2022 $ 45,396 6/1/2022-5/31/2023 $ 46,758 6/1/2023-5/31/2024 $ 48,158 6/1/2024-5/31/2025 $ 49,608 6/ l/2025-5/31/2026 $ 51,096 Standby Equity Purchase Agreement and Convertible Promissory Notes On October 24, 2025, we entered into the SEPA with Yorkville.
Business Segments The Company uses the “management approach” to identify its reportable segments. The management approach requires companies to report segment financial information consistent with information used by management for making operating decisions and assessing performance as the basis for identifying the Company’s reportable segments. The Company has identified one single reportable operating segment.
Business Segments The Company uses the “management approach” to identify its reportable segments in accordance with ASC 280, Segment Reporting. The management approach requires companies to report segment financial information consistent with the information regularly reviewed by the Chief Operating Decision Maker (“CODM”) for purposes of making operating decisions and assessing performance.
As a result of the conversion feature of the note being removed the Company recorded a one-time gain on the modification of the debt of $951,868 and a new derivative liability of $407,494 was recorded related to the Senior Secured Note. 88 On August 8, 2024, the Company, and the Holder of the Senior Secured Note entered into an amendment to extend the maturity date of the Senior Secured Note to October 11, 2024.
As a result of the conversion feature of the note being removed the Company recorded a one-time gain on the modification of the debt of $951,868 and a new derivative liability of $407,494 was recorded related to the Senior Secured Note. 77 During December 2024, the Company fully repaid the Senior Secured Note pursuant to the terms in the amount of $2,102,797.
There is substantial doubt regarding our ability to continue as a going concern as a result of our historical recurring losses and negative cash flows from operations as well as our dependence on financings.
As noted in our financial statements, as of December 31, 2025 and 2024, we had an accumulated deficit of $34,667,026 and $26,022,129, respectively. There is substantial doubt regarding our ability to continue as a going concern as a result of our historical recurring losses and negative cash flows from operations as well as our dependence on private equity and financings.
Interest expense is primarily attributable to interest expense associated with our previously outstanding notes payable, convertible notes payable, notes payable to our Chief Executive Officer, Christer Rosén, and interest expense on our corporate credit card.
In 2025, interest expense is primarily attributable to accrued interest on the SEPA and interest expense on our corporate credit card and the note payable to our Chief Executive Officer, Christer Rosén, which was repaid during 2025.
Recent Developments On December 2, 2024, the Company priced its initial public offering of 2,750,000 shares of common stock at a price of $4.00 per share. The offering closed on December 4, 2024, and the Company started trading on the Nasdaq Capital Market under the ticker symbol “JUNS”.
The offering closed on December 4, 2024, and the Company started trading on the Nasdaq Capital Market under the ticker symbol “JUNS”. The Company sold 2,750,000 shares of its Common Stock to the underwriters and yielded proceeds of $9,725,213, net of underwriters and other fees of $1,274,787.
Financial Position For the fiscal years ended December 31, 2024 and 2023, we generated no revenues from product sales and reported net losses of $2,439,625 and $4,783,689, respectively, and negative cash flow from operating activities of $3,911,004 and $480,953, respectively. As noted in our financial statements, as of December 31, 2024, we had an accumulated deficit of $26,022,129.
For the fiscal years ended December 31, 2025 and 2024, we generated net revenues of $21,796 and $0, respectively from product sales and reported net losses of $8,644,897 and $2,439,625, respectively, and negative cash flow from operating activities of $5,413,736 and $3,911,004, respectively.
Results of Operations Year Ended December 31, 2024 Compared to Year Ended December 31, 2023 Revenue and Federal Awards There was no revenue from product sales during the years ended December 31, 2024 or 2023 as we are focused on research and development.
There was no revenue from product sales during the years ended December 31, 2024 as Nugevia was launched in 2025. Research and Development Expenses Research and development (“R&D”) expenses were $2,086,574 for the year ended December 31, 2025, compared to $492,660 for the year ended December 31, 2024.
Total research and development costs for the fiscal years ended December 31, 2024 and 2023 were $492,660 and $954,793, respectively. 91 Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the provisions of Accounting Standards Codification (ASC) Topic 718, Compensation—Stock Compensation, or ASC 718, which requires the recognition of expense related to the fair value of stock-based awards in the statements of operations.
Total research and development costs for the fiscal years ended December 31, 2025 and 2024 were $2,086,574 and $492,660, respectively. Stock-Based Compensation The Company records stock-based compensation equal to the grant date fair value of the stock awards issued.
Accrued interest relating to the loan was $1,064 and $11,308 as of December 31, 2024 and 2023, respectively, and is included in accrued interest on the accompanying balance sheets. The Company repaid a total of $100,000 during the year ended December 31, 2024, $83,880 in principal and $16,120 in accrued interest.
The Company fully settled the debt in 2025 by repaying a total of $150,782, $146,432 in principal and $4,350 in accrued interest. The Company repaid a total of $100,000 during the year ended December 31, 2024, $83,880 in principal and $16,120 in accrued interest.
Business” of this Annual Report on Form 10-K, which was paid down with the proceeds from the initial public offering. For the fiscal years ended December 31, 2024 and 2023, we generated no revenues from product sales and reported net losses of $2,439,625 and $4,783,689, respectively, and negative cash flow from operating activities of $3,911,004 and $480,953, respectively.
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.” Financial Position For the fiscal years ended December 31, 2025 and 2024, we generated net revenues of $21,796 and $0, respectively from product sales and reported net losses of $8,644,897 and $2,439,625, respectively, and negative cash flow from operating activities of $5,413,736 and $3,911,004, respectively.
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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.
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The Company is advancing a therapeutic pipeline targeting CNS disorders and rare diseases, while also expanding into the consumer longevity market with its Nugevia product line. Both efforts are powered by JOTROL™, Jupiter’s proprietary, enhanced resveratrol formulation that has demonstrated potential for improved bioavailability compared to standard resveratrol.
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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.” Business Overview The Company’s platform product, JOTROL, is an enhanced orally administered resveratrol formulation designed and intended to deliver therapeutically relevant, safe levels of resveratrol.
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The Company’s therapeutic development pipeline is focused broadly on CNS disorders, presently with a planned Phase IIa clinical study in Parkinson’s disease. The Company’s Nugevia product line brings clinical-grade science to the supplement space, supporting mental clarity, healthy-looking skin, and longevity. The Company completed preclinical studies at the University of Miami for Parkinson’s Disease in 2021.
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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. The present primary target for the Company is treatment of Parkinson’s Disease (PD).
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These studies used a validated mouse model to mimic human disease characteristics. 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.
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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”.
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The Company also aims to investigate other CNS indications, such as 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.
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The model of Parkinson’s Disease that was used in this preclinical study 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.
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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.
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We believe that results from this preclinical study 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 the process to start its first Phase II clinical trial in a patient population.
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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.
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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. We are also targeting the treatment of MCI/early Alzheimer’s Disease.
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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.
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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’.
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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.
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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. Alzheimer’s study.
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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.
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We presently have a pending grant application, $16.5 Million, for a Phase II trial in MCI/early Alzheimer’s Disease with the NIA. 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. We expect a decision on this grant application in May 2025.
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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. During 2025, the Company launched Nugevia, a premium line of longevity and performance supplements to support longevity, mental clarity and skin vitality.
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There is no guarantee that the application will be approved, and the trial will be put on hold if an approval is not awarded to the Company. A draft of the final study design is not yet determined but a draft synopsis is described in “Item 1.
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The Nugevia brand targets the growing consumer demand for science-backed wellness solutions, leveraging Jupiter’s proprietary JOTROL™ technology—a resveratrol-based platform with an improvement in bioavailability profile of resveratrol.
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Business - “ of this Annual Report on Form 10-K. 83 We have recently entered into service agreements in the areas of Business Development, CMC (Chemistry, Manufacturing, and Controls), regulatory affairs and clinical trial management with companies that has their main operation in Hong Kong.
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Nugevia’s initial product line features three core formulations, each targeting a major aspect of wellness and longevity: Product Name Focus Area Target Consumer Benefit GLO Skin beauty Support skin beauty and healthy appearance MND Cognitive performance Supports mental clarity, cognitive resilience PWR Mitochondrial and physical health Maintains energy, endurance, muscle recovery 72 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 therapies.
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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”.
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The debut products—GLO, MND, and PWR—are formulated to support wellness and longevity through synergistic ingredient combinations, all optimized for absorption via the JOTROL™ system. On October 24, 2025, the Company entered into a Standby Equity Purchase Agreement (the “SEPA”) and related Registration Rights Agreement with YA II PN, Ltd.
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In 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.
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(“Yorkville”), providing the Company the right, but not the obligation, to sell up to $20.0 million of common stock from time to time, subject to customary conditions, including an effective resale registration statement. In connection with the SEPA, Yorkville agreed to provide up to $6.0 million of pre-paid advances via convertible promissory notes.
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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.
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On October 27, 2025, the Company received $3,720,000 and issued a $4.0 million note (7% original issue discount, “OID”). A second $1,860,000 tranche was received in December 2025, upon registration effectiveness and receipt of stockholder approval, against a $2.0 million note (7% OID).
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Research and Development Expenses Research and development (“R&D”) expenses were $492,660 for the year ended December 31, 2024 compared to $954,793 for the year ended December 31, 2023. R&D expenses related to the federal grant were segregated in the chart of accounts from non-federal award costs.
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The notes bear interest at 8% (increasing to 18% upon default), mature on October 24, 2026, and are convertible at $1.50 per share, subject to proportional anti-dilution and price-protection adjustments (not below a contractual floor).
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At this time, we are not tracking R&D expenses per indication as all of the R&D expenses incurred to date related to JOTROL, which is the platform product used in each indication defined in our product pipeline.
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Beginning January 7, 2026, and monthly thereafter, the Company must repay one-tenth (1/10) of the then-outstanding principal plus accrued interest (a 5% premium applies to cash repayments). Installments may be satisfied via SEPA advances without the premium, and SEPA proceeds must be applied first to repay the notes until they are repaid in full.
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In addition, the probability of success for JOTROL will depend on numerous factors, including manufacturing capability, satisfactory results in follow on clinical trials, regulatory approvals and commercial viability. See “Risk Factors”. General and Administrative Expenses General and administrative expenses were $2,598,622 for the year ended December 31, 2024 compared to $2,915,978 for the year ended December 31, 2023.
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On February 20, 2026, the Company and Yorkville entered into an Omnibus Amendment (the “Amendment”). Among other changes, the Amendment revises the terms of the convertible promissory notes to defer the commencement of monthly installment payments to April 1, 2026, effectively providing an extension of approximately three months.

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