JUPITER NEUROSCIENCES, INC.
For the period ended Mar 31, 2025. Filed May 15, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 15, 2025
JUNS$2.20+3.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-12-23.
0001493152-24-051847
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0001641172-25-010990
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 85 previous paragraphs and 63 current paragraphs.
15 unchanged; 12 reworded; 35 added; 53 removed; 5 previous and 1 current paragraphs rearranged.
Tables are not compared: 8 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (35)
Current report
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Current report
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and related notes included in this Quarterly Report on Form 10-Q and the audited financial information and related notes included in our Annual Report on Form 10-K for fiscal 2024, which was filed with the Securities and Exchange Commission, or the SEC, on March 28, 2025, or the Annual Report.
Current report
Special Note Regarding Forward-Looking Statements
Current report
All statements other than statements of historical fact included in this Quarterly Report on Form 10-Q, including, without limitation, statements under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” regarding the Company’s financial position, business strategy and the plans and objectives of management for future operations, are forward-looking statements. When used in this Quarterly Report on Form 10-Q, words such as “anticipate,” “believe,” “estimate,” “expect,” “intend” and similar expressions, as they relate to us or the Company’s management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, the Company’s management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors detailed in our filings with the SEC.
Current report
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the financial statements and the notes thereto contained elsewhere in this Quarterly Report on Form 10-Q. 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.
Current report
Business Overview
Current report
We are a clinical stage research and development company. We have developed a unique resveratrol platform product primarily targeting treatment of neuro-inflammation. Our platform product, JOTROL, an enhanced oral formulation of resveratrol, has many potential indications of use for rare diseases. In the larger disease areas, we are primarily targeting Parkinson’s Disease and Mild Cognitive Impairment/early Alzheimer’s disease.
Current report
In December 2024, we received gross proceeds of $11 million, before deduction of underwriting discounts and other related expenses, 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. 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.”
Current report
Business Overview
Current report
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 of planning its first Phase II clinical trial in a patient population. This will be a Phase IIa study conducted with the assistance of Zina Biopharmaceuticals that is led by Dr. Charbel Moussa, MBBS,Ph.D. The study is expected to start in the third quarter of 2025 and have results available approximately 12 months thereafter.
Current report
In October 2024, we submitted an application for a $16.5 million grant from the NIA for a Phase II trial in MCI/early Alzheimer’s Disease. In May 2025, we learned that the application will not be approved. Therefore, studies focused on this indication will be paused until we receive biomarker results from our Phase 2a in Parkinson’s Disease. We expect that several of those biomarkers, particularly in cognition, will be used to further validate the use of JOTROL in Alzheimer’s Disease. This will enable us to determine the best path forward in MCI/early Alzheimer’s Disease.
Current report
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. 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.
Current report
For the three months ended March 31, 2025 and March 31, 2024, we have generated no revenues from product sales since inception and incurred net losses of $1,528,867 and $634,100, respectively, and had negative cash flow from operating activities of $1,063,041 and $65,165, respectively. As noted in the accompanying condensed consolidated financial statements, as of March 31, 2025, we had a working capital surplus of $1,721,604 and an accumulated deficit of $27,550,996. 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. 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” in our Form 10-K for fiscal 2024.
Current report
Three Months Ended March 31, 2025 Compared to the Three Months Ended March 31, 2024
Current report
Research and development (“R&D”) expenses were $466,745 for three months ended March 31, 2025 compared to $98,667 for three months ended March 31, 2024. The increase in research and development expenses was primarily driven by costs incurred under a three-year service agreement associated with product development and distribution efforts in the Southeast Asian market. The remainder of the increase relates to heightened R&D activities, specifically the procurement of clinical trial supplies for our Parkinson’s disease program.
Current report
General and administrative expenses were $1,071,258 for the three months ended March 31, 2025 compared to $472,028 for the three months ended March 31, 2024. The increase is due to employees receiving their full salaries in the current period compared to the prior period. In addition, there was an increase in legal and professional fees in the current period compared to the prior period as a direct result of the Company being listed on a public exchange. Lastly, the increase in general and administrative expenses is attributed to an increase in insurance expenses and consulting fees. This is a direct result of the Company expanding its operations in the current period compared to the prior period.
Current report
For the three months ended March 31, 2024, derivative liabilities were marked to market, and the resulting change in fair value of the derivative was recorded as a loss of $37,711. There were no derivative liabilities during the current period.
Current report
Net Cash Flows From Operating Activities:
Current report
Net cash used in operating activities during the three months ended March 31, 2025 was $1,063,041, as compared to net cash used in operating activities of $65,165. The increase in net cash used in operating activities was primarily related to the changes in our net loss.
Current report
Net Cash Flows From Investing Activities:
Current report
No net cash was provided by or used in investing activities for the three months ended March 31, 2025 and 2024.
Current report
Net Cash Flows From Financing Activities:
Current report
Net cash provided in financing activities during the three months ended March 31, 2025 was $0, as compared to net cash provided in financing activities of $45,000. The decrease in net cash provided was primarily related to no new financing being provided in the current period compared to the prior period.
Current report
Business Development Activities
Current report
The agreements executed are very similar in nature that include an equity investment in our Company by the other party and in turn we issued equity in the form of shares of common stock, in lieu of cash, for 3 years of services from each company.
Current report
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.
Current report
Contractual Obligations
Current report
We do not have any long-term capital lease obligations, operating lease obligations or long-term liabilities, except as follows:
Current report
Notes Payable to Related Parties and Other Transactions
Current report
The Company’s Chief Executive Officer (CEO) has loaned the Company working capital since inception. The balance of the loans to the CEO as of March 31, 2025 and December 31, 2024 and 2023 was $146,432, respectively. The loan is due on demand and accrues interest at 3% per year. Accrued interest relating to the loan was $2,147 and $1,064 as of March 31, 2025 and December 31, 2024, 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.
Current report
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. 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.
Current report
As of March 31, 2025 and December 31, 2024, $84,105 and $64,105, respectively, was due to a company wholly owned by the Company’s Chief Financial Officer. The amount is included in accrued compensation on the Company’s balance sheets.
Current report
Our accounting policies are more fully described in Note 2 – Significant accounting policies to our consolidated financial statements included as part of this Quarterly Report and our Annual Report on Form 10-K for fiscal 2024, filed with the SEC on March 28, 2025. As disclosed in Note 2, the preparation of financial statements in conformity with U.S. GAAP requires management to make substantial judgment or estimation in their application that may significantly affect reported amounts in the consolidated financial statements and accompanying notes. Actual results could differ significantly from those estimates. We believe the following discussion addresses our most critical accounting policies, which are those that are most important to the portrayal of our financial condition and results of operations and require management’s most difficult, subjective and complex judgments.
Current report
Off-Balance Sheet Arrangements
Current report
We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
Removed paragraphs (53)
Previous report
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited interim condensed financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included in this Quarterly Report on Form 10-Q, as may be amended, supplemented or superseded from time to time by other reports we file with the SEC. All amounts in this report are in U.S. dollars, unless otherwise noted.
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Throughout this Quarterly Report on Form 10-Q, references to “we,” “our,” “us,” the “Company,” or “Jupiter Neurosciences,” refer to Jupiter Neurosciences, Inc.
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Overview
Previous report
Jupiter Neurosciences, Inc. (the “Company”) is a clinical stage research and development pharmaceutical company located in Jupiter, Florida. The Company incorporated in Delaware in January 2016. The Company has developed a unique resveratrol platform product primarily targeting treatment of neuro-inflammation.
Previous report
The Company intends to follow the various opportunities closely with a particular focus on seeking available funding to accelerate research and development JOTROL’s Parkinson’s Disease indication. However, there is no assurance that such funding will ever become available or be awarded to the Company.
Previous report
We believe that a high dose of resveratrol is needed for therapeutic effects. Currently available resveratrol products are associated with severe gastrointestinal (GI) side effects at the dose levels we believe are needed. Our belief is based on available scientific literature, preclinical trial results conducted in mice and rats, and previously conducted human trials with resveratrol. We believe that JOTROL, based on the results from our Phase I trial, see section “Description of Business”, has the potential to deliver a therapeutically effective dose of resveratrol in the blood stream without causing gastrointestinal (GI) side effects. Based on our pre-clinical and Phase I study results, we expect that JOTROL will resolve “the major obstacle of resveratrol’s poor bioavailability” as discussed in AY Berman’s summary article in the Journal of Precision Oncology (AY Berman, 2017). Based on our own preclinical studies we believe that resveratrol has the ability to cross the blood-brain barrier. In studies conducted in Friedreich’s ataxia (FA) and Alzheimer’s disease (AD) patients, resulted in positive effects on oxidative stress, inflammation, and mitochondrial function. The FA study was concluded in Australia by Murdoch Children’s Research Institute in 2015 (Yiu et al.). The AD study was conducted in 2015 by the Alzheimer’s Disease Cooperative Study with Professor Raymond Turner, MD, Ph.D., Georgetown, as principal investigator (Turner et al.). Both studies have been published in scientific journals and further described in the section “Description of Business”.
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Since inception, we have operated with limited human capital, utilizing agreements with academia to get pre-clinical work executed at no cost, negotiating favorable deals for data already produced for resveratrol (e.g. toxicity studies and Phase II clinical study data), obtaining a full grant from the NIA for our first clinical trial and building a management and scientific consulting team (consisting of the Scientific Advisory Board and business advisors) as well as negotiating service agreements with companies to handle CMC, Regulatory work and Clinical trials in South-East Asia primarily compensated with equity securities of the company. We believe that this compensation method aligns the management, Scientific Advisory Board members and business advisors’ interests with the shareholders. We believe that our structure with a core management team that has experience in the utilization of outside resources makes it possible for us to efficiently execute several programs simultaneously in a cost-effective way.
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Resveratrol
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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 9,000 scientific publications. Several of these publications, including a summary paper by AY Berman.et al, published in Precision Oncology 2017, point to the issue of the poor bioavailability that has stopped medical utilization of regular resveratrol and never received regulatory approval for any indication. We believe that the Phase I study we have conducted indicates that we have resolved the poor bioavailability issue with JOTROL. Resveratrol (3,4′,5- trihydroxystilbene) is a nutraceutical that has recently attracted a lot of research attention due to its pharmacological potential. It is a phytoalexin found in many plants including grapes, peanuts, and berries. Resveratrol was first isolated in Veratrum grandiflorum, or white hellebore plant, in the 1940’s. Stilbene compounds are known for their ability to provide plants with resistance to microbial and fungal infection. Early research showed that resveratrol was present in large quantities in injured, infected, and ultraviolet-treated leaves. Processed plant products also contain a significant amount of resveratrol.
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Based upon available scientific literature, it appears that resveratrol is an activator of SIRT1, one of the mammalian forms of the sirtuin family of proteins. SIRT1 deacetylates histones and nonhistone proteins including transcription factors. The SIRT1-regulated pathway affects metabolism, stress resistance, cell survival, cellular senescence, inflammation/immune function, endothelial functions, and circadian rhythms. Resveratrol has been documented in scientific literature to activate SIRT1, NrF2, NLR3P inflammasomes and have an epigenetic mechanism and therefore is predicted to benefit diseases affected by abnormal metabolic control, inflammation, and cell cycle defects. Nonetheless, resveratrol application is a major challenge for the pharmaceutical industry, due to its poor solubility and bioavailability, as well as adverse effects, such as severe gastro-intestinal side effects when taken at effective dose levels (over 2,000 mg daily). In this context, studies have proposed that structural changes in the resveratrol molecule, including glycosylation, alkylation, halogenation, hydroxylation, methylation, and prenylation could lead to the development of derivatives with enhanced bioavailability and pharmacological activity. Resveratrol has never been developed with all the necessary steps to achieve an approval as a pharmaceutical product since the existing natural supplements cannot provide high enough levels of resveratrol in blood plasma to be able to provide a therapeutically effective dose without generating severe gastro-intestinal side effects. This means that we need to take JOTROL™ through the full regulatory NDA (New Drug Application) requirement to obtain a prescription marketing approval in the USA.
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Resveratrol holds a significant place in Traditional Chinese Medicine (TCM) due to its potent antioxidant and anti-inflammatory properties. In TCM, resveratrol-rich plants, such as the root of Polygonum cuspidatum (commonly known as Hu Zhang), have been used for centuries to treat a variety of ailments. The compound is prized for its ability to combat oxidative stress and inflammation, which are underlying factors in many chronic diseases. This aligns with the TCM principle of restoring balance and harmony within the body to maintain health and prevent disease. Resveratrol’s role in TCM extends to supporting cardiovascular health, boosting immune function, and even exhibiting anti-aging properties, making it a versatile and valuable component of the medicinal repertoire.
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The growing body of scientific research on resveratrol has further cemented its importance in TCM by providing a modern understanding of its mechanisms and potential therapeutic benefits. Studies have shown that resveratrol can modulate various molecular pathways, including those involved in cell survival, apoptosis, and inflammation, which are crucial in the management of conditions such as cardiovascular diseases, neurodegenerative disorders, and cancers. This scientific validation supports TCM practitioners in integrating resveratrol into their treatment protocols, enhancing the credibility and acceptance of traditional remedies. Additionally, the compound’s ability to improve metabolic health and its neuroprotective effects are particularly relevant in addressing the rising prevalence of metabolic syndrome and cognitive decline in aging populations. As research continues to unveil the full spectrum of resveratrol’s benefits, its integration into TCM practices is likely to increase, further bridging the gap between ancient wisdom and contemporary medicine.
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The Traditional Chinese Medicine (TCM) market is experiencing several technological trends that are transforming how traditional remedies are developed, delivered, and integrated with modern healthcare practices. These advancements are helping to increase the efficacy, accessibility, and acceptance of TCM. Below are some of the key technological trends in the TCM market:
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(source Emergn Research, Global TCM Market, Forecast to 2033).
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JOTROL
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JOTROL was developed together with our technology partner Aquanova AG, Darmstadt, Germany. JOTROL is formulated with a unique patented micellar technology that is projected to increase the bioavailability profile of resveratrol. Manufacturing technology transfers were completed in 2017 and manufacturing procedures and clinical trial supply manufacturing has been completed at Catalent Pharmaceutical Services, Inc., St Petersburg, Florida.
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JOTROL is a micellar non-aqueous solution of resveratrol delivered in a softgel capsule. Each capsule includes 100mg of resveratrol. Pre-clinical trials in mice and rats were conducted comparing JOTROL to micronized resveratrol, labeled to have the highest bioavailability in the nutritional market, to demonstrate that we could achieve a significantly higher bioavailability. Summary details of these studies are included in the section “Description of Business”. A Phase I dose finding pharmacokinetic (“PK”) study in healthy volunteers was completed during the first half of 2021. The study results met our targeted goals. The results from this study will be used as a cross-reference for all indications where JOTROL will be used in Phase II and Phase III clinical trials. The Phase I results and the FDA guidance of cross-referencing is further described in the section “Description of Business”. The Company has not discussed the use of cross-referencing in this manner with the FDA or other comparable regulatory authorities.
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Three Months Ended September 30, 2024 Compared to Three Months Ended September 30, 2023
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We intend to apply for additional federal grants through the Small Business Innovation and Research programs through the National Institute of Health (“NIH”). 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. 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. We have since submitted 3 grant applications, with budgets of $20 M or higher, to the NIA for full funding of such Phase II trial but none of those applications were successful. After discussions with the NIA, we have decided to apply, in September of 2024, for a much smaller grant, $2.5 million, for a Proof of Concept study focusing on JOTROL’s effect on validated biomarker. The final study design is not yet determined but a draft synopsis is described in the section “Description of Business”. There is no guarantee that this and future grant applications will be successful and therefore the rejection of our future grant application may significantly delay the Company’s plans in connection with MCI and Alzheimer’s and may have a significant impact on the Company’s financial performance. We intend to apply for Phase IIB for clinical trial related to Orphan diseases. Phase IIB grants may fund 50% of clinical trial expenses over three years, not to exceed approximately $2,500,000 per year for a maximum of three years. However, those limits may be adjusted annually at the discretion of the Small Business Administration. We recognize there is no guarantee of future federal grant funding and that might have an impact on our possibility to conclude our planned MCI/early Alzheimer’s disease project.
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Research and development (“R&D”) expenses were $91,911 for the three months ended September 30, 2024 compared to $239,458 for the three months ended September 30, 2023. The decrease is primarily due to the reduction of employee salaries that began in December 2023.
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General and administrative expenses were $401,636 for the three months ended September 30, 2024 compared to $1,202,669 for the three months ended September 30, 2023. The decrease is primarily due to the reduction of employee salaries that began in December 2023.
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Loss on Extinguishment of Debt and (Loss)
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During 2024 and 2023, the Senior Secured Convertible Note were 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. This resulted in a loss on extinguishment of debt in the three month ended September 30, 2024 and 2023 of $0 and $217,527, respectively.
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Nine Months Ended September 30, 2024 Compared to Nine Months Ended September 30, 2023
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Revenue and Federal Awards
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We intend to apply for additional federal grants through the Small Business Innovation and Research programs through the National Institute of Health (“NIH”). 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. 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. We have since submitted 3 grant applications, with budgets of $20 M or higher, to the NIA for full funding of such Phase II trial but none of those applications were successful. After discussions with the NIA, we have decided to apply, in September of 2024, for a much smaller grant, $2.5 million, for a Proof of Concept study focusing on JOTROL’s effect on validated biomarker. The final study design is not yet determined but a draft synopsis is described in the section “Description of Business”. There is no guarantee that this and future grant applications will be successful and therefore the rejection of our future grant application may significantly delay the Company’s plans in connection with MCI and Alzheimer’s and may have a significant impact on the Company’s financial performance. We intend to apply for Phase IIB for clinical trial related to Orphan diseases. Phase IIB grants may fund 50% of clinical trial expenses over three years, not to exceed approximately $2,500,000 per year for a maximum of three years. However, those limits may be adjusted annually at the discretion of the Small Business Administration. We recognize there is no guarantee of future federal grant funding and that might have an impact on our possibility to conclude our planned MCI/early Alzheimer’s disease project.
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Research and Development Expenses
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Research and development (“R&D”) expenses were $291,655 for the nine months ended September 30, 2024 compared to $710,063 for the nine months ended September 30, 2023. The decrease is primarily due to the reduction of employee salaries that began in December 2023.
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General and Administrative Expenses
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General and administrative expenses were $1,341,271 for the nine months ended September 30, 2024 compared to $2,625,066 for the nine months ended September 30, 2023. The decrease is primarily due to the reduction of employee salaries that began in December 2023.
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Interest Expense
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Interest expense was $ 217,821 for the nine months ended September 30, 2024 compared to $160,322 for the nine months ended September 30, 2023. Interest expense is primarily attributable to interest expense associated with our previously outstanding notes payable, convertible notes payable and related amortization of the debt discount, notes payable to Chief Executive Officer, Christer Rosén, and interest expense on our corporate credit card. The increase is mainly attributed to the increase in the interest rate associated with the notes as agreed upon in January 2024.
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Loss on Extinguishment of Debt and (Loss)
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During 2024 and 2023, the Senior Secured Convertible Note were 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. This resulted in a gain (loss) on extinguishment of debt in the nine month ended September 30, 2024 and 2023 of $951,868 and $(887,946), respectively.
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As of September 30, 2024, we had cash and cash equivalents of $253. Our cash equivalents are held in high yield savings account. Since inception, we have incurred net losses and negative cash flows from operations. On September 30, 2024, we had an accumulated deficit of $24,494,502.
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On December 4, 2024, the Company closed on an offering in which we sold 2,750,000 shares of Common Stock to the underwriters for total gross proceeds of $11,000,000. After deducting the underwriting commissions, discounts, and offering expenses payable by the Company, the Company received net proceeds of approximately $9.5 million.
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Management expects operating losses to continue for the foreseeable future. As we continue to incur losses, a transition to profitability is dependent upon the successful development, approval and commercialization of our drug candidate and the achievement of a level of revenues adequate to support our cost structure. We will continue to require additional capital to develop our drug candidate and fund operations for the foreseeable future. We may seek to raise capital through private or public equity or debt financings, collaborative or other arrangements with other companies, or through other sources of financing. Adequate additional funding may not be available to us on acceptable terms, or at all.
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Net Cash from Operating Activities:
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Cash used in operating activities during the nine months ended September 30, 2024, decreased $104,591 from September 30, 2023, mainly attributable to a decrease of $158,019 in stock-based compensation, $1,356,960 in accrued compensation, and $86,384 in accounts payable and accrued expenses, offset by a $1,798,673 in changes associated with debt (amortization of debt discounts, loss on extinguishment of debt, and gain/loss on change in fair value of derivative liabilities).
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Net Cash Provided by Financing Activities:
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Reworded paragraphs (12)
Previous wording
The product, called JOTROL, has many potential indications of use for rare diseases, which of we primarily are targeting 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.
Current wording
The Company’s platform product, JOTROL, is an enhanced orally administered resveratrol formulation designed and intended to deliver therapeutically relevant, safe levels of resveratrol. This platform has many potential indications of use for rare diseases, which include Mucopolysaccharidoses Type 1, Friedreich’s ataxia and MELAS. In the larger disease areas, we are primarily targeting Parkinson’s Disease and Mild Cognitive Impairment/early Alzheimer’s disease.
Previous wording
The Company has recently completed preclinical activities in a validated mouse model of Parkinson’s Disease (PD) at the University of Miami. The model of PD that was used mimics many aspects of the disease utilizing a unilateral injection of a neurotoxin precursor that elicits nigral cell loss, striatal dopamine loss and behavior deficits similar to physiological characteristics of human disease. We believe that results from this trial indicates that PD might be the best target for treatment among the multiple indications where JOTROL might play a role. The trial design and outcomes are further described section “Description of Business”. On May 23, 2024 the US Senate unanimously passed theNational Plan to End Parkinson’s Act, the first-ever federal legislation dedicated to ending Parkinson’s disease. A cross-country strategy to end Parkinson’s and atypical parkinsonism has the potential to:
Current wording
The present primary target for the Company is treatment of Parkinson’s Disease (PD). The Company completed preclinical activities in a validated mouse model of Parkinson’s Disease (PD) at the University of Miami in 2021. 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.
Previous wording
In 2020, we received approval for full funding, $1.76 million, for our Phase I study from the National Institute on Aging (“NIA”). 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. 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. 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. 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. 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. A score of 40 or below is necessary for being considered for funding. After discussions with the NIA, we have decided to apply, in September of 2024, for a much smaller grant, $2.5 million, for a Proof of Concept study focusing on JOTROL’s effect on validated biomarker. The final study design is not yet determined but a draft synopsis is described in the section “Description of Business”. There is no guarantee that this and future grant applications will be successful and therefore the rejection of our future grant application may significantly delay the Company’s plans in connection with MCI and Alzheimer’s and may have a significant impact on the Company’s financial performance. Further, the Company may never receive any future grants or costs savings. The Company continues to apply for grants opportunistically and on August 12, 2022, submitted a $10.1 million grant to the Department of Defense for a Phase II Friedreich’s Ataxia study. This study planned to assess the efficacy of JOTROL as a potential treatment for FA through a randomized, blinded, placebo-controlled clinical trial. On December 30 the Company received notification that the application was not recommended for funding. The grounds for denial were the weaknesses noted in the peer review summary statement specifically concerning clinical impact and research strategy and feasibility. Reata Pharmaceuticals has recently received an approval for their product, Omaveloxolone, for treatment of …
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Current wording
We are also targeting the treatment of MCI/early Alzheimer’s Disease. We received funding of $2.2 million from the National Institute of Aging (“NIA”) in in 2020 and 2022 from a grant application for a Phase 1 study for Mild Cognitive Impairment/ Alzheimer. In the NIA scientific review summary statement of our Phase I study application, it is stated that the NIA is looking forward to a Phase II study with an enhanced resveratrol product, based on the earlier study results from the well published Turner et al. Alzheimer’s study.
Previous wording
We have over the past 2 years received a strong interest in JOTROL from various Asian organizations. We believe that this interest has been triggered, in part, by (i) resveratrol becoming commonly used in Asian herbal medicines as a therapeutic strategy as described in available scientific literature published by PubMed Central: PMCID: PMC7498443 (September 2020), (ii) Hong Kong’s and China’s recent approval of the patent for JOTROL, (iii) China releasing a list of approximately 120 rare disease indications issued jointly by five national bodies, including the National Health Commission, Ministry of Science and Technology, Ministry of Industry and Information Technology, State Drug Administration, and State Administration of Traditional Chinese Medicine (May 2018), that we believe JOTROL can be applicable as a treatment for MPS-1 and MELAS in this population and (iv) recent publications regarding JOTROL in the Journal of Alzheimer’s Disease and AAPS Open (Journal of Alzheimer’s Disease 86 (2022) 173–190 February 2022; Kemper et al. AAPS Open June 2022). (v) the projected increase of the TCM market due to several factors which of one is reformulation of existing compounds. Our Chairman & CEO, Christer Rosén, presented in person, our company’s status and pipeline at the BIOHK 2023 in Hong Kong in September of 2023. The presentation led to several follow-on meetings, and we have therefore recently agreed to service agreements in the areas of CMC (Chemistry, Manufacturing, and Controls), regulatory affairs and clinical trial management. These agreements are with companies that, we believe, have the knowledge and network in the South-East Asian market to accelerate steps that is needed to have a product that can have treatment value in the territory. In addition, we are planning to use some of the IPO proceeds to engage a partner in business development in the South-East Asian market since we believe that this will increase the potential of an out-licensing deal within the near future. The agreements are further described in the section “Other Material Agreements”. In addition, we are in active negotiations with Dominant Treasure Health (“DTH”), a BVI company. DTH has demonstrated to us, through several company introductions, that they have business relationships, either directly or through affiliates, with many South-East Asian pharmaceutical companies as well as companies involved in distribution and sales of TCM, Traditional Chinese Medicine. We are therefore planning to engage DTH in active business development in China, Malaysia and Singapore as soon as we have financing in place for their engagement. 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 corpo…
Excerpt shortened here; the source contains the full paragraph.
Current wording
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. 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.
Previous wording
R&D expenses related to the federal grant were segregated in the chart of accounts from non-federal award costs. 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. Costs will be segregated amongst the different indications beginning next fiscal year.
Current wording
R&D expenses related to the federal grant were segregated in the chart of accounts from non-federal award costs. 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.
Previous wording
Interest expense was $ 107,382 for the three months ended September 30, 2024 compared to $80,610 for the three months ended September 30, 2023. Interest expense is primarily attributable to interest expense associated with our previously outstanding notes payable, convertible notes payable and related amortization of the debt discount, notes payable to Chief Executive Officer, Christer Rosén, and interest expense on our corporate credit card. The increase is mainly attributed to the increase in the interest rate associated with the notes as agreed upon in January 2024.
Current wording
Interest expenses were $1,229 for the three months ended March 31, 2025, compared to $65,756 for the three months ended March 31, 2024. 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, and interest expense on our corporate credit card. The decrease in interest expense is directly attributed to the conversion and repayment of our convertible notes in prior periods; therefore, no new interest expense is being incurred in the current period.
Previous wording
As of September 30, 2024 and 2023 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 gain (loss) of $9,885 and ($34,086), in the three month ended September 30, 2024 and 2023, respectively.
Current wording
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 of $37,711 for the three months ended March 31, 2024. There were no derivative liabilities during the current period.
Previous wording
We have historically financed our operations primarily through the sale of common stock and convertible debt. On April 11, 2022, we issued a senior secured convertible note in the principal amount of $1,111,111 in exchange for $1,000,000 as described above under “Description of Business – Corporate History.”
Current wording
Historically, we have financed our operations primarily by selling common stock and convertible debt. 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 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. On April 11, 2022, we issued a senior secured convertible note in the principal amount of $1,111,111 in exchange for $1,000,000, which was paid down with the proceeds from the initial public offering.
Previous wording
For the fiscal years ended December 31, 2023 and 2022, we generated no revenues from product sales and reported net losses of $4,783,689 and $4,957,580 respectively, and negative cash flow from operating activities of $480,953 and $1,248,504, respectively. For the nine months ended September 30, 2024 and 2023, we generated no revenues from product sales and reported net losses of $911,998 and $4,354,044, respectively, and negative cash flow from operating activities of $215,225 and $319,816, respectively. As noted in our financial statements, as of September 30, 2024, we had an accumulated deficit of $24,494,502.
Current wording
For the three months ended March 31, 2025 and March 31, 2024, we generated no revenues from product sales and reported net losses of $1,528,867 and $634,100, respectively, and negative cash flow from operating activities of $1,063,041 and $65,165, 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 financings.
Previous wording
See “Risk Factors” for additional risks associated with our capital requirements.
Current wording
See “Risk Factors” included herein and in our 2024 Annual Report on Form 10-K for fiscal 2024 filed with the Securities and Exchange Commission (the “SEC”) on March 28, 2025 for additional discussion of risks associated with our capital requirements.
Previous wording
Cash Flows for the Nine Months Ended September 31, 2024 and 2023
Current wording
Cash Flows for the Three Months Ended March 31, 2025 and 2024
Previous wording
The following table shows a summary of our cash flows for the nine months ended September 30, 2024 and 2023.
Current wording
The following table shows a summary of our cash flows for the three months ended March 31, 2025 and 2024.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
The Company initiated business development activities in the Asian region in 2021. The Company has a strong strategic interest in accelerating the drug development and potential commercialization efforts of JOTROL in this market. Our Chairman & CEO, presented in person, our company’s status and pipeline at the BIOHK 2023 conference in Hong Kong in September of 2023. The presentation led to several follow-on meetings, and we have recently agreed to service agreements in the areas of business development, CMC (Chemistry, Manufacturing, and Controls), regulatory affairs and clinical trial management. 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.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
There was no revenue from product sales during the nine months ended September 30, 2024 or 2023 as we are focused on research and development.
Previous report — wording carried elsewhere
R&D expenses related to the federal grant were segregated in the chart of accounts from non-federal award costs. 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. Costs will be segregated amongst the different indications beginning next fiscal year.
Previous report — wording carried elsewhere
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”.
Previous report — wording carried elsewhere
Loss on Change in Fair Value of Derivative Liability
Previous report — wording carried elsewhere
As of September 30, 2024 and 2023 the variable conversion options embedded in our convertible notes was marked to market and the change in fair value of the derivative was recorded as a loss of $53,257 and $15,458, in the nine month ended September 30, 2024 and 2023, respectively.