Jupiter Neurosciences, Inc. is a clinical research and development pharmaceutical company that has developed a unique resveratrol platform product primarily targeting treatment of neuro-inflammation. (Incorporated in Delaware)

The product candidate, called 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.

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.

Our product candidate, JOTROL,  has many potential indications of use for rare diseases. We are primarily 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. Recent developments are guiding us to focus strongly on Parkinson’s Disease as well as development of our product in the South-East Asian market.

We currently plan to use the net proceeds from this offering, together with our existing resources, 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 advance the manufacturing of JOTROL clinical trial supplies.

We have several pre-clinical trials and one completed Phase I clinical trial to evaluate the safety and tolerability of JOTROL in healthy volunteers. Subsequent to this offering, we will prepare for Phase II clinical trials. This will be our first clinical efficacy trial, and JOTROL has not previously been tested in humans with a specific disease although we can rely on data that exist for resveratrol.

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 solution among the multiple indications where JOTROL might play a role. The trial design and outcomes are further described in the section “Description of Business”. On May 23, 2024, the U.S. Senate unanimously passed the National Plan to End Parkinson’s Act, the first federal legislation dedicated to ending Parkinson’s Disease.

We have over the past two 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, (iv) recent publications regarding JOTROL in the Journal of Alzheimer’s Disease and AAPS Open (Journal of Alzheimer’s Disease 86 (2022) 173–190 February 2022; Kemper et al. AAPS Open June 2022), and (v) the projected increase of the Traditional Chinese Medicine (“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 needed to have a product that can have treatment value in the territory.

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.

In 2020, we received approval for full funding, $1.76 million, for our Phase I study from the National Institute on Aging (“NIA”). We plan to continue pursuing grant funding opportunities in all areas where they are available, such as Phase II and Phase III trials in Alzheimer’s disease as well as any funding available for our rare disease projects.

**Note: Net loss and revenue figures are for the 12 months that ended June 30, 2024.

(Note: Jupiter Neurosciences, Inc. priced its small-cap IPO at $4.00 – as expected – and sold 2.75 million shares – the number of shares in the prospectus – to raise $11.0 million on Monday, Dec. 2, 2024, after the closing bell.)

(Note: Jupiter Neurosciences, Inc. named Dominari Securities as a joint book-runner in the lead left position on the prospectus – to work with Revere Securities – in an S-1/A filing dated Sept. 3, 2024.)

(Note: Jupiter Neurosciences, Inc. increased its IPO’s size to 2.75 million shares – up from 2.61 million shares – and lowered the assumed IPO price to $4.00 – the low end of the price range of $4.00 to $5.00 – to raise $11.0 million, according to an S-1/A filing dated July 12, 2024. This mid-July 2024 SEC filing named Revere Securities as the sole book-runner – replacing Spartan Capital.)

(Note: On Jan. 6, 2023, Jupiter Neurosciences, Inc. filed an S-1/A updating its financial statements through Sept. 30, 2022, and keeping its terms the same as in its Dec. 2, 2022, SEC filing: 2.61 million shares at $5.75 to raise $15.0 million. On Dec. 2, 2022, Jupiter Neurosciences filed an S-1/A revising its IPO by increasing the number of shares to 2.61 million shares (2,608,695 shares) from 2.5 million shares and stipulating an assumed IPO price of $5.75, below the mid-point of its previous range of $5.00 to $7.00, to raise $14.99 million.)

(Note: On Sept. 20, 2022, Jupiter Neurosciences, Inc.’s IPO was postponed due to NASDAQ – just ahead of its expected pricing that night. The pricing date changed to “TBA”. A week earlier, on Sept. 13, 2022, the deal’s timing was moved back a week, “due to market conditions,” following the U.S. stock market’s plunge after shocking U.S. CPI data for August 2022.)

(Background: On Aug. 16, 2022, Jupiter Neurosciences changed underwriters – to Spartan Capital as the sole book-runner – and revamped its IPO to a stock-only deal, dropping the warrants. The new terms: 2.5 million shares at $5.00 to $7.00 to raise $15.0 million, with the proposed stock symbol “JUNS” on the NASDAQ. On Aug. 26, 2022, Jupiter Neurosciences updated its S-1/A filing. **A 1-for-2 reverse stock split was effective Jan. 25, 2022; All share and per-share information in the prospectus have been adjusted to account for that event. Background: This IPO’s previous joint book-runners were Roth Capital and Dawson James Securities.)

(Note: Jupiter Neurosciences, Inc., revived its IPO – postponed on Thursday, Feb. 10, 2022, due to market conditions – in an S-1/A filing dated April 26, 2022. Background: The unit IPO had been tentatively scheduled for pricing after the close on Feb. 10, 2022. Previously: Jupiter Neurosciences cut the size of its unit IPO to 2.2 million units, down from 3.33 million units, and increased the price range to $6.00 to $8.00, up from $5.00 to $7.00, in an S-1/A filing dated Jan. 26, 2022. Each unit consisted of one share of common stock and one warrant to buy one share of common stock. Background: The S-1 was filed Oct. 12, 2021.)