Jupiter Neurosciences (NASDAQ: JUNS) Signs Definitive Agreement for Exclusive U.S. Rights to ALA-002 in Transaction Valued at Up to $100 Million

Transaction expands Jupiter into a dual clinical-stage CNS company by adding a differentiated FDA-designated Novel Chemical Entity alongside its Phase II Parkinson’s disease program

JUPITER, FL, July 21, 2026 (GLOBE NEWSWIRE) -- Jupiter Neurosciences, Inc. (NASDAQ:JUNS) today announced that it has entered into a definitive license agreement with PharmAla Biotech Holdings Inc. for perpetual exclusive U.S. rights to ALA-002. The transaction has a potential value of up to $100 million, including milestone payments, and expands Jupiter from a single-program company into a dual clinical-stage CNS developer. Management believes the transaction strengthens the Company through diversification across two-clinical-stage CNS assets; expanding its portfolio to include both its natural resveratrol program and a Novel Chemical Entity; near term clinical milestones; and long-term participation in U.S commercialization opportunity through perpetual exclusive rights.

Transaction Highlights

• Deal Value: Up to $100M (including milestone payments; exclusive of ongoing royalties)
• Upfront Payment: $3.3M ($1.5M cash + $1.8M JUNS common stock, 120-day lock-up)
• Development Milestone: $3.3M upon Phase 3 First Patient In
• Regulatory Milestone: $20M upon U.S. NDA Approval
• Commercial Milestones: $10M / $30M / $33.3M at $333M / $1B / $2B cumulative U.S. net sales
• Royalty: 3% of net sales (commencing after third commercialization milestone)
• Asset: ALA-002 — FDA NCE-designated, non-racemic MDMA (patented)
• Rights Granted: Perpetual, exclusive to United States
  
  
  
  

About ALA-002

ALA-002 is a patented, non-racemic MDMA formulation that has received Novel Chemical Entity (NCE) designation from the U.S. Food and Drug Administration (FDA), providing enhanced regulatory protection and a five-year data exclusivity period upon approval. ALA-002 has been engineered to deliver materially improved cardiovascular safety and reduced abuse liability compared to racemic MDMA while preserving the pro-social and therapeutic properties central to MDMA-assisted psychotherapy. PharmAla’s MDMA supply is currently active in U.S. government-sponsored VA and DHA clinical trials. ALA-002 targets a U.S. psychedelic therapeutics market estimated at $3 B in 2024 and growing to $8 B by 2030 (source: Strategic Market Research), addressing millions of Americans living with treatment-resistant PTSD, anxiety, and related neuropsychiatric conditions.

GMP Drug Supply

PharmAla is a globally recognized manufacturer and supplier of MDMA for clinical use, with supply contracts for clinical trials on 3 continents, and serving such institutions as the US Veterans Affairs Administration and several Ivy League universities. Under the terms of the Definitive Agreement, PharmAla will continue to manufacture ALA-002 drug product for Jupiter under commercial terms to be negotiated, greatly accelerating Jupiter’s development timelines.

Executive Order and Regulatory Alignment

On April 18, 2026, President Donald J. Trump signed a landmark Executive Order titled "Accelerating Medical Treatments for Serious Mental Illness," directing the FDA and DEA to expand access to investigational psychedelic therapies. Key provisions include: a Right to Try pathway for eligible patients; Commissioner’s National Priority Vouchers enabling 1–2 month expedited FDA review timelines for psychedelic drugs with Breakthrough Therapy designation; and $50M in federal funding through ARPA-H for state and federal psychedelic medicine programs. Jupiter’s acquisition of exclusive U.S. rights to ALA-002 directly leverages this regulatory acceleration, which management believes may allow the Company to benefit from an evolving regulatory environment intended to accelerate development of eligible psychedelic therapeutics.

Management Commentary

"This agreement significantly expands our CNS strategy by adding a differentiated clinical-stage asset that complements our Parkinson's disease program. We believe ALA-002 addresses a large unmet medical need and provides Jupiter with a second independent development opportunity. Our focus is now disciplined clinical execution, prudent capital allocation and advancing both programs toward meaningful value-creating milestones, while recognizing the inherent risks of clinical development." — Christer Rosén, Chairman and Chief Executive Officer, Jupiter Neurosciences

— Christer Rosén, Chairman and Chief Executive Officer, Jupiter Neurosciences

"This agreement broadens our strategic reach in CNS and brain plasticity while strengthening our shareholders’ equity and establishing a clear path to build long-term value through disciplined clinical and regulatory execution in the United States. We’ve spent the past few months aligning strategy and mobilizing for execution in the space of psychedelic medicines, exemplified by the two new experts we have brought onto our Board of Directors. Drs. Tomas Philipson and Andrew Cutler. The next 12 months will be transformative for Jupiter.: ."

— Alison Silva, President and Chief Business Officer, Jupiter Neurosciences

"PharmAla developed ALA-002 with the goal of delivering a greatly improved MDMA-based therapeutic candidate, with an improved safety profile, for patients who need better treatment options for a range of neuropsychiatric disorders. While PharmAla will continue to advance ALA-002 outside of the United States, Jupiter’s focus on CNS disorders and its commitment to advancing innovative brain therapies in the United States make this a strong strategic fit for both companies."

— Nicholas Kadysh, Founding Chief Executive Officer, PharmAla Biotech Holdings Inc.

About Jupiter Neurosciences, Inc.

Jupiter Neurosciences, Inc. (NASDAQ:JUNS) is a clinical-stage biopharmaceutical company advancing a therapeutic pipeline targeting central nervous system disorders and neuroinflammation. The Company’s present lead program, JOTROL^™ — a proprietary, enhanced-bioavailability resveratrol formulation — is currently in a Phase IIa clinical trial for Parkinson’s disease. JUNS also commercializes Nugevia^™, a consumer longevity supplement. The acquisition of exclusive U.S. rights to ALA-002 further strengthens the Company’s CNS pipeline by adding a next-generation, patented psychedelic NCE at a pivotal moment in U.S. regulatory policy. For more information, visit www.jupiterneurosciences.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding the expected benefits of the Agreement, the closing of the transaction, the issuance of shares of JUNS common stock, the potential development, regulatory approval, commercialization, market opportunity, safety profile, abuse-liability profile, data exclusivity, and therapeutic potential of ALA-002, the potential achievement and timing of milestone payments and royalties, Jupiter’s ability to fund and execute development and commercialization activities, the availability or applicability of regulatory pathways or federal initiatives for investigational psychedelic therapies, and the potential impact of the April 18, 2026 Executive Order on Jupiter, ALA-002, or the psychedelic medicine sector. These statements are based on current expectations and assumptions and are subject to substantial risks and uncertainties, including risks relating to the satisfaction of closing conditions, Jupiter’s reliance on PharmAla and other third parties, the early-stage and investigational nature of ALA-002, unexpected safety or efficacy data, clinical trial timing, site activation and enrollment, regulatory review and approval, DEA scheduling, intellectual property protection, market acceptance, competition, Jupiter’s capital requirements and ability to obtain additional financing, and the other risks described under "Risk Factors" in Jupiter’s filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date of this press release, and Jupiter undertakes no obligation to update or revise them except as required by law.

Investor Relations Contact

Jupiter Neurosciences, Inc.

ir@jupiterneurosciences.com

Tel: +1 561 406 6154

c.rosen@jupiterneurosciences.com

a.silva@jupiterneurosciences.com

SOURCE: Jupiter Neurosciences, Inc.

© 2026 Jupiter Neurosciences, Inc. All rights reserved. JOTROL^™ and Nugevia^™ are trademarks of Jupiter Neurosciences, Inc. LaNeo^™ is a trademark of PharmAla Biotech Holdings Inc.