Methylenedioxymetamfetamine

TORONTO, July 21, 2026 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTCQB: MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), is pleased to announce that it has entered into a definitive license agreement (the “Agreement”) on July 20th, 2026 with Jupiter Neurosciences, Inc. (NASDAQ: JUNS) (“Jupiter”), under which PharmAla has granted Jupiter an exclusive, perpetual, royalty-bearing license to develop, manufacture and commercialize ALA-002, PharmAla’s lead drug candidate, in the United States. PharmAla retains all rights to ALA-002 outside the United States and will continue to advance the molecule internationally. Under the Agreement, the total consideration payable to PharmAla is up to approximately US$100 million, consisting of a US$3,333,333 upfront payment and up to US$96,666,666 in contingent development, regulatory and commercialization milestone payments, plus royalties on all future U.S. net sales following the conclusion of milestone payments. The milestone payments and royalties are contingent on the achievement of specified development, regulatory and sales events, which may not be achieved. Key Terms of the Agreement Rights granted: Exclusive, perpetual license to develop, manufacture and commercialize ALA-002 in the United States. PharmAla retains all rights outside the United States.Upfront payment: US$3,333,333, comprising US$1,500,000 in cash and US$1,833,333 in Jupiter common stock, subject to a 120-day lock-up and customary Nasdaq and U.S. securities-law limitations.Development and regulatory milestones: Up to US$23,333,333, including US$3,333,333 on first patient dosing in a Phase 3 clinical trial and US$20,000,000 on FDA approval of a New Drug Application for a licensed product.Commercialization milestones: Up to US$73,333,333, payable on first achievement of US$333.3 million, US$1.0 billion and US$2.0 billion in cumulative U.S. net sales (US$10 million, US$30 million and US$33.3 million, respectively).Royalty: 3% of U.S. net sales of licensed products, commencing after the third commercialization milestone.Manufacturing and supply: PharmAla has committed to manufacturing a supply of GMP-grade ALA-002 drug product to Jupiter under a separate supply agreement to be negotiated on commercial terms. “This Agreement is a landmark transaction for PharmAla and its shareholders. It delivers near-term capital, meaningful milestone and royalty participation, and a dedicated U.S. development partner in Jupiter, all while PharmAla retains full ownership of ALA-002 outside the United States,” said Nick Kadysh, Founding CEO, PharmAla Biotech. “We developed ALA-002 to deliver an improved MDMA-based therapeutic candidate for patients who need better treatment options across a range of neuropsychiatric disorders. Jupiter’s focus on central nervous system disorders and its commitment to advancing innovative brain therapies in the United States make this a strong strategic fit, and allow us to concentrate our own resources on advancing ALA-002 and our broader MDXX pipeline in the rest of the world.” “Structuring this transaction as an out-license of U.S. rights allows PharmAla to unlock value from ALA-002 without diluting our interest in the asset elsewhere, and without taking on the full cost of U.S. clinical development,” said Will Avery, CFO, PharmAla Biotech. “The upfront payment, potential milestones and ongoing royalty are intended to support the Company’s continued growth as we pursue our clinical and manufacturing strategy – and the development diligence elements of the agreement give us confidence that Jupiter will continue to meaningfully advance the asset.” “This partnership with PharmAla is exactly the kind of high-conviction, strategically aligned transaction we have been working toward,” said Christer Rosén, Chairman and Chief Executive Officer of Jupiter Neurosciences. “PharmAla has established itself as a world-class developer and manufacturer of next-generation MDXX therapeutics, and ALA-002 — a patented MDMA formulation with FDA New Chemical Entity designation — is precisely the type of differentiated asset that can define a company. Most importantly, this deal is genuinely transformative: Jupiter now holds two independent clinical-stage programs across two distinct CNS sectors — JOTROL™ targeting neurodegeneration in Parkinson’s disease, and ALA-002 targeting neuropsychiatric disorders — two areas where patients have waited far too long for meaningfully better treatment options, and where we intend to deliver a real difference. These are early-stage clinical programs, and their advancement remains subject to significant clinical, regulatory and financing risks.” About ALA-002 ALA-002 is PharmAla’s lead drug candidate: a patented, non-racemic MDMA formulation that has received New Chemical Entity (NCE) designation from the U.S. Food and Drug Administration (FDA). ALA-002 has been designed with the goal of delivering an improved cardiovascular safety profile and reduced abuse liability relative to racemic MDMA, while preserving the therapeutic properties associated with MDMA-assisted therapy. ALA-002 is an investigational product that has not been approved by the FDA or any other regulatory authority, and its safety and efficacy have not been established. 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. 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. About PharmAla PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. For more information, please contact:Nicholas KadyshChief Executive OfficerPharmAla Biotech Holdings Inc.Email: press@PharmAla.caPhone: 1-855-444-6362Website: www.PharmAla.ca Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release. Forward-Looking Statements This press release contains certain “forward-looking statements” within the meaning of applicable Canadian securities legislation that reflect the Company’s current expectations and projections about its future results. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential”, or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to: the anticipated benefits of the Agreement to PharmAla and its shareholders; the satisfaction of closing conditions and the effectiveness of the license; the receipt, timing and amount of the upfront payment, milestone payments and royalties; the issuance of Jupiter common stock to PharmAla and related lock-up and resale matters; the development, manufacture, regulatory approval, commercialization and therapeutic potential of ALA-002; the negotiation and terms of any supply and technology-transfer arrangements; and PharmAla’s continued development of ALA-002 and its broader pipeline outside the United States. These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements, the Company has applied several material assumptions, including that the closing conditions to the Agreement will be satisfied; that ALA-002 will advance through clinical development and regulatory review; that the milestone events giving rise to payments will be achieved; that the parties will negotiate and enter into supply and related agreements; and that the Company will retain and be able to exploit its rights to ALA-002 outside the United States. Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements, including, but not limited to: the failure to satisfy the closing conditions to the Agreement; the early-stage and investigational nature of ALA-002 and the possibility that clinical trials do not demonstrate adequate safety or efficacy; reliance on Jupiter and other third parties; the timing and outcome of regulatory review, approval and drug scheduling; intellectual-property protection; competition and market acceptance; and the risks discussed under the heading “Risk Factors” in the Company’s annual information form and in its latest management’s discussion and analysis, copies of which are available under the Company’s SEDAR+ profile at www.sedarplus.ca. Forward-looking statements are made as of the date of this press release, and PharmAla is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. There can be no assurance that any milestone payments or royalties will be earned or paid, or that ALA-002 will be approved or commercialized. This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction. LaNeo™ is a trademark of PharmAla Biotech Holdings Inc. JOTROL™ is a trademark of Jupiter Neurosciences, Inc.