Mr. Nicholas Kadysh reports
PHARMALA BIOTECH EXECUTES DEFINITIVE LICENSE AGREEMENT GRANTING JUPITER NEUROSCIENCES EXCLUSIVE U.S. RIGHTS TO ALA-002
Pharmala Biotech Holdings Inc. has entered into a definitive licence agreement on July 20, 2026, with Jupiter Neurosciences Inc. (Nasdaq: JUNS), under which Pharmala has granted Jupiter an exclusive, perpetual, royalty-bearing licence 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 $100-million (U.S.), consisting of a $3,333,333 (U.S.) upfront payment and up to $96,666,666 (U.S.) 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
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Rights granted: exclusive, perpetual licence to develop, manufacture and commercialize ALA-002 in the United States. Pharmala retains all rights outside the United States;
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Upfront payment: $3,333,333 (U.S.), comprising $1.5-million (U.S.) in cash and $1,833,333 (U.S.) in Jupiter common stock, subject to a 120-day lock-up and customary Nasdaq and U.S. securities-law limitations;
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Development and regulatory milestones: up to $23,333,333 (U.S.), including $3,333,333 (U.S.) on first patient dosing in a phase 3 clinical trial and $20-million (U.S.) on Food and Drug Administration approval of a new drug application for a licensed product;
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Commercialization milestones: up to $73,333,333 (U.S.), payable on first achievement of $333.3-million (U.S.), $1.0-billion (U.S.) and $2.0-billion (U.S.) in cumulative U.S. net sales ($10-million (U.S.), $30-million (U.S.) and $33.3-million (U.S.), respectively);
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Royalty: 3 per cent of U.S. net sales of licensed products, commencing after the third commercialization milestone;
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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 chief executive officer, 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, chief financial officer, 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 Rosen, 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 Pharmala
Biotech Holdings Inc.
Pharmala 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.
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