TORONTO, May 13, 2026 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTCQB: MDXXF) ("PharmAla" or the "Company"), a leader in the research, development, and manufacturing of clinical-grade MDMA and novel MDXX-class compounds, today announced that it has executed a definitive SPV Formation, Shareholder and License Agreement (the "Definitive Agreement") with Aluvaris Inc. ("Aluvaris") and Diteba Inc. ("Diteba"). The Definitive Agreement establishes a jointly-owned special purpose vehicle called Restora Neurosciences (the "Restora" or the "SPV") to lead the clinical and regulatory development of APA-01, the Company's patented novel MDXX molecule, with the explicit objective of filing a first Investigational New Drug application with the U.S. Food and Drug Administration.
The Definitive Agreement was executed on the timeline contemplated by the binding Letter of Intent announced on April 27, 2026, and well in advance of the parties' agreed June 8 outside date.
A Repeatable Execution Model
Restora is the second major partnership-based development vehicle PharmAla has structured and brought to signing. The first - Cortexa, PharmAla's 50/50 joint venture with ASX-listed Vitura Health Limited (ASX: VIT) - has become PharmAla's most visible commercial proof point. Cortexa is today the leading supplier of GMP-grade MDMA into the legal Australian clinical market, completed the world's first Australian-manufactured GMP MDMA capsule run, and is currently expanding its commercial footprint under Australia's Authorised Prescriber pathway.
Restora applies the same execution- clear governance, an aligned partner with capital-raising capability, a specialist services provider, and equity economics that retain meaningful upside for PharmAla shareholders - to a U.S.-patented novel molecule. PharmAla retains ownership of the underlying intellectual property and a continuing economic interest in any product commercialized by the SPV through equity, license fee, royalty, and sublicense participation, while Restora's operating cash needs are met by capital raised by Aluvaris.
Diteba Appointed as Specialist Analytical Partner for IND Development Program
Pursuant to the definitive agreement, Diteba has been appointed as Restora's principal provider of bioanalytical and scientific project-management services for the duration of the IND development program. The agreement is structured to be highly capital-efficient for Restora, materially extending the development runway for each dollar of capital raised by the SPV.
Headquartered in Mississauga, Ontario, Diteba is exceptionally well suited to serve as the anchor laboratory for the program, supported by a robust Quality Management System and a multidisciplinary scientific team with extensive experience in regulated drug development. Diteba's credentials include:
- Licensed by Health Canada as a Drug Establishment, conducting GMP- and GLP-compliant activities;
- Registered as a drug establishment with the U.S. Food and Drug Administration (FDA) and recognized by the European Medicines Agency (EMA);
- Licensed by Health Canada to handle controlled drugs and substances; and
- Established CRO expertise in analytical and bioanalytical services, including formulation support, complex method development and validation, stability studies, and release testing across multiple dosage forms.
Diteba's platform is uniquely positioned to support the APA-01 program, conducting GMP- and GLP-compliant activities within a single, integrated Quality Management System that supports specialized analytical, bioanalytical, and regulatory development activities required to advance MDXX-class molecules-from preclinical bioanalysis through IND approval and beyond. By consolidating these capabilities within its anchor-laboratory operating model, Diteba enables sponsors such as Restora to run IND-enabling programs with optimized operational efficiency, rigorous regulatory readiness, and superior project management. This combination of authorizations, technical depth, and integrated research services is unique within the Canadian CRO landscape and serves as a critical enabler of a credible, regulator-ready APA-01 development pathway.
APA-01 and the Regulatory Tailwind
APA-01 is (R)-2-[(2H-1,3-benzodioxol-5-yl)methyl]pyrrolidine, a novel molecule covered by United States Patent No. 12,042,478 and a related international patent estate. APA-01 is being developed for therapeutic applications in psychological trauma and neurological conditions, including Post-Stroke Neurorehabilitation and Traumatic Brain Injury ("TBI"). APA-01 is not considered a controlled substance in either Canada or the United States.
TBI is among the indications expressly emphasized by the Executive Order titled "Accelerating Medical Treatments for Serious Mental Illness," signed by President Donald J. Trump on April 18, 2026. That Executive Order directs the U.S. Food and Drug Administration to issue Commissioner's National Priority Vouchers to qualifying drug programs that have received Breakthrough Therapy designation, and singles out post-traumatic stress and traumatic brain injury - particularly in U.S. military veterans - as priority targets for accelerated federal research support and expedited regulatory pathways. Restora's Development Plan has been structured with these federal priorities in view.
Material Terms of the Definitive Agreement
The full Definitive Agreement will be filed as a material contract on PharmAla's SEDAR+ profile. The principal economic and governance terms are as follows:
- Founding equity - 50/50. At closing, PharmAla and Aluvaris will each be issued 50% of the founding common shares of the SPV on a fully-diluted basis.
- Conditional global exclusive license. At closing, PharmAla will grant Restora an exclusive, worldwide, royalty-bearing license under the PharmAla intellectual property to research, develop, manufacture, and commercialize Licensed Products in all therapeutic fields of human use, with the right to grant sublicenses subject to PharmAla consent.
- Funding Threshold - US$2,500,000. The license is conditional at closing and becomes final and irrevocable upon Restora receiving aggregate cash subscriptions of not less than US$2,500,000 from one or more third-party investors, evidenced by executed subscription agreements and funds received in the Restora's bank account.
- Funding Threshold Deadline - three months, extendable. The Funding Threshold must be satisfied within three (3) months of the Effective Date, with a single additional three (3) month extension exercisable at PharmAla's sole option. Aluvaris will lead the capital raise.
- License Fee - US$500,000. The SPV will pay PharmAla a one-time License Fee of US$500,000 upon achievement of the Funding Threshold, in consideration for the grant of the License.
- Royalty - 3% of Net Sales. PharmAla will receive a perpetual royalty equal to three percent (3%) of Net Sales of all Licensed Products sold by or on behalf of the SPV, its affiliates, or its sublicensees, on a country-by-country and product-by-product basis, payable quarterly in arrears.
- Anti-dilution floor - 25%. PharmAla benefits from a pre-emptive right on new issuances and an anti-dilution floor preventing its equity interest in Restora from being diluted below twenty-five percent (25%) on a fully-diluted basis through and including the first priced equity financing immediately following the round that satisfies the Funding Threshold.
- Governance - equal board representation; PharmAla IP veto. Restora's initial board will consist of four directors, two nominated by PharmAla and two nominated by Aluvaris, with the chair rotating annually. Reserved Matters require approval of at least one director from each side. PharmAla retains a unilateral veto over IP-related matters, including any amendment, surrender, or sublicensing of the License, patent prosecution decisions, and any change in the field of use or territory.
- Diteba Services - Cost Efficient Structure. Diteba will enter into a Services Agreement with Restora at closing under which it will provide GMP analytical, GLP bioanalytical, regulatory support, and scientific project-management services to Restora. Diteba service fees are structured to be highly capital-efficient for Restora, materially extending the development runway for each dollar of capital raised by the SPV for the duration of the program. Restora retains audit rights and is not obligated to direct any minimum volume of services to Diteba. Diteba holds a ten-business-day right of first offer on services within its capabilities.
- Improvements assigned to PharmAla. Any improvements, modifications, derivatives, or further inventions relating to APA-01 conceived during the Term - including by Diteba in the course of providing services - are owned by PharmAla and automatically licensed back to the SPV under the License.
- IND Milestone - 36 months. The SPV will use commercially reasonable efforts to file the first IND in respect of APA-01 within thirty-six (36) months of the date the Funding Threshold is satisfied, subject to an available six-month remediation extension on customary terms. Failure to achieve the IND Milestone is a termination/reversion trigger.
- Reversion on revocation. If the Funding Threshold is not satisfied by the deadline, or on uncured material breach by the SPV, Aluvaris, or Diteba, PharmAla may revoke the License and all rights in the PharmAla intellectual property revert to PharmAla free of any encumbrance.
The foregoing summary is qualified in its entirety by reference to the full Definitive Agreement, which will be filed by PharmAla as a material contract on SEDAR+ at www.sedarplus.ca
Management Commentary
"Closing the definitive agreement well ahead of our outside date reflects not only how this management team executes, but also how excited we are to partner with Diteba and Aluvaris to advance this transaction," said Nicholas Kadysh, Founding CEO of PharmAla Biotech. "Cortexa demonstrated that PharmAla can structure complex, multi-party partnerships that deliver product, generate revenue, and align long-term incentives around a clear clinical thesis. Restora Neurosciences applies that same discipline to a novel, U.S. & PCT patented molecule whose target indications align squarely with the priorities articulated in the recent Presidential Executive Order. This is precisely the kind of capital-efficient, partner-driven development model that Canadian capital markets have been asking biotech management teams to deliver."
"Programs for novel central nervous system therapeutics face a distinct and elevated risk profile on the path from preclinical development through IND," said Steven Overgaard, Chief Executive Officer of Diteba. "These risks include heightened regulatory scrutiny, the analytical and bioanalytical complexity of stereoisomer-discriminating method development, and the need for tight integration across analytical, bioanalytical, and project-management workstreams under a single quality system. Diteba is uniquely positioned to manage that risk for Restora as its anchor laboratory. We combine a twenty-year regulatory track record, deep scientific expertise in advancing MDXX-class molecules through IND-enabling studies, and a capital-efficient operating scale that helps extend the value of every dollar raised. We are proud to take on this role for the founding partners of Restora."
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 Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Websites: www.PharmAla.ca & www.restoraneuroscience.com
Neither the CSE nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of applicable securities laws. All statements contained herein that are not clearly historical in nature may constitute forward-looking statements. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as "plans", "strategy", "expects" or "does not expect", "intends", "continues", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or may contain statements that certain actions, events or results "will be taken", "will launch" or "will be launching", "will include", "will allow", "will be made" "will continue", "will occur" or "will be achieved". We direct readers to refer to the "Caution Regarding Forward-Looking Statements" contained within the Company's management's discussion and analysis for the period ended February 28, 2026, as filed on Sedar+ www.sedarplus.ca
Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements. Although the Company believes that the expectations reflected in these statements are reasonable, such statements are based on expectations, factors, and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond the Company's control, including but not limited to the risk factors discussed in the Company's management's discussion and analysis, and elsewhere in this press release, as such factors may be further updated from time to time in our periodic filings, available at www.sedarplus.ca, which factors are incorporated herein by reference. Forward-looking statements contained in this press release are expressly qualified by this cautionary statement and reflect the Company's expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results, or otherwise, or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws.
