PharmAla Signs Supply & Data Agreement with Nautilus Sanctuary for Phase 2 MDMA Clinical Trial Treating Post-Traumatic Stress and Adjustment Disorder in Frontline Healthcare Workers and First Responders

TORONTO, March 03, 2026 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), announced that it has executed a Supply & Data Agreement with Nautilus Sanctuary Inc. (“Nautilus Sanctuary”) of Brooklyn, New York, for the provision of MDMA for use in a Phase 2 clinical trial in the United States.

Under the agreement, PharmAla will supply its LaNeo™ MDMA to Nautilus Sanctuary for use in an open-label clinical trial entitled “An Open Label Study to Treat Post-Traumatic Stress in Frontline Healthcare Workers and First Responders Using MDMA-Assisted Therapy”

“We deeply appreciate PharmAla’s donation of LaNeo MDMA to our study of frontline responders,” said Dr. Willa Hall, President of Nautilus Sanctuary. “Their generosity helps accelerate important clinical research into the therapeutic potential of MDMA as a safe and effective adjunct to good trauma care.”

In consideration for the supply of LaNeo™ MDMA, Nautilus Sanctuary will grant PharmAla a perpetual, non-exclusive license to the Clinical Trial Data, which includes pseudonymized and de-identified raw data sets as well as Nautilus Sanctuary’s analysis of the safety and efficacy of the intervention. The license permits PharmAla to use the data for regulatory approvals and any commercial purpose in any jurisdiction globally.

“This agreement represents a continuation of our innovative supply-for-data model, which we believe creates significant value for both parties,” said Nicholas Kadysh, CEO of PharmAla Biotech. “Frontline healthcare workers and first responders bear an enormous mental health burden, and we are proud to support Nautilus Sanctuary in their efforts to bring MDMA-assisted therapy to these critical populations. The clinical data generated in the United States under this agreement will be an important addition to our growing portfolio of clinical evidence supporting the safety and efficacy of LaNeo™ MDMA.”

Researchers interested in accessing LaNeo™ MDMA for clinical trials may visit https://pharmala.ca/clinical-trials for additional information, including access to drug product quality documentation.

PharmAla Completes Shipment of LaNeo MDMA to University College London

PharmAla has completed the shipment of LaNeo MDMA to University College London (UCL) for a previously announced clinical trial.

About PharmAla Biotech

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. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. Forward-looking statements may be identified by the use of words such as “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “plans”, “strategy”, “anticipates”, or variations of such words and phrases, or state that certain actions, events, or results “may”, “could”, “would”, “might”, or “will” be taken, occur, or be achieved. Forward-looking statements are based on the reasonable assumptions, estimates, analysis, and opinions of management made in light of its experience and perception of trends, current conditions, and expected developments, as well as other factors that management believes to be relevant and reasonable at the date that such statements are made. Forward-looking information involves known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those anticipated in such forward-looking information. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in PharmAla’s management’s discussion and analysis, which is available on PharmAla’s profile at www.sedarplus.ca. PharmAla cautions that the foregoing list of material factors is not exhaustive. PharmAla is not obligated to, and does not intend 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.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

For further information, please contact:

PharmAla Biotech Holdings Inc.
Nicholas Kadysh, CEO
press@pharmala.ca
1-855-444-6362
www.PharmAla.ca