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PharmAla Signs Agreement and Initiates R&D with Corealis Pharma for GMP Manufacturing of its patented ALA-002 Drug Product

News originally published by

GlobeNewswire

TORONTO, Nov. 05, 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 MDXX-class molecules, including its proprietary LaNeo™ MDMA, announces that it has signed an agreement with Corealis Pharma Inc. ("Corealis"), a GMP-compliant contract development and manufacturing organization ("CDMO") based in Laval, Québec, for the GMP manufacturing of ALA-002 drug product for clinical supply.

The agreement adds a high quality drug product manufacturer to PharmAla's ALA-002 supply chain. Corealis was selected following a technical, quality, and regulatory evaluation of Contract Development and Manufacturing Organizations (CDMOs).

"We’re confident that Corealis is the right partner to execute this work," said Farnoud Kazemzadeh, Chief Operating Officer, PharmAla Biotech. "We are also excited to bring this drug development work back to Canada."

Corealis has already begun R&D on the drug product formulation, with GMP manufacturing of the first ALA-002 drug product batch scheduled upon completion of development activities. ALA-002 will initially be developed and launched as a 50mg capsule.

"We are pleased to support PharmAla with the clinical manufacture of ALA-002. This expansion builds on our expertise in oral solid dosage development and manufacturing, enabling us to support the development of potential therapies for conditions such as PTSD," said David Leroux-Petersen, Chief Executive Officer of Corealis Pharma.

"As MDMA winds its way towards regulatory approval in more jurisdictions - with media reports indicating that a New Drug Application (NDA) has been accepted for review by the US Food and Drug Administration (USFDA) - it is critically important that PharmAla’s next-generation patented MDMA-derived products be ready for testing and clinical development," said Nicholas Kadysh, Founding CEO of PharmAla. "Since the signing of our US out-licensing agreement for ALA-002 earlier this year, interest in the asset has only increased. Having a GMP drug product formulation completed is a necessary step for clinical research (both in-house and via partners) but also opens the door to numerous new commercial opportunities.”

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.

About Corealis Pharma

Corealis Pharma is a specialized oral solid dosage (OSD) CDMO supporting pharmaceutical and biotechnology companies from early formulation development through GMP clinical manufacturing and clinical supply. With integrated formulation, analytical and manufacturing capabilities, Corealis helps development-stage programs advance efficiently toward the clinic through science-driven formulation strategies, flexible manufacturing and experienced project execution. For more information, visit www.corealispharma.com

For more information, please contact:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Website: 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.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmAla’s current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by PharmAla at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. The forward-looking information contained in this press release is made as of the date hereof, 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. 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.sedar.com.

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.


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