TORONTO, July 06, 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 the successful completion of GMP (Good Manufacturing Practice) manufacturing of drug substance necessary for the manufacturing of ALA-002. This milestone marks a significant step forward in the program's development, providing sufficient material to support upcoming clinical activities.
With drug substance manufacturing now complete, the Company is prepared to begin GMP manufacturing of the drug product, the formulated finished form that will be used in clinical activities globally. The successful scale-up and execution of the drug substance batch under GMP conditions demonstrate the maturity and reproducibility of the Company's manufacturing process and underscore its readiness to advance ALA-002 toward the clinic.
"This GMP manufacturing milestone represents not only an important step in PharmAla's development, but a key achievement for the development of the second generation of MDMA analogues," said Farnoud Kazemzadeh, COO, PharmAla Biotech. "PharmAla's management team has worked hard to ensure that ALA-002's development will accelerate in the coming months, with manufacturing of the drug substance being the 'starting gun'."
PharmAla Granted Australian Patent for its lead candidate, ALA-002
PharmAla has been granted an Australian patent, number 2022330718, entitled "Compositions Comprising Non-Racemic Mixtures of (R)- and (S)-3,4-Methylenedioxymethamphetamine or (R) and (S) N-Methyl-1,3-Benzodioxolylbutanamine and Uses Thereof" - the composition-of-matter foundation for its lead drug candidate, ALA-002. The Australian grant is a meaningful milestone for PharmAla's regional strategy.
Cortexa to Exercise Option to ALA-002 for the Australian Market
Pursuant to the Joint Venture agreement executed between Pharmala Biotech Inc. and Vitura Health Ltd., Cortexa (the 50/50 joint venture owned by the two companies) has a Right of First Refusal to any new innovation developed by PharmAla. PharmAla is pleased to announce that the board of Directors of Cortexa has voted to exercise its rights to commercialize the ALA-002 intellectual property. Cortexa's option rights relate solely to the Australia territory.
PharmAla Brands ALA-002 for Commercial Utilization in Australia
Subsequent to Cortexa's decision to exercise its option for ALA-002, PharmAla is proud to announce that the ALA-002 Drug Product will be known in Australia as LaNeo Gen 2. PharmAla already owns, and sublicenses to Cortexa, the "LaNeo" branding in Australia.
"PharmAla's LaNeo branding represents the epitome of the legal MDMA market globally, and in Australia especially - where Cortexa has a dominant market position," said Nick Kadysh, CEO, PharmAla Biotech. "As we bring new and innovative products to market, we believe it is critical to utilize the goodwill that our established branding represents. LaNeo stand for GMP manufacturing quality, reliability, and safety; Our LaNeo Gen 2 product represents that, and innovation to improve both Patient safety and Clinic Operator efficiency. We look forward to additional announcements regarding LaNeo Gen 2 in the coming months."
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
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.
