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Pharmala Biotech Holdings Inc
Symbol MDMA
Shares Issued 108,599,715
Close 2026-07-06 C$ 0.145
Market Cap C$ 15,746,959
Recent Sedar+ Documents

Pharmala completes ALA-002 GMP drug substance run

2026-07-06 18:08 ET - News Release

Mr. Nicholas Kadysh reports

PHARMALA COMPLETES GMP MANUFACTURING OF DRUG SUBSTANCE COMPONENTS FOR ALA-002 PROVIDES CORPORATE UPDATE REGARDING ALA-002 ASSET

Pharmala Biotech Holdings Inc. has successfully completed 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, chief operating officer, 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, No. 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 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, chief executive officer, 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 Biotech Holdings Inc.

Pharmala Biotech Holdings 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.

We seek Safe Harbor.

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