Mr. Nicholas Kadysh reports

PHARMALA BIOTECH AUSTRALIA CONTRACTS WITH UK-BASED CDMO FOR MANUFACTURE OF ALA-002 DRUG SUBSTANCE

Pharmala Biotech Holdings Inc.'s wholly owned subsidiary, Pharmala Biotech Australia, has contracted with a United Kingdom-based CDMO to execute manufacture of its ALA-002 drug substance.

"Pharmala Australia worked diligently, executing a global RFP search to find our ideal partner for process development and manufacturing of the ALA-002 drug product components," said Nick Kadysh, founding chief executive officer, Pharmala Biotech. "This is an important and necessary step to us executing our ALA-002 phase 2 clinical trial in 2026, and the first time since 2022 that Pharmala will be developing a wholly new active pharmaceutical ingredient for human use."

ALA-002 is Pharmala's patented, novel, non-racemic MDMA formulation. Pharmala has publicly announced that it will be initiating phase 2a/2b clinical research into the formulation exploring social anxiety disorder in 2026. Due to the nature of ALA-002 as a controlled substance, Pharmala is not publicly disclosing the name of the CDMO at their request.

Delivery to Mt. Sinai Hospital

Pursuant to the announcement made on Oct. 21, 2024, Pharmala is also pleased to announce that the company has completed one of two contracted shipments of LaNeo MDMA to the Parsons Research Center for Psychedelic Healing at Mount Sinai. The material is scheduled to be used in clinical research.

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.

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