PharmAla Biotech Holdings Inc. has established a wholly-owned Australian subsidiary to advance its clinical research and development activities for MDXX class molecules, including MDMA and its proprietary LaNeo™ MDMA formulation. The Toronto-based biotechnology company announced the incorporation of PharmAla Biotech Australia Pty Ltd. on September 3, 2025, marking a strategic expansion into the Australian biotech market.
Strategic Expansion into Australian Market
The Australian subsidiary will receive comprehensive licensing rights to PharmAla's lead drug candidate ALA-002 and all associated patents. This arrangement positions the new entity to execute both manufacturing development and clinical research activities within Australia's regulatory framework.
"As many know, Australia continues to be a thriving market for biotech development. We believe that our familiarity with the market – our relationships and our experience - will drive significant synergies," said Nick Kadysh, Founding CEO of PharmAla Biotech.
Will Avery, CFO of PharmAla Biotech, emphasized the strategic advantages of the Australian market, stating, "While we see Australia as having a very strong set of experts in clinical research and drug discovery, we are confident it also has an exceptional regulatory environment for launching clinical trials. PharmAla Australia will benefit from that, as well as a growing environment of biotech financiers and government incentives."
Scientific Advisory Board Strengthened
Concurrent with the subsidiary establishment, PharmAla appointed Dr. Evan Lewis to its Scientific Advisory Board, effective September 1, 2025. Dr. Lewis brings extensive expertise in neurology and psychedelic medicine to the company's scientific leadership.
Dr. Lewis is an adult and pediatric neurologist with specialized training in epilepsy and pediatric neurology. He holds a clinical appointment as Adjunct Assistant Professor in the Department of Pediatrics at the Hospital for Sick Children and the University of Toronto. His professional background includes founding and leading the Neurology Centre of Toronto from 2016 to 2024 and serving as Vice President of Psychedelic Neurology at Numinus from 2021 to 2024.
During his tenure at Numinus, Dr. Lewis advanced clinical care and research in medical cannabis and developed and directed a Ketamine-Assisted Therapy program for neurological conditions. His clinical focus encompasses epilepsy, brain injury, concussion and persistent post-concussion symptoms, functional neurological disorders—especially functional seizures—and the use of cannabis and psychedelics in neurological treatment.
Company's Unique Market Position
PharmAla distinguishes itself in the psychedelics industry through its dual focus on addressing the global shortage of clinical-grade MDMA while developing novel compounds in the same therapeutic class. The company reports being the only organization currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials.
The company's research and development unit has completed proof-of-concept research into several intellectual property families, with ALA-002 serving as its lead drug candidate. PharmAla operates under a "regulatory first" principle, emphasizing the importance of maintaining excellent relationships with regulatory authorities for long-term success in the psychedelics industry.
The establishment of the Australian subsidiary represents PharmAla's commitment to expanding its global footprint while leveraging favorable regulatory environments for psychedelic research and development.
