Toronto, ON – December XX, 2025 - PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), is pleased to announce that its wholly-owned subsidiary, PharmAla Biotech Australia, has contracted with a UK-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 CEO, 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 October 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.
PharmAla Biotech Holdings Inc. (CSE: MDMA) 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, and to develop novel drugs in the same class. 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. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.
Nicholas Kadysh, CEO
press@pharmala.ca