1 domain / 3 areas / 2 specializations
PharmAla BiotechCSE: MDMA | OTCQB: MDXXF
PharmAla Biotech (CSE: MDMA) is a Canadian biotech specialising in MDXX-class molecule R&D and GMP MDMA manufacturing. Founded in January 2021 by CEO Nick Kadysh, the company operates two business lines: (1) LaNeo — clinical-grade GMP MDMA supplied to research institutions worldwide under a supply-for-data model, now with a US distribution hub and agreements spanning Mt. Sinai, Yale, UAB, University of Washington, and institutions in Norway and Netherlands; and (2) proprietary drug development led by ALA-002, a patented non-racemic MDMA (70–80% R-MDMA / 20–30% S-MDMA) targeting social anxiety in autism, plus APA-001, a novel non-scheduled MDXX molecule discovered via University of Windsor AI collaboration. ALA-002 holds US Patent No. 12,053,452 (composition of matter, issued 2024), MHRA written guidance that no further preclinical data is needed, and FDA NCE classification. Phase 2a clinical trial drug substance manufacture was contracted with a UK CDMO in December 2025 in preparation for an Australian Phase 2a with University of Sydney (Dr. Adam Guastella). Revenue grew 95% in FY2024 to C$1.04M from MDMA product sales. Note: master list originally classified as private, but is publicly listed on CSE.
Manufacturing Snapshot
Research-Led (Partner Manufacturing)Scope & Capabilities
Supply Use Cases
GxP / Compliance
Facilities & Access
Partner-lab manufacturing model across Canada and international trial supply channels.
Manufacturing DetailsSupported Substances
Clinical-grade LaNeo MDMA and additional MDXX compounds delivered through licensed partner laboratories.
Manufacturing Sources
Development Programmes
2ALA-002 (Non-Racemic MDMA)
Patented non-racemic MDMA formulation enriched in R-enantiomer (70-80% R-MDMA / 20-30% S-MDMA). US Patent 12,053,452 (composition of matter, issued August 2024). FDA classifies as Novel Chemical Entity (NCE) — separate regulatory pathway from racemic MDMA. Preclinical data shows reduced hyperthermia, improved pro-social effect in autism-model mice (BTBR), and lower abuse liability vs racemic MDMA. Targets social anxiety disorder in autism spectrum disorder — an orphan indication with no FDA-approved treatments.
Programme Tracker
Autism Spectrum Disorder (ASD)
Phase 2a/2b preparation. UK-based CDMO contracted December 2025 for drug substance manufacture. ALA-002 capsule encapsulation on production schedule. Phase 2 protocol completed with University of Sydney (Dr. Adam Guastella, Michael Crouch Chair in Child and Youth Mental Health). Trial expected to initiate 2026 in Australia. No CTA/TGA approval yet announced.
Milestones
regulatory-milestone
CompletedActual: Dec 13, 2022
Pre-IND meeting completed with FDA. ALA-002 dossier submitted November 2022, FDA meeting held December 2022. FDA classifies ALA-002 as a Novel Chemical Entity (NCE), separate active moiety from racemic MDMA.
Why it matters: NCE classification is a major regulatory win — ALA-002 gets its own data exclusivity upon approval, is not subject to the Lykos/racemic MDMA regulatory baggage, and the safety concerns cited in the FDA AdCom rejection (cardiovascular risk, hyperthermia, functional unblinding) are precisely what the non-racemic formulation is designed to address.
regulatory-milestone
CompletedActual: Jul 20, 2023
UK MHRA provides guidance that no further preclinical data is needed before clinical trials of ALA-002. Clinical development agreement signed with University of Sydney; Dr. Adam Guastella named lead investigator; Phase 2 protocol completed.
Why it matters: MHRA green light on preclinical package reduces development cost and timeline. University of Sydney partnership provides access to world-leading ASD clinical research expertise (Guastella lab) and Australian TGA regulatory pathway.
ip-milestone
CompletedActual: Aug 9, 2024
US Patent 12,053,452 formally issued for ALA-002 composition of matter — non-racemic MDMA formulation (70-80% R-MDMA / 20-30% S-MDMA). Patent allowance first granted March 2024.
Why it matters: Composition of matter patent is the strongest form of IP protection. Combined with FDA NCE classification, provides dual regulatory and IP moats. Differentiates from pure R-MDMA approaches (Definium DT402, AtaiBeckley EMP-01) and racemic MDMA (Lykos).
Company milestone
CompletedActual: Dec 15, 2025
UK-based CDMO contracted for manufacture of ALA-002 drug substance. CDMO name undisclosed due to controlled substance regulatory sensitivity. Capsule encapsulation on production schedule for 2026 Phase 2 trial supply.
Why it matters: Drug substance manufacturing is the critical gating step before Phase 2 can begin. CDMO engagement signals imminent clinical trial initiation in 2026.
Recorded Events
Dec 15, 2025: Company milestone
Aug 9, 2024: ip-milestone
Jul 20, 2023: regulatory-milestone
Dec 13, 2022: regulatory-milestone
Evidence Links
peer-reviewed - Neuropsychopharmacology (Nature) - Aug 1, 2024 - Verified
APA-001 (Novel MDXX Molecule)
Novel MDXX-class molecule ((R)-2-[(2H-1,3-benzodioxol-5-yl)methyl]pyrrolidine) discovered via Phenesafe AI computational drug discovery platform (University of Windsor / Ontario Centres for Innovation). Strong pro-social signal at doses far lower than racemic MDMA. Induces neuroplasticity. Low abuse liability. USPTO patent allowance granted March 2024. Preclinical proof-of-concept at University of Arkansas for Medical Sciences (Prof. William Fantegrossi lab). Indications: trauma, TBI, stroke, fear disorders, neurological damage.
Programme Tracker
Traumatic Brain Injury (TBI)
Preclinical proof-of-concept research at University of Arkansas for Medical Sciences (Fantegrossi lab). Phenesafe AI platform identified APA-001 as first output. Pro-social and neuroplasticity signals confirmed in animal models. IND-enabling studies timeline not yet disclosed.
Milestones
ip-milestone
CompletedActual: Mar 20, 2024
USPTO patent allowance granted for APA-001 (formerly P-1) composition of matter. Novel MDXX molecule discovered via in-silico computational modelling.
Why it matters: First drug candidate from Phenesafe AI platform. Composition of matter patent protects a structurally novel compound — not a reformulation of existing MDMA. Validates computational drug discovery approach for psychedelic-adjacent molecules.
Company milestone
CompletedActual: May 15, 2025
Phenesafe AI drug discovery platform launched — world's first computational value chain for novel phenethylamine/MDXX-class molecules. Combines QSAR model (University of Windsor) with AI chemical pathway modelling.
Why it matters: Platform approach enables systematic discovery of novel MDXX molecules beyond APA-001. Could accelerate pipeline expansion if initial candidates show clinical promise.
Recorded Events
May 15, 2025: Company milestone
Mar 20, 2024: ip-milestone
Quick Facts
- Type
- Public Biotech
- Ticker
- CSE: MDMA | OTCQB: MDXXF
- Lead Stage
- Pre-clinical
- Website
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