Psyence Biomedical

What Psyence Biomedical does

Psyence Biomedical Ltd. (NASDAQ: PBM) is a clinical-stage biopharmaceutical company headquartered in Toronto, Canada, developing nature-derived (non-synthetic) psilocybin and ibogaine-based psychedelic therapeutics for mental health disorders. Its lead asset NPX-5, a GMP-compliant, nature-derived psilocybin candidate formulated as 25mg capsules, is currently being evaluated in a Phase IIb clinical trial across five Australian sites for the treatment of Adjustment Disorder in cancer patients in palliative care. The trial enrolls approximately 87 participants and combines psilocybin administration with structured psychotherapy.

The company's technology platform is anchored by its investment in PsyLabs (Psyence Labs Ltd.), a GMP-compliant, ISO 22000-certified manufacturing operation in Southern Africa that handles the full supply chain from cultivation at source, through extraction and purification, to pharmaceutical-grade API production. PsyLabs supplies both psilocybin (used in the NPX-5 program) and pharmaceutical-grade ibogaine HCl and total alkaloid extracts for substance use disorder indications. Following a February 2026 share-for-share exchange, PsyLabs holds approximately 49.98% of Psyence BioMed's outstanding shares, effectively consolidating the upstream manufacturer and clinical developer under shared ownership.

Psyence is pre-revenue, with no registered commercial products and no disclosed pricing. Its cash position stood at approximately $9-12 million as of late 2025 / early 2026, with no debt. The company monetizes through future regulatory approval and commercialization of its psychedelic therapeutic candidates, targeting three primary use cases: palliative care mental health (Adjustment Disorder in cancer patients), substance use disorders (opioid and alcohol addiction via ibogaine), and a newly launched longevity research program investigating psilocybin's effects on biological aging markers. Go-to-market relies on clinical trial partnerships with Australian research institutions and CROs, conference-driven investor engagement (H.C. Wainwright, ICPR 2026), and emerging U.S. policy engagement around ibogaine research.

Name

Psyence Biomedical

Legal name

Psyence Biomedical Ltd.

Website

https://psyencebiomed.com

Company type

Public

Founded year

2023

Operating status

Operating

Headcount range

11–50 employees

Short description

Psyence Biomedical is a pre-revenue, Toronto-based clinical-stage biopharmaceutical company developing nature-derived psilocybin (NPX-5) and ibogaine therapeutics for palliative care mental health, substance use disorders, and longevity, with GMP manufacturing through its PsyLabs subsidiary in Southern Africa.

Ownership category

akta.pro rank

Product category

Psychedelic Therapeutics

NAICS

Medicinal and Botanical Manufacturing (325411), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

Keywords

• Psychedelic therapeutics
• Clinical-stage biopharmaceutical
• Nature-derived psilocybin
• Palliative care therapy
• GMP psychedelic manufacturing

Headquarters

HQ city

Toronto

HQ country

Canada

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical Product Sales: Pre-revenue clinical stage company with no registered commercial products. Future revenue expected from FDA-approved nature-derived psychedelic treatments for mental health disorders following successful clinical development and regulatory approval.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels7 records

Core offering

Psyence Biomedical is a clinical-stage biopharmaceutical company developing nature-derived (non-synthetic) psilocybin and ibogaine-based psychedelic medicines for mental health disorders in palliative care, addiction, and longevity applications. The company conducts Phase IIb clinical trials with its lead candidate NPX-5 (psilocybin) for Adjustment Disorder in cancer patients, and develops pharmaceutical-grade ibogaine for substance use disorders. Manufacturing is secured through strategic investment in PsyLabs, a GMP-compliant psychedelic API production facility in Southern Africa.

Product overview

Psyence Biomedical operates as a vertically integrated biopharmaceutical company developing nature-derived psychedelic therapeutics. The company focuses on two core products: NPX-5, a GMP-compliant nature-derived psilocybin candidate in Phase IIb trials for Adjustment Disorder in cancer patients, and pharmaceutical-grade ibogaine for substance use disorders. Manufacturing capabilities are secured through strategic investment in PsyLabs, which operates a GMP-compliant facility in Southern Africa producing psychedelic APIs including psilocybin and ibogaine. The company combines drug development with psychotherapy protocols, operating clinical trials across multiple Australian sites.

Differentiator

Problem solved

Functional benefit

Brands

• NPX-5: GMP-compliant, nature-derived psilocybin candidate (25mg dose) for treatment of Adjustment Disorder in cancer patients in palliative care
• PsyLabs
• Psyence Labs

Products and services

• NPX-5 (Nature-Derived Psilocybin) A GMP-compliant, nature-derived (non-synthetic) psilocybin candidate formulated as 25mg capsules for use in Phase IIb clinical trials evaluating treatment of Adjustment Disorder in cancer patients in palliative care.
• Pharmaceutical-Grade Ibogaine GMP-compliant, pharmaceutical-grade ibogaine (including ibogaine HCl and total alkaloid extracts) produced through vertical integration with PsyLabs at source in Africa, supporting clinical development for substance use disorders and research initiatives.
• Psilocybin-Assisted Psychotherapy Therapeutic treatment approach combining nature-derived psilocybin (NPX-5) with structured psychotherapy for treatment of Adjustment Disorder in palliative care patients with cancer.

Quantifiable outcome

• Phase IIb trial for Adjustment Disorder in palliative care - 87 participants across 5 Australian sites, top-line results expected 2026
• +2 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• PsyLabscoreStrategic or Co-development Partner · 15 August 2025Strategic manufacturing partnership through multi-stage investment ($500,000 in April 2025, $3.5 million in November 2025, $5 million share-for-share exchange in February 2026). PsyLabs operates GMP-compliant manufacturing facility in Southern Africa producing pharmaceutical-grade psilocybin and ibogaine. PsyLabs owns 49.98% equity stake in Psyence BioMed. PsyLabs is federally licensed to cultivate, extract, and export psilocybin mushrooms and other psychedelic compounds including ibogaine, operating from ISO 22000 and GMP-compliant facility.
• Southern Star ResearchcoreImplementation/ SI/ Consulting Partner · 27 May 2025Award-winning, full-service Australian Contract Research Organization (CRO) providing clinical trial management services for Phase IIb study. Partnership accelerates development of psilocybin-assisted therapy for Adjustment Disorder through operational expertise and regulatory compliance support.
• Empax CentreminorImplementation/ SI/ Consulting PartnerClinical trial site in Perth, Australia conducting Phase IIb dosing of natural psilocybin for Adjustment Disorder in palliative care patients.
• Mind Medicine Australia ClinicminorImplementation/ SI/ Consulting PartnerClinical trial site in Melbourne, Australia conducting Phase IIb dosing as part of expanding clinical site network.
• Paratus Clinical ResearchminorImplementation/ SI/ Consulting PartnerClinical trial site in Melbourne, Australia activated to expand Phase IIb study to three actively enrolling sites and accelerate data collection.
• Ramsay Health CareminorImplementation/ SI/ Consulting PartnerAdded to Australian clinical site network expanding from three to five sites to support Phase IIb trial. Ramsay Health Care is a major healthcare provider with multiple facilities.
• NeuroCentrixminorImplementation/ SI/ Consulting PartnerAdded to Australian clinical site network to support Phase IIb trial expansion and accelerate patient recruitment.
• Australian Clinical Trial NetworkminorImplementation/ SI/ Consulting PartnerPartnership for Phase IIb trials mentioned in site management organization market report as notable strategic alliance in psychedelic therapeutics sector.

Scale indicators5 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Compass Pathways: Lead clinical-stage competitor developing synthetic psilocybin (COMP360) for treatment-resistant depression; the most directly comparable public psychedelic biopharma pursuing CNS indications with rigorous Phase II/III trials.
• MindMed: Clinical-stage psychedelic medicine company developing LSD-based therapies and psilocybin for anxiety and ADHD; comparable as a public psychedelic therapeutics peer targeting CNS/mental health indications.
• Atai Life Sciences: Clinical-stage biopharma developing psychedelic and non-psychedelic compounds for mental health (depression, anxiety, addiction); directly comparable as a multi-asset psychedelic platform with similar go-to-market approach.
• GH Research: Clinical-stage company developing mebufotenin (5-MeO-DMT) for treatment-resistant depression; a directly comparable psychedelic therapeutics peer with a similar late-stage clinical focus.
• Cybin: Clinical-stage psychedelic therapeutics company developing deuterated psilocybin analogs (CYB003) for depression and anxiety; competes in the same psilocybin-based CNS indication space.
• Filament Health: Developer of natural psilocybin drug candidates with proprietary extraction and manufacturing; the closest peer to Psyence's nature-derived (non-synthetic) psilocybin positioning.
• Small Pharma (now atai): Formerly Small Pharma (acquired by atai in 2024), developed deuterated DMT (SPL026) for depression; directly comparable as a clinical-stage DMT-based psychedelic therapeutics company.

Emerging players

• Beckley Psytech: Private clinical-stage company developing synthetic psilocybin (BPL-003) for treatment-resistant depression and other CNS indications; an emerging peer with overlapping psychedelic CNS pipeline.
• Delix Therapeutics: Clinical-stage company developing novel neuroplastogens (non-hallucinogenic psychoplastogens) for CNS indications; an emerging peer pursuing psychedelic-inspired CNS therapies.

Broad incumbents

• MAPS / Lykos Therapeutics: Established psychedelic therapeutics organization advancing MDMA-assisted therapy (now via Lykos Therapeutics); broader incumbent in psychedelic medicine with a commercial-stage focus in PTSD that informs the regulatory environment Psyence operates in.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/ThePsyenceGroup
• LinkedInlinkedin.com/company/psyence-biomed-ltd
• Instagraminstagram.com/psyence_group

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries2 records

Funding overview

Funding rounds2 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments2 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Psyence Biomedical