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Lead program: Phase II
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Biomind LabsNEO/CBOE: BMND | OTC: BMNDF | Frankfurt: 3XI

2 Drug Candidates3 Trials

Biomind Labs (NEO: BMND) is a Canadian clinical-stage biopharmaceutical company developing inhaled DMT, sublingual 5-MeO-DMT, and mescaline-class compounds across TRD, Alzheimer's-related depression, obesity/neuroinflammation, and Parkinson's disease. Founded in 2019 and publicly listed via RTO in July 2021, the company's clinical work is primarily conducted in Brazil (UFRN, PI Prof. Dráulio de Araujo) and Argentina (Dr. Martin Bruno). Their BMND08 (sublingual 5-MeO-DMT for Alzheimer's depression) achieved a 100% remission rate in a Phase 2 RCT at subpsychedelic doses (February 2024) and is now advancing to FDA-directed Phase 3 via a proprietary nano-formulation platform with FDA Breakthrough Therapy Designation planned. BMND01 (inhaled DMT) is in Phase 2 for TRD with the unique advantage of a ~10-minute experience duration vs hours for psilocybin or LSD. Note: master list originally classified as private, but is publicly listed on NEO/CBOE.

Development Programmes

2

BMND08

5-MeO-DMT
Phase II

Depression and anxiety in Alzheimer's disease

Programme Tracker

Neurocognitive Disorders

Primary: US (FDA)
Phase IIActive

Phase 2 complete (100% response and remission; NCT06816667); Phase 3 and Breakthrough Therapy Designation application planned; nano-formulation FDA pathway accelerated Dec 2025

Milestones

Phase II started

Completed

Actual: May 1, 2023

Phase 2a trial began (depression/anxiety in Alzheimer's patients)

Why it matters: BMND08 is a 5-MeO-DMT sublingual formulation — a very short-duration psychedelic (15–30 min experience) versus psilocybin (4–6 hours). This brevity may be particularly important for Alzheimer's patients who cannot tolerate long supervised sessions.

Phase II topline

Completed

Actual: Feb 29, 2024

Phase 2 results: 100% of participants responded; 100% achieved remission from depression, anxiety, and stress by Week 5; safe and efficacious at max 12 mg once weekly x4 weeks (NCT06816667)

Why it matters: 100% response and remission in an Alzheimer's psychiatric symptoms trial is an extraordinary signal. While the sample size was small, complete remission in a population with severe, treatment-resistant neuropsychiatric symptoms positions BMND08 for Breakthrough Therapy Designation, which would dramatically accelerate the regulatory pathway.

Watch next: Breakthrough Therapy Designation application result; Phase 3 trial design and initiation

Regulatory review accepted

Completed

Actual: Dec 1, 2025

FDA pathway accelerated for nano-formulation BMND08 (proprietary nano-formulation of 5-MeO-DMT)

Why it matters: A proprietary nano-formulation improves drug solubility, bioavailability, and dosing precision — potentially enabling more consistent plasma levels than the sublingual formulation and strengthening the IP position for Phase 3.

Watch next: Breakthrough Therapy Designation decision and Phase 3 design announcement

Recorded Events

Dec 1, 2025: Regulatory review accepted

Feb 29, 2024: Phase II topline

May 1, 2023: Phase II started

Evidence Links

BMND06

Mescaline
Pre-clinical

Obesity (neurological pathway) — repurposed from depression/anxiety

Programme Tracker

Major Depressive Disorder (MDD)

Primary: US (FDA)
Pre-clinicalActive

Repurposed from depression/anxiety to obesity (July 2024); targeting a neurological pathway for weight regulation

Milestones

Pre-clinical completed

Completed

Actual: Jul 1, 2024

BMND06 indication pivot: new target announced — neurological pathway for obesity

Why it matters: Mescaline's 5-HT2C agonism is hypothesised to influence satiety signalling — a mechanism shared by lorcaserin and other appetite-suppressant serotonergic drugs. Repurposing to obesity represents an enormous market expansion opportunity, though the mechanism requires preclinical validation.

Watch next: Preclinical obesity efficacy data and IND-enabling study design

Recorded Events

Jul 1, 2024: Pre-clinical completed

Quick Facts

Type
Public Biotech
Ticker
NEO/CBOE: BMND | OTC: BMNDF | Frankfurt: 3XI
Lead Stage
Phase II
Website
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