MindBio TherapeuticsCSE: MBIO
MindBio Therapeutics is a clinical-stage biotechnology company developing MB22001, a proprietary titratable form of LSD designed for take-home microdosing. The company's Phase 2B trials in major depressive disorder and advanced-stage cancer distress have reported strong antidepressant effects, with Phase 2a data showing a 72% reduction in depressive symptoms and 58% remission at six months. MindBio is listed on the Canadian Securities Exchange and the Frankfurt Stock Exchange.
Development Programmes
1MB22001 (Titratable Microdose LSD)
MDD, cancer-related distress, PMDD/PMS — titratable take-home microdose LSD capsule
Programme Tracker
Major Depressive Disorder (MDD)
Phase 2B MDD completed November 2025 — PRIMARY ENDPOINT MISSED. N=89 (44 LSD, 45 placebo/caffeine). LSD: 29.9% MADRS reduction; placebo: 36.4% reduction (p=0.5469). Earlier open-label Phase 2A showed 60% reduction / 53% remission. CSE:MBIO.
Milestones
Phase II started
CompletedActual: Aug 1, 2023
First patients dosed in Phase 2 take-home microdosing study — world-first take-home LSD microdosing clinical trial in MDD patients
Why it matters: MB22001 is a take-home, self-administered microdose LSD capsule — fundamentally different from clinic-supervised macrodose psychedelic therapy. The take-home model could scale to primary care if efficacy is proven.
Phase II topline
CompletedActual: Nov 1, 2025
Phase 2B MDD results: PRIMARY ENDPOINT MISSED. No significant difference vs placebo on MADRS at 8 weeks (p=0.5469). LSD group 29.9% MADRS reduction; placebo (caffeine) 36.4% reduction. N=89.
Why it matters: Critical setback. The strong open-label Phase 2A data (60% improvement) did not replicate in a controlled setting — the placebo group actually outperformed LSD. This is a cautionary example of how psychedelic open-label results can be inflated by expectancy effects. The microdosing hypothesis for MDD is seriously challenged by this result.
Watch next: Cancer and PMDD trials may use different endpoints/populations that could still show effects
Efficacy data
CompletedActual: Feb 1, 2024
Phase 2A positive results: 60% reduction in depressive symptoms, 53% complete remission at 8 weeks (open-label)
Why it matters: Impressive open-label results generated significant media coverage and investor interest. However, open-label psychedelic studies carry high placebo-response risk due to participant expectancy effects.
Watch next: 6-month follow-up and Phase 2B controlled data
Efficacy data
CompletedActual: Jun 1, 2024
6-month follow-up data: 72% sustained reduction in depression severity, 58% complete remission
Why it matters: Durable open-label response is encouraging but does not control for placebo effects. The real test is the randomised Phase 2B.
Recorded Events
Nov 1, 2025: Phase II topline
Jun 1, 2024: Efficacy data
Feb 1, 2024: Efficacy data
Aug 1, 2023: Phase II started
Palliative & End-of-Life Distress
Phase 2B in 40 advanced-stage cancer patients ongoing. Existential distress, depression, anxiety in cancer as indication.
Milestones
Phase II started
In progressPhase 2B cancer distress trial (ACTRN12623000478617) enrolling 40 advanced-stage cancer patients
Why it matters: Cancer-related existential distress is a distinct indication from MDD — patients may respond differently to microdose LSD. The failed MDD trial does not necessarily predict failure in cancer distress, where psilocybin has shown strong effects (Johns Hopkins, NYU studies).
Watch next: Enrollment completion and data readout
Quick Facts
- Type
- Public Biotech
- Ticker
- CSE: MBIO
- Lead Stage
- Phase II
- Website
- Visit