Vancouver, British Columbia – TheNewswire – June 11, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (“MindBio”), (the “Company”), a clinical-stage biopharma/biotechnology company dedicated to developing novel and effective mental health treatments, is pleased to announce the enrolment of the 85th participant in its landmark Phase 2B clinical trial evaluating MB22001 for Major Depressive Disorder (MDD).

MB22001, MindBio’s proprietary, titratable formulation of lysergic acid diethylamide (LSD) designed for safely monitored, take-home microdosing, has shown a robust safety, adherence, and tolerability profile across thousands of self-administered doses under randomized controlled conditions. This Phase 2B trial, in 90 patients with Major Depressive Disorder is an 8-week triple blind, double dummy, active placebo-controlled trial. The sub-hallucinogenic microdoses administered in this innovative trial design, allow patients to seamlessly integrate the treatment into their daily lives, offering a practical, convenient and commercially scalable alternative to clinic-based, high-dose psychedelic therapies.

The milestone comes as MindBio launches its first commercial project Booze AI app.booze-ai.com in Silicon Valley.  Booze AI is the world’s first voice activated and AI powered blood alcohol estimator over a smartphone. The intellectual property stemming from data collected in clinical trials is an important part of the Company’s commercialisation strategy.

MindBio remains the only organization in the world to have secured regulatory approvals for at-home patient administered dosing of this type of medicine now in multiple Phase 2B clinical trials.  The trial design replicates real world conditions by enabling patients to self-administer MB22001 microdoses at home, empowering patients to manage their condition without the time and cost burdens associated with clinic-based psychedelic treatments.  The Company is developing MB22001 as the most advanced take-home use case of psychedelic medicines in late-stage clinical trials anywhere in the world.  

In addition to the ongoing depression trial, MindBio is actively dosing participants in a second Phase 2B trial for cancer-related existential distress, further demonstrating the versatility of its therapeutic platform.  The company also recently received approval for a third Phase 2B trial targeting Pre-Menstrual Syndrome (PMS) and Pre-Menstrual Dysphoric Disorder (PMDD), with plans to commence dosing pending strategic funding partnerships. MindBio is actively engaging with investors to support this trial, which aims to address another critical unmet need in women’s mental health.

“Enrolling the 85th participant in our Phase 2B depression trial marks a significant step forward in our mission to transform mental health treatment,” said Justin Hanka, Chief Executive Officer of MindBio Therapeutics.

MindBio invites stakeholders, partners, and the global community to join in supporting its vision for a brighter future in mental health.

About MindBio Therapeutics

MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6) is a clinical-stage biopharmaceutical company, focused on developing novel psychedelic-based medicines for mental health disorders. With a commitment to scientific rigor and patient accessibility, MindBio is pioneering the use of microdosing to provide safe, effective, and scalable treatments for conditions such as depression, anxiety, and other psychological challenges. The company’s mission is to improve global mental health outcomes through innovative, evidence-based treatment that is accessible and affordable.

For further information, please contact:

Justin Hanka, Chief Executive Officer

61 433140886

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Media Inquiries

Kristina Spionjak

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