Vancouver, British Columbia – TheNewswire - August  6, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6) (“MindBio” or the “Company”), a clinical-stage biopharmaceutical company focused on novel treatments for depressive disorders, is pleased to provide an update on clinical trials and corporate activity.

The Company is in the completion stages of testing its lead candidate drug MB22001, in a Phase 2B trial in patients with Major Depressive Disorder (MDD). This landmark trial is a randomised active placebo controlled trial in 90 patients and is due for completion by shortly.  An initial top line read out of the clinical trial data is expected in Q4.

MB22001 is MindBio’s proprietary, titratable microdose formulation of lysergic acid diethylamide (LSD), developed and designed for safe, at-home patient use.

The upcoming presentation of results from this trial is of significant importance to advancing treatments with psychedelic medicines, as MindBio remains the only company in the world to have approvals for the take-home use of this type of medicine in late stage trials, the results of which will determine the advancement of MB22001 for depressive disorders into Phase 3 trials and potential future commercialization.

In randomized, controlled trials, MB22001 has already demonstrated statistically significant improvements in mood and sleep — including quality of sleep, total sleep time and REM sleep.  These remarkable and surprising findings related to improvements in sleep are augmented by improvements in clinical depression scales including an impressive 72% reduction in depressive symptoms sustained 6-months post an 8-week treatment with MB22001 as measured by the Montgomery Asberg-Depression Rating Scale or (MADRS).    

Importantly, the microdosed form of this medicine is non-hallucinogenic, and the Company believes that microdosing is the most advanced take home use case of a psychedelic medicine.  MindBio is the clear leader in microdosing treatments.  MindBio patients do not need to attend a clinic to take their doses.  Patients take the medicine at home in the same way they would take any other medication and then get on with their day.

MindBio’s previous trials of MB2001 have demonstrated statistically significant and clinically meaningful improvements in important mood and quality of life features resulting in patients being “happier”, more “energetic”, “socially connected” and “creative”, “less depressed”, “less angry”, “less anxious”, “less irritable”  positioning MB22001 as a promising depression treatment that is convenient and commercially scalable.

The Company has incorporated a new subsidiary MindBio Therapeutics Labs Pty Ltd to explore  new research and development opportunities in Australasia and has seeded it with CAD$100,000 of funding committed in the form of two convertible loans provided by investment firm Shape Capital Pty Ltd and MindBio Therapeutics CEO and Director Justin Hanka.  The convertible loans convert to an aggregate of 20% equity in the subsidiary.

Further, the board has approved the issuance of 61,500,000 Restricted Stock Units (RSUs) under the Company’s Omnibus Incentive Plan, of which 24,000,000 RSUs have been issued to 4 directors, officers and insiders of the Company in lieu of cash compensation and 37,500,000 have been approved for issue to 11 employees and consultants of the Company in lieu of cash compensation.

Justin Hanka, Chief Executive Officer of MindBio, commented: “We are very pleased to be advancing our work towards completion of Phase 2B trials and we are looking forward to reporting the results later in the year”.

We invite you to join us in support of creating a brighter future for mental health.

For further information, please contact:

 

Justin Hanka, Chief Executive Officer

61 433140886

justin@mindbiotherapeutics.com

 

Media Inquiries

Kristina Spionjak

pr@hlthcommunications.com

 

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.

 

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