Vancouver, British Columbia – TheNewswire - Nov 13, 2025 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a biotechnology company leading clinical health research and product development has completed its initial assessment of results from its recently completed Phase 2B clinical trial in patients with Major Depressive Disorder (MDD).

Background 

Theories suggest that repeatedly taking low doses of a psychedelic medicine (microdosing) may have benefits for mental health symptoms.  This Phase 2B trial aimed to determine the superiority of repeated microdosed LSD, also known as MB22001 – a microdose of Lysergic Acid Diethylamide, over placebo to treat MDD. 

 

Prior to this trial, the Company had sponsored two successfully completed trials.  A Phase 1 randomised, placebo-controlled trial in 80 healthy individuals and a second Phase 2A open label trial in 20 patients with MDD.  The Phase 1 trial yielded statistically significant dose day related elevations in mood, such as enhanced feelings of wellbeing, increased energy and feelings of social connectivity, creativity and reduced irritability and anger. Statistically significant and clinically meaningful improvements in sleep were also noted.  The Phase 2A open label trial in patients with MDD yielded a 60% reduction in depressive symptoms at the end of the trial and a 72% reduction in depressive symptoms sustained 6 months post treatment.  The data from both these trials was sufficiently supportive of the Company persisting to Phase 2B trials.

 

The Company’s approach to data collection and utilisation in clinical trials has led to many important discoveries. Notably, we made the groundbreaking speech and LSD prediction discovery in that we can predict whether someone is microdosing LSD by using patient’s speech.  This has already led to the commercialisation of the Booze AI app, app.booze-ai.com which in turn has become a world first prediction model for alcohol intoxication and blood alcohol concentration estimation using speech analysis over a smartphone.

    

Methods 

This clinical trial was a single-site, randomised phase 2B clinical trial. Physically healthy adults with MDD  and no history of psychotic disorders were included. Participants took 16 LSD or active placebo (caffeine) doses twice weekly, starting at 8 µg of LSD and subsequently determined by a titration scheme (4 – 20 µg) in a double-dummy design. Concurrent use of antidepressants was allowed with no difference in response between antidepressant users and non-antidepressant users recorded. Participants were encouraged to engage in a self-selected beneficial activity when dosing. Participants, investigators and efficacy assessors were blinded to the allocation.  Primary efficacy was depression severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at the eight-week point.

 

Findings 

89 people (mean age 38.3 +- 10.3 years; 53 [60%] females) were randomised to placebo (n = 45) or LSD (n = 44). The placebo group had a MADRS score of 23.0 (SD = 6.4) at Baseline and 14.6 (SD = 8.6) at eight weeks, presenting a 36.4% reduction. The LSD group had a MADRS score of 23.6 (SD = 6.5) at baseline and 16.6 (SD = 8.1) at eight weeks, presenting a 29.89% reduction. There was no effect of drug allocation on depression severity (MADRS) score at the eight-week time-point (p = 0.5469).

 

The safety profile of LSD was favourable. Adverse event rates were low. The most frequent adverse events on dosing days were abdominal pain and digestive issues (placebo n [%]; LSD n [%]: 10 [22%]; 13 [29%]), blood pressure and cardiovascular issues (11 [25%]; 12 [27%]), and headache (10 [22%]; 9 [20%]).  No serious adverse events occurred in the LSD arm, and the regimen was well-tolerated.

 

Interpretation

Repeated microdosed LSD is not effective for treating major depressive disorder.  

However, there is strong evidence to suggest that there are dose day related mood elevating effects and improvements to sleep resulting from microdosed LSD in healthy individuals.

The data collected from clinical trials continues to inform the Company’s product development activities and the development of novel technologies using AI and machine learning such as the Booze AI app app.booze-ai.com which has already advanced its first iteration into consumer sales and is working towards potential enterprise level opportunities in drug and alcohol intoxication detection using speech analysis.

 

For further information, please contact:

 

Justin Hanka, Chief Executive Officer

61 433140886

justin@mindbiotherapeutics.com

  

About MindBio Therapeutics

 

MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6) is a clinical-stage biotechnology company headquartered in Vancouver, British Columbia, that for several years has been conducting clinical trials and is focused on developing novel treatments for mental health disorders and health prediction technologies using AI and machine learning.

 

Cautionary Note Concerning Forward-Looking Statements:

The press release contains "forward-looking statements" within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "budget," "believe," "project," "estimate," "expect," "scheduled," "forecast," "strategy," "future," "likely," "may," "to be," "could," "would," "should," "will" and similar references to future periods or the negative or comparable terminology, as well as terms usually used in the future and conditional. Forward-looking statements are based on assumptions as of the date they are provided. However, there can be no assurance that such assumptions will reflect the actual outcome of such items or factors.

Additionally, there are known and unknown risk factors that could cause the Company's actual results and financial conditions to differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important risk factors that could cause actual results and financial conditions to differ materially from those indicated in the forward-looking statements, include among others: general economic, market and business conditions in Canada and Australia; market volatility; unforeseen delays in timelines for any of the transactions or events described in this press release.  All forward-looking information is qualified in its entirety by this cautionary statement.

The Company disclaims any obligation to revise or update any such forward-looking statement or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except as required by law.

Neither the Canadian Securities Exchange nor its Regulation Service Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.