Hi

I announce this news a little earlier than planned. The initial results are in and its not what we expected!

Surprised, Disappointed. Indeed. But the Work Continues......

I'm very surprised and as you can imagine, as a founder hopeful to be doing something progressive for mental health, I am disappointed to discover that microdosing lysergic acid diethylamide (LSD) or (MB22001) is not effective, compared to placebo in changing depression scores using the global standard MADRS (Montgomery Asberg Depression Rating Scale) to measure depression severity. See presentation here.

I don't yet have the full report on my desk, but we know with certainty that the primary endpoints were not met, when compared to placebo responses.

This is the nature of scientific endeavour, to figure out what works, what is safe and what is just conjecture and that is how I entered this work 5 years ago when we founded the company.

We can put to rest, with a good level of certainty, that microdosing LSD is not effective at treating patients with Major Depressive Disorder in placebo controlled trials. An incredibly surprising result.

Click Here for Presentation

What about Microdosing in Healthy Individuals?

However, what we also know with a strong level of certainty, from a our large Phase 1 randomised controlled trial in 80 healthy individuals there were statistically significant mood elevating properties from microdosing LSD that are expressed as increased "energy", improved "social connectivity", enhanced feelings of "wellness", enhanced "creativity", less "irritability" and less "anger" and also improved sleep quality and REM sleep time, compared to placebo. The results from this large Phase 1 study in 80 healthy individuals and our successful Phase 2A open label trial in 20 patients with Major Depressive Disorder which showed a 60% reduction in depressive symptoms at the end of the trial, was good evidence to progress to Phase 2B trials.

Well designed trials will invoke a strong and measurable placebo response and in this case, LSD microdosing is not shown to be better than placebo in improving clinical depression scores.

Our research and thesis in microdosing was inspired by user reports over the decades, that microdosing psychedelics, improves the symptoms of various mental health conditions, from anxiety, depression, pre-menstrual symptoms, menopausal symptoms and more. It is not surprising from our clinical trials, given the obvious mood elevating properties that users of LSD consistently report feeling better. They commonly report having reduced depression and anxiety but that evidence cannot be backed up clinically in what we believe is the most rigorous regulated clinical trial in microdosing LSD ever completed.

What microdosing LSD shows more promise for, is for wellbeing improvement, an energy and creativity boost that is much healthier and probably safer than your average energy drink! That is what we can say with more certainty, and it is safe, in fact with less side effects than paracetamol.

Clinical Trials Yielded Discoveries in Speech & Genetics

In our clinical trials we have collected millions of data points, always with the view to rigorous processes in collection and analysis. Our approach has led to a number of incredible discoveries, most notably the discovery that we can predict LSD in the blood by analysing speech recordings of patients. The discovery has progressed to the development of the Booze AI app, the world's first Speech AI powered intoxication detection and blood alcohol concentration estimator over a smartphone.

It Doesn't Stop

We are on a mission to improve global mental and physical health. I'm strongly set in my mission to continue this positive work that continues from the findings of these trials and I believe there is tremendous opportunity to continue to commercialise our predictive tools for medical conditions and to enhance and commercialise our drug and alcohol intoxication technologies to improve global health and prevent suicide.

Grateful for all the support from investors and our colleagues, and Im looking forward to the next stage of this important work.

Stay Well!

JUSTIN HANKA

Chief Executive Officer & Co-Founder

MindBio Therapeutics Corp (Frankfurt: WF6), (CNSX: MBIO)

Initial Results Presentation