Hi

It's a very small dose of a proprietary form of LSD (lysergic acid diethylamide) for take-home microdosing (MB22001) that we have so much hope for in our Phase 2 clinical trials.

On 14th February 2024 we will complete the final dose in our Phase 2a trial in patients with Major Depressive Disorder and a short time later, likely in March we expect to announce the top line results and initial findings.

REGULATED MICRODOSING - A POTENTIAL GLOBALLY SCALABLE TREATMENT FOR DEPRESSION.

What is most unique about these clinical trials is that we have regulatory approval for the take-home use of LSD in microdoses. This is a world first and an important step to getting these medicines approved by regulators around the world. We have been testing MB22001 in the community in clinical trials for the past 2.5 years with regulatory approvals.

Regulated microdosing is potentially a highly scalable and cost effective treatment solution for depression. A patient can take a sub-hallucinogenic dose of MB22001 at home and out in the community and get on with their day in the same way they would if they were taking any other medication.

MICRODOSING MB22001 IMPROVES MOOD IN HEALTHY INDIVIDUALS!

In 2022, our world first take-home microdosing Phase 1 randomized controlled trial in 80 healthy individuals using MB22001 was completed and revealed some surprising statistically significant results. Not only is the drug safe, well tolerated and the protocols well adhered to, also on dose days participants had enhanced subjective feelings of:

-"happiness"

-"social connectivity"

-"creativity"

-"wellness"

-"energy

They also experienced reduced subjective feelings of "anger" and "irritability".

We noted an overstimulation effect in about 10% of healthy participants, even with just a microdose and subsequently we discovered the relevant genotype that helps us identify vulnerable patients through genetic testing so we can deal with this effect in advance. As a result we have developed precision dosing protocols to deal with these types of dosing sensitivities. These novel discoveries are accelerating our knowledge and adding a wealth of Intellectual Property and we are building a massive repository of data in what is also a big data play for the company.

MICRODOSING MB22001 IMPROVES SLEEP IN HEALTHY INDIVIDUALS!

We also surprisingly discovered that MB22001 improves sleep! Even more surprising, we saw statistically significant improvements in REM sleep, total time of sleep and total quality of sleep the day after dose days.

The sleep data in healthy individuals was also a good signalling for MB22001 to treat depressed patients that so commonly struggle with sleep.

WHAT CAN WE EXPECT TO SEE IN PATIENTS WITH DEPRESSION?

Our Phase 1 trial results are in a cohort of healthy individuals with no history of mental illness, depression or anxiety. This gives us a lot of confidence that MB22001 might prove to be effective in patients suffering from depression, because we see in depressed patients, low energy, social withdrawal, irritability, loss of enjoyment and low motivation - the precise mood signals we are seeing in healthy individuals! We also see problematic sleep patterns in depression that exacerbate depressive feelings in a negative cycle of illness propagated by the inherent symptoms of depression.

What we are trying to do is change the course of mental health treatments by developing medicines that are more effective than what is currently available in anti-depressant medications and also with a lower side effect profile. We raised millions of dollars from hopeful investors to complete these trials. A necessary part of pursuing innovation in pharmaceutical science is the ability to fund it and garner support for the vision and hope that a new drug might work better. We certainly hope so!

We have cast the data collection net very wide in our microdosing clinical trials to understand the nuances of the effect of microdosing and how it works on the body and the brain in depressed patients. After years of work, we are about to find out!

If we get a positive signal, namely by an improvement in severity of depression rating, measured using the MADRS (Montgomery Asberg Depression Rating Scale), it will be transformative for the company as it enters late stage pharma drug development. If the result is not positive or inconclusive, then we would need to pivot and reconsider the direction of our research. In any event, that is the absolute beauty and nature of this scientific and innovative work and why it is so exciting for our team to be at the forefront.

We are very excited to be completing our Phase 2a depression trial on 14th Feb and learning from the scientific information it gives us so we can progress our work with these promising medicines.

Stay tuned and stay Well!

JUSTIN HANKA

Co-founder and Chief Executive Officer

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