Hello, Mr. Tennyson and thank you for joining us today! We are very excited to have the opportunity in speaking with you and get a little more insight into what Awakn Life Sciences Corp (NEO: AWKN) (OTCQB: AWKNF) is doing within the psychedelic sector, and further discuss its recent accomplishments! 

• 1) For those who are just discovering Awakn Life Sciences, could you tell us a little bit about what the company is doing and how it started?

Awakn Life Sciences is a biotechnology company, researching, developing, and delivering psychedelic therapeutics to better treat addiction. 

We are focused on treating addiction as it is one of the world’s biggest unmet medical needs – affecting many hundreds of millions of people each year.

Substance addictions, like alcohol, affected 20% of the global population. Behaviour addictions, like gambling and pornography, affected many more hundreds of millions of people. For each one of the those there is a partner, a child, a relative, a friend also affected.

The current treatments are not always as effective as we need them to be. But there is a now an emerging body of scientific research and clinical trial data showing that psychedelic-assisted therapy could be more effective in some cases that current treatments. 

And we are driven relentlessly everyday to provide hope to the individuals, their families and their communities who suffer with addiction by researching,  developing and delivering ground-breaking therapeutics approaches. 

• 2) Awakn is focused on treating a multitude of illnesses and disorders but with a special focus on Alcohol Abuse Disorder using Ketamine-Assisted Therapy. We would like to know why the company decided to focus on Ketamine specifically, and what led to this decision?

As I am sure you know Ketamine is a schedule 2 drug, that means that it can be prescribed off label. Therefore, we are in a position already to deliver these revolutionary treatments to people in our clinics now!!! That is a huge point of differentiation. But that’s only one part of the pie. We have a ‘near’, ‘medium’ and ‘long term’ therapeutics strategy. 

Ketamine being the near term and as said above is available now. We have also initiated the world’s first ketamine study for a number of behavioural addictions which we will talk about in a minute.

In the medium term we are working with MDMA. Last year we released the results of our phase-IIa MDMA for AUD clinical trial, which again showed some ground-breaking results (75% had not relapsed after 9 months in comparison to a ‘treatment as usual’ groups who 79% HAD relapsed at the 9-month mark). We are looking to progress this into phase IIb this year if we can. 

Then in the longer term we are working with New Chemical Entities (NCE), so that means we are developing our own drugs and therapies to be used in combination to provide more efficient and more effective treatments. We are looking to develop a new entactogen that can work in a shorter time window that MDMA does, approximately a 2hr window would be ideal and make the treatment easier to adapt for national health systems. We have some of the world’s leading experts in our team, notably Prof. David Nutt who we acquired 6 years’ worth of his data and research which has given us an incredible insight into this field which no one else in the world has got. So it’s very exciting!! 

• 3) In early January, AWKN received the approval from the ethical committee to expand its ketamine study to include behavioral addictions/disorders such as internet gambling disorder, binge eating disorder and compulsive sexual disorder. Would this require a new clinical trial? If so, in your best estimate, when does the company expect Phase I clinical trials to begin?

No it won’t require a new trial. To be precise this is actually a study and what we have done is expand the current study into a basket study, which means we now will include a number of other behavioral addictions such as, Binge Eating Disorder, Internet Gaming Disorder and Compulsive Sexual Behavior. With Ketamine being the drug that is used in the study, this means we would not need to go through phase-I for this. Phase-I is around safety to see is the drug/treatment safe and as you might already know, ketamine has been used for decades in hospitals all over the world as an anesthetic and is universally regarded as a very safe drug when used in a clinical setting. So this means we will aim to go straight into a combined Phase-IIa/b trial once we have this study complete which will help speed up the process and ultimately we hope it means that we can get eth treatment available quicker.

• 4) Although Awakn is currently in the early stages of revenue, when do you anticipate AWKN will begin to generate revenue and what does revenue look like in the future for the company?

Thanks to the delivery side of our business, Awakn is already generating revenue. Since late last year, we have two operational clinics up and running, one in Bristol in the UK, and one in Oslo Norway, with our London clinic due to be operational very soon. Each clinic will provide approximately £4m sterling topline per year, with the goal of 20 clinics open by the end of 2024. That would mean that we hope to enter 2025 with all 20 clinics open and with a revenue of £80M which is approximately $110 USD. We are also launching our licensing partnerships business in 2022, which will allow existing addiction treatment centres starting with the US and Canada to. In this model we will enable traditional addiction treatment clinics to provide ketamine-assisted therapy to their clients, a therapeutic treatment that has been proven in clinical trial to be more effective that any other treatment currently available. With the significant scale of the AUD problem globally, we cannot solve this issue on our own by building clinics. So our approach here is to partner with responsible and ethical providers to scale our reach and help as many individuals, families, and communities as possible.

• 5) Last Tuesday, the company announced that its Phase IIb clinical trials were published in the American Journal of Psychiatry. What does this mean for the company and its investors? 

It’s a transformational event, both for company and for the wider psychedelics industry. We have now proven in a clinical trial that our Ketamine-assisted therapy for the treatment of Alcohol Use Disorder (AUD) is more effective than any available treatments.  AUD is huge debilitating global issue. 5% of global population suffer from it. Unfortunately, treatment rates are so low because the poor success rates which is not motivating people to get seek out treatment. Only 16% of people that suffer from AUD will actually seek treatment, and of those few that do, 75% of them will have relapsed within one year. That is just not good enough in our eyes. And these results show we have the potential to radically move the needle in the right direction and start to help a lot of people.

From Awakn’s perspective, the news puts us at the forefront of the industry. Only Compass and MAPS have trials at the same level of maturity. We are looking to progress the research into a phase 3 (for AUD) in UK. Working with the University of Exeter and the UK National Health System (NHS). As you might have seen, we signed an MOU with the NHS late last year, to work with them to progress the trial and also assess their operational readiness to adopt the treatment, which is an incredible statement of intent by them. The NHS are the world’s second largest purchaser of medicines/drugs. We are also seeking co-funding from UK state for the trial. 

It also means as I talked about above it gives us a great opportunity to commercialise the treatment in our clinics and through our Licensing partnerships in the US and Canada. 

And finally for investors it means there is a significant shareholder value in our company. When you look at other companies that are this far along or not even close in terms of their R&D/clinical trials, there is significant delta in the market cap between Awakn and them and as an investor you will know that is where a real value opportunity lies.

• 6) As we conclude todays’ interview, what is one thing you would like to say to investors or shareholders?

As a company and something I alluded to earlier in the interview is that, as a company we are driven tirelessly to democratize psychedelics, as we believe and the research shows, that there is a new more effective way to help so many people who are suffering and have been suffering for decades, all the while creating significant value for our shareholders. That is a very rare thing to be able to say, we are making real change for the good of the world, but we are doing so while driving real value for our investors. We have some really significant milestones coming over the next 12 months, which we are very excited about too, obviously I can’t talk about all of those, but we have publicly said a number of times we are planning to move to NASDAQ this year, which again will give far greater visibility to more investors and give us the platform to push ahead with our research.

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