We will email you to start the conversation.
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OK, wonderful and it looks like we are.Live here, so I want to welcome Albert Labs,Barnhill Chan, Jagpal and Mark Malcolm Barrett Johnson.Really appreciate you gentlemen coming on Barney maybe do you want to sort of introduce yourself,say hello and how we can get things started with you guys?
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Yeah, absolutely so hello everyone where Abbott Labs and our mission is to ensure accelerated access to safe and effective psychedelic assisted therapy for patients with urgent unmet needs.
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So of course I would labs Albert Hofmann,the Pioneer who discovered LSD and then later synthesized Cillessen from psilocybin.He was a hugely renowned academic test and he was notable for for his work in psychedelics and we want to pay homage to him.And this is Albert Labs and I'm going to introduce you to Chan Jagpal,our Chief Operations Officer Officer and later your.
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You'll hear from Malcolm Barrett Johnson who is our Chief Medical Officer.
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Fantastic thank you Barney. So I'm at also director of Albert Labs and I just want to really quickly introduce Albert Labs.Our website is a website isalbertla-bs.com there's invest Now button to top right hand side and you can go there and click on it and find all sorts of informationand get a corporate update there as well.So so really quickly I want to move into why Albert Labs different were different than a lot of other psychedelic deals because we're asset light were what were calledBlue Ocean strategy. And we're targeting fast results.
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And so when I talk about asset light,we're not a company that's investing in a lot of clinics or real estate.We're not a company that's investing into novel molecules.You know, that could be hundreds of millions.We do have a lab in Burnaby where we can import,export, sell. We're going to target some R&D for psilocybin cultivation,extraction and formulation technologies. But the bulk of our capital expenditure is going to be on actually.
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Setting up the rule evidence team.Getting in a situation where we can get to patients quickly that require treatment that have unmet medical need and and then move forward with revenues and create shareholder valueso. As a blue ocean strategy or rnic,mental health indication has to do with a cancer related anxiety,and this cancer related anxiety,of course, is going to be within the oncology centers in the UK and these on ecology centers already have multidisciplinary teams and they have patient pools,clinicians and experts, and so we're adding our psilocybin based assisted therapy.
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Uh, the two. This team an and what we really want to do is get to these patients fast.These patients they really need this therapy and we know that psilocybin is a great help in the quality of life to patients that are suffering from cancer later inanxiety and then Step 2 would be to to prove that those therapies approved an move quickly into revenue generation.So really quickly as a value.Mission what is Albert Labs?
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Well, we're going to be a first mover.We're going to be the first psychedelics company to leverage real world evidence studies to deliver the therapies to patients with unmet medical needs.We're also going to have an IP strategy.We're going to run these trials so the rules,evidence trials. We are collecting data and this data will be published.
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It will be published. The results will be published so that we can then turn around and use those publications to to market more clinicians and patients.On how well the therapy works and Thirdly were scalable and portable model.So although we're starting with with cancer related anxiety,we can quickly move into other niche mental health indications and beyond that we can move this same strategy across Europe so we can access other oncology Centers for instancethrough the Scandinavian countries down throughout Germany and throughout the rest of Europe.
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So, so in summary. I just want to mention I want to summarize that our commercialization model is based on an asset.Light strategy is based on the real world Evidence team that we've put together.We have experts in market access,drug development, regulatory.UK regulatory compliance issues. Anne Anne.
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What we're really going to do is spend the money to make sure that ruled evidence team can get access to those patients into those revenues.And what I'll do is I'll hand it over to Malcolm and Malcolm can do a deep dive into ruled evidence of what it's all about.
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And thank you very much.Hello, good evening everybody evening in the UK over here anyway.I'm Malcolm Johnson. I'm I'm on the CMO of the company and my background is I'm I'm a medical doctor and I trained in London I then went and becamean Anita Tistan, then joined the MHRA.The regulatory body in the in the UK,and my background is very much regulatory based.
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And then I went into the European Commission.I joined the with the Innovative Medicines Initiative and then I set up a series of companies working on the regulatory space and in.As Sean said, in the weekly in the market access side and the medical affairs side.So I'm very much into medical side of cancer and everything we're dealing with here.And when you look at normal clinical trial,randomized clinical trial, it's a very expensive process.
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It costs about 1/4 of a billion if you're lucky,and it takes many years.Three to five years. Again,if you're very lucky and you still don't really get out there at the other end,the results you really want.
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It's a bit of a lottery.What's happened recently is we've developed a series of models across the regulatory space and into market access,which allow us to actually look at the real world data.Will would evidence as a as a concept has been around quite a long time,but only recently have you really been able to capitalize on that and use it correctly.
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Now, on this slide you can see basically this wheel on the right hand side here.Now what we're going to be?Do you do that using is with real world evidence you can
actually target patients quicker.You can get the data in quicker.And why do we need that?
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Because nowadays innovation medicines have gone so far.Is it's very complex to actually get a product in,take it to market in any time frame at any cost,which is a reasonable one.Not only that, the patients are waiting around this chance.
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Said earlier this is a very interesting space,but a very very vital space.Cancer patients and especially at this point in time when we got COVID-19 and we gotta pack counts cancer patients suffering very badly,need to have access to these medicines quickly there to do that in a cruel trick.Locally in a clinical trial setting.
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An RCT takes time and effort.With this we can get,as I said, the products in quickly and we can work with people you know what they're doing on the oncology space.We're going to be using a model which,as Sam said, we're going to go into the major centers in the UK,like the Marsden, and we're going to be working with oncology specialists and cancer specialists actually giving these medicines to them and seeing results really quickly.
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That way, Ashan said we aren't using assets ourselves.We're using the assets of the NHS and innovators.And investigators who already knew how to treat patients,but by giving them another tool with the psychedelics.We can actually see the results much quicker Barney next slide please.
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On here we've got the timeline of it.So what we've started already here,the end of 2020.We formed the company. We got advisory boards on board now and what we're doing in the moment we're actually putting the protocols together to go into these centers.Now, when we've done that.
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We can actually expand that center structure up to 10 centers in the UK and I hope is within a very short space of time.Expand That across Europe.Into June we can then start file partnerships properly.And then expand that out,distributing psilocybin. And we're hoping by the end of the year we can get interim analysis.
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Now that's an amazing thing to do,because with the world outward evidence we can do something with our cities,do we can get interim analysis,and we were hoping to get real publications out,if not by the end of this year by the very beginning of 2022.
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To do that is quite an achievement,and what we can also then do is we can tie this information in with the regulatory authorities and with new process is now present in Britain because of theBrexit allows regulators to go much more independent than they've ever had before,and they will be working with us in actually Co dropping these drugs and working with us to get these drugs into patients officially and license them.
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So should I hand it back to you now?Thank you very much welcome so so we are listing the CSE very soon.The next couple months we're raising 4,000,000 as our target.The valuation is really good.It's 12, 1/2 is less than 12 million actually dollars as a corporate company valuation.
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And like I said before,you can go to our website.You can register there and there's even a sub agreement to see if you qualify for our pre IPO raise.Um, I guess I can hand it back to you Barney now or for questions.
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Yeah, absolutely. I think Patrick was going to jump into the questions.If not.
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Very comes.Hello everybody, questions coming in hot?So and then just a note to the audience.If you do have any questions,feel free to pop them in the Q and a bar there,but in the meantime I'm just going to kind of run off a couple questions here that we had ahead of time.
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So as the UK is now a single state outside the European Union,does this effect. Albert labs?If so, how?
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I'll take that when I see Patrick.Thank you, I'm. It does in a good way.As I said, Brexit has occurred very recently and I'm no big fan of exit.I'm out in Italian and I like you up enormously,but it has allowed is allowed the UK to actually go in depends on the regulatory side and what does that mean.
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It allows actually the regulators to develop new ways of developing medicines.Now littering the last few days in the last few weeks,we've had a new process putting being put in place,which will allow us to work with the regulators officially to develop a clinical development plan with them all the way to market access.Is something that UK can do that pretty well and no other country can do?
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We've seen the beginnings of that because as you can see probably with the vaccines we've had the commotions recently between the UK and Europe,which was only on the BBC this morning and we are actually now very adept at actually allowing the regulators to come in and help companies early in the earlystages of these these things.Also what we've got is a new process between the FDA and the MHRA.The regulatory board in the UK which allows us to work with the FDA officially,and indeed other countries like Australia and Singapore.
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Then once we get regulatory approval,once we get regulatory help in the UK.Working with the UK government.Then that will allow us so much free reign into every other market in the world.And the MHRA is a very very good regulator.
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And why is it doing it?Is doing it because the UK wants to to show it can actually?Leave the field in innovative medicines.And we're very much hoping they want to leave the field and psychedelics as well.And we want to show that actually UK research and clinical trial centers are some of the best in the world,if not the best. And so it's going to be a very,very interesting thing, but I think the UK is the place to be at the moment.
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Beautiful and a question about your R&D lab.How do you can you touch on it and how you intend to supply your real world evidence studies like how those got sure solve this supply chain real quick
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or lab in in Burnaby,BC close to Vancouver. Here is is set up as a place for business where we can import,export, hold, psilocybin and other psychedelics.But really what
it's about it is getting a psilocybin.Based medicine, so using actually sort psilocybin as an API and getting that to the important racial distribution centers in the UK and they already exist.
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We've already got relationships with them next Lexon Pharmaceuticals will then take that formulation.To distribute it to each of the pharmacies in the owner quality centers and then to the main patients.So it's about the supply chain and ensuring that we have that we have a source of that supply chain all the way back to North America.
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Beautiful and then Speaking of supply chain.Can you go into a bit more detail about their reimbursement systems in the UK and how that can generate revenue?
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Yeah, sure Patrick what we got in the UK is a fairly constant complex system by which the regulator we got sort two borders in the in the in thein the UK ones called Nice which is the market access program and the other one is the Scottish Medicines Consortium.So we divide into two sort of Scotland and England.We got that sort of rivalry still going.And nice looks very much at areas or quality of life.
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They have qualities, the quality of life measures and these are things like agitation in this sort of area.There like how old patients feel,what they're quoting, life is in certain specific parameters and what they do they put up against the natural measure and a cost.Now very they're very much.They're very much work in the space where they look at the data and they work.
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Well, they have worked very independently up to this point.They are now joining up with the MHRA,the regulators, and they're going to be looking at the way that goes forward now.Once you got the market access teams on board and we're very hopeful we can do for this new process,the UK government put in place.
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That allows us access to the NHS once the market access teams on board things.Basically the whole of the NHS systems open to you in the space in which we're working,which will be oncology patients in the UK.We've got about 1.2 million oncology patients.He would need this medicine and have use of this medicine.
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And that's amazing. So once in.That's what we got access to.And it's not just a matter of accessing patients and oncology patients who need it is a matter of 1 square there.You could be used in a variety of other ways,and it could be used in a variety of other studies.
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What we have is an investigator initiated studies where people start using it because it already used to using it.So by that it rolls over and over and over.And it's a very good way of introducing doctors and clinicians to what the medicine can be.So we're very much hoping that the market access will be a huge clusters.And again, as we have a well developed in the UK in this space,again, we really do think that's a place to be and we think this Community big advantage to then getting across into the market access programs across Europe as well.
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So Speaking of kind of market access and you know starting somewhere in terms of,you know your first development,why did you choose cancer rate related anxiety as your first symptom to approach?
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Yeah, I'll take this one so cancer Anne Anne Anne mental health are two national agenda items for the UK and it's very important to come up with solutions forboth these and cancer related.Anxiety is an unmet medical need,so it's important to understand that you know out of the three million cancer patients in the UK,1.2 million suffer from some sort of distress and anxiety.
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And out of those, half of those patients more than 500,000 patients.Don't have any means to deal with it,and that's why I can't really anxiety.Would be our first choice.It is. It is a huge market an it's a huge for us.
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It's a huge way to help someone's quality of life.That's also that's going through some suffering right now.
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It's also actually it's. It's a completely as you search,and it's a completely unmet need.You know I did oncology for number of years as a condition and oncology patients are very,very undemanding group. As such,they suffered terribly and you see them going for home after stuff.
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And this is something which just hasn't got any other medicine.It's got no other compound which is being used in it in some of those parts because conditions are too scared to.They feel it may affect the immunotherapy may affect the way that other medicine works,but we know is psilocybin that we really can get to a point where we can get up to four times.That affect oriented person in some cases,and that's an amazing thing to have.
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You don't see that sort of thing with any other drug that early on in treatment and we we see a continuation or the effect over long time.
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So really will make an effect on these patients almost above any other patient group we could think of well.Beautiful question from somebody in the audience here.J Chu is wondering, are you planning to develop your own patents here?Sorry to develop and pattern your own psychedelic at all.I want to touch on that Malcolm.
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No specific patents, we're we're basing our IP around novel formulations in our brand name.So we would love to entertain other companies that have novel molecules and maybe try to integrate them into our studies.But as far as a path that we're going to go down,
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that's not something that we tend to spend money on.Having said that, my space and what we're doing is,
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well, there we are. We are looking for a real world evidence which goes into a license drug when we get the license for that drug.Then that that formulation, as you said Chan will basically be specific to us.We will have access to that and that will be Isles like any other medicine in the world.So you might not pattern,but we will have access to it solely,
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so that would be a very interesting out of work.
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Um so and then just back to the question I had here is one thing about your data.Will you be publishing it publicly?Is there, you know, certain data quest that you'll keep private,certain that you'll put out there?Or how is the data being treated?
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The data will be will be Pacific to the company,so that's sort of our IP as well,so we would have access to that and that will be the companies the data will be released.Would it be nice to the regulators?But it was released in posters.
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It will be released in publications like any other medicine would be in terms of development.So it will be a very phase development of the data appeared that I'm through conferences through publications and into into learning journals.What we're doing is effectively using psilocybin like any other medicines of web of real world evidence base as you would have done the old days with a randomized controltrial. But doing a much quicker.
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Fantastic and the Q&A bar here.I've got a question from a previous panelist,Mr Peter. What issues are you running into with respect to standardization impurity profiles which with naturally sourced psilocybin?
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That's something we need to develop.We need to work on that,but definitely you have to have consistent product and you know that's one of the keys.And there's critical thresholds that we have to meet throughout the production and we need to make sure that it's all audited properly by GCP auditor.So there's a lot to that process,
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but it's something that we have the expertise to take care of.Fantastic, just sort of nearing towards the end of the the section here.I want to leave with,you know, sort of a question of past moving for its future.What barriers have you identified?
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You know with scaling Albert Labs and what kind of patient scale up do you envision for the WRWE route?
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Patrick, what we're doing so we're going to go into 10 centers in this coming year in the UK,and we're looking to have thousand patients or so in that time frame.As I said, what we've got is 1.2 million patients in the UK alone would be eligible for this.Order medicine.I think we have to be realistic,so we're looking towards the end of this year.
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We get those 10 centers on board.My guess is when we show that the drug works and so and the psychedelics work in this space.We're gonna have a lot more patients in 2022.I think 2022 is going to be ridiculously busy and we're going to then expand out into Europe into 30 centers.And then we're going to have.
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I don't know, 10,000 patients by the mid 2022.
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