and it makes your mind more receptive to the ideas that fear and depression and conditions like this can be overcome and that's just so exciting when we look at the massive number of people who are suffering from this the pain they go through and it's not just them it's their families as well [Music] hello and welcome to CEO insights I'm Marilyn De Guzman with investing News Network today we're talking about psilocybin and its emerging potential in the pharmaceutical industry and to share


his insights on the subject is Dr Michael Raymond CEO of Albert Labs hello Dr Raymond hello and thank you for inviting me yeah it's good to have you can we start off our conversation I guess if you could provide an overview of your company sure Alba Labs is developing licensed medicines for treating unmet needs in mental health and we are using psychoactive substances that is probably going to be in our concern and interest to some of your viewers great so I uh you're focusing on psilocybin and for viewers that are not


familiar with this could you just provide a little bit of a description of what this is and what the potential is psilocybin is a an extract uh the compound that occurs naturally in certain strains of mushrooms fungi and we have a process at Albert Labs which extracts psilocybin plus other active compiles which have been shown to in research studies to have amazingly interesting properties for treating Mental Health so how and why have research approaches around Silas have been changed in recent


years well it's a very interesting question because actually sidewalk to the substances like psilocybin have been known and used for thousands of years literally by primitive societies and more recently uh but it wasn't until the 50s that some of these substances psychoactive substances not just salice event were investigated actively for some of their potential as drugs and as prescription drugs but then we had the period of the 60s and being of that sort of generation some of your viewers also might remember


that um you know it was a time of illegal drug use of drug experimentation and these kinds of drugs developed I think are very bad connotation but in many ways thoroughly undeserved just deserved because it led to all sorts of uh let's say just societally inappropriate behavior uh but nevertheless it put researchers off stud making these drugs and and some of these psychoactive drugs were actually passed as illegal plus one substances uh particularly by the US and by other regulatory authorities


however recently more recently research and a lot of extremely uh well-recognized academic institutions has shown that they can open up Pathways in the brain and lead to mental health treatments and protocols that are just simply amazing in terms of what they can do okay that's a turn that's very interesting so let's talk about safety first uh I guess can you discuss sort of this you know safety profile of psilocybin absolutely and I think many of your viewers will be surprised by the


comments I'm about to make so psilocybin is as I mentioned the psychoactive substance but then so are nicotine caffeine alcohol as well as of course the things that people assume to be psychoactive like heroin cocaine so on and so forth and let's talk a little bit about what safety really means so safety has two components toxicity because toxicity basically is a measure of how much do you have to ingest before you have dangerous side effects or fatal side effects from taking a substance


that's his Tropic there's also is addictedness so if you start taking it how much does your body pray more and more and more so there's been a lot of research done and and summaried psilocybin is actually less toxic and less addictive than caffeine in the cups of coffee people had this morning and in alcohol and nicotine and far far less so of course than substances we don't really want to talk about but like heroin and these kinds of substances so while psilocybin is psychoactive


it has been shown in academic study this to be utterly safe and indeed the FDA has said it's a breakthrough therapy full mental health conditions so you know really safety we can make analogies to mushrooms from which psilocybins extracted but think of different types of fungi so song fungi we eat and brown mushrooms often as far to our diet they're totally said it physically thousand pounds of mushrooms they wouldn't do any harm at all but there are some species of mushrooms I think one's called uh deadly nightcap


UE a teaspoonful and you can die so these substances while they might fall but it seem to be types of fungi some aside some are not psilocybin abstracted rubber mushroom is incredibly safe and that to me was an incredible Railways who Revelation by the science that it is a safe safer as I say than coffee nicotine alcohol which to me is an utter surprise but it's true it's there in the science and is accepted by uh basically by regulatory authorities these days that it is a safe substance


Are there specific conditions or symptoms and you've mentioned mental health um mental health issues um what specific conditions or symptoms have have been identified where evidence suggests efficacy of psilocybin that's a great question too because there have been a lot of studies recently the Resurgence in the science of psychedelics and psychoactive substances really started about uh well one into two thousand perhaps early days was 2005 2010 but lately there are a lot of studies that are


coming out one of the most famous is by Johns Hopkins uh very famous Medical College in the U.S and uh they look at um anxiety and specifically anxiety caused by uh a diagnosis of cancer obviously a very threatening thing and something that causes extreme anxiety in in many people so in this study a single dose of psilocybin along with Associated Psychotherapy and that that condition of associated Psychotherapy is very important in what I'm talking about but psilocybin an Associated psychotherapy


so 86 of the patients in this study had no anxiety symptoms after six months for that six month period and even after that six month period where it expired that's quite remarkable to the effectiveness of a drug because you know the many drugs even antibiotics or over-the-counter medicinals or prescription medicines they're really not that effective 86 percent is an enormous um and surprising result from that study but it's been back to others backed up by the adults from New York University


and there's been work going on of many UK universities all over the world in fact studies are again and again improving how effective these substances and particularly Focus has been on psilocybin how effective it is in treating not only anxiety but also depression and PTSD it's been tried for addiction so all of these things are being done at the academic research level just to follow up on that you mentioned um you know anxiety uh depression associated with cancer and is that just because the the research has been done


in those specific area as well or is it uh do is there evidence as well of you know efficacy in just you know treating depression and anxiety and PTSD in general um yes I I think I think one can say there is evidence to suggest that these kinds of substances can be extremely effective what's important now is having established that they're safe or some of the the psychoactive substances are safe and in particular psilocybin which is the one that we at Albert Labs have focused on are how medicine our drug


candidate is not just psilocybin it's psilocybin and some other bioactives that are present and we have a answered process for extracting these but the these kinds of substances have been shown to have a very significant effect on a number of different conditions and there are now trials going on uh these are tentacle trials to achieve regulatory approval or some of these substances for probability of mental health disorders right so that's actually a good segue for my next question which is you know


talk us about tell us about how Albert labs are developing psilocybin treatments and the conditions that are that you're targeting for your job development well yes um as I mentioned uh one of our breakthroughs was to be able to grow certain strains but only a certain part of the mushroom called the mycilio uh think of it as the roots of the mushroom in a sense the little strands at the bottom that's where the psilocybin and some of the these bioactors are concentrated people have tried before to grow those


and uh unsuccessfully and but what we were able to do are scientists and Engineering people was develop a bioreactor technology that has now been patented uh which is able to produce consistent yields in high quality and high quantity of the products we need for our candidate drug and this is really important because if you think about mushrooms grown in a field or in a warehouse for that matter um there's a huge variety of quality and output that's going to come because it depends on uh like any biological system


is Enzo so many inputs you know how much light temperature nutrients and all these kinds of things in a bioreact figure we can control these absolutely 100 whereas in uh field grown crops you're going to get huge barriers now what's really important to a regulator uh looking at approving a drug it is that your product is consistent consistent consistent day in Day Out because you do not want that dosage to vary you want to be able to assure the regulator that every time that same L contains the same quantity of that


active substance so what's the current progress of your um of your development right now and um what's the upcoming Milestone that we should be expecting well that's uh yes we're very excited because we're just finishing off our free clinical work which involves animal studies and so on again around safety not really efficacy at this point but primarily on safety and the metabolism of these substances in other words when you take it what happens to it in the human body what happens to it how is it processed


how quickly does it stay in the human body and put together those residues are eliminated from the body so that basically you would never know you've taken it these are really important again to a regulator and so we've just finishing up our pre-clinical work and we have signed uh terms with a cro very experienced cro in Australia to conduct our first in human studies and those will start uh well in something about around a month to six weeks from now so that's a very exciting step because


when we have from those preclinical studies and we're very confident that we will have success to show that it's safe because basically our krn 101 drug candidate at Albert Labs is psilocybin with some other um synergistic drug elements that are part of it as well but they're all extracted from a natural substance so with that in had when we go into our PK study it's called that's the in-house sorry in human trial that Regulators say okay that data you can go and now do efficacy efficacy


studies and from that you can get actual license approval to use the medical Physicians can prescribe it so I want to emphasize to read is that Albert Lads is not interested in any how can I put this out of a recreational Market that may or may not exist we are going totally for licensed medicines to treat significance and severe conditions that affect actually arguably not just tens of millions of people but hundreds of millions of people certainly worldwide now the regulatory approach that and we


have competitors of course but the regulatory approach that different companies are using uh depends on a number of things the compound that they're trial in but also the end point that they're trying to reach are they trying to get approval for as you mentioned earlier all types of anxiety all types of depression that's going to be very very very difficult for a regulator to approve and that's why our cynical trial plan focuses on cancer-related distress because it's very simple if you receive


a diagnosis of cancer and you're distressed by that then you go through the treatment which is one one 25 milligram dose an Associated psychotherapy and then three months later are you free of that anxiety and if more little even 50 percent of the patients are free of that anxiety Then the regulator has a very easy choice to make and this benefit patients the answer is yes did it approved I I understand um you know your Going Global with with you know your product development one I wonder what your thoughts are on


you know do you think regulatory bodies you know in Canada or the us or anywhere in the world have sufficient legislation or regulation in place to ensure you know patient access to beneficial psilocybin treatments yeah um we've seen some very interesting developments lately so Australia has basically said okay uh now this was not specifically psilocybin but it is another psychoactive but they are very open to the approval of that I mentioned earlier that the FDA have designated psilocybin specifically as a breakthrough therapy


and the UK is looking very very favorably in this too in fact they have a a parliamentary committee I believe that's actually charged with looking at some of their treatments for mental health the important thing here is to realize that although all these governments and um that they're all very supportive in the sense that they're saying we believe there's some science here which makes sense and we believe that there are some drugs that could be developed that can then be approved later


that can be prescribed by doctors to be used for mental health and patients with mental health illnesses so while there's this opening up of the mindset of a lot of governments and health authorities to say this these kinds of substances absolutely look as though they have enormous potential to help mental health with mental health no single medicine has yet been approved so that's a different process that's where specifically the F you have to conduct clinical trials and we have a clinical trial plan that's


um specially accelerated because our particular approach our protocol is as I mentioned earlier one single dose and Associated Psychotherapy and that's it now the alternative today is something say for depression like uh ssris um so lective serotonin real in reuptake Inhibitors fancy name uh their prescription medicine you have to take them every day and that you're depressed and there's no assurance that when you come off them you will fall back into depression but the substances that weird Albert


labs are working on and others have enormous potential because it's single doses or maybe a dose every six months a little bit of psychotherapy and then you're good to go so it sounds like I've got to tell viewers I take blood pressure medication and I have to take it every day and thank goodness The Regulators looked at this and established 25 years of safe use but we don't have to do that because this will be one dose and basically it's out of the human body within about 72


hours perhaps a little more than that so you wouldn't even know you had it but by that time it it basically makes your brain more receptive to the uh Psychotherapy that's associated with it and the Psychotherapy is a very important part that protocol and it makes your mind more receptive to the ideas that fear and depression and conditions like this can be overcome and that's just so exciting when we look at the massive number of people who are suffering from this the pain they go through and it's


not just them it's their families as well mental health illnesses are wrecking families they're destroying marriages it's it's and it's getting worse it's an absolute crisis that we're facing today yeah that's that's very true and that's certainly it uh you know one dose treatment is you know something that a lot of people would be responding positively to um I guess investors or just members of the general public can't help but make sort of sort of a parallel comparison


between psychedelics or you know and you know work medical cannabis was years ago should the the government bodies be taking or shouldn't they be taking the same approach in terms of Regulation uh when it comes to psychedelics uh interesting question personally and this is a personal view personally I would be disappointed if governments did take the same approach because again I and Weird Albert Labs feel strongly that this is a substance that although it's safe should be taken only under the care of a physician and a


licensed psychotherapist so that will occur uh only if it's given a licensed medicine approval as are things like any other prescription medicine now yes they can be abused but we hope that if regulators and so on are are appropriate and Physicians are doing their job that this would stay within the Realms of a medicine that is given only by physicians and only in association with Associated Psychotherapy so I think those are very very important that is different from the sorts of approvals


that are being given for medical cannabis which is yes you can walk into a store buy it instead of dose yourself that to me is dangerous but and maybe I'm old-fashioned I mean I it's not for me to tell other people what to do with their bodies but I believe that Physicians inside the therapists have a tremendous amount of knowledge that most people out there don't have they know they're suffering from anxiety or depression go and see somebody like this get a treatment it's not available yet


and I want to say that we are still working on the research side of this but I believe because of our accelerated Pathway to regulatory approval which is just as rigorous as other Pathways but that we will have a licensed Medicine by the late summer of 2024 so we're 15 months 18 months away from having this Treatment available to sufferers out there of both anxiety for cancer that will be the initial approval but it might interest viewers also to know that it is actually almost an obligation of Physicians when a


prescription drug is available if that physician feels it can help any patient not just one suffering from cancer distress but suffering from depressed or PTSD or other indications or generalized anxiety as you mentioned that that physician has the right to prescribe that medicine for that patient so there's the potential for the market once we get approval and I've been optimistic here but once we get approval for the focused indication of cancer-related distress Physicians of their discretion can then expand that


market into many other mental health conditions solely as they see fit the company will not be promoting it but if decisions and then of course that leads to more research which publishes more papers more conferences and if they have success and they see results with their patients waiting to see this Market absolutely explode so how are you going to support this initiative and developments that you're doing well we are a public company as viewers may know and uh will this still a Canadian Stock Exchange and we have


broader plans to be listed on other stock exchanges so the buyers in the U.S potential bars in the US window uh we need to raise some additional funds to support these clinical trials to get this medicine through to the licensed and approved stage and uh access is very timely because we are just opening a private placement as we speak uh that placement is seeking to raise uh three million dollars at uh eight cents and that includes a half warrant as well so any viewers who are interested in this find this story


interesting and feel that from an investor point of view it makes sense as part of their portfolio they would be welcome to contact Albert Labs so they can find it on Google or it's Albert labs.com they can go to that and they can find us uh and and we can help them through the process of participating in this upcoming private placement that sounds great and it seems like an exciting time for the company ahead thank you for sharing your insights today Dr Raymond thank you it's been a pleasure being


talking to you today it's great to have you and thanks for watching everyone join us again next time for another engaging conversation on CEO insights thank you [Music]