During the conversation, host Bruce Eckfedlt asks the hard-hitting questions we all want to know about the development and future accessibility of these medicines.
New episodes of the podcast are released weekly. Stay tuned and subscribe to be notified when a new episode is published. This podcast is available on Apple Podcasts, Spotify, Google Podcasts, and everywhere podcasts can be found.
Transcription
You’re listening to the psychedelic invest podcast where we speak with founders, CEOs, investors, advisors, experts, and thought leaders in the brave new world of psychedelics and entheogenic medicines brought to you by psychedelic and best bring you unparalleled psychedelic investing data and analysis. Psychedelic invest is the industry’s leading resource for those looking to invest in the burgeoning psychedelic industry. For more information and to access all of the podcast episodes, check out our website at psychedelic invest.com/podcast And now here’s the host of the psychedelic invest podcast Bruce exiled.
Welcome, everyone. This is the psychedelic invest podcast. My name is projectile I’m your host, our guest today is Danny Motika. He is co founder and chief executive officer at sai Jen, we’re going to talk to him about the work they’re doing in psychedelics and really kind of looking at that production side the development of compounds development of the psychedelics themselves, everything from manufacturing, formulation, chemistry management, how to really kind of provide the industry with the products, it needs to actually bring these solutions or bring these molecules to various therapeutics, markets, therapeutic opportunities. And what goes into that both from a process point of view, a manufacturing point of view, chemistry point of view, regulatory point of view, this is really I think, kind of the challenges we’re gonna have in psychedelics and beyond just the regulatory issues is how do we stand up in industry with manufacturing, supply chain controls all the things that go into really creating a robust industry and really any, any process? So with that, Danny, welcome to the program.
Thanks so much, Bruce. Pleasure beyond.
Yeah, it’s a pleasure to have you. So before we dive into what you’re doing today, love to get us into the background, you know, personally, what was your what’s been your journey? How did you get into psychedelics give us a little bit of the history?
Yeah. So you know, in a nutshell, as a teenager, I suffered from a severe depression, kind of all tied into terminal brain cancer diagnosis that my father received, when I was 13, did a lot of research online, I wasn’t interested in trying SSRIs, what I looked at as these are palliative medicines, I didn’t want to be taking something every day. And my research kind of indicated that anecdotally, psilocybin mushrooms could really help people who are struggling with depression. So as a teenager, I spoke with my parents about my interest, and they created a safe space for me, in our basement at the time. And yeah, I just, it was that first experience of psilocybin mushrooms that really just demonstrated the power of awe. And so you know, subsequent LSD experiences, it just kind of inspired me that these drugs are controlled and restricted, but they have medical value, I truly believe that. And so I knew that I wanted to try and improve access to these compounds for other people who will, who are also suffering. And, you know, as my use kind of evolved from, I guess, curative to what I’ve now considered preventative medicine, I also kind of an advocate for changing the focus of psychedelics from just treating mental health conditions to wellness, prophylactic medicine applications, and found my passion for chemistry in high school. And so kind of everything came together, and it was like, wow, I need to manufacture these compounds, and other people can figure out how to actually apply them in medicine.
Yeah, I guess, what was your takeaway from your experience? I mean, where it was the benefit, or that sort of the therapeutic process for you, you know, that psychedelics gave, I mean, where did you see the kind of the change or the opportunity to use in psychedelics?
Yeah, so I guess it just, you know, it went from feeling completely helpless from feeling like there was like, no point in living to, you know, all in the course of three hours just experiencing awe and wonder and this deep sense of connection to myself and to the world around me and to the people that I was with. And, you know, kind of also this understanding that if my father was to pass away that I still had some time left with him on earth, and that I could make the most of that it was just, you know, it’s the interesting thing is all these insights that come into your mind that it’s almost like, there’s things that you already know, and you’re just remembering, or you’re re realizing them. And that’s where I think that’s true value is, is, you know, it’s not like, it’s not like it taught me anything that I didn’t already know, it just kind of shifted my perspective and helped me remember these important values.
Yeah, that’s powerful. And so going from this experience, this personal experience, you know, dealing with this early situation, how did you go to kind of figure out like, really, how do you want to participate in the in the industry? Like you mentioned, getting involved in the chemistry side? Like, what what did you learn? Or what did you have to learn to really understand that side of this business to really figure out how you’re going to participate at an industry level?
Yeah, so I guess, I was interested, I initially thought that being a psychiatrist would kind of lend the most credibility to, you know, helping bring these substances to the mainstream. And as I went through high school, and I discovered my passion for chemistry, I was kind of just diving into what it would actually take to manufacture these things, saw how Maps was evolving and kind of came to realize that there was a lot Have psychiatrists already on board. You know, I didn’t need to spend a decade or more going through medical school, when I could focus in on manufacturing and chemistry, which I just found I was really passionate about. And so when I graduated from chemistry, I knew that there was a lot to learn. And the Canadian cannabis industry was just the medical cannabis industry was just kind of coming into being. So I saw that as an opportunity to learn the control Drugs and Substances regulations and kind of what it would take to develop relationships with Health Canada, the regulator, and what was needed to be compliant. And just make sure that you could operate in a way that the regulator would be comfortable with. So kind of worked through the cannabis industry. And it was in 2018, when there was a conference in Stockholm, the colloquium on psychedelic therapy, where researchers were all calling for the same thing. Like they were saying, our research is constrained by a lack of access to GMP, psychedelic drug products. And so everything was just kind of coming into place. It was like, wow, the market fit is finally here for what I’ve been passionate about. And Rick Doblin from Maps put me in touch with Peter Vander Heyden, who’s Sargents. co founder, and he and I were both kind of independently working on a business plan, that was the same thing. So Rick put us in touch. And ever since Peter and I have basically been building this business,
yeah. So what does it mean to build a GMP facility that is going to provide these compounds, you know, for therapeutic use, like, what what actually goes into that? Yeah, so
I mean, you know, good manufacturing practices is really, you know, a set of guidelines that from the design phase all the way through to the implementation phase just means that you’ve, you know, basically thought about your entire process, you’ve designed a series of procedures to validate those processes, so that every batch of material that you produce is consistent and repeatable and have the highest quality. So for us, you know, it was finding the right space, designing a laboratory, it’s been the last year and a half, building this laboratory out. At the same time, we were kind of collaborating with another licensed dealer in Alberta. And we were developing our manufacturing processes for large scale production of psilocybin. And that was kind of our initial value proposition, the problem that we’re solving was, you know, there are no dedicated manufacturers for these compounds. So we need to develop our processes, develop a laboratory get licensed, and that problem is now solved. So, you know, looking forward, the next big piece is okay, well, how do you take this from, you know, supplying a clinical research market, which, you know, might take kilos per year to supplying a true commercial market, which is projected once we really have a lot of trained therapists, and we’ve got clinical infrastructure to developed, you’ll likely need, you know, hundreds of kilos of MDMA a year and dozens of kilos, if not hundreds of kilos of psilocybin. So, you know, that’s kind of the next problem that scientist is jumping on to is how do we take our existing processes and ramp them up to meet true commercial demand? Yeah. And that’s something we’re really excited about
hundreds of kilos of psilocybin isn’t interesting idea. Yeah, absolutely. Well, and let’s talk a little bit about the chemistry because I mean, you’re you’re dealing with what is originally a, you know, agricultural kind of product, or you know, something that’s coming out of a grown product, how do you go from that kind of process to producing things at scale? I mean, how do you actually figure out how to amp up accelerates, you know, create volume to that process? Well, fortunately,
the first synthetic procedure for psilocybin was developed in the 50s by Albert Hoffman, same person that discovered LSD. And so there’s been a lot of work, developing synthetic procedures, you Sona a few years ago published a really elegant solution to the phosphorylation of silos and into psilocybin, which arguably, was probably one of the major bottlenecks remaining in the process. And that that was published in the public domain. So Saajan has kind of incorporated that into our process as well. But it’s really been, you know, kind of taking what has existed, and then hiring really talented synthetic chemists who can do retroactive synthesis. And they can just think about creative and elegant solutions to to scaling up synthetic production, because it’s one thing to produce, you know, in a 50 milliliter round bottom flask or 100 milliliter round bottom flask, you can use more hazardous reagents when you’re working at a small scale, because if there is, if something does go wrong, it’s not going to be catastrophic. If you’re scaling something to a 5000 liter reactor, and you’re using really explosive chemicals, you know, there’s safety issues, there’s environmental impact issues. And so, you know, it’s really just kind of looking at all of our procedures and trying to figure out what kinds of you know, what kinds of reductions and oxidations we can do that are that are scalable and, and safe?
Yeah. And in terms of molecule itself, I know you know, coming out of cannabis, right, there’s all this kind of entourage effect we have all these cannabinoids and everything but in the psychedelics or at least for you know, the ones that we’re using right now, these these are more kind of single molecule, single compound. Is there any difference? between what I would experience, you know, taking psilocybin from a mushroom grown mushroom versus laboratory produced,
what I would say is yes, there will be differences. And the caveat there is, when you’re comparing it to cannabis, the clinical research that was done with THC, you know, it really showed that THC alone would be much more likely to induce paranoia, you know, acute psychosis, and a lot of the negative side effects that come along with when people think about cannabis and difficult experiences with psychedelics and psilocybin, specifically, most of the clinical research has been done with psilocybin. So it’s demonstrated that you don’t need the entourage effect in order to have the therapeutic benefit. And that being said, there are, you know, there’s a number of alkaloids in the psilocybin mushroom, it appears that a compound called Bay asst, you know, like, I would maybe relate that to the CBD of the mushroom world, it may help reduce anxiety, but it’s not required in order to, you know, help relieve symptoms of treatment resistant depression. And I think at the end of the day, I am sides and in general, are advocates for whatever the patient thinks is best. So if the patient believes that a whole mushroom product is going to be better for their healing than those products should be available, part of the problem with whole mushrooms is that there’s a lot of other compounds, there’s, you know, like the cell walls, all the tissue, and mushrooms, all of that stuff can cause nausea. And so one of the nice things about synthetic product is that you’re simplifying what you’re putting into your body. And so you’re going to be simplifying the adverse events like nausea. And so we’ve we’ve actually heard a lot of reports that, that patients who have used synthetic psilocybin report significantly less nausea than patients who are taking mushrooms, and in some of the exemptions that have been granted in Canada for treating patients with end of life anxiety. You know, a lot of several of these patients have complained about not being able to really get deep into their experience, because they’re just so distracted by the really difficult body sensations that they’re experiencing from home mushroom products.
Yes, interesting. And how many I know various companies are looking at, you know, slight kind of tweaks at the compound to try to create different kinds of effects or, you know, changing the experience parameters, timeframe, depth, things like that, I guess, how much are you getting into, you know, innovating on some of these compounds, or looking at various formulations for different, you know, different kinds of therapeutic situations, versus, you know, just wanting to provide the industry with kind of the base, psilocybin and other psychedelic compounds.
So what I would say is that our core business is to focus on production of the classic psychedelics like psilocybin, LSD, DMT, MDMA, once we validated those processes, and essentially, that will be you know, we’ll have inventory, so that will be off the shelf product that people can order from us, we will expand our business into kind of a typical contract manufacturer, where we can do custom synthesis for people. So if there’s a group, you know, I’d say that field trip would be a good example with their ft 104. You know, if field trip came to Sergeant, and they said, hey, you know, we’ve got good preclinical data on ft 104, we’re looking for a partner to scale up production, we need, you know, one kilo this year, and maybe five kilos next year, that’s definitely something that we would be interested in doing. So it’s, we are focused on developing a lot of these compounds, then trying to just find a market for them. But if there are groups that have a potential market, they can come to us. And you know, that’s, that’s true to a degree, we do have some interesting herbal things that we’d like to produce, we do have some interesting tryptamines we’d like to produce, but our focus until our lab is up and running and smoothly operating is just on validation of our existing procedures and products.
Yeah. And what have you had to do? Like, what is the process been for actually getting this getting the business up and running, getting the facilities designed and built, you know, give us a sense of regulatory? Like, what do you actually do least in the Canadian market in terms of getting the regulatory things in place? And then I just give a little overview of what the facility actually looks like. Yeah. So
it’s, you know, the first thing is really getting the lab designed and coming up with a security plan that meets the expectations of the security directive in Canada. So basically, when you’re dealing with restricted drugs, and almost every psychedelic is a restricted drug, the main thing that Health Canada cares about is diversion to illicit markets. So in order to prevent diversion, and to be a licensed facility, you need to make sure that you have sufficient security in place that includes secure storage, you know, a cage around the safe or the vault that you’re going to be building sufficient controls in place. And then you need to make sure that you’re also complying with all the reporting requirements. So because they’re restricted substances, you also need to have submit a monthly report with everything that you’ve purchased, sold, imported, exported, anything that you’ve produced, you need to detail what starting material you produced all that information from and it’s it becomes quite a laborious and you know, intense It’s a monthly report that you have to submit to Health Canada, they want this
information just so that they can kind of keep track of what’s actually being produced, they can kind of audit and check some that nothing is leaving the facility and appropriately.
Exactly. And my understanding I could be wrong is that this is an obligation that Canada has to the convention, the single convention on narcotics. So I think that, you know, all of the countries that are part of the UN has to have obligations to that convention, and part of that is imposing controls on restricted drugs.
So a lot of monitoring, reporting, transmitting data. So getting the facility to design what from a actual construction point of view, I mean, is this just any old industrial building? Or are there unique things about the facility you’re creating? That’s particularly difficult or challenging?
Yeah, I would say that it’s, you know, it is what you would expect to be a clean lab. So I think the challenges in construction come more around good manufacturing practices and kind of having a specific specification for you know, the number of particles that you have in your air, the heat and the humidity that you have constantly. So all of those requirements for GMP kind of add complication, the restricted drugs part really is only about security, and then kind of controlling access to different parts of the facility where precursors or production or storage of compounds is happening.
Got it. And, uh, give us a sense of where are you located, and why choose the location that you you built in?
Yeah, so we’re kind of in the industrial zone in Calgary, Alberta. Calgary has a number of benefits, we have very low operating costs. We have an international airport, that’s, you know, a 10 minute drive away. So we are targeting the global market, the Canadian market is, you know, we’re quite a small country, we’ve got 35 million people or so. So we do have our sights set on Europe, the United States. And in order to really participate effectively, we needed import export options. The other you know, the other big reason is that Calgary is kind of an evolving city right now. So Alberta has mostly been focused on oil and gas, we’ve kind of needed to think about how to diversify the economy locally. And biotech is kind of this new up and coming industry in Alberta, along with technology. So there’s a lot of people who are interested in moving here, we’re very close to the Rocky Mountains, we’ve got a great quality of life. So you know, I think that all of those things, just Calvary fit the bill.
Yeah. And tell me a little bit about how from capitalization of the business. I mean, obviously, building this facilities are is not cheap. How have you done your fundraising? How is that what was that process been? Like? Where have been some of the challenges?
Yeah, to date, we’ve raised about $12 million. It has been a constant grind, and something that I didn’t have experience with before starting Sajan. So it’s been, you know, a lot of learning on the go, you know, happy to have been supported by a great CFO when we were in our startup phase and our transition to a new CFO. So, you know, I’ve always had the support that I’ve needed. Typically, you know, most of our capital has come from funds that are focused in the psychedelic space bind Ventures has been our primary supporter, we’ve got another family office down in Florida, it has been really supportive founders, directors, you know, we’ve put in a fair amount of cash, I think that it’s probably around $3 million, collectively at this point. So you know, it’s something that we all really believe in, and we’re, you know, we would take this as far as we possibly could, this next stage of growth is going to be interesting. So, you know, we’ve basically, we’ve capitalized the facility, we’ve got it up and running. And now we just need to kind of do one last push to raise operating capital and to raise some cash for the r&d project that we’re we’re kind of initiating, we’ve called it project sunflower, and it’s basically to take our existing chemistry and look for, you know, essentially the most creative, efficient, and novel production methods that can take us from that kilo scale up to that 100 kilo scale. And we’re pretty excited because we believe that it’s going to generate a lot of intellectual property. One challenge, I would say, in raising our initial cash was that the methods of production weren’t really protectable, like we do, we do have one provisional patent for an improved tryptamine synthesis. But, you know, we’ve had funds kind of say, well, you know, the only issue is that you don’t really have a competitive moat, like, if all it takes for competitors is to, you know, raise 10 to 15 million bucks, build a lab, you know, get a controlled substances licensed, then, you know, how do we how do you have any assurances that you’re not just going to get, you know, competed out of business. And so, this new scale of project is going to lend, we believe is going to lend itself well to innovation and intellectual property and, you know, give us a lot of opportunities to license out these production methods to other areas of the world. So, you know, I think that there’s different ways that Saajan can capitalize on that we could either kind of copy and paste the production methods into a controlled substances lab in Europe and you know, have that lab fulfill demand for the European continent. or we could just license the technology out to an existing GMP lab there who then wants to take on the risk. So, yeah, it’s
Yeah, fun challenges, and what have been some of the other things you’ve had to do, you know, just as a CEO, you know, building teams, you know, HR issues, like what else has been kind of kind of on your plate as you’ve grown the company?
Yeah, I think the two biggest has been, you know, strategy, like, who does sai Gen want to be? And how do we want to show up in the world, you know, psychedelic values are something that are really important to us. And, you know, we kind of see the quote, unquote, psychedelic industry is bifurcating, I think all companies are kind of aligned with the same mission, everyone wants to see improvements in mental health, you know, but there are, I think that there are different sets of core values that are driving some companies forward and inside and really wants to aspire to being a company, that’s generous, you know, really kind and thoughtful, we want to be philanthropists, we want to give back to the community and support something that’s really, you know, kind of putting patients before profit. And it’s, it’s a hard line to walk when you have shareholders to consider and, you know, technically our, our fiduciary duty is to shareholders above the other stakeholder groups, like there’s no public benefit corporation standing in Canada yet. So it’s been you know, that’s been one of the other challenges is, Sargent, from the very beginning, has had this kind of this intent to donate up to 10% of our profits to various causes. And while there’s definitely a lot of impact investors that that attracts, it can be kind of hard to take those values forward. And, you know, make sure that we’re not being taken advantage of from other other companies that are just kind of looking at profit first.
Yeah. And where are some of the challenges in the industry right now for you, as you kind of look at really what is what is it going to take to, you know, bring psychedelics to those people that have need and can benefit from it? Like, what are the big kind of challenges you see in the overall industry?
Yeah, I think one of the biggest challenges that I see is this divide between groups that believe that believe there’s enough evidence that psychedelic is psychedelics are effective and safe. And other groups that say, No, we need to, we need to collect more clinical data. And so there’s this push in Canada, right, we we’ve got medical cannabis, and there’s a movement that believes that we should have a set of medical psilocybin regulations, there is some pushback against that, because the challenge, of course, when you have a medical access system, it can make clinical research harder, because then the control group doesn’t really exist when that control group just has access to a medical system. And so I think that that’s one of the biggest challenges, like psychedelics are just very, you know, we know at least psilocybin LSD, they’re safe substances, physically, you know, there’s some mental risk, but with sufficient pre screening, you can, you can really mitigate a lot of the site psychological risks. And so, you know, it’s just the timeline, I think, to scaling access is the biggest risk right now, we likely won’t see large scale medical access for psychedelics other than MDMA until 2026, I would guess, at best. And so I think a lot of investors who saw this as a early cannabis boom, where all of a sudden we’re going to see a legalization event or a you know, a medicalization event, and then a legalization event and there was all these growth multipliers. That just I think that this industry is a slower burn, and making sure that investors kind of understand that is one of the biggest challenges. I mean, I’m sure you’ve followed what’s happened in the, in the, in the public market space for psychedelics companies, it’s been a very weak performance. And I think a lot of that is just because of the timelines to see profit.
Yeah. And do you think that’s going to just turn off investors for oil? Do you think that’s just the nature of it, and just different investors will come in that are, you know, have a different investment horizon and understand the both the opportunities and the challenges of psychedelics?
Yeah, I think it’ll be the ladder, I think that there’s going to be an investor base that comes in that has a long time horizon and will support the visions and the requirements, right, because in order to get regulators on board, to see a wellness market emerge, you know, you need to do the research, you need to prove that they’re safe. And the last thing that I think the industry would benefit from is trying to force these things to market and rush forward. You know, we need to do this slowly and methodically and carefully and and make sure that the regulator’s comfortable. Tell me a little
bit about the other facets of growing the business, either to this point, as well as looking forward minutes. How have you handled, you know, some of the other kinds of traditional business challenges, you know, finding the right people getting other kinds of systems in place? I mean, where how much of this has been just kind of normal business stuff, and where, where have you seen challenges?
Yeah, I think a lot of it is normal business stuff. I mean, Saajan you know, right now, I would say that we’re kind of evolving from the startup phase to a growth phase company. And so, you know, in order to support what is going to be a growth phase Year version, you know, we need to Start where we need to establish foundations and processes and systems to support that growth. Because otherwise, you know, it’s just you get into a position where there’s going to be a lot of wasted cash spent and, you know, unnecessary burn. So I think that it’s really just traditional business problems. We’ve been very fortunate in the team that we’ve assembled. You know, we have a lot of experts in psychedelic chemistry, we have an incredible regulatory and compliance team. And, you know, our operations team is it’s all coming together. So it’ll be very interesting to see this month how, you know, we we move into operations. But no, I do think that those challenges are mostly are mostly traditional business. We’re about to reach that critical mass of people where I think that HR challenges Yeah, start to rear their ugly head, but it’s just, you know, that’s just part of being human.
Yeah, no, it was. I remember as being a founder and CEO that the first time that you meet somebody that you then realize works for you and you didn’t know it. Yeah. You’ll lose touch at some point of everyone that’s in the in the company. So I got it. Excellent dandy. There’s been a pleasure. If people want to find out more about you more about Sai. Jen, what’s the best way to get that information? Yeah, best
way we are. Our website is www dot Sai gen.ca. And we’re in the process of updating that it’s still claims that we’re a licensed dealer applicant. But you know, if you want to reach out, feel free to reach out to Danny and saajan.ca to contact me. You know, paul@saajan.ca is our chief financial officer. And then, you know, for any sales inquiries are interests. nadia@saajan.ca is our Director of Sales and she’s done an amazing job at kind of, you know, drumming up a lot of interest and support for businesses that are doing drug development.
That’s great. I’ll make sure that all that informations in the show notes. Danny has been a pleasure. Thank you so much for taking the time today. Yeah,
thank you. Thank you for listening to the psychedelic invest podcast. If you liked this episode, please be sure to leave a five star rating and leave us a review. You can find more episodes on all the major podcasting platforms and our website at psychedelic invest.com/podcast