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Meet Psybio Therapeutics - Winner of the CPIS Miami 2023 Pitch Contest

Please check out our Q&A with Evan Levine, CEO, Chairman and Founder.

Interviewed by Erin Roche of Candy & Flowers




Q: What is Psybio Therapeutics?

We are a pure-play intellectual property-driven life sciences company in the psychedelic medicine space. We’re developing new treatment paradigms for drugs for neurological and psychiatric health. We utilize a platform technology that was invented by a team of scientists at Miami University that have invented a way to use bacterial synthesis to very efficiently grow tryptamines and phenethylamines that is more competitive, more effective and less costly than any other production method of drug development in our space.


Q: What is your background and why did you start Psybio Therapeutics?

I’ve actually been working in different areas of sciences my entire career––started off in the investment banking business where I worked for two middle-market firms in New York City doing healthcare and technology banking. That’s really where I cut my teeth in the space and doing that, putting investors together for companies, was a very fee-centric part of my existence. And then I went on into asset management where I joined a private equity firm as a senior partner and portfolio manager, and there I moved from investment banking into managing a very large, $600 million book of business, investing directly in biotechnology and technology companies. I was the portfolio manager and had a team of scientists and analysts that did the deep-dive due diligence for us, so moving from investment banking, where it’s very focused on the short-term fee, going into portfolio management I was very attentive on the long-term life of the company, the milestones and the exit strategy.


When I sold my position out of the private equity fund,I bought out an solvent biotechnology company down in San Diego. I had been making bridge loans into the company for a couple of years and they were not performing, they kept running out of money and coming back to me. So I decided to buy a controlling interest in the company, I restructured it, I went in as a re-org expert, I replaced most of the management team, I replaced the entire board of directors with a group of gentlemen that I knew; they were public CEO’s and CFOs in the biotechnology space, in order to revamp the company. I ended up becoming CEO for eight years. I restructured it and got it uplisted from the OTC to the American Stock Exchange. It was at very low market capital when I bought it and I got it up to over half a billion dollars. I raised $80 million for the company and had multiple institutional analysts covering us. From a the capital markets perspective, it was a great success, but more importantly, after all those years of running it, I received a very robust operational executive experience running a global life sciences company. I’ve run pivotal studies: Phase 3, Phase 2B, 505B2 Bioequivalence, in North America, South America and Europe. So I brought the full package of life sciences experience into this company.


Q: Tell me a little more about the team at Psybio Therapeutics. First, how long have you been around, what has the evolution of the team looked like and where are you today?

Miami University in Oxford, Ohio put out a press release in December, 2019 that this team of scientists had accomplished this research first, using a prokaryotic host to turn it very efficiently into psilocybin and its side products. I identified this, then I approached the university, where there were other groups at this time that were actually becoming interested in psychedelics; the word was just starting to work its way into the zeitgeist, but I was very interested in setting up a biotechnology company in the space.


I registered the company in collaboration with Miami in February 2020; we closed definitive docs in May 2020, during that time we satisfied our research responsibility to the University and I’m going public on the Toronto Venture exchange on my one year anniversary. The first round we did was at a $5 million evaluation; we raised just over a million dollars. One year later, we went out to raise $5 million; I got orders for $17.5 million. The space was starting to light up. I took $14.5 million (Canadian dollars), led by OrbiMed advisors, the largest biotechnology investor on the globe, LifeSci Ventures, and Noetic Capital up in Toronto; it was a really robust institutional round. We came out, went public and it traded really well and that’s when I was able to really put together more of a team. But, in the interim, with the money that we had given Miami University, we were supporting the research scientists that originally invented the technology The team is in the chemical engineering department and they had expertise in metabolic engineering. That’s how they were able to genetically modify the bacteria and turn it into target drug candidates. From there, right after we went public and I had more of a war chest, I brought on a few more people.


I brought on Dr. Michael Spigarelli. Mike has a PhD in Medicinal Chemistry and an M.D. in Clinical Pharmacology. He was chair of the American Board of Clinical Pharmacologists for four years. So he has extraordinary experience but more than his education, Mike has run over 6,000 clinical trials. He has drugs under his belt, drugs that you would know, he’s got hundreds of approvals from therapeutics to diagnostics to devices. He came in to run pretty much all the clinical and regulatory operations and set us up for clinical trials. And we have a Chief Financial Officer who has been my business partner now for seven or eight years––we actually own multiple other businesses together––I mostly run this one, he runs a lot of the other ones but he does support us financially. My Chief Legal Officer, Ross, runs a mid-sized securities legal firm in New York City, so we built around the team but most of the activity goes on within the University. After we went public and received the capital, we added the psychology department to our portfolio and funded them so we have a vivarium where we do animal studies on a daily basis on these target molecules.


What’s different about your approach to medicine like Psilocybin?

Now this platform is highly flexible. Psilocybin became a household word, I mean everybody knew what a magic mushroom was –– there’s never been a magic mushroom that I know of, in our laboratories at Miami. What we do is we modify the bacteria, we grow the psilocybin, we could also grow multiple other targets––there’s thousands of drugs that could come out of either magic mushrooms or other. What’s important is that we believe we’ve completely blanketed the space of bacterial synthesis of tryptamines and phenethylamines. Nobody else can touch us, so when I compare us to a magic mushroom, which everybody knows what it is; you swallow this, you know, lousy tasting thing, you have no idea what you just put into your body. It is not a pharmaceutical product, and we see that when you grow these, there could be as much as a ten-fold variation in the amount of these psychoactive compounds within a magic mushroom.


If you want to try to extract psilocybin out of a magic mushroom, you will need fields and fields of this because once you clip the magic mushroom, it undergoes this blue-dying degradation where it loses its potency right away, so you have two choices there; you could dehydrate it and that will stop that dying experience or you could attempt to extract out of it. There’s such a small amount of psilocybin in it that you would need an enormous amount, a biomass of wet mushrooms to extract. If you want to extract anything else from the magic mushroom, there are just trace amounts. It’s absolutely impossible.


Our platform does this exactly the way we’d make psilocybin. I will do this in 3 days. I start with a feeding structure, I put it in with the genetically modified bacteria in a bioreactor which you’ve certainly seen before if you’ve been to a brewery, similar technology, and in 3 days I will get extracellular psilocybin or extracellular any other drug, like DMT, that I want out of it, and you purify it. So it’s less than a week that I could make a purified product. The chemical synthetic that our competition is using, you need 12 steps to make this, 5 scale-up and purification steps, it is very expensive. Thousands upon thousands of dollars a gram it costs and heavy metals go into it, solvents go into it, you get waste disposal issues but even inferior to that, there’s no real patent protection on the chemical synthetic. It was invented in the 1940’s by Sandoz’s Dr. Albert Hoffman, it was published and patented back in the ‘50’s, it’s been in the public domain all these years and nobody really owns it. The 800 pound gorilla in the space, Compass Pathways, that is what they’re developing and that’s the only group that I really reference ourselves in comparison to. They’re going into pivotal studies, we plan to go into pivotal studies with our biosynthetic formulation, but it’s really the same drug at the end of the day. It’s just the production method that allows us to get there, but again we find the platform, the highly flexible variability that we could make all these different drugs with the exact same bacterial strains far more valuable than just being able to make biosynthetic psilocybin. And its pennies on the dollar compared to chemical synthetic. We would only need to purify once.

Q: What would you like investors to know about Psybio Therapeutics?

We deployed most of that capital that we raised in our go public round into commercial manufacturing, intellectual property, and new drug discovery. So, as far as commercial manufacturing, these drugs were invented in an academic lab, that’s where biosynthetic psilocybin was first discovered. They used small––one liter, two liter––bioreactors, we eventually went all the way up to twenty. We went to Berkeley National Lab under the Department of Energy, we worked with them for quite a long time and spent an enormous amount of capital. We scaled to 300 liters there. We don’t believe anybody else has scaled the commercial level for tryptamine. We worked with Curia Global, we have scaled and purified. We have spent millions of dollars on this effort, so that is all in the rear-view window, that we’ve done the development work already and we’re ready to move on to our CGMP manufacturing. As well, with the discovery going on in the optimization lab and the animal facility, plus all of the commercial manufacturing, we’ve filed 29 patent submissions on this.


We have completely blanketed the entire space of bacterial synthesis of tryptamines and phenethylamines. We’ve also devised this technology that's so highly flexible, we could make thousands of different drug targets depending on what we’re looking to accomplish. What’s really unique is that we have discovered some natural compounds here that when we do our animal studies, and we compare some of our lead compounds––and we haven’t identified the second compound that’s going to go into the clinic–– but we know we’re going to bring a second one into IND phase in the next year, we have seen with animal studies, and these animal studies have a multitude of modalities here, we use of course the industry talks about a head twitch model or a wet dog shake, everybody knows these words. We do sucrose preference testing, elevated maze testing, social avoidance testing, forcedswim testing, and there’s even a rat casino there. You look at these behavioral studies to see what type of characteristics the drugs are reacting on the animals. The next generation compound we have seen and there’s a few of them that are exhibiting these characteristics, we see equivalent anti-anxiolytic, anti-depressive activity as psilocybin and as Prozac as a control, plus the absolute control, without eliciting the hallucinogenic response. So we have non-hallucinogenic hallucinogens that we’re going to bring into the clinic subsequently that are targeting mental and neurological health as well. That’s what is far more exciting to us than synthetic psilocybin. And the analysts put psilocybin as a multi- billion dollar product in in a number of years.

Q: Where can we find more information about Psybio Therapeutics?

You can go to our website, you can look at the pages there, and download the presentation.


 

The Cannabis & Psychedelics Investment Summit Series showcases the best and brightest cannabis and psychedelic entrepreneurs and is the premiere summit for institutional investors, family offices, and ultra high net worth investors. Details on upcoming summits can be found at www.kahnerglobal.com. Please email us at info@kahnerglobal.com for speaking and sponsorship opportunities.


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