David Lin – America’s Biggest Crisis (Uncut) 01-29-2025

America’s Biggest Crisis: Is This The Cure? | Doug Drysdale

On this show, we often talk about protecting our wealth, but one of the most important aspects of our wealth is our health. A lot of Americans, more than 10%, 20%, according to some figures, suffer from mental illness. And we’ll be talking about the state of depression and mental illnesses in the US and how these issues can be solved with modern technology and medicine.

Joining us to discuss this and the next steps forward for us, our society, is Douglas Dreisdell. He is the CEO of Saibin, a very interesting company listed on the NYSE. Welcome to the show.

Thank you for being here. Hey, David. Thanks for having me on today.

Appreciate it. Take a look at my screen, Doug. This is from the National Institute of Mental Health.

And according to their reports, mental illnesses are common in the US and around the world. It’s estimated that more than one in five US adults live with a mental illness. So about 59 million people in 2022, 23% of the US population.

Mental illness includes many different conditions that vary in degree of severity, ranging from mild to moderate to severe. Before we talk about the particulars of mental illness, how do we get to this point where nearly one in five Americans suffer from some sort of mental illness, Doug? Yeah, it is pretty staggering, isn’t it? That number one in five. I think what’s even more staggering is that number one in five is on an annual basis.

So any one time during the year, one in five of us is suffering from some kind of mental health disorder. Over our lifetimes, it’s actually one in two. So that means 50% of us in our lifetime to experience some form of mental illness.

That might just be a bout of depression or maybe an anxiety disorder, but one in two is quite staggering. The problem is that the mental health care system is pretty backed up. We have a lack of psychiatrists, a lack of mental health infrastructure.

If you’re a new patient presenting with depression and you want to see a psychiatrist, typically it’s going to take you somewhere between 40 and 70 days to get that first appointment. And these are fairly high touch patients. They need to see their physician six or nine times a year, adjusting medications, dealing with side effects.

So the system is really overwhelmed. What we’ve been doing for the last 40 years since the advent of Prozac is really just treating the signs and symptoms of depression. We’ve found no way to change the course of disease or to cure it.

And that’s what we’re working on at Cybin, is a new approach that acts really quite differently from those daily chronic treatments, kind of acts like a pharmaceutical intervention where we’ve shown in a study that we can remove patients’ depressive symptoms rapidly, so within a day. And for some patients, up to 70% of patients, perhaps we can remove their depressive symptoms for as long as a year from just a couple of doses. So you can imagine that could dramatically change the mental health care landscape if we’re taking people out of the system for long periods of time, just freeing up a lot of resources to treat others that are suffering.

Okay, and this leads to the space of medicinal psychedelics. So take a look here at the National Center of… So this is from the National Library of Medicine. According to this study here, findings show that psilocybin-assisted psychotherapy lowered anxiety and improved mood without clinically significant adverse effects.

Tell us about the rise of this space and what sort of mental illnesses it aims to assist with. Yeah, of course we know a lot about these compounds, of course. For millennia, indigenous peoples have used various types of psychedelics, whether it’s peyote or ayahuasca or magic mushrooms, psilocybin mushrooms.

So it’s not new, but what’s new is now in the last decade or so is we’re focused on really isolating the active ingredients, synthesizing these so we have control over quality and purity, and turning them into Western-style medicines. There’s a ton of data, various academic studies, Johns Hopkins, NYU, Imperial College London, looking at a wide range of disorders from depression to anxiety to substance use disorders. So it looks like that these treatments have the potential to be really quite trans-diagnostic.

And now our task at Cybin is turning those into medicines and taking them through the FDA process to get approval. We’re in phase three right now in our depression study. That’s the final stage before approval.

We’ve been through the first couple of stages where you really find out whether something is safe and effective. So we’re seeing a very good safety profile. And as I mentioned earlier, we’re seeing just these really dramatic results.

We see patients responding within a day of the single dose. And after just two doses, 75% of patients in remission. So I’m not talking about blunting the science and symptoms.

If you take a typical antidepressant today, most people have some form of emotional blunting. So blunts their depressive symptoms, likely blunts their positive emotions as well. But people tolerate that because it’s getting rid of some of those negative feelings.

But they’re taken daily along with the daily side effects. What we’re talking about here are patients in remission. That means zero depression after just two doses.

And a year after those two doses, we still saw 70% of patients free from depression. So as I mentioned, really a paradigm shift and a really different way to treat these disorders. Okay.

This is from the Harvard Medical Journal here. Back to the future, psychedelic drugs in psychiatry. So recently, psychedelic drugs have once again taken popular culture by storm from psychedelic startup companies like yourself, newly forming a Wall Street to a recent New York Times article claiming that psychedelic drugs are closer to medicinal use.

This was dated a few years back. So progress has been made. So the question is posed in this particular article, do they work? And the answer is apparently a resounding yes.

Is there evidence for using psychedelics medicinally to the extent that research has been allowed on drugs and medicines that aren’t yet legal? The answer is an increasing and astounding yes, according to studies. Now, if it’s not yet legal, why is it not yet legal if they have been proven clinically to have medicinal properties and as you suggested, lower side effects and traditional antidepressants? Yeah, that’s a really good question. So these substances are illegal to sell, commercially sell.

It’s not illegal for us to study them. We have to be licensed by the DEA, of course, to do that. And anyone that touches the substances has to be licensed.

So we’re studying them in a very controlled way. But the scheduling of these drugs, so DEA schedules drugs as controlled substances. Anything that is scheduled two, three or four or five can be commercially sold.

Anything that’s scheduled one cannot. These substances are scheduled one, along with heroin, for example. And this really came about, this whole scheduling process in DEA as a result of the sort of countercultural experimentation with psychedelics in the 60s and 70s that really got out of hand, Timothy Leary and all of that stuff.

So that led to the Nixon administration founding the DEA and starting the war on drugs. So to this day, those scheduling those restrictions are remaining in place. Part of the definition of schedule one is not medically useful.

So, you know, our task is to continue to push this through the FDA drug approval process. Once approved and shown to be safe and efficacious by the FDA, then clearly this would no longer meet the definition of not medically useful. And we’d expect to see a DEA rescheduling.

And there are many examples of this happening in the past, as well with cannabinoids, with GHB, various medicines that were in that category previously, and new evidence leads to them becoming available to the general public with a prescription. What are the side effects that may be potentially dangerous by using psychedelic drugs? Yeah, so these are treatments that we’re giving in a controlled setting. So these aren’t go to the pharmacy, get a prescription, take it home.

We are dosing these treatments in a controlled setting. Patients are observed during the dosing sessions by clinical staff. They’re given psychoeducation before the dosing, so they know what to expect.

They are given some tools to deal with any anxiety that may come up from their session. Some of these sessions can be quite powerful. As you can imagine, if you’re delving into someone’s, if someone’s delving into their own mind and trying to get to the underlying cause of their trauma and their depression, then that can bring back some quite powerful memories at times.

So we give them those tools ahead of time. And after, of course, they talk with their psychiatrist, their therapist, and unpack the experience they have. We make sure that there’s no lingering effects.

Side effects are really quite innocuous. The most common side effects we see during dosing only are some elevated blood pressure, nausea in some cases, headache in some cases. These all are mild to moderate in their severity, and they’re all spontaneously resolved without any need for any intervention.

And of course, because we’re only dosing a couple of times, patients aren’t experiencing these side effects on a daily basis like they might do without the drugs. This is an interesting development from the government. Take a look at this article.

R.F.K. Jr., whom Trump appointed to head the health department, wants psychedelics free from corporate control. For decades, the federal government’s stance on psychedelic drugs has been that they are a threat to public health and safety on par with that of hardcore substances. Despite showing no addictive properties, LSD and psilocybin mushrooms are classified as Schedule 1 drugs.

You talked about that, which places them on a level with meth and heroin and above drugs like cocaine and fentanyl. Joe Biden signed into law a bill that authorizes researchers to study psychedelics and treating PTSD and other brain disorders. So according to this Guardian article here, R.F.K. Jr. will probably cut prescription drugs and increase weed and psychedelics access.

So he basically wants to explore the space that you’re in in greater detail and with more support from the government. How do you see this space changing and regulations around psychedelics changing? So mental health is clearly a bipartisan issue, not least because… Sorry, how is it a for example, soldiers off to war zones and they come back traumatized and suffering. And so veterans are a bipartisan issue at the very least.

But depression doesn’t discriminate. Whether you’re white, black, old, young, male, female, whatever, it doesn’t discriminate. So it’s an issue that affects everyone.

There have been policymakers on both sides of the aisle that are pro-studying psychedelics. And it’s good to see someone as prominent as R.F.K. Jr. standing up and being supportive as well. His son, I believe, personally had an experience with psychedelic mushrooms that helped his mental health.

So here’s a personal story. What R.F.K. has said is that he advocates for regulated access to these treatments. So he said that he would like to see approved access to these treatments within some form of regulatory framework.

And I think to quote him, he said not in retail stores. So I think that aligns really well with exactly what we’re aiming to do is demonstrate safety and efficacy through FDA and then make these treatments available under supervision in clinical settings and ultimately get them approved by FDA and reimbursed by insurance companies for broader access. I don’t see this new administration getting in the way of that in any way.

Will it help? It’s hard to say. It’s early days at this point. But it’s not a negative, I would say that.

Well, it’s the rise of psilocybin startups like yourself is not new. Your company, for example, has been around since 2019, I believe. What’s taken the FDA so long? It’s a long process and it’s a difficult one.

You’re right. If you look back to 2019, 2020, there were allegedly 60 or so psychedelic drug development companies. And now there are about less than a handful of us that are thriving and doing late stage development work.

Drug development is complicated and it’s expensive. And it’s in many ways, it’s glacially slow because of all the steps we have to go through for public safety. So we have to go through those steps of determining dosing side effects, interactions with other drugs.

And as we do that in small populations, gradually increase the population size as we get more safety data and then study in the final phase, which we’re in now, phase three, larger populations. So it’s not really FDA that’s being slow. There’s no company yet that has been ready to be approved, but we’re getting there.

I think within the next couple of years, we’ll be at that stage and really not in the not too distant future. Well, before we talk about the phase that you’re in and what’s next, just maybe walk us through the investment case here. Why would any investor in today’s fast paced environment dominated by 10% moves in Bitcoin or altcoins in one day, with a NASDAQ moving up or up and down 3% in a single day? Why would anyone look at a company involved with a very long and tedious FDA approval process? Yeah, that is a really good question.

Because I think we definitely live in a world right now where the next shiny object gets people’s attention. But maybe we see on days like today, with DeepSeek and Nvidia falling 17%, that these things could also fall pretty quickly as well. When things are overhyped, they can also disappear pretty quickly.

Look, we’re a public company, we’re well funded. We’ve raised over $350 million. So far, we have a market cap at this point of about $200 million.

And when you consider there are 40 million people in the US alone, forgetting all other markets around the world, that take SSRIs today, and are potential users of our treatments, clearly the upside in terms of revenues is multiple billions of dollars per year. Without a lot of difficult math, it’s really quite easy to see that. So I would say that in general, the biotech sector has been quite lackluster in the last few years.

We had a bit of a bear market and now it’s just kind of lackluster. And some of that is because of these shiny objects that we talked about. But some of it has led also to many kind of Me Too and less innovative companies falling by the wayside.

So there’s still smart money out there investing in biotech. They’re able to be more selective in this current environment and investing in innovation first Companies like Saibon that we think have a potential to really change the landscape, not just make small incremental changes. So the timeframe may be a little longer.

But we’ve been through now the most complex and most challenging and most risky phases of development. We know these treatments work. There hasn’t been a single psychedelic trial that has failed on efficacy, not one.

And we know they’re safe. And now it’s really about execution at a larger scale before we head to approval. But Doug, even if and once the FDA approves these drugs, the issue is whether or not people will actually take them, whether or not doctors and people in the medical community will actually prescribe these drugs.

Have you talked to people, medical professionals, about their stance on psychedelic-based drugs and medicines? Yes, absolutely. The psychiatric community, the psychology community is quite excited. Both APAs, so the American Psychologists Association and the American Psychiatrists Association, both came out with papers at the beginning of this year, in early January, talking about how psychedelics might fit into the future of treatment of mental health.

So I think there’s no question about the science here anymore. There’s no question about efficacy. When we talk to payers, they are very open to this as well.

By the time patients get past the first couple of lines of treatment, these SSRIs, SNRIs like Prozac we talked about, there are very few options for them. And down the road, if patients aren’t treated well, they end up either hospitalized or often facing suicidal ideation. And those are both incidents that payers want to avoid.

So I think there is a demand. There’s also a bit of an analog as well. Esketamine, which is a product, the brand name is Spravado, approved by Johnson & Johnson back in 2019.

It’s a similar kind of approach in that it’s an interventional treatment, given in a clinical setting, very similar to what we anticipate. But it only lasts a couple of weeks. So patients are coming in every two weeks for treatment, so 26 times a year.

But despite that, it’s on a runway right now of about $1.2 billion of annual revenues. So if patients are willing to go through those hurdles of visiting a clinic and having a treatment 26 times a year, you can imagine that the demand for treatment that’s just twice a year would be significantly higher. So I think a lot of the questions that we had in the past around whether these treatments could be commercialized or not have been answered in the affirmative.

So what’s your longer-term plan after you finish clinical trials and eventually the drug gets approved? Hopefully, do you plan to just sell the assets, the intellectual property, to another pharmaceutical company, like a larger one, to produce? Or do you plan to actually produce and commercialize these drugs yourself? Look, I think we know that the number of sites and clinics where these treatments could be administered is relatively small and manageable. There are about 4,500 of them today. And that’s likely to grow between now and when we have approval.

It’s a customer-based size that we can manage and service ourselves, we believe. But of course, as with any emerging field, if we felt that there was a partner that could help de-risk a launch or accelerate a launch, then we’d be obviously open to looking at that. I think beyond depression is what is exciting, because right now we have two programs, one in depression, one studying generalized anxiety disorder.

And anxiety disorders affect 16 or 17% of the population, very, very large prevalence. But beyond that, there’s evidence that these treatments work in PTSD and postpartum depression, bipolar disorder, alcohol use disorder, tobacco, smoking cessation, opioid use, chronic pain, cluster headaches. So beyond this first set of studies, we can see the potential for quite a large expansion of the platform into other diseases.

Okay. Let’s talk about two of the molecules that you have right now, CYB003 and CYB004. So starting with CYB003, I believe in a recent trial that you did, 71% of patients or test subjects showed in remission after 12 months from just two doses, very promising results.

How does this efficacy compare to other treatments of major depressants in this field that exist already? Yeah. So let me put it into context. So we’re seeing 75% remission after a couple of doses, typically with SSRIs, drugs like Prozac.

And we’ve looked at all the studies on these drugs, so 230 of them since the late 70s, early 80s. And typically about one third of patients are in remission with those drugs after six weeks of daily dosing. So they’re slow to work.

Only about a third of patients are freed from their depression. They’re taken every day, and they come with some pretty unpleasant side effects like weight gain, insomnia, sexual dysfunction. And these are side effects that often need treating on their own right as well.

So patients end up taking multiple other drugs for these two. To kind of put it into context, we measured depression on a well-used scale. It was called the Madras scale.

And we take the patient’s depression score baseline, we give them a treatment in the study, and then we measure after treatment. It’s pretty straightforward. With current antidepressants, on average, patients see about a two-point improvement.

And two to three points is deemed to be clinically meaningful. With CYB3, after a single dose, we’re seeing a 14-point improvement. So really quite dramatic and quite a stepwise change.

If you want to look at it statistically, the effect size, 0.2 to 0.3 with SSRIs, 2.5 with CYB3. So without getting into a bunch of stats, about 10 times greater effect size in current standard of care. And CYB4, what is it? How does it differ from CYB3? Yeah, CYB4 is a little different.

It’s a different type of experience. It’s more immersive, more intense, but shorter acting. We’re studying it for generalized anxiety disorder.

Anxiety disorders are really broad, widespread, 16 to 70% of the population. So really incredible prevalence. There’s really not much out there that is approved to treat anxiety disorders.

These SSRIs work in about half of patients. So half the population is not getting benefit, those that are prescribed. And for many patients, they’re not treated because there’s really nothing that’s particularly beneficial.

Benzodiazepines can help, but they’re not something you want to take over the longer term. So there’s a lot of undertreated and untreated patients because of the lack of options. And like with CYB3, we expect to see really rapid results.

We expect to see highly durable results that last for long periods of time from just one or two doses. And we’ll have our first results for that compound in quarter two, so second quarter of 2025 coming up. So an important milestone for us.

Yeah, it’s in phase two study right now, correct? Correct, yeah. So what is the estimated timeline, if you had to guess, of the next phase and ultimately FDA approval? Yeah, so for CYB3, that is in phase three, we expect to have a complete phase three results around about the end for the whole program, two studies plus some longer term follow-up, around about the end of 2026, early 2027. So in 2027 is when we would expect to file an NDA or new drug application with the FDA.

And then the approval process should take about six months. We expect an accelerated approval. FDA did grant us breakthrough therapy designation in 2024.

This is a fast track designation granted by FDA that should smooth through the review and approval process. Excellent. Tell us a little bit about yourself before we close off the discussion.

Who are you? What was your background before CYB3 and your professional experience? Sure, happy to. Thanks for the interest. I’ve spent 35 years involved in drug development and building drug development companies of some kind or other.

I started out in a lab, actually, a biochemistry lab, but then spent half of my career piecing together drug pipelines. So through partnerships, licensing, product acquisitions, M&A, I’ve acquired 17 different companies now across three continents. But for the last 16 years, I’ve been the CEO of four different pharma companies, two public and two private, two startups and two turnarounds, and a wide range of different businesses from generics to especially pharma manufacturing and biotech.

So I’m a lot older than I look. It’s been quite a journey. But this, to me, is the most exciting opportunity I think I’ve had in my career.

I’d say in general, when I look back at the sort of track record of drug development, drug development is typically incremental in that each new treatment is a little bit incrementally better than the one that came before it. And here, it’s rare that you see these big leaps forward. They happen, but it’s rare.

And this is what we have, what we’re working on at Cybin is an opportunity to really leap forward and make a big change. All right. And the shares, the stock’s currently trading at around $9.59 on the NYSE.

Is the stock price waiting for the next phase of the clinical trials process or something else? In other words, what can you as CEO do to add shareholder value from here on? Yeah, that’s right. Typically, you see biotech stocks increase with each phase of development. Phase two is often a big pivotal time.

So we have phase two results coming up in quarter two. For us, we also have phase three results starting in mid-2026. That will be a large study in depression.

We expect both of those to be very large catalysts. And typically, a company at our stage would have right now, even though biotech is somewhat depressive last few years, we’d still expect an evaluation of around $600 or $700 million. So to be around the $200 million mark, we think clearly is a good entry point and a good point, a good value based on the safety and efficacy data that we have today.

Excellent. Thank you very much, Doug. Where can you learn more from Cybin? Cybin.com, C-Y-B-I-N.com. And as you mentioned, we’re traded on the NYSE under the ticker symbol CYBN.

Excellent. We’ll put the links down below. So make sure to follow Doug and his company there.

Appreciate it. Good luck on your next phase and we’ll speak again soon, hopefully. Great.

Thank you, David. Thank you for watching. Don’t forget to like and subscribe.