Cybin Inc. (HELP) Earnings Call Transcript & Summary

Yes. I've spent the last 35 years involved in building drug development companies of some form or other. And what's clear to me is that for the most part, drug development is incremental. We see small changes, small improvements over previously approved treatments. And that's not a criticism. It's just the nature of science. And those small changes are challenging when you come to study psychiatric disorders. So often with depression studies, you see new treatments being looked at that have quite small effect sizes. And so a small improvement in symptoms. And the problem is in the psychiatric disorders that when you give a patient a placebo, they also react to that placebo because of psychological effect. So often, one of the challenges with depression studies is that the active agent doesn't separate from placebo because of that placebo effect. So that, I think, inhibits development of new treatments in this area that could be helpful, but often don't make it through rigorous Phase III studies. So what's very different about these treatments, and we're seeing this with CYB003 in particular so far, is that the effect sizes are very large. And because we are dosing infrequently just 2 doses 3 weeks apart. We're also only giving the placebo infrequently as well. So we're not getting a perpetual placebo effect from daily dosing of placebo. So the risk of separation from placebo is quite small here. And I think we've seen very good separation from placebo in pretty much every larger psychedelic study. So I think that takes a lot of risk out of the development program. We know these treatments work. And what we're seeing is as compared to other treatments today that are slow to work and have retained chronically, we're seeing very rapid onset of effects here, very large effect sizes that are highly durable. So again, if you can move away from this chronic daily treatment of symptoms, to these interventional treatments that can remove someone's depressive symptoms for many months at a time, then that has the potential to really change the landscape. And when you think that only 18% of psychiatrists are available to see new patients. It's -- they're pretty overwhelmed. The system is overwhelmed. These patients are quite high touch. They have a lot of visits to their doctor in the course of the year, as you can imagine, because of the nature of their disease. So it's hard for many psychiatrists to fit in new patients. And the average wait time for a new psychiatrist visit is somewhere between 43 and 67 days, depending on whether you want a telemedicine visit or an actual in-person visit. So if we can remove someone's depressive symptoms for many months at a time, and take them out of the system, then that frees up an awful lot of capacity for psychiatrists and mental health workers to see new patients. So we really could be making a difference in the entire system with these treatments.

And I mean, let's -- you talk about your differentiations with other developments currently happening. You mentioned deterioration already. Why -- I mean, why have you gone through to that -- down that path? Obviously, you've mentioned the adjunctive benefit. What about the ability to the short duration, which I assume does that give you an advantage in terms of leveraging existing infrastructure rather than having to wait for infrastructure to be built out to roll out to you?

Yes. That's a good question. So I mean we're quite fortunate in that the infrastructure is now kind of in place and continuing to expand. So there are a number of interventional psychiatric treatments, if you like, that already exists today. And I would include among those ECT, TMS, Esketamine as examples. And many of these require a lot of visits, 30 to 40 visits a year for some of these treatments, ketamine, 26 visits a year into a clinic. So those centers, though, are established. There are about 4,500 of them today. and continuing to grow. So that's an infrastructure where we know our patients can be dosed with our treatments. Esketamine today typically takes about 2 hours for a dose of treatment. CYB004 is about 90 minutes. CYB003 is 4 to 6 hours. But we're talking about 2 treatments a year potentially for many patients and not 26 visits a year. I can imagine the motivation actually the patients that put themselves into that setting 26 times a year and then can't drive a car afterwards, can't go to work afterwards. So yes, I think these are relatively short acting. They can fit within the existing infrastructure. But at the end of the day, I think the durability of response is really going to make a difference and patients don't have to keep coming back so frequently.

Right. Great. So going -- moving on to another area, probably an area that we wouldn't have considered at the beginning of the year. But you've probably had discussions with the FDA post the regulator's issue of a complete letter response to Lykos's MDMA-assisted therapy NDA submission. So can you share with us? I've got -- this is a 3-part question. Firstly, what questions did you initiate to ask the FDA in light of the NDA rejection?

Yes. It's had a lot of press on this situation and disappointing for PTSD patients that are going to have to wait quite a bit longer now. We had our end of Phase II meeting in February of this year. So we already had a good sense of what the FDA was looking for our Phase III design. We're then very fortunate because of our breakthrough therapy designation with FDA to have a follow-up Type B meeting with them in August. So this was after the Lykos Adcomm. And so all of that discussion, all those issues were public and available to us, which is perfect timing ahead of starting Phase III. It gives a great opportunity for us to ask pertinent questions and to reconfirm expectations, making sure nothing has changed from our February discussion. And we discussed, as you'd expect, study design, patient population. It was quite an interesting topic and the definitions of various endpoints. I can't say there's any really significant major changes that came out of those discussions because we've been fortunate enough to have previous conversations with FDA. We've seen their guidance. Nothing much honestly at the Adcomm was particularly new or surprising to us, but valuable to have that meeting with the FDA at that point in time and ahead of our Phase III beginning. I think that's quite an advantage for us.

So on that basis, were there any lessons you actually learned from these post Lykos discussions that you may have -- may not have been that apparent from your prior consultation with the FDA? And on that basis, was there -- is there anything at all that you have to adjust or at least tinker in the -- even in the smallest way with your approach to the upcoming CYB003 Phase III trial in order to maximize its chances for it to pass must over the FDA?

Not really. I think the issues that were raised at the Adcomm were not new and not a surprise and definitely not a surprise to the FDA, but good to have that chance for alignment with them. I think there is a disconnect between what we're seeing from the FDA's communication and behavior and what you saw at the Adcomm. We're seeing FDA being quite supportive positive. I think my personal opinion is that they are genuinely looking for a way to safely approve these treatments because they see the potential. Obviously, we've got to go through all the rigorous work of Phase III trials. But I'm not seeing the FDA purposely stand in the way. I think what you saw at the Adcomm was a number of issues that -- where people were somewhat outraised by some events that happened. And then a lot of focus on functional unblinding. So -- which again is not a new thing for FDA. So if there's anything we've had to do differently following the Adcomm is to reassure investors and stakeholders that we're tackling this issue of functional unblinding. It's not a new issue. It is an issue that's seen with every CNS drug. If you are taking benzodiazepine, you know you are. If you're taking antipsychotic, you know you are. So this isn't a new issue. But it was an opportunity for us to confirm with FDA what they are looking for to address that issue. And that is, for the most part, they want a 3-arm study where there's 2 active arms at a therapeutic level dose and a subtherapeutic level dose where patients still feel some kind of psychedelic effects or PD effects. So it confuses patients and it removes sort of expectancy bias. Not a new thing, not a new element of design, but good to have a chance to communicate that with them. But other things that we've had to share with our investors to reassure them is, yes, we are following FDA guidance. Yes, we're doing a 3-arm study. Yes, we're using independent raters that are remote and don't have any visibility to the patient's experience or what dose they received. And we're using auditing of various sessions. So we know what's going on in the room between any facilitators and the patients for safety. And this is also -- I think the last thing is this is also a psychedelic naive population for the most part. And I think that was a concern in the Adcomm that a number of -- a large number of patients in one of the studies had a lot of experience with MDMA and so may have had some expectancy. So I think we've covered all the bases. There weren't any really material changes following the Adcomm or the FDA discussions. But as I mentioned, it's a really good opportunity for us to make sure we are 100% aligned with FDA and then sharing that with our investors.

Well, great. Thanks. Well, I think we'll wrap it up there. Thank you, Doug, for all your thoughts and insights on the development programs that you have at Cybin. So just addressing the audience, if you have any more questions for Doug, please send them to me, and I'll pass them on to him. So for our analysis of the company, please refer to our open access website at www.watertowerresearch.com. The views expressed in this fireside chat may not necessarily reflect the views of Water Tower Research and are provided for information purposes only. Finally, I'd like to thank Doug again for your participation, and thank you, everyone, for joining us, and have a great day.

Thanks, Rob.