Drysdale, for this fireside chat. Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing novel next-generation treatment options to address the large unmet need. The phase III program for Cybin's lead CYB-003 candidate for the adjunctive treatment of major depressive disorder is underway and currently dosing. Cybin trades on the NYSE American and CBOE Canada under the ticker CYBN, and you can find Cybin's safe harbor statements in the company filings, which are filed with the SEC and Canada's SEDAR. Great to see you.
Good to see you again, Robert. Thanks for doing this today.
Right. Cybin has been pretty busy. It's been announcing key partnerships and collaborations during the course of the past several weeks. While all are undoubtedly strategically important to you, arguably the one that many think, including myself, is the most intriguing and the most forward-looking is your partnership with Osmind to help accelerate commercial preparation for your late-stage clinical programs. Before we delve into that partnership, I think it would be helpful if you could start by helping us understand the state of the interventional psychiatry clinics landscape in the U.S. today, how it is evolving, and the clinic infrastructure's level of preparedness for effectively administering innovative therapies such as CYB-003 that could become largely available in the next two to three years and potentially revolutionize the treatment of mental disorders.
Yeah, I think it's a good place to start. I think that this emergence of a network of interventional psychiatry centers is really exciting for patients. We know that there's a limited amount of mental health resources in the U.S., but these centers that have begun to emerge over the last five years, now there's around 5,000 or so of them, they're offering a range of services to patients from ECT to TMS, S-ketamine, regular ketamine, and appear to be, from our work and our interactions with these centers, appear to be really good sites for potential dosing and treatment with psychedelics as they come to market. To see this sort of for-profit network being formed that's driven by, and expansion that's being driven by demand, is just, I think, something that's very exciting for patients given limited access to mental health disorders.
We visited many of these centers. Many are physician-owned, sort of entrepreneur-owned. Some are small chains, are private equity-owned. These sites typically have five or ten treatment rooms, sort of private, discreet rooms. They have centralized monitoring of the rooms with cameras. They're staffed with technicians, nurse practitioners. They do a lot of work onboarding patients, patient monitoring for safety. They offer this range of services where patients come in fairly frequently for treatments. TMS treatments are fairly frequent. S-ketamine is pretty frequent. It can be as much as 26 times a year. When we talk to physicians about potential use of those centers for psychedelics, it's clear that many of them would see very little change needed to make that happen.
In particular, the sites that are currently involved in dosing S-ketamine, which is probably a good solid sort of 50% or so of these sites that do that on a regular basis. It is a good starting point. This infrastructure is growing. I expect that by the time we come to market, there will be even more of these sites. We are quite fortunate, I think, to have some dedicated, highly motivated centers that we can immediately go to to help distribute and administer our treatments.
Right. Thanks for that. Following on from that, what was the thought process behind the decision to enter a partnership with Osmind, and what steps will you be taking to best leverage that partnership to make your therapies, if and when approved, accessible to as many patients that need them as possible?
Look, Osmind is quite a unique opportunity, and it's a partnership that we believe will develop and create value now and now until we come to market and beyond. It's not just about commercialization later, but learning now. It's a technology platform that operates in about 800 of these interventional psychiatry clinics or mental health centers, and they have kind of a unique perspective in that they interact with the clinics, the providers, the patient, and the payers. When we think about this reach, we are using this now to understand clinic resources, clinic infrastructure, what is needed to support our treatments, what's the workflow, what's the economics of the clinics, what's the profitability factors, what are the things that drive profitability and motivation for these centers, and what are the things that would get in the way.
From a provider point of view, what are their treatment protocols? What are their decision-making processes as they move patients through those decision trees? What's their reaction to our potential treatments? When would they see themselves prescribing? Which patients would they see themselves prescribing to? From a patient point of view, what's the patient journey? What steps do the patient have to go through to get them to the point when they're in one of these centers and ready for one of our treatments? How long did that take? What's the patient's product reaction, the reaction to our potential treatment? What's their likelihood to try it? Which types of patients would be willing to try it? Ultimately, finally, payers, of course, what's the reimbursement patterns? I mean, having access to all of these EHR, electronic health records, that's very valuable to understanding reimbursement patterns.
Which drugs are getting reimbursed? At what point are they getting reimbursed? What are the step edits along the way? What's the prior authorization process? How successful is the prior authorization process for each plan? You can see that there's a massive amount of data within this operating system that's really going to help us understand all of the nuances and all the steps that'll help us create the most successful launch.
Great. Now, let's turn to your phase III CYB-003 paradigm program. You've added more sites with additional strategic partnership agreements penned. What is the rationale for entering in these SBAs, and how do you see it expediting the clinical trials?
With any clinical trial, you have sites that have higher volume of patients and sites that have lower volumes of patients. We've identified out of the 45 sites we're working with in the U.S., so far we've identified 18 and likely a few more coming that we believe will be our core sites, those that will deliver the highest volume and highest throughput of patients and carry the study, if you like. The purpose of these agreements is that they're meant to create more than just a vendor-type relationship, but more of a strategic alignment between the sites and us and the study, providing the right resources, providing the right incentives for the sites. It's critical for us that this core group of sites delivers. We're also tapping into these centers to form working committees, steering committees that help identify issues along the way and address them.
The machine is kind of self-fixing and self-adjusting, and we're taking input from the folks on the ground, the investigators on the ground, the site monitors on the ground, the study coordinators that are doing all of the work. We have 45 sites now so far engaged, and of course, it's a heavy lift. I mean, no one shouldn't believe anyone that tells you that clinical trials are easy. That's definitely not the case. There's a lot of contracting, obviously, going on, hundreds of investigators being trained, hundreds of session monitors being trained. Every site needs a DEA license. It's moving along very well. Dosing is underway, and approach at this point has become very U.S.-focused for speed and for simplicity. In our embrace study coming up later this year, we plan to include many E.U. sites as well.
Great. You also have got a manufacturing agreement with Thermo Fisher, which is pretty critical and just not only just to take care of your trial needs, but also for future manufacturing if and when you commercialize. Are you looking to partner with other CDMOs so that you do not become over-reliant on one source of supply?
Yeah, I know this problem very well, having run the CDMO in the past. Look, Thermo Fisher is fantastic. We've been working with them for a very long time now, developing the products and the supply chain. I think they're at this point probably the largest CDMO in pharma globally. I think the market cap is something like $150 billion. We've chosen a very financially strong partner that will be around for the long term. They have just excellent technology platforms in the U.S. and in many other geographies as well, which could prove to be useful. They have very deep resources. Any issues, any CMC issues that come up along the way, we don't expect those to be a problem or a bottleneck because of the resources that Thermo Fisher has. They're really an excellent partner.
They are manufacturing our active ingredients and also the finished product, the capsules for CYB-003 in both South Carolina and Ohio. U.S.-based manufacturing, no importation concerns or delays or issues there because of its U.S. base, no tariff concerns, of course. I think the partnership gives us an awful lot of options. Volumes are low. Volume expectations are low with these treatments because we're expecting dosing just to be maybe a couple of times a year for most patients. I don't see volume capacity being an issue. Of course, we'll always retain the right to be able to qualify other sources as backup as well. We're very happy with this partnership with Thermo Fisher.
Thank you for that. Can you now run through Cybin's key near and longer-term milestones?
As you know, with CYB-003, the paradigm program, phase III program is underway, starting with the first short-term study, 12-week study, which is Approach. As I mentioned, we're fully engaged with Approach, dosing patients, ramping up sites, and that's going very well. We expect that study will read out in the second half of 2026. It's hard to be much more granular than that at this stage. There's an awful lot involved in ramping up these studies, but we think that's a reasonable timeline. For Embrace, which is the next phase III study, we need two phase III studies for CYB-003. We plan to start up that study around mid-year also this year. On our second program, which is CYB-004, our deuterated DMT program for generalized anxiety disorder, we have a phase II study ongoing, and that should complete around mid-year this year.
I have to say it's going a little bit slower than we anticipated. It's a small study, so we have a small number of sites. It's very competitive out there, actually, for psychedelic study resources. At the moment, there are six, seven, eight psychedelic studies going on in some of these centers all competing for the same staff and same time, same rooms, infrastructure. We're seeing a little bit of that, but we expect this to complete around mid-year, and the focus is on quality of patients, obviously, in the study and not pushing and pressuring the sites too aggressively because we want to make sure we retain that quality.
Right. So, it seems that Cybin is making progress on multiple fronts based on what you've just said to us and on the announcements you've been making. At the end of the day, it all hinges on successfully navigating the regulatory pathway. Doug, let's conclude this fireside chat by talking about the FDA. On the plus side, key appointments and some of the comments that have come out of them seem to be very favorable towards psychedelics. On the flip side, many in the pharma and biotech community are deeply concerned about the impact of reduced FDA resources, workforce cuts that have been occurring under the Trump administration. It would be certainly interesting to get your take on all of this, perhaps based on your own interactions with the Trump FDA.
Yeah, I can understand those concerns. Of course, when you see those headlines, it's always concerning to us as well and every other biotech company, I'd imagine. I have to say that our interactions with the FDA have been tremendous, actually. We've had several meetings. The last one just a few weeks ago, they remained fully engaged and responsive. We had great attendance. The last couple of meetings, we've had 20-plus people from the FDA attend. These meetings have been in person, which is also good. Often they'll seek remote meetings if anything is too important. We're seeing really broad representation from the FDA across a wide range of departments. It's clear to us that they're paying attention to psychedelic drug development, that they're learning across many programs, not just ours. We don't see any issues with timelines or responsiveness either. There's no slowdown.
So far, very, very encouraging. I think when you add that great interaction that we've had to the positive comments, the vocal comments that have been made by Marty McCarry and RFK Jr., I think it's safe to say we're in a very favorable regulatory environment right now for psychedelic drug development.
That's great. I think we'll wrap it up there. Thank you, Doug, for those updates and your latest insights. Busy and exciting times ahead, and thank you for all those who have joined this fireside chat. If you have any additional questions for Doug, please send them to me, and I'll be sure to pass them on. For our analysis of the company, please refer to our open access website at www.watertowresearch.com. The fireside chat will also be accessible on demand on our website. The views expressed in this fireside chat may not necessarily reflect the views of Watertow Research and are provided for information purposes only. Finally, I'd like to thank everyone for joining us and have a great day.