Good morning, everyone, and welcome to MindMed's Q3 2021 Earnings Call. I'm Rob Barrow, the Interim CEO of MindMed. I'm also joined today by our Chief Financial Officer, Dave Guebert; and our Chief Medical Officer, Dr. Dan Carlin. I'd like to draw your attention to the fact that this is a conference call that will contain forward-looking information, which may include, but is not limited to statements with respect to anticipated business plans or strategies of MindMed. Forward-looking statements are made as of today's date may involve known and unknown risks and uncertainties and other factors, which may cause the actual results, performance or achievements of MindMed to be materially different from the forward-looking statements. We draw your attention to the full disclaimer contained in our filings on SEDAR and EDGAR. As a reminder, please e-mail any questions you may have to investors@mindmed.co. This year at MindMed has been one of significant growth and maturation of the company with the evolution of our management team, Board of Directors and Scientific Advisory Board. I believe that the company is only as good as the people that make it up, and I'm very pleased to report that at every level of our organization, our people are excellent and excelling. I'm inspired by the expert -- expertise, passion and drive MindMed team brings to our work every single day, and I'm honored to work alongside such outstanding colleagues. Over the course of 2021, we have expanded our team by approximately 50 people across the U.S. and Europe, and we have recruited some of the top talent from the pharmaceutical industry from the likes of AstraZeneca, Sanofi, GW Pharma, Janssen and many others. Additionally, the world-class business and scientific leaders that we have added to our Scientific Advisory Board and Board of Directors over…

Thanks so much, Rob, and good morning, everybody. Moving on to an overview of our drug development pipeline. MindMed made major strides in the third quarter to advance our lead drug programs. Project Lucy, in which we are developing LSD for the treatment of generalized anxiety disorder remains one of our lead commercial drug development programs. Our planned Phase IIb clinical study under Project Lucy is a study of 200 patients with generalized anxiety disorder across 5 treatment arms, including placebo. The study will assess improvement in anxiety symptoms following a single administration of LSD or placebo. This study will inform our decision on the dose to be taken forward into our Phase III pivotal clinical trials. Additionally, based on the rigorous dose optimization design of the study, we believe it will significantly advance our scientific understanding of the mechanism of action that underlies and predicts clinical response. I'm very pleased to report that we've continued to make significant progress in the preparations to begin this study and as reported in our last earnings call, we remain on track to begin enrolling patients in the study in late 2021 or early 2022. Moving on to Project Flow in which we are developing LSD for the treatment of adult ADHD. We have also continued to make strong progress toward initiation of Phase II clinical trial. The final regulatory review is ongoing, and we anticipate that we will begin enrolling patients by the end of this year. Earlier this year, we announced the launch of Project Angie, a component of our pain franchise. We are advancing preparations to engage FDA for a formal discussion of our clinical development plans for psychedelics and pain. We remain on track to file a pre-IND meeting request before the end of this year. Switching to our…

Thanks, Dan. The complete financial statements, along with related management discussion and analysis can be found in the system for electronic document analysis and retrieval. The electronic filing system for the disclosure documents of issuers across Canada at www.sedar.com and also on EDGAR at sec.gov/EDGAR. I'll provide a brief summary of our quarter end financial statements. As a reminder, all figures are expressed in U.S. dollars. MindMed continues to build its operating capabilities and to expand its clinical research and development activities. The highlights of the quarter included the growth of our core team being assembled to execute on our strategic plan. Our net and comprehensive loss for the 3 months ended September 30 was $24.3 million, made up primarily of research and development costs of $7.1 million, general and administrative expenses of $5 million and noncash items, including share-based compensation of $8 million and amortization of intangible assets of $3.3 million. Research and development expenses for the quarter were comprised of payroll and consulting fees of $1.9 million. Clinical research and regulatory costs of $1.9 million. Manufacturing-related costs of $1.0 million. Data and study acquisition costs of $1.2 million and other R&D costs of $603,000. Research and development expenditures include all direct and indirect costs for programs, compensation, licensing fees for intellectual property as well as manufacturing, clinical and regulatory costs. General and administrative expenses for the quarter consisted of payroll and consulting fees of $1.5 million, Marketing and Investor Relations of $199,000, professional fees of $1.2 million, insurance of $825,000, public company-related costs of $532,000 and $706,000 for other G&A. Turning to the balance sheet. Our cash balance at September 30 was $145.9 million, and our working capital was $140.7 million. Our cash used in operations was $10.8 million during the quarter. Net proceeds from financing, which is primarily option and warrant exercises was $800,000 during the quarter. With that, I'll turn the presentation back to Rob.

Thanks so much, Dave, and thanks so much, Dan. I'd now like to address some investor questions. We have a number of analysts on the phone and for any of you that are there, please feel free to the raise hand function and we would be happy to open up audio for you. We'll start there. And then as that concludes, we'll go into other questions we received in writing.

[indiscernible] From [ capital ], are you there? Can you...

Yes. Can you hear me okay?

Yes.

Congrats on the continued execution. I'd just love some clarity on how you think about the timing for your interactions with the FDA, specifically, I guess, the filing of the IND for the Phase IIb? And then also on that note, I've heard some mention in your MD&A around time needed to take a look at the Phase I results for Layla before interacting with the FDA. So I just wanted some color on kind of what you expect the timing of those 2 first on the Phase IIb side for LSD and then also for Layla, what you expect for data analysis turnaround?

Yes. Thank you so much. So on the first point, we tend to have regulatory interactions, including a number of meetings with FDA. And certainly, as we have significant milestones, those are going to be announced and shared. We don't, as a practice, typically announce when we file applications or requests. And so as soon as we have a cleared IND, we'll certainly let everyone know. What I will say is that we have been making tremendous regulatory progress and remain very much on track to initiate that study by the end of this year, as we previously communicated. So obviously, with only about 6 weeks left in the year, we've had an active engagement there. And I guess I can say all signs are go from our perspective at this point. On the 18-MC front, and certainly, as we wrap up the Phase I study that we're currently conducting, we always need time to interpret data and package data and present it to FDA. We had previously engaged with FDA earlier this year to seek a meeting. But ultimately, they requested that we come back once the study was completed. So we had a full Phase I package to present and discuss as we move into Phase II. So with the 18-MC study coming close to conclusion and wrapping up by the end of this year, we are gearing up to really rapidly submit those data to FDA. And then based on FDA time lines for meetings, just typically help to 75 days for Type C meetings, we'll be engaging with the division as soon as we can and then progressing the Phase II study from there.

Got it. Got it. So basically, expect it to wrap by year-end and then have that engagement of the FDA. Just one last question for me. Given the breadth of data from obviously, the prior Phase I and now this Phase Ib, would this be a place where you'd be in a position to maybe discuss surrogate endpoints and the potential for designations like accelerated approval and maybe have a starting point for some of those discussions with the FDA? Or do you think that's something that would come subsequent to Phase II.

Certainly, the requirements for any of the expedited programs, will -- that fast track requires, of course, has unique requirements, but any expedite programs such as breakthrough that are going to need clinical data in order to obtain those designations. And so as we have readouts from any of the Phase II investigator-initiated trials at UHB, we certainly will look to utilize those as appropriate to engage FDA and we're always very much aware of the balance of those expedited programs being granted, but also very motivated to get those designations as the data become available. So it's a little premature to say at this time. And certainly, those designations are -- need to be in place before we would start having dialogues about accelerated approvals. At this point, there aren't surrogate endpoints, in particular, for anxiety that would be a path for an approval or justification for clinical effectiveness. So that is not something that we see in the near term and something likely to be pursued by us. But certainly, if someone were to be able to develop a surrogate endpoint, we'd be very interested and happy to pursue that.

Understood. So more likely maybe a surrogate end point on the substance use side potentially than on the anxiety side?

Yes. I think sort point to anything the CNS are also quite difficult and haven't been the basis for approval generally. So most of them what we're looking here are outcomes, kind of meaningful clinical outcomes for the intended label claims. So we get end points are not something that are -- I wouldn't think of as a priority in terms of our leading drug candidates or programs at this point. Jason McCarthy, I'll open you up as well.

This is [ Michael Kini ] on the line for Jason. So I'd like to ask a bit about the treatment protocols as it relates to the upcoming Phase IIb. As we saw from Compass, it seems like one dose for the pre-bar-bones psychotherapy cohort was enough for significant results, but not to the magnitude expected by investors. So I'd like to see how you think that could translate to LSD. I know it's a different indication and a different drug, but would you expect a similar strategy to kind of establish that baseline for what you can achieve largely dependent on the result of the drug and to find the Phase III dose?

Yes. Thanks so much, Michael. Great question. And I think the answer categorically there is yes. So obviously, everyone is very excited about the readouts of these Phase II studies. And I think it can be lost on anyone, the magnitude of response from the psychedelics is such that even in Phase II studies, we are seeing remarkable responses and there will applaud Compass for the results for both conducting that study and for the positive readout from the study. When you look at -- in depression, in particular, you look at most antidepressant development programs for the SSRI, for instance, and you look in it, if 3 to 5 often, 300 to 500 patient studies in order to get those approvals historically. So the fact that in 70 to 80 patients per arm, Compass was able to demonstrate statistical significance can't be underappreciated. I think it's pretty substantial. But it's also important to emphasize that this is the precise point of Phase II programs is to define the dose, to define the duration to define optimization. If we had all the answers in terms of what is the optimal either clinical or real-world dosing paradigm, of course, we would take it forward, but there remain a number of open questions and it's an area of exploration. So as we think about our program and going into the 200-patient LSD study in generalized anxiety disorder, our focus is to both define that dose, that optimal dose to take forth in the Phase III and to characterize the response profile both in magnitude and temporarily so that we can understand what an optimal dose paradigm is. We are -- as many of you know, we are looking at doses of 25, 50, 100 and 200 micrograms of LSD compared to a placebo. And that will give us real characterization across a full dose range of both the magnitude and duration of each of those doses and will help them form. It very well may be that we see similar acute response in a 100 to 200-microgram dose but we see a prolonged activity in one or the other. And that's extremely valuable before we go into our pivotal trials and will help us narrow this design. So as we think about [indiscernible] and simplifications and as we approach our study, I think our focus really remains on being diligent about learning as much as we possibly can so that we have the narrowest fastest path forward in Phase III in approval.

And then I'd like to just follow up on that point and as can you give a bit more color on what sort of the therapy protocol you're intending to pursue in terms of the number of press sections and integration sessions.

Yes, absolutely. I'll answer briefly and then ask Dan Carlin to comment as well. Generally, though, in an overall framework, we know that good psychotherapy works well -- from a huge body of literature that stands far beyond psychedelics. And we are obviously big supporters and fans of psychotherapy. But what we need to do in development programs in order to have these therapies be accessible and scalable is to find a way to bring them to market, not with a pared-down approach but with one that is actually manageable and scalable. And so it's with that kind of general framework in mind that we've developed our specific training protocol. And our protocol has been informed by the great relationships we have with other physicians in Switzerland who have been administering these drugs for years. And also with, I think, I want to say thank you to our friends at MAPS, who've also been a valuable asset to our clinical team as we've defined our treatment protocol. So we definitely have a narrower focus. But Dan, I will ask Dan, would you please give a few more thoughts on this?

Yes, sure. And obviously, you covered the critical points there. But as Rob said, what we're looking to do here is balance the intention to ensure that someone has a repeatable, reliable and not negative an experience as possible regardless of dose rate, there will be folks who get get placebo and they have to have an experience as well. It may not be a psychedelic experience, but they're going to be in that clinic with some folks for the day, and we need to ensure that they are able to anticipate what that may be like and not have a bad day while they're at it, because they maybe didn't get what they were hoping for when they enrolled in the trial, and there will be folks who get a significant dose of LSD and an experience that's quite conformed by that. And so what we're really focused on is making sure that people are informed about what they're heading in for. So that regardless of the experience they have, they're ready for that. And that as they come out, they're able to report on their status and to the extent that they feel they need to discuss the effect of what happened to them without engaging in a program of psychotherapy where we start to confuse the issue of what was the psychotherapeutic effect and what was the medication effect. So it is a balancing act, but the clinical team has been working with a range of experts across psychedelic, psychotherapy and psychotherapy in general and good clinical trial practices to be sure we strike as best of balance as we can there.

All right. And one last one if you don't mind, and then I'll hop back in the queue. I wanted to ask on the low-dose program in particular because that's sort of a repeat dosing paradigm. What are your thoughts on 5-HT2B activation? And does this represent an anti target for your next-gen discovery programs?

Rob, do you wan't...

Yes, I'll turn that one over to Dan as well to comment on.

Yes. And so obviously, that's a question informed by experience in the field and something that we give a lot of thought to the risk of 5-HT2B liability is something that the entire field needs to pay attention to. It's probably not as well characterized or explicated as maybe it seems at times because it can be taken a bit on faith that 2B is necessarily responsible for some of the downstream adverse events that have been described in the past. But certainly, as we proceed down paths that include more than intermittent dosing with pretty significant periods between the dose as we get into more continual or continuous dosing, we need to be very aware of those risks and liabilities. And to that end, we're certainly digging in, in that direction. And then as you said, Jason, as we develop next-generation molecules staying off of 2B if, in fact, 2B agonism is the mechanism of action for some of the adverse events is going to be an important consideration as well. So as with so many things here, lots of work to be done, but absolutely paying attention to it.

Great. So I think with that, we'll take a couple of more questions that were sent in previously. And obviously, if anyone has any follow-up questions, we always welcome them at investors@mindmed.co. So we have one question from an investor asking can you provide an update on when investors may expect any material disclosures in relation to Project Layla, Project Lucy, Project Angie, or HealthMode? And I think we covered where we are in our progress today. Certainly, as we hit in these milestones and there are a number that if you look into our corporate deck that are cited by the end of the year, our team has been working feverishly to ensure that we hit all of those and everything remains on track to do so. So certainly, as we hit any of those milestones, we will be making announcements. And as data become available or we have more depth of disclosure, we would be happily setting up webinars or meetings to discuss those further. And then one more, I'm going to ask Dan to respond to the question is in the MD&A that was filed last week, the company stated each product candidate consists of -- and this is with respect to Albert and HealthMode, each product candidate consists of a platform that contains a number of separate underlying components, some of which the company anticipates will be within the scope of the FDA -- excuse me, of the Food Drug and Cosmetic Act's definition of medical devices and others will not be regulated as medical devices. Can you elaborate on the product candidates that may fall outside the scope of FDA regulations, ID exemption, nonsignificant risk Class I or Class II software as a medical pipes? And I think what I'll say here is that this is an ongoing discussion with FDA. We have an active program to engage FDA around our digital medicine products. Certainly, some of these components, we intend and desire to develop as medical devices, software as a medical device. And some of them just based on the scope may fall out of that. So where exactly the lines between those claims and regulatory status fall is an active dialogue. We appreciate everyone's patience. Of course, we've been doing quite a bit of work on our digital medicine side. And certainly as we have a show and tell for everyone at some point in the future, look forward to disclosing quite a bit more. But we are so much engaged in the product development effort and our regulatory strategy around these that we'll ask for continued patience as we develop that. And then as soon as we are able, we'll certainly look forward to displaying that for everyone to see. So, Dan, if you want to add anything, yes, please.

Maybe just a little color there, which is that when it comes to software as medical device, the agency and folks working in the digital medicine field are working together to figure out where the rate boundaries are for what constitutes a medical device. The agency has obviously released guidance from time to time and continues to evolve that guidance. And then we contribute to the agencies thinking on that through our ongoing conversations with them about both specific products and about general topics as they relate to the regulatory science and digital medicine. Some of these conversations can happen on a company-by-company basis. Generally, we think that they're better held in a pretty competitive space with a group like C-Path, Critical Path Institute, which we are now a member of, CTTI, the Clinical Trials Transformation Initiative, which we are now a member of and of course, Digital Medicine Society, which we're participating in as well. So each of these groups can help the agency and folks building products to think together about where the regulatory edges and boundaries are. I will say from a general perspective, as we build things, if we think about a platform that may contain software that clearly is intended to provide the function of a software as medical device and, therefore, be regulated. You could imagine in that same platform, there may be informational components or inter-patient interaction components or support components, that clearly are not medical devices, right? So yes, if we talk about the blurry line of what is and what isn't, there something that clearly are and clearly aren't. And when we think about either patient or provider facing platforms, we can envision components of those platforms again, such as maybe general information resources, that clearly wouldn't be regulated as a medical device, living alongside components, say, decision support or measurement that would clearly be a medical device. So it's -- I know it's tricky to have these conversations without having disclosed specific products. But as we go down that path and as we are able to disclose those things, certainly, we'll keep you all in the loop on our thinking about what is and what isn't a regulated medical device.

Good. Thanks so much, Dan. Thanks, everyone, for submitting questions and for being here today. That concludes today's earnings call. We'd like to encourage anyone who has follow-up questions to contact us at investors@mindmed.co. A recording of today's call will be posted on our website after the call. And again, thank you so much for being here. We look forward to the next time we're together and many more to come. Thanks, everybody.