Good afternoon, and welcome to the MindMed Second Quarter 2025 Financial Results and Corporate Update Conference Call. [Operator Instructions] This call is being webcast live on the Investors and Media section of MindMed's website at mindmed.com, and a recording will be available after the call. I would now like to introduce Stephanie Fagan, Chief Corporate Affairs Officer of MindMed. Please go ahead.

Thank you, operator, and good afternoon, everyone. Thank you for joining us today for a discussion of MindMed's second quarter 2025 business highlights and financial results. Leading the call today will be Rob Barrow, our Chief Executive Officer. He will be joined by Dr. Dan Karlin, our Chief Medical Officer; and Brandi Roberts, our Chief Financial Officer. After our prepared remarks, we will open the call for Q&A, and Matt Wiley, our Chief Commercial Officer, will also be available for questions. An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call. During today's call, we will be making certain forward-looking statements, including, without limitation, statements about the potential safety, efficacy and regulatory and clinical progress of our product candidates, our anticipated cash runway and future expectations, plans, partnerships and prospects. These statements are subject to various risks such as changes in market conditions and difficulties associated with research and development and regulatory approval processes. These and other risk factors are described in the filings made with the SEC and the applicable Canadian securities regulators, including our annual report on Form 10-K and our Form 10-Q filed today. Forward-looking statements are based on the assumptions, opinions and estimates of management at the date the statements are made, including the nonoccurrence of the risks and uncertainties that are described in the filings made with the SEC and the applicable Canadian securities regulators or other significant events occurring outside of MindMed's normal course of business. You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, July 31, 2025. MindMed disclaims any obligation to update such statements even if management's views change, except as required by law. With that, let me turn the call over to Rob.

Thank you, Stephanie, and thank you, everyone, for joining our call today. I'm very pleased with our overall performance and execution through the first half of the year. We are currently on track with enrollment with our three pivotal Phase III trials for our lead asset, MM120 ODT, which is being evaluated in patients with Generalized Anxiety Disorder, or GAD, and Major Depressive Disorder, or MDD, the two most common psychiatric disorders in the U.S. We took a strategic approach in selecting GAD and MDD as the initial indications for MM120 ODT, driven by the unmet medical need, clinical development feasibility as well as the large commercial opportunity. Targeting both indications potentially provides us with the broadest label possible and enables us to reach a wider patient population. In the U.S., more than 60 million people live with GAD or MDD and notably, more than 50% of patients with GAD also suffer from MDD. This creates a meaningful opportunity to address both conditions with a single therapeutic approach, particularly considering the limitations of current treatments. We believe MM120 ODT has the potential to offer a differentiated novel best-in-class treatment option for these patient populations. MM120 was granted breakthrough therapy designation from the FDA based on the results of our Phase IIb trial in GAD, which showed an effect size of 0.81 in the 100-microgram cohort, more than double that of standard treatments. And as a reminder, a single dose of MM120 demonstrated strong clinical remission rates with 48% of participants in the 100-microgram cohort achieving remission at week 12. Our Phase III trials are thoughtfully designed to build on the strong foundation of these successful Phase IIb results while also positioning MM120 ODT for real-world implementation. A key advantage of our approach is the efficient single visit treatment model, which…

Thank you, Rob. As you mentioned, we continue to be very encouraged with the enrollment trends we are seeing for our pivotal Phase III studies. Starting with our GAD studies, Voyage and Panorama, we remain on track and continue to expect top line readouts from Voyage in the first half of 2026 and Panorama in the second half of 2026. As a reminder, each study consists of two parts, Part A, a 12-week randomized, double-blind, placebo-controlled parallel group period assessing the efficacy and safety of MM120 ODT versus placebo; and Part B, a 40-week extension period with opportunities for open-label treatment designed to provide important long-term data on the durability and response patterns with MM120 ODT. In Voyage, we are targeting enrollment of approximately 200 participants who are being randomized 1:1 to receive MM120 ODT 100 micrograms or placebo. While in Panorama, we are targeting enrollment of approximately 250 participants who are being randomized 2:1:2 to receive MM120 ODT 100 micrograms, 50 micrograms or placebo. We modeled these Phase III studies after our successful Phase IIb study of MM120 in GAD. The primary outcome measure is the Hamilton Anxiety Scale, or HAM-A, which was the outcome measure used in our Phase IIb study and with the outcome measure used for the approval of currently available GAD therapies. In our Phase III studies, the primary endpoint is the HAM-A change from baseline to week 12. In our Phase IIb trial, we observed an almost 8-point HAM-A improvement for MM120 over placebo at week 12. We designed the Phase III trials to have 90% powered to detect a 5-point improvement over placebo based on certain statistical assumptions. To ensure our actual statistical power is maintained, we are using an adaptive design in our GAD Phase III studies, which includes an interim blinded…

Thanks, Dan, and thanks, Rob, for the warm welcome and introduction. I'm thrilled to be here with you today, having joined MindMed at such an exciting time. The opportunity to work with an experienced and passionate management team, especially with their deep drug development expertise, was a huge draw. Additionally, the chance to make a meaningful impact on mental health, an area with significant unmet need really resonated with me. I'm excited to bring my experience to support our path to commercialization, which includes potential billion-dollar market opportunities. I will also be focused on enhancing our investor communications and leading our financing strategy to ensure we're well capitalized to execute our priorities and create long-term shareholder value. As Rob and Dan mentioned, I'm also pleased that we are conducting our Phase III studies with remarkable efficiency, which is a testament to the thoughtful and strategic approach taken by our team. From a financial perspective, I want to underscore the significance of this efficiency. By optimizing our study designs and regulatory pathway, we are not only maximizing the potential for clinical success, but also ensuring the thoughtful use of our resources. This approach enables us to allocate capital in a way that drives value for our shareholders. I'm confident that our strategic and fiscally responsible approach will enable us to deliver sustainable growth for years to come. Now to review our financial results for the quarter ended June 30, 2025. We ended the quarter with cash, cash equivalents and investments totaling $237.9 million. Just a reminder that when looking at our balance sheet, this total comes from three line items, cash and cash equivalents, short-term investments and long-term investments. Based on our current operating plan and anticipated R&D milestones, we believe that our cash, cash equivalents and investments as of June…

Thanks, Brandi, and it's great to have you on board. In closing, 2025 is a critical year of execution, and I'm extremely proud of how our team is delivering. Our three ongoing pivotal trials remain on track with strong clinical site engagement, underscoring both the significant unmet need and the transformative potential of MM120 ODT. We have built a high-caliber leadership team with the expertise to execute our strategy and drive long-term shareholder value. With 2026 expected to be a catalyst-rich year, we remain confident in our ability to deliver on our mission of bringing a differentiated best-in-class novel treatment option to the millions of patients who desperately need it. Thank you for joining us on the call today. Dan and I are now happy to answer your questions.

Thank you. [Operator Instructions] Our first question comes from the line of Marc Goodman with Leerink.

There's been a lot of data that's come out by other psychedelic companies. I was just curious your thoughts on what you've seen so far and how you think about that just relative to your programs?

Yes. Thanks so much for the question, Marc. Yes, it's an exciting time for the field. And certainly, as we get into 2026 and especially exciting time we have the three pivotal readouts from GAD and MDD next year. One of the things we've been really excited about with our data from Phase II and obviously would be great to see replicate as we progress is the magnitude and the significance of the change that we've been able to demonstrate that is also durable for many months. And that's something we haven't yet seen from any other drug in the class or any other program so far. And so we've been -- I think as we've engaged with physicians, and payers and everyone, we've been particularly excited by the reception of those data and by the promise of a drug that has such a significant impact and such a durable impact on patients and one that we, again, hope to continue to show strong evidence of efficacy and safety in the pivotal study. So certainly, again, excited for the field, excited for our programs, especially as we get into the Phase III readouts next year.

Our next question comes from Pete Stavropoulos from Cantor.

Congratulations on the progress. Brandi, nice to hear you, and congratulations on your new position. For the Voyage and Panorama studies, can you just discuss the powering assumptions and the assumed dropout rate or study discontinuation rates? And for the Phase IIb, I believe there was a 25% dropout rate. Can you expand on steps you're taking to drive better retention? And how much of that is attributed to the OLE design or higher probability of active treatment?

Yes. Thanks so much for the question, Pete. I'll cover the first part of that and then turn it over to Dan. The powering assumptions are consistent across both Voyage and Panorama, which is we assumed 90% power to detect a 5-point difference between those groups. And it's important to note that while a power analysis is incredibly important, we also look at the minimum clinical difference that would need to be observed to get a statistically positive outcome. And that by nature of the math is almost -- always lower than the powering assumptions. And so while we're powered for a 5-point delta at 90%, and that assumes a 10-unit standard deviation and a 15% dropout rate, we certainly would anticipate that we wouldn't necessarily need to see a 5-point difference between the groups to get a statistically positive outcome. I'll turn it over to Dan to talk about patient retention and how we're thinking about that in Phase III.

Yes. Thanks, Rob, and thanks, Pete. I think you actually identified exactly [indiscernible] features of the study that are going to control that dropout rate. And obviously, having more folks in an active treatment arm yields less dropout. But you identified I think what we'd look at is the absolute key feature, particularly for folks who aren't feeling better after their first blinded dose is that knowing if they hang in there for that full 12-week observation period that we will provide the opportunity for open-label treatment is a real encouragement for people to stick around for the entire double-blind period. So we're optimistic about that dropout rate and optimistic about the ability to provide those open-label treatments during the extension phase.

And then one more question, if you don't mind. I guess, assuming positive Phase III data and MM120 is approved, what do you expect from real-world use and commercialization? And what I'm sort of asking is, how are the Phase IIIs and the OLE designed to sort of generate real-world treatment patterns?

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

Yes. That's another really exciting part of the extension phase is that, as we've said before, the extension phase gets us the ability to watch long term over that full year of observation and even beyond, what the effect of the double-blind treatment is for folks who do progress to the extension phase and then are able to get open-label treatment, we intentionally set a limit of 4 treatments per year, thinking that, that is more than folks would need because we don't want to rate limit those data. So we want to actually get at exactly, as you say, real-world treatment patterns. So given the availability of those open label with a threshold that's below the threshold for enrollment, the threshold set for retreatment being right at the threshold for mild to medium illness. And what we think we'll see in the extension phase is very much what we expect to see in the real world. So that given that threshold for treatment, given the fact that it's open label, given the fact that we have the clinical trial sites closely engaged with patients, we think that we'll be able to establish the range of treatment patterns that are to be anticipated in real-world treatment and be able to describe those as we come out of that study and the results of the extension phase.

Our next question comes from Brian Abrahams with RBC Capital Markets.

Congrats on the continued progress and congrats to Brandi on the role. Two questions for me. I guess, first, just kind of thinking about the enrollment trends for the Voyage study. It sounds like those are going quite well. And just sort of wondering if you're kind of at the point where more than 50% of the trial has enrolled and an interim analysis would be taken to determine whether you'd expand sample sizes? And then secondly, I'm curious sort of the degree of commercial preparatory work that you might start to do at this point. And what your sense is from just operationally, the study -- the execution of the studies, what are the key areas that you're going to need to focus on or want to focus on first in the launch with respect to site education and awareness?

Yes. Thanks so much, Brian. To your first question, we have not given exact numerical updates on enrollment. As a reminder to everyone, the interim analysis would be conducted after about half of the patients have completed 12 weeks of the study, but we've yet to give precise update on numbers and certainly are excited to get through that milestone and get through to data. In terms of the second question, I'll turn it over to Matt Wiley as well for, our Chief Commercial Officer, to answer.

Yes. Thanks for the question, Brian. And so as we have spent the last several months working through a number of key strategic elements of the plan. First and foremost, the market access, we want to understand the different pathways to reimbursement. We're anchoring our market access strategy into practice economics. We want to make sure that clinicians not only have access to the drug, but it's not a loss-making opportunity for them. So we've spent a lot of time examining the industry progress, the different pathways that are used in interventional psychiatry. We've also spent quite a bit of time breaking down the targeting methodology for GAD. We want to ensure that we're targeting those facilities out of the gate that have the highest volume of GAD patients, those that are probably most appropriate for MM120 right at launch. So we've gone through that process. We've built out a targeting apparatus that we think is pretty tight. And so now we know where our patients are and where the clinicians who manage them are as well. So that's where we've been focused. And over the last month or 2, we've really zeroed in on our product positioning, and we're working on our messaging platforms and market conditioning efforts as well. So as we move through our process over the next several months, we'll have more to update on our premarket conditioning activities and also more on our market entry strategy.

Our next question comes from Arabella at H.C. Wainwright. Our next question comes from Jay Olson of Oppenheimer.

Congrats on the progress. Can you just talk about your expectations for the durability of efficacy beyond 12 weeks? And when do you expect us to see that longer term efficacy data?

Yes. Thanks so much for the question, Jay. In Phase II and the highest quality data we have to go on, we didn't continue observing patients formally in a structured manner beyond 12 weeks. And so we certainly also didn't see a trend where there was a loss of separation or a trend back towards baseline for patients who received the 100 micrograms. And so if those trends were to replicate, they would certainly suggest that durability could last beyond 12 weeks period. We do have some evidence from prior studies, from collaborators who have conducted prior studies to suggest that in anxiety disorders, the effects can be quite long lasting. And in the event and not uniformly distributed either, of course, where sometimes a second administration can have even further prolonged extension of that durability. So it'd be premature to make assumptions about exactly where those data would fall out, but we're certainly very eager to get to those data as we progress in the studies. We haven't given a specific guidance around when those data would be made available. But again, we would certainly be very excited to get those data and share those as they do become available.

Okay. Great. And if maybe I could ask one follow-up. Assuming that your Phase III study results do confirm the initial observations from Phase II, what would you expect the dosing interval to be in terms of number of doses per year in a real-world setting?

Yes, I'll turn that one over to Dan.

Yes. It's a great question, Jay. And obviously, we're working in a somewhat speculative space there. But as Rob pointed out, we did not see loss of efficacy in folks who had a strong response to a single dose in Phase II, and we expect that will be the case for many folks in the Phase III as well and of course, in the real world. So what we anticipate for the use of this drug is not so much predictive intervals where we can prespecify for any individual or you're likely to need to take this every 6 months or every year, but we expect that different people will have different response patterns. And those response patterns will range from on the best possible response, someone who takes a dose and goes into remission and has a sustained period of remission such that if they ever were to need a subsequent dose, we could almost think of that as a new development of the disorder all the way through to on the other end, folks who do need some sort of regular redosing. Now given that we were seeing efficacy out to 12 weeks in Phase II and that very likely proceeded longer, that interval could be 6 months, it could be a year, it could be 3 months in some cases. But unlike daily drugs today or unlike other drugs that have a requirement for a prespecified interval because they lose efficacy either when off drug or shortly after taking drug, we think real-world treatment patterns will be quite a bit more variable with our drug.

Our next question comes from Elias Georgas from Canaccord.

This is Elias on for Sumant. I was just thinking about with your discussions with the FDA, have you -- can you provide any color on what maybe the design of the second Phase III MDD study would look like? Are you going to be required to use the 50-microgram dose as you had to do in your GAD studies as well?

Yes. Thanks for the question. We haven't yet disclosed the design of that study, and we've continued to have a lot of progress with both the GAD and MDD programs. Obviously, there's been a historical discussion around expectancy and functional blinding and different approaches to try to mitigate that in these studies. We always refer back to the reality that every drug in psychiatry deals with functional unblinding. It just so happens that this is based on the qualitative nature, kind of the first time that programs are widely being asked to go an extra mile to try to control for and look at this. But we certainly see some utility in inclusion of a dose such as that, which is, of course, why we included it in our second GAD study. But when the time comes and we're in a position we were able to share study design, we'll certainly also want to be sharing and talking through rationale for any of the choices we've made in terms of how the second MDD study is designed and how we're executing it.

Our next question comes from Patrick Trucchio from H.C. Wainwright.

This is [ Luis ] in for Patrick. Welcome, Brandi, to the team. I would like to ask a little bit about the strategic collaborations that you've already established with interventional psychiatry treatment centers. You mentioned that you have grown your partnerships and that your payer discussions and reimbursement strategy is aligned along with the deployment of your treatments in this network of centers. Can you give any updates with respect to the services, specifically monitoring time and time in the clinic?

Yes. Thanks for the question. One of the elements of our Phase III program is to -- as we approach development generally is to really try to have a prespecified and a thoughtful approach to understand all the dynamics of treatment, whether it be real-world like redosing in the extension phase of the study or the dynamics of a single administration of the drug. And so we are monitoring that and have a structured way of doing so that we've talked through and presented with FDA in prior discussions. And so defining that time line and what it is for individual patients and on average and the various summary statistics you can come up with that could be suggestive of how long patients need to stay in the clinic is something we're very focused on and certainly thinking about as we analyze the data from the Phase III study. So as we engage in that and have additional clarity we can offer, we can certainly be in a position to share that at some point in the future.

And reimbursement, any updates on how it would fit in the current Medicare plans?

Yes, it's premature to talk specifically about reimbursement. We have -- continued to have strong engagement with payers and feel confident in our approach going forward, but certainly premature today to say anything precise around the dollars for reimbursement.

Our next question comes from Chris Chen from Baird.

I just had one on enrollment. I know you've previously talked about the synergies between the GAD trials and Emerge such that if a patient is screened for GAD, but turns out they're diagnosed with MDD, they can roll into the MDD trial. Can you just confirm that? And if so, can you comment on whether some of the sites are seeing this happening?

Yes. Thanks so much for the question, Chris. That certainly was our intent in designing the studies and running them in parallel and making sure that we have as much efficiency in the conduct across both of the indications. And as the studies have progressed, we've seen that play out exactly as we had hoped, where we're getting nice retention. And for patients who do have a depressive episode, we have an easy path to move them into a depression program if that ultimately emerges in the screening process.

Great. And then I did have one more follow-up. Just in terms of the treatment visit itself, can you kind of add a little more color if -- is there a health care provider in the room the whole time during that dosing? And if so, what guardrails are in place to avoid kind of crossing that line between providing psychotherapy versus just assisting the patient?

Yes. Thanks. I'll turn it over to Dan to answer.

Yes. Thanks, Chris. It's a great question, and there is a provider in the room. There's also always another person watching the conduct in the room. And we're very explicit on what folks are allowed to do in that room and where their focus needs to be and their focus is on assistance. And for the most part, not engaging with the participant. Most of the time participants are in the room, they're engaging with their own internal process and the monitor is doing just that monitoring. So through that process of training and monitoring of the conduct in the room, we stay on the side of monitoring and away from psychotherapy.

Our next question comes from Rudy Li from Chardan.

Congrats on progress, and welcome to the team, Brandi. So it's good to hear that the time line for the 12-week primary readout was confirmed. Could you remind us what additional data are required by the FDA? And what will be the rate-limiting status for filing the NDA for GAD?

Yes. Thanks so much for the question, Rudy. Certainly, the studies have been designed such that the primary endpoints at 12 weeks and the double-blind placebo-controlled parallel group portion of the study, Part A, of both the Voyage and Panorama are studies we expect to have completed before we potentially moving forward with an NDA. So all eyes are on that top line readout, which would drive the path forward from there.

Cool. I do have a quick follow-up question because you mentioned that you're exploring additional programs, including potentially external collaborations to expand the pipeline. So can you provide additional color on your overall strategy, like what kind of product or indication that you look at?

Yes, it's a great question. We're incredibly excited about all that we have in our pipeline with three pivotal studies ongoing, of course, a lot of focus gets put on those studies and certainly MM120 as an asset. It's one of the best known drugs in the entire class and one so far that seems to have provided some really standout activity in our Phase IIb program. But there is certainly much more that our team is working on and that we're capable of bringing forward in the future. And as we look at the landscape, we feel incredibly confident in the organization we've built and the team's ability to execute and the scope of what we think we can accomplish long term to really drive meaningful change for patients and meaningful shareholder value is something that we are always focused on. So certainly, stay tuned because we're excited about 120. We're excited about everything else we're doing as well, and we're excited to share that as time progresses.

I guess just to kick things off, I'd like to see if you could talk a little bit about your IP position and strategy and how important that this might be in the context of any discussions with potential partners or pharma. And I bring this up now because I'm sure you saw the report from a few days ago regarding Gilgamesh and AbbVie.

Yes. Thanks for the question, Michael. Yes, we're really confident in our IP strategy and with the patents we've been granted and continue to file and the team we've been working with for many years to advance our approach and make sure that we're filing applications on real meaningful innovations and delivering a product that is targeted to be optimized for patients and that is also something we can protect and that continues to play out, and we continue to progress with our IP strategy and filing. So we feel very comfortable with that position and are also comfortable that anyone looking at would feel similarly.

All right. And then we have seen a lot of enthusiasm behind psychedelics come out of FDA. Even earlier today, COMPASS mentioned that it's exploring opportunities for an accelerated pathway. Is this something that could make sense for MindMed? Or is it a bit of a different situation with your two Phase III readouts being so close together and generalized anxiety versus treatment-resistant depression?

Well, certainly, we have breakthrough therapy designation, which already offers some avenues for, of course, greater engagement, but also opportunities for acceleration. So it's always something we're looking to do is be as efficient and execute and deliver on time and then expedite the path from there. So we're certainly exploring all avenues and all options to do that. The timing of the readouts, we also feel it's important to provide robust evidence and a comprehensive program that would stand up to any degree of scrutiny at any point in time under any review time lines. And so we're eager to get to our readouts next year and having both pivotal readouts in the same calendar year gives us an opportunity to be, I think, in the strongest possible position with the GAD program.

Our last question comes from Sumant Kulkarni from Canaccord.

I'd like to welcome Brandi with a question. How are you thinking about the appropriateness of the financial resources that are available given so many pivotal trials are running right now at MindMed?

Yes. Thanks so much, Sumant. It's great to have joined the team. This is such an exciting time for the company. I mean I think when you look at that, I'm really impressed with how we've put our Phase IIIs together so that there are efficiencies built in there, like we've just talked about with being able to use sites that are enrolling in our GAD and our MDD studies. So I think that, that's really helpful. I also think we've been really prudent as we've grown, and we will continue to do that and really analyzing when we need to add resources and making sure that those are all responsible in terms of the time lines that we're adding people and adding activities to it. So I think that's been really our focus. I will say that we really do like to make sure that we have flexibility as well. This quarter, we did amend our debt agreement with K2. And so that provides us with additional flexibility if we need to and there are things that we think would enhance our programs. But as we stated in the call, we feel very comfortable with our cash position and guidance getting into 2027 and 12 months post our top line GAD readout. And so I feel like we're in a good position to execute and are looking forward to next year.

I'll squeeze a commercial question in. Nowadays, investors seem to be kind of jumping to a conclusion on a perceived fact that less time in the clinic is potentially always better when it comes to psychedelic therapeutics. How are you thinking about your MM120 in the context of that kind of thinking?

Yes. Thanks, Sumant. I'll take this one. We remain incredibly convicted about both the activity and the dynamics of MM120 in relation to both approved products and the potential there, but also in the broader field of drugs with similar mechanisms of action. I think it tends to be an easy assumption to fall back on what is already being done. But like any real meaningful innovation, those precedents and assumptions have only -- can only serve anyone so far. And so we, again, remain in all of our discussions and all of our planning and as we think about the landscape, we're incredibly encouraged by those discussions and by the dynamics of MM120. I think it's -- there's some other dynamics as we progress and share more about commercial strategy. I can also highlight some dynamics. But certainly, there's -- the SPRAVATO model is one that exists. It emerged in response to the availability of a treatment, which -- in SPRAVATO that is, which we're now again, if Phase II data are something we can replicate that we feel really confident about being able to stand out in the field in terms of the kind of magnitude and durability of response that we've seen so far. So as we think about every dynamic from practice economics, as Matt alluded to earlier, to patient and provider preferences and the desire to make sure that if a patient is going to have such a durable effect that their providers have the opportunity to navigate that with them and really support them throughout their overall care journey, not just the administration of our product. Again, we feel really, really good about the dynamics of our program and our product and are eager to show the world how that plays out over long term.

There are no further questions. So this does conclude the question-and-answer session. At this time, I'd like to thank you for your participation in today's conference. This does conclude the program, and you may now disconnect.