Good morning, and welcome to MindMed's First Quarter 2025 Financial Results and Corporate Update Webcast. Currently, all participants are in listen-only mode. This call is being webcast live on the Investors and Media section of MindMed's website at mindmed.co and a replay will be available after the webcast. I would like to introduce Stephanie Fagan, Chief Corporate Affairs Officer of MindMed. Please go ahead.

Thank you, operator, and good morning, everyone. Thank you for joining us today for a discussion of MindMed's first quarter 2025 business highlights and financial results. Leading the call today will be Rob Barrow, our Chief Executive Officer. He will be joined by Matt Wiley, our Chief Commercial Officer; and Dr. Dan Karlin, our Chief Medical Officer. After our prepared remarks, we will open the call for Q&A. 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 being 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, May 8, 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 everyone, for joining our call today. Before we dive into our business updates and financial results, I want to acknowledge that May is mental health awareness month, something that is deeply important to us. This is the time to recognize the millions of individuals around the world who are affected by mental health disorders, including generalized anxiety disorder, or GAD, and major depressive disorder, or MDD. At MindMed, our mission to transform the treatment of brain health disorders is closely aligned with the goals of Mental Health Awareness Month. This month, we stand with others working to address the significant challenges faced by those living with mental health conditions. As we continue to advance our clinical programs and deliver on key milestones, we also recognize the vital contributions of the broader community. From the investigators leading our trials to the patients who participate, and the many advocates driving awareness and progress, each plays a crucial role in shaping a future where mental health is treated with the urgency and innovation it deserves. The mental health crisis underscores the need for novel therapies like MM120, our lead program for the potential treatment of GAD and MDD. Our pivotal Phase 3 trial evaluating MM120 ODT in patients with GAD and MDD, Voyage, Panorama and Emerge are now actively enrolling, and we're seeing strong engagement from clinical sites and patients as momentum continues to build. We're on track to report top-line data from Voyage in the first half of 2026, with Panorama and Emerge to follow in the second half. With breakthrough therapy designation for MM120 ODT and GAD, a well-defined regulatory strategy and consistent execution across our programs, we are delivering against our strategic objectives. We believe MM120 ODT has the potential to become a differentiated best-in-class treatment for GAD and MDD, addressing a significant unmet need for over 50 million people in the US alone. Our focus remains on driving this innovation forward and positioning the company for long-term value creation as we move towards commercialization. With three of our pivotal trials now underway and enrollment progressing, we continue to generate evidence to support MM120 ODT's potential and highlight its tremendous commercial opportunity. To lead this effort, we recently welcomed our new Chief Commercial Officer, Matt Wiley, to our team. Matt is uniquely positioned to lead our commercial strategy during this critical growth phase. He has more than 25 years of experience, having successfully driven the commercialization of innovative therapies with a focus on CNS and psychiatry. He has guided products from development to market launch and accelerated the growth of in-line marketed therapies. His expertise and insights bring tremendous value to our team, and we couldn't be more excited about having him on board at such a pivotal time. With that, I'd like to turn the call over to Matt, so he can formally introduce himself. Matt?

Good morning, everyone, and thank you, Rob, for the introduction. It's an exciting time to be at MindMed. I joined this team because what we're doing here isn't just incremental, but something potentially transformational. The data from our Phase IIb trial of MM-120 in GAD is among the most compelling I've seen in neuroscience, and the disciplined approach behind it speaks volumes about this company's caliber. Now that I'm inside the organization, my conviction is even stronger. MM-120 could redefine the treatment paradigm for GAD and MDD, and we're moving with urgency to build a commercial engine that matches the ambition and rigor of our science. Over the past 25 years, I've led commercial strategies for multiple breakthrough therapies in psychiatry and CNS, navigated complex regulatory environments and secured market access in some of the most competitive markets. I've helped companies successfully manage critical product transitions from late-stage development through launch and beyond. And I've built commercial organizations from the ground up that are patient-focused, science-driven and launch-ready. What we're building here at MindMed is no exception. I believe that we're laying the foundation for both a successful launch and for lasting leadership in this space. Every element of our strategy is intended to reflect the same high standards and determination the company has shown in clinical development. Thank you again to Rob and to the rest of the team for their warm welcome. I'm honored to be here and looking forward to what we can achieve together. And I'm excited to share more about our progress in the months ahead. I'll now turn the call over to Dan for an update on our clinical programs.

Thank you, Matt. It's great to have you with us. As Rob mentioned, we have dosed participants in three of our pivotal Phase III clinical studies, Voyage, Panorama evaluating MM120 ODT in GAD and Emerge evaluating MM120 ODT in MDD. Starting with Voyage, Panorama, we remain highly encouraged by the pace of enrollment. Patients and providers continue to show enthusiasm and high levels of engagement. 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 study assessing the efficacy and safety of MM120 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. In Voyage, we expect to enroll approximately 200 participants who will be randomized 1:1 to receive MM120 ODT 100 micrograms or placebo, while in Panorama, we expect to enroll approximately 250 participants who will be randomized 2:1 to receive MM120 ODT 100 micrograms, 50 micrograms or placebo. In both design and execution, we closely modeled our Phase 3 GAD studies after our successful Phase IIb study of MM120 in GAD. In both Voyage and Panorama, the primary endpoint is the change from baseline to week 12 in the Hami Scale, which was the outcome measure used for the approval of currently available GAD therapies. We designed these trials to have 90% power to detect a 5-point improvement over placebo based on certain statistical assumptions, whereas in the Phase IIb trial, we observed an almost 8-point improvement for MM120 over placebo at 12. To ensure our actual statistical power is maintained, we are using an adaptive design in our GAD Phase 3 studies, which includes an interim blinded sample size reestimation that allows for increased enrollment of up to 50% in each trial, if necessary. This approach helps to adjust for any unexpected variability in response parameters, specifically dropout rates and pooled variance of handmade response, maintaining statistical power and enhancing the interpretability of our results, if needed. We've kept our inclusion and exclusion criteria consistent with our successful Phase IIb study of MM120 in GAD, incorporating exclusion criteria around the recency and total use of psychedelics to ensure a representative sample is recruited. We also conduct comprehensive safety assessments and labs before and after the administration of MM120 and ensure the collection of all adverse events. Turning to our MDD program with MM120, we are thrilled to have dosed our first participant in the pivotal Phase 3 Emerge trial and are encouraged by early enrollment trends. Just like our GAD program, our MDD program will consist of two pivotal clinical studies. Our first study, Emerge, will be comprised of two parts. Part A, a 12-week randomized, double-blind, placebo-controlled parallel group study assessing the efficacy and safety of a single dose of MM120 ODT versus placebo, and Part B, a 40-week extension period during which participants will be eligible for open-label treatment with MM120 subject to meeting eligibility requirements. In Emerge, we plan to enroll at least 140 participants with a primary diagnosis of MDD randomized 1:1 to receive MM120 ODT 100 micrograms or placebo. The primary endpoint in Emerge is the change from baseline in Montgomery Asberg Depression Rating Scale or MADRS at week six between the groups. We continue to anticipate top-line data from Emerge in the second half of 2026. Overall, we're excited to have three pivotal trials actively recruiting with all three readouts anticipated next year.

Thanks, Dan. Turning to our financial results for the quarter ended March 31, 2025. We ended the quarter with cash, cash equivalents and investments totaling $245.5 million. We believe that our cash, cash equivalents and investments as of March 31, 2025, will be sufficient to fund our operations into 2027. Overall, based on our current operating plan and anticipated R&D milestones, we expect our cash runway to extend at least 12 months beyond our first Phase 3 top-line data readout for MM120 ODT and GAD. In April, we amended our loan agreement with K2 HealthVentures to provide greater financial flexibility and optionality. The revised facility provides us with access to up to $120 million based on the achievement of certain milestones and extends the interest-only period through at least May 1, 2027. The company received approximately $17.8 million in net cash at closing after refinancing in full all term loans outstanding under the original agreement and the payment of fees and expenses in connection with the amendment and refinancing of the existing term loans. Research and development expenses were $23.4 million for the three months ended March 31, 2025, compared to $11.7 million for the three months ended March 31, 2024, an increase of $11.7 million. The increase was primarily due to $9.4 million in expenses related to our MM120 program, an increase of $2.4 million in internal personnel costs as a result of increasing research and development capacities, and an increase of $0.1 million in preclinical and other program expenses, partially offset by a decrease of $0.2 million in MM402 program expenses. We anticipate R&D expenses will continue to ramp up in 2025 due to the costs associated with running three pivotal Phase 3 studies. General and administrative expenses were $8.8 million for the three months ended March 31, 2025, compared to $10.5 million for the three months ended March 31, 2024, a decrease of $1.7 million. The decrease was primarily attributable to stock-based compensation expenses. To close, this is an exciting and pivotal time for MindMed. Our three Phase 3 trials of MM120 ODT are active, and the enthusiasm from our clinical sites speaks volumes about the need for and promise of MM120. We are energized, aligned and confident in where we're headed with breakthrough therapy designation for MM120 ODT and GAD, a clear regulatory strategy and consistent execution across our pipeline, we are delivering on our mission and driving meaningful value for patients, physicians and shareholders alike. Thank you for being with us on the call today, and the team and I are now happy to answer your questions.

Certainly. Our first question comes from Marc Goodman with Leerink Partners.

Hi, good morning. Thank you for taking our question. We have a question regarding the MDD trial. Would you please remind us again whether you still need to assess the low dose of 5 micrograms in this trial or maybe in the second Phase III trial that you're planning to start? And regarding the therapeutic effective dose, is it fair to assume that the same therapeutic dose in GAD, which is 100 micrograms, will also be effective in MDD? And that's it for us.

Perfect. Thanks so much for the question. I'll turn it over to Dan to answer that one.

Yeah. Thanks so much for the question. So as you noted, in our second GAD study, we're using that 50-microgram intermediate blinding control dose. And in our disclosed MDD study, we are not using an intermediate dose. We're using a 2-arm study, so 100 micrograms versus placebo as we've done in our first GAD study, but it's reasonable to think that at some point in the MDD development program as we move into any additional required studies that we might use that same 50-microgram intermediate blinding control arm. So while we haven't disclosed the plan to do so, it's not unreasonable to think that at some point in the MDD program, we would do similar blinding control as we've done in GAD. With regard to the therapeutic dose that we would bring forward in MDD, what we have disclosed is that we'll be using that same 100-microgram active arm, which we have reason to believe from our GAD results in Phase IIb has high efficacy against depression cluster symptoms. So yes, that's what we're using in our disclosed program and reasonable to think that that's what we'll continue to use moving forward in the 100-microgram arm.

Thank you very much. That's very helpful.

Thank you. And our next question comes from the line of Brian Abrahams with RBC Capital Markets.

Hey, guys. Thanks for taking the questions. Congrats on the progress. And Matt, welcome to the team. Just curious as the trial enrollment really gets going, if there are any kind of learnings that you're taking away initially from GAD epidemiology or treatment patterns, disease recognition, provider engagement, that sort of thing? And any surprises so far and kind of how that's shaping your overall commercial approach? And then I guess I'm also curious then kind of following up on the prior question on how your latest views on how the low dose might play in, if you're seeing any kind of evolution in regulatory perspectives and what you might be looking for out of the 50-microgram dose for either indication? Does it need to look less efficacious than the 100 or kind of what happens if you show no efficacy there or comparable efficacy?

Thank you for the question, Brian. I will address them in reverse order, and Dan will respond to the second one. Regarding the 50-microgram dose level, we've had extensive discussions about the various controls used in drugs currently under development in this category. We decided to include a 50-microgram dose group to address some of those concerns and the methodological requests from the FDA. It's important to note that this dose level does not provide any information about the performance of the clinical dose we are interested in, which is 100 micrograms of MM120 compared to placebo. Even though we have included the 50-microgram dose level, patients in the trial will not be able to draw any conclusions about their experience on dosing day that would influence the final clinical outcome assessments. While we are measuring responses and activity in the 50-microgram group, its lack of relevance to the performance of 100 micrograms versus placebo means it does not impact our study findings, both statistically and clinically. There are various scenarios to consider, and we are eager to understand them. However, we have conducted the first comprehensive study in this class looking at dose response, establishing a minimum clinically effective dose several months after a single administration. Therefore, we are very confident in our dose selection and the rationale behind it. It would be impractical to disregard the compelling evidence we've gathered so far merely to accommodate a second methodological control. As such, we are primarily focused on the 100 micrograms versus placebo, adding the second dose level to prevent patients from being uncertain about whether they received an active dose of the drug. I'll now pass it over to Dan to address the other part of your question.

Yes. Brian, it's a great question of GAD and learnings and change over time for us, of course, having run through the Phase 2b and GAD, which was not something most have done, right? There haven't been GAD approvals in 20 years. And so to be running sponsored research in GAD, we've, of course, learned a lot about how to find patients, how to recruit them, how to get the right folks into the study. So for us and the sites we work with, of course, learnings from Phase 2 that we've brought forward into Phase 3 here, I think there's a broader perspective on that. You mentioned the epidemiology of the illness. And what we found just in the time since we've started working on GAD is that there is clearly broader awareness and attention to the disorder just in the time that we've been working in it. So over time, as more people see anxiety as an issue for themselves as something that's worth seeking clinical attention that's worth seeking out clinical trials. I think we're only benefiting from the pendulum swing back in the direction of GAD from where it's been sort of penned over the last 20 years on MDD where people are more and more willing to talk about and think about anxiety as a source of distress in their lives. So all of that to change both on our level and on really what we're seeing as sort of systematic societal level is all working in favor of both the disorder as a target of clinical research and ultimately, if approved, as a commercial target.

Super helpful. Thanks, Dan and thanks Rob.

And our next question comes from the line of Gavin Clark-Gartner with Evercore ISI.

Hi, this is Yasha on for Gavin. Thanks for taking our question. Just a more general one from us given the recent change of the cat leadership. Could you maybe speak to how engagement has been going with the FDA over the course of the year? Thank you.

Yes. Thanks so much for the question. Yes, we obviously are very much aware and there's been a lot of headlines about changes at HHS and at FDA. So far, our engagement has stayed strong. FDA has been an incredible partner throughout our development program, and that's only continued. So we've continued to have strong engagement and timely responses on any sort of correspondence we have with the agency. So we're not seeing any direct impact at this point, and we're really encouraged by the dialogue we continue to have.

Thanks so much.

Thank you. And our next question comes from the line of Charles Duncan with Cantor.

Hi, good morning. This is Elaine Kim on for Charles. Thank you for taking our questions. It's great to hear that enrollment is on track for the GAD and MDD trials. But what are the steps that you're taking to limit enrolling professional patients and maintaining the same robust effect size that you've seen in the Phase IIb trial? And I have a quick follow-up.

Yes. At the highest level, everything about how we've designed and are executing the Phase III program is consistent with what we did in Phase II. So obviously, as we progress through development, we have incremental learnings to make ourselves more efficient and make sure we're getting the right patients into these studies. Maybe I'll turn it over to Dan to elaborate a little bit on patient selection.

Yes, so from a patient selection perspective and an enrollment perspective, we have several confirmatory steps as we enroll folks. So we look at records from outside providers. We have a confirmatory interview, call it the SAFR, that's done by a third-party rater. So each step through the screening process and ultimately leading up to enrollment is really oriented around ensuring strict adherence to protocol and the inclusion exclusion criteria and screening out folks who might be enrolling for reasons other than trial participation as it's intended to be. So we're confident in our sites. We have close relationships with our sites. And ultimately, it really does come down to the intersection between high-quality sites who are in it to get the right patients and good external confirmation to ensure that the folks we get are the folks we intended to.

Okay. That's really helpful. And while the risk versus suicidality is not as high as it is in GAD and MDD versus treatment-resistant depression, what are the steps that you are taking to monitor and prevent the safety risk?

Yes. From enrollment through trial completion, we're, of course, very attuned to suicidality. In any treatment in psychiatry and in truth, any treatment in medicine, there is always the risk for suicidal thinking and even suicidal behavior. And of course, that's something that's been appropriately paid attention to in our field. From screening on, we conduct the industry-standard Columbia Suicide Severity Rating Scale, CSSRS to ensure that patients we enroll are safe to be enrolled, that anyone who is actively suicidal should be getting care that's not research-based care, that's true clinical care. So we're able to refer people back into the clinical care system when they present they're too ill to participate. And then throughout the trial, we continue to monitor both through, of course, adverse event reporting, but also through serial CSSRS and clinical assessments to ensure that if there is a suicide signal, that we're able to detect it and respond appropriately. Of course, in our Phase II, we did not see a suicide signal, which we were really glad to see, of course, for the treatment and for the disease state population. So we'll just continue to do what we've done and make sure we're enrolling appropriate patients and that we're monitoring them through the course of treatment appropriately so that we can ensure participant safety and that we can have a good ability to report out on our safety signals at the end of the trials.

Very helpful answers. Thank you.

Thanks, Elaine.

Thank you. And our next question comes from the line of Joel Beatty with Baird.

Good morning. Thanks for taking our question. This is Chris on for Joel. Congrats on the progress. We're looking forward to data and some feedback from investors, though as 2025 is a little light on catalysts. And I'm wondering if there's any plan to release any interim data between now and the final readouts? And then just another question, a quick question on 402. If you can provide any color on the next steps in terms of that?

Yeah. Thanks so much for the question. We are laser-focused on executing these studies. I think we've in the past and continue to set the standard for the pace in which we're executing on them and with the readouts coming next year, we're incredibly eager to get these data out there as quickly as possible. We do have a blinded sample size reestimation that is going to occur, although we haven't provided any guidance around whether, or if or when we would announce any findings from that analysis. And beyond that, we certainly don't have an anticipation that there will be analyzing or releasing any unblinded data that would be informative about treatment effect over the course of this year. So we're, like I said, focused on getting the data as quickly as possible and getting the highest quality study results. In terms of 402, we completed the Phase 1 study. We're continuing to develop that program, and we'll be sharing some additional details at an appropriate time about what comes next for that development program and starting to think about how we can get the program progressed in the patients that are diagnosed with Autism Spectrum Disorder.

Thanks a lot. Helpful.

Thank you. And our next question comes from the line of Rudy Li with Chardan.

Thanks for taking my question. I’m just curious about your current thoughts on the market dynamics of epidemic under current environment given the Spravato growth trajectory? And can you talk about your commercial planning activities moving into the second half of the year? Thanks.

Sure. Hi. Thanks for the question. This is Matt. So first of all, both populations for GAD and MDD are quite large. There are significant unmet needs in both. So we feel really confident about how we're planning into the second half of the year, and how we're going to address these unmet needs. First of all, I'll take on GAD, I mean there's no shortage of GAD patients; it’s a durable market. And even though it's been dormant for some time, what we've seen in claims data is diagnosis rates that have been pretty consistent over time. So this is a disease state that is recognizable by clinicians; the diagnoses are made. There's some interesting work to do in how we frame our market. And so as we think about our positioning and messaging, we intend to complete that work and roll that out in the second half of the year, and that will help the market better understand the opportunity for a drug like MM120.

Just a quick follow-up. What are we planning to just leverage the commercial infrastructure just to capitalize on the commercial success of Spravato?

As we consider Spravato as a benchmark, it presents an intriguing opportunity to analyze their reimbursement system and the utilization of capacity, as well as any capacity available beyond Spravato patients. In terms of the market, we view GAD differently, as GAD patients may be situated in locations distinct from those of Spravato patients, although some overlap could exist. We also think that certain physicians who have embraced Spravato might be inclined to adopt MM120. Therefore, while we anticipate some overlap in capacity utilization, there are additional capacities and operational prospects beyond that.

And I'll just add one comment on top of that, which is that while we're certainly encouraged by the growth in the expansion for Spravato. When we look at the relative data, obviously in different populations, but the kind of response we can generate in patients, I think we and everyone we speak to is encouraged by the quality and both the depth and duration of effect that we can demonstrate. So Spravato is an interesting proof point. But so far in development, we're incredibly confident in our data and how it would stack up against that drug and how it would position us to have perhaps even a more expansive opportunity.

Got it. That's very helpful. Thanks.

And our next question comes from the line of Sumant Kulkarni with Canaccord Genuity.

Good morning. Thanks for taking the question. This one is for Matt. And I know you provided some details on your rationale for joining the company, and I apologize if this has been asked because I've been hopping between calls. But what specifically in your prior experience with commercializing scheduled products might help you best on setting up MM120 for success? And what are the unique challenges associated with LSD versus the other scheduled products that you might have been involved in commercializing so far?

Sure. Thanks, Sumant. Well, first of all, I think that having worked on a couple of products with REMS historically is going to be helpful. And most specifically, work on sodium oxybate when I was at Jazz, which was Schedule 1 outside of indication; there are a lot of parallels to what we're doing here. So I do think that the REMS operations and the hub service model will be applicable here. As it relates to LSD specifically, I think that there's a lot of education to come for the market in how to view both the underlying disease state scientifically and then how a drug like MM120 fits into that disease for GAD and also for MDD, so more to come on that. But I think that reframing scientifically is top order for us.

Thank you. And our next question comes from the line of Jason McCarthy with Maxim Group.

Hey, guys. This is Michael Okunewitch on the line. Thank you so much for taking my questions today. So I guess maybe directed towards Matt, just thinking from a commercial perspective, could you talk a little bit about how you think about patient targeting within MDD or GAD? Just given that this will require more upfront time in the clinic than other therapies, do you expect you'll be looking at patients already looking into interventional options like TMS or Spravato, patients who are on chronic drugs who may not have satisfactory efficacy or side effects, or even patients untreated who may be discouraged from taking chronic pharma. Could you just give a bit more color on your thoughts?

Well, we're still early days on targeting. We use claims data to identify where the patients are, and certainly, we will examine a lot of different factors that will go into our targeting model. That work is ongoing. We expect to have better clarity on that in the second half of the year.

All right. And then just one more for me. Just when thinking about seeking approval in both generalized anxiety and major depressive disorder, do you expect there could be some competitive benefit to having evidence in each indication individually, just given the rates of comorbid anxiety and depression symptoms?

Yeah. I'll maybe ask Dan to comment on just psychiatrist perspective on this because we've done a lot of work with providers in the field. And certainly, Danny can give some more color to that.

We've clearly decided that from a regulatory standpoint, these disorders, while significantly overlapping, are recognized as distinct conditions, and there are definitely patients who may only have one or the other without the comorbidity. Generally, healthcare providers are used to diagnosing conditions and focusing on a primary treatment target. Therefore, we believe that having a label that encompasses both disorders positions us as the preferred choice, regardless of whether a patient presents with a major depressive episode or mainly anxiety symptoms with a history of depression, which would qualify them for a major depressive disorder diagnosis. We've made this decision, and the experts we consult agree that by covering the full spectrum of depression and anxiety, we can become the preferred option if we gain approval, regardless of the condition the patient presents with.

All right. Thank you. I really appreciate that additional clarity.

Thank you. Ladies and gentlemen, this does conclude today's program, and you may now disconnect.