Good day and thank you for standing by. Welcome to the Mind Medicine (MindMed) Inc. Third Quarter Earnings Conference Call and Webcast. At this time, all participants are in listen-only mode. After the speakers' presentation, there will be a question and answer session. You will hear an automated message advising your hand is raised. To withdraw your question, please press 1. Please be advised that this conference is being recorded. I would now like to hand the conference over to our first speaker today, Gita Jain, Head of IR. Please go ahead.

Thank you, Operator. And good afternoon, everyone. Thank you for joining us today for a discussion of Mind Medicine (MindMed) Inc.'s third quarter 2025 business highlights and financial results. Leading the call today will be Rob Barrow, our Chief Executive Officer, Dr. Daniel Rollings Karlin, our Chief Medical Officer, and Brandi L. Roberts, our Chief Financial Officer. 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 our 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 applicable Canadian securities regulators, including our annual report on Form 10-Ks and our Form 10-Q filed today. Forward-looking statements are based on the assumptions, opinions, and estimates of management as of the date the statements are made, including the non-occurrence 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 Mind Medicine (MindMed) Inc.'s normal course of business. You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, 11/06/2025. Mind Medicine (MindMed) Inc. 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, Gita, and thank you, everyone, for joining our call today. We delivered another solid quarter advancing our clinical programs and continuing to build one of the most robust late-stage pipelines in our field. In addition, this quarter saw the publication of our full Phase 2b clinical trial results in the Journal of the American Medical Association, highlighting the rigor and impact of the clinical results we have generated to date. Building on this scientific momentum, we successfully completed an underwritten public offering last week, raising approximately $259 million in gross proceeds. This additional capital further strengthens our balance sheet and enables us to strategically accelerate the development of NM120 and NM402. We continue to expand and strengthen our investor base, welcoming in new high-quality healthcare-dedicated funds and mutual funds while deepening support from our long-term shareholders. This financing underscores the strength of our science and positions us for a transformational 2026, a pivotal year ahead with three top-line Phase III data readouts expected between our generalized anxiety disorder (GAD) and major depressive disorder (MDD) programs. Enrollment is strong and steady across our ongoing pivotal studies of MM120. We reiterate our guidance and continue to expect top-line results from VOYAGE in 2026 and PANORAMA in 2026. Due to faster-than-anticipated enrollment in the past quarter, top-line results from the EMERGE study are now anticipated in mid-2026, an update from our prior guidance of the second half of 2026. We are also excited to share further details of ASCEND, our second Phase III study of MM120 in MDD, which we expect to initiate in mid-2026. We continue to deploy resources and operationalize our programs with remarkable efficiency in pursuit of approvals in both GAD and MDD, two of the most prevalent and burdensome psychiatric disorders. Over the course of 2025, we…

Thanks, Rob. We continue to be highly encouraged by the enrollment trends we are seeing across our pivotal Phase III studies. As Rob mentioned earlier, in GAD, we expect to report VOYAGE results in 2026 and PANORAMA results in the second half of 2026. Given the especially strong enrollment in our ongoing MDD study, EMERGE, we are excited to now be in a position to report results from EMERGE in mid-2026. This quarter, we also saw the publication of our full Phase 2b trial results in the Journal of the American Medical Association (JAMA). It's a big moment, not just for us, but for the entire field of psychiatry. This study represents the most robust randomized placebo-controlled trial of Lysergic Acid Diethylamide (LSD) in a psychiatric population using today's modern scientific standards. This trial evaluated a single treatment across four dose levels—25, 50, 100, and 200 micrograms—and demonstrated compelling clinical activity with a statistically significant dose response. Our optimal 100 microgram dose showed both rapid and durable effects with a statistically significant 7.7 greater reduction in HAM-A versus placebo at week twelve. Additionally, 65% of patients in the 100 microgram cohort showed clinical response, and 48% achieved remission twelve weeks after a single administration of MM120. Moving to our Phase III program, our GAD studies each have two parts: Part A, a twelve-week randomized double-blind placebo-controlled of MM120 ODT versus placebo, and Part B, a forty-week extension phase with open-label treatment opportunities to evaluate long-term durability and response patterns. In VOYAGE, we are targeting enrollment of approximately 200 participants who are being randomized one-to-one to MM120 ODT 100 micrograms or placebo, while in PANORAMA, we are targeting enrollment of 250 participants who are being randomized two-to-one-to-two to MM120 ODT 100 micrograms, 50 micrograms, or placebo. These Phase III studies are…

Thanks, Dan. Turning to our financial results for the quarter ended 09/30/2025, we ended the quarter with cash, cash equivalents, and investments totaling $209.1 million. As Rob noted earlier, we successfully completed an underwritten public offering last week, raising $258.9 million in gross proceeds. After deducting underwriter commissions and expenses, net proceeds are $242.8 million. We are very pleased with the outcome of our recent financing, which puts us in an excellent position for the future. We were encouraged by the strong level of high-quality investor interest in Mind Medicine (MindMed) Inc. and in our development programs, a clear reflection of the confidence the investment community has in our mission. This funding allows us to accelerate key initiatives that will set MM120 up for success, including NDA preparation, state prioritization efforts for scheduling, market research, and KOL education, among others. These efforts position us well to move quickly in the years ahead, pursuing submission of an NDA for MM120 ODT as soon as possible and, if approved, executing a robust and well-prepared commercial launch. Based on the company's current operating plan and anticipated R&D milestones, the company believes that its cash, cash equivalents, and investments as of 09/30/2025, along with the net proceeds from the recent offering, are sufficient to fund the company's operations into 2028. Expenses for 2025 were in line with our internal expectations as we continue to make significant progress with MM120 and MM402. R&D expenses were $31 million for 2025, compared to $17.2 million for 2024, an increase of $13.8 million. The overall increase was primarily due to an increase of $11.7 million in MM120 program expenses, $2.5 million in internal personnel costs, reflecting expanded research and development capabilities, and $200,000 in preclinical and other program expenses. These amounts were partially offset by a $600,000 reduction in MM402 program expenses. G&A expenses were $14.7 million for 2025, compared to $7.6 million for 2024, an increase of $7.1 million. The increase was primarily due to increases of $3 million in legal-related expenses, $2 million in commercial preparedness-related expenses, $1.6 million in corporate affairs expenses, and $500,000 in other miscellaneous administrative expenses. Net loss for 2025 was $67.3 million, compared to $13.7 million for the same period in 2024. Note that our net loss can be impacted dramatically by the changes in the fair value of our 2022 USD financing warrants from quarter to quarter as our stock price fluctuates. The change in fair value for the third quarter was $22.5 million as our stock price increased from $6.49 at 06/30/2025 to $11.79 at 09/30/2025. I'll also note that warrant exercises related to the 2022 financing have brought in approximately $2.5 million of cash this year, with an additional $17.6 million of potential funding remaining prior to the warrant expirations in 2027. With that, I'll now turn it back over to Rob for closing remarks.

Thank you, Brandi. This year has been one of bold ambition and disciplined execution. We are delivering on our programs and actively shaping the future we believe is possible. Enrollment remains strong across all three of our ongoing pivotal trials, VOYAGE, PANORAMA, and EMERGE, and we are eager to continue this momentum with the initiation of our second pivotal MDD trial, ASCEND, in mid-2026. At the same time, we are advancing MM402 into a Phase II study, a meaningful milestone as we work to bring much-needed innovation to the ASD community. 2026 is shaping up to be a defining year in our evolution, one where science, purpose, and precision converge to advance the therapeutic potential of MM120 and our broader pipeline. With a strong balance sheet and a late-stage pipeline with multiple catalysts in the year ahead, we are excited to continue driving value for our shareholders and the millions of patients who deserve more than better. Of course, none of this progress would be possible without our exceptional team, whose passion, commitment, and unmatched execution continue to set the standard for our field. Thank you again for joining our call today. We will now open the line for questions.

Thank you, dear participants. Now we're going to take our first question. And it comes from the line of Gavin Clark-Gartner from Evercore. Your line is open. Please ask your question.

Hi. This is Yashan for Gavin. Thank you so much for taking our question. We just had a brief one on the blinded sample size re-estimation. Mostly wondering if this has been completed and if so, given that the trial size expectation is still 200 patients, is it reasonable to assume that the trial is not being upsized? Thank you.

Thanks so much, Yash. So, we haven't disclosed anything about a public disclosure of our sample size re-estimation. And I know you're referring to the ability to increase the sample size to maintain 90% power in both VOYAGE and PANORAMA, our two GAD studies. So we continue to be excited by enrollment and on track for our readout in that program next year. But I have yet to say anything publicly about those announcements.

Awesome. Thank you. Thank you.

Now we're going to our next question. Just give us a moment. And the question comes from the line of Pete Stavropoulos from Cantor Fitzgerald. Your line is open. Please ask your question.

Hi, this is Sarah Medeiros on for Pete. Thanks for taking our questions and congrats on the progress in your quarter. Really two questions for you. The first one being, just curious to know how easy or difficult it is to find patients that are willing to enroll in the psychedelic that are willing to enroll that are psychedelic inexperienced and they're naive with all the attention focused on this class of drugs for psychiatric indications. And is there a specific demographic that are willing to enroll, such as age of patients?

Yes. Thanks so much for the question, Sarah. I'll turn that over to Dan.

Yes. So, while I would never say that enrolling a trial is easy because obviously that's something that we pursue on a daily basis to think about how to get the right patients into our trials. What we have maintained and what we strive for is a representative sample so that we see a background epidemiological rate of people who have some psychedelic experience hovering around fifteen percent. And that tends to be what we aim for in our studies. We want to have a sample that looks like the general GAD population, and so that's what we ended up with in our Phase 2b study, and it's what we're striving for in our Phase III study where we're using meaningfully the same inclusion-exclusion criteria. So, despite being attention on these studies and attention on the category, of course, for those of us who are in it, that attention is much more obvious. Many of the participants who encounter our studies are just people who are looking for studies for their GAD or MDD. And the vast majority don't find the studies because they're specifically looking for a study in the psychedelic category or even necessarily our study.

Great. And just a follow-up, your earlier stage asset MM402, can you help us understand the biological and therapeutic rationale in ASD and what outcomes would look like? And potentially study design in terms of chronic administration and are you looking at home administration?

It's a great question. And obviously, a lot of the attention on the company recently has been on our lead asset, of course, that we're very excited about MM402. The interesting feature of how we're thinking about using R-MDMA or MM402 is that in our development plan, we are developing it as a drug that would be taken either daily or as needed. So the analogous set of drugs would be psychostimulants in ADHD, where people with attentional difficulties are able to use psychostimulants to enhance their ability to pay attention when they're in environments or doing activities that would benefit from that. So depending on the conversation people have with their doctor, that might be at school or for family events or whatever else is deemed appropriate by the care provider and the patient working together. So we very much see MM402 working in that direction. The specific acute effects and transient effects obviously for MM402 or R-MDMA are enhanced social awareness, social communication. People become more attuned to their own emotions, potentially the emotions of others. And of course, a core challenge for folks who have ASD is and can be difficulty with those sorts of social communication situations and awareness of emotions in themselves and others. So we think the very direct effect of the drug while it's on board is exactly what will support people with those challenges. As we've now disclosed, we're moving toward an early sign of efficacy study where we'll look for indications that the drug is doing the thing that we think it will based on the preclinical and some academic clinical evidence. And obviously, that will guide our ongoing development of the drug.

Thank you.

Thank you. Now we're going to take our next question. And the question comes from the line of Brian Corey Abrahams from RBC Capital Markets. Your line is open. Please ask your question.

Hi, everyone. This is Nevan on for Brian. Congrats on a good quarter so far and all the updates. Just had a question on some of the potential read-throughs, I guess, from one of the other competitors in the field that recently updated on a more accelerated timeline as well. One of their studies. Is there perhaps an underlying reason as to why in this case the EMERGE study got accelerated, but not the GAD studies? And I think with the competitor as well, it was in a depression study. So does it have anything to do with the particular indication that you're looking at? Or does that have more to do with the excitement around psychedelics? And then is there any additional clarity or granularity you might be able to provide on the timing for VOYAGE and PANORAMA readout? I guess how has the pace of enrollment in those pivotal compared to what you saw in the Phase 2b?

Yes. Thanks so much for the question, Nevan. Yes, obviously, we can't speak to other companies and what they're doing in their trials, but we've been really encouraged across the board, and enrollment has been strong across all three of our ongoing studies. And again, we continue to be really encouraged and committed to hitting timelines with readouts next year. With EMERGE, we certainly got started with that study quite early in terms of the window of time we had initially indicated and, you know, continue to see enrollment strong across the board. We don't necessarily believe there's any distinct difference between GAD and MDD and continue to see a lot of engagement and throughput and randomizations across all three of the studies. So, we're on track and excited about getting two top-line readouts, as guided next year.

And if I may just ask a follow-up as well. So given that the EMERGE study looks like it's readout a little over a year after it started, could we assume a similar timeframe for the ASCEND trial as well, perhaps maybe a little bit more just given the increased sample size? Then I guess kind of a broader question just given some of the recent or given the recent fundraise and kind of the strong cash position, why not just initiate the MDD studies, the Phase III ASCEND study even sooner? Why, I guess, wait or what's the rationale for waiting until the first one reads out?

Yes. Thanks. With the recent financing, we feel incredibly fortunate with the support we've received, and we're positioned to score in the next year. And we're accelerating on everything that we're doing. So we are certainly not sitting on our hands and waiting for anything. We like to set timelines where we feel confident we can deliver, and that's really informed how we've thought about the timelines that have been announced. But, of course, any opportunity we have to accelerate those timelines and bring in study initiations and bring in data readouts earlier than anticipated, we certainly will take advantage of those. So all systems go across the board in both programs and everything we're doing.

Okay, great. Thank you so much.

Thank you. And now we're going to take our next question. And the question comes from the line of Matthew Herschenhorn from Oppenheimer. Your line is open. Please ask your question.

Hey, guys, congrats on all the progress. Thanks for taking our question. So congrats on the JAMA publication. Could you please share any physician feedback you've received on that so far? And generally just what that publication means for the psychiatry community? And are there any details from the data to stay from your discussions that you believe might still remain underappreciated? And then I just had one follow-up. Thank you.

Yes, I'll turn that over to Dan.

Yes, everything about the way we planned, conducted, and ultimately wrote about that study was meant to be digestible, familiar, a study design and analytic plan that physicians and others in the space would be able to read and fully understand. We've made a real effort to make claims that were deeply supported by the evidence we were able to generate. And obviously, conclusions we were able to draw from the study that have allowed us to move forward with breakthrough designation and into a Phase III program that looks in many, basically all design ways except for the number of arms, nearly identical to the successful Phase II. So I think across the board, that's recognized and appreciated in the physician community and in all the other stakeholders we engage with. That reaction has been overwhelmingly positive. And we're proud of the work we did, and we're really glad for what it indicates about what we anticipate being able to show in the Phase III programs. I think when it comes to underappreciated, perhaps the nature of a single monotherapy intervention without any sort of assisted therapy being able to induce remission in just under fifty percent of a patient population who start with, on average, severe GAD and looking twelve weeks later and seeing that sort of remission rate from a single intervention. I think even no matter how much we look at these data, we look at them probably more than anybody, that still strikes me as just being truly a remarkable opportunity for potential sea change in psychiatry.

Okay, got it. That makes sense. Appreciate it. And then the one other question we had was just if you don't mind to talk about just from the commercial opportunity, how you plan to practically manage patients considering the eight-hour in-clinic administration time, just considering we get a lot of questions on the perceived challenges that you could potentially solve for in the real-world setting. And maybe if you could talk about that in the context of SPRAVATO in terms of the aggregate treatment time over a year, would definitely appreciate it. Thank you so much.

Yes. Thanks so much. I think the talk about SPRAVATO, obviously, there's been a lot of attention paid, and it's really encouraging. I think the most encouraging signals there are the reality that psychiatry has and will adapt to the introduction of new treatment options. But the dynamics of, as you referenced, the dynamics and the durability of response after a SPRAVATO session are in stark contrast to the long-lasting durable effects we've seen so far with MM120. So certainly, there are some parallels. There are some dynamics from an infrastructure and delivery standpoint. Things that have been worked out since the launch of SPRAVATO that we certainly believe we can leverage. But it's really almost an apples and oranges comparison when we think about the kind of treatment dynamics and the benefits that we've been able to show so far in our clinical trials. And so that just speaks to the overwhelming desire for MM120 that we hear from patients and providers when we go out and conduct research with those groups. And so again, there's certainly this MM120 is not and will not ever be intended to be a replica of SPRAVATO. We think it offers some significant advantages both in terms of the magnitude of change and the durability of that change. Positioned incredibly well. So, again, great learnings, great infrastructure that can be leveraged, but a totally different dynamic and one we think is quite favorable compared to any drugs that are on the market today for these indications.

Okay, got it. Thanks again. Really appreciate it.

Thank you.

And now we're going to take our next question. And the question comes from the line of Francois Brisebois from LifeSci Capital. Your line is open. Please ask the question.

Hey, guys. Thanks for taking my questions. Just the first one I had was on the market potential here between MDD and GAD. Can you just talk a little bit about the overlap? And obviously, they are massive, massive markets. But can one cannibalize the other here or just maybe a better understanding of the difference here between both?

Yes. Actually, I'll have Dan talk about it clinically in a second. From a market opportunity, there certainly is a long history of drugs being labeled for both MDD, GAD, and other indications in psychiatry. Some of the biggest drugs in psychiatry historically have been labeled for both of these indications. And typically, those drugs, and speaking about SSRIs here, have started with an MDD label and then expanded into GAD. And we think that's representative of the challenges and the limitations of those drugs in treating GAD symptoms. So there's certainly a high degree of overlap. We don't think about it as so much as cannibalizing anything as much as offering an opportunity to essentially treat two core symptom clusters that are overlapping in the diagnoses. But in an ideal outcome, any patient who walks in the door with anxiety and depression symptoms and qualifies as a diagnosis could then be directed to MM120 if we're successful in getting both of these indications on the label. But I'll turn it over to Dan maybe to comment a little bit more about the clinical presentation.

Yes. And thanks for the question, Francois. The overlap between these two disorders is a really interesting phenomenon. And the way that we have come to think of this is that while there are certainly patients who have a major depressive episode and as a result are diagnosed with major depressive disorder who don't have GAD level of anxiety between their depressive episodes. So while they're euthymic, they don't have depression. And there are patients with GAD who have a high level of anxiety, is more of a constant thing, not episodic, who don't go on to have a major depressive episode. From fifty percent to eighty percent of people who have either diagnosis would qualify for both. And that means that these are people who have had generally a pretty high level of background anxiety often for most of their lives and because they don't really know you're not supposed to feel that way and until recently there wasn't really screening recommendation for anxiety disorders so that of course changed in the last three years with USPSTF recommendations for anxiety screening. It's kind of just like, oh, this is how you're supposed to feel. And people often have an intellectualized way of thinking about that, which is to say, the world is a scary place. Of course, I'm anxious all the time. Many of those folks will then go on to have a major depressive episode at which point because of the episodic nature of the condition, they'll end up seeking care in a world where there was more screening for depression because that recommendation has been around for a lot longer and because there's just this change in condition from one day to the next. So that will lead people then to potentially seek care on the onset of a major depressive episode. So like Rob said, addressing one set of the symptom cluster, so getting to the anxiety of things or the more anionic depression side of things, rather than being a worry about sort of cannibalizing a market. It's much more about being able to provide people an overall relief from their distress than drugs that they just have shown efficacy for ending a major depressive episode and leave people with this euthymic but highly anxious state between those depressive episodes. So we're really enthusiastic about having been able to demonstrate the kind of efficacy we did in Phase II for GAD and the remarkable effect we were able to show in those patients on MADRS scores. So we're highly optimistic about our Phase III program in MDD as well. And again, just see this as additive benefit for people who in the majority of cases are suffering from, in essence, both.

That's great. That's very helpful. And then maybe just the last one in terms of the KOL education that was brought up in terms of something to work on in the future and I was just wondering for a field that hasn't had a lot of new options in a long time, what do you think will be the biggest hurdles here with KOLs? Is it easy where the data kind of speaks for itself? Or do you expect different tiers of KOLs where some guys are a lot more willing to try something new and maybe earlier in the treatment paradigm? I'm just wondering where do you think the biggest challenges might be here for the KOL education process?

Yeah. Having been out in the world in the conferences and working with a lot of these KOLs over the last several years, we are incredibly encouraged by the strong desire for something new and encouraged by the respect that high-quality evidence has garnered from KOLs and from practicing psychiatrists almost at every level. And so, you know, we can't almost can't overstate how enthusiastic many of those conversations are. Now there are undoubtedly detractors. There's a much smaller, but there will be a segment of practicing psychiatrists who likely don't want to deliver MM120. What we see is an overwhelming majority in conversations with KOLs and, again, practice psychiatrists out in the world who many of them say, well, I'm not set up and wouldn't deliver any of the interventional psychiatry treatments today, but I certainly have an intent to do so with MM120 should it get approved. And so while there's going to be a major effort ahead, so that we shape the market and make sure that the world is fully aware of the exciting data we are generating. We don't see any sort of barrier in terms of getting that kind of engagement. And if anything, it's quite rare to see the kind of enthusiasm that we do as a field. This far in advance of pivotal readouts since it's going back several years now. So I remain highly encouraged, but highly focused on getting that messaging right. And amplifying it to the greatest extent possible.

That's great. And does SPRAVATO help here? Or do you consider it so different that it's not because someone prescribes SPRAVATO that they're more likely to prescribe this here?

Well, we think any sort of infrastructure build-out that has happened certainly is something that we can leverage. And for providers to, quite frankly, for providers to be delivering as many treatment sessions of SPRAVATO as they have over the past several years, and then to see something with higher magnitude, more durable effect that seems to drive a whole different kind of outcome for some of these patients. That contrast, we feel very good about and think positions us incredibly well. So certainly, we think there is a segment of psychiatry that is delivering not only SPRAVATO but other interventional psychiatric treatments. And those tend to be some of the earlier adopters and some of those folks who are the most enthusiastic, but it is certainly not limited to SPRAVATO centers or providers who are coming to us and talking about their enthusiasm for what MM120 could offer patients.

Thank you very much. Thanks.

Thank you. Now we're going to take our next question. And it comes from the line of Amy Fadia from and Company. Your line is open. Please ask your question.

Hi, good afternoon. Thank you for taking my question and congrats on the quarter. My first question is, can you talk about the persistency rates of patients in VOYAGE and PANORAMA studies that you're seeing on a blinded basis and how that might be progressing relative to the dropout rates that you'd assumed in the trial design? And in terms of what we can expect from a communication perspective, should we assume that when you do conduct, you know, the sample size re-estimation that will not be made public? And then I have one or two other questions. Thank you.

Yes. Thanks so much for the question. We won't comment on ongoing studies or even on blinded data from those studies until we hit a point of having data and being able to announce fully the outcomes of the study. But we certainly have been really encouraged by a lot of the metrics, really all of the metrics that we've been measuring in the trials. And continue to be committed to executing these studies with the highest quality and on time and get the results at an appropriate time next year. And again, we haven't commented specifically on whether or not we would announce a sample re-estimation publicly or not.

Got it. That's helpful. And then in the PANORAMA and ASCEND studies where you have two doses of MM120, once we sort of get the results and especially from a regulatory perspective, how much of a difference across the doses would you like to see or you think the FDA would like to see in terms of efficacy and safety to be able to sort of address the functional unblinding question or maybe kind of a dose-dependent change across the doses question?

I think the important point there is about the need for programs to demonstrate dose response. So we think about things like functional unblinding, are problems across all of psychiatry, anything really in the CNS, of course. We think in demonstration of dose responses is really critical and gives a high degree of confidence there being a real treatment effect of a drug. And that's why we did the Phase II study we did, and uniquely in our field have comprehensively characterized the dose response. We have a study that has been completed and published and that we're really excited about, of course, that demonstrated both clinically from an observational standpoint, but also statistically that there is a dose response. And that was in even in light of the fact that virtually all patients, regardless of the dose of active drug they received, reported being functionally unblinded by correctly guessing that they were on drug. And so there's not really at this point in our minds about whether there is a dose response because we did a dedicated study to demonstrate that. And successfully proved that there is. And so, the availability, existence of the lower dose, the fifty microgram arm, really is a sort of prospective use in the study, and that it allows us in the consent process to kind of confound expectations. So effectively, say to a patient, if you were to feel the effects of drug on the day of dosing, you can't assume it's the full real dose of drug. It actually is a dose of drug in the prior study that we showed functionally unblinding. But does not have clinical activity in reducing anxiety symptoms. And so it is a design element and a sort of functional control in the study in terms of the outcomes of the data, primary outcome measures in both VOYAGE and PANORAMA and in EMERGE and ASCEND is testing one hundred micrograms versus placebo. And no outcome of the fifty microgram group can alter the finding of that primary analysis. So regardless of what happens in terms of the group response to fifty micrograms, we'll be seeking to clinically and statistically prove MM120, one hundred micrograms is superior to placebo.

Got it. That's very helpful. Maybe my last if I could squeeze one in. The feedback that we've received from a lot of KOLs is that the key differentiating fact and maybe a huge unmet need is the potential to reduce the frequency of retreatment. Can you comment on any sort of follow-up or sort of experience from the Phase II that can throw some light on, you know, what is sort of the range of timeframe within which patients will require a retreatment?

Thanks so much. So what we saw in terms of the average curves and responses that we didn't see any sort of deterioration of effect out to twelve weeks. And because of that, we can't really even attempt to project those curves and arrive at a time when we would anticipate reliably that patients would need a retreatment. Of course, we're trying to characterize that in Part B of our Phase III studies that are ongoing and planned. You know, we certainly hear and have looked at real-world use and compassionate use programs and have been encouraged by the durability of LSD that they can last well beyond twelve weeks in some of those studies. And I'm really excited to characterize that in a robust fashion in our Phase III program. But it's a little bit premature to say decisively or exactly where we expect retreatment, although what we do know is that and we believe we have alignment around the right approach to characterizing this. Is to do exactly what we're doing in the Part B of the Phase III studies, which is to screen patients when they have a recurrence of symptoms, handling of 16 or greater, or a MADRS of 20 or greater, depending on the study. The availability of open-label retreatment to try to characterize those dynamics, the intervals between doses, and the ultimate frequency over the course of a twelve-month period in the study. So really excited to get to those data, but a little premature to say so today.

Makes sense. Thank you. Thank you.

And now we're going to take our next question. Just give us a moment. And the question comes from the line of Sumant Kulkarni from Canaccord Genuity. Your line is open. Please ask the question.

Good afternoon. Nice to see all the progress and thanks for taking our questions. I have a few. First, because MDD is more episodic versus GAD that has more chronic characteristics, do you expect any difference in durability of effect with MM120? And what could that mean for a number of treatments per year for each indication? And would you expect price per treatment for MM120 to be the same in GAD and MDD? And then I have a follow-up.

Yes. Thanks so much, Sumant. I mean, exactly why we're doing the studies is to try to characterize that. We believe that based on what we've seen and that the curves of describing for both anxiety and depression symptoms in the Phase II, saw somewhat similar response patterns. And so we're certainly very focused and very interested in characterizing those treatment responses and retreatment characteristics, and that will certainly inform everything from how we approach this clinical regulatory and pricing discussions.

Got it. And the follow-up, if you look at Slide 23 in the MM120 commercial framework of your latest slide deck, it says psychotherapy is not offered or required but may be added outside a dosing session based on individual needs and goals. In real-world usage, what percentage of patients do you think this might be applicable to and how would that impact commercial or reimbursement-based variables?

Well, I think, overall, we hope that every patient gets the availability of every treatment. We know that psychotherapy is not reimbursed particularly well today, and it's not our position or place within MM120 to exactly change that. So certainly, we expect in the real world that some patients who are already in psychotherapy would be candidates for MM120 and could likely continue on. We've certainly, again, from observations out in the world, seen both patients and academic studies and in real-world use who are administered psychedelic and then decide to pursue psychotherapy thereafter. So, we, of course, want to have labeling and a development program that enables the widest adoption and the widest set of use cases for MM120 should it get approved and out in the world. But we do not, as part of the development program, require or deliver any sort of psychotherapy in our program.

Got it. Thanks. Thanks, Rob.

And now we're going to take our next question. And the next question comes from the line of Patrick Trucchio from H.C. Wainwright. Your line is open. Please ask a question.

Thanks. I have a couple of questions. The first is, I think you noted that the Phase III program in GAD is powered 90% to detect a five-point improvement on the HAM-A. And I think that compared to the 7.7 placebo-adjusted difference observed in the Phase 2b, I'm wondering if you can put that five-point threshold into a clinical context. How should we think about the relevance to patients in real-world outcomes? And then just, I guess, a clarification is for the depression program EMERGE, have you shared how that study is powered as well? And your expectations heading into that mid-2026 data readout?

Yes. Thanks so much for the question, Patrick. Yes. So, I mean, when we look at the context of historical and currently approved products in generalized anxiety disorder, we typically see an under five-point placebo-adjusted change. And more commonly, somewhere in the mid-three-point over placebo. And on an absolute basis, typically in the low teens in terms of the absolute magnitude of HAM-A improvement, the approved 22 improvement and a 7.7 placebo-adjusted delta in our Phase II study at twelve weeks after a single dose of drug. And so we're trying to be, of course, conservative in empowering assumptions so that we can give ourselves a good probability of success. The same approach applies. We want to see clinically meaningful change in both GAD and in MDD, that's how we approached the powering and design of all four of the Phase III studies.

So I think earlier, 2025 was described as a year of constructive dialogue with the FDA. I'm wondering if you can elaborate on key areas of alignment that have been achieved so far and what still needs to be finalized ahead of potential NDA submissions? And as well, would you anticipate submitting the NDA for GAD with the twelve-week data, or would you need longer-term data from Part B prior to submitting?

Yes. We've had an ongoing and incredibly constructive dialogue with the FDA and are very grateful for their level of engagement on the breakthrough therapy designation. We've really taken advantage of that and tried to seek an ongoing dialogue and a high degree of alignment on all the studies we're conducting, including in particular the Phase III studies. And so we don't tend to speak about specific agency interactions on that ongoing basis. But we do believe there's a high degree of alignment. We believe the most important data is the data that we need to demonstrate or the Part A from our Phase III studies to demonstrate that twelve weeks in GAD and at six weeks in MDD, that we have two studies that show hopefully the safety and effectiveness of MM120. So that's been our approach. And again, incredibly constructive dialogue. And as we progress and deliver pivotal data over the course of 2026, we'll continue that dialogue and do everything. The team has an incredible track record of hitting our milestones and being incredibly efficient with how we operationalize our program. We continue to do that in clinical development. We intend to do that through the remaining regulatory and commercial milestones that lie ahead.

Lastly, I'm wondering if you're anticipating an FDA advisory committee meeting as part of the review process for GAD and/or MDD. And how is your clinical development program positioned to prepare for that discussion?

Our approach has been to generate the strongest, most robust evidence and data package to stand up to any stakeholder, any form of scrutiny. And so whether or not an advisory committee is required, we certainly will be prepared, but it's premature to say. Until we've gotten to that stage of the review cycle and had the dialogue with the FDA at that point to say one way or another whether an advisory committee would be required or not.

Great. Thanks so much. Thanks, Patrick.

Thank you. Now we're going to take our next question. And it comes from the line of Christopher W. Chen from Baird. Your line is open. Please ask your question.

Excuse me, Christopher, your line is open. Can you hear me now?

Yeah, we can.

Okay. Great. Yeah. I apologize. I think I'm having some connection issues. But thanks for taking my questions, and congrats on the quarter. Just regarding the currently running Phase III's, can you talk a bit more about the safety monitoring in that interim three-month period following the initial dosing? I'm just curious what guardrails are in place for patients and how you toe that line between ensuring support for these patients while not crossing over into psychotherapy? And then I do have a follow-up.

Yeah. I'll turn it over to Dan.

Yeah. I mean, it's a great question, and obviously, we want to ensure the safety of people as they participate in our studies. Through the entire duration of the participation per participant, that's for the full year, folks are in regular contact with the site, and we do regular AE assessments, we do regular CSSRSs to ensure that no one has developed suicidality. We are very attentive to these things. But that kind of monitoring is completely consistent and coherent with the history of psychiatric drug development. It says something about the category and assumptions that had been made prior to some of our research about what was required to do research in the category. And so the difference between safety monitoring and if someone were to have a safety issue and we needed to refer them out to a higher level of care, of course, we could do that. That person would be discontinued from the study because that would be an event leading to early termination from the study. But none of that even borders attempts to change symptoms through engagement and interaction. So none of that in no way does any of that safety monitoring even touch on the sorts of interventions that would constitute psychotherapy.

I'll just make one final point to emphasize this. Psychotherapy is a defined construct and something that has a long history. I think there's been attempts to sort of conflict the meaning of what that is. And so, you know, we are very intentional about how we instruct the sites to conduct the study, and that is to specifically not deliver psychotherapy in the context of our studies, and we've maintained a high degree of adherence to that throughout our development program.

Great, great. No, super helpful. And then just real quick, just regarding the treatment session itself, do you have protocols in place just in the rare event that a patient might need to stay beyond that eight-hour time point? And then, will the final data read include data on instances of that?

Premature right now to say exactly which data we'd be sharing at which point in time. We certainly tend to be complete with disclosures at the time we have top-line data from our Phase III studies. But we have plans in place and contingency plans in place for all sorts of eventualities as any clinical trial does. But we've been really encouraged with the ODT formulation and our approach to patient safety monitoring in Phase III. I've been really encouraged by what we've been observing so far and throughout our development program. And really aligned with our intention is to develop an incremental body of evidence that arrives at a really efficient delivery framework for roughly labeling discussions and commercialization of the product.

Great. Thank you.

Thanks. Thank you. Dear speakers, there are no further questions for today. This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.