MindMed at RBC Conference: Progress in Psychedelic Therapies

On Wednesday, 21 May 2025, Mind Medicine Inc. (NASDAQ:MNMD) presented at the RBC Capital Markets Global Healthcare Conference 2025. The company showcased its strategic advancements, focusing on the clinical progress of MM120 for anxiety and depression, alongside potential commercialization plans. While the company is optimistic about its engagement with the FDA, the stock saw a decline of 7.7%, reflecting mixed market reactions.

Key Takeaways

• MindMed is advancing MM120 in Phase 3 trials for Generalized Anxiety Disorder and Major Depressive Disorder.
• The company is actively preparing for MM120’s commercialization, leveraging existing psychiatric infrastructures.
• R-MDMA is being developed for Autism Spectrum Disorder, showing early promise in safety studies.
• Strong engagement with the FDA and policymakers supports expedited development.
• The company is focused on the US market, anticipating regulatory changes in psychedelic therapies.

Operational Updates

• Enrollment in Phase 3 trials for MM120 is progressing positively, with encouraging early trends.
• The trials utilize an adaptive design to maintain 90% power, adjusting for dropout rates and data variance.
• MindMed has appointed Matt Wiley as Chief Commercial Officer to lead commercialization strategies.
• The company is exploring MM120’s use in traditional psychiatric settings, potentially without the need for physiological monitoring.

Future Outlook

• MindMed is preparing for potential commercialization, focusing on engaging payers, providers, and patient groups.
• The company is leveraging existing infrastructure used for SPRAVATO and TMS to adapt for MM120.
• MindMed is concentrating efforts on the US market, which presents the largest opportunity for growth.
• R-MDMA development for Autism Spectrum Disorder aims to improve social and communication skills.

Q&A Highlights

• MindMed’s adaptive trial design accounts for study increases without considering effect size until primary analysis.
• The company has broad support from policymakers and payers, who have indicated willingness to cover the treatment.
• There are currently 4,000 to 5,000 clinics capable of integrating MM120 into interventional psychiatry practices.

Readers are encouraged to refer to the full transcript for a detailed account of the conference call discussions.

Full transcript - RBC Capital Markets Global Healthcare Conference 2025:

Brian, Capital Markets: Capital Markets. Thanks for, for joining us and for being here. Our next featured company is MindMed, represented by their CEO, Rob Arrow, and their CMO, Dan Carlin. Thanks, Rob and Dan. Appreciate you being here.

Thanks so much, Brian. Great. So, let’s maybe kick it off on MM120 for GAD and MDD in the ongoing studies. It sounds like the studies are all the phase threes are all progressing on track based on your latest updates. So I guess I’m curious if you could provide some more color on what you’re seeing early on with respect to enrollment trends and conduct for the phase three.

How how Voyage and Panorama are going in in GAD, first of all, and maybe similarities and differences to what your experiences were from the phase two.

Rob Arrow, CEO, MindMed: Yeah. I’ll start it off and turn it to Dan. But at a high level, we’ve been really, really encouraged by the early enrollment. I mean, everything we’ve done to design and operationalize our studies has been aimed at replicating the kind of, efficiency and and progress we had in the phase two program. So, so far, we’re we’re off to a great start.

We’ve been, as I said, really encouraged. Dan, and any color?

Dan Carlin, CMO, MindMed: Yeah. I think one one of the upshots of having run the phase two program that we did is that almost entirely, we’ve brought forward design elements from that phase two into the phase three program. So, for our folks, our staff, for the the site staff and the sites and the PIs, they’re in essence, in many cases, doing a protocol they’ve they’ve already done and particularly for And a

Brian, Capital Markets: lot of the sites are the same, I think. Right?

Dan Carlin, CMO, MindMed: Yeah. Some of them. We’ve we’ve got many more sites.

Rob Arrow, CEO, MindMed: Yeah.

Dan Carlin, CMO, MindMed: And and in part, that’s because in the time between when we started phase two and now, a lot more capacity to do research in this space has emerged. So while when we started phase two, there were some pretty specialized sites working on these sorts of things, what we’ve seen in the interim is that high quality psychiatry sites who are used to running phase three psychiatry trials have added the capacity to do session based therapies like ours.

Brian, Capital Markets: I imagine that’s a that’s a trend we may see, you know, going forward as some of these types of therapies reach commercialization. Absolutely. And then how does that compare to the EMERGE study in in MDD? Guess, what are you starting to see there? How is that

Rob Arrow, CEO, MindMed: I mean,

Dan Carlin, CMO, MindMed: I I the the again, when we think about the efficiencies of these particular studies, running a GAD study and an MDD study at overlapping sites at the same sites means that the recruitment efforts yield almost exponential benefit there because when folks come in, many MDD and GAD patients qualify for both diagnoses. Right? Yeah. You’ve ever had a major depressive episode, now you’re an MDD patient. So which trials do they go?

Well, that’s if you don’t have both, then then they can only go into one or they or they disqualify. In our case, if folks come in in a major depressive episode and they qualify for the MDD study, they go into that study. If they come in despite having an MDD diagnosis, not in a major depressive episode with GAD, then they can go into the GAD study. Okay. So the real operational efficiency is starting to emerge from that.

And, actually, what emerged what we what we saw was that when we launched, EMERGE, two sites that were already running Voyager Panorama, they, in fact, had MDD patients who had showed up, screened out, and were ready to go for for EMERGE.

Brian, Capital Markets: That’s great. Seems like really good potential synergy there. Can you remind us on the trial design, the powering for your phase three GAD studies? And talk to us a little bit more about the adaptive study design features that Voyage and Panorama have and how those work.

Rob Arrow, CEO, MindMed: So powering was, 90% to pick up a five point difference between the hundred microgram group and the placebo, which is the the primary analysis in both of our phase three studies in GAD and and, likewise, in in EMERGE. As as a reminder, in phase two, we saw very much more response than how we saw almost an eight point delta between the 7.7 difference between the hundred and placebo. But we wanna be conservative, obviously, getting the bigger bigger study sizes. We’re very used to in psychiatry effect sizes dropping as you get into pivotal studies. And so be conservative.

We we assume the five point delta, have 90% power. That give us a hundred patients per arm. It’s based on a couple other assumptions. One is a a old standard deviation of 10 units and a dropout rate of ten of fifteen % non evaluable rate in those studies. And so the adaptive design, the interim sample size re estimation, it allows us to maintain the power at 90% if any of those two nuisance assumptions dropout or or variance in the data are higher than we expected.

Obviously, there’s there’s no learnings about the delta between the the active placebo arms, and therefore, we don’t spend any alpha, but we do make sure that that power is maintained if there are are a random distribution such that the the variance parameter is a little bit different than

Brian, Capital Markets: what we expected. So was it just standard deviation and dropout rate that guides this, or is effect size, does that go into the calculus for how much to increase the study?

Rob Arrow, CEO, MindMed: Just those two nuisance parameters as they’re called. The the actual effect between the groups,

Brian, Capital Markets: the actual effect size will not be assessed until the primary analysis once enrollment is fully complete. Got it. And then if you were to increase the sample size, how would that impact the timelines for for readout? And what would your plan be for how you conveyed that news to the street?

Rob Arrow, CEO, MindMed: We we’ve accommodated that within our plan. So, you know, we certainly, there there’s sort of an exponential growth in any study’s enrollment. And so, regardless of whether we increase sample size or not, we’ve guided accordingly.

Brian, Capital Markets: So the maximum of what by which you could increase the study size is already encompassed in your timeline guidance. Right. So is that something we would just sort of see on clintrials.gov potentially?

Dan Carlin, CMO, MindMed: Or I

Rob Arrow, CEO, MindMed: think we’ll we’ll announce, you know, the at the right time, you know, important data that would give any further clarity. And so as get closer to the the readouts, we’ll be off potentially able to offer a little bit more clarity about exact timing and and such. But, at this point, we haven’t we haven’t sent anything specific. Okay.

Brian, Capital Markets: And and know you’re gonna be doing open label extension follow-up and and and work. Can you talk about what specific safety or symptoms severity criteria you’re gonna be used you’re gonna use to determine whether a patient might be eligible, to be retreated with with 120 during that kind of extension period? And I guess how you’ve kind of defined and validated? Because I know that’s it’s a maybe somewhat of an unknown. The durability obviously looks looks good so far, but we don’t know exactly how long it it’s going to go and sort of how do you how do you manage that in context of retreatment.

Dan Carlin, CMO, MindMed: Yeah. I mean, there are a couple of interesting points about the extension phase. One one of which is that unlike a daily drug paradigm where on the day that someone finishes their double blind period, the next day, they get open label treatment. So while the allocation they were initially assigned to isn’t revealed at that point, from the point they get open label treatment forward, they are known to be in a treated state. Right.

In this paradigm, because there’s not daily treatment, it’s reasonable to think that a a large number of participants will remain in a blinded state for that entire year. So we will be able to characterize the double blind controlled effects of a single dose out to a year. Starting, the week after someone qualifies for the extension phase by completing the the double blind period, they’ll get monthly hemase, and the threshold to be treated in that extension phase is 16. So the threshold to enroll in this study is 20. And so moving into the open label treatment, we’re we’re lowering the threshold there.

And that that 16 represents the the sort of the category difference between mild and moderate. So we expect it it’s reasonable to think that in the real world, people with moderate or worse severity would be treated. Okay. We make up to four treatments available, though we don’t expect that to be the number that very many people get because we didn’t want to right limit those data. We wanted to actually see a sort of a curve where we could describe what different types of patients, what different types of response patterns look like with that treatment available to them.

Brian, Capital Markets: Okay. But presumably, a fair number of patients originally randomized to placebo or a a a less less effective dose, you know, could be eligible for retreatment or really would be We would

Dan Carlin, CMO, MindMed: expect that there is a higher nonresponse rate in the placebo arm, because we won’t know what they were allocated to initially. But, when when we do look at the data, of course, we would expect to see that more people initially allocated to placebo or 50 end up getting earlier treatment in the extension phase.

Brian, Capital Markets: Let’s talk about the regulatory plan because that’s obviously gonna be the next step once the phase three phase three is read out. Given how some of the FDA leadership has evolved and come together, do you think that the regulatory bar for psychedelics is going to evolve as these trials get closer to reading out? Where where do you think we stand? I I know there’s been last couple years, there’s been, you know, a lot more guidelines and guidance from the agency around what they’re looking for. I know you’ve had really good engagement with them.

Are are things continuing to evolve, or do you think we’re sort of at a steady state now with what FDA wants to see?

Rob Arrow, CEO, MindMed: I I think it you know, as with any novel treatment or or novel treatment paradigm, there’s inevitably going to be an evolution in in the regulatory framework and discussions around it and and really, you know, tremendous respect for DaVinci Psychiatry and all the folks at FDA who have been engaged with us for the last about years at at MindMed, and we’ve been fortunate of working with them even before that on this drug class. And so they’ve they’ve been incredibly thoughtful about the approach and trying to deal with some of the the complexities that that present themselves, but also hold to the historical standards. And so and we’re seeing more and more of that. We’ve we’ve had an have continued in really strong engagement this year with the agency. And even with all of the the changes and and turnover and things that have, you know, grabbed headlines for our application, obviously, breakthrough therapy designation, it helps quite a bit.

You get commitment from from both division and senior levels of management to try to expedite development. That’s what that program is there for. And we’ve had really consistent, strong, thorough engagement from the division with timely feedback that’s very clear and is very much aligned with, what we wanna deliver, which is the the most complete robust package that that could be imagined.

Brian, Capital Markets: Have you experienced any meaningful changes in your interaction with the agency in the past couple of months?

Rob Arrow, CEO, MindMed: Really, not nothing that that stands out as a meaningful change. We’ve continued to have really positive interactions and very, you know, again, clear and and extensive, collaboration in approaching these challenges, but but nothing that has, stood out as a, you know, stark change in any way.

Brian, Capital Markets: And in maybe some of your recent conversations with, like, policymakers and and folks like that, do they continue to sound supportive of psychedelic therapies? Do do they sound more interested even and and and supportive than before?

Rob Arrow, CEO, MindMed: Yeah. I I think, you know, again, a lot of headlines and and ink gets spilled around the executive branch, but we’ve been it doesn’t really matter across DC and and really across the country and and state and and federal legislatures even. We’re getting just broad support and broad engagement and and an interest to really identify how this can be efficiently moved forward. The the need is we don’t even need to to comment on the need almost. Everyone is aware of the the credible, vast need in in these populations.

The promise of the data has really captured everyone’s excitement, and I think that is really showing up in in tangible ways across the board. So it’s not, you know, one party or one group or one position. It’s really throughout, you know, every level of of government. We where we’ve engaged, we’ve been really encouraged.

Dan Carlin, CMO, MindMed: I think one one reason that we are able to engage smoothly with policymakers is that, for the most part, our message is don’t think of this as something that’s radically different from what’s come before it, that everything we’re doing in our development paradigm leading up to a potential commercial launch is to say, yes. These drugs have remarkable properties, but nothing about this needs to be treated as completely new. Right. Right. There’s precedent for everything here.

There’s precedent for people having their consciousness changed by medicine. We’ve had anesthesia for under fifty years. Yep. And so that that where possible, we try to give that message to policymakers so that they can relay to to one another, and in their thinking that we don’t have to treat this as some big, bad, big, weird, new thing that we’re trying to do this in as familiar and recognizable way as possible.

Brian, Capital Markets: And you’re running both tradition traditional phase threes. Yep. So that that makes a lot of sense too. Given some of the setbacks from some of your competitors, m m one twenty may be the first or one of the first psychedelic therapies approved for psychiatric disorder. And so there’ll be a lot of commercial ground groundwork building that you guys will will be doing.

Can you speak to some of those efforts you’ve made so far and how you’re planning to approach commercialization broadly?

Rob Arrow, CEO, MindMed: Yeah. We we’re really fortunate to to have a new addition, and and Matt Wiley came on as our chief commercial officer who’s an incredible experience with complex launches and and complex products. Those with REMS, those are controlled substances. And so, you know, we as an organization and and, you know, with Matt especially, have really supercharged our engagement and our thinking about how we, you know, carry the the operational excellence from our development program forward into a commercial setting, and that includes engaging, you know, payers, providers, patient groups, you know, legislatures, as I said, I mean, really just across the board, being thoughtful about the the infrastructure in the world that needs or exist to to to, you know, lead to rapid and and expansive uptake of these drugs. It is a world that doesn’t entirely exist today to the scale that it could.

Even the infrastructure that is available today is is quite large and has grown really, really rapidly, just in response to the available of of esketamine and and ketamine and and such. But we see opportunity far beyond that. We see a a wide recognition of the need, a wide recognition of the potential, an understanding of what’s going to be needed to to get this done at scale. And then I think, you know, again, I think the thing that gets can can often get missed is just how we need to orient. If we have providers who are enthusiastic, which we do, and we have patients who are in need, which we do, and we can deliver a product that that meets that need and that’s profitable for those providers, all the ingredients are there.

Payers tell us, yes, we’re going to pay for this. We understand the dynamics. We’re going to find a way if the data really are as good as as what we’ve been able to generate so far. And so a lot of of work to be done, a lot of the the finer details that need to be worked out, but it just at a very high level right now for where we are in development, all of the science we have and all the data we’ve been able to to gather are extraordinarily encouraging about the theoretical potential and then the the practical Yeah. Sort of uptake of that into the real world.

Brian, Capital Markets: And and let let’s talk about the the practical real world up uptake, because I think that’s an area that maybe there’s less, maybe the street understands a little bit less and is looking to to learn more about. So how should we think about, like, the the patient journey, and what logistically will be required to deliver this drug, in terms of just the type of center and how many centers are out there right now that could that are equipped, what type of personnel would be needed to be at the site to monitor the patient and administer it, what type of payment structure would enable kind of reimbursement for, you know, a treatment of this nature where, you know, you’d be, you know, in a room for a long period of time during the day, but then really wouldn’t need to be treated again and wouldn’t need therapy for or psychotherapy before that or after that? Like, what how does it all sort of come together? What’s what’s in place and what needs to be built?

Rob Arrow, CEO, MindMed: Yeah. Maybe I’ll turn turn it to Dan, talk a little bit about that. Yeah.

Dan Carlin, CMO, MindMed: Yes. The the everything we’ve done in our development program is meant to make the commercial target as wide as possible so that where we’ve assessed safety, we’ve made sure that there there is not a physiological risk to the drug, so physiological monitoring can be eliminated. One of the blockers to Sperato’s uptake was that it requires physiological monitoring, but we don’t think we have physiological liability, and we’re gathering the data to to demonstrate that. In in the world of interventional psychiatry today, there are four to 5,000 clinics. The the data on those is always a little lagging because it has to be pulled out of the REMS applications in this, but and that’s a number that’s going up.

So even as we as we speak today, there are more people opening more clinics to deliver interventional psychiatry. Interventional psychiatry in those clinics today is SPRAVATO and TMS. Yep. Any place that can do SPRAVATO or TMS can be a launch target for m m one twenty. And and the requirements really are a place for a patient to be.

It’s comfortable enough for them to be there for the day and a way of monitoring that patient for psychological needs. So does does the patient, need reassurance? Are they comfortable? Do they need a snack? Do they need to go to the bathroom?

And and then most of the rest of what happens that is the the effect of the drug just happens. It’s not mediated by the other person in the room, so there’s no psychotherapy requirement. There’s no structured intervention requirement. All that’s really required is is assistance when and, sometimes comforting people as they as they go through that experience. That’s an easy core target.

Right? Clinics that today do interventional psychiatry. I would APA, the annual meeting of the American Psychiatric Association, was Saturday to today. So I came back from that last night. There were half a dozen dedicated sessions to essentially our drug, right, to psychedelics.

I have never before seen a phase three asset getting even one dedicated educational session, let alone half a dozen. There’s tremendous demand from psychiatry to be able to do this. So beyond centers that exist for the purpose of interventional psychiatry, our development program is also oriented toward can this drug be used in more conventional psychological and psychiatric settings? So could an individual therapist who has a place they do therapy be a session monitor for a day instead of doing, say, eight hours of psychotherapy? And by all appearances, based on the data that we’ve been able to gather, there’s no reason that that couldn’t be the case.

Prescribing of the drug will look like prescribing any other psych drug. It’ll be billed under the usual E and M codes. It will be done in whatever length visit the the prescribing psychiatrist or mid level thinks is appropriate. That that already exists. The the question of monitoring is an interesting one because that sort of service, psychological monitoring, already exists in the E and M coding system, and it’s time based.

So, really, all you need to be able to get to a place where payers are paying for the five to eight hour monitoring session is contracting with with payers so that now they expect to see an

Brian, Capital Markets: hour

Dan Carlin, CMO, MindMed: of initial monitoring, five hours of add on monitoring, and they reimburse it at the negotiated rate. So while, again, a lot about this drug seems exceptional, and and certainly the evidence of efficacy we’ve gathered so far is exceptional, The the infrastructure, the systems of care, they exist today.

Brian, Capital Markets: That’s that’s a really important point. What about Europe? Have you had any discussions with European regulators and any sense of what the commercial infrastructure might look like there?

Rob Arrow, CEO, MindMed: We we’ve had a lot of discussions across the board, in in Europe as well. And we and we have a a good understanding. I think we’re we’re, as an organization, from a commercial standpoint, you know, laser focused on on getting The US right. And that’s where certainly the largest opportunity is and, you know, where where we have, you know, organizational know how and the capacity to to build out that that commercial infrastructure. So that that’s been our our, you know, first and and foremost focus in as we think about the commercialization.

But we are continuing to to make progress, both development, regulatory, and, and, you know, with with commercial payers and and everyone over over in Europe to make sure that that opportunity is is something we can we can harvest as well.

Brian, Capital Markets: Great. And then just in the last minute or two, maybe talk quickly about your your other program in autism spectrum disorder and your expectations for for MDMA there, potential timelines for the phase one, and maybe some of the preclinical work suggesting that pathogenic molecules like MDMA can drive a benefit in that population?

Rob Arrow, CEO, MindMed: Turn to

Brian, Capital Markets: you again.

Dan Carlin, CMO, MindMed: So in the minute thirty left, we’ll talk about the other program we’re doing. So we’re developing our MDMA, the right enantiomer of MDMA, as a potential daily drug in autism spectrum disorder. The the properties of our MDMA versus the other enantiomer versus the left enantiomer is that it seems to be stereospecifically the serotonin releasing enantiomer of MDMA, while the left enantiomer is much more amphetamine like, much more dopaminergic. In order to get to a place where that this can be possibly done, we’ve had to do safety studies, obviously. And based on a single ascending dose that we’ve established, we will be able to move that forward into an ESOE study, an early sign of efficacy study, where effectively we because we have every reason to believe that one dose of this drug does everything that multiple doses of the drug does, and so we have every reason to think that we will be able to take folks with ASD into a into a space, in essence, where we can monitor them for their social skills, their communication skills, their empathy, their their ability to self reflect, reflect on others, and give them a dose of the drug and look to see if we get the effect we’re looking for.

That’ll give us enormous confidence to be able to bring the drug forward into a multidose paradigm.

Brian, Capital Markets: Great. Well, we’re just about out of time. So, Rob Dan, great to see you guys. Thanks again, and thanks, everyone.

Rob Arrow, CEO, MindMed: Thanks, Brian.

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