All right, thank you everyone for joining the Oppenheimer Healthcare Conference. This is day two in the morning on day two here. The next company we have presenting is MindMed, and we have CEO Rob Barrow to present. My name is François Brisebois. I'm one of the biotech analysts at Oppenheimer. I do cover MindMed. And with that, in terms of format, what we'll do is a fireside chat. We'll jump right into it. There's a lot going on. It's a big year of prep for MindMed, a lot going on in the space, and not to get too political, but a lot of buzz around this space as well recently. So thanks again, Rob, for joining. And if anyone has any questions, you can send them in the Q&A.
But just to start, maybe if you could just let us know, there's been a lot of movement, even with the competitor recently in the space. So just let us know, where does MindMed stand these days?
Absolutely, and thanks so much for hosting us. We are coming off of a really exciting year in 2024, where we put out exciting Phase 2 data, received a breakthrough therapy designation, and a great Phase 2 meeting with the agency, and at the end of the year, launched our first Phase 3 study in generalized anxiety disorder with our lead product MM120. So year to date so far, we've also initiated and dosed patients in our second study, the Panorama Study in generalized anxiety disorder, and have a Phase 3 study in major depressive disorder that will be getting started in the first half of the year. So all of those studies will be reading out in 2026 with Voyage, our first study in the first half, and the other two in the second half of the year.
So very much a year where execution is key and leading into a really exciting period of several pivotal readouts as we head into next year.
Okay, great. So for investors in 2025, what kind of updates could be expected? Is this more of an execution kind of year? And then 2026 is the big data year for MindMed, or what should investors be looking at for this year?
We certainly hope to have a lot of developments throughout the year, but in terms of the key and late stage milestones, certainly 2026 is the year when all three of our current studies and at some point we'll be talking about and have previously disclosed at some point we'll be conducting a second study in major depressive disorder. So we'll likely have some more to share there as we go throughout the year and finalize the approach for that indication. But certainly a year about execution and making sure that we're delivering our clinical readouts on time and that our team has been really extraordinary at doing, I think, uniquely in our field, where there's been a lot of setbacks in other regards.
We've been able to deliver all of our milestones on time and very much intend to keep doing that as we go into these Phase 3 studies.
Yeah, that's interesting. That actually brings me to my next point I wanted to ask about, because you always wonder with delays and stuff, maybe it's the indication, maybe it's the trial, the space, or whatnot. But so why, for those everyone knows TRD, everyone knows MDD, people are a lot less familiar with GAD, although logically through just life, they kind of see a correlation that's inevitable between MDD and GAD. So just help us understand why you guys went with GAD?
If we really go back in time prior to the introduction of SRIs in the early 1990s, the large focus of psychiatry historically has been on anxiety. If you can really go back in time and think about barbiturates and then obviously the introduction of benzodiazepines, really only the advent of SRIs shifted that pendulum pretty severely in favor of major depressive disorder. Of course, there's been a pretty complete campaign since that time to make sure that there are screening tools available. Obviously, depression is a highly burdensome and prevalent condition as well. Generalized anxiety disorder is something where there are far fewer treatments available. The treatments that are available seem to work less well than the available treatments, even SRIs and depression.
There's an incredible opportunity, both just because of the lack of competition in the space, but also because anxiety has increasingly come back into focus. The prevalence of anxiety disorders is estimated to be about 10% of the U.S. adult population, which is just enormous. To have seen no new entrants in anxiety treatments since 2008, the introduction of Cymbalta, we've gone 20 years almost with next to nothing new for generalized anxiety disorder. One of the things that would be particularly impactful for patients, more broadly though, the ability to pursue both generalized anxiety disorder and major depressive disorder broadens that opportunity even further and allows us effectively any patient coming into a psychiatric clinic that presents with anxiety or depressive symptoms, if we're able to get both of those approvals, would then be able to access our treatment.
Trying to really cover the broadest opportunity, that carries incredible commercial potential, but it also has important implications for the conduct and how we think about operationalizing our clinical trials. It allows us to get patients in the door faster and really enroll at a pretty efficient pace in both of those programs.
Is GAD a little like MDD where there's a part of the population that's treatment resistant to GAD, or is it not broken out like that, or as obviously it is?
Yeah, the concept of treatment-resistant GAD is not something that is well defined or generally agreed upon, and even the definition of treatment-resistant depression we find to be somewhat underwhelming. When you have drugs that just don't work well enough to treat a condition, it's hard to say that that's a distinct psychophysiological or psychopathology that is driving some discrete disease process. Really what's happening in treatment-resistant anything is that the drugs aren't serving the patients well enough, and so in GAD, that's something that is definitely less well defined, but something that, given that backdrop and also the challenges that TRD launches have had in recent years, our overall strategy was to go for the broadest possible label and cover both GAD and MDD.
We talked about the challenges. The TRD, so it's Spravato, obviously it was approved for TRD. There were hiccups at first. You just talked about the hiccups at first and ultimately, which is good for the field just because of the kind of centers or whatnot, the similarities maybe, the learnings from it, but Spravato is well on its way. I mean, we're talking blockbuster potential here. So I think success is probably a fair term to describe that at this point. Can you help us understand what your thoughts about business-wise, the early issues with Spravato and what's coming out of it and how you can learn for your space?
Absolutely. Spravato is one of those examples that there's certainly some attributes that we will be able to leverage, we expect, and there's certainly some attributes that I think should get everyone encouragement that the landscape for interventional psychiatry is moving very quickly and aggressively in favor of these sorts of treatments. It's not just a daily take-home drug that's prescribed at primary care. We look at that as positive signals. The challenge with Spravato, and even to this day, the big challenge is that the durability is not there. The magnitude of response is not there, and historically, the label has been as an adjunctive treatment in TRD and MDD with suicidal ideation and behavior.
And so when we think of the opportunity, both from a label perspective, but also from an infrastructure perspective, we're talking about in our program so far, a single administration that, while a little bit longer on the day of administration, a single administration that has months of clinical benefit and many patients' remission, whereas Spravato requires 56 treatments a year on label. So that dynamic, it does serve as somewhat of a proof point, but really more like a springboard that we can leverage the infrastructure that exists. And what we see when we go out and survey the Spravato and other interventional psychiatry clinics is that the vast majority of them say, yes, we're doing Spravato today for our patients because it's new and it is available.
But something like 90% say we will be referring patients and/or administering MM120 or treatments such as that that has that profile if it should become approved. So just an extraordinary pull from the field of psychiatry and then leveraging an infrastructure that is continuing to accelerate in these clinics that are well set up. As we look at those dynamics, the REMS requirements for Spravato, the dynamics of delivery are probably, and obviously it's too early to definitively say for our product because we don't have a label and REMS negotiated yet. But for Spravato, when we look comparatively, we certainly think we will be able to get to a place where there's less onerous REMS, there's less onerous documentation requirements just from the sheer volume of dosing sessions or treatments that are needed.
Again, we look at it as certainly a sign in the right direction, but probably a very low-set expectation for what we would think about as the potential for this drug class that really has a sort of transformational impact on patients and providers.
Interesting, and then can you touch on the new personnel adds that you've had, Greg and Javier, and their backgrounds and why it's relevant to Mind Medicine?
Yeah, we've continued to build out our team over the last several years, but especially in the second part of last year. Gregg Pratt, who joined us as Chief Regulatory and Quality Officer, came to us from Karuna Therapeutics and BMS, where he just led the approval of Cobenfy, of KarXT in schizophrenia. And so he, and in fact, his entire regulatory team just joined us last fall and have been a great addition from day one. And it has such an incredible track record of working with the Division of Psychiatry at FDA and navigating novel products. I think when we look at the label for Cobenfy, it's a testament to that team, and we're certainly thrilled to have them on our team.
We've also recently added, as you mentioned, Javier Muñiz, who is the acting deputy director of psychiatry at FDA, and his insights in the field and the direction he's able to offer in our R&D group has also been an incredible addition, and it's not even mentioned a few additional adds, including Juli Garner, who joined us from Sage as the head of government affairs and is very active in Washington and throughout the country, trying to make sure that the regulators and the government at large is very much aware of how we're approaching this and why we're doing it the way we are and the rigor and science behind what we have here in hopes that if we're fortunate enough to get a regulatory approval, that the entire country and the entire world will be ready for embracing this as a new treatment paradigm in GAD and MDD.
Great, and you brought up Washington, you brought up the FDA. I don't have a choice but to bring up RFK. Do you have any prepared remarks on that side? I'll leave it totally open up to you.
Look, I think regardless of anyone's political leanings, we have a new administration who has shown an interest in engaging around innovative treatments such as what we are pursuing. We are absolutely committed, regardless of who is in Washington or in any office, to do a rigorous science and development program that will stand up to the highest degree of scrutiny like we should expect of any new drug. But certainly when we see an interest in comments about, I think in many cases, rightfully recognize a truth, even if perhaps the words that are used are not the words we would choose, there's a recognition that the current treatment landscape and the trajectory of the mental health epidemic in our country is really not how we want to have the path forward. We don't want a continuation of the last 20 years.
So an embracing of new options, new treatment paradigms such as what we're developing is something that we've seen broad bipartisan engagement around. I mean, that includes congressional, Senate, and executive branch offices. We're again committed to developing these drugs to the highest standards, but certainly having regulators and government authorities who are supportive is a great tailwind for our field, we think.
On the rigor side, what I've always thought was great about MindMed was the rigor on the science here in terms of, so can you just talk a little bit more about in your Phase 2, you had five dose arms and we've heard a lot about functional unblinding, which is no surprise. I mean, it's been a discussion for years, sort of thing. So if you could just help us understand why did you have all these dose arms and what you think you're doing to approach functional unblinding?
So really two factors driving the study design in Phase 2. One that's critical is dose response, something that has not been looked at in the field. And one thing that we as a company scientifically just will not do is rely on assumptions that aren't backed up by data. We need to have data to make arguments about everything from the clinical activity of the drug to the safety profile of the drug to the administration parameters. And so we go to great lengths to design and document all of those elements. I think probably uniquely in the field, we go to such great lengths because it's really important in discussions with health authorities, both here with FDA and throughout the world, that we have data. We're not scared of acquiring data. We're going to embrace that and make thoughtful arguments regardless of what those data tell us.
The design in Phase 2 was first and foremost, as I said, to develop a dose response, which we did both observationally and clinically, but also statistically. That tells us the proper dose to select to move forward, which turns out to be our 100 microgram dose group. There hasn't been a lot of dose response in the field, and there has been an assumption that just the day of feeling of effects is going to translate directly into clinical activity. We've actually proven that now, but we haven't seen that before in the field. The other thing that it conferred, our Phase 2 design, is to have two low dose groups in the study, 25 and 50 microgram dose groups.
Now, we obviously didn't have the answer until we conducted the study, but going into the study, certainly the historical data would suggest that probably one of the two higher doses, 100 or 200 micrograms, were the most commonly used in historical studies. So having a 25 and a 50 microgram dose level did a few things. It allowed us to characterize the functional unblinding at those levels, clinical activity at those levels, but it also likely inflated the placebo response in the study. So what do I mean by functional unblinding? Really, the fact that patients who take the drug can sense that they're on a drug. We asked all the patients in our studies about this. Do they think, are they sure, or are they unsure whether they got drug or placebo?
What we found is that regardless of the dose level of drug that a patient received, 25 up to 200 micrograms, 88% or more of them, 90% at 50 micrograms and 100% at 100 and 200 micrograms, correctly guessed that they were on drug. Regardless of dose, firstly, everyone knew that they were on drug. We saw a dose response still. We saw that 100 micrograms had almost eight-point separation from placebo and 50 micrograms had no clinically meaningful separation from placebo at any of the time points. That gives us the confidence that there's a real drug effect going on here. It can't be explained by functional unblinding if all of the groups had functional unblinding and only two of the groups actually clinically responded.
The other thing from a study of validity that I mentioned before, by having an 80% likelihood of being allocated to get drug and by having low doses that presumably allowed patients getting placebo to think, maybe I did get something, maybe I am feeling different. We saw a placebo response that was about 14 points from baseline. That is far in excess of what we've seen for historical studies in GAD and is about as good as an absolute change we see for SSRI. So when we see studies that there's only evidence of clinical activity because there's no placebo response, it has to, at a program level, call into question how much of that is really due to drug effects and how much of it is due to this sort of functional unblinding.
Now we have evidence, we have complementary designs across that in our Phase 3 program to really understand how does this drug behave irrespective of the placebo allocation, irrespective of what it does, but we have shown that even if we have an extraordinarily large placebo response, we can still beat that with an effect size greater than 0.8, is more than double the standard of care, which I think got us really excited about the real validity of the clinical outcomes in that study.
That's great. Okay, that makes a lot of sense. And then another, when people are trying to figure out, I mean, there used to be a million companies looking at this space and now there's only a few left, which I think a lot of people kind of predicted. But there's been data recently on another one that's a little shorter acting kind of on the GH side. Are you willing to comment a little bit on the treatment duration and importance on the commercial side of an LSD versus a DMT or something else like that?
What I can say is our engagement with sites of care has been really eye-opening in that what we can look at there is Spravato, which is a two-hour dosing session. And the thing we hear from these clinics is that a two-hour dosing session presents a huge administrative burden. So if you think of running the site economics or running a clinical site of care, you got to have staff there for the day. You got to dose patients and you got to have staff there typically for eight or 10 hours. That's how those days and work is constructed. And so for sites of care where they're delivering Spravato, in order to get paid, and they get paid by the hour, generally, in order to get paid for that time, you have to turn over the rooms four or five times a day.
They tell us also that it means an additional hour of unpaid administrative work. So you're not getting reimbursement from payers for filling out REMS forms and filling out prior authorizations and everything. So the degree of turnover that's required at these clinical sites, they've indicated is a significant burden on them and something that would make our product favorable compared to Spravato, for instance. So we were actually, I think we're quite encouraged and quite surprised by how strong the data we've had from these sites that the duration of our product, which we're keeping patients in the clinic for at least eight hours in our Phase 3 program, that very much aligns with a day of work and has some real economic efficiencies at sites of care where those incentives matter most. So we're really pleased with the duration of our product.
And I think it also is worth mentioning, we have yet to see the magnitude and durability of response from any other drugs in the field after a single administration. And that is what's so exciting. I mean, a new product where patients have to come in every couple of weeks may have a place, but that burden on patients is extraordinary. And it's one of the things that stood in the way of Spravato's uptake. So the magnitude and durability of response that we've been able to generate also confers this huge advantage so far, we think, in terms of relative position in the field.
Remind us the primary endpoint, the durability that you saw in the Phase 2, and what you're trying to get to in the Phase 3?
In the Phase 2, we gave patients a single dose and followed them for 12 weeks. In the Phase 3 study, we're doing virtually the same design. Single administration, we follow patients for 12 weeks. In the Phase 3 study, the 12-week Hamilton Anxiety Scale is the primary outcome. The one difference is that we've added on a nine-month extension to this study. We talk about it as an extension phase where patients have the opportunity for open-label treatment. Regardless of initial allocation in either of the studies, patients at the end of the 12 weeks will start to be screened for the return of symptoms or just the presence of symptoms. If they have a HAM-A of 16 or greater, they become eligible for open-label treatment with 100 micrograms of MM120, up to four additional doses during that nine-month period.
The thing it also gives us, though, is the opportunity to look at durability beyond 12 weeks. For the patients, until a patient takes an open-label dose of drug, they are still blinded. We won't tell anyone or them what they received at their initial treatment, what they were randomized to, and so we can get things like Kaplan-Meier curves for how long it takes for a patient to have a relapse or inefficacy, is probably a better term for it. That could expand as far as a year if we were to see that in the active group versus placebo, so we have a really incredible opportunity to look at single dose durability and then to characterize the retreatment, the safety of the retreatment, and the kind of real-world use case of what retreatment might look like over the course of the nine months after the randomized period.
Awesome. Okay. No, that's super helpful. And I guess I have to ask you, there's been a lot of buzz. The AdCom from Lykos obviously brought a lot of attention to it. I just want to give you the opportunity on this presentation to explain to us why you feel like that doesn't affect you guys.
I think there's a real reality here that it's a different drug in a different drug class. It's a different program and was developed by a completely different organization. So everything we've been talking about, about the rigor of our design, the completeness of the package we intended to present to FDA and develop, and the strength of the team we have built here over the past three or four years and our ability to navigate novel approvals with FDA gives us encouragement for our path forward. The way we approach these things, when you're standing in front of an AdCom, you want to have an answer, a thoughtful answer that has been discussed and agreed upon with the agency throughout the development program. And so while there was anything novel, there are always unique questions that come up.
Our approach has been one that is as highly rigorous as possible and that will give us, we think, the best opportunity to stand in front of an AdCom with a strong argument for why the safety and effectiveness, hopefully, will be proven out. The other thing I was really pointing to is that one of the decisions we made before the Phase 2 study, when it's somewhat unpopular to do this, was to eliminate any surrounding therapy. It used to be talked about as prep sessions and integration sessions, and what we wanted to establish is that there is a real drug effect, a standalone drug effect. It is incredibly different from drug-assisted therapy, which was in front of the advisory committee before, and it does away with several complex questions.
I feel obligated always to say our decision to do that was in no way discrediting or undervaluing therapy or psychotherapy. We think psychotherapy is great. We think it's so great that it shouldn't be used as a second intervention in clinical trials because you need to isolate a drug's effect, and our approach has been, if we get the product on the market with as flexible of a label as possible, then practitioners are going to, this is medical practice, practitioners are going to develop the best ways to use these drugs, but it's been really important in our design. I think it gives us also a significant advantage in terms of the reduction in complexity versus what was in front of the FDA and the advisory committee last summer.
Okay, great. And then how does the company look in terms of the balance sheet right now?
Yeah, as of Q3 earnings, we had just under $300 million of cash, which gives us a runway into 2027 and at least 12 months beyond our first Phase 3 readout. So we're in a very fortunate position where we're well capitalized to get through all of the Phase 3 readouts that we've announced currently. And certainly, we've had a huge support by some really great investors that we're really grateful to have behind in our company. And I think as we get closer and closer to data, we've also seen a continued enthusiasm for the opportunity here and a continued engagement. So we're excited about the capital formation and the future of a position for our company.
Awesome. Okay, great. Is there anything kind of last minute here, anything we should have talked about, we didn't talk about, or closing comments on your end?
As usual, you've covered it thoroughly. So as you mentioned, we're in an execution year. 2026 is a really, really exciting time. We'll have multiple pivotal readouts, something that is a really special thing in any development programs. We're excited to get there and hopefully deliver some great results.
Awesome. Appreciate the time, Rob.