My name is Michel Fernandez. I'm part of the banking team here at Jefferies. Welcome to this presentation. I'm delighted to host Rob and Brandi, CEO and CFO of MindMed. We'll have a fireside chat. I'll just briefly introduce MindMed. So you're advancing MM120, an orally disintegrating tablet of lysergide in phase III trials for GAD and MDD. The company recently raised $259 million to fund pivotal programs. Congratulations on that to the both of you and to the team, with phase III readouts expected in 2026. Rob, Brandi, welcome. Maybe let's start for the audience here a little bit. For those new to the company, maybe you can tell us what the company is about, and what makes MM120 different maybe from other mental health treatments.
Yeah, thanks for hosting. It's been a great conference. MindMed was, there's over the last decade or so been a sort of reemergence in psychiatry of drugs that are very old, psychedelics, sort of a loosely defined category of these serotonin agonists that have profound perceptual alterations. While these drugs were used, extensively from their discovery and LSD being the first to be discovered in Switzerland in the 1930s, used extensively in clinical research and in clinical practice, up until the Controlled Substances Act and various iterations around the world in the 1970s. They've been sitting on the shelf for the last 50 or so years.
Some researchers sort of re-enlivened the field about a decade ago. Then we picked up the mantle with LSD, which is the most researched, the most potent, sort of the most well-known drug in the field, starting a development program only a few years ago and just had phase II results last year that showed the most remarkable results we have ever seen in anxiety and in depression, dramatic reductions after a single dose of drug that lasted for at least three months. This is in a disorder, internalized anxiety disorder, that has grown, has tripled in prevalence over the last 20 years. The last approval happened with Cymbalta, the SNRI that we all know, and very, very old drug. I feel where there has been very little innovation, huge patient need.
We're talking about tens of millions of patients that suffer from anxiety and depression and very little innovation. We've been really fortunate to have the opportunity to bring this molecule forward to generate some intellectual property that is, you know, incredibly important for our product and for our program and organization. Now, on the strength of those phase II results, we have pivotal programs in depression and anxiety, all of which, three of the studies of which we'll be reading out next year and a fourth study that we'll be getting off the ground next year. Incredibly exciting time for us in the field. There's been also a focus on interventional psychiatry and a new, more high-touch delivery of care in psychiatry.
J&J has a product, Intranasal Esketamine, that's seen some really dramatic uptake over the last few years. You know, on the heels of that, to be bringing a product forward with even more profound efficacy and durability of effects, we're really, really excited about the commercial prospects and what that will, what we'll be able to get done both in a development standpoint and when we get the product out in the world.
Thank you, Rob. As you mentioned, some of the other, you know, health treatments out there, there's a lot of attention therefore on these psychedelics, psychedelic-inspired medicines, but also some skepticism, arguably. What are the top reasons to be excited about MindMed? I know you alluded to some of your readouts next year, but just give us a bit of a taste.
Yeah, I'll maybe ask Brandi to comment, and I'm happy to elaborate.
Yeah, I mean, for me, I, so I joined the company in June of this year. I was previously the CFO at Longboard. I was really planning on taking this year off. Longboard was a, was a really fun project for four years, but was introduced to Rob and the team and was so compelled by what we're trying to do here. I, I think we're looking at significant unmet need, you know, in these two conditions, where we could have a significant impact. I think, you know, Rob, Rob talked about, you know, efficacy and durability. I think that's the part that sometimes gets missed is, you know, in our phase II, we saw, we saw effects out to 12 weeks. In our phase III, we'll be looking at patients the whole way through a year.
We will be able to really see retreatment patterns and what that looks like. If we are able to see, you know, efficacy that was similar to our phase II and having durability out to 12 weeks or greater, I mean, I think that is a dramatic approach for patients who have been struggling, especially in anxiety where there has not been an approved drug in almost 20 years.
Fantastic. Maybe on phase II-b results in GAD, where they showed rapid and durable effects after a single dose, right? The single dose piece. How do you see this translating into sort of real-world impact for both patients and providers?
Yeah, I mean, the world of psychiatry has been lacking in any sort of meaningful innovation for a long time. With worsening prevalence, a lack of new, really meaningful, you know, leaps forward in innovation, there is just an overwhelming demand from patients and from providers, the entire field, to have something new. That is exactly, you know, what this represents. Every time we see a new class of drugs in psychiatry come to market, we not only see the infrastructure and the sort of care paradigm adapt to embrace it, but we see just rapid other extraordinarily large opportunities. This goes all the way back to the introduction of [benzodiazepines], which, you know, when we zoom out a little bit, the long history of psychiatry was predominantly focused on anxiety, actually, as it were.
You know, going all the way back, thalidomide was an anxiolytic. People do not really focus on this, but thalidomide was then replaced, you know, with barbiturates, which obviously had significant toxicities. Then benzodiazepines came along to replace those as being the safe alternative, which we now know have a significant abuse liability. It was only with the advent of SNRIs, the introduction late 1980s, early 1990s, that we then saw this massive diagnostic drift and focus away from anxiety onto depression symptoms, largely because SNRIs are better equipped at treating sort of anhedonic symptoms and less well suited to treating anxiety symptoms. When we look at that landscape and see the growth in these disorders and we see data like we have never seen before in treating these, again, patients and providers get remarkably excited.
Now, it does require a bit of, you know, ability to see around the next corner, right? These are not daily drugs that are taken home. It requires patients to come into a clinic to take a day to be treated. The magnitude and the durability of those effects that we were able to observe after just one treatment, or for some patients, it's gonna require probably a couple of treatments over time.
Right.
or more. You know, that meaningful state change that we're seeing, right, it's not just about symptom suppression. It's really about a reorientation to the experience of living with these symptoms and living with, you know, mood and anxiety effects. That ability to drive a meaningful and long-lasting change is something that really we think is gonna reshape an important part of the field. This is not gonna be for everybody, but when we go and talk to patients, providers, the vast, vast majority are incredibly excited about what this field entails. Now that we're coming to pivotal data, you know, we've always been reticent to get ahead of the science, to get ahead of the clinical data.
We've seen really promising phase II results, but now coming to multiple pivotal studies gives us exactly what we need to really make a compelling case and hopefully a pretty efficient path to get these products out in the world.
Fantastic. Maybe on this phase III then, maybe on the design and the timelines, can you perhaps walk us through the design of your phase III studies for MM120 and how they build on phase II-b results?
Yeah, so we designed our phase II study to be a phase III study that we thought would have all the design elements. The thing we needed to answer first, though, and I think I, I do not know that our field's done an adequate job historically of answering, is whether it is to define the dose response with these drugs and to actually have data to justify an appropriate dose to take forward in pivotal studies. We started there. We did a five-arm phase II study, established a dose response, answered a lot of really important questions, actually, for the field and the dynamics of how the drug works. That set us up to basically replicate that phase II study with simpler, more streamlined designs in phase III.
Two studies in both indications, one and two in anxiety, two in depression. Single dose, we follow patients for 12 weeks. In anxiety, the primary endpoint is the gold standard of the Hamilton Anxiety Scale at 12 weeks, which is where we saw a statistically significant effect in phase II. We then follow patients for an additional 40 weeks, and they have opportunities for open label retreatment if they have a return of symptoms. We will not only characterize the durability of a single treatment, but retreatment patterns over the course of a year. For those who have been sort of casual observers of the field, there used to be a discussion about psychedelic-assisted therapy, the concept that there is sort of a dyadic therapy happening alongside the drug. That is something we took out before going into the phase II study.
There's been a lot of changes made in the field too over that time, for others sort of adapting that lighter, lighter touch model. Every study we've conducted has been with that. Everything about how we deliver the treatment in phase III is the same as what we did in phase II. There's been some learnings and some streamlining of certain criteria in the phase III program. By and large, it's a replica of what we did in phase II and gives us an extraordinary degree of excitement for the probability of success. One thing about the phase II data that was so interesting is that we saw a remarkably high placebo response, something that is not usual, again, for our field.
A lot of studies see almost no change in, you know, concerns about functional lining and these sorts of things that we've gone to great lengths to mitigate. We saw a 7.7-unit improvement over placebo at our go-forward 100-microgram dose, but it was on top of a placebo response that was 14.2 units improved from baseline. It's about almost double what we see for most placebos in these studies. That gives us a lot of confidence in the robustness of the data. Also, in the translatability into phase III, right? If we're starting from a place where there's a low bar that you've cleared, you know, you worry that placebo grows and you lose effect size and get sort of delta compression in phase III.
You know, if anything, if we see a return to, to sort of normal effects, in a placebo arm in phase III, that should give us even wider margin, margin of error. A lot of excitement, a lot of confidence. The first GAD study reads out first half of next year, second study in the second half, and then our first depression study reads out, mid, mid-2026, and we'll have a, a second study coming online around that same time. Incredibly exciting couple of years ahead with, with readouts across these programs.
That's a great answer. Thank you. Maybe then on the, on the capsule, you raised $259 million at the end of October. How does that position you for the next phase, therefore? What are your top priorities for deploying this amount?
Yeah, it was great to do the raise. You know, again, since I'm fairly new to the team, it's been great doing a lot of investor outreach and understanding what people are interested in, where we can hone in on our messaging. We did a lot of work over the last three to four months in really talking to investors, and had a lot of interest in the company. When we were thinking about next year, the company did a tremendous job in being well-capitalized, raised $250 million last year, set us up well for, you know, having cash through our three readouts next year and into 2027.
When we were looking at the budget and thinking about our plans for next year and talking about it with the team that we've put together, you know, there were so many things that we could supercharge if we had additional funds. We just decided that it was the right time to do it. There were great investors who wanted to be involved. It was a right-sized amount of money that lets us do things like be prepared for our NDA submission. As soon as we get these clinical data results, to get that submission in as soon as we can, things like state prioritization and making sure that we're set for a commercial launch as quickly as we can.
A lot of these states take longer, in terms of scheduling to get situated, you know, KOL education and really getting the word out about what we're trying to do here and how this is very different for GAD and MDD and how we would plan to commercialize it. There are so many great places to really put that money to work, while we're waiting for these three phase III readouts. Then again, kicking off that fourth study, which will be the second MDD study, and really being able to leverage the great enrollment we're seeing on that study and being able to just move that right into the second MDD study, as one's finishing up.
Fantastic. Sounds like you have it laid out to the dot. That's good. Maybe just to, maybe a final question then. You, Rob, you mentioned there's, you know, it's a, it's exciting 12-18 months. And, and Brandi, please also, you know, chip in. I, I wanna hear what you have to say. What, what are the most important milestone, milestones for investors, right, that they should watch out for?
Yeah, with three phase III study readouts in 2026, we have a few things going on that are incredibly exciting. And then, you know, what comes after that, right? I mean, with now hopefully replicating the findings from phase II and the phase III study and, as Brandi said, getting ahead of, so we can be really aggressive with how fast we get an NDA prepared and hopefully on file and moving forward towards commercialization. I think we're, you know, unlimited reasons to be excited over the next couple of years. And even beyond that, I mean, again, the world is continuing to wake up to the reality that this, you know, I think is the next era of psychiatrist, something that's really gonna have a massive impact and, most importantly for patients, right?
The patients who have been living without really good options for a long time. We've seen just such a dramatic growth in these, in the impact and the, the prevalence of these conditions. To be able to be an early mover here and to really set the standard and drive the infrastructure, the adoption and position so that the world can, you know, that there's an easy path for this to be adapted and adopted out in the real world. You know, we're doing a lot to get excited about what even becomes after that. With now four over the next several years, four phase III readouts, it's an incredibly exciting time for us and for the whole field.
Fantastic. Thank you both for joining the conference, and hope you enjoy it. I hope the listeners here also enjoyed the presentation or the chat.
Great. Thank you so much. Appreciate it.
Thank you very much.