All right. Welcome back from lunch, everyone. I'm going to go ahead and get started. Next up, we have the team from MindMed. We have CEO Rob Barrow and CFO Brandi Roberts. Thank you both for joining. Thanks. Great to see you here. I'll just turn it over for kind of a quick overview of the company, where things stand today, and then we'll get into it. Yeah, absolutely. Thanks so much for hosting. It's been a great conference to kick off the little push to the end of the year here. MindMed, we've late-stage asked that we're one of the leading companies developing psychedelics for a variety of psychiatric disorders. With our lead program, MM120, is the ODT formulation of LSD in development for generalized anxiety disorder and major depressive disorder. We had some really exciting phase II data in 2024 and launched the two phase III programs over the course of last year and received a Breakthrough Therapy Designation in 2024. Now excited moving into 2026, we're going to have three pivotal readouts, two in anxiety and one in depression, and we'll be launching our second pivotal in depression. Been an exciting couple of years for the field and for MindMed in particular. Awesome. All right. Let's just start off on the regulatory side. Kind of an obligatory question, but it's worth asking given all the changes, even today. How have your FDA interactions been going? Have there been any changes over time, whether that's changes in staff, changes in discussions, anything like that? Regulatory interaction has been remarkably positive. I think we and FDA have both come at, look, we see the potential of what this field could offer and know that it requires thoughtful, rigorous science and thoughtful engagement from both the sponsors, but also from the regulators. I think Tiffany Farchione, who's Division Director of Psychiatry, has done a remarkable job at building the sort of continuous engagement and thoughtful engagement throughout the entire development program. I mean, sitting down from our first pre-IND meeting with her all the way through to today, FDA has been remarkably responsive as well. Again, all of us see that, I think, the potential of what this could offer and want to get to the end of the road with something that we've aligned along the way and have really built in collaboration. We've very much felt that. Our regulatory team was coming right off of the approval of Cobenfy at Karuna, and I think have been, even they have been said how pleasantly surprised they've been about the kind of positive tenor and degree of engagement we've been receiving for our program. I think bodes very well for what lies ahead, certainly. Awesome. All right. Multiple phase III data readouts next year. Let's kind of just dive right into it and kind of set some expectations, go into the nitty-gritty. Then we'll come back for kind of the commercial bigger picture view of things. There have been other psychedelic trial delays. What makes you really confident in your own timelines? Are you doing anything differently kind of from a site activation or engagement perspective? We'll start there. Yeah, I think our team does a tremendous job at running these studies. We hear this from sites all the time. I get messages periodically of investigators saying, "In 20 years of research, I've never had a team that is this engaged." We don't turn a single thing over. First and foremost are the people and the execution. I mean, the way we run trials, I think, is how we get the results we have. It comes down to the people who are doing it. I cannot say enough good things about our clinical development team. The other is designing the design of the studies. We design our studies with sites in mind, with trial conduct in mind, and try to design clean studies that allow these sites to get the studies set up and get them running. Across the board, we've beginning in the phase II and now through the phase III programs have seen a high degree of engagement, enrollment, and throughput in these studies and feel really confident about where we are heading into the three readouts next year. So much so that we just pulled forward our first depression readout in the mid next year, which was starting later in the year. Yeah, awesome. I guess starting more so on the GAD side of things, I just wanted to level set, be really clear before we get data. Are you planning to put out any types of metrics or give any commentaries as we get closer? Like I'm thinking about baseline characteristics. Like some companies will talk about OLE enrollment or discontinuations, kind of rescue drug use, blinded variability. Every company has a different level of disclosure that they kind of give. I'm curious what we should expect on that front. I think where we're positioned today and given the speed at which we're moving here, we want to be very diligent with how we disclose that information and set ourselves up so that we can have the cleanest regulatory discussions. For us, it tends to not be a whole lot of utility in trying to overextend ourselves. When we get the data, it'll be a full readout. We'll sort of fully contextualize everything. I think there's a lot of familiarization that we have been doing and we'll need to continue to do because there has been so little research in anxiety in the last 20 years, less approval of Cymbalta. I mean, it's not like a new drug that we've seen. It was approved in 2007. I do think there's some utility in educating everyone on what anxiety is, how we've approached the study, what we will be able to say coming out of the study. Certainly, disclosing data, even in a blinded fashion, is something we tend to shy away from where this closer readout. Awesome. All right. Thinking about the primary endpoint then, I think in the prior phase II/B for HAM-A, you did seven to eight points placebo adjusted, which is a huge effect size. At least from our investor conversations, I think there's the expectation there'll be a couple point regression, not for any reason other than the fact that it's a late stage psych trial. How are you guys thinking about the expectation there? What do you want to see? I think we have to parse these things into a fundamental drug development expectation versus what everyone who's here and having these conversations wants to see. Obviously, the bigger, the better. We want to see a huge effect. We'd love to replicate what we saw in phase II. From a development standpoint, a three-point difference is as good as we have for any approved drugs. Now, this isn't any approved drug, though. This is going to be more involved intervention. Seemingly, the expectation tends to be levitating around four points or gravitating around four points. I think if we set that as a sort of baseline expectation, let's say, give or take, obviously 3.9 isn't bad and four is good. In that sort of neighborhood, if we see a four-point delta, that's going to be larger than any approved drug. Even if we see a little bit of compression from what we saw before, that'd be a great outcome. We have reason to believe that what we saw, there's even opportunities to do as well as we did before. Not just because the drug will necessarily do any better. It almost maxed out what we could reasonably expect. In phase 11, we saw such an extraordinarily large placebo response, a 14-point reduction from baseline in our placebo group at week 12. That is larger than any of the approved drugs. It's about as large as the active groups in most of the approved products. If we saw a normalization of that, if we see something more along the lines of seven, eight points placebo reduction, and we even lose a few points on the active group, then you're talking about a similar or potentially even wider margin. We have a lot of reasons to be optimistic, but a four-point, let's be realistic, people want to see something good and something that's impressive. I think four points or better would be exactly that. Yeah. I think that actually aligns with the statistics pretty well. I was running some of this, so I'm curious if you kind of agree with these numbers. You really only start running into powering issues if you fall below a four-point effect size and honestly kind of closer to the three-point range. From a statistics perspective, I guess it's probably not all that relevant. Am I in the right range when I kind of did some of that math? Yeah. In anxiety, we've powered both studies to have a 90% power for a five-point difference, which is, of course, a different thing than how large does the effect need to be to see a positive study. We think about both of these things. If we see a clinically meaningful effect, we want to make sure the statistics result in a positive study. That's exactly where we land. It's a little bit over a three-point difference that would imply you have to go down to scenario and modeling here, but most likely would lead to a positive statistical outcome for the study. Both of those need to be true. It has to be clinically meaningful and statistically significant for anyone to get excited, including regulators. We've sized the studies appropriately and accordingly. Even if we do see that compression and see something in the three, 3.5 point range, we still expect a good likelihood of a positive study. Yeah. Large margin of safety on the powering side based on the prior phase II/B. So large. We don't really need to talk about it in much more detail. Fair. Okay. Awesome. All right. What about the MDD side of things, especially since that data has kind of been pulled forward to the middle of the year? I think the prior GAD study where you had the patients with comorbid depression, there was about a six-point effect size on MADRS. Is that in the range of what you're looking for? I guess we should frame all of this in the context of durability that you've seen previously in the study. Yeah. I think in the GAD context, we're looking at a 12-week endpoint, which is not only as long as any approved product on the market, but is, I think, longer than anything else being looked at in the field in relation to single-dose durability. That is already setting an extraordinarily high bar for ourselves in the GAD program. In depression, out of some of convention, we're using a six-week primary endpoint. Obviously, we want to see durability out beyond that, out to 12 weeks as well. Again, I think similar kind of expectation setting is appropriate here. Three, 3.5 points is sort of the ballpark of what we have for currently approved therapies. We want to see four better, I think, is a reasonable expectation for what would be a really positive outcome from the study. Awesome. All right. Turning over to, I guess, regulatory commercial with more of a commercial lens. If the first phase III is positive for GAD, is there an opportunity to file on that? In today's world, there may be many opportunities for a lot of creativity, but I think we don't intend, especially for this drug class. This is a drug class that's been around for a long time, has a storied history of its own. We want to be standing in front of regulators and any stakeholders with the strongest possible package. Fortunately, the pace at which we've been able to conduct our program and enroll these studies means if we were talking about a three-year difference or a two-year difference, that'd be one thing. Right now, we're seeing data first half for our first study, second half for our second study. It's not worth cutting corners for the long run. We certainly intend to file with two GAD studies. Awesome. I think that that's helpful for payers and providers as well to be able to show the robustness of the data. Yeah. Agreed. All right. From a labeling and from a REMS perspective, what's your expectation on how the monitoring requirements are going to read? It's a great question. Obviously, there tends to be an over-indexing on some precedents, but when it comes down to REMS and safety, the precedents are pretty useful because there's both a safety consideration. There's also a public health consideration. REMS are not supposed, intended to be so burdensome that patients can't get access to the drugs. When we look at the precedents that exist today and what a REMS is for, the safety it's actually there for, really what it boils down to is can we monitor patients in a way that is safe so while they're taking the drug, they're in a safe setting, that we can monitor them for that duration and we can have a reasonable way of determining when they're safe to leave. We've oriented the safety monitoring in a very granular way in our phase three program to really replicate what is being used out in the world today for something like Spravato, intranasal esketamine, which has a REMS with an ETASU with specific monitoring criteria and duration requirements. We think those criteria that we're using for our ongoing clinical research are something that could be very clearly leveraged out in a real-world setting. Because we take such a granular look at this on an item level and on an hourly basis starting five hours after the drug is administered, we'll have both a, so again, item level and temporal assessment of when patients need to be monitored, why, and then use that to make a data-driven argument to regulators about what appropriate monitoring should be. What we're seeing is something in the sort of six to eight-hour time range across our studies. It tends to be how long we expect patients to be monitored. That monitoring is really just for perceptual changes that happen. We're not seeing any sort of liabilities outside of that. Again, something to be discussed later on, but something that we feel really clear on the data we will have and the data we'll be able to use to argument. Awesome. All right. How much of the Spravato infrastructure can you leverage commercially? I guess really the question is from an operational economic perspective for the practices themselves, what makes this therapy viable for them? Yeah. Yeah. I mean, the nice thing that we've seen with Spravato is there are about 5,000-6,000 centers open that can administer Spravato. A large majority of their sales are done at about 500 of those centers. We know that that infrastructure has been set up and that there are providers that know how to give an administration that would be similar to something like an MM120. I think that's kind of the low-hanging fruit as we see it because there are lots of providers out there who are doing therapy sessions right now. This is really not a high infrastructure need. You need some type of place for someone to lay down on. Setting does matter. You want to make sure that people know that they're in an environment where they're going to be supported with a monitor, etc. I think Spravato lays a nice infrastructure to start with, especially those sites that are not doing high-volume Spravato right now because they have the infrastructure set up. I think when we think about what providers are looking for, there's two things: efficiency and profitability. Making sure that they're going to be able to have both of those is really important for us. Thinking about a session where you're going to have people in for a day, ensuring that they're going to be able to be paid for that entire monitoring period. From an efficiency standpoint, it's actually a lot easier to only have one patient in during a day or perhaps multiple if you had multiple monitors and you wanted to set something up from that perspective. That's a lot easier to administer. Our monitoring process is a pretty simple process. It is really ensuring safety and just making sure that people can get to the restroom or get a snack. The efficiency model is really set up well for providers in that perspective as well. I'll just add one comment, which is that the degree to which it is easy to reflect on an infrastructure and a delivery modality that exists today, it is easy to do that. It's easy to say, well, Spravato exists. Can we just do that on repeat? As Brandi said, it's a convenient low-hanging fruit to try to focus there early. When we see the kind of enthusiasm by providers and practitioners, the people who ultimately need to deliver this, the eagerness to get their hands on something new that actually drives a meaningful and long-lasting change in these patients who have had very little, we're not limiting ourselves to just what exists today. We have to think expansively and how to broaden it over time. We absolutely are investing and spending a lot of time and effort getting that right. While the infrastructure to start is more than enough capacity than we would possibly need at day one, there's almost limitless potential for where we could take it from there. On the provider economic side of things, is this profitable for them? Do you envision it being profitable for them? As I look ahead, you can see, I think an increasing portion is going through the buy-and-build channel for Spravato. We're hearing a lot of signs that channel's continually going to be grown and built out. I kind of draw analogs to the community oncology practices, how they essentially made their businesses around a lot of that, which feels like it has a lot of the similar elements in this class for the psych side. Is that how you guys see this evolving? How are those pieces going to fall together? Yeah. It's certainly premature to be too precise about what those numbers or plans are, but absolutely. I mean, when we look at the things that drive treatment adoption and drive clinical practice, it's making patients better. It's making physicians' and clinicians' lives easier and making sure that they make enough money to keep the lights on and ideally make some profit with it. Everything we do in terms of how we think about pricing and how we think about the infrastructure and the rollout and the ultimate commercial model is integrating all of that, is making sure that obviously the drug needs to perform so we can get patients better. We have a drug that we, as Brandi was saying, believe lends itself to very efficient delivery and efficient revenue generation. If we can get it priced and contracted and set up in a thoughtful way, that means clinics can make money and make it worth their investment in whatever limited infrastructure is needed, put those three together and you have all the ingredients for a really, really widespread uptake. We are absolutely focused on that and making sure we get that right. When we think about pricing and contracting everything, it is aimed at practice economics first and foremost, really. Awesome. All right. Let's wrap up on the financial strategic side. It's worthwhile asking. I'll just ask it point blank. The question investors have asked me. You raised money recently, fairly close to in front of data. Are you seeing anything concerning? What was the rationale to raise money at this point? No. We're not seeing anything concerning. I think what we were seeing was an enthusiasm to do even more and to set ourselves up for a really big 2026. What we're able to do with that financing is twofold. One, bring great investors into the story who really wanted to hear about it. We already had a good cash runway, but we were able to bring them in. What it does is it lets us get ahead of so many things. Starting with our NDA writing, we'll be able to submit an NDA as soon as we can. KOL education, getting in front of providers, talking more about what we're trying to put together here. Things like state prioritization and making sure that we can get ahead of that on our priority states. It just puts us in such a good position to be ready to go as soon as we get this data and get moving with the FDA. Yeah. Awesome. Obviously, a lot of demand heading into and pricing was very strong, so. Those help as well. I think that speaks to exactly what you just said. All right. Thinking about partnerships too, outside the U.S. geographies, a lot of indications to go for. You think that's something that would be valuable? Are you planning to kind of keep this wholly owned at the moment? Yeah. We're absolutely focused on any way we can generate value out of what we have and what we're doing. Obviously, there are dynamics within XUS pricing that come into play that we, I think, need to see settled out before we're never going to put ourselves in a position where we tie our hands and then don't have operating leverage and flexibility. We've got something I think we know how to do this better than anybody, frankly. We're going to do it as long as we can do it better than anybody. We're seeing a ton of interest and I think a real realization that in psychiatry, there's been so little for so long and that this is obviously contingent on getting the trials done and good data and drugs approved. From a practice standpoint, people think this is coming. In psychiatry, we rarely see drugs that launch that have any sort of utility that are not huge revenue opportunities. We certainly see those opportunities emerging for us, but again, we want to make sure that we are putting ourselves in the best position for everything from pricing here to how we think about the commercial rollout here and worldwide. Awesome. All right. Huge 2026 ahead. We'll be talking again soon. Thanks so much for joining. Thank you.