Joe Coletti 00:06
Welcome back to Pathfinders, a podcast series from RBC Capital Markets, where we uncover the key trends and catalysts shaping the fast-moving world of biopharma and healthcare. I'm your host, Joe Coletti. Today we're exploring one of the most closely watched frontiers in neuroscience: psychedelic medicine. We're joined by Rob Barrow, CEO of MindMed, a clinical stage company at the forefront of psychedelic drug development. With multiple late-stage programs underway, Rob's leading the push to bring therapies like LSD into the mainstream for conditions like anxiety and depression.
Rob, thanks for being here.
Rob Barrow 00:40
Thanks so much.
Joe 00:42
So we have spoken to you at this conference before, a couple years ago, not on the podcast, but in a similar interview, and the psychedelics therapeutic space has continued to gain significant momentum since then. Can you tell us what's changed most for MindMed, but also the science and the broader ecosystem at large.
Rob 00:59
Absolutely, the last few years have been really extraordinary. We've seen FDA guidance issued on this drug class specifically, which is not something we typically see in any field. For us as an organization, 2024 was an absolutely transformational year, we went from a position where we had no clinical data of our own to all of a sudden having some of the most compelling data in the field last March and receiving a breakthrough therapy designation as a result of those data, launching our phase III program in both generalized anxiety disorder and major depressive disorder, and now we're underway with three pivotal studies, with readouts coming next year. So for us as an organization, it's just been a continued growth and evolution and trying to continue to make progress getting closer and closer to pivotal data.
Joe 01:44
It's been a real sea change in a short amount of time. So MindMed’s MM-120 program has reached phase III trials for generalized anxiety disorder. How significant is this milestone in this field, but also, what does it say about where psychedelic therapeutics are really headed next?
Rob 02:02
Yeah, it's an incredible milestone, especially as fast as we've been able to move. I mean, we had our first meeting with FDA in 2020 and now to be on the cusp of having pivotal data from two studies, is in GAD and then a study in depression, all of which will be in 2026. We're moving at a remarkable pace. It's a credit to the team, the organization we've been fortunate to build over the last few years. Really, when you look back at the full history of this drug class, though, there's extraordinary promise in the 1950s and 60s, the drugs got set on the shelf for many decades, and then with the re-emergence of research from which we've been fortunate to be leaders in this field over the last several years, to come to pivotal data and to come to a really rigorous assessment of the clinical outcomes and the potential as therapeutics is extremely exciting to us.
Joe 02:54
Can you talk a little bit more just about MindMed’s approach and what really kind of sets you apart in this space? You know, whether it's clinical design to patient selection to delivery method.
Rob 03:04
Looking at the ultimate opportunity here, one of the things we always felt was not being fully realized with this drug class, was the scope and the breadth of what could be achieved, that by some very limiting study design, some limiting approaches using psychotherapy in addition to drugs, that when we get these products out into the world, hopefully one day, that that would really constrain the scale at which they could be delivered. So early decisions we made, for example, were to just study the drug as a drug, to establish its standalone efficacy, when everyone else was really focused on the combination approach. Again, we think that that allows an extraordinary scale and access that others may not be able to achieve if we're ultimately successful with that. But we've also taken a really unique view of even the indications, right? So many of the programs and products are being pursued in treatment-resistant depression. It's a really important area in patients, we hope to help as well.
04:06
But one that's only a small fraction of the ultimate population that could benefit potentially from these therapies. And if we're successful in getting label for the broadest indications, for generalized anxiety disorder and major depressive disorder, we're talking about tens of millions of patients versus a small fraction of one of those indications.
Joe 04:23
You've secured funding and navigated a really tight capital environment. How are you thinking about capital allocation right now, which I'm sure is something you've talked about a lot today, and how has investor sentiment sort of evolved around the science. You know, what have you been hearing in your conversations with investors?
Rob 04:40
Yeah, it's been quite a time, the last four years, to be leading a biotech company has not been without its twists and turns, but we've been very fortunate that the quality of the data and the kind of outcomes we've been able to achieve attracted some really high-quality investors in 2024 even there, from a financing standpoint, was a high impact year for us. So, we're in a fortunate position to be able to continue to navigate what are some choppy waters in a macro environment, to be able to fund ourselves through to 2027 through all of the pivotal readouts we have ongoing. And to stay really disciplined, we're still a small organization – about 80 employees, we've stayed very nimble and efficient with both the scale and our approach to the organization.
Joe 05:25
This wouldn't be a capital markets podcast if I didn't bring up the topic of M&A. There's been some growing consolidation in the mental health and neuroscience space. What do you see out there? What are your thoughts on the M&A landscape and how it is evolving or not right now?
Rob 05:39
There certainly have been some major transactions, we think of Karuna Therapeutics and Intra-cellular.
There's a continued interest in neuroscience, particularly from a handful of the biggest strategics that are out there. The market, the opportunity is so extraordinary, the need is so great, and the potential, particularly our products, but any new entrants in psychiatry are so great. I think strategic, strategic interests, and M&A interests will only continue to grow.
Joe 06:06
How are you sort of engaging with the regulatory bodies in terms of shaping how this path is going to evolve even more in the years ahead?
Rob 06:14
Yeah, I've had, personally, the good fortune of working on these drugs since 2018 and when the field was in its real infancy, and having some of those conversations over the last seven or so years has been really rewarding. I think FDA, from that point on, have been great partners and have been really thoughtful about the approach, and have, as we have presented data – both we as a company, but we as a field – they've shown a willingness to engage thoughtfully with that be data driven in decision making, a huge credit to the vision of psychiatry and the office of neuroscience. I mean, they've been highly engaged. Obviously, the breakthrough therapy designation we received last year only furthers that level of engagement from senior management at FDA down to the clinical reviewers, and so, even as there have been a lot of headlines about the changes at FDA and some uncertainties, we in our program have only seen continued enthusiasm, continued engagement, prompt responses, thoughtful, complete correspondence with the agency that's given us a high degree of conviction. And over the last 12 months, we've also, Cobenfy™ and corona therapies, we've been fortunate, thanks to the VMS acquisition, to bring over that entire regulatory team are coming off a major win in psychiatry, and hope to replicate exactly that kind of success here.
Joe 07:31
As the as the field continues to mature, you know, as 5, 10 years from now, as this continues to grow, you know, there's obviously other questions that are going to come up, from accessibility, scalability, reimbursement, even sort of cultural acceptance, ultimately, which, which obviously has changed a lot in a short amount of time. What does leadership look like in that context, in your view, and what do you think is going to set apart the winners from everyone else?
Rob 07:57
It's a great question. It's one that we think about a lot, because with such an extraordinary need, and we're talking about 50 million patients who have anxiety, depressive symptoms, not all of them have yet received a diagnosis, but very, very large populations, and that's just here, here in the U.S. alone, with that kind of need to actually have the kind of meaningful impact that we aspire to have, it's really takes an ambitious view of what we can accomplish, of being thoughtful about accessibility, about the dynamics for the delivery of the drug if we're ultimately able to get it approved, thinking about the sites of care and the providers, the types of providers that could be leveraged to deliver this at that kind of scale. And I think our field, in some ways, has been self-limiting to its own detriment, focusing on very narrow populations and thinking a little bit too small. And so, we as an organization continue to prioritize the magnitude at which we can achieve both regulatory success, but really patient access, and for us as a business, for the commercial success that would come along with helping the hopefully millions of patients who can benefit.
Joe 09:02
When you think about the key milestones that lie ahead, that you guys see, that you guys are looking to achieve. Can you give our listeners a little bit of sense of what those are, what you're really eyeing, and how you hope MindMed will continue to sort of shape the future of mental health care.
Rob 09:18
Absolutely. So right now, we are just laser focused on executing and delivering our pivotal readouts in 2026 which we have, three of them, two internalized anxiety disorder and the first depression study, and we'll have a second depression study that we have yet to announce timelines on, but we'll be progressing with at some point here. So many conversations we have for folks who have yet to fully understand what we are doing and how we hope to do it over indexes on the care environment that exists today. And as we see it, if the care environment and the drugs we had available today were doing an adequate job, we wouldn't have a need as an organization. We wouldn't need new drugs. People would be better. Obviously, that is not the case. These disorders are growing and growing rapidly and from already very, very large base.
10:08
So we need to reshape the landscape, and it requires, again, at that scale, it's going to require an ambitious view of what can be achieved, and something that I think we are uniquely equipped and have uniquely been developing from day one as an organization to try to achieve. And obviously delivering on clinical data is first and foremost. Getting an FDA approval is going to be critical, but from there, we continue to invest and really try to get ahead of what is inevitably going to be an exciting field, and one that we hope to continue to lead.
Joe 10:41
I think that's a great way to wrap up. Rob, really appreciate you being on the podcast. Really appreciate you coming back to the conference and interviewing with us again, and we hope to bring him back again next time.
Rob 10:52
Thanks so much. It's always a pleasure.
Joe 10:57
Thanks for listening to Pathfinders in Biopharma, brought to you by RBC Capital Markets. Please remember to subscribe to get more great content and be alerted about future episodes. This episode was recorded on May 21, 2025. If you’d like to learn more or continue the conversation, please visit rbccm.com/biopharma. See you all next time.
Disclaimer
This content is based on information available at the time it was recorded and is for informational purposes only. It is not an offer to buy or sell or a solicitation, and no recommendations are implied. It is outside the scope of this communication to consider whether it is suitable for you and your financial objectives.