MindMed at Jefferies Global Healthcare Conference: Psychedelic Drug Advances

On Thursday, 05 June 2025, Mind Medicine Inc (NASDAQ:MNMD) presented at the Jefferies Global Healthcare Conference 2025, detailing their strategic focus on developing psychedelic drugs for psychiatric disorders. CEO Rob Barrow discussed the promising potential of their lead drug, MM120, currently in Phase 3 trials for generalized anxiety disorder (GAD) and major depressive disorder (MDD). While the company highlighted the transformative impact of MM120, challenges remain in navigating regulatory landscapes and ensuring market access.

Key Takeaways

• MindMed is advancing MM120, an ODT formulation of LSD, in Phase 3 trials for GAD and MDD.
• Phase 2 trials showed rapid action and durable responses, with half of GAD patients achieving remission 12 weeks post-dose.
• The company is engaging with the FDA, leveraging breakthrough therapy designation to facilitate regulatory progress.
• MindMed aims for broad labels for GAD and MDD to enhance market access and reimbursement.
• The patient experience with MM120 is described as inducing illusions rather than hallucinations.

Operational Updates

• Pipeline Focus: MindMed’s primary focus is on MM120, in late-stage development for GAD and MDD.
• Phase 3 Trials: Ongoing studies are designed to replicate Phase 2 results, with data expected in 2026. Two studies (Voyage and Panorama) focus on GAD, while EMERGE targets MDD.
• Trial Design: The trials use a 1:1 randomization to 100 micrograms of MM120 versus placebo, with a secondary control arm for perceptual alterations.
• Enrollment: Active enrollment in all three Phase 3 studies, with strategic site selection to retain patients.
• Extension Period: A 40-week open-label extension will assess real-world treatment patterns, including re-treatment needs.

Future Outlook

• Strategic Focus: MindMed aims to be the preferred treatment for neurotic psychiatric disorders, potentially expanding to other areas.
• Labeling Strategy: The company seeks broad labels for GAD and MDD to maximize market access.
• Reimbursement and Market Access: MindMed is generating evidence to support favorable reimbursement and market access.
• Infrastructure Leverage: Plans to leverage existing and new interventional psychiatry clinics for MM120 treatment protocols.
• Commercial Strategy: Developing pricing and contracting frameworks attractive to clinics.

Q&A Highlights

• Patient Experience with MM120: The drug induces illusions, leading to a reorientation to distress-causing factors, rather than challenging experiences often associated with psychedelics.
• Regulatory Engagement: Strong engagement with the FDA has been facilitated by breakthrough therapy designation, aiming for a clear path to market.

For more details, refer to the full transcript below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Brett Gallagher, Healthcare Investment Banking team, Jefferies: Good afternoon everybody. Welcome to the Jefferies Global Healthcare Conference. My name’s Brett Gallagher with the Healthcare Investment Banking team. It’s my pleasure to welcome up Rob Barrow, CEO of MindMed.

Rob Barrow, CEO, MindMed: Great. Well thanks everyone for being here and for Jeffries for hosting us this week. It’s an exciting time for us as an organization and and our field generally. We’re we’re hitting a a really interesting point in the the regulatory environment and our development programs that gets us really excited about the the years to come. Before we start, I’ll put out the disclaimer that it will will include forward looking statements, and, you know, those those are as of today.

And, obviously, we they may change, and we we will not be changing them here on the stage if they change subsequently. You know, we are working MindMed is an organization. It’s a phase three clinical stage development organization working on the the drug class of psychedelics, a class that’s been sitting on the shelf for the better part of the last hundred years when what we’ve seen so far in modern clinical data is that there’s real potential in treating some of the largest and least well controlled conditions in psychiatry today. So we as an organization have had a lot of momentum and progress over the last twelve or eighteen months. March of twenty twenty four, we put out phase two data, the only and first comprehensive dose response study in the field.

We saw remarkable efficacy results, which we’ll get into, and allowed us to get a breakthrough therapy designation from FDA and subsequently to have really strong engagement across the board both here in The US and throughout the world with regulators to map out a path to get these products ultimately to market hopefully with some successful data from our phase three program. In terms of pipeline, our primary focus in late stage today is on our lead program MM120. It is an ODT formulation that we have received patents on and that has some some unique advantages both physiochemically but also from a clinical standpoint in terms of its its behavior and performance in in patients. We have ongoing phase three studies in both generalized anxiety disorder, two studies, and and a study that is ongoing in major depressive disorder, all of which we’ll we’ll read out next year in 2026. We saw the earlier stage program with the RNN tumor of MDMA, which we’re developing initially in in autism spectrum disorder.

And this is one where our field has been characterized by a lot of historical assumptions and and and sort of inherited practices from an era that is long past that we have intentionally not not followed. We we wanna be evidence based in everything we do. And and with that second program, the analogy we like to draw is how psychostimulants are used in in ADHD. Right? In ADHD, patients take a psychostimulant every day and it allows them to focus.

In in autism where there are no drugs approved to treat the core symptoms, the the goal is that the pharmacodynamics of RMDMA would allow patients who otherwise have a social communication deficit to improve that that social communication deficit. And, obviously, earlier stage, but if success will be first program ever to show that kind of effect in that population. When we look at the current landscape, and most of rest of this will focus on our later stage programs, When we look at the current landscape for GAD and MDD, we have been living in an era for the last thirty years of focus on SSRIs. Our lead indication, the one that we had phase two data on last year is in generalized anxiety disorder. The last approval was in 2007 with Cymbalta.

We have been living in a in an era where the the only focus is on a framework of, you know, fast med management meetings in psychiatry, largely that happens at at primary care. We have around a dozen SRIs, but we still have a growing problem with anxiety and depression. And and part of the the shift away from anxiety was because the drugs we have weren’t particularly well equipped to treat them. We saw chronic use of benzodiazepines fall out favor, right rightly so, many ways, due to abuse liability and some of the adverse events that are associated there. And what we hear from patients and physicians is just a a urgent need for new products that actually drive meaningful change.

So much of what we have been doing is symptom suppression. And, really, for the first time, we see an opportunity to to have a sort of transformational impact on this population. And and some of the patient testimonials as they come out of trials suggest that those that are getting better say, not not I don’t just feel less. I I have a new relationship to the to the disorder that I’ve been living with in many cases for for decades. So incredibly encouraging.

Again, I talked about the the chronic sort of symptom suppression. There’s also, I think, an interesting challenge that comes with this. We have millions of patients that would be potentially eligible for treatment. We have a model that everyone’s gotten used to even though it’s not good enough. It’s underserving the the patients we have.

The current model that is is so low touch and and not particularly effective is one that emerged because of the availability of these treatments again. It is the model of of the SSRI era. Where we want to go are is a whole new state, though, and that’s gonna require changes. It requires changes in how we think about drug development and clinical trials. It just requires a redefining of what good life looks like for these patients, and then ultimately, a clinical infrastructure and a clinical model that recognizes that and embraces it and and it, you know, leads to that that ultimate change.

What we’ve seen in our clinical data, which we’ll certainly get into in greater detail, is is rapid action, durable responses. About half the patients that got a single dose of our drug in in phase two were in remission twelve weeks later, and it’s just because we stopped following them at twelve weeks. It’s another thing that that, you know, I think is underappreciated is just how big of a pull there is from psychiatry. We’ve many of us have gotten very well familiar with J and J’s intranasal s s ketamine product, and there’s been a a pretty substantial infrastructure build out to to adopt that. It it’s a nice proof point.

It’s certainly not the the optimized, you know, best case scenario for for what products could do or for what a treatment paradigm looks like for providers. So when we go on and ask interventional psychiatry clinics and we ask psychiatrists generally how they are thinking about psychedelics in in anxiety and depression, and we see the numbers here. I mean, the availability will change their approach. Eighty six percent of providers that are doing SPRAVATO and ketamine and TMS and ECT today say that’s the case. Seventy four percent of all psychiatrists, and this is survey data that that we generated internally.

These are numbers that are practice changing kind of feedback from the field. This is an incremental change. This is a whole paradigm shift and something that providers for so long have been asking for and are now really, really embracing as we get more and more data accumulated. Digging a little bit more into our our lead program. So LSD, like the classic serotonergic psychedelics, and it is important distinction.

Even FDA’s guidance on this on psychedelics says that, you know, out of convenience, a lot of drugs are lumped together. Ketamine and and psilocybin and LSD and MDMA are not part of the same drug class. Psychedelics has basically come to mean drugs that feel like something, and there’s no surprise that a high dose, a hundred microgram dose of LSD very much feels like something, and that that’s good. That’s an that’s an okay thing. These drugs work by agonism at serotonin two two a in particular.

That drives network effects in in the brains. We talk about things like the default mode network. It talk it it drives neuroplasticity. Really, even though the the sort of loudest noise in the room, the thing that people focus on are the perceptual alterations in terms of the sensorium, it it really drives an also similar sort of change in sort of the the cognitive framing of of one’s self narrative and and the things about anxiety and depression that are driving its its recurrence and its its duration. This is one I almost never have to spend a whole lot of time on in in any discussion because everyone knows that anxiety and depression are highly prevalent disorders that have been growing rapidly.

We’ve had the drugs we have today for thirty years, and yet the rates are still growing. That’s why there is the need, and that’s why we have such an incredible opportunity. I think it also gets missed, and it’s worth spending a second on GAD. You know, GAD is is a disorder that has been overlooked for for so long, so we don’t have many drugs available. The burden of GAD is also extraordinary.

And and so much of the focus was intentionally shifted away from anxiety. Most of the history of psychiatry, going back to the the early drugs, thalidomide was an anxiolytic. Right? Barbiturates were anxiolytics, benzodiazepines, and then we get the advent of SRIs, and all of a sudden there’s a pretty strong push to move diagnoses towards depression. It turns out SRIs work a bit better on anodontic symptoms on on the depressed mood and and such and can be acutely angiogenic in in in treating GAD.

And so when we look at this framework, we think, of of course, there’s an incredible opportunity in GAD, but given the prevalence, given the focus on both of these disorders, we have programs in both and want and aim to be the the product on the market that has the broadest possible appeal. That when patients show up with neurotic psychiatric disorder, includes things, of course, GAD and and MDD, but also other other areas where we could explore in the future that would become the the drug of choice. Our program, our phase three programs, again, two studies ongoing in in major depressive or excuse me, in generalized anxiety disorder, one study ongoing in in major depressive disorder with a second study that that we anticipate starting at some point in the future. These are largely replicas of what we we conducted in phase two. In our phase two study, again, we’ll we’ll get into in a second.

Voyage, our first phase three in in GAD is a a 200 patient study randomized one to one to our clinical dose, a hundred micrograms versus placebo, hundred patients in each of those arms. Twelve week primary endpoint using the Hamilton anxiety scale. It is the primary endpoint for every approved drug and internalized anxiety disorder. It’s a well trodden path that we understand very well. Second study, same design, same primary endpoint, same comparison, hundred micrograms versus placebo.

Because of the feature of this drug class, that they have such clear profound perceptual alterations when on the day that patients take the the dose, FDA has has asked all of us, all sponsors in this field, to include a secondary control. And I think the point of that has been, I think, confused at times. But the point effectively is is to be able to tell patients if you feel something on the day of dosing, it may be a real dose of drug or it could be a dose that isn’t clinically active. So we showed in phase two that our hundred microgram dose group had an effect that was more than double the standard of care, and that’s both on an absolute basis and on a placebo adjusted basis. Fifty micrograms showed nothing.

It was the same as placebo, statistically, clinically. And so to be able to include that allows us to add a layer of of integrity in terms of the interpretation of the overall program. At the end of the day, if these two studies are successful, we’ll have three studies, three different designs. The point of showing continued clinical activity across those three studies is that we can make robustness arguments. No matter how we study the the the drug, if it keeps performing and keeps outperforming placebo in a a large magnitude, that gives us really strong evidence that there’s something real happening here, that isn’t just people saying, oh, I feel something, then I’m gonna say I’m better.

Mentioned it before, you know, the rapid effects. We can’t measure the Hamilton anxiety scale before one week after dosing. This one week recall instrument is how the instrument is set up. We can use momentary assessments like the the CGIS, clinical global impressions of severity that is used across medicine. There we see reductions as early as the next day and statistically significant two point reductions within twenty four hours.

Those reductions then translate into one week Hamilton anxiety reduction and a twelve week durable response. Again, forty eight percent of the participants in our phase two study were in remission, meaning a Hamilton anxiety score of seven or less twelve weeks after treatment. And these patients came in with severe anxiety with a starting point of around 30, which is is quite severe. When we look at the historical drug classes, benzodiazepines, SRIs, effect sizes, so normalized for the variants in those studies, around point three six, point three eight. We saw an effect size at twelve weeks of of point eight one.

Again, regardless of how we slice the data, we’re seeing almost more than double the the standard of care on almost every every point. Another thing another feature, the the adverse event profile is very limited to the dosing day. So and mostly looks like the effects of taking LSD, and we know what that is. It’s perception alterations. We have some some transient effects that resolve mild to moderate severity.

In our study, there’s one SAE in the fifty microgram arm that happened three months actually, later than three months after after administration. So a profile that that fits very nicely. Obviously, it’s a different delivery profile in a in a medical setting, but but one that clinically is quite meaningful and is very exciting for us. Just focusing on on the hundred microgram arm in that study versus placebo, again, you see a really interesting feature is that we both saw reductions in Hamilton anxiety scores, but also MADRS scores, which is the primary endpoint in depression programs and in our depression program. These responses were as early as we could measure them at week one.

And then interestingly and and uniquely in our field, really, were durable out to twelve weeks. We didn’t see any sort of reversion back to to baseline. That feature is certainly what’s gotten clinicians we’ve spoken to incredibly excited because we’re not talking about getting better and then sort of trending back to baseline and needing a dose every couple of weeks if these data hold. What we’re saying is that there is a many month durable effect and and maybe even well beyond twelve weeks, something we won’t won’t know until the conclusion of our phase three program. Also, for for context, again, a lot of folks don’t know the Hamilton Anxiety scale quite as well as they do other scales.

And so it’s worth putting into context. These patients started very severe, and these are median scores represented here. But, you know, on average, on the median average, patients started around 30, very severe, ended up median in remission in the hundred microgram group. Just data we’ve never seen before in treating GAD or MDD for that matter. Touch on the AE profile, so maybe we’ll transition and talk a little bit about what comes next.

So we’re actively enrolling in our three phase three studies. The the two in in GAD or Voyage and Panorama already described somewhat of the the study design for the acute phase. There’s two parts of these studies, though. After twelve weeks, patients continue on into a forty week extension period where they have the opportunity for open label treatment with with the active drug, hundred micrograms of Mn one twenty. That gives us an ability to look at the the real world kind of treatment profile.

What happens over the course of nine months or or a year for patients who get active drug first? How often do they need the drug? How many doses of drug do they need on average? What happens upon subsequent retreatment with the drug? It it’s triggered retreatment.

So patients who have symptoms of 16 or greater on the Hamilton Anxiety scale will be eligible for treatment, and they can get up to four doses of drug in that extension phase. Another feature of the design is that because we don’t unlike most studies, a daily drug, an open label extension period, on the first day of that open label extension period, patients are unblinded. They get open label drug. In our study, they’re randomized, get a dose of drug, follow them for twelve weeks. But after that twelve weeks, until they have symptoms return, we also just continue to follow them.

They’re still blinded. They’re still randomized. We can still analyze their data accordingly. And so until they those patients take up a label drug, we have a longer term randomized withdrawal or, excuse me, randomized controlled study that that can can speak to things like durability longer than twelve weeks. Okay.

Kaplan Meier curves, time to hitting a certain endpoint or time to needing a retreatment, which gives us a lot of ability to argue for that extended durability of of a single treatment of the drug. EMERGE, I can say copy and paste almost. The the main difference here is that a slightly smaller study, 70 patients per arm. Out of a well established practice in in depression. We use the the mattress as the primary endpoint.

We use the mattress at six weeks. Again, this is consistent with virtually all with FDA’s guidance and virtually all all the approvals and and MDD. And so single administration where we again follow patients for twelve weeks have the same extension period where patients can have open label drug. And a feature operationally is that this study is also running at the same sites as our Voyage Panorama sites, gives us the ability to keep patients in our studies. If they screen out of a JAD study because they’re in a depressive episode, we’re able to retain them and keep them and put them in the EMERGE study, something that a few months ago was theoretical and now we’re actually seeing happen in practice, which is quite encouraging.

From a regulatory standpoint, there has been obviously a lot of regulatory progress that we’ve made over the last twelve months. We’ve been really encouraged by comments from the new administration, by new leadership at FDA, and are seeing an incredible dialogue. We’ve had been very fortunate with breakthrough therapy designation to have very frequent and thorough engagement with the division. I’ve been fortunate to work with them for the last seven years on this drug class and know, you know, the ins and outs, our program has the ins and outs of how they’re thinking about and how we need to stand up to the highest level of regulatory scrutiny and be positioned best possible if we get compelling phase three data. Another feature of our program is that while there’s been a whole spectrum of approaches to sort of patient course on a day of treatment, what it looks like to get the drug, there used to be terms like prep and integration that got talked about quite extensively.

Those became unpopular and have now been rebranded as as as other things. You know, from day one in our program starting in our phase two study, we just give patients drug. We give them informed consent, of course, as we have to do in any clinical trial, and we would expect informed consent in the real world just like happens in everyday medical practice. But what we do is is then give them the drug on the day of dosing. They’re kept in a monitored setting under observation.

They’re kept under observation for a fixed eight hour period in our phase three program so that, you know, we don’t want placebo patients saying two hours in, oh, I feel fine. I’m gonna I’m gonna leave the room. That wouldn’t be a good thing for for trial integrity. So everything about our program has been designed to maximize the flexibility and the breadth of of potential adoption if we get an approval in marketing drug and are are fortunate enough to to be to be launching it. When we think about our overall strategy, again, we talk about as a field sometimes, we talk about the broad potential.

We talk about the unmet need that is in the millions and millions of patients. It is informed that need has informed our labeling choices. It’s intentional that we’re going after the broad labels for GAD and MDD. It it’s also informed how we think about generating evidence for value and for the real world treatment patterns. We have the best possible case with payers to get reimbursement, market access.

And the the infrastructure that, as we showed before, is already asking for for this, is saying we’re really excited about a practice changing new drug approval, that we can leverage that, that we can lean into that. There is a wide, wide range of clinics that are doing interventional psychiatry today that we can leverage. There are undoubtedly others that will want to be involved that are already telling us they’re excited about the potential and want to adapt and want to be ready to deliver these drugs if we get them approved. Another feature is when we talk about value and we talk about the outcomes, a lot of questions we get from time to time are, okay, well, that’s that’s great. You know, how does this fit into this bravado framework that has evolved?

It doesn’t, and it shouldn’t. And that’s our view of why we’re doing something different is because it is transformative. Is something that is going to align nicely with patient desires, with site economics. Of course, incumbent on us is to price the drug and come up with a contracting and a commercial framework at the end of the day that is attractive for clinics. But you put the ingredients together of patients are getting better, we get site economics right so that they’re making money.

The clinician experience with this is is quite attractive. I mean, in our phase two study, we had investigators come to us and say, you know, I I sat in the corner and caught up on notes for most of the day. It’s not very much that’s happening while they’re in the room watching watching patients. And so add all of that together, if we can drive value and drive attractive economics for sites of delivery and drive the best outcomes we’ve ever seen in a field, all of those ingredients are exactly what you would ask for for a sort of paradigm shifting drug and something that we’re very, very excited about building more and more evidence on all these facets as we progress. Won’t spend a ton of time on on the specifics.

I’ve got a few minutes left. I guess happy to take questions. Otherwise, happy to to wrap up a few minutes early. Alright. Everyone has places to be, so we’ll let you go.

Thanks so much. Oh, we we have one question. Alright. Please. How’s the experience of the MM120?

In in what capacity? For the patient. Yeah. I mean, so the question was experience of the patient with MM120. You know, we have gotten into and and just it’s an orally dissolving tablet.

You know, patient Lero, please. Yes. So the question are, you know, the the the sort of phenomenologic aspects of it. What what do patients go through? Hallucination is a word that is probably is, you know, commonly used.

It it’s not quite precisely what what happens. So, you know, and and it’s worth maybe spending one second. Hallucinations mean, you know, a de novo view that something is real that is not. There’s no sensory input to suggest it’s real. People talk a lot about, you know, seeing seeing taste and hearing colors and and things of this nature.

Synesthesia, these are are more properly characterized as illusions. Yes. These absolutely happen. Where there are sensory inputs, there can be distortion. And, really, this is a function of turning off the brain’s filtering network.

When we talk about the default mode network, that is your brain organizing a bunch of very confusing if you walk around the streets of New York, lots of sensory inputs that we have to filter through so that we can navigate the the world and and, you know, live live a life. So that disorganization of the brain’s normal filtering mechanism leads to sensory changes. It leads to cognitive changes that also allow for this sort of processing. And that’s why we we look at and and why we’ve been studying the drug is sort of auto therapeutic, if you will, that there is no sort of dyadic therapy that is needed with the drug. Any drug is therapeutic, of course, but really what’s happening and what we hear from patient experiences is there’s some sort of processing, reframing of a person’s relationship to the things that are the source of of distress, of anxiety, of depression, whatever it may be.

And, again, as they come out of that experience, they say, you know, largely they they feel sort of a a a reorientation to the things that were causing them distress in the past. From an observer, from the outside looking in, maybe, generally, it looks like a patient’s laying down on the couch taking a long nap. Occasionally, they’ll sit up and say, I need water. I need to go to the bathroom. I’d like a snack.

There’s not a lot that that ends up happening, and so it’s a a very sort of I mean, again, we we had you hear a lot of historical stories and and, you know, naturalistic illicit use of of psychedelics, and people talk about very challenging experiences and and things. And these are just not features of really what we’ve seen in the development program to date. Challenging experiences. I mean, words like bad are in psychiatry quite interesting because sometimes they’re the things that drive the most insight and the most change. And so, certainly, there will be challenging experiences that happen.

There will be patients that don’t respond. There’ll be patients that have bad outcomes as there are with any any drug. But by and large, what we hear is that patients have a fairly pleasant and enjoyable experience. And and many times they say, I don’t really want to do that again. I would if I needed to, but we’ve been really encouraged by all all that we’ve seen from a patient experience standpoint.

Alright. Thank you.

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