Mind Medicine at H.C. Wainwright: Strategic Insights on MM120 Trials

On Tuesday, 09 September 2025, Mind Medicine (NASDAQ:MNMD) presented at the H.C. Wainwright 27th Annual Global Investment Conference, providing a comprehensive overview of its strategic direction. The company showcased its confidence in ongoing clinical trials while addressing financial and operational readiness. However, challenges such as cost considerations and the need for broad market access remain.

Key Takeaways

• Mind Medicine is advancing three Phase 3 trials for MM120, with results expected in 2026.
• The company maintains a strong cash position, ensuring funding through 2027.
• Commercial preparations are underway, including payer engagement and team expansion.
• MM402 is being explored for autism spectrum disorder, expanding the company’s therapeutic focus.

Financial Results

• Cash Runway: Mind Medicine has secured a cash runway extending into 2027, ensuring financial stability through Phase 3 readouts.
• Investment: The company raised $250 million last year, focusing on its three Phase 3 trials.
• Capital Allocation: Prioritization is on the Phase 3 trials, with potential consideration for MM402 development.

Operational Updates

• MM120 Clinical Trials:

- Three active Phase 3 trials: Voyage and Panorama for generalized anxiety disorder (GAD), and EMERGE for major depressive disorder (MDD).

- All trial results are anticipated in 2026, with the Panorama trial including a 50 microgram dose to mitigate functional unblinding.

• Commercial Readiness:

- Matt Wiley has been appointed as Head of Commercial.

- The company has begun early discussions with payers and is expanding its Medical Affairs team.

• MM402 Program:

- Investigating potential in autism spectrum disorder, distinct from session-based therapies like MDMA for PTSD.

Future Outlook

• Key Milestones:

- Voyage data is expected in the first half of 2026, with Panorama and EMERGE data in the second half.

• Commercial Strategy:

- Emphasis on the clinical and economic benefits of MM120, aiming for broad access.

- Payer engagement will shape a compelling value proposition, starting in early 2026.

• Drug Placement:

- Initial step therapy is expected due to cost, but there is potential for earlier access based on remission potential.

• Dosing Frequency:

- Treatment patterns will vary, with some patients requiring a single dose and others more frequent dosing.

Q&A Highlights

• Advisory Committee:

- No new insights from the MDMA Complete Response Letter (CRL), but the company has proactively built its studies to address potential concerns.

• Functional Unblinding:

- Measures are in place to address this, including a 50 microgram dose arm in the Panorama trial.

• MM120 Delivery:

- Aiming for broad access beyond an interventional psychiatry model, ensuring safe and effective use with minimal intervention.

For a detailed understanding, readers are encouraged to refer to the full transcript below.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: Good afternoon, everyone, and welcome back to HC Wainwright’s 27th annual Global Investment Conference held on September 8 to 10, 2025. My name is Patrick Truchio. I’m a Senior Healthcare Analyst at HC Wainwright. It’s my pleasure to introduce our next company, Mind Medicine (MindMed) Inc., a clinical-stage neuropsychiatric company focused on transforming mental health treatment through next-generation psychedelics. Its lead candidate, MM120, a proprietary oral disintegrating tablet formulation of LSD tartrate, is currently being evaluated in three active phase 3 trials across generalized anxiety disorder in the Voyage and Panorama programs and major depressive disorder in the EMERGE trial, with all three readouts expected in 2026. It’s my pleasure to introduce the Chief Financial Officer, Brandi Roberts, and the Chief Medical Officer, Daniel R. Karlin. Thank you very much for joining us. First, maybe we can start jumping right into MM120.

If you can give us an overview of MM120, its mechanism of action, and your vision for its role in reshaping the treatment of GAD.

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: This one’s me. Yeah, that makes sense. MM120 is an oral disintegrating tablet formulation of LSD tartrate. In the body, it acts as LSD. Folks take a dose of the ODT, and within about a half hour, they start to have a pretty profound set of changes to their perception, their cognition, and their affective state. Those changes peak over the next couple of hours and persist for five, six, seven hours. By about seven to eight hours after taking the drug, folks are ready to leave the monitored session. Over the course of that experience, people have mostly an internal experience. They’re mostly wearing eye shades. They are allowed to put on earphones and listen to music. There is someone in the room with them while this is happening.

Someone with a clinical license in the state where the treatment is taking place needs to be there to monitor, and a second monitor is watching remotely via video. This is all per FDA guidance for the conduct of trials in the category. The mechanism is likely multimodal. You’ll have heard a lot of folks talk about psychoplastigens, neuroplastigens, this sort of thing, drugs that make changes in the brain that persist after the drug is no longer in the brain itself. They have to be plastigens because for change to persist in the brain, it has to change the brain, right? The mechanism likely consists of that direct neurobiological effect and also probably has a component that is mediated by the psychological effect of having had that session and having had the changes that the drug drives transiently.

As Patrick said, we have three phase 3 studies running right now, two in GAD, one in MDD. Those are all predicated on a phase 2b study that we conducted, which read out now more than a year ago, but was just published last Thursday in JAMA that details all of the outputs of that study. Primarily, what we saw was a rapid, robust, and durable change in GAD that at the highest level took patients who were, in many cases, very severely ill with GAD and put half of them in remission that lasted 12 or more weeks after that single session, with no other intervention, monotherapy, no psychotherapy.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: Great. Both Voyage and Panorama are enrolling. Can you walk us through the designs and what each study is intended to show?

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: Yeah, so Voyage and Panorama are, in fact, very similar to the phase 2b in their primary period. They all have a part A, and that part A for Voyage and Panorama is a 12-week randomized, double-blind, placebo-controlled parallel group study with a primary outcome being the change in HAM-A of 100 micrograms of MM120 oral disintegrating tablet versus placebo. The primary difference between Voyage and Panorama is that Panorama also includes a lower enrolling 50 microgram dose arm in addition to the 100 and placebo, which serves to act as an additional control to mediate the potential effects of participant functional unblinding.

What we’ve tried to do across our development program in generalized anxiety disorder is a set of studies that in total add up to say we’ve controlled for the variable in different ways in different studies, and we’re able to repeatedly and consistently show a measured drug effect that we now believe we can say represents that real drug effect.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: In the phase 2b study showed a rapid and durable efficacy. How are you thinking about replicating that profile in phase 3?

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: That’s what we’d like to do. We think we have a very high probability of being able to replicate that performance, in part because we set a very high bar for ourselves with the phase 2b. That was driven by the fact that we had a five-arm study. We had 25, 50, 100, and 200 microgram doses of MM120 in addition to placebo. By having a higher likelihood of getting drug, we likely overrepresented the true placebo response. The reported placebo response is likely an overmeasurement of the actual placebo response.

That’s also driven by the fact that we did not have open-label treatment available to folks at the conclusion of their 12-week participation in the phase 2b, which meant that the sickest patients, the patients who were least responsive, particularly in the placebo group, were most likely to drop out and have their data replaced by the people who were doing better, right, through that imputation strategy. For those two reasons, we think that the measured placebo response in the phase 2b is about as high as we’re going to see in any of our studies. In fact, it was nearly 14 points, which means that our placebo outperformed any existing treatment for generalized anxiety disorder (GAD). Despite having that very robust placebo response, we still exceeded it by nearly eight points 12 weeks after a single treatment.

We’re very confident that in the phase 3s, which now include an extension phase with up to a year of additional observation, including the opportunity for up to four open-label treatments, we’re going to have an even higher probability of showing a difference versus placebo that potentially even exceeds what we saw in phase 2b.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: Right. Can you talk about this question around functional unblinding, and I guess what measures are in place to address this or mitigate it? What is the purpose of the 50 microgram arm included in Panorama?

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: There’s been a lot of talk about functional unblinding in the category, right? I think that’s in part because eyes that hadn’t previously been on psychiatric drug development were newly looking at psychiatric trials. The reality is that drugs that make you feel different, which is the point of psychiatry and psychopharmacology, feel like something. There’s been functional unblinding in every class of psych drugs. You know, benzodiazepines are a great example. They acutely reduce your anxiety and make you sleepy. People can reliably detect that in clinical trials. All that said, people are pretty good at guessing when they’ve gotten an adequate dose of psychedelics or when they’ve gotten placebo. Though that said, in our phase 2b, about 30% of people on placebo guess that they’d gotten drug.

As I said when I was talking about that 50 microgram dose arm the first time around, we accept that people become functionally unblinded. We separate the people in the room who themselves become functionally unblinded from the people conducting efficacy assessments. We try to control for the blinding of the assessors. Our primary assessment is conducted by a remote blinded central rater, someone who has no idea what visit it is and certainly doesn’t know the allocation to drug and has no clues from having been in and around the clinic as to what might have happened in there.

We include this 50 microgram control arm as another way of saying that someone who has a drug experience in Panorama can’t reliably know whether they got the true treatment dose or if they got a lower dose that we don’t believe is a treatment dose, but that reliably feels like something. You can’t completely control the fact that the drug feels like something. In fact, as I said before, I think that the drug feels like something is a part of its mechanism. What you can do is measure the drug effect in a number of different controlled states and say if in each of these different controlled states we’re able to reliably and repeatedly measure the drug effect and it looks about the same in these different states, that makes it extremely likely that the measured drug effect represents a real drug effect.

That’s the point of the experiment.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: Right. That’s interesting. How do you see MM120 fitting into the treatment algorithm for GAD if it’s approved first line, second line, or later?

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: The unfortunate reality of the current state of psychiatry is that when we get a new drug, even if it works better than drugs before it, it ends up further down the treatment algorithm per payers, right? You end up with step therapies, therapies where someone has to have been failed by a less effective drug or less effective drug or two. We think that’s likely to be the place in the therapy we launch into. It’s going to be more expensive than a generic SRI. There’s going to be an expectation that less effective drugs effectively are tried first. That said, that’s been the case for every new drug in MDD. There hasn’t been a new drug in GAD in almost 20 years. Those drugs have been able to be very successful despite having prior authorization requirements that put them further down a step pathway.

The difference here is we have a drug that if it continues to show the performance characteristics that we showed in phase 2b, that represents a radical departure from the opportunity available previously in psychopharmacology. The argument at launch won’t be that it should be further up the step therapy, but I think there is a place for an argument to say that people shouldn’t be forced to suffer and take intolerable and ineffective drugs for a substantial period of time before being given access to something that can induce remission.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: Can you expand on the durability of effect that you’ve seen so far and what you would expect after the phase 3 potentially, and what dosing frequency you might expect in real-world practice?

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: What we saw in phase 2 was 12 weeks of durability and no real tailing off after 12 weeks. There was no real reason to think that we were seeing the end of the likely efficacy at week 12. That said, we had to stop the study at some point, and we weren’t in a position to give open-label doses at that point because we hadn’t established through the phase 2b evidence that the drug was effective and safe enough to do that. In phase 3, we have a full year of observation after that double-blind controlled dose.

For people who don’t qualify for an open-label dose because they’re not sick enough through that extension phase, they will remain in that blinded controlled condition for a full year and will have a way to continue to monitor them for as long as they continue to give us data after that study. There’s a possibility that some patients need dosing, say, every 12 weeks. I don’t think that’s how this drug works. I think what we will find is that different treatment patterns emerge where some people get a single dose and have a protracted period of substantial improvement. Other people might need two doses to have that same period. Certainly, some people may need more than that, but I don’t think what we’re going to end up looking at for the vast majority of patients is some sort of scheduled interval dosing.

Rather, I think most people will sustain benefit for a period of time that we don’t yet know. At some point, we’ll have what looks more like a recurrence of the illness than it looks like a tailing off of drug effect. At that point, they should get another treatment.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: As we look further in the future to a potential advisory committee, I guess first, would you expect an advisory committee for MM120 in GAD? Can you talk about the read-throughs from the CRL that was released on MDMA and PTSD? I guess what learnings maybe emerged from that advisory committee experience and then also the CRL, and again how this maybe reads forward to a potential advisory committee for MM120?

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: I feel like I’m taking all of these.

Brandi Roberts, Chief Financial Officer, Mind Medicine (MindMed) Inc.: No, I’ve got some coming, so you’re good.

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: All right. We’ll keep going then. No new learnings from the release of the CRL. Nothing all that surprising in that we have been building our studies and our clinical development program to accommodate the sorts of concerns that were raised at the ADCOM and the contents of that CRL since almost five years ago when Rob and I started doing this together. We had confidence in our plans then. We’ve stuck with those plans. As evidence has emerged at the stumbling blocks that others have encountered along the way, it just builds our confidence that we’re on the right path.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: I want to move on to MM120 and major depressive disorder. Maybe you can introduce the EMERGE trial and what you aim to establish here.

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: Yeah, we saw great movement on the mattress in the phase 2b. GAD and MDD are massively overlapping diagnoses, about 80% construct overlap, 50% or more comorbidity in the real-world patient population. We move the mattress on those folks with primary GAD in phase 2. We have every reason to think we’ll move the mattress in people who primarily are in a major depressive episode. We’d like to establish a pivotal body of evidence for an MDD SNDA.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: What gave you confidence to move directly into a phase 3 in MDD? How is the trial designed, just as MDD trials are designed to address FDA expectations? How does this compare to GAD?

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: Yeah, very similar studies. Obviously, the MADRS is the primary for MDD. The HAM-A is the primary for GAD. Week 12 is the primary outcome measure for GAD. In MDD, it’s week six, but we’ll continue to look out to week 12 in a double-blinded fashion. We tried to build three studies that were almost entirely operationally interchangeable to make life easier for our sites. We do a lot of work with these sites to make sure that we are enabling them to do the best work that they can. Designing studies that essentially can slot patients into one or another and then be basically the same for the site has always been our goal.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: Can you remind us, I think in the phase 2b trial, you did have data on depression in that trial.

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: We measured the MADRS in the phase 2b. We saw great movement on the MADRS despite encountering a floor effect because the entry MADRS was lower than it would be for an MDD trial where people are in a major depressive episode. We have tremendous confidence in our ability to move the MADRS in any neurotic population.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: Where do you believe MM120 will fit in the MDD treatment paradigm?

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: I think probably a similar place to the GAD treatment paradigm, likely to be a step therapy. Again, the argument that I made for GAD stands for MDD. I think we’re not doing the best we can by patients if we’re withholding effective treatment and making them be failed by treatments that are known to be more failure-prone.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: Looking ahead even further to potential commercialization, how are you approaching payer engagement and step therapy discussions ahead of a potential launch?

Brandi Roberts, Chief Financial Officer, Mind Medicine (MindMed) Inc.: Yeah, I’ll take this one. We hired Matt Wiley earlier this year. He’s our new Head of Commercial, and we’ve started our discussions with payers. Really just starting those conversations, we really want to understand the nuances and the things that they’re considering. At this time, what we’re doing is really focusing on the insights so that we can shape a compelling value proposition. A lot of what Dan just talked about for MM120, which will be informed by our phase 3 studies and our eventual pricing strategy. The goal is to open up as broad access as we can. We’ll do that by making sure that we can talk about the clinical and the economic benefits of MM120. A lot more to come on that as we come into early 2026.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: Can you walk us through a little bit how MM120 would be delivered in practice, and what role the interventional psychiatry model will play?

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: Yeah. Okay. What we saw in response to the arrival of Spravato on the scene was this psychopharmacological interventional psychiatry model. There’d been a little of that with TMS. Certainly, we’ve had ECT for a long time, though that tends to be delivered in more hospital settings. We think that model is a great place for us to live, but we don’t think we will be restricted to that model. Our goal through our development program has been to establish that the drug can be used safely and effectively with minimal intervention from a monitor, that the monitor is really there for assistance and comfort, and that there doesn’t need to be, there’s no real physiological risk profile. There’s no hemodynamic risk profile. Our toxicology is extraordinarily clean.

Our goal is for this drug to be available to the psychiatric and psychological community to use in all sorts of systems of care, because broad access is absolutely our goal.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: Maybe moving on to MM402, maybe you could provide a high-level overview of this program and why you believe our MDMA has promise in autism spectrum disorder.

Daniel R. Karlin, Chief Medical Officer, Mind Medicine (MindMed) Inc.: I can try to do that very quickly, which is that we’ve been talking about a session-based intervention, a real interventional psychiatry type thing. Our R-MDMA is the enantiomer of MDMA that seems to have the more serotonergic and less dopaminergic effect. We are not developing it to be a session-based therapy or any sort of psychotherapy enabler as it’s been developed, as the racemic mixture has been developed in PTSD. Rather, we see this as analogous to psychostimulants in ADHD, where someone suffering from difficulties with social communication, social connection, can take a dose of the drug while the drug is on board. Its direct neurobiological effects enable social communication, enable social connection, social recognition, emotional awareness in self and others. As the drug comes off, the person is as they were.

Again, thinking about this as a tool that folks with autism spectrum disorder can use if it’s beneficial to them.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: With cash runway going into 2027, how are you thinking about capital allocation and readiness for commercialization?

Brandi Roberts, Chief Financial Officer, Mind Medicine (MindMed) Inc.: Yeah, I mean, one of the things that really stood out to me when I was thinking about joining Mind Medicine (MindMed) Inc. was how responsibly they’ve grown over the last year, raised $250 million last year. The goal was really to make sure that we could get through these phase 3s and have cash runway into 2027, be prepared to have 12 months of cash after our first readout. We still continue to do that. We’re very excited that we’re running three phase 3s. That’s obviously keeping us very busy, but we are interested in MM402 as well. I think we’re being really thoughtful about our approach as we take on new things, and we want to be prepared for our NDA and eventual commercialization too. You’ll hear more about that in the coming year, but we’ve just started to deploy some MSLs out into the field.

We are starting to build out our Medical Affairs team, and it’s really an exciting time at Mind Medicine (MindMed) Inc. as we prepare for next steps.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: Great. Maybe as a final question, over the next year or so, what are the key milestones that investors should be aware of? What do you think investors may be missing about the story?

Brandi Roberts, Chief Financial Officer, Mind Medicine (MindMed) Inc.: Yeah, I mean, obviously looking to have Voyage data in the first half of 2026, Panorama in the second half of 2026, and then EMERGE in the second half of 2026 as well. Three phase 3 readouts next year. I think you’ll continue to see us work on the education. I think really explaining what that treatment or the treatment looks like over the five to eight-hour time period is something that I think is a nuanced conversation and more people seem to understand as we talk through it. I think the durability that we see and really being able to show again 12 weeks or potentially more, and we’ll be able to get all that retreatment information from those phase 3s.

Patrick Truchio, Senior Healthcare Analyst, HC Wainwright: Great. Terrific. Brandi and Dan, thank you so much. Thank you to Mind Medicine (MindMed) Inc. for attending. Thanks to everyone for being with us today. Have a great rest of your day.

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