Mind Medicine (MindMed) Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 8, 2025
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Operator

Good morning and welcome to the MindMed's First Quarter twenty twenty five Financial Results and Corporate Update Webcast. Currently, all participants are in a listen only mode. This webcast is live on the Investors and Media section of MindMed's website at mindmed.co, and a replay will be available after the webcast. I would like to introduce Stephanie Fagan, Chief Corporate Affairs Officer of Please go ahead.

Stephanie Fagan
Stephanie Fagan
Chief Corporate Affairs Officer at Mind Medicine (MindMed)

Thank you, operator, and good morning, everyone. Thank you for joining us today for a discussion of MindMed's first quarter twenty twenty five business highlights and financial results. Leading the call today will be Rob Barrow, our Chief Executive Officer. He will be joined by Matt Wiley, our Chief Commercial Officer and Doctor. Dan Carlin, our Chief Medical Officer.

Stephanie Fagan
Stephanie Fagan
Chief Corporate Affairs Officer at Mind Medicine (MindMed)

After our prepared remarks, we will open the call for Q and A. An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call. During today's call, we will be making certain forward looking statements, including without limitation, statements about the potential safety, efficacy and regulatory and clinical progress of our product candidates, our anticipated cash runway and future expectations, plans, partnerships and prospects. These statements are subject to various risks, such as changes in market conditions and difficulties associated with research and development and regulatory approval processes. These and other risk factors are described in the filings made with the SEC and the applicable Canadian securities regulators, including our annual report on Form 10 ks and our Form 10 Q being filed today.

Stephanie Fagan
Stephanie Fagan
Chief Corporate Affairs Officer at Mind Medicine (MindMed)

Forward looking statements are based on the assumptions, opinions and estimates of management at the date the statements are made, including the non occurrence of the risks and uncertainties that are described in the filings made with the SEC and the applicable Canadian securities regulators or other significant events occurring outside of MindMed's normal course of business. You are cautioned not to place undue reliance on these forward looking statements, which are made as of today, 05/08/2025. MindMed disclaims any obligation to update such statements even if management's views change, except as required by law. With that, let me turn the call over to Rob.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

Thank you, Stephanie, and everyone for joining our call today. Before we dive into our business updates and financial results, I want to acknowledge that May is Mental Health Awareness Month, something that is deeply important to us. This is a time to recognize the millions of individuals around the world who are affected by mental health disorders, including generalized anxiety disorder or GAD and major depressive disorder or MDD. At MindMed, our mission to transform the treatment of brain health disorders is closely aligned with the goals of Mental Health Awareness Month. This month, we stand with others working to address the significant challenges faced by those living with mental health conditions.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

As we continue to advance our clinical programs and deliver on key milestones, we also recognize the vital contributions of the broader community. From the investigators leading our trials to the patients who participate and the many advocates driving awareness and progress, each plays a crucial role in shaping a future where mental health is treated with the urgency and innovation it deserves. The mental health crisis underscores the need for novel therapies like MM120, our lead program for the potential treatment of GAD and MDD. Three of our pivotal Phase three trials evaluating MM120 ODT in patients with GAD and MDD, Voyage, Panorama and EMERGE are now actively enrolling, and we're seeing strong engagement from clinical sites and patients as momentum continues to build. We're on track to report top line data from Voyage in the first half of twenty twenty six with Panorama and EMERGE to follow in the second half.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

With breakthrough therapy designation for MN120 ODT and GAD, a well defined regulatory strategy, a consistent execution across our programs, we are delivering against our strategic objectives. We believe MM120 ODT has the potential to become a differentiated best in class treatment for GAD and MDD, addressing a significant unmet need for over fifty million people in The US alone. Our focus remains on driving this innovation forward and positioning the company for long term value creation as we move towards commercialization. With three of our pivotal trials now underway and enrollment progressing, we continue to generate evidence to support M120 ODT's potential and highlight its tremendous commercial opportunity. To lead this effort, we recently welcomed our new Chief Commercial Officer, Matt Wiley, our team.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

Matt is uniquely positioned to lead our commercial strategy during this critical growth phase. He has more than twenty five years of experience having successfully driven the commercialization of innovative therapies with a focus on CNS and psychiatry. He's guided products from development to market launch and accelerated the growth of inline marketed therapies. His expertise and insights bring tremendous value to our team and we couldn't be more excited about having him on board at such a pivotal time. With that, I'd like to turn the call over to Matt so he can formally introduce himself. Matt?

Matt Wiley
Matt Wiley
Chief Commercial Officer at Mind Medicine (MindMed)

Good morning, everyone, and thank you, Rob, for the introduction. It's an exciting time to be at MindMed. I joined this team because what we're doing here isn't just incremental, but something potentially transformational. The data from our phase 2b trial of MM120 in GAD is among the most compelling I've seen in neuroscience. And the disciplined approach behind it speaks volumes about this company's caliber.

Matt Wiley
Matt Wiley
Chief Commercial Officer at Mind Medicine (MindMed)

Now that I'm inside the organization, my conviction is even stronger. One hundred twenty could redefine the treatment paradigm for GAD and MDD, and we're moving with urgency to build a commercial engine that matches the ambition and rigor of our science. Over the past twenty five years, I've led commercial strategies for multiple breakthrough therapies in psychiatry and CNS, navigated complex regulatory environments and secured market access in some of the most competitive markets. I've helped companies successfully manage critical product transitions from late stage development through launch and beyond. And I've built commercial organizations from the ground up that are patient focused, science driven, and launch ready.

Matt Wiley
Matt Wiley
Chief Commercial Officer at Mind Medicine (MindMed)

What we're building here at MindMed is no exception. I believe that we're laying the foundation for both a successful launch and for lasting leadership in this space. Every element of our strategy is intended to reflect same high standards and determination the company has shown in clinical development. Thank you again to Rob and to the rest of the team for their warm welcome. I'm honored to be here and looking forward to what we can achieve together.

Matt Wiley
Matt Wiley
Chief Commercial Officer at Mind Medicine (MindMed)

And I'm excited to share more about our progress in the months ahead. I'll now turn the call over to Dan for an update on our clinical programs.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

Thank you, Matt. It's great to have you with us. As Rob mentioned, we have dosed participants in three of our pivotal phase three clinical studies. Voyage and Panorama evaluating MM120 ODT and GAD and EMERGE evaluating MM-one hundred twenty ODT in MDD. Starting with Voyage and Panorama, we remain highly encouraged by the pace of enrollment.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

Patients and providers continue to show enthusiasm and high levels of engagement. We remain on track and continue to expect top line readouts from VOYAGE in the first half of twenty twenty six and PANORAMA in the second half of twenty twenty six. As a reminder, each study consists of two parts. Part A, a twelve week randomized double blind placebo controlled parallel group study assessing the efficacy and safety of MM120 versus placebo and Part B, a forty week extension period with opportunities for open label treatment designed to provide important long term data on the durability and response patterns with MM120. In VOYAGE we expect to enroll approximately 200 participants who will be randomized one to one to receive MM120 ODT one hundred micrograms or placebo while in PANORAMA we expect to enroll approximately two fifty participants who will be randomized two to one to two to receive MM120 ODT one hundred micrograms, fifty micrograms or placebo.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

In both design and execution, we closely modeled our phase three GAD studies after our successful phase 2b study of MM120 in GAD. In both VOYAGE and PANORAMA, the primary endpoint is the change from baseline to week 12 in the HAM A scale which was the outcome measure used for the approval of currently available GAD therapies. We designed these trials to have 90% power to detect a five point improvement over placebo based on certain statistical assumptions. Whereas in the phase 2b trial we observed an almost eight point improvement for MM120 over placebo at week twelve. To ensure our actual statistical power is maintained we are using an adaptive design in our GAD phase three studies which includes an interim blinded sample size re estimation that allows for increased enrollment of up to 50% in each trial if necessary.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

This approach helps to adjust for any unexpected variability and nuisance parameters, specifically dropout rates and pooled variants of HAM A response, maintaining statistical power and enhancing the interpretability of our results if needed. We've kept our inclusion and exclusion criteria consistent with our successful phase 2b study of MM120 and GAD incorporating exclusion criteria around the recency and total use of psychedelics to ensure a representative sample is recruited. We also conduct comprehensive safety assessments and labs before and after the administration of MM120 and ensure the collection of all adverse events. Turning to our MDD program with MM120, we are thrilled to have dosed our first participants in the pivotal phase three EMERGE trial and are encouraged by early enrollment trends. Just like our GAD program, our MDD program will consist of two pivotal clinical studies.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

Our first study EMERGE will be comprised of two parts. Part A, a twelve week randomized double blind placebo controlled parallel group study assessing the efficacy and safety of a single dose of MM120 ODT versus placebo and Part B a forty week extension period during which participants will be eligible for open label treatment with MM120 subject to meeting eligibility requirements. In EMERGE we plan to enroll at least 140 participants with a primary diagnosis of MDD randomized one to one to receive MM120 ODT one hundred micrograms or placebo. The primary endpoint in EMERGE is the change from baseline in Montgomery Asperger depression rating scale or MADRS at week six between the groups. We continue to anticipate top line data from EMERGE in the second half of twenty twenty six.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

Overall, we're excited to have three pivotal trials actively recruiting with all three readouts anticipated next year. With that, I will turn the call over to Rob to discuss our first quarter financial results. Rob?

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

Thanks, Dan. Turning to our financial results for the quarter ended 03/31/2025, we ended the quarter with cash, cash equivalents and investments totaling $245,500,000 We believe that our cash, cash equivalents and investments as of 03/31/2025 will be sufficient to fund our operations into 2027. Overall, based on our current operating plan and anticipated R and D milestones, we expect our cash runway to extend at least twelve months beyond our first phase three top line data readout for MM120 ODT and GAD. In April, we amended our loan agreement with K2 Health Ventures to provide greater financial flexibility and optionality. The revised facility provides us with access of up to 120,000,000 based on the achievement of certain milestones and extends the interest only period through at least 05/01/2027.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

The company received approximately $17,800,000 in net cash at closing after refinancing in full all term loans outstanding under the original agreement and the payment of fees and expenses in connection with the amendment and refinancing of the existing term loans. Research and development expenses were $23,400,000 for the three months ended 03/31/2025, compared to $11,700,000 for the three months ended 03/31/2024, an increase of $11,700,000. The increase was primarily due to $9,400,000 in expenses related to our MM120 program, an increase of $2,400,000 in internal personnel costs as a result of increasing research and development capacities and an increase of $100,000 in preclinical and other program expenses, partially offset by a decrease of $200,000 in MN402 program expenses. We anticipate R and D expenses will continue to ramp up in 2025 due to the costs associated with running three pivotal Phase three studies. General and administrative expenses were $8,800,000 for the three months ended 03/31/2025, compared to $10,500,000 for the three months ended 03/31/2024, a decrease of $1,700,000 The decrease was primarily attributable to stock based compensation expense.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

To close, this is an exciting and pivotal time for MyMed. Our three phase three trials of MM120 ODT are active, and the enthusiasm from our clinical sites speaks volumes about the need for and promise of MM120. We are energized, aligned, and confident in where we're headed. With breakthrough therapy designation for MM120 ODT and GAD, a clear regulatory strategy, and consistent execution across our pipeline, we are delivering on our mission and driving meaningful value for patients, physicians, and shareholders alike. Thank you for being with us on the call today, and the team and I are now happy to answer your questions.

Operator

Certainly. Ladies and gentlemen, to ask a question at this time, please press 11 on your telephone

Analyst

Hi, good morning. Thank you for taking our question. We have a question regarding the MDG trial. Would you please remind us again whether you still need to assess the low dose of five microgram in this trial or maybe in the second phase two trial that you you're planning to start? And regarding the therapeutic effective dose, is it fair to assume that the same therapeutic dose, in GAD, which is a one hundred microgram, will also be, in MDD effective in MDD? And, that's that's it for us. Thank you.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

Perfect. Thanks so much, Basma. I'll turn it over to Dan to answer that one.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

Yeah. Thanks so much for the question. So as you noted in our second GAD study, we're using that fifty microgram intermediate blinding control dose. And in our disclosed MDD study, we are not using an intermediate dose. We're using a two arm study, so one hundred micrograms versus placebo, as we've done in our first GAD study.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

But it's reasonable to think that at some point in the MDD development program, as we move into any additional required studies, that we might use that same fifty microgram intermediate blinding control arm. So while we haven't disclosed the plan to do so, it's not unreasonable to think that at some point in the MDD program we would do similar blinding control as we've done in GAD. With regard to the therapeutic dose that we would bring forward in MDD, What we have disclosed is that we'll be using that same one hundred microgram active arm, which we have reason to believe from our GAD results in phase 2b has high efficacy against depression cluster symptoms. So yeah, that's what we're using in our disclosed program and reasonable to think that that's what we'll continue to use moving forward, the one hundred microgram arm.

Analyst

Thank you very much. That was very helpful.

Operator

Thank you. And our next question comes from the line of Brian Abrahams with RBC Capital Markets.

Brian Abrahams
Brian Abrahams
MD & Global Sector Head - Health Care Research at RBC Capital Markets

Hey, guys.

Brian Abrahams
Brian Abrahams
MD & Global Sector Head - Health Care Research at RBC Capital Markets

Congrats on the progress. And Matt, welcome to the team. Just curious as the trial enrollment really gets going, there are any kind of learnings that you're taking away initially from GAD epidemiology or treatment patterns, disease recognition, provider engagement, sort of thing. And any surprises so far and kind of how that's shaping your overall commercial approach? And then I guess I'm also curious then kind of following up on the prior question on how the like your latest views on how the low dose might play in, if you're seeing any kind of evolution in regulatory perspectives and what you might be looking for out of the fifty microgram dose for either indication?

Brian Abrahams
Brian Abrahams
MD & Global Sector Head - Health Care Research at RBC Capital Markets

Does it need to look less efficacious than one hundred or kind of what happens if you show no efficacy there or comparable efficacy? Thanks.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

Yeah, thanks so much for the question, Brian. Take them in reverse order and I'll ask Dan to answer the second one. I I think with regard to the fifty microgram dose level, there's been a lot of discussion about various controls used in, you know, across drugs that are under development in this in this category. And we made the decision to include a fifty microgram dose group to answer some of those questions and some of the methodological, asks from from FDA. It is really important for everyone to understand that that dose level tells us nothing about the performance of the clinical dose of interest.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

As with any program, are looking at a dose of drug, in our case, a hundred micrograms of one twenty versus placebo. And while we've included the fifty microgram dose level, it's there so that patients coming into the trial will not be able to draw a degree of certainty between feeling something on the day of dosing and what expectancy they might have coming into the study that that wouldn't bias the ultimate clinical outcome assessments. So while we are measuring the response and and the activity in the fifty microgram dose group, because it can provide no logical or statistical learnings about the performance of a hundred micrograms versus placebo, is really irrelevant to, you know, to the findings from the study both statistically and what we'd interpret clinically. Now there are a number of scenarios that could play out, and, you know, we're certainly very keen on on understanding those. But we we've already looked really the the first and only study in the class to look comprehensively at a dose response, and we've established the minimum clinically effective dose out at at several months after a single administration.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

So we feel incredibly confident in the dose selection and the justification for that dose and thinking that it would be somewhat illogical to then throw away the evidence we've generated so far, which is so compelling, in a study just where we have a second methodological control. We're just simply focused on the hundred micrograms versus placebo and include that second dose level, again, just to aid in, sort of confounding of patients that they may not be able to to know with certainty because they felt something on a day of dosing that they got a real clinically active dose of drug. Turn it over to Dan to answer the other part of the question.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

Yeah. Brian, it's a great question about GAD and learnings and change over time. For us, of course, having run through the phase IIb in GAD, which was not something most have done. There haven't been GAD approvals in twenty years. And so to be running sponsored research in GAD, we've, of course, learned a lot about how to find patients, how to recruit them, how to get the right folks into the study.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

So for us and the sites we work with, of course, learnings from phase two that we've brought forward into phase three here, I think there's a broader perspective on that. You mentioned the epidemiology of the illness. And what we've found, just in the time since we've started working on GAD, is that there is clearly broader awareness and attention to the disorder just in the time that we've been working in it. So over time, as more people see anxiety as an issue for themselves, as something that's worth seeking clinical attention, that's worth seeking out clinical trials, I think we're only benefiting from the pendulum swing back in the direction of GAD from where it's been sort of pinned over the last twenty years on MDD, where people are more and more willing to talk about and think about anxiety as a source of distress in their lives. So all of that, the change both on our level and on really what we're seeing, the sort of systematic societal level, is all working in favor of both the disorder as a target of clinical research and ultimately, if approved, as a commercial target.

Brian Abrahams
Brian Abrahams
MD & Global Sector Head - Health Care Research at RBC Capital Markets

Super helpful. Thanks, Dan, and thanks, Rob.

Operator

Thank you. And our next question comes from the line of Gavin Clark Gardner with Evercore ISI.

Yesha Patel
Equity Research Associate at Evercore

Hi, this is Yasha on for Gavin. Thanks for taking our question. Just a more general one from us. Given the recent change up in FDA leadership, could you maybe speak to how engagement has been going with the agency over the course of the year? Thank you.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

Yeah, thanks so much for the question, Yesha. We obviously are very much aware and there's been a lot of headlines about changes at HHS and at FDA. So far, our engagement has stayed strong. FDA has been an incredible partner throughout our development program and that's only continued. So we've continued to have strong engagement and timely responses on any sort of correspondence we have with the agency.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

So we're not seeing any direct impact at this point and are really encouraged by the dialogue we continue to have.

Yesha Patel
Equity Research Associate at Evercore

Thanks so much.

Operator

Thank you. And our next question comes from the line of Charles Duncan with Cantor.

Elaine Kim
Biotech Equity Research Associate at Cantor Fitzgerald

Hi, good morning. This is Elaine Kim on for Charles. Thank you for taking our questions. It's great to hear that enrollment is on track for the GAD and NDD trials. But what are steps that you're taking to limit enrolling professional patients in maintaining the same robust effect size that you've seen in the Phase 2b trial? And I have a quick follow-up.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

Yeah. At the highest level, you know, everything about how we've designed and are executing the phase three program is consistent with what we did in in phase two. So, obviously, we as we progress through development, we have incremental learnings to to make ourselves more efficient and and and make sure we're getting the right patients into these studies. Maybe I'll turn it over to Dan to elaborate a little bit on on patient selection.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

Yeah. So from a patient selection perspective and enrollment perspective, we have several confirmatory steps as we enroll folks. So we look at records from outside treaters. We have a confirmatory interview called the SAFR that's done by a third party rater. So each step through the screening process and ultimately leading up to enrollment is really oriented around ensuring strict adherence to protocol and to inclusionexclusion criteria and screening out folks who might be enrolling for reasons other than trial participation as it's intended to be.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

So we're confident in our sites. We have close relationships with our sites. And ultimately, it really does come down to the intersection between high quality sites who are in it to get the right patients and good external confirmation to ensure that the folks we get are the folks we intended to.

Elaine Kim
Biotech Equity Research Associate at Cantor Fitzgerald

Okay. That's really helpful. And while the risk for suicidality is not as high as it is in GAD and MDD versus, you know, like treatment resistant depression, but what are steps that you are taking to monitor and prevent the safety risks?

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

Yeah, from enrollment through trial completion, we're of course very attuned to suicidality. In any treatment in psychiatry, and in truth, any treatment in medicine, there's always the risk for suicidal thinking and even suicidal behavior. And of course, that's something that's been appropriately paid attention to in our field. From screening on, we conduct the industry standard Columbia Suicide Severity Rating Scale, CSSRS, to ensure that patients we enroll are safe to be enrolled, that anyone who is actively suicidal should be getting care that's not research based care, that's true clinical care. So we're able to refer people back into the clinical care system if when they present they're too ill to participate.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

And then throughout the trial, we continue to monitor both through, of course, adverse event reporting, but also through serial CSSRSs and clinical assessments to ensure that if there is a suicide signal that we're able to detect it and respond appropriately. Of course, in our phase two, we did not see a suicide signal, which we were really glad to see, of course, for the treatment and for the disease state population. So we'll just continue to do what we've done and make sure we're enrolling appropriate patients and that we're monitoring them through the course of treatment appropriately so that both we can ensure participant safety and that we can have a good ability to report out on our safety signals at the end of the trials.

Elaine Kim
Biotech Equity Research Associate at Cantor Fitzgerald

Very helpful answers. Thank you.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

Thanks, Lynn.

Operator

Thank you. And our next question comes from the line of Joel Beatty with Baird.

Analyst

Good morning. Thanks for taking our question. This is Chris on for Joel. Congrats on the progress. We're looking forward to data.

Analyst

And some feedback from investors though is 2025 is a little light on catalysts. And I'm wondering if there's any plan to releasing any interim data between now and the final readouts. And then just another question, quick question on four zero two, if you can provide any color on the next steps in terms of that. Thanks.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

Yeah, thanks so much for the question. We are laser focused on executing these studies. Think we've, in the past and continue to set the standard for the pace in which we're executing on them. With the readouts coming next year, we're incredibly eager to get these data out there as quickly as possible. You know, we do have a blinded sample size re estimation that is going to occur, although we haven't provided any any guidance around whether or or or if or when we would announce, any findings from that analysis.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

And, beyond that, we we certainly don't have any anticipation that we'll be analyzing or releasing any unblinded data that would be informative about treatment effect, over the course of of this year. So, you know, we're we're, like I said, focused on getting the data as quickly as possible and getting the highest quality study results. In terms of four zero two, we completed a phase one study. We're continuing to, develop that program, and and we'll be sharing some additional details, at appropriate time about what comes next in that development program and and starting to think about how we can get the program progressing to patients that are diagnosed with autism spectrum disorder.

Analyst

Thanks, Rob. Helpful.

Operator

Thank you. And our next question comes from the line of Rudy Li with Chardan.

Rudy Li
Director at Chardan Capital Markets

Hey, thanks for taking my question. I'm just curious about your current thoughts on the market dynamics of Securedetics under current environment, given the sporadic growth trajectory? And can you talk about your commercial planning activities moving into second half of the year? Thanks.

Matt Wiley
Matt Wiley
Chief Commercial Officer at Mind Medicine (MindMed)

Sure. Hi. Thanks for the question. This is Matt. So first of all, both populations for GAD and MDD are quite large. There are significant unmet needs in both. So we feel really confident about how we're planning into the second half of the year and how we're going to address these unmet needs. First of all, I'll take on GAD. Mean, there's no shortage of GAD patients. It's a durable market, and even though it's been dormant for some time, what we've seen in claims data is diagnosis rates that have been pretty consistent over time. So this is a disease state that is recognizable by clinicians. The diagnoses are made. There's some interesting work to do in how we frame our market, and so as we think about our positioning and messaging, we intend to complete that work and roll that out in the second half of the year, and that will help the market better understand the opportunity for a drug like MM120.

Rudy Li
Director at Chardan Capital Markets

Just a quick follow-up. What are we planning to just leverage the commercial infrastructure just to leverage on the commercial success of SPRAVATO?

Matt Wiley
Matt Wiley
Chief Commercial Officer at Mind Medicine (MindMed)

So, it's, you know, as we think about SPRAVATO as a surrogate, it does provide an interesting opportunity to examine their reimbursement structure, how the capacity is utilized, what capacity exists beyond SPRAVATO patients. But as a market itself, we think about GAD in a slightly different way, that the GAD patients may be in slightly different locations than where the SPRAVATO patients are, or there could be overlap. But we believe that there will be a phenotype of physician that has adopted SPRAVATO that could also be adopters for MM120. And so while we would expect that there would be some overlap in capacity utilization, there also could be additional capacity and operational opportunities beyond that.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

And I'll just add one comment on top of that, which is that while we're certainly encouraged by the growth and the expansion for SPRAVATO, when we look at the relative data, obviously in different populations, but the kind of response we can generate in patients, I think we and everyone we speak to are is encouraged by the the quality and the both the depth and duration of of effect that we can demonstrate. So SPRATAL is an an interesting, proof point, but so far in development, we're incredibly confident in our data and how it would stack up against that drug and and how it would position us to have perhaps even a more expansive opportunity.

Rudy Li
Director at Chardan Capital Markets

Got it. That's very helpful. Thanks.

Operator

Thank you. And our next question comes from the line of Sumant Kulkarni with Canaccord Genuity.

Sumant Kulkarni
Sumant Kulkarni
Managing Director at Canaccord Genuity Group

Good morning. Thanks for taking my question. This one is for Matt, and I know you provided some details on your rationale for joining the company, and I apologize if this has been asked because I've been hopping between calls. But what specifically in your prior experience with commercializing scheduled products might help you best on setting up MM120 for success? And what are the unique challenges associated with LSD versus the other scheduled products that you might have been involved in commercializing so far?

Matt Wiley
Matt Wiley
Chief Commercial Officer at Mind Medicine (MindMed)

Sure, thanks, Sumant. Well, first of all, I think that having worked on a couple products with REMS historically is gonna be helpful, most specifically, on sodium oxybate when I was at Jazz, which was Schedule I outside of indication. There are a lot of parallels to what we're doing here. I do think that the REMS operations and hub service model be applicable here. As it relates to LSD specifically, I think that there's a lot of education to come for the market in how to view both the underlying disease state scientifically and then how a drug like MM120 fits into that disease state for GAD and also for MDD. More to come on that, but I think that reframing scientifically is top order for us.

Sumant Kulkarni
Sumant Kulkarni
Managing Director at Canaccord Genuity Group

Got it. Thank you.

Operator

Thank you. And our next question comes from the line of Jason McCarthy with Maxim Group.

Michael Okunewitch
Senior Biotechnology Analyst at Maxim Group

Hey guys, this is Michael Okunowicz on the line. Thank you so much for taking my questions today. So I guess maybe directed towards Matt, just thinking from a commercial perspective, could you talk a little bit about how you think about patient targeting within MDD or GAD? Just given that this will require more upfront time in the clinic than other therapies, do you expect you'll be looking at patients already looking into interventional options like TMS or SPRAVATO patients who are on chronic drugs, who may not have satisfactory efficacy or side effects or even patients untreated who may be discouraged from taking chronic pharma. Could you just give a bit more color on your thoughts?

Matt Wiley
Matt Wiley
Chief Commercial Officer at Mind Medicine (MindMed)

Well, we're still early days on targeting. We use claims data to identify where the patients are, and certainly we'll examine a lot of different factors that will go into our targeting model. That work is ongoing. We expect to have better clarity on that in the second half of the year.

Michael Okunewitch
Senior Biotechnology Analyst at Maxim Group

All right, thank you. And then just one more for me. Just when thinking about seeking approval in both generalized anxiety and major depressive disorder, do you expect there could be some competitive benefit to having evidence in each indication individually, just given the rates of comorbid anxiety and depression symptoms.

Robert Barrow
Robert Barrow
Director & CEO at Mind Medicine (MindMed)

Yeah, maybe ask Dan to comment on just psychiatrist's perspective on this, because we've done a lot of work with providers in the field, certainly, Danny can give some more color to that.

Daniel Karlin
Daniel Karlin
Chief Medical Officer at Mind Medicine (MindMed)

Yeah, well, I mean, we've made the choice clearly that from a regulatory perspective that these disorders, though massively overlapping as you note, do exist as distinct entities. There are certainly patients who were not in that comorbid condition who have one or the other. In general, providers are accustomed to making a diagnosis and having a primary target for treatment. So we think that from a provider perspective, having a label that covers both disorders makes us the go to, regardless of whether someone presents in a major depressive episode or with more dominant anxiety symptoms having had a depressive episode in the past and therefore qualifying for the major depressive disorder diagnosis. So clearly, we have made the choice, and the experts we talk to agree with this, that by having the entire waterfront of depression and anxiety covered, that we become the if approved, we can become the sort of go to regardless of the condition at presentation.

Michael Okunewitch
Senior Biotechnology Analyst at Maxim Group

All right. Thank you. I really appreciate that additional clarity.

Operator

Thank you. Ladies and gentlemen, this does conclude today's program, and you may now disconnect.

Executives
    • Stephanie Fagan
      Stephanie Fagan
      Chief Corporate Affairs Officer
    • Robert Barrow
      Robert Barrow
      Director & CEO
    • Matt Wiley
      Matt Wiley
      Chief Commercial Officer
    • Daniel Karlin
      Daniel Karlin
      Chief Medical Officer
Analysts
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Key Takeaways

  • Three pivotal Phase 3 trials for MM120 ODT in GAD (Voyage, Panorama) and MDD (EMERGE) are actively enrolling, with top-line data expected from Voyage in H1 2026 and Panorama and EMERGE in H2 2026.
  • MindMed ended Q1 2025 with $245.5 million in cash, cash equivalents and investments, projecting a cash runway into 2027 and at least 12 months beyond its first Phase 3 readout.
  • MM120 ODT has received Breakthrough Therapy designation for GAD and is positioned as a potential best-in-class treatment addressing an unmet need for over 50 million patients in the US.
  • Veteran commercial leader Matt Wiley joined as Chief Commercial Officer to build a launch-ready CNS and psychiatry team, leveraging over 25 years of experience.
  • MindMed amended its loan facility with K2 Health Ventures to access up to $120 million based on milestones and received $17.8 million net cash from the refinancing.
AI Generated. May Contain Errors.
Earnings Conference Call
Mind Medicine (MindMed) Q1 2025
00:00 / 00:00

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