Mind Medicine (MindMed) - Earnings Call - Q1 2025

Executive Summary

• Q1 2025 diluted EPS was $-0.35, a modest beat vs Wall Street consensus of $-0.36*, driven primarily by non-cash warrant fair value gains ($7.0M) and higher interest income, despite stepped-up R&D investment.*
• Cash, cash equivalents and investments totaled $245.5M, supporting operations into 2027; runway extends at least 12 months beyond the first Phase 3 topline for MM120 ODT in GAD.
• Clinical execution advanced: first patient dosed in EMERGE (Phase 3 MDD); VOYAGE and PANORAMA (Phase 3 GAD) enrollment “on track” with topline readouts expected 1H 2026 (Voyage) and 2H 2026 (Panorama, Emerge).
• Financing flexibility improved via amended K2 HealthVentures facility (up to $120M availability, $17.8M net cash received, interest-only extended through at least May 1, 2027), adding a near-term liquidity catalyst for investors.

What Went Well and What Went Wrong

What Went Well

• “All three of our pivotal Phase 3 trials…are actively enrolling” with strong site and patient enthusiasm, reinforcing momentum toward 2026 data readouts. CEO: “We’re delivering on our goal of advancing MM120 ODT as a potential best-in-class…therapeutic option”.
• Commercial build-out: appointment of Matt Wiley (25+ years CNS/psychiatry launches) to lead go-to-market readiness; Wiley emphasized building a “patient-focused, science-driven and launch-ready” organization.
• Liquidity and runway: $245.5M CCE+investments, amended debt facility ($120M availability) and interest-only extension bolster execution capacity into/through pivotal trials.

What Went Wrong

• Operating spend ramp: R&D rose to $23.4M (+$11.7M YoY) as Phase 3 programs scale; management expects further R&D increases through 2025, pressuring near-term EPS/CF.
• No interim efficacy catalysts in 2025: management does not plan to release unblinded interim data; only a blinded sample-size re-estimation may occur, limiting near-term clinical data flow.
• Pre-revenue profile persists; net loss of $23.3M and diluted EPS of $-0.35 reflect financing/gains mix (e.g., warrant revaluation) rather than commercial traction, maintaining binary pipeline risk into 2026.

Transcript

Rob Barrow (CEO)

Good morning and welcome to MindMed's first quarter 2025 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 MindMed. Please go ahead.

Stephanie Fagan (Chief Corporate Affairs Officer)

Thank you, Operator, and good morning, everyone. Thank you for joining us today for a discussion of MindMed's first quarter 2025 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 Dr. Dan Karlin, our Chief Medical Officer. After our prepared remarks, we will open the call for Q&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-K and our Form 10-Q being filed today. 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, May 8th, 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.

Rob Barrow (CEO)

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. 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 striving 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 III 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 2026, with Panorama and Emerge to follow in the second half.

With breakthrough therapy designation for MM120 ODT and GAD, a well-defined regulatory strategy, and 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 50 million people in the U.S. 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 MM120 ODT's potential and highlight its tremendous commercial opportunity. To lead this effort, we recently welcomed our new Chief Commercial Officer, Matt Wiley, to our team. Matt is uniquely positioned to lead our commercial strategy during this critical growth phase.

He has more than 25 years of experience, having successfully driven the commercialization of innovative therapies with a focus on CNS and psychiatry. He has guided products from development to market launch and accelerated the growth of in-line 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 (Chief Commercial Officer)

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 IIb 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. Now that I'm inside the organization, my conviction is even stronger. MM120 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 25 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. 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 the 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, 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.

Dan Karlin (Chief Medical Officer)

Thank you, Matt. It's great to have you with us. As Rob mentioned, we have dosed participants in three of our pivotal phase III clinical studies: Voyage and Panorama evaluating MM120 ODT in GAD, and Emerge evaluating MM120 ODT in MDD. Starting with Voyage and Panorama, we remain highly encouraged by the pace of enrollment. 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 2026 and Panorama in the second half of 2026. As a reminder, each study consists of two parts. Part A, a 12-week randomized double-blind placebo-controlled parallel group study assessing the efficacy and safety of MM120 versus placebo, and Part B, a 40-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 100 mcg or placebo, while in Panorama, we expect to enroll approximately 250 participants who will be randomized two-to-one-to-two to receive MM120 ODT 100 mcg, 50 mcg, or placebo. In both design and execution, we closely modeled our phase III GAD studies after our successful phase IIb study of MM120 and 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 IIb trial, we observed an almost eight-point improvement for MM120 over placebo at week 12.

To ensure our actual statistical power is maintained, we are using an adaptive design in our GAD phase III studies, which includes an interim blinded sample size re-estimation that allows for increased enrollment of up to 50% in each trial if necessary. This approach helps to adjust for any unexpected variability in nuisance parameters, specifically dropout rates and pooled variance 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 IIb 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 III Emerge trial and are encouraged by early enrollment trends. Just like our GAD program, our MDD program will consist of two pivotal clinical studies. Our first study, Emerge, will be comprised of two parts. Part A, a 12-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 40-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 100 mcg or placebo.

The primary endpoint in Emerge is the change from baseline in Montgomery-Åsberg 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 2026. 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.

Rob Barrow (CEO)

Thanks, Dan. Turning to our financial results for the quarter ended March 31st, 2025, we ended the quarter with cash, cash equivalents, and investments totaling $245.5 million. We believe that our cash, cash equivalents, and investments as of March 31st, 2025, will be sufficient to fund our operations into 2027. Overall, based on our current operating plan and anticipated R&D milestones, we expect our cash runway to extend at least 12 months beyond our first phase III 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 million based on the achievement of certain milestones and extends the interest-only period through at least May 1st, 2027.

The company received approximately $17.8 million 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 $23.4 million for the three months ended March 31st, 2025, compared to $11.7 million for the three months ended March 31st, 2024, an increase of $11.7 million. The increase was primarily due to $9.4 million in expenses related to our MM120 program, an increase of $2.4 million in internal personnel costs as a result of increasing research and development capacities, and an increase of $0.1 million in preclinical and other program expenses, partially offset by a decrease of $0.2 million in MM402 program expenses.

We anticipate R&D expenses will continue to ramp up in 2025 due to the costs associated with running three pivotal phase III studies. General and administrative expenses were $8.8 million for the three months ended March 31st, 2025, compared to $10.5 million for the three months ended March 31st, 2024, a decrease of $1.7 million. The decrease was primarily attributable to stock-based compensation expense. To close, this is an exciting and pivotal time for MindMed. Our three phase III 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 in 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 (participant)

Certainly. Ladies and gentlemen, to ask a question at this time, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. One moment, please, for our first question. Our first question comes from the line of Marc Goodman with Leerink Partners.

Basma Radwan (Equity Research Analyst)

Hi, good morning. Thank you for taking our question. We have a question regarding the MDD trial. Would you please remind us again whether you still need to assess the low dose of five micrograms in this trial or maybe in the second phase III trial as you're planning to start? Regarding the therapeutic effective dose, is it fair to assume that the same therapeutic dose in GAD, which is 100 mcg, will also be effective in MDD? That is it for us. Thank you.

Rob Barrow (CEO)

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

Dan Karlin (Chief Medical Officer)

Yeah, thanks so much for the question. As you noted, in our second GAD study, we're using that 50 mcg intermediate blinding control dose. In our disclosed MDD study, we are not using an intermediate dose. We're using a two-arm study, 100 mcg versus placebo as we've done in our first GAD study. It's reasonable to think that at some point in the MDD development program, as we move into any additional required studies, we might use that same 50 mcg intermediate blinding control arm. While we haven't disclosed a plan to do so, it's not unreasonable to think that at some point in the MDD program, we would do a 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 100 mcg active arm, which we have reason to believe from our GAD results in phase IIb has high efficacy against depression cluster symptoms. 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 100 mcg arm.

Basma Radwan (Equity Research Analyst)

Thank you very much. It was very helpful.

Operator (participant)

Thank you. Our next question comes from the line of Brian Abrams with RBC Capital Markets.

Brian Abrams (Senior Biotechnology Analyst)

Hey, guys. Thanks for taking our questions. Congrats on the progress. Matt, welcome to the team. Just curious, as the trial enrollment really gets going, are there any kind of learnings that you're taking away initially from GAD epidemiology or treatment patterns, disease recognition, provider engagement, that sort of thing? Any surprises so far and kind of how that's shaping your overall commercial approach? I guess I'm also curious, kind of following up on the prior question, on 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 50 mcg dose for either indication. Does it need to look less efficacious than 100, or kind of what happens if you show no efficacy there or comparable efficacy? Thanks.

Rob Barrow (CEO)

Yeah, thanks so much for the question, Brian. Take them in reverse order and ask Dan to answer the second one. I think with regard to the 50 mcg dose, again, there's been a lot of discussion about various controls used across drugs that are under development in this category. We made the decision to include a 50 mcg dose group to answer some of those questions and some of the methodological asks 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. As with any program, we are looking at a dose of drug, in our case, 100 mcg of MM120 versus placebo.

While we've included the 50 mcg 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 would not bias the ultimate clinical outcome assessments. While we are measuring the response and the activity in the 50 mcg dose group, because it can provide no logical or statistical learnings about the performance of 100 mcg versus placebo, it's really irrelevant to the findings from the study, both statistically and what we interpret clinically. There are a number of scenarios that could play out, and we're certainly very keen on understanding those. We've already looked, really, the first and only study in the class looked comprehensively at a dose response.

We have established the minimum clinically effective dose out at several months after a single administration. We feel incredibly confident in the dose selection and the justification for that dose. It would be somewhat illogical to then throw away the evidence we have generated so far, which is so compelling in a study just where we have a second methodological control. We are simply focused on the 100 mcg 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 know with certainty because they felt something on the 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.

Dan Karlin (Chief Medical Officer)

Yeah. Brian, it is 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, right? There have not been GAD approvals in 20 years. To be running sponsored research in GAD, we have, of course, learned a lot about how to find patients, how to recruit them, how to get the right folks into the study. For us and the sites we work with, of course, learnings from phase II that we have brought forward into phase III here, I think there is a broader perspective in that. You mentioned the epidemiology of the illness. What we have found just in the time since we started working on GAD is that there is clearly broader awareness and attention to the disorder just in the time that we have been working in it.

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 20 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. All of that, the change both on our level and on really what we're seeing as 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 Abrams (Senior Biotechnology Analyst)

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

Operator (participant)

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

Jessup Shean (Senior Managing Director)

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

Rob Barrow (CEO)

Yeah, thanks so much for the question, Yasha. 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. We've continued to have strong engagement and timely responses on any sort of correspondence we have with the agency. We're not seeing any direct impact at this point, and we're really encouraged by the dialogue we continue to have.

Jessup Shean (Senior Managing Director)

Thanks so much.

Operator (participant)

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

Elaine Kim (Biotechnology Equity Research)

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 MDD trials. 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 IIb trial? I have a quick follow-up.

Rob Barrow (CEO)

Yeah. At the highest level, everything about how we've designed and are executing the phase III program is consistent with what we did in phase II. Obviously, as we progress through development, we have incremental learnings to make ourselves more efficient 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 patient selection.

Dan Karlin (Chief Medical Officer)

Yeah. From a patient selection perspective and enrollment perspective, we have several confirmatory steps as we enroll folks. We look at records from outside treaters. We have a confirmatory interview called the SAFER that's done by a third-party rater. Each step through the screening process and ultimately leading up to enrollment is really oriented around ensuring strict adherence to protocol and to inclusion/exclusion criteria and screening out folks who might be enrolling for reasons other than trial participation as it's intended to be. We're confident in our sites. We have close relationships with our sites. 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 (Biotechnology Equity Research)

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

Dan Karlin (Chief Medical Officer)

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. 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 when they present they're too ill to participate.

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 II, 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. We will 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 (Biotechnology Equity Research)

Very helpful answers. Thank you.

Rob Barrow (CEO)

Thanks, Elaine.

Operator (participant)

Thank you. Our next question comes from the line of Joel Beedy with Baird.

Good morning. Thanks for taking our question. This is Chris on for Joel. Congrats on the progress. We're looking forward to data. Some feedback from investors, though, is 2025 is a little light on catalysts. I'm wondering if there's any plan to releasing any interim data between now and the final readouts. Just another question, quick question on 402, if you can provide any color on the next steps in terms of that. Thanks.

Rob Barrow (CEO)

Yeah. Thanks so much for the question. We are laser-focused on executing these studies, I think, 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. We do have a blinded sample size re-estimation that is going to occur, although we haven't provided any guidance around whether or if or when we would announce any findings from that analysis. Beyond that, we certainly don't have an anticipation that we're going to be analyzing or releasing any unblinded data that would be informative about treatment effects over the course of this year. Like I said, we're focused on getting the data as quickly as possible and getting the highest quality study results.

In terms of 402, we've completed a phase I study. We're continuing to develop that program. We'll be sharing some additional details at an appropriate time about what comes next in that development program and starting to think about how we can get the program progressed in the patients that have diagnosed with autism spectrum disorder.

Thanks, Rob. Helpful.

Operator (participant)

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

Rudy Li (VP and Senior Equity Research Analyst)

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

Matt Wiley (Chief Commercial Officer)

Sure. Hi. Thanks for the question. This is Matt. First of all, both populations for GAD and MDD are quite large. There are significant unmet needs in both. 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. I mean, there's no shortage of GAD patients. It's a durable market. 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. 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.

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. That will help the market better understand the opportunity for a drug like MM120.

Rudy Li (VP and Senior Equity Research Analyst)

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 (Chief Commercial Officer)

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. As a market itself, we think about GAD in a slightly different way. The GAD patients may be in slightly different locations than where the Spravato patients are, or there could be overlap. We believe that there will be a phenotype of physician that has adopted Spravato that could also be adopters for MM120. While we would expect that there would be some overlap in capacity utilization, there also could be additional capacity and operational opportunities beyond that.

Rob Barrow (CEO)

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 encouraged by the quality and both the depth and duration of effect that we can demonstrate. Spravato is 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 how it would position us to have perhaps even a more expansive opportunity.

Rudy Li (VP and Senior Equity Research Analyst)

Got it. That's very helpful. Thanks.

Operator (participant)

Thank you. Our next question comes from the line of Samarth Kulkarni with CRISPR Therapeutics.

Samarth Kulkarni (CEO and Chairman)

Good morning. Thanks for taking your 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. What specifically in your prior experience with commercializing scheduled products might help you best on setting up MM120 for success? 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 (Chief Commercial Officer)

Sure. Thanks, Samarth. First of all, I think that having worked on a couple of products with REMS historically is going to be helpful. Most specifically, working 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 the hub service model will 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. I think that reframing scientifically is top order for us.

Samarth Kulkarni (CEO and Chairman)

Got it. Thank you.

Operator (participant)

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

Michael Okunewitch (Senior Biotechnology Analyst)

Hey, guys. This is Michael Okunewitch on the line. Thank you so much for taking my questions today. 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 (Chief Commercial Officer)

We're still early days on targeting. We use claims data to identify where the patients are and certainly will 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)

All right. Thank you. And then just one more from 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?

Matt Wiley (Chief Commercial Officer)

Yeah. Maybe I'll stand to comment on just psychiatrist perspective on this because we've done a lot of work with providers in the field, and certainly, Dan can give some more color to that.

Dan Karlin (Chief Medical Officer)

Yeah. I mean, we've made the choice clearly that from a regulatory perspective, these disorders, though massively overlapping, as you note, do exist as distinct entities. There are certainly patients who are 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. 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.

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)

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

Operator (participant)

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