Mind Medicine (MindMed) Q2 2025 Earnings Report

Mind Medicine (MindMed) EPS Results

• Actual EPS: -$0.50
• Consensus EPS: -$0.38
• Beat/Miss: Missed by -$0.12
• One Year Ago EPS: N/A

Mind Medicine (MindMed) Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Mind Medicine (MindMed) Announcement Details

• Quarter: Q2 2025
• Date: 7/31/2025
• Time: After Market Closes
• Conference Call Date: Thursday, July 31, 2025
• Conference Call Time: 4:30PM ET

Mind Medicine (MindMed) (NASDAQ:MNMD), a clinical stage biopharmaceutical company, develops novel products to treat brain health disorders. The company's lead product candidates include MM-120, which is in phase 2 for the treatment of generalized anxiety disorder and attention deficit hyperactivity disorder; and MM-402, a R-enantiomer of 3,4-methylenedioxymethamphetamine, which is in phase I clinical trials for the treatment of core symptoms of autism spectrum disorder. Mind Medicine (MindMed) Inc. is headquartered in New York, New York.

Mind Medicine (MindMed) Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Enrollment is on track for three pivotal Phase 3 trials of lead asset MM120 ODT in generalized anxiety disorder and major depressive disorder, with top-line readouts expected throughout 2026.
• Positive Sentiment: The FDA granted MM120 ODT Breakthrough Therapy designation after Phase 2b results showed a 0.81 effect size and 48% remission in GAD patients at 100 μg, more than double standard therapies.
• Positive Sentiment: MindMed held $237.9 million in cash, equivalents, and investments at quarter end, providing a runway into 2027 and at least 12 months beyond the first Phase III data readout for GAD.
• Negative Sentiment: Research and development expenses increased to $29.8 million in Q2 2025 versus $14.6 million a year ago, driven by Phase III trial costs and higher personnel expenses.
• Positive Sentiment: New CFO Brandi Roberts, with 25 years of life sciences finance experience and a track record of an IPO and $2.6 billion acquisition, joins to lead financing strategy during this growth phase.

Presentation

[Operator]

Good afternoon, and welcome to the MindMed second quarter twenty twenty five financial results and corporate update conference call. Currently, all participants are in a listen only mode. This call is being webcast live on the Investors of Media section of MindMed's website at mindmed.com, and a recording will be available after the call. I would now like to introduce Stephanie Fagan, chief corporate affairs officer of MindMed. Please go ahead.

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

-Thank you, operator, and good afternoon, everyone. Thank you for joining us today for a discussion of MyMed's second quarter twenty twenty five business highlights and financial results. Leading the call today will be Rob Vero, our Chief Executive Officer. He will be joined by Doctor. Dan Carlin, our Chief Medical Officer, and Brandi Roberts, our Chief Financial Officer.

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

After our prepared remarks, we will open the call for Q and A, and Matt Wiley, our Chief Commercial Officer, will also be available for questions. 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 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 filed today.

[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, 07/31/2025. 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, CEO & Board Director at Mind Medicine (MindMed)]

Thanks, Stephanie, and thank you everyone for joining our call today. I'm very pleased with our overall performance and execution through the first half of the year. We are currently on track with enrollment with our three pivotal phase three trials for our lead asset, NM120 ODT, which is being evaluated in patients with generalized anxiety disorder or GAD and major depressive disorder or MDD, the two most common psychiatric disorders in The US. Took a strategic approach in selecting GAD and MDD as the initial indications for MM120 ODT, driven by the unmet medical need, clinical development feasibility, as well as the large commercial opportunity. Targeting both indications potentially provides us with the broadest label possible and enables us to reach a wider patient population.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

In The US, more than sixty million people live with the GAD or MDD, and notably more than fifty percent of patients with GAD also suffer from MDD. This creates a meaningful opportunity to address both conditions with a single therapeutic approach, particularly considering the limitations of current treatments. We believe MM120 ODT has the potential to offer a differentiated novel best in class treatment option for these patient populations. MM120 was granted breakthrough therapy designation from the FDA based on the results of our Phase 2b trial in GAD, which showed an effect size of zero point eight one and one hundred microgram cohort, more than double that of standard treatments. As a reminder, a single dose of MM120 demonstrated strong clinical remission rates with forty eight percent of participants in the one hundred microgram cohort achieving remission at week twelve.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Our Phase three trials were thoughtfully designed to build on the strong foundation of these successful Phase 2b results, while also positioning MM120 ODT for real world implementation. A key advantage of our approach is the efficient single visit treatment model, which we believe aligns with existing reimbursement pathways and supports full session coverage. This approach not only streamlines delivery, but also reduces the administrative burden on sites where MN120 ODT may be delivered. Commercial opportunity for MN120 ODT is significant, supported by strong provider interest. Our market research shows that seventy eight percent of interventional psychiatric providers believe the availability of psychedelic therapies will transform the treatment landscape for GAD and MDD.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

We remain focused on advancing our pivotal trials with urgency. Across all three studies, Voyage and Panorama and GAD and EMERGE and MDD, enrollment trends remain strong with continued enthusiasm and engagement from clinical sites. As our pivotal trials continue to progress, we are actively laying the groundwork for commercial readiness. This includes building our organization and making strategic hires support both near term execution and long term growth, ensuring we're well positioned to capitalize on the opportunity ahead. We're incredibly excited about the leadership we've been able to bring to the company, including most recently our new CFO, Brandi Roberts, who joined our team last month.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Brandi brings over twenty five years in life sciences financial leadership experience and is uniquely positioned to lead our financial strategy during this critical growth phase. Most recently at long board pharmaceuticals, she successfully led the company through its IPO and multiple financings culminating in a $2,600,000,000 acquisition by Lundbeck. Her proven track record of scaling operations, supporting clinical development and managing strategic investor relations brings tremendous value to our organization on behalf of mind med. I'd like to welcome Brandy to our team. In summary, with three of our pivotal phase three trials, well, underway and top line readouts for each of these trials anticipated in 2026, we're anticipating a catalyst rich year as we progress MN-one 120.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

With that, I'll turn the call over to Dan for an update on our clinical programs.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

Thank you, Rob. As you mentioned, we continue to be very encouraged with the enrollment trends we are seeing for our pivotal phase three studies. Starting with our GAD studies, Voyage and Panorama, we remain on track and continue to expect top line readout from Voyage in the 2026 and Panorama in the 2020. As a reminder, each study consists of two parts. Part A, a twelve week randomized double blind placebo controlled parallel group period assessing the efficacy and safety of MM120 ODT versus placebo.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

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 ODT. In VOYAGE, we are targeting enrollment of approximately 200 participants who are being randomized one to one to receive MM120 ODT one hundred micrograms or placebo. While in PANORAMA we are targeting enrollment of approximately two fifty participants who are being randomized two to one to two to receive MM120 ODT one hundred micrograms fifty micrograms or placebo. We modeled these phase three studies after a successful phase 2b study of MM120 and GAD. The primary outcome measure is the Hamilton anxiety scale or HAM A, which was the outcome measure used in our phase 2b study and with the outcome measure used for the approval of currently available GAD therapies.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

In our phase three studies, the primary endpoint is the HAM A change from baseline to week twelve. In our phase 2b trial, we observed an almost eight point HAM A improvement for MM120 over placebo at week twelve. We designed the phase three trials to have 90% power to detect a five point improvement over placebo based on certain statistical assumptions. 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. 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.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

Just like our GAD program, our MDD program will consist of two pivotal clinical studies. Our first study EMERGE is comprised of two parts. Part A, a twelve week randomized double blind placebo controlled parallel group period 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 ODT subject to meeting eligibility requirements. In EMERGE, we are targeting enrollment of 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 is the change from baseline in Montgomery Asper Depression Rating Scale or MADRS at week six between the groups.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

We continue to anticipate top line data from EMERGE in the 2026. In conclusion, our MM120 clinical development program is well positioned for success. The FDA's breakthrough designation underscores the potential of this innovative therapy. We continue to have productive engagement with FDA and appreciate the division's collaboration and responsiveness. Our phase three studies are well aligned with FDA guidance.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

Further, these studies have been designed to demonstrate standalone drug effect. To increase our chance of clinical success, these trials closely mirror a positive phase 2b study, which demonstrated substantial improvement over current therapies. With that, I'm happy to introduce Brandi to discuss our second quarter financial results. Brandi?

[Brandi Roberts, CFO at Mind Medicine (MindMed)]

Thanks, Dan, and thanks, Rob, for the warm welcome and introduction. I'm thrilled to be here with you today having joined MindMed at such an exciting time. The opportunity to work with an experienced and passionate management team, especially with their deep drug development expertise, a huge draw. Additionally, the chance to make a meaningful impact on mental health, an area with significant unmet need, really resonated with me. I'm excited to bring my experience to support our path to commercialization, which includes potential billion dollar market opportunities.

[Brandi Roberts, CFO at Mind Medicine (MindMed)]

I will also be focused on enhancing our investor communications and leading our financing strategy to ensure we're well capitalized to execute our priorities and create long term shareholder value. As Rob and Dan mentioned, I'm also pleased that we are conducting our phase three studies with remarkable efficiency, which is a testament to the thoughtful and strategic approach taken by our team. From a financial perspective, I want to underscore the significance of this efficiency. By optimizing our study designs and regulatory pathway, we are not only maximizing the potential for clinical success, but also ensuring the thoughtful use of our resources. This approach enables us to allocate capital in a way that drives value for our shareholders.

[Brandi Roberts, CFO at Mind Medicine (MindMed)]

I'm confident that our strategic and fiscally responsible approach will enable us to deliver sustainable growth for years to come. Now to review our financial results for the quarter ended 06/30/2025. We ended the quarter with cash, cash equivalents, and investments totaling $237,900,000 Just a reminder that when looking at our balance sheet, this total comes from three line items: cash and cash equivalents, short term investments, and long term investments. Based on our current operating plan and anticipated R and D milestones, we believe that our cash, cash equivalents, and investments as of 06/30/2025, will be sufficient to fund our operations into 2027 and at least twelve months beyond our first Phase III top line data readout for MM120, ODT, and GAD. Research and development expenses were $29,800,000 for the 2025 compared to $14,600,000 for the 2024, an increase of $15,200,000 The net increase was primarily related to increases of $14,500,000 related to our MM120 ODT program, dollars 1,500,000.0 in internal personnel costs as a result of increased headcount, and $200,000 related to preclinical activities, offset by a decrease of $1,000,000 in MM402 program expenses based on the timing of studies.

[Brandi Roberts, CFO at Mind Medicine (MindMed)]

We anticipate that our R and D expenses will continue to ramp up for the remainder of 2025 due to the costs associated with running three pivotal Phase III studies. General and administrative expenses were $11,100,000 for the 2025 compared to $9,800,000 for the 2024, an increase of $1,300,000 This increase was primarily related to personnel costs as a result of increased headcount to support corporate growth and prepare for commercialization. With that, I'll now turn it back over to Rob for our closing remarks.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Thanks, Brandi, and it's great to have you on board. In closing, 2025 is a critical year of execution, and I am extremely proud of how our team is delivering. Our three ongoing pivotal trials remain on track with strong clinical site engagement underscoring both the significant unmet need and the transformative potential of IMMUN-one hundred twenty ODT. We've built a high caliber leadership team with the expertise to execute our strategy and drive long term shareholder value. With 2026 expected to be a catalyst rich year, we remain confident in our ability to deliver on our mission of bringing a differentiated best in class novel treatment option to the million of patients who desperately need it. Thank you for joining us on the call today. You and I are now happy to answer your questions.

[Operator]

Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. Please standby while we compile the Q and A roster.

[Operator]

Our first question comes from the line of Mark Goodman with Lee Leary. The floor is yours.

[Marc Goodman, Senior MD - Neuroscience at Leerink Partners]

Hey. How are you guys? Bob, there's been a lot of data that's come out, by other psychedelic companies.

[Marc Goodman, Senior MD - Neuroscience at Leerink Partners]

I was just curious your thoughts on what you've seen so far and and how you think about, you know, that just relative to your programs.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yes, thanks so much for the question, Mark. Yeah, it's an exciting time for the field, and certainly as we get into 2026, and especially exciting time, we have the three pivotal readouts from GAD and MDD next year. One of the things we've been really excited about with our data from phase two, and obviously, it would be great to see replicate as we progress is the magnitude and the significance of the change that we've been able to demonstrate that is also durable for many months. And that's something we haven't yet seen from any other drug in the class or any other program so far. And so we've been, I think as we've engaged with physicians and payers and everyone, we've been particularly excited by the reception of those data and by the promise of a drug that has such a significant impact and such a durable impact on patients.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

And one that we, again, hope to continue to show strong evidence of efficacy and safety in the pivotal study. So they again excited for the field excited for our programs, especially as we get into phase three readouts next year.

[Operator]

Thank you for your question. One moment, please. Our next question comes from Pete Stavonopoulos from Cantor. The floor is yours.

[Pete Stavropoulos, Director - Biotech Equity Research at Cantor Fitzgerald]

Yeah. Hi, Rob and team. Congratulations on the progress. Brandy, nice to hear you and congratulations on your new position. For the VOYAGER and PANORAMA studies, can you just discuss the powering assumptions and the assumed dropout rate or study discontinuation rates?

[Pete Stavropoulos, Director - Biotech Equity Research at Cantor Fitzgerald]

And for the phase 2b, I believe there was a twenty five percent dropout rate. Can you expand on steps you've taken to drive better retention? And how much of that is attributed to the OLE design or higher probability of active treatment?

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yeah, thanks so much for the question, Pete. I'll cover the first part of that and then turn it over to Dan. The power assumptions are consistent across both Voyage and Panorama, which is we assumed 90% power to detect a five point difference between those groups. And it's important to note that while a power analysis is incredibly important, we also look at the minimum clinical difference that would need to be observed to get a statistically positive outcome. That by nature of the math is almost always lower than the powering assumptions.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

And so, while we're powered for a five point delta at 90%, that assumes a 10 unit standard deviation, a 15% dropout rate. We certainly would anticipate that, we wouldn't necessarily need to see a five point difference between the groups to get a statistically positive outcome. I'll turn it over to Dan and talk about, patient retention and how we're thinking about that in phase three.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

Yeah, thanks Rob and thanks Pete. I think you actually identified exactly the right features of the study, that are going to control that dropout rate And obviously, having more folks in an active treatment arm yields less dropout. But you identified, think, we look at is the absolute key feature, particularly for folks who aren't feeling better after their first blinded dose, is that knowing if they hang in there for that full twelve week observation period that we will provide the opportunity for open label treatment is a real encouragement for people to stick around for the entire double blind period. So we're optimistic about that dropout rate and optimistic about the ability to provide those open label treatments during the extension phase.

[Pete Stavropoulos, Director - Biotech Equity Research at Cantor Fitzgerald]

Thank you. One more question, if you don't mind. Guess assuming positive phase three data and MM120 is proved, what do you expect from real world usage commercialization? And what I'm sort of asking is how are the phase threes and the OLE designed to sort of generate real world treatment patterns?

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yeah, I'll turn that over to Dan as well.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

Yeah, that's another really exciting part of the extension phase is that, as we've said before, the extension phase gets us the ability to watch long term, so over that full year of observation and even beyond, what the effect of the double blind treatment is. For folks who do progress to the extension phase and then are able to get open label treatment, we intentionally set a limit of four treatments per year, thinking that that is more than folks would need, because we don't want to right limit those data. So we want to actually get at exactly, as you say, real world treatment patterns. So given the availability of those open label with a threshold that's below the threshold for enrollment, the threshold set for retreatment being right at the threshold for mild to medium illness. And what we think we'll see in the extension phase is very much what we expect to see in the real world.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

So that given that threshold for treatment, given the fact that it's open label, given the fact that we have the clinical trial sites closely engaged with patients, we think that we'll be able to establish the range of treatment patterns that are to be anticipated in real world treatment, be able to describe those as we come out of that study and the results of the extension phase.

[Pete Stavropoulos, Director - Biotech Equity Research at Cantor Fitzgerald]

Alright. Thank you. Helpful, and, congratulations once again.

[Operator]

Thank you for your question. Our next question comes from Brian Abrahams with RBC Capital Markets. The floor is yours.

[Brian Abrahams, MD & Co-Head - Biotechnology Research at RBC Capital Markets]

Hi, there. Good afternoon. Thanks for taking my questions. Congrats on the continued progress and congrats to Brandy on the role. Two questions for me.

[Brian Abrahams, MD & Co-Head - Biotechnology Research at RBC Capital Markets]

Guess, first, just kind of thinking about the enrollment trends for the VOYAGE study, sounds like those are going quite well. Just sort of wondering if you're kind of at the point where more than 50% of the trial has enrolled and interim analysis would be taken to determine whether you'd expand sample sizes? And then secondly, I'm curious sort of the degree of commercial preparatory work that you might start to do at this point and what your sense is from just operationally the studies, the execution of the studies, what the key areas that you're going to need to focus on or want to focus on first within the launch with respect to site education and awareness? Thanks.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yeah, thanks so much, Brian. To your first question, we have not given exact numerical updates on enrollment. As a reminder to everyone, the interim analysis would be conducted after about half of the patients have completed twelve weeks of the study, but we've yet to give precise update on numbers and certainly are excited to get through that milestone and get through to data. In terms of the second question, I'll turn it over to Matt Wiley as well, our Chief Commercial Officer to answer.

[Matt Wiley, Chief Commercial Officer at Mind Medicine (MindMed)]

Yeah, thanks for the question, Brian. And so, as we have spent the last several months working through a number of key strategic elements of the plan, first and foremost, the market access, we want to understand the different pathways to reimbursement. We're anchoring our market access strategy into practice economics. We want to make sure that clinicians not only have access to the drug, but it's not a loss making opportunity for them. So we've spent a lot of time examining the industry progress, the different pathways that are used in interventional psychiatry.

[Matt Wiley, Chief Commercial Officer at Mind Medicine (MindMed)]

We've also spent quite a bit of time breaking down the targeting methodology for GAD. We want to ensure that we're targeting those facilities out of the gate that have the highest volume of GAD patients, those that are probably most appropriate for NM120 right at launch. So we've gone through that process. We've built out a targeting apparatus that we think is pretty tight. And so now we know where our patients are and where the clinicians who manage them are as well.

[Matt Wiley, Chief Commercial Officer at Mind Medicine (MindMed)]

So that's where we've been focused. And over the last month or two, we've we've really zeroed in on our product positioning, and we're working on our messaging platforms and market conditioning efforts as well. So as we as we move through our process over the next several months, we'll have more to update on our pre pre market conditioning activities and also more on our market entry strategy.

[Brian Abrahams, MD & Co-Head - Biotechnology Research at RBC Capital Markets]

It makes a lot of sense. Thanks so much.

[Operator]

Thank you for your questions. Our next question comes from Al Rubella at H. C. Wainwright. The floor is yours.

[Operator]

Arabella, the floor is yours. We're just gonna continue on. One moment, please. Our next question comes from Jay Olson of Oppenheimer. The floor is yours.

[Jay Olson, MD & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.]

Hey guys, congrats on the progress and thanks for taking the questions. Can you just talk about your expectations for the durability of efficacy beyond twelve weeks and when expect us to see that longer term efficacy data?

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yes, thanks so much for the question, Jay. Phase II and the highest quality data we have to go on, we didn't continue observing patients formally in a structured manner beyond twelve weeks. And so we certainly also didn't see a trend where there was a loss of separation or a trend back towards baseline for patients who received one hundred micrograms. And so if those trends were to replicate, they would certainly suggest that durability could last beyond a twelve weeks period. We do have some evidence from, prior studies from collaborators who have conducted prior studies to suggest that, in anxiety disorders, the effects can be quite long lasting and in the event, and not uniformly distributed either, of course, where sometimes a second administration can have an even further prolonged extension of that durability.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

So be premature to to make assumptions about exactly where those data would fall out, but, we're certainly very eager to to get to those data as it progress in in the studies. We haven't we haven't given the specific guidance around when those data will be made available, but, again, we would certainly be very, very excited to get those data and share those as they do become available.

[Jay Olson, MD & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.]

Okay. Great. Thank you. And if maybe I could ask one follow-up. Assuming that your Phase III study results to confirm the initial observations from Phase II, what would you expect the dosing interval to be in terms of number of doses per year in real world setting?

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yeah, I'll turn that one over to Dan.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

Yeah, it's a great question, Jay. And obviously, we're working in a somewhat speculative space there. But as Rob pointed out, we did not see loss of efficacy in folks who had a strong response to a single dose in phase two, and we expect that will be the case for for many folks, in the phase three as well and, of course, in the real world. So what we anticipate for the use of this drug is not so much predictive intervals where we can pre specify for any individual, though you're likely to need to take this every six months or every year. But we expect that different people will different response patterns.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

And those response patterns will range from the best possible response, someone who takes a dose and goes into remission and has a sustained period of remission such that if they ever were to need a subsequent dose, we could almost think of that as a new development of the disorder, all the way through to on the other end folks who do need some sort of regular redosing. Now given that we were seeing efficacy out to twelve weeks in phase two and that very likely proceeded longer, that interval could be six months, it could be a year, it could be three months in some cases. But but unlike daily drugs today or or unlike other drugs that have a requirement for a prespecified interval because they lose efficacy either when off drug or shortly after taking drug, We think real world treatment patterns will be will be quite a bit more variable with our drug.

[Jay Olson, MD & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.]

Great. Super helpful. Thanks for taking the questions.

[Operator]

Thank you for your question. Our next question comes from Elias Kajouras from Canaccord. The floor is yours.

[Elias Georgas, Equity Research Associate - Biotechnology at Canaccord Genuity Group]

Hi. This is Elias on for Sumant. Thank you for taking the question. I was just thinking about with your discussions with the FDA, have you can you provide any color on what maybe the design of the second phase three MDD study would look like? Are you gonna be required to use the fifty microgram dose as you had to do in your GAD studies as well?

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yeah, thanks for the question. We haven't yet disclosed the design of that study, and we've continued to have a lot of progress with both the GAD and MDD programs. You know, obviously, there's been a historical discussion around expectancy and functional and blinding and different approaches to try to to mitigate that in these studies. You know, we we always refer back to the reality that every drug in psychiatry deals with functional and blinding. Just so happens that this is based on the qualitative nature, kind of the first time that programs are widely being asked to to go, an extra mile to to try to control for and and look at this.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

But, we certainly see some utility in in, inclusion of a dose such as that, which is, of course, why we, included it in our second GAD study. But, you know, when the time comes and we're in position we were able to share the study design, we'll certainly, also wanna be be sharing and and talking through rationale for any of the choices we've made in terms of how the the second study is designed and how we're executing it.

[Elias Georgas, Equity Research Associate - Biotechnology at Canaccord Genuity Group]

Awesome. Thank you.

[Operator]

Thank you for your question. Our next question comes from Patrick Trujillo from H. C. Wainwright. The floor is yours.

[Luis Santos, Senior Equity Research Associate - Healthcare & Biotechnology at H.C. Wainwright & Co., LLC]

Hello, everyone. This is Luis in for Patrick. Thank you so much for taking our questions and welcome, Brandy, to the team. I would like to ask a little bit about the strategic collaborations that you've already established with interventional psychiatry treatment centers. You mentioned that you have grown your partnerships and that your payer discussions and reimbursement strategy is aligned along with the deployments of your treatments in this network of centers.

[Luis Santos, Senior Equity Research Associate - Healthcare & Biotechnology at H.C. Wainwright & Co., LLC]

Can you give any updates with respect to the services, specifically monitoring time and time in the clinic? Thank you so much.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yes, thanks for the question. Know, one of the elements of our phase three program is to, you know, as we approach development is to really try to have a pre specified and a thoughtful approach to understand all the dynamics of treatment, whether it be real world like redosing in the extension phase of the study or, the dynamics of a single administration of the drug. And so we are monitoring that and have a structured way of doing so that we've talked through and presented with FDA in prior discussions. And so defining that timeline and what it is for individual patients and on average and the various summary statistics you can come up with that could be suggestive of how long patients need to stay in a clinic. It's something we're very focused on and so they're thinking about as we analyze the data from the phase three study. So, as we engage in that and have additional clarity we can offer, we can certainly be in a position to share that at some point in the future.

[Luis Santos, Senior Equity Research Associate - Healthcare & Biotechnology at H.C. Wainwright & Co., LLC]

And reimbursement, any updates on how it would fit the current Medicare plans?

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yeah, it's premature to talk specifically about reimbursement. We have continued to have strong engagement with payers and feel confident in our approach going forward, but certainly premature today to say anything precise around the dollars for reimbursement.

[Luis Santos, Senior Equity Research Associate - Healthcare & Biotechnology at H.C. Wainwright & Co., LLC]

Great, thank you and congratulations on your comments.

[Operator]

Thank you for your question. Our next question comes from Chris Chen from Baird. The floor is yours.

[Christopher Chen, Research Analyst - Biotechnology at Baird]

Thanks for taking my question. I just had one on enrollment. I know you've previously talked about the synergies between, you know, the GAD trials in EMERGE such that if a patient is screened for GAD, but turns out, you know, they're diagnosed with MDD, they can roll into the MDD trial. Can you just confirm that? And if so, can you comment on whether some of the sites are seeing this happening?

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yes, thanks so much for the question, Chris. Certainly was our intent in designing the studies and running them in parallel and making sure that we have as much efficiency in the conduct across both of the indications. And, you know, as the studies have progressed, we we've seen that play out exactly as as we had hoped where we're we're getting, you know, nice retention. And and for patients who do have a depressive episode, we have an easy path to move them into a depression program if that ultimately emerges in the screening process.

[Christopher Chen, Research Analyst - Biotechnology at Baird]

Great. Then I did have one more follow-up. Just in terms of the treatment visit itself, can you kind of add a little more color? Is there a healthcare provider in the room the whole time during that dosing? And if so, what guardrails are in place to avoid kind of crossing that line between providing psychotherapy versus just assisting the patient? Thank you.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yes, thanks. I'll turn it over to Dan to answer.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

Yeah, thanks, Chris. It's a great question. And there is a provider in the room. There's also always another person watching the conduct in the room. And we're very explicit on what folks are allowed to do in that room and where their focus needs to be.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

And their focus is on assistance. And for the most part, engaging with the participant. Most of time, participants were in the room. They're engaging with their own internal process. And the monitor is doing just that monitoring.

[Daniel Karlin, Chief Medical Officer at Mind Medicine (MindMed)]

So through that process of training and monitoring of the conduct in the room, we stay on the side of monitoring and away from psychotherapy.

[Christopher Chen, Research Analyst - Biotechnology at Baird]

Great. Thank you. And congrats again on the progress.

[Operator]

Thank you for your question. Our next question comes from Rudy Li from Sheridan. The floor is yours.

[Rudy Li, Senior Research Analyst at Chardan Capital Markets]

Hi, thanks for taking my question. Congrats on progress, and welcome to the team, Randy. So, it's good to hear that the timeline for the twelve week primary data was confirmed. Could you remind us what additional data are required by the FDA, and what will be the rate limiting steps for filing NDA for GAD? Thanks.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yes, thanks so much for the question, Rudy. Certainly, studies have been designed such that the primary endpoints at twelve weeks and the double blind placebo controlled, parallel group, portion of the study part a of of both the VOYAGE and PANORAMA are studies we expect to to have completed, before we potentially move forward with an NDA. So, you know, all eyes are on on that top top line readout, which would drive the path forward from there.

[Rudy Li, Senior Research Analyst at Chardan Capital Markets]

Cool. I I do have a quick follow-up question because, you mentioned that you are exploring, additional programs, including potentially, like, an external collaboration to expand the pipelines. Can you provide additional color on your overall strategy? Like, what kind of product or indication that you're looking at?

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yes, it's a great question. We're incredibly excited about all that we have in our pipeline. Three pivotal studies ongoing, of course, a lot of focus gets put on those studies, and certainly, m one twenty is an asset. It's one of the best known drugs in the entire class and one so far, it seems as, you know, provided some some really, standout activity in our phase two b program. But there is, certainly much more that our team is is working on and that we're capable of of bringing forward into the future.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

And, as we look at the landscape, and we feel incredibly confident in the organization we've built and the team's ability to execute and and the scope of what we think we can accomplish, long term to to really drive meaningful change for patients and and meaningful shareholder value is is something that we are always focused on. So, certainly, stay tuned because we're excited about 01/2020. We're excited about everything else we're doing as well and excited to share that as time progresses.

[Rudy Li, Senior Research Analyst at Chardan Capital Markets]

Cool. Very helpful. Thank you.

[Operator]

Thank you for that question. Our next question comes from Michael Okenwitch from Maxim Group. The floor is yours.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

Hey guys, thanks so much for taking my questions today. I guess just to kick things off, I'd like to see if you could talk a little bit about your IP position and strategy and how important that this might be in the context of any discussions with potential partners or pharma. And I bring this up now because I'm sure you saw the report from a few days ago regarding Gilgamesh and AbbVie.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yeah, thanks for the question, Michael. Yeah, we're really confident in our IP strategy and with the patents we've been granted and continue to file. And the team we've been working with for many years to you know, advance our approach and make sure that we're filing applications on real meaningful innovations and delivering a product that is targeted to be optimized for patients, and that is also something we can protect and that continues to play out and continue to progress with our IP strategy and filing. So, we feel very comfortable with that position and also comfortable that anyone looking at would feel similarly.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

All right, thank you. And then we have seen a lot of enthusiasm behind psychedelics come out of FDA. Even earlier today, COMPASS mentioned that it's exploring opportunities for an accelerated pathway. Is this something that could make sense for MindMed, or is it a bit of a different situation with your two phase three readouts being so close together, and generalized anxiety versus treatment resistant depression?

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Well, we have breakthrough therapy designation, which already offers some avenues for, of course, greater engagement, but also opportunities for acceleration. It's always something we're looking to do is be as efficient and execute and deliver on time and and then expedite the the path from from there. So, we're certainly exploring all avenues and all options to to do that. You know, the the timing of of the readouts, we also feel it's important to provide robust evidence and a comprehensive program that would stand up to any degree of scrutiny at any point in time under any review timelines. So eager to get to our readouts next year and having both pivotal readouts in the same calendar year gives us an opportunity to be thinking the strongest possible position with the GAD program.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

All right, thank you very much and congrats on all the progress you're making.

[Operator]

Thank you. Thank you for your question. Our last question comes from Sumant Kulkami from Canaccord. The floor is yours.

[Sumant Kulkarni, Managing Director at Canaccord Genuity Group]

Good afternoon. Thanks for taking my question. I'd like to welcome Brandy with a question. How are you thinking about the appropriateness of the financial resources that are available given so many pivotal trials are running right now at nightmare?

[Brandi Roberts, CFO at Mind Medicine (MindMed)]

Yeah, thanks so much, Sumant. It's great to have joined the team. This is such an exciting time for the company. I think when you look at that, you know, I'm really impressed with how we've put our phase threes together so that there are efficiencies built in there, like we've just talked about, with being able to use sites that are enrolling in our GAD and our MDD studies. So, I think that that's really helpful.

[Brandi Roberts, CFO at Mind Medicine (MindMed)]

I also think we've been really prudent as we've grown, and we will continue to do that and really analyzing when we need to add resources and making sure that those are all responsible in terms of the timelines that we're adding people and adding activities to it. So, I think that's been really our focus. I will say that we really do like to make sure that we have flexibility as well. This quarter, we did amend our debt agreement with K2, and so that provides us with additional flexibility if we need to, and there are things that we think would enhance our programs. But as we stated in the call, we feel very comfortable with our cash position and guidance getting into twenty twenty seven and twelve months post our top line GAD readout.

[Brandi Roberts, CFO at Mind Medicine (MindMed)]

And so, feel like we're in a good position to execute and are looking forward to next year.

[Sumant Kulkarni, Managing Director at Canaccord Genuity Group]

I'll squeeze a commercial question in. Nowadays, investors seem to be, kind of jumping to a conclusion on the the perceived fact that less time in the clinic is potentially always better when it comes to psychedelic therapeutics. How are you thinking about your one twenty in the context of that kind of thinking?

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

Yeah. Thanks, Sumant. I'll take this one. You know, we remain incredibly convicted about both the activity and the dynamics of MN120 in relation to both approved products and the potential there, but also in the broader field of drugs with similar mechanisms of action. I think tends to be an easy assumption to fall back on what is already being done.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

But like any real meaningful innovation, those precedents and assumptions have you know, only can only serve anyone so far. And so, we, again, remain in all of our discussions and all of our planning. And as we think about the landscape, we're incredibly encouraged by those discussions and by the dynamics of MM120. I think it's, there's some other dynamics as we progress and share more about commercial strategy. It can also highlight some dynamics, but, certainly there's the SPRAVATO model is one that exists.

[Robert Barrow, CEO & Board Director at Mind Medicine (MindMed)]

It emerged in response to the availability of a treatment, which, in SPRAVATTA that is, which we're now, again, if phase two data or something we can replicate, we feel really confident about being able to stand out in the field in terms of the kind of magnitude and durability of response that we've seen so far. So as we think about every dynamic from that practice economics, as Matt alluded to earlier, to patient and provider preferences and the desire to make sure that if a patient is gonna have such a durable effect that their providers have the opportunity to navigate that with them and really support them throughout their overall care journey, not just the administration of our product. Again, we we feel really, really good about the dynamics of of our program and our our product and are eager to to show the world how that plays out over long term.

[Sumant Kulkarni, Managing Director at Canaccord Genuity Group]

That's very helpful. Thanks.

[Operator]

Thank you for that question. There are no further questions. So this does conclude the question and answer session. At this time, I'd like to thank you for your participation in today's conference. This does conclude the program and you may now disconnect.

Participants

Executives

• Stephanie Fagan, Chief Corporate Affairs Officer
• Robert Barrow, CEO & Board Director
• Daniel Karlin, Chief Medical Officer
• Brandi Roberts, CFO
• Matt Wiley, Chief Commercial Officer

Analysts

• Marc Goodman, Senior MD - Neuroscience at Leerink Partners
• Pete Stavropoulos, Director - Biotech Equity Research at Cantor Fitzgerald
• Brian Abrahams, MD & Co-Head - Biotechnology Research at RBC Capital Markets
• Jay Olson, MD & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.
• Elias Georgas, Equity Research Associate - Biotechnology at Canaccord Genuity Group
• Luis Santos, Senior Equity Research Associate - Healthcare & Biotechnology at H.C. Wainwright & Co., LLC
• Christopher Chen, Research Analyst - Biotechnology at Baird
• Rudy Li, Senior Research Analyst at Chardan Capital Markets
• Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group
• Sumant Kulkarni, Managing Director at Canaccord Genuity Group