Good morning, and welcome to the Mind Medicine Second Quarter 2024 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 and media section of MindMed's website at mindmed.co, and a recording will be available after the call. I would now like to introduce Rob Barrow, CEO of MindMed. Please go ahead.

Thank you, and good morning, everyone. Welcome to our second quarter 2024 financial results and corporate update conference call. Today, we will be sharing highlights from the second quarter along with the significant progress we've made with plans for our Phase 3 program in Generalized Anxiety Disorder, or GAD. Additionally, I'm excited to share further specifics about the expansion of our R&D program for MM120 into Major Depressive Disorder, or MDD, both of which are further supported by the financing we announced last week. The press release reporting our financial results and the presentation we will be using on today's call are both available in the investors and media section of our website, and our quarterly report on Form 10-Q for the quarter ended June 30, 2024 was filed this morning with the Securities and Exchange Commission. During today's call and outlined on Slide 2, 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 our 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, including our annual report on Form 10-K and our Form 10-Q filed today. Forward-looking statements are based on the assumptions, opinions and estimates of management of 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, 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,…

Thank you, Rob. Turning to Slide 10 . We believe MM120 has the potential to address large unmet needs in major brain health disorders, based on the compelling results we shared from our Phase 2 trial for MM120 in GAD. In this trial, we observed a rapid onset of effect with a 1.8 point reduction in clinical global impression severity or CGI-S, within 24 hours in participants treated with 100 micrograms, which was highly statistically significant, with a p-value less than 0.0001. The response was durable, showing a 21.9 point improvement in the Hamilton Anxiety Scale, or HAM-A, at week 12 in participants treated with 100 micrograms. This further improvement from week four indicates potential long lasting effects. Importantly, the magnitude of response in participants given MM120 was such that 48% of participants who received from 100 micrograms remained in remission at week 12. This high remission rate is particularly encouraging for a chronic condition like GAD. The treatment also demonstrated a favorable safety and tolerability profile, with most adverse events limited to the dosing day, which is crucial for patient acceptance and adherence. Finally, these results were achieved with no additional therapy, highlighting the potential for MM120 as a standalone treatment for GAD. These outcomes support our Phase 3 program in GAD. I'll now discuss our Phase 3 development plan for MM120 in GAD on Slide 11. As Rob mentioned, in June, we completed a highly collaborative and constructive End-of-Phase 2 meeting with FDA, reaching alignment on our Phase 3 pivotal trials. This program will consist of two pivotal clinical trials, the Voyage study and the Panorama study. Each trial consists of two parts. Part A will be a 12 week, randomized, double-blind, placebo controlled, parallel group study assessing the efficacy and safety of MM120 ODT versus placebo. Part…

Thanks Dan. I'm very excited about the Phase 3 development programs that you just shared, as I believe they stand to make a significant impact in the field of psychiatry. I've been personally thrilled with the results I've seen so far from MindMed's MM120 development program, the GAD Phase 2b results are truly impressive, with MM120 exhibiting rapid and robust efficacy sustained 12 weeks after a single dose. Equally impressive is the change in MADRS score from baseline to week 12 in the Phase 2b GAD trial, participants showing improvement in comorbid depressive symptoms. For people suffering from GAD, including with comorbid depression, these trials offer a beacon of hope, and I've seen firsthand how debilitating both conditions are severely impacting quality of life. Given that current standards of care are falling short of meeting our patient’s needs, it is vital that we develop and bring to market new, effective treatment options. Three things stand out about the Phase 3 development programs that are important from an investigator and physician perspective that I want to share with you today. First, the Phase 3 programs are operationally efficient. Second, they enhance our ability to recruit patients. And third, the Phase 2 and 3 trials are similar in design, suggesting a high degree of read through as possible. All of this will make our execution of these trials more seamless. I'll break all three attributes down further. From an operational perspective, the key design elements of both Phase 3 programs make them efficient to run. This operational ease is crucial as it allows my team to manage the trials effectively while maintaining scientific rigor. In the GAD trials, reducing treatment session monitoring from 12 to 8 hours is an example of this, making delivery of MM120 more practically feasible, mirroring how I…

Thank you, Dr. Robison. We're excited to get started and grateful to be aligned on our pivotal programs with clinicians like you. I'll now turn to our financial results for the quarter ended June 30, 2024, which are highlighted on Slide 15. As of June 30, 2024, the company had cash and cash equivalents totaling $243.1 million, compared to $99.7 million as of December 31, 2023. We believe that our cash and cash equivalents as of June 30, 2024, combined with the proceeds from our recently closed financing will be sufficient to fund our operations into 2027. Based on our current operating plan and anticipated R&D milestones, we expect this cash runway to extend at least 12 months beyond the top line data readout for our first Phase 3 trial of MM120 in GAD. For the six months ended June 30, 2024, net cash used in operating activities was $36.6 million, compared to $27.2 million for the same period in 2023. Research and development expenses were $14.7 million for the quarter ended June 30, 2024, compared to $14.8 million for the same period in 2023, representing a decrease of $0.1 million. The decrease is primarily due to decreases of $0.5 million in expenses related to our MM120 GAD program and a decrease of $2 million in expenses related to preclinical activities, partially offset by an increase of $1 million in internal personnel costs as a result of increasing research and development capacity and an increase of $1.4 million in expenses related to our MM402 program. We do anticipate R&D expenses to ramp up in the second half of this year and in 2025 as we get the Phase 3 studies in GAD and MDD up and running. General and administrative expenses were $9.8 million for the quarter ended June 30,…

Thank you. [Operator Instructions] Our first question comes from the line of Charles Duncan with Cantor. Your line is now open.

Hi. This is Elaine Kim on for Charles. Thank you for taking our questions. This is a two-parter. For the first question, is the open label 100 microgram dose to help maintain response or remission rates versus having patients continue the 50 microgram dose in the 40 week follow-up? And for my second question, is for reduction of the treatment session duration to 8 hours from 12 hours, what information enabled this decision to be agreed by the FDA and what requirements for patient care following the 8 hour treatment session, what requirements will be implemented? Thank you.

Yeah. Thanks so much, Elaine. To the first question, so when we're designing the Phase 3 program, continuing patients on -- I think two things are worth pointing out with the open label Part B portion of the study, I should say, the extension Part B of the study versus that -- would be really thoughtful about how we analyze and think about the extension phase of the study because until patients actually receive open label treatment in that Part B of the study, they remained in a blinded status, until someone has actually received open label drug, while it's an extension study with open label opportunities for treatment they haven't actually received anything which is unusual here. It certainly wouldn't be the case -- in the case of open label extension of a daily medicine. The selection of 100 micrograms is because it is the clinical dose of interest. Relying on our Phase 2b results, we believe 100 microgram dose is our go-forward dose and our modeling from the Phase 2b results in the MCP-Mod analysis we conducted there suggests that it is the dose to take forward and the efficacious dose we should be studying, whereas the 50 microgram dose, is there simply as a functional mask is an additional control to aid in addressing the concept of functional unblinding, that's the rationale. We're not interested in 50-micogram as a clinical dose to take forward or to be submitted at this time. The intent is to characterize what happens in a more real world like setting or patients who have the opportunity for retreatment upon the reemergence or the continued in efficacy after the initial phase of the study. In terms of Part B of your question or the second part of your question, we presented data. So…

That's very helpful. Thank you so much for taking all of our questions.

Thank you. Our next question comes from the line of Brian Abrahams with RBC Capital Markets. Your line is now open.

Hi. Good morning. Thanks for taking my question, and really appreciate all the detail on the trial designs. Two questions from me. I guess, first off, can you elaborate on the degree of follow-up and retreatment data that is going -- that you think will be required prior to filing and potential approval in GAD. Is there a bar for the durability that you need to demonstrate beyond 12 weeks and/or a certain proportion of patients who will need to be retreated? And then I had a follow up.

Yes. Thanks so much, Brian. So our expectation is that because we are limited in the extent of randomized control period of studies, we run to pragmatic and ethical issues if we keep patients with severe anxiety on no background treatment after a single placebo intervention, for instance, beyond 12 weeks. So we run into a sort of limitation on how long we can do randomized controlled parallel group study. So in that -- because of that, we've aligned around a 12 week duration. And even FDA's guidance talks about a 12 week duration to establish the response. We believe those data are sufficient to demonstrate the durability and that in terms of initial application, we would use the extension phase in the study to inform the characteristics of dynamics of retreatment that would be informative in labeling, but we certainly are focused on our primary endpoint in our End-of-Phase 2 meeting really had good discussion with the agency, and we believe reached alignment around that 12 week primary endpoint being the most important outcome of the study to demonstrate that durability of response after a single treatment.

Okay. Got it. And then, how much dose dependence will you need to demonstrate between 50 and 100 micrograms in order to address the potential regulatory questions about functional unblinding, do you need to show a statistical separation between those two arms or just a trend? Thanks, I'll hop back in the queue.

Yeah. This is a great and a really interesting question and one that we have both thought about extensively and internally as we designed our Phase 3 program and discussed extensively with the agency. Our view is that the 50 microgram control is simply there as a control. It is not a statistical interest to us. Our Phase 2 study was intentionally designed to establish dose response. That was the primary analysis of the Phase 2 study, which we did with a high degree of statistical significance. And as part of the MCP-Mod analysis, we come away with characterization of what we believe is the minimum clinically effective dose to achieve kind of clinical outcomes we're pursuing. That, coupled with the reality that in our Phase 2 study, we saw a high degree of functional unblinding or unmasking across all active doses of drug, but that only the two high doses achieved a clinical response. Our belief is that 100 microgram is the go-forward dose and that any other dose groups we include are not there to reestablish the dose response. They're there to try to confound patient expectancy, there's been a good degree of confusion, I think in the field about what the methodological things like an intermediate control group are there to do. And there's been a lot of confusion about the differences and similarities between expectancy bias functional and blinding in these studies. Our view is that 50 micrograms is a dose that overlaps with 100 microgram dose of clinical interest in terms of its perceptual effect, such that patients coming into the study would -- if the story we're ultimately trying to develop here is that when a patient comes into the study, with obviously a degree of expectancy because patients only enroll in clinical trials…

That's really helpful. Thanks so much.

Thank you. Our next question comes from the line of Rudy Li with Leerink Partners. Your line is now open.

Hi. Thanks for taking my question. Congrats on the progress. Regarding the regulatory pathway in GAD, did you confirm with the FDA that the Phase 2b can be used as one of the pivotal trials or do you still means both Phase 3 trials to file NDA? And quickly, just a follow-up to Brian's question. With the first Phase 3 GAD starting in the second half of the year, what will be the rate limiting step for filing considering the 40-week of label retention trial? Thanks.

Yeah. Thanks so much, Rudy. In terms of regulatory pathway, the Phase 2b study that we conducted is not a pivotal study. We intend to file with two Phase 3 studies which are planned, the Voyage and Panorama studies. Secondly, in terms of the rate limiting, of course, we have come away with end of Phase 2 with a high degree of alignment. Always there's the caveat that many of the final decisions about what is going to be required for NDA are reserved for discussions at a pre-NDA meeting. But our belief at this stage is that the completion of the Part A of Voyage and Panorama studies is the rate limiting factor to demonstrate two well-controlled studies that demonstrate the safety and efficacy of the drug. And that while we have an ongoing clinical pharmacology program, we will have Part B of the study that will be informative in that process, we believe a data cut from Part B of our Phase 3 studies would be adequate to enable submission.

Got it. Very helpful. Thanks.

Thank you. Our next question comes from the line of Francois Brisebois with Oppenheimer. Your line is now open.

Hi. This is Dan on for Frank. Thanks for taking our questions. I guess related to some of the questions that have been going on. Could you talk a little bit more about the End-of-Phase 2 meeting, especially considering the Lykos AdCom, whether there were any issues or concerns that were raised during the meeting? And thanks for all the color around the strategies that you've taken, but was there any surprises during the meeting. Anything you want to add there?

Yes. Thanks so much for the question, Dan. In Phase 2, we got fortunate in the sequencing of the regulatory events that have happened this year. So we had our end of Phase 2 meeting very shortly after the Lykos Advisory Committee, which we thought it was a great benefit because it allowed us to integrate the thinking and feedback and obviously the public conversation from the Lykos AdCom into our discussions with the agency and something that we greatly valued to us to be able to learn from other happenings in the field to make sure we're pursuing a strategy we're really confident. And so we had a great discussion with the agency. I think we came away with a high degree of alignment there are no surprises. There's certainly a shared dialogue around trying to solve complex issues. And I think we're incredibly appreciative of the agency in terms of their willingness to engage in those conversations, their willingness to be pragmatic and to tackle these complex issues in a way that doesn't slow down development. Our view coming out of that meeting is that with the plan we have designed, we'll have a strong case to be made both to at the agency and to any commentators or observers or whether that be an advisory committee or and peer-reviewed publications and the broader narrative that we can go over the compelling argument for both the value proposition and the safety and efficacy of the drug that would allow us to then proceed to a submission. So no surprises. I would say that we had a very constructive dialogue and came up with a clear path forward.

Great. And just as a quick follow-up, the dose relationship being -- going after 50 microgram and 100 microgram. Does the FDA generally agree with that approach that's demonstrating a dose relationship just address the expectancy bias or functional blinding issue?

I think I understood your question. So we presented our view, and our logic, and our strategy, at end of our Phase 2 meeting and in our Phase 3 protocols, and we're certainly confident in the path forward and our plans to address these issues. I think it's really important to -- for us to highlight the reality that this is a very common issue in psychiatry, while there's been a sort of spotlight shown on the matter of expectancy and functional unblinding. This is how psychiatry drugs work, particularly for mood and anxiety disorders. 2 milligrams of Xanax is fully functionally unblinded and based on historical research, even SRIs have something like a 70% incidence of patients being able to correctly guess they're on SRI, it's only that under 5% of historical studies of SRIs that actually asked the question or appeared to look. So while this is being scrutinized in our field, it's not unusual and in that, we believe that we should follow the well-established precedents for evidence required to establish the safety and efficacy of drugs, which is demonstrating statistically and clinically significant improvement over placebo, that's what our program is designed around. And while we include many, many aspects to try to mitigate and address the questions around expectancy and functional unblinding, we have a line that we believe with the agency on the path forward. Again, this is just something that is not all of that new even though it's been highly talked about over the last couple of months.

Great. Thanks for taking our questions.

Thank you. [Operator Instructions] Our next question comes from the line of Joel Beatty with RW Baird. Your line is now open.

Good morning, This is Christopher Chen on for Joel. Thanks for taking our question. In terms of 120, I know your primary focus is the domestic market, but have you started at all analyzing ex-U.S. opportunities? And if so, how would you characterize that analysis? Thank you.

Yeah. Thanks so much, Christopher. We have started to analyze ex-U.S. markets and engage in certainly some dialogue about those opportunities. We do not, at this time, intend to develop a sales force or launch the drug in most ex-U.S. markets, our focus would be on the U.S. markets, and we're certainly open to engaging and discussing collaborations and partnerships ex-U.S. when it makes sense about commercialization on those markets. But obviously, the dynamics of, for instance, launching a drug in Europe and the pricing and various considerations there would be we think a lower return on investment than our focus on launching the drug in the U.S. primarily.

Thank you.

Thank you. Our next question comes from the line of Sumant Kulkarni with Canaccord Genuity LLC. Your line is now open.

Good morning. Thanks for taking my questions. Do you have any specific targets for prior use of LSD or other psychedelic inclusion criteria in your Phase 3 trials? And in the open-label portions of your studies, how do you ensure integrity is maintained to make sure that any potential durability of effect is more purely attributable to MM120 versus other treatments or therapy?

Yeah. Thanks so much, Sumant. I'll turn that over to Dan Karlin to address that one.

Yeah. So thanks, Sumant. For prior psychedelic or LSD exposure, we have explicit exclusion criteria related to recent use and any heavy use over a number of years, preceding enrollment. So while we don't specify beyond that from an inclusion and exclusion perspective, we certainly want to be sure that we're getting folks who aren't currently using or recent heavy users. We also will in Phase 2b track, use history, of course. And what we found in Phase 2 was, in essence, with these criteria because we're moving into Phase 3 very much with the inclusion exclusion mirroring Phase 2. What we found was about a 15% to 20% historical usage in the population we ended up enrolling, which interestingly aligns almost exactly with epidemiological findings used in the general population. So as ever, we want to get a population that is representative of the overall GAD population as possible. I think we did that in Phase 2, and we'll continue to do that in Phase 3. As far as data integrity, attribution of efficacy, the extension phase that we discussed and that Rob expanded on a bit in a prior question is really going to be run very much the same way that the blinded phase is run. So that in all of our studies, we watch people out of background therapy if folks are engaging in psychotherapy outside of the trial, that has to be stable and unchanging for a period of time both before and through the trial. And we'll continue to enforce those same restrictions on outside treatment, other treatments, newly added psychotherapy through the entire extension phase. So while we do give folks the opportunity to get either dosed for the first time if they started in a placebo arm or a control arm, the expectation is that the only treatment that they're receiving the only new or change treatment that they're receiving and the only pharmacological treatment that they're receiving through the entire extension phase is MM120.

Thank you.

Thank you. And I'm currently showing no further questions in the queue. This does conclude today's conference call. Thank you all for joining and you may now disconnect.