Good afternoon, and welcome to the Mind Medicine Third Quarter 2023 Financial Results and Corporate Update Conference Call. [Operator Instructions] 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. [Operator Instructions] For opening remarks, I would like to introduce Rob Barrow, CEO of MindMed. Please go ahead.

Thank you, and good afternoon, everyone. Welcome to our third quarter 2023 financial results and corporate update conference call. The press release reporting our financial results is available in the Investors and Media section of our website and our quarterly report on Form 10-Q for the quarter ended September 30, 2023, will be filed today with the Securities and Exchange Commission. During today's call, we'll be making certain forward-looking statements including without limitation, statements about the potential safety, efficacy and regulatory and clinical progress of our product candidates, financial projections and our future expectations, plans, partnerships and prospects. These statements are subject to various risks such as changes in market conditions, difficulties associated with research and development and regulatory approval processes that are described in the filings made with the SEC, including the most recent annual report on Form 10-K and quarterly report on Form 10-Q. 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 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, November 2, 2023. MindMed disclaims any obligation to update such statements, even if management's views change, except as required by law. Joining me on today's call are Schond Greenway, our Chief Financial Officer; Dr. Daniel Karlin, our Chief Medical Officer; and Dr. Francois Lilienthal, our Chief Commercial Officer. We are excited to be providing this financial and business update during this important period for MindMed. Over the past year, we have made significant progress on our diversified R&D pipeline which has positioned us for a series of…

Thanks, Rob, and thank you all for joining us today. We will now turn to the company's financial results for the quarter ended September 30, 2023. As of September 30, 2023, MindMed had cash and cash equivalents totaling $117.7 million compared to $142.1 million as of December 31, 2022. The company believes its available cash and cash equivalents, as well as its committed credit facility are expected to fund operations into 2026, if certain milestones are achieved that unlock additional capital. For the 9-month period ended September 30, 2023, the company's net cash used in operating activities was $43.8 million compared to $37.3 million for the same period in 2022. Research and development expenses were $13.2 million for the quarter ended September 30, 2023, compared to $7.8 million for the same period in 2022, an increase of $5.4 million. The increase was primarily due to increases of $6.4 million in expenses related to clinical research and product development for the MM-120 GAD study, and $0.4 million in internal personnel costs as a result of increasing research and development capabilities, which were partially offset by a decrease of $0.4 million in expenses related to our MM-402 program, a decrease of $0.2 million related to our MM-110 program, a decrease of $0.5 million in preclinical activities, and $0.2 million in connection with various external R&D collaborations. General and administrative expenses were $8.4 million for the quarter ended September 30, 2023 compared to $9.2 million in the same period for 2022, a decrease of $0.8 million. Decrease was primarily related issuance cost, related to the company's 2022 U.S. dollar financing warrants that were issued as part of the company's public equity offering which closed on September 30, 2022. I will now turn the call back to Rob, who will provide some closing comments.

Thank you, Schond. This is a very exciting time for MindMed in which we are rapidly approaching significant milestones for our organization. These milestones include our 4-week primary endpoint top line data and our Phase IIb trial of MM-120 and GAD, which is expected in the fourth quarter of this year with 12-week data expected by the end of the first quarter of 2024. We also anticipate presenting full data from the study at the scientific meeting in 2024. We also anticipate reporting proof of concept results for MM-120 and ADHD with top line data expected by the end of the first quarter of 2024. For our MM-402 program, we are on the cusp of initiating our Phase I trial later this quarter and anticipate sharing top line data from the UHB investigator-initiated study of RS, racemic MDMA in the first half of 2024. As we come to a close, I want to extend my sincere appreciation and gratitude for the critical work and unmatched execution that has brought MindMed ever closer to realizing our mission. I'd like to thank our highly talented and deeply committed team, our research collaborators and clinical investigator teams, our investors, and the many other individuals who have been supportive, including especially our patients and their families. We are working tirelessly to deliver on the therapeutic potential of our pipeline and transforming the treatment of the landscape for many individuals living with brain health disorders. With that, I'd like to thank you all, again, for joining us today, and I'm happy to take any questions.

[Operator Instructions] Our first question comes from Brian Abrahams of RBC Capital Markets.

Looking forward to seeing the data soon. Maybe just a bigger picture overall market question and then a question on the upcoming data. Can you -- you give some of this information in the prepared remarks and it was really helpful. I was wondering if you could elaborate a little bit more on the unmet need in generalized anxiety disorder. I guess, what's your understanding of -- I guess, what do we know about the proportion of patients who fail SSRIs and then try, will go on to one of these, next line agents. How many of those would be considered treatment resistant? And how are you thinking about that in the context of the overall market opportunity, and I guess, the proportion of patients, you think would be most likely, I guess, initially to try a drug like MM-120?

I'll respond briefly and just turn over to Dr. Karlin to respond further. But at the high level, the concept of treatment resistant anxiety or generalized anxiety disorder is less well agreed upon than it is for depression, if you've ever resisted depression, the label that has been given to other therapies and the concept that has been more clearly articulated in various guidances and industry standards and things of practice. That same construct has not been as directly applied to generalized anxiety disorder. What we do see is that a significant driver of value is the severity of the disorder. And as it happens, many of the patients, even those treated today are moderate or severe maintain moderate or severe symptoms over time. I'll turn over to Dan Karlin to talk further about demand and value generally and [indiscernible] to dig into those specific numbers.

Yes. Hey, Brian, and thanks for that question. It's a really interesting space for us to discuss because, of course, for the last 30 years or so that as Rob mentioned, the conversation around these disorders has been focused on major aggressive disorder for a number of reasons that have less to do with the reality of people's experience with these illnesses and more to do with the marketing of SRIs. So, that we know that there's a lot of undiagnosed GAD, which as Rob mentioned, we've seen this really multiple increase in both diagnosis of GAD and in the measured prevalence of GAD, which has now been estimated to be as high as 10% on U.S. adults. What we do know about the distribution of folks with GAD is that between 70% and 80% of folks present with moderate to severe symptoms and that as many as 50% of people fail their first SRI trial, and so you're going to have inadequate response or have the intolerable side effects and that as many as 20% seem to fail multiple treatment attempts. So while there isn't a sort of community accepted definition of treatment resistant GAD, we'd say it's going to land somewhere between having failed 1 and 2 treatments. Now is that exclusively the population that would try a drug like MM-120? I think the answer to that is probably no. So people end up on the best medicines we have, even if they have side effects that aren't entirely tolerable, but are more tolerable than the disease itself. And people accept inadequate treatment response when there aren't great options to move on to. Of course, the hope is that if we have the sorts of effect sizes that have you suggested in prior academic work, and of course, the extraordinarily low rate of persistent adverse events that this wouldn't necessarily just be a drug that exists in the domain of folks who in the current state of psychiatry have sort of been defined as treatment resistant or when drugs have failed.

All right. That's really helpful context. And then just on the MCP-Mod analysis that you're doing on HAM-A, I guess, first off, could you talk about the sort of models that you're using for the assumed dose response? Are those [ 6 ] curves that you presented are those the actual models? Or if not, how are you kind of thinking about that? And then, given that you're not doing pair-wise comparisons specifically, what are the tools that you're going to use to hone in on and articulate an optimal dose, I guess, with respect to inputs on magnitude of activity and consistency across patients?

Yes, great questions, Brian. Thanks so much. In terms of the curves, those are the illustrative curves that we are using, of course, there are very precise measures against which those are established in the statistical analysis plan for the study. But generally, the shapes of those curves that we had presented are in line with the general kind of response model that we are testing against. It captures, we believe a good number of potential dose response curve that very well could correspond to some of the healthy volunteer data we have and the pharmacodynamics of LSD from historical studies and, in our view, perfectly captures a variety of different responses at each of those dose levels. In terms of the tools we'll use because that's one of the actual benefits both in terms of its physical efficiency and using all of the available data to establish whether there is indeed a treatment effect or not, but there's also an added benefit here with the MCP-Mod that already established, baked into that analysis just because part of the statistical test is measuring against those nominated response curves, the selection of an optimal efficacy response and where and the MCP slope of that response curve and the selection of an appropriate dose to move forward is already embedded in the analysis, using MCP-Mod. So coming out of the analysis, we will have a curve that we believe is the best to characterize the dose response we have observed in the GAD population and that will be one of the key aspects that informs the selection of this to take forward in this in subsequent studies.

Our next question comes from Francois Brisebois of Oppenheimer. François Brisebois: Can you just maybe discuss -- in terms of expectations for the GAD data, can you help us understand maybe the importance of the effect size for each dose or is this more a question of being a dose relationship with maybe only 1 of them getting an effect size of comparable to the SSRIs that are out there? And then, maybe on the second part of the answer in terms of effect size, it is compared to placebo here and we've seen differences in different placebo responses in trials. I was just wondering, if you had any comments about expectations around the placebo response?

So in terms of your first question, with respect to the effect size, we'd potentially be observing in relation to that context, that backdrop of currently available therapies for GAD. The model is such that we believe that if any of the doses being tested were to achieve a clinically relevant effect size or response, that it would be well captured and that would be enough to support the kind of conclusion that on our last earnings, [ we] had reported that through simulation analysis, we have a high degree of confidence that if we do observe that clinically relevant response, it would be likely to result in a statistical positive outcome using the MCP-Mod analysis. So, it is not pre-specified necessarily which exact one of these doses that we have tested would reach that maximum or optimal effect size of the response. And that both adds the statistical efficacy of the methodology and also allows us with some flexibility for the interpretation because we don't know definitively what the response curve is until we get to the conclusion of the study. It provides some flexibility even if we see a response at a lower dose than we may be anticipating end of that. In terms of your second question about the placebo control, this is one that is critically important and the field, of course, is still digesting the appropriate controls in the context of potential functional unblinding. FDA's guidance from June this year highlights the importance of doing dose response studies, both to characterize the response in itself, but also because it is such a strong way to control for functional blinding. One of the very important lines of inquiry we'll certainly have as we reach the ultimate analysis and [ transact ] analyses of the study would…

Our next question comes from Jonathan Aschoff Of ROTH MKM.

I had a cash question. You burned about $17 million or $18 million in the third quarter. If you hold that absolutely flat over the next 9 quarters, that barely gets you through 2025, and you say cash in into 2026. So, if we call those 2 things the same, we're only going to burn as much cash as you burned in 3 quarter on average for 9 quarters?

Yes, thanks for the question, John. And so, we welcome Schond to respond as well. But generally based on the status of our development programs, expenditures on a quarterly basis, of course, are driven in large part by our R&D expenditures. And so, as we progress and have further clarity, we could certainly offer additional insights in terms of expectations for various milestones. And turning to the cash that's available to us including the credit facility you entered into early this quarter, as we noted [indiscernible] additional capital, right.

And if you include that $35 million it still requires you to not increase cash burn over the next 9 quarters. And I mean, yes or no, is that realistic average cash burn?

Yes, certainly believe -- yes, go ahead, Schond.

We can certainly -- I'm sorry, we can certainly circle that offline, but as we said before, we haven't provided an actual quarter-over-quarter cash forecast, but we certainly will reiterate our current guidance into 2026. We can certainly take it out like an offline as well.

Our next question comes from Patrick Trucchio of H.C. Wainwright.

Here is [ Louise ] on for Patrick. On the base of enrollment for 120 and GAD, can you tell us a little bit more about the level of enthusiasm of investigators, physicians, patients and how this could impact the pace of enrollments? And on the potential Phase III program and possible launch?

Thanks so much, Louise. So having been to many of the clinical sites and spoken with numerous investigators in our study, I would say, we have a high degree of confidence in our ability to continue executing on the kind of efficiency we have. We've seen extraordinary enthusiasm and engagement, both because of the conduct of the study and, the interest in novel therapies for GAD, for the product candidate we're developing [indiscernible] give credit to our team for the extraordinary engagement they have had with clinical sites and their hands on connectivity with the conduct of this study. It could master a better clinical team to run a development program. And like any study, it always comes down to the ability to execute. And our team has shown over and over again the ability to do just that. In terms of enthusiasm as we go into subsequent studies, we certainly believe we will continue to execute as we have historically. And having conducted this study and enrolled 198 patients in just over 1 calendar year or just over 12 months, I should say, we feel like we have proven that this can be done very efficiently and we'll continue to do so.

And on the ADHD data readout that's coming soon, what would you need to see on that readout to have confidence to move forward? And moving forward, would it mean another Phase II trial or right onto a Phase III?

Yes, absolutely. For the ADHD study and certainly as we get to that data availability, we'll be able to provide additional context. But in terms of expectations or what we need to see to move forward, certainly a clinically relevant and I guess, specifically relevant, statistically significant response in that study would be obviously indicative of some activity that would be supportive of further investigation. In terms of what comes next, we haven't given specific thoughts on exactly what studies will come next, but certainly, with the challenges of administering a drug that, if overdose would have the kind of effect. And I say overdose in the context of administering more than the 20 micrograms twice a week that we administering that study. Given some of the dynamic there, we certainly have to be in a position to look at alternate dosage forms or consider exactly how we'd approach that maybe part of the discussion would help with various exploration of what comes back to that program.

Our next question comes from Michael Okunewitch of Maxim Group.

This is [ Chad ] on for Michael. So, I was wondering, how will the data generated from Phase I for MM-402 differ from the UHB study?

Yes. It's a great question. In the UHB study, patients that were administered -- excuse me, healthy volunteers were administered each of 4 different doses, 2 different dose levels of RMDMA, SMDMA and racemic MDMA. In our sponsored Phase I study, we'll be doing a standard ZAD MAD kind of approach where we'll be exploring the repeated administration as well as the single dose administration. So while we're getting a preliminary characterization of the pharmacokinetics and pharmacodynamics effect, I'm going to look forward to or excuse me, RMDMA, SMDMA and the racemic MDMA and the EHB study. The Phase I study, we are conducting will give more granular definition and more elucidation of what happens with repeat administration and characterization of how we might take that forward in a more standard dosing paradigm.

Okay. And then, how long will you continue to follow patients in the Phase IIb for GAD, will there be like an extended follow-up beyond the 12 weeks?

In the Phase IIb study, we followed patients for 12 weeks, given that we're doing full dose characterization in this study and wouldn't be selecting a dose, and as you previously disclosed, we'll be transitioning to an oral dissolving [indiscernible] key formulation as we progress in the clinical development for MM-120. We anticipate that in subsequent studies, additional follow-up may be warranted, but in this study, we are only going to be following patients for 12 weeks.

This concludes the question-and-answer session. I would like to turn the conference back over to Rob Barrow for any closing remarks.

Thank you, operator, and thank you everyone again for joining us today. We look forward to sharing further results in the near future.

This concludes today's conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.