Good afternoon, and welcome to the Mind Medicine First Quarter 2023 Financial Results and Corporate Update Conference call. Currently, all participants are in 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. 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 first 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 MindMed's website and our quarterly report on Form 10-Q for the quarter ended March 31, 2023, will be filed today with the Securities and Exchange Commission. Joining me today is Schond Greenway, our Chief Financial Officer; Dr. Dan Karlin, our Chief Medical Officer; and Dr. Miri Halperin Wernli, our Executive President. 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 caution not to place undue reliance on these forward-looking statements which are made as of today, May 4, 2023. MindMed disclaims any obligation to update such statements, even if management's views change, except as required by law. I would like to begin by reiterating our deep commitment to advancing our organization and delivering new life-changing treatment options to the many individuals living with brain health disorders. As we pursue our strategy to bring our lead product candidates to…

Thanks, Rob, and thank you all for joining us today. We will now turn to our financial results for the first quarter ended March 31, 2023. As of March 31, 2023, our cash and cash equivalents totaled $129.4 million compared to $142.1 million as of December 31, 2022. We believe that our current cash and cash equivalents on hand positions us to accelerate our preparation for moving quickly into our pivotal studies for our lead program MM-120 and we’ll be sufficient to meet our operating requirements beyond our key development milestones in 2023 and into the first half of 2025. Our net cash used in operating activities was $13.3 million for the quarter ended March 31, 2023 compared to the $12.9 million in the quarter end March 31, 2022. Research and development expenses were $12.6 million for the quarter ended March 31, 2023 compared to $10.2 million for the quarter end March 31, 2022, an increase of $2.4 million. The increase was primarily due to increases of $2.9 million in expenses related to clinical research for the MM-120 GAD study, $0.9 million in expenses related to our MM-402 program and $0.2 million in internal personnel costs as a result of increasing research and development capabilities, which were offset by a decrease of $0.7 million in expenses related to our MM-110 program and a decrease of $0.9 million of expenses in connection with various external R&D collaborations. General and administrative expenses were $8.3 million for the quarter ended March 31, 2023, essentially flat compared to the same quarter a year ago. Our net loss for the three month ended March 31, 2023 was $24.8 million compared to $18.5 million for the same period in 2022. Lastly, I wish to reiterate that we are continuing to execute on a very efficient operation in terms of quarterly cash burn and headcount when compared to our peers in the space. As we have highlighted during our prior business update conference calls, we intend to continue to be thoughtful with our cash, while also focusing and prioritizing our support for our most precious resource and development activities directed toward our key value drivers. More specifically, we will review our discretionary expenses on a constant basis to ensure that we are seeking to capture value from operational efficiencies where we can. I will now turn the calls back to Rob, who will provide some closing comments.

Thank you, Schond. We remain laser focused on driving our key programs forward, which includes advancing our MM-120 product candidate in GAD and ADHD to Phase 2 clinical readouts later this year, as well as initiating our first clinical trial of MM-402. Additionally, our early R&D activities are progressing and our collaboration with University Hospital Basel continues to offer the opportunity to generate early clinical evidence to inform our pipeline’s progression. I also want to extend my sincere appreciation and gratitude for the foundational work has brought us closer to advancing novel treatments for brain health disorders. In particular, I would like to thank our highly talented and deeply committed team here at MindMed, our investors and the many people who have been supportive along the way, including our research participants and their families. We’re working tirelessly to deliver on our mission of transforming the treatment landscape for the many individuals living with brain health disorders who are underserved by today’s available therapies. Finally, I’d like to remind everyone that the purpose of today’s call is to discuss our first quarter updates and the progress of our business, and we’ll not be addressing matters related to our annual meeting. We encourage all of our shareholders to review our definitive proxy statement within filed with the SEC and on SEDAR and visit www.protectmindmed.com updates pertaining our proxy campaign. With that, I’d like to thank you all again for joining today, and I’m happy to take questions.

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] Your first question comes from Charles Duncan, Cantor Fitzgerald. Charles, please go ahead.

Okay. Yes, good afternoon, Rob, Schond, thanks for taking my questions. And also thanks for all of the clinical trial design details, particularly for 120 and ADHD and 402 that was helpful. I do have a couple of questions though regarding MM-120 in GAD. I’m wondering with a sample size of, call it, 200 five arms, so about 40 per arm. I’m wondering if you could frame what you would like to see out of that study in terms of some of the effect sizes and if you anticipate a full kind of dose response or would it be really bookended by placebo versus the highest dose? So tell us what you think would be good out of that 420 or out of that 120 study in GAD. Thanks.

Thanks, Charles. Thanks for the question and for joining us today. With respect to the size and design of the Phase 2bstudy. So as you mentioned, 200 patients we’re anticipating enrolling across the five treatment arms, which for everyone’s – as a reminder, is – does this 25, 50, 100 or 200 micrograms for placebo, patients receive a single dose and then are followed for 12 weeks. This study was designed in such a way where this statistical methodology we’re using really gives us power across the entire spectrum. So we benefit from the response across the treatment segment. That methodology, something, that’s developed at Novartis and it’s something that. Ultimately, it’s a two-part statistical test, one that would test whether or not there is any treatment response at all. And the second part of the test as we nominate candidate profiles, which would reflect exactly what you’re getting to in terms of the type of dose response, the magnitude, effectively the slope and the shape of that dose response curve. In terms of the maximum magnitude that we anticipate seeing, we’ve really designed the study so that we can characterize the effect size and power of Phase 3 program. But our expectation was really set to demonstrate just anything at or above the standard of care. So the standardized effect size for most available anxiolytics is around 0.3 to 0.5, whether you look at SSRIs or benzodiazepine. And so even if we saw a response of that magnitude, we would anticipate seeing significant outcome. That said, we certainly want to see an improvement over the standard of care and believe there’s an opportunity to do exactly that. So, in terms of our expectations, we do want to fully characterize the response across the doses both acutely and in terms of durability. I think it’s particularly important to emphasize that by looking at multiple doses that we believe would be at or above within the therapeutic window that actually gives us important insights, both in terms of the magnitude and durability of response at those different doses and the sort of sub-therapeutic doses as we anticipate it. So the design has been, again, to robustly power and detect the difference, but also to make sure we’re characterizing adequately the acute and durable response to power and design our Phase 3 program.

Okay. So that’s helpful, Rob. So we should not consider that this is a pivotal program or pivotal study and judge its outcome based on that, but that whether or not it’s viable to help you move forward into Phase 3, correct?

That’s correct. It would be very much premature to consider this a pivotal study. Now, it’s certainly an important part and we’ve even seen presentation by representatives at FDA at recent conferences, particularly at ECMP a few weeks ago, about the importance of demonstrating dose response. And again, I think we as a sector studying this drug class really need full comprehensive information and data sets before we go into a pivotal program that is going to be very efficient, very clean design as we anticipated today. So it has been – the study – the Phase 3 study has been designed to give important insights in that design, characterize the response in this population, which has not been done at this scale or this magnitude, and really no studies to date that we’re aware of have looked at a comprehensive exploration of dose response. So that is the intent of this study, and ultimately we believe that will give us both additional support for our ultimate clinical package, as we summit NDA, but also would help us be very efficient with our Phase 3 design.

Very good. And then one quick perspective builder on the recent CPT codes, CPT III codes, I’m wondering if you could provide your perspective on how you think the AMA’s recent, I guess, approval of – first step approval to establishing CPT codes to enable really intermittent therapy that involves both a drug and a therapist, if you have a perspective on that? And how that may actually reduce the risk of not only approval but commercialization of these types of drugs? Thanks.

Thanks, Charles. I’ll turn it over to Karlin, our Chief Michael Officer to respond on that one.

Hi, Charles, Dan here. It is a really important question, obviously something we’ve been paying a lot of attention to as progress has been made in that CPT III code. As folks listening will know that the Level III codes are used for experimental and new services that have not yet been cleared, approved or have a substantial body of evidence behind them. Now we think this is an important step in the right direction, and we applaud Compass and MAPS for the collaboration on, on getting to that point. But we also know that, while that code is specific to psychedelic services in general, it’s a little more applied to everybody across the board. In many cases, for existing parallel services such as S-ketamine administration, while there is an existing HCPCS Level II code or G code specific to those services, many if not most commercial insurers are actually being billed for services like this under existing level I codes. So there are a number of paths to coding success and obviously some official recognition from the AMA and in the CPT is important. It’s only one sort of leg on the process to having a fully robust cutting system that that will cover all forms of third-party payers, including government and non-governmental commercial payers.

That’s helpful. Thanks for the added color, Dan. Thanks for taking my questions.

Thanks, Charles.

Thank you. Your next question comes from Brian Abrahams, RBC Capital Markets. Brian, please go ahead.

Hey there, good afternoon. Thanks for taking my questions. Two for me, I guess first off, on MM-120. As you think about how you might interpret the upcoming Phase 2 data, I’m curious your latest thoughts on how to find the best dosing window and dose levels that’s going to – that are going to maximize the benefit risk profile. And I guess, I’m curious if multiple doses are effective, would you move forward with two doses or more in Phase 3? And I guess, how might you think about steering which dose might be appropriate for which patient and balancing efficacy with safety?

Yes. Thanks so much for the question, Brian. It’d be a little bit premature to say specifically and obviously that we have many thoughts about how we generally think about safety and efficacy and the balance of benefit and risk as we design a Phase 3 program. What I would say is that we are very much intent on being extremely efficient and clean in our study design and want to make sure that we have as direct of a path and as efficient of a program as possible. So as we look to the data from this study, it is important to note one of the things particularly exciting about the drugs we’re working on, and MM-120 in particular is that the acute administration seems to drive both an acute and durable response. And because of that, it does offer some advantages potentially in terms of the risk profile. So we wouldn’t expect physiological risk to persist like what if you’re taking a daily medication. So we’ll certainly be monitoring outcomes, both efficacy and safety for the duration of the 12 weeks. We want to make sure that whatever dose we select to move forward in the Phase 3 is both responsive and in terms of efficacy, but also as well tolerated and we anticipate it would be safe as we get into a larger part of the development program. With all that said, too, I think it’s really important to note that based on the historical effect sizes, including the effects as we’ve seen from investigator-initiated studies, while they’re preliminary, in part or up to a standard that would support being evidence for an approval necessarily those effect sizes are quite large. And so we would anticipate that even if we were to choose a dose with those better tolerated, let’s say, just theoretically or had a similar response, we would be able to have a high degree of confidence, I think, based on the historical effect if we’re also able to replicate that the size of the Phase 3 program would be adequate and it would give us plenty of patients to be able to demonstrate a statistical difference if we see a clinically meaningful response as we anticipate.

That’s really helpful. Thanks Rob. And then I guess, secondarily, with regards to the 402 program. You mentioned the study that’s going to be looking at racemic DNA and the antimiRs [ph] in healthy volunteers in collaboration with UHP. I was wondering if you could elaborate a little bit more on that study. What specifically you’re going to be looking for in terms of to better understand the pharmacology, the parameters you’ll be exploring and when we might report data there? And I’ll hop back in the queue. Thanks.

Yes. Thanks so much. So in terms of the study design, it’s two different doses of our MDMA, so 125 milligrams and 250 milligrams, a single dose of SMDMA and single racemic MDMA. And this is inpatient, all the patients would be crossed over and received these different treatments. And in the 125 milligrams of S and the racemic MDMA is being administered here. So in terms of the outcomes that we’re looking to, largely the pharmacodynamic outcome. So overall drug effect in terms of intensity and duration, we’re conducting as one of the primary outcome measures or I should say, Dr. Liechti’s Lab disconnecting the 5-Dimensional Altered States of Conscious, the 5D-ASC scale. It’s also investing functional perceptual activity of the antimiRs and racemic MDMA. So we look at a number of autonomic effects, of mood effects, of course, characterizing pharmacokinetics and looking at other endocrine effects, levels of oxytocin, prolactin, cortisol, vasopressin. So many of the pathways that have been implicated in the activity of our or racemic MDMA to characterize that response with two different doses and ultimately seek to inform how we advance our own Phase 1 program and further into the clinical Phase 2 and beyond.

Got it. Thanks so much.

Thank you. Your next question comes from Francois Brisebois, Oppenheimer. Francois please go ahead.

Thanks for taking my question. Congrats on the progress here. Just a couple here. In terms of the recent Hospital Basel study that you mentioned there, so maybe if you can remind us just the differences here. So multiple doses comparison is not to a true placebo and obviously, a different indication, although similar comorbidities. And then soo maybe just talk about the differences and how this could be a read-through towards your study? And any thoughts on patients, keeping them on SSRIs versus winding them off and what they can do? Thank yo.

Great. Thanks so much Fran. So in terms of study design, this is an investigator-initiated study looking at the impact in patients with major depression disorder, patients in the active arm received two different doses that were separated by a month. The first was 100 microgram dose. The second was a 200 microgram dose, which again was separated by four weeks. The control group in this study was administered a 25-microgram dose both in the treatment days, both the dosing session. So it was not an inert placebo, but we still did see a statistical and clinically meaningful differentiation between the response to those two doses. So we saw a 3.6-point improvement in the IDS-C score, which is the inventory of depression symptomology score, six weeks after administration of the first treatment session for the low-dose arm, and we also saw a 12.9-point improvement on the IDS-C and the higher dose, 100 microgram and the 200 microgram dose arm. Those effects remain durable up to 16 weeks, and we saw a number of encouraging secondary endpoints in the study. So overall, we view it as particularly impactful and important given the relevance to depression, which is, of course, an area an indication where there’s a huge growth and incidence and prevalence and one where they have – we’ve also seen historical evidence of activity of LSD or lysergide. But it’s also particularly important to note that there’s a high degree of comorbidity between generalizing anxiety major depressive disorder, both in terms of diagnostic overlap, which we think is incredibly high, but also the number of patients the prevalence of diagnosis in overlap – and population. So we think it’s both relevant to our GAD program, but also opens up an opportunity. We’ve seen historically strong, consistent responses in many studies and hundreds of patients with lysergide and anxiety and depression and other neurotic illness. And so this seems – as consistent with the data we reported in anxiety back in 2022, again, demonstrating a strong statistically significant response after acute administration. What anyone hope to see in a depression study and something, again, we think is particularly important, both in anxiety and opens up the door to potentially having other indications in the future.

Okay. Great. And can you remind me if the – were the patients on SSRIs or whatever they were on or were they waned off to this trial?

Yes. Some additional details about the specifics there will be forthcoming as full publication is released. But generally to comment broadly about your question, we don’t have modern data to fully characterize the difference in either pharmacokinetics or pharmacodynamics, which I think would be particularly have more interest with concomitant administration of SSRIs and a molecule like MM-120. But historical data has suggested that there may be an alteration of the PD profile, but we haven’t seen any evidence for that would be alarming or safety signal. So something we are certainly monitoring and know others and academic researchers have been interested in that differentiation of response and certainly as we progress in development. So we’re going to be looking at very closely.

Okay, great. And then in terms of the R&D Day that you mentioned would still be in the second quarter, is that where you plan on sharing more details about your commercialization plans for each product? Or is that kind of at a later time?

I think as we think about an R&D Day in the second quarter, and one of the key things we would like to highlight is an update on the progress of the clinical trial of our overall programmatic approach. We’ll speak much more to the intellectual property and market protection strategy, and they got some important insights that should make it a very clear story to anyone who’s been looking at market protection and the ability to protect a novel asset. So that will be one area of focus. We obviously dig into and have some key opinion leaders talking about generalized anxiety disorder as an indication and where the treatment might fit in the overall landscape. And then we’ll also have an opportunity to present some individuals who have actively finding clinical trials and research with LSD with the drug class generally, and provide some insights into the commercial viability in that way. I think certainly as we progress and reach a Phase 2 readout and are getting to, into Phase 2 program, total clarity on what the path to our late stage program looks like, we’ll be in a position at that point to speak a little bit more about market access and the overall commercialization strategy. But certainly at our Investor Day coming up in the second quarter will be giving a lot more insight into the status of the programs and I think greater clarity on of the elements of our ultimate product that we try to take to market and our overall approach there.

Okay, great. Thank you very much.

Thanks, Frank.

Thank you. Your next question comes from Elemer Piros, EF Hutton. Elemer, please go ahead.

Yes, good afternoon. What I’d like to verify, Rob, is 20 clinical sites that you previously identified. Is this the final number for the GAD trial?

So we – the 20 clinical sites was certainly the number of study, excuse me, the number of sites that as we noted earlier in the year were brought online and we’re fully recruiting the beginning of the year. And we’ve seen a lot of interest from a number of sites in a number of highly experienced sites. And as we think about site engagement and bringing sites online, they can both be driven by an individual study but also programmatically, right? So we have an opportunity to engage with sites that might be great sites in a later stage Phase 3 program. So we’re actively engaged with a number of discussions in a number of different avenues to make sure we can be as efficient as possible getting into that pivotal program. But certainly 20 sites is where we started and currently actually enrolling patients.

Yes. And at the end of the year, would we – shall we expect primary endpoint information? So efficacy at four weeks or maybe some later time points, eight weeks and 12 weeks as you have those as secondary endpoints?

We certainly anticipate reading out at least as a top line read out the four-week data, which is the primary endpoint in the study. So we’re getting greater clarity as we progress and give an update on the study in the future. But our expectation when we speak to top line results, we’d be at least reading out the primary endpoint.

Yes. Yes. And I just found this company called MindBio who is doing a – or plan to do a microdosing LSD trial in MDD. Do you think that they would have freedom to operate if they continue to pursue that indication with?

Well, again, in terms of intellectual property, certainly in a research setting, there’s a carve out for doing research. So anything of that nature wouldn’t come into play until much later down the road. But where we are positioned in the program and the kind of support we’ve had, the team we’ve built, the efficiency we will have demonstrated as we get the read out by the end of this year, think we’ll make it very clear where everyone stands in the market and who’s likely to be first to market with any sort of LSD product.

I see. And just last two small questions here. Do you have a cutoff value for the HAM-A score at baseline in the GAD trial or minimum severity?

We do – I’ll turn over it over to Dr. Karlin again.

I don’t believe that we publicly disclosed that minimum cutoff score at the current time just to maintain trial integrity. So yes, we do have the score, but I think in general, just for integrity purposes, I don’t believe that this publicly disclosed.

Yes.

I’ll just expand on that real quickly. We have – if we printed to our investor presentation, which published on our website. The minimum score we require to be enrolled in the trial as an entry criterion is a Hamilton Anxiety Score of 20 or greater.

20 or greater. Okay. Thanks for clarifying that. And do you expect a good portion of the patients to have depression as a comorbidity in this study?

Based on the overall population, the comorbidity of GAD and major depressive disorder, we certainly anticipate that the patients would have comorbid diagnosis with depression. What’s critically important is to have a GAD as a primary diagnosis. But it would not be a representative population if you had an indication such as GAD, there wasn’t some comorbid depression in the study.

But you are not examining efficacy based on reduction in depressive symptoms.

[Indiscernible] as secondary outcome measures, we’re absolutely looking at response on standard depression scales and would use that as another important insight into potential response in depression.

Yes, wonderful. Thank you very much for both of you.

Thanks, Elemer.

Thank you. Your next question comes from Patrick Trucchio H.C. Wainwright. Patrick, please go ahead.

Thanks. Good evening. Just I'm wondering, as you look at the broader space of sponsors exploring psychoactive agents, how do you view the differentiation of MM-120 relative to some of these shorter-acting compounds like psilocybin or 5-MeO-DMT? Do you see the advantages primarily on the efficacy and potential duration of remission? Or is there also a potential to separate on safety and tolerability profile as well?

Yes. Thanks for the question, Patrick. So when we look at the history of research of this drug class as a drug developer, you want to see drugs that have a likelihood of demonstrating this – or how benefit-risk profile that it’s ultimately gets you to an application and approval and LSD is the most characterized drug in the entire class. There's certainly been a lot of discussion about shorter-acting molecules. What we know from the real world, I think it's important to highlight, there's a fairly large expanded access or capacitate use program that's ongoing in Switzerland. And our collaboration, both with Dr. Liechti UHB and more broadly with many of the psychiatrists in Switzerland has given us some real insights. These providers are able to utilize psilocybin or LSD. And in many instances, when we have discussions about the preference, they choose to use LSD. They also have indicated on multiple occasions that the actual conduct of administration sessions, whether it's LSD or psilocybin, occurs for approximately the same duration. That's going to obviously vary by the individual. But we thought it was a particularly important insight that in practice in the real world, where this is being done regularly and has been done for several years, there isn't a significant differentiation between those two molecules. Now some of the ultrashort-acting molecules such as DMT or 5-MeO-DMT, these are certainly molecules that work on serotonin system. But what we need to characterize is both the acute and durable response, and that's what we certainly have seen more from historical data of LSD and gives us an extraordinary degree of excitement around the potential of our product candidates.

Can you talk more about the health economic outcome research that you referred to earlier? And understanding that there's still more planning here to be done. I'm wondering what would this potentially look like prior to the launch. And how big of a differentiator would it be for MM-120 if you have this type of data at the time of or soon after a potential launch?

Yes. So I certainly don't want to speak too much of the specifics at this point, but we are actively engaged both with Francois Lilienthal, our Chief Commercial Officer, who's an incredible career and commercial launches, including most recently at Merck before coming over to MindMed to demonstrate the value proposition and make sure we have a path for commercialization for market access for reimbursement and also our digital medicine programs, which gives us an extraordinary opportunity to gather such data and engage in longer-term observational studies, both of patients with the disorders we are seeking to treat but also more specifically and some particular areas of research interest to us, both internally and through some of our collaboration. So we'll certainly be sharing more as we progress and as we get to have more clarity or share more clarity, I should say, on the commercialization pathway and also the plans will give us additional insights in terms of our approach to issue our data generation and also the implications for market access pricing, reimbursement and such.

That's helpful. Just one last one for me. Can you talk about just broader strategic priorities as it relates to business development? And specifically, how do you think about potential partnership activity following the Phase 2 readouts for MM-120 later this year?

Yes. We've certainly seen quite a bit of interest in our program and our readout and at any time where we were advanced to the point where we reach the disclosure threshold we certainly do so. But at this point, we do not have any business involvement or licensing or partnership agreements for subsequent development program. But again, we've seen, I think, a high degree of engagement and excitement both in terms of the serotonin system as a target, which is one of the best-characterized systems and all psychiatry, but also, in particular, in our program and our approach, the ability to generate the kind of robust data and the consistency with which we're approaching our clinical development program. Our Phase 2 study design and the way we've operationalized the study is exactly how we anticipate progressing into the Phase 3 program. And we think that gives us a great opportunity to transition out without changing any of the variables that are important in terms of conduct of the study and ultimately could impact safety or effectiveness. So there's been a lot of excitement across the board, and we'll keep any of our options open as it progress.

That’s helpful. Thank you very much.

Thank you. [Operator Instructions] There are no further questions at this time. I will now turn it back for closing remarks.

Thank you, operator, and thanks, everyone, again for joining us today. We're extremely pleased with where we've come so far this year and are incredibly encouraged by moving very quickly to a data readout in late 2023 for our lead program and getting our second lead program and MM-402 in the clinic later this year. Thanks, everyone again, for joining us, and we look forward to sharing future updates.

Thank you. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating. And ask that you please disconnect your lines.