Good morning and welcome to the Mind Medicine Full Year 2021 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. For opening remarks, I will turn the call over to Rob Barrow, CEO of MindMed. Thank you. Please go ahead.

Thank you and good morning everyone. Welcome to our full year 2021 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 annual report on Form 10-K for the year ended December 31, 2021 will be filed today with the Securities and Exchange Commission. Joining me today is Dr. Dan Karlin, our Chief Medical Officer and Dr. Miri Halperin Wernli, our Executive President. During today’s call, we will be making certain forward-looking statements, including without limitation, statements about the potential safety, efficacy and regulatory and clinical progress of our product candidate, financial projections and our future expectations, plans, partnerships and prospects. These statements are subject to various risks that are described in the filings made with the SEC, including the most recent Annual Report on Form 10-K. You are cautioned not to place undue reliance on these forward-looking statements which are made as of today, March 28, 2022. MindMed disclaims any obligation to update such statements even if management views change. Before we dive into our program and corporate update, I feel it is important to acknowledge the backdrop against which we have embarked on our mission to revolutionize the treatment of brain health disorders. The social isolation of the COVID-19 pandemic, the realities of climate change, the tragedies of war and refugee crises have contributed to soaring rates of anxiety, depression, substance abuse, and other brain disorders. The good news is that there has been a significant resurgence and research of novel therapies to treat these conditions, and MindMed is leading the way in this effort. We have big ambitions to revolutionize the treatment of brain health disorders by delivering on the therapeutic potential of psychedelics and other novel drug classes. We are applying our pharmaceutical expertise to develop these innovative therapies with the aim of generating rapid and sustained improvements in patient outcomes, with applicability to anxiety, addiction, and even autism. This matters today more than ever. The incredible team we have assembled at MindMed is unmatched expertise and we are utilizing decades of academic research to accelerate our three lead drug candidates MM-120, MM-110, and MM-402 along with other novel therapies. We are extremely pleased with the progress and transformational growth that propelled our business for the past year. We made significant strides to advance all of our product candidates. And as I speak to you today, I believe MindMed has never been in a better position to become the leader in developing novel therapies to treat brain health disorders and to improve patient outcomes in areas of unmet medical need. I will now turn the call over to our Chief Medical Officer, Dr. Dan Karlin to provide additional updates on each of our development programs. Dan?

Thank you, Rob. Our drug pipeline at MindMed is comprised of a wide array of exciting product candidates that are either currently in or are nearing clinical trials. On this call, I will focus on the programs with the most near-term visibility and highlight upcoming milestones, starting with our lead drug candidate, MM-120. MM-120 is a proprietary pharmaceutically optimized form of LSD that we are developing for the treatment of generalized anxiety disorder, or GAD. GAD is an often, debilitating mental health disorder that affects approximately 6% of U.S. adults in their lifetime. Symptoms of GAD include excessive anxiety and worry that persists for over 6 months, which can lead to significant impairments in social, occupational, and other functioning. There has been very little innovation focused on the treatment of GAD over the past several decades. In January of this year, FDA cleared our investigational new drug application or IND for our Phase 2b dose optimization trial of MM-120 for the treatment of GAD. This trial is expected to initiate in the second quarter of 2022 with top line results expected in late 2023. The trial plans to enroll a total of 200 participants who will receive a single administration of up to 200 micrograms of MM-120 or placebo. The primary objective of the study has determined the reduction in anxiety symptoms for up to 12 weeks after a single administration of MM-120 across five treatment arms. I want to thank our dedicated clinical and regulatory teams here at MindMed for all their hard work in rapidly addressing the clinical hold related to the participant monitoring aspects of the protocol. Overcoming this regulatory hurdle represents a significant milestone for MindMed and for the industry as a whole as it marks the first large commercially sponsored study of LSD in more…

Thank you, Dan. In addition to our sponsored development programs, over the past year, we have significantly strengthened our early research and development capabilities both internally and through the external collaborations we have in place with leading academic and research organizations around the world. Before we dive into our ongoing collaborations, I want to highlight the critical role that academic institutions have played in advancing the psychedelic landscape, despite the many obstacles and regulatory hurdles. As a company, whose mission is to unlock new pathways to improve patient outcomes in brain health disorders, we are proud to join efforts with pioneers in the field to advance the understanding and development of new treatment modalities and biopharmaceuticals. Now to our specific ongoing projects. Let me begin by discussing our collaboration with Liechti Lab at the University Hospital Basel in Switzerland. Under this partnership, we retained exclusive worldwide rights to data, compounds and patents associated with their research program evaluating LSD and MDMA, and the collaboration was extended last year to also include two additional psychedelic compounds, mescaline and DMT. This includes data from preclinical studies as well as 17 completed and seven ongoing clinical trials. Our ongoing research collaboration with the UHB Liechti Lab has generated a number of patent applications based on preclinical and clinical data collected over the past decade. And the data coming out of this partnership have been invaluable in accelerating our drug development program. The Liechti Lab recently published a peer-reviewed paper in neuro psychopharmacology comparing the acute effects of LSD and psilocybin in healthy subjects. The study demonstrated that the key differences between LSD and psilocybin are dose-dependent rather than substance-dependent. This study further expands our knowledge and has the potential to inform future studies evaluating the therapeutic utility of psychedelics. We also have a…

Thank you, Mary. We’ll now turn to our financial results for the fourth quarter and fiscal year ended December 31, 2021. As of December 31, 2021, MindMed had cash totaling $133.5 million compared to $80.1 million as of December 31, 2020. MindMed believes its available cash and equivalent will be sufficient to meet its operating requirements beyond its key development milestones and into 2024. The net cash used in operating activities were $45.8 million for the year ended December 31, 2021, compared to $23.6 million for the same period in 2020. R&D expenses were $34.8 million for the year ended December 31, 2021, compared to $18.6 million for the year ended December 31, 2020. The increase was primarily due to an increase of $2.3 million in expenses related to our MM-120 clinical research, $2 million in expenses related to our MM-110 clinical research, $3.5 million in expenses related to other research programs. Internal costs increased $11.1 million, primarily related to an increase in non-cash expenses of $6.6 million of stock-based compensation and $2.6 million of amortization of our developed technology. G&A expenses were $59.1 million for the year ended December 31, 2021, compared with $14.4 million for the year ended December 31, 2020. The increase was primarily due to higher professional services and personnel costs to support the growth of the company and an increase of $28.9 million in non-cash stock-based compensation expenses. Excluding stock-based compensation, G&A expenses were $29.7 million for the year ended December 31, 2021, compared to $13.3 million for the year ended December 31, 2020. The net comprehensive loss was $92.3 million for the year ended December 31, 2021, compared to $33.7 million for the year ended December 31, 2020. Overall, 2021 has been an extraordinary year for MindMed, through which we made huge strides in building a world-class pharmaceutical organization that is well positioned to deliver important therapies to patients in need and to deliver significant value to our shareholders. We have been very fortunate to attract top talent within our organization at every level, including with significant additions to our executive management team, Board of Directors and Scientific Advisory Board. I am incredibly proud of our numerous achievements across all areas of the organization, and I cannot be more grateful for the incredible people, both within and outside our organization who make this critical work possible. We expect 2022 to be another significant year in the growth of MindMed as we continue advancing our drug and digital medicine pipeline. With that, I would like to thank you all again for being here today and I am happy to take any questions.

[Operator Instructions] Our first question is coming from Patrick Trucchio of H.C. Wainwright. Please go ahead.

Thanks. Good morning and congrats on all the progress. First, a couple of questions on MM-120, made a few follow-up questions around the trial design and expectations around the Phase 2 dose-optimization trial in anxiety disorder. So, just first, how is the dose of 200 micrograms selected? As well how many preparation and integration therapy sessions are anticipated? How long are those sessions anticipated to last, and would they be conducted in person or virtually? And then just what is the placebo or control in the trial expected to be?

Great. Thanks so much, Patrick. So, to take your first question, the dose range and the doses were selected in part driven by past research studies on LSD, which had looked at, in particular, a recent study by our colleagues at UHB looked at doses of 25 micrograms, 50 micrograms, 100 micrograms, and 200 micrograms and characterized the pharmacokinetic and pharmacodynamics of those doses. And so, when we approached the study, looking at those four dose levels plus the placebo control, both allowed us to leverage those preliminary PK/PD data, but also gives us the breadth of exposure across the full dose range and can really optimize and select a key dose to take forward into the pivotal efficacy studies. The statistical methodology we have been using also supports the need to look across the broad spectrum, so to have a roughly tenfold difference in exposure from the low dose to the high dose or when you include the placebo zero up to 200 micrograms, allows us to maximize our statistical power while also leveraging those PK/PD results. Yes, about placebo, really, there has been a lot of dialogue, of course, around the appropriate choice of placebo in these clinical trials. Because we are doing a dose-optimization study, we have five treatment arms, including the placebo. We felt that a true placebo control was appropriate as a control condition. That said, the 25-microgram dose also serves as a sub-perceptual, sub-experiential dose of LSD, and therefore we view both of those as somewhat of control. Nonetheless, it is a dose optimization study we are looking at the response curves across this dose range. And so, including the placebo control and looking at each of these dose levels will inherently important in assessing the response across the full range and allow us to choose a dose to move into pivotal studies that we can ultimately select a single competitor again.

Yes. That’s helpful. And then just I think it was mentioned that there would be one – or it’s expected to be – have the one active session. And so, I am just wondering how the – I guess, how is the protocol kind of determined, how do the regulators kind of view the therapy sessions. And is there a way that you could have some of those sessions done virtually, or how should we think about that?

Yes, I think it’s important to contextualize exactly what you are asking, which is the role of psychotherapy. Obviously, when we zoom out, we think globally, psychotherapy, we view as a critical element in the care of patients and essential for maximizing patient outcomes. That said, in the clinical research realm, we explicitly are not delivering psychotherapy as a part of this protocol. There is, of course, a level of patient education that goes into prior to a dosing session and making sure the patients are ready for the treatment administration. There is a very rigorous level of oversight during the treatment session, which includes observation by two individuals, and this has become standard for all drugs in this class. And then there are additional follow-up visits, but none of these are psychotherapeutic in the – by definition in our protocol and certainly wouldn’t qualify as psychotherapy as you think about it traditionally.

Got it. That’s helpful. And if I may, just one on MM-110, so just with the Phase 1 trial evaluating MM-110, just regarding that top line release, what do you anticipate providing at that time? Would there be any biomarker imaging or other data, give further confidence that the compound is demonstrating more acceptable safety and tolerability profile compared to ibogaine?

Certainly, one of the key features that we are going to be looking at in those clinical results would be cardiovascular risk. That seems to be the number one liability with ibogaine based on its target emission and for arrhythmic effects. And so, we did do a characterization of the cardiovascular risk profile and along with the safety and tolerability and PK of the MM-110. So, overall, it’s going to be generally what you would anticipate from a Phase 1 kind of clinical study and all the endpoints are described on clinicaltrials.gov. So, there are not any biomarkers for clinical efficacy in this study. We certainly are looking at the data to fully characterize safety and tolerability, but also glean whatever we can about, of course, the CNS exposure and the potential to confirm that we are seeing CNS activity. So, as we look at these results, in the context of a typical Phase 1 study, I think, will be really quite interesting, and we see the comparisons to what we know in the literature about ibogaine and also what we can glean from this in terms of the likelihood of having some CNS effects.

Yes. That’s very helpful. Thank you so much.

Thanks Patrick.

[Operator Instructions] Our next question is coming from Sepehr Manochehry of Eight Capital. Please go ahead.

Thanks and congrats on the continued progress. With regards to the program that is enrolling currently, just can you give me some color on the level of enrollment? I think you mentioned there are 62 patients. When do you expect the last patient to be enrolled and I guess do you have visibility on pre-qualified subjects?

Yes. Thanks. I think you are referring to the ADHD study that’s ongoing at the moment with LSD. Yes, we have…

Yes, exactly on the December announcement. Just wondering since then, how many have been enrolled?

Absolutely, yes. We haven’t made public the current enrollment, and we typically don’t announce ongoing enrollment dates from our studies. We still anticipate a readout in the second half of 2023 from that study.

Sorry, is that second half of ‘23, correct?

Correct.

Okay. So, just wondering in terms of like, are there levers in place that you guys could play with to whether it’s accelerated enrollment or like just looking at the duration of some of these trials, I think that one is the six-week trial? What translates to this kind of late ‘23 readout timeline, and is there any levers you can pull to pull that forward? And the first thing that comes to my mind would be maybe more sites or qualifying, pre-qualifying patients? But is there anything you can point me to that might make that a little bit of a conservative estimate, or is that what you are thinking?

It’s definitely our anticipation at this point. We don’t have plans to enroll fight beyond those that we have already announced. We do pull – we have all of the levers available to us, any of these studies. There are some specific requirements for the patients to enroll in terms of the kind of the medication used and the need to wash out. And ultimately, working with Schedule 1 controlled substances creates additional burden for site start-up and the ability to fully enroll perhaps at the same rate you see with a non-controlled substance in certain instances. So, we are always looking and trying to ensure we get clinical readouts as quickly as possible. We have a number of options available to us. But at this point, we are continuing on the plan we have in place.

Understood. And with regards to the Phase 2b, maybe is there – or any of your other trials, do you have particular partnerships in place or sources of data that give you insight into potential pre-qualified patients or patients you could pre-qualify or is it going through your third-parties that are conducting the basically operating the trial sites and going through enrollment there?

Yes. Typically, the enrollment for these studies is largely driven – and recruitment efforts are largely driven at a site level. We actually have seen elsewhere from some of our peers that testing that even broader and going for centralized recruitment efforts can – in some cases, can muddy the waters further. You can get a huge volume of patients that actually screening those patients become a recruitment challenge itself to actually get to eligible patients. And so we do have multiple layers of recruitment activities that we will be pursuing both at a site level, and that’s where we largely rely at the outset. And then as we progress, as we identify enrollment rates, we can always use our terminology. We can always pull additional levers to enhance enrollment and patient availability. But at the central to these studies is really having sites that know their local population than other patients that are able to go out and recruit that.

Understood. That makes sense. And with regards to, I guess the formulation side of things, are there any hurdles in place for you to initiate the Phase 2b in terms of having enough compound or in the – at a certain level of purity that you do require for Phase 2b where you gain outside of the U.S. jurisdiction, like is there any hurdles there, or are those ready to go?

All the requisite information that would be required, both on the quality and CMC package and as well as on the clinical side was included in our IND submission. And we will certainly be updating that as we progress. But everything is included in our IND submission that was ultimately cleared by FDA. So, we feel very confident and have the materials – that we will have the materials available and that we are able to progress on that study in Q2.

Awesome. And then just the one question regarding the – I know there is the LSD/trip-stopper Ketanserin. Is that something that you expect that anticipated readout on in the near-term or…

Studies such as that, we are containing that progress of that study. Studies such as that and the investigator-initiated studies that we conducted with our colleagues at University Hospital Basel are subject to their disclosure time lines and largely come out via publication. While we have looked at the data, they are not driven by our corporate readouts as a trial that we sponsor would be. We are anticipating a readout from that study this year, although the precise timing of that is going to be subject to publication time lines and release criteria of the university.

Understood. I understand, maybe some key industry events or conferences, things like that. So, we will look out for those?

Absolutely.

Awesome. Thank you.

Thanks Sepehr.

Thank you. This concludes the question-and-answer portion of the call. I will now turn the call back over to MindMed’s CEO, Rob Barrow, for closing comments. Mr. Barrow?

Thank you. And thank you, everyone, again, for being here this morning. Before we conclude, I would also like to thank our entire team at MindMed, our investors, our analysts and many people who have made this all possible and has been supportive along the way, including, in particular, our study participants and their families, and to the – a critically important time in the treatment of brain health disorders, and we are very excited to be a part of it. I would like to thank you, again, and look forward to reconnecting the future.

Ladies and gentlemen, thank you for your participation. This concludes today’s event. You may disconnect your lines or logoff the webcast and enjoy the rest of your day.