Mind Medicine (MindMed) Inc.

Good morning, and welcome to the MindMedicine full year 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 morning, everyone. Welcome to our full year 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 annual report on Form 10-K for the year ended December 31st, 2023 is being filed today with the Securities and Exchange Commission. 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 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 that are described in the filings made with the SEC, including our annual report on Form 10-K being filed today. 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, February 28, 2024. 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 Sean Greenway, our Chief Financial Officer, and Dr. Daniel Carlin, our Chief Medical Officer. We are excited to be providing this financial and business update during this important period for MindMed. 2023 was a highly productive year for MindMed, which concluded with positive Phase IIb results for MM120 in the treatment of patients with generalized anxiety disorder, or GAD. We believe that the initial data we shared validates our scientific understanding of MM120's mechanism of action and shows the potential for an emerging best-in-class product profile compared to today's standard of care. On March 7th, we will be hosting a virtual investor event during which we look forward to sharing top-line 12-week data from our Phase 2b study of MM120 and GAD, as well as KOL perspectives on the generalized anxiety disorder market, the data, and our initial views on the commercial opportunities. In addition, we anticipate sharing results from our Phase I pharmacokinetics bridging trial to support the differentiated product profile of our MM120 orally dissolving tablet, or ODT formulation, and its advancement into pivotal clinical trials in GAD. We are excited about this upcoming event and hope most of you will be able to join us. Please keep an eye out for additional information. Looking further into 2024, we'll be working closely with the FDA to finalize our phase three development program for MM120 and GAD, and expect to hold our end of phase two meeting with the FDA in the first half of the year. This is intended to enable the initiation of our phase three clinical program in the second half of the year. In addition, this year we anticipate sharing one year follow up results from a study of lysogyne and anxiety disorders, which was conducted by our collaborators at University Hospital Basel. Our progress comes at a crucial time with an urgent unmet need for better treatments to address the ongoing epidemic of brain health disorders, a situation that has grown significantly worse over the past several years. In our lead indication, GAD, for example, a recent mental health prevalence study that was prepared for the Substance Abuse and Mental Health Services Administration found that 10% of U.S. adults report having symptoms consistent with a GAD diagnosis. making it the second most common mental health disorder among adults 18 to 65 years old. In comparison to historical studies of the prevalence of GAD, the condition appears to have tripled in the last two decades alone. This growth in prevalence and focus of anxiety disorders has unfortunately not been matched by innovative treatments, with the treatment landscape remaining dominated by SRIs, benzodiazepines, and in more limited cases, antipsychotics. In fact, The last original approved marketing application that was focused on the treatment of JAD was obtained for Cymbalta in 2004. While each of these medicines have gone on to become blockbuster products driving significant value to the innovators, the efficacy of these products has been limited, and in many instances, intolerable side effects such as sexual dysfunction and weight gain have led to noncompliance and discontinuation of treatment, which we believe has created a significant need in the market for novel treatment options. Seeking to address these growing issues, our R&D pipeline is focused on two lead product candidates, MM120, or lysogide detartrate, and MM402, or RMDMA. Additionally, through a broad collaboration with researchers at University Hospital Basel in Switzerland, we are exploring the potential of several assets to potentially expand our development pipeline as our lead programs continue to progress. Across these development programs, we are utilizing two different delivery pairs. For MM120 and GAD, we are pursuing a session-based delivery approach in which the product candidate is administered under ongoing healthcare supervision. Separately, for MM402 and ASD, we are pursuing a standard outpatient drug delivery approach in which we envision the product candidate being administered on a daily at-home basis. Our MM120 program in GAD has seen extraordinary progress over the past year, culminating in the four-week data from our Phase IIb trial that we announced in December 2023. The trial met its primary endpoint with statistical and clinically meaningful reductions in HAM-A scores four weeks after a single administration of MM120. We observed the largest clinical activity in the 100-microgram dose group with an observed effect size of 0.88. On an absolute basis, this represents a 21.3-point improvement in HAM-A score from baseline to week four, and with 7.6 points better than placebo, with an associated p-value of 0.0004. In this group, we also observed a 78% clinical response rate and a 50% clinical remission rate at four weeks, meaning that four weeks after a single dose of MM120, half of the participants no longer showed clinically significant anxiety, and 78% of participants achieved a 50% or greater reduction in HAM-A score. Additionally, we observed clinically and statistically significant improvements in all of the secondary endpoints at all time points analyzed as part of the top-line analysis, which included HAM-A, CGIS, and Madras results through week four. MN120 was well-tolerated in the trial with mostly transient, mild to moderate adverse events that predominantly occurred on the dosing day. In the context of currently available therapies for GAD, these results represent a major step forward in a field that has suffered from practically no innovation in the last 20 years. The Cohen's D standardized effect size of 0.88 in the 100 microgram dose group is more than double the effect size of the current standard of care for GAD, which are estimated to have effect sizes below 0.4 on average. We believe this result can wholly be attributed to the standalone effect of MN120 treatments as the study was conducted in the absence of any other therapeutic intervention. These results also go on over 20 legacy studies of lysogide or LSD in anxiety, depression, and other neurotic disorders, including our collaborators' investigator-initiated trial in anxiety that delivered statistically significant results in mid-2022. We believe that the MM120 Phase IIb data clearly supports dose selection for our subsequent research, and it supports advancement into pivotal Phase III clinical trials for GAD. With the results of this trial, we achieved all of our goals of Phase II development for MM120. In particular, we have rigorously characterized the dose-response relationship of MM120 and GAD, achieved statistically significant and clinically meaningful results supporting its clinical activity, and demonstrated the standalone impact of MM120 to deliver rapid and durable clinical benefits on validated and regulatory-accepted endpoints. With this exciting progress, we are entering a phase of many anticipated key development milestones in the quarters ahead. As I mentioned earlier, at our upcoming investor event on March 7th, we will be sharing top-line 12-week data from our Phase 2b study of MM120 and GAD, along with PK bridging data for our intended go-to-market formulation, which we believe will serve to further differentiate our product candidate and demonstrate its compelling clinical potential. We anticipate having an end-of-Phase II meeting with FDA in the first half of 2024 to align on the scope of our Phase III development program for MM120 and GAD, and to initiate our Phase III clinical program in the second half of the year. We also plan to present full data from our Phase IIb trial of MM120 and GAD at a scientific meeting in 2024, and are excited to share the breadth of findings from this rich data set. Additionally, based on the promising data we have observed for MM120 and indications beyond GAD, such as depression, we're actively evaluating additional clinical indications and believe the overall development program for MM120 may represent the best-in-class treatment for GAD and beyond. Our second lead program is MM402, which is the RNA instrument of MDMA. We believe MM402 holds promise for its potential pro-social effects and favorable tolerability profile versus racemic MDMA or the S enantiomer. The focus of our MM402 program is to develop a regularly administered product that treats the core symptoms of autism spectrum disorder, or ASD, in particular social communication difficulties. Remarkably, despite the significant and increasing prevalence of ASD, there are currently no approved therapies specifically targeted at its core symptoms. MDMA, often referred to as an empathogen, is a synthetic molecule known to enhance feelings of connectedness and compassion. The RN antimer of MDMA, in particular, is believed to boost serotonin and other neurotransmitter levels in the brain, leading to increased sociability and interpersonal emotional connection. Preclinical studies of RMDMA, including those we reported earlier in 2023, have shown acute prosocial and empathogenic effects. while its reduced dopaminergic activity suggests it might exhibit fewer stimulant, neurotoxic, hyperthermic, and abuse-related effects compared to racemic MDMA or the S enantiomer. With robust preclinical evidence supporting our approach, we have initiated our first clinical trial of MM402, a single ascending dose trial in adult healthy volunteers in the fourth quarter of 2023. This Phase I trial is intended to characterize the tolerability, pharmacokinetics, and pharmacodynamics of MM402 and will enable further clinical studies to characterize the effects of repeated daily doses of MM402 and the exploration of early signs of efficacy in the ASD population. Concurrently, we have collaborated with our colleagues at University Hospital Basel to conduct a comparative Phase I pharmacokinetics and pharmacodynamics study of RS and racemic MDMA. which has been completed with data anticipated in the first half of this year. This study enrolled healthy volunteers and was designed to evaluate the tolerability pharmacokinetics in acute subjective physiological and endocrine effects of the three molecules. We believe the results from this trial will expand and expedite our understanding of MM402's pharmacological profile as we progress into later stage clinical development. With that, I will turn the call over to Sean Greenway to go over our financial results. Sean?

Thanks, Rob, and thank you all for joining us today. We will now turn to our financial results for the year ended December 31st, 2023. As of December 31st, 2023, the company had cash and cash equivalents totaling $99.7 million compared to $142.1 million as of December 31st, 2022. We believe that our available cash and cash equivalents, as well as our committed credit facility, are expected to fund operations into 2026 if certain milestones are achieved that unlock additional capital. For the year ended December 31st, 2023, net cash used in operating activities was $64.4 million compared to $50.1 million for the year ended December 31st, 2022. Research and development expenses were $52.1 million for the year ended December 31st, 2023 compared to $36.2 million for the same period in 2022, representing an increase of $15.9 million. The increase was primarily due to increases of $16.1 million in expenses related to clinical research and product development for the MM120 GAD Phase IIb trial, and $2.6 million in internal personnel costs as a result of increase in research and development capacities, which were offset by a decrease of $0.7 million in expenses related to our M402 program, a decrease of $0.8 million in expenses related to various external research and development cooperations, and a decrease of $1.2 million in expenses related to preclinical activities. General and administrative expenses were $41.7 million for the year ended December 31, 2023, compared to $30.2 million for the same period in 2022. representing an increase of $11.5 million. The increase was primarily attributable to professional services fees and expenses related to the proxy contest in connection with our 2023 annual general meeting of shareholders and additional costs to support the growth of our business. The company's net loss for the year ended December 31st, 2023 was $95.7 million compared to $56.8 million for the same period in 2022. I will now turn the call back to Rob, who will provide some closing comments.