Mind Medicine (MindMed) Inc.

Good afternoon, and welcome to the Mind Medicine 3rd 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. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star, then one, on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and zero. 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, the quarter ended September 30, 2023, will be 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, financial projections, 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 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 MyMed'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. MyMed disclaims any obligation to upstate 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, Dr. Daniel Carlin, our Chief Medical Officer, and Dr. Francois Lowenthal, our Chief Commercial Officer. We're 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 important milestones in the coming quarters, in particular, the top-line data readout from our Phase 2b trial of MN120 and Generalized Anxiety Disorder, or GAD. We believe our team continues to demonstrate best-in-class execution and with a cash runway that funds our organization into 2026 if certain milestones are achieved that unlock additional capital. We feel that we are well positioned to continue accelerating across our R&D pipeline. Our progress comes at a critical time with an urgent 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 aged 18 to 65 years old. In comparison to historical studies of the prevalence of GAD, this condition appears to have tripled in the last two decades alone, with an estimated prevalence of about 10% today. This growth in prevalence and focus on anxiety disorders has unfortunately not been matched by innovative treatments, with the treatment landscape continuing to be dominated by serotonin reuptake inhibitors, benzodiazepines, and in more limited cases, antipsychotics. In fact, the last approved original marketing application for the treatment of GAD was obtained for Cymbalta in 2004. Seeking to address these growing issues, our R&D pipeline is focused on two lead candidates, MM120, the lysergi 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 both a session-based delivery paradigm such as with MM120 and GAD, in which the product candidate is administered under ongoing healthcare supervision, and the standard outpatient drug delivery paradigm, such as with MM120, as we explore recurrent non-hallucinogenic administration models, and with MM402 in autism spectrum disorder, which we envision being administered on a daily at-home basis. Our MM120 program in GAD has seen extraordinary enthusiasm and execution over the past year. In August 2022, we dosed the first patient in our Phase IIb dose optimization study at MN120 for GAD. We completed enrollment in the study in just over one year and are now on the cusp of reporting top-line data through four weeks of follow-up later this quarter. GAD is a common debilitating brain health disorder that is underserved by currently available therapies. These therapies include serotonin reuptake inhibitors, benzodiazepines, and in more limited cases, fusferon and antipsychotics, all of which present inadequate efficacy profiles in many patients and often involve side effects that are intolerable and dose or duration limiting. Against this backdrop, we seek to develop MM120 in a best-in-class therapy with a novel mechanism of action, in which an acute or single administration leads to weeks or even months of clinical benefit. In addition to the session-based delivery of MN120 and GAD, we are investigating the direct neuropharmacological activity of MN120 as a serotonin agonist in an innovative treatment regimen. One such exploratory approach is our Phase II proof-of-concept study of MN120 in ADHD. This study is being conducted in collaboration with University Hospital Basel in Switzerland and Maastricht University in the Netherlands and was designed to evaluate the therapeutic utility of repeat low doses of MN120 in adult patients with ADHD. To date, no SAEs have been reported, suggesting the real-world potential of this treatment regimen, as well as demonstrating our ability to deliver MN120 with innovative dose and frequency combinations. As we announced in October, enrollment in this proof-of-concept study is complete with a total of 53 participants administered either 20 micrograms of MM120 or placebo twice weekly for up to six weeks. The primary endpoint in the study is a mean change from baseline in ADHD symptoms as assessed by the Adult ADHD Investigator Symptom Rating Scale, or AISRS, after six weeks of administration. We anticipate reporting top-line results from this study by the end of the first quarter of 2024. Our second lead program is MM402, which is the RNA tumor of MDMA. We believe MM402 holds promise for its potential prosocial effects and favorable tolerability profile versus racemic MDMA. 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 RNA tumor 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 this year, have shown acute prosocial and pathogenic effects. while its reduced dopaminergic activity suggests it might exhibit fewer stimulant, neurotoxic, hyperthermic, and abuse-related effects compared to racemic MDMA or BS enhancement. With robust preclinical evidence supporting our approach, we are excited to launch the Phase I clinical trial of MM402, which we expect to initiate later this quarter. The trial aims to assess MM402's tolerability, pharmacokinetics, and pharmacodynamics and we are actively exploring all possibilities to generate early indications of efficacy during development. Concurrently, we are collaborating with University Hospital Basel to conduct a comparative Phase I pharmacokinetic and pharmacodynamic study of R, S, and racemic MDMA. This study was designed to enroll healthy volunteers and to evaluate the tolerability of pharmacokinetics in acute subjective, physiological, and endocrine effects in the three molecules. Successful completion of this study is expected to expedite our understanding of MM402's pharmacological profile as we progress into later stages of clinical development. We've been informed by the UHB investigators that they anticipate completing enrollment of the study by the fourth quarter of this year and anticipate that data will be presented in the first half of 2024. With the upcoming readout for our Phase IIb study of MM120 and GAD, We'll now take a moment to dive deeper into the context and approach to this important program. Lysergide, or LSD, is the most extensively studied drug in the psychedelic drug class, with over 10,000 individuals administered the molecule in clinical trials alone. This includes hundreds of patients suffering from anxiety, depression, and other neurotic disorders across dozens of studies, which has consistently shown the potential of lysogide to deliver rapid and durable benefits with a magnitude of clinical activity that is double or triple that of the standard of care. Our Phase IIb study of MN120 and GAD was designed to characterize dose-response relationship of MN120 and GAD across a wide range of doses. Our approach utilized an industry-standard study design with entry criteria and clinical endpoints that we believe are replicable in pivotal studies. As announced in September, we completed enrollment and dosing in our Phase 2b trial with top-line results to be reported later this quarter. A total of 198 patients were randomized and administered a single dose of either 25, 50, 100, or 200 micrograms of M120 or a placebo. and followed for up to 12 weeks. The primary objective of this study is to determine the dose-response relationship of MN120 across the four active dose arms as measured by the change in Hamilton Anxiety Rating Scale, or HAM-A, at four weeks post-dosing. This is the first large modern study to test the standalone pharmacological effects of a psychedelic drug candidate, that is, in the absence of any psychotherapeutic intervention. the importance of which was emphasized in the FDA draft guidance on clinical trials with psychedelic drugs earlier this summer. We believe that it will also help provide key insights to inform an optimal Phase III program, the design of which we anticipate discussing with the FDA at an end-of-Phase II meeting after the conclusion of our Phase IIb study. We believe the design and conduct of our Phase IIb study is perhaps the most closely aligned with the FDA guidance that has ever been conducted, and as such, We are well-positioned to seamlessly transition into typical studies of MN120 and GAD, subject to positive results from our Phase IIb study rate of this quarter. From a statistical standpoint, our Phase IIb study utilized an approach called the Multiple Comparison Procedure Modeling, or MCP-MOD approach, a sophisticated statistical technique developed by Novartis in 2004, which we believe is especially well-equipped to demonstrate dose response and optimize dose selection. The MCP mod analysis involves a two-part statistical test, which first assesses whether any dose response exists, then assesses which of the pre-specified dose response curves, as illustrated on the right, most closely fits the data. This statistical methodology has received qualification opinions from both FDA and EMA, with both agencies commenting on the statistical efficiency and effectiveness of the approach due to the utilization of all available data that is captured across the study arms. and informs the statistical conclusion. As we approach top-line data for MM120 and GAD, it is important to contextualize the current treatment landscape and associated magnitudes of clinical response. The current standard of care for GAD is dominated by serotonin reuptake inhibitors and benzodiazepines, which account for approximately 80% of the market by dollar value here in the U.S. Even so, results from peer-reviewed publications highlight the relatively modest clinical response to currently available therapies, exemplified by a standardized effect size of under 0.4 for the leading GAD therapies. As a reminder, the standardized effect size can be conceptualized as a mean placebo-adjusted change divided by the standard deviation of that change. It is a useful measure of overall treatment effect between studies. A commonly cited review of GAD treatment that analyzed clinical data from 21 double-blind placebo-controlled studies found an average effect size of 0.36 for SRIs, 0.38 for benzodiazepines, and only 0.17 for buspirone. These results and other published literature suggest that an effect size of 0.36 or better is viewed by the medical community as a clinically meaningful outcome, which is consistent with the feedback we have received from numerous key opinion leaders and practitioners in psychiatry. In addition to our conviction that MN120 may represent a best-in-class therapy for the treatment of GAD, We believe that we will be able to achieve a scalable, widely adoptable treatment model with attractive delivery dynamics in comparison to recent innovative products in psychiatry, such as Janssen Spravato or intranasal S-ketamine, which is currently approved to treat treatment-resistant depression.

Each Spravato administration session requires two hours of monitoring. Spravato is indicated for administration twice weekly during a four-week induction phase. for a total of up to eight treatment sessions or 16 hours of monitoring in the first month alone.