Mind Medicine (MindMed) Inc.

And welcome to MindMed's second quarter 2023 financial results and corporate update conference call. Currently, all participants are analysts and no limos. This call is being webcast live on the investor and media session 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 second 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 10Q, the quarter ended June 30th, 2023, will be filed today with the Securities and Exchange Commission. Joining me today is Sean Greenway, our Chief Financial Officer, Dr. Dan Carlin, our Chief Medical Officer, and Dr. Miri Halpern-Wernley, 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 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 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 were made as of today, August 3, 2023. MindMed disclaims any obligation to update such statements, even if management's views change, except as required by law. We are very excited to be providing this financial and business update as we rapidly approach an exciting and critical period for MindMed, Over the past year, we have made significant progress on our R&D pipeline, which has positioned us for a series of important milestones in the coming quarters. Our most advanced lead program, MM120, or Generalized Anxiety Disorder, or GAD, has seen extraordinary enthusiasm and execution over the past 12 months. In August 2022, we dosed the first patient in our Phase IIb study of MM120 for GAD, and with the significant momentum we have achieved, We are on track to complete enrollment and patient dosing by the end of the third quarter, with top-line data on the primary endpoint through week four to be reported in the fourth quarter of this year. It is worth a moment of reflection on the significance of this upcoming milestone, given the historical importance and compelling opportunity for lysogide, or LSD. LSD is the most studied, storied, and perhaps most stigmatized drug in the psychedelic class, and it is our aim that with compelling clinical data from our Phase 2B study, our proprietary form of LSD, MM120, will become one of the leading candidates, if not the leading candidate, in the psychedelic drug class. Before we dive further into our R&D and financial updates, I would like to highlight the current backdrop of brain health disorders, which has experienced increased visibility due to worsening epidemiology and recognition of its significance on overall well-being. with a particular appreciation for the breadth and magnitude of impact that anxiety plays in driving brain health disorders. We've been heartened by the recent comments from the president regarding the need to improve access to mental health care and remain supportive of broad and concrete steps to do just that. Given that the annual health care costs for people with a behavioral health condition are three and a half times higher than for those without a behavioral health condition, the need for better access to mental health care is clear. We believe the re-emerging potential of LSD as a pharmaceutical candidate is also mirrored by the growing appreciation for the core nature of anxiety and psychiatric disorders, including GAD in particular. GAD is an often debilitating mental health disorder associated with excessive anxiety and persistent worry, which can lead to significant impairment, including less accomplishment at work and reduced labor force participation, as well as significantly higher rates of other comorbid conditions. And unfortunately, the problem has grown significantly over the past several years. A recent mental health prevalence study that was prepared for the Substance Abuse and Mental Health Services Administration, or SAMHSA, found that 10% of U.S. adults report having generalizing anxiety disorder diagnosis, making it the second most common mental health disorder among adults. In comparison to historical studies of the prevalence of GAD, the condition appears to have tripled in the last two decades alone. This reality is reinforced by the recent emphasis on anxiety screening as last year, the U.S. Preventative Services Task Force, or USPSTF, issued a recommendation to screen for anxiety all children and adolescents aged 8 to 18 years and issued a draft recommendation to screen all adults under the age of 65. This growth in prevalence and focus of anxiety disorders has unfortunately not been matched by innovative treatments. with the treatment landscape remaining dominated by SSRIs, SNRIs, benzodiazepines, and in more limited cases, antipsychotics. In fact, the last original approved marketing application that was focused on the treatment of GAD was obtained for Cymbalta in 2004. And despite their broad use, which represents approximately $3 billion in annual U.S. revenues, available therapies suffer from a variety of efficacy, safety, and tolerability challenges. that lead to low rates of compliance and remission. The simple reality is that for many years, GAD has been an overlooked indication, precisely because the most used treatment options, such as SSRIs, appear to be less well-equipped to treat anxiety symptoms than depression symptoms. This presents both in the relatively lower response to SSRIs in GAD versus MDD, but also in the fact that MDD patients with heightened anxiety typically respond less well to current standards of care. Quantitatively, this is displayed by the fact that current therapies for GAD have demonstrated a standardized effect size of around 0.4 in clinical trials, with some demonstrating a considerably lower response. The research we have conducted with patients and healthcare practitioners in the U.S. and Europe tells us that there is a significant demand for a new pharmacological class that could offer faster, more profound, and more durable efficacy responses, as well as favorable safety and tolerability. This is particularly true in the segment of patients who, despite having tried currently available therapies, continue to experience intolerable anxiety. We believe this is a major contributor to the high degree of enthusiasm we consistently hear from patients, providers, and payers on the revolutionary potential of MM120 in psychiatric disorders. As one prominent psychiatrist recently put it, the days of SSRIs and the like are limited. On a related note, in June, FDA released draft guidance for developing drugs in psychedelic drug class. Notably, this guidance highlights the reality that dose response is not well understood to the drug class and emphasizes the need for elucidation of dose response relationships exactly as we are doing. The draft guidance also notes the importance of establishing a standalone drug effect that is in the absence of psychotherapy, which is exactly as we designed our clinical trial over two years ago. In our view, our approach is clearly in line with the FDA guidance and importantly allows for consistent study design and treatment delivery paradigm as we potentially advance into pivotal clinical trials. To our knowledge, our Phase IIb study of MM120 in GAD is the largest controlled study of LSD ever conducted and will guide the dose selection and development strategy for MM120 in GAD. as well as deepen our scientific understanding of its clinical effects and its underlying functional mechanisms of action. It's important to point out that we dosed our first patient just under one year ago in August of 2022, with activation of all of our clinical sites only occurring at the beginning of 2023. The ability of our team to execute a study of this size so seamlessly and efficiently stands out within the field and also speaks to the quality of the organization we have built at MyMed. It also reinforces our high degree of confidence in our team's ability to launch and enroll future studies in a very efficient manner. Patient dosing and enrollment for our Phase IIb trial in GAD is progressing well across our 20 active sites, and we expect to complete study enrollment in the third quarter of this year, with top-line results to be reported in the fourth quarter of this year. Patients in the trial are randomly assigned to receive a single administration of either 25, 50, 100, or 200 micrograms of MM120 or a placebo, and are then followed for up to 12 weeks. The primary objective of the study is to determine the dose-response relationship of MM120 across the four active dose arms as measured by the Change in Hamilton Anxiety Rating Scale, or HAM-A, at four weeks post-dosing. The statistical analysis being employed in the study is a multiple comparison procedure modeling, or MCP-MOD approach, a sophisticated statistical approach developed by Novartis which is especially well-equipped to demonstrate dose response and optimize dose selection. This statistical approach, which has received qualification opinions from both FDA and EMA, has superior power and lower estimation errors compared to more traditional design, which we believe bolsters the probability of success of our approach. As we finalized the statistical analysis plan for our Phase 2b study, we have also made the determination that due to the high powering of our approach, a reduction in the minimum sample size is warranted. And as a result, we are reducing the enrollment target by 10% from 200 patients to 180 patients. We believe this change maintains a statistical power of approximately 90% to achieve the study's objectives. And based on our internal modeling, this is a high degree of confidence in obtaining statistically positive results if we observe an effect size that represents even a marginal improvement over the standard of scare. As we rapidly approach conclusion of our Phase IIb study, we are also excited to share our plans for the ultimate formulation we intend to advance for our MM120 product candidate, specifically utilizing Catalan Zytis ODT technology, as we announced earlier today. Over the past years, we explored numerous advanced dosage forms with the aim of enhancing pharmaceutical performance and intellectual property protection, creating a product that is difficult to replicate and has the opportunity to demonstrate more attractive pharmacokinetic performance characteristics, such as faster absorption, better bioavailability, reduced variability, and as a result, the potential for reduced duration of perceptual activity. Toward this end, we entered into an exclusive license agreement with Catalin that covers all forms of LSD across all major pharmaceutical markets. Catalin is a global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development launch, and supply a better patient treatment across multiple modalities. With our agreement, MyMed has gained access to Catalan's patented Zydus Orally Disintegrating Tablet, or ODT, technology for use with NM120. Catalan's proprietary Zydus technology is a unique freeze-dried oral-solid dosage form that disperses almost instantly in the mouth without the need for water. We believe that the Zytus ODT delivery technology, when incorporated into our MM120 product candidate, represents an optimized pharmaceutical product that has the potential to enhance our competitive advantage in the marketplace and continue to expand our intellectual property estate, with the first relevant patent application not expiring until 2042, assuming our patent application claims are issued and granted. To further support this transition, we are also planning to initiate a Phase I pharmacokinetics bridging study, to support the advancement of MN120 ODTs into pivotal clinical trials. We believe this will allow for precise dose selection for phase three, providing valuable data to bolster our intellectual property position. Additionally, we have either completed or in advance planning to complete all prerequisite studies that we believe will enable an efficient transition from the conclusion of our phase two clinical program into pivotal phase three studies. In addition to the session-based delivery of MN120 and GAD, We are investigating the direct neuropharmacological activity of MN120 as a serotonin agonist and innovative treatment regimen. One such exploratory approach is our phase two proof of concept study of MN120 for ADHD. This study is being conducted in collaboration with University Hospital Basel in Switzerland and Maastricht University in the Netherlands and is designed to evaluate the therapeutic utility of repeated low doses of MN120 in adult patients with ADHD. Notably, this is the first study in which MM120 has been administered outside of a clinical setting. To date, no SAEs have been reported suggesting the real-world potential of this treatment regimen, as well as demonstrating our ability to deliver MM120 with innovative dose and frequency combinations. We expect to enroll a total of 52 participants who will receive a 20-microgram dose of MM120 or placebo twice weekly for six weeks, with the primary import for this study being the mean change from baseline and ADHD symptoms, as assessed by the AISRS after six weeks of treatment. Enrollment in the study has continued to progress with over 80% of enrollment complete. However, due to controlled substance importation challenges at our Netherlands site, we now anticipate reporting top-line results in either the fourth quarter of 2023 or the first quarter of 2024.