Mind Medicine (MindMed) Inc.

Good morning and welcome to the Mind Medicine Full Year 2021 Financial Results and Corporate Update Conference call. Currently, all participants are on 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 MyMed's website, and our annual report on Form 10-K for the year ended December 31st, 2021 will be filed today with the Securities and Exchange Commission. Joining me today is Dr. Dan Carlin, our Chief Medical Officer, and Dr. Miri Halpern-Wernly, 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 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. MyMed disclaims any obligation to update such statements, even if management views change. Before we dive into our program and corporate updates, 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 in 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've assembled at MindMed is unmatched expertise, and we are utilizing decades of academic research to accelerate our three lead drug candidates, MM120, MM110, and MM402, along with other novel therapies. We are extremely pleased with the progress and transformational growth that propelled our business forward over 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 and 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 Carlin, 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, MM120. MM120 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 US adults in their lifetimes. Symptoms of GAD include excessive anxiety and worry that persists for over six 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 MM120 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 MM120 or placebo. The primary objective of the study is to determine the reduction in anxiety symptoms for up to 12 weeks after a single administration of MM120 across five treatment arms. I want to thank our dedicated clinical and regulatory teams here at MyMed 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 MyMed and for the industry as a whole, as it marks the first large commercially sponsored study of LSD in more than 40 years. The results of this trial will guide the dose selection and development strategy for our pivotal phase three clinical trials, as well as deepen our scientific understanding of the clinical effects of MM120 and its underlying mechanisms of action. With a clear regulatory path, We look forward to building on this momentum and advancing this trial as quickly and efficiently as possible to address the unmet needs of patients who suffer from GAD. In parallel, we are currently enrolling patients in our phase 2A proof of concept trial of MM120 for the treatment of ADHD. We expect top line data in late 2023. While ADHD is often associated with children and adolescents, adults living with the disease face numerous challenges, from debilitating struggles with time management and impulsivity to mood swings and disorganization. Between 2007 and 2016 alone, the rate of ADHD amongst adults increased by 123%. Of the estimated 10 million American adults with ADHD, it is estimated that only about 10% seek and receive treatment for their condition. Interestingly, There is anecdotal evidence suggesting psychedelics such as LSD have beneficial and lasting effects on mood and selective cognitive processes when administered repeatedly at low doses. Further, low doses of LSD have been shown to be safe, well-tolerated, and have minimal effects on physiological parameters. This Phase IIa POC trial is being conducted in collaboration with the University Hospital Basel in Switzerland and Maastricht University in the Netherlands. and is designed to evaluate the therapeutic utility of repeated low doses of LSD in adult patients with ADHD. The trial plans to enroll a total of 52 participants who will receive a 20-microgram dose of MM120 or placebo twice weekly for six weeks. The primary endpoints for this study are immune change from Bayfine and ADHD symptoms as assessed by the AISRS after six weeks of treatment. We look forward to driving this exploratory trial forward as part of our broader comprehensive LSD clinical development strategy. In addition to our ongoing phase two studies for MM120 in GAD and ADHD, we are currently advancing our strategic plans for MM120 in the treatment of select pain conditions and plan to initiate a clinical study of MM120 in chronic pain in late 2022. Moving on to our work in substance use disorders. The ongoing and ever-growing opioid crisis claims over 75,000 lives each year and impacts the lives of countless others. While Ibogaine has been used and studied as a treatment for opioid addiction, its efficacy, while promising, has been overshadowed by significant safety concerns. Our proprietary molecule, MM110, also known as Zolunacant and 18MC, is an alpha-3, beta-4 nicotinic cholinergic receptor antagonist that has been tested extensively in preclinical models of withdrawal and substance use disorders. MM110 was demonstrated to reduce scientific opioid withdrawal and reduce self-administration of opioids, stimulants, nicotine, and ethanol. Extensive preclinical characterization has also shown Zolunocant to have a strong safety and tolerability profile. Importantly, Zolunocant has the potential to overcome safety limitations of Ibogaine and has not demonstrated proarrhythmic or neurotoxic activity. We recently completed a phase one study of MM110 in late 2021, which assessed the safety, tolerability, pharmacokinetics, and cognitive effects of MM110 in healthy volunteers. In this phase one single ascending dose and multiple ascending dose trial, subjects either received doses between four and 325 milligrams twice per day for one day, or doses between two and 90 milligrams twice per day for up to seven days. We plan to release top line data from the phase one study and to initiate our phase 2A clinical trial of MM110 in opioid withdrawal in the second quarter of 2022. Turning to a few key updates on our third lead program, MM402 or RMDMA, which is a synthetic and anti-mere MDMA that exhibits pro-social and in pathogenic activity in preclinical models. We are developing MM402 for the treatment of the core symptoms of autism spectrum disorder, or ASD, which is a developmental disorder characterized by atypical social communication and interactions, repetitive patterns of behavior, and restricted interests. Despite its significant and growing prevalence, there are no therapies approved to treat the core symptoms of ASD, with currently used medications serving either to treat comorbid disorders or used for behavioral control. Our hope for MM402 is to demonstrate efficacy at enhancing social engagement and interaction rather than having sedating or blending effects on individuals with ASD. Preclinical studies of RMDMA demonstrate its acute prosocial effects while its diminished dopaminergic activities suggest that it will exhibit a favorable safety and tolerability profile compared to racemic MDMA or DS enantiomer. We are currently conducting comprehensive preclinical studies to facilitate sponsored clinical research studies of RMDMA beginning in 2023. Additionally, through our research collaboration with University Hospital Basel, we plan to initiate a comparative phase one pharmacokinetics and pharmacodynamic study of RS and racemic MDMA in mid-2022. Moving on to digital medicine. Our drug development strategy is closely complemented by a platform of digital medicine products that have the potential to facilitate adoption, use, and access to our therapeutics. In February 2021, the company completed the acquisition of Health Mode and fully integrated its team to enable rapid progression of our digital medicine and business operations functions. With that team in place, we engaged in a productive pre-submission meeting with FDA in late 2021. In January of this year, the first subjects were enrolled into the Session Monitoring System, SMS01, study. SMS01 is evaluating the passive collection of sensory data during a consciousness-altering therapeutic session using the MindMed Session Monitoring System, or MSMS. MSMS is a technological platform that provides the foundation for the development and implementation of a suite of products for use by clinicians and patients during treatment sessions It may also include the use of consciousness-altering medications. The launch of this study is an important milestone for our future development of regulated devices and software as medical devices, or SAMD products, that are designed to support novel analyses of multimodal data in the delivery of psychiatric care. The study will provide data that support the development of critical analysis algorithms. Subsequent studies will intend to provide the evidence necessary for FDA clearance. The second of our key active digital medicine efforts called Anxiety Digital Diagnoses for Precision Psychiatry, or ADAPT, is a combination of a natural history study and a newly developed mobile application to support the study. The study and its supporting app are expected to launch in private beta in the second quarter of 2022. Our third key digital medicine effort progressed such that in September 2021, The first participants were enrolled by invitation in the Quantifying the Processes and Events of Psychotherapy at Scale study, which will provide a rich data set to enable a better understanding of patient progression, trends, and characteristics in the real-world treatment environment, and inform all aspects of our program planning. We believe our digital medicine products and projects could have monitoring and therapeutic benefits across a range of psychiatric disorders. By refining the techniques used to capture, model, and map the autonomic and behavioral outflow and other correlates to neural activity, we aim to improve the experience of clinicians and the outcomes for patients in the delivery of psychedelic and other perception-altering substances and psychotherapies. Our team has worked incredibly hard to advance this product into the clinic, and we remain dedicated to rolling out these novel approaches and improving psychiatric outcomes for patients. Overall, we are extremely excited about these advancements and the value-driving milestones ahead. With that, I will turn the call over to Dr. Miri Halperin-Wernly, our executive president, to discuss our exciting research collaboration and early-stage research and development activities.