Mind Medicine (MindMed) Inc.

Good day and thank you for standing by. Welcome to the MindMed Q1 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Rob Barrow, CEO of MindMed. Please go ahead.

Thank you, and good afternoon, everyone. Welcome to our first quarter 2024 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 from 10Q for the quarter ended March 31, 2024, 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. These and other risk factors are described in the filings made with the SEC, including our annual report on Form 10-K and our Form 10-Q 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 of the SEC or other significant events occurring outside of MyMed's normal course of business. Your caution not to place undue reliance on these forward-looking statements, which are made as of today, May 8, 2024. MyMed 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 Dr. Daniel Carlin, our chief medical officer, and Dr. Francois Lillevaux, our chief commercial officer. Earlier today, we announced the transition of Sean Greenway, who as of May 3rd is no longer serving as our chief financial officer. On behalf of the board and the company, I want to thank Sean for all of his hard work and dedication to our mission over the past two years and wish him the best of luck in his future endeavors. We've retained an executive search firm to assist in identifying a new chief financial officer to support the next phase of MindMed's growth and evolution. Moving back to our first quarter results, we are excited to be providing this financial and business update during this important period for MindMed. It has been a fantastic start to the year and a highly productive quarter for MindMed, which was highlighted with the positive 12-week data from our Phase IIb clinical trial for MM120 and the treatment of generalized anxiety disorder, or GAD. Alongside the data, we were thrilled to announce that FDA designated MM120 as a breakthrough therapy in the treatment of GAD. This designation is reserved for therapies that are intended to treat a serious or life-threatening condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. We believe receiving this FDA designation in the positive phase 2b trial data we shared reinforces MM120's potential as an emerging best-in-class product compared to today's standard of care. On the heels of the MM120 data in March, we completed a successful oversubscribed underwritten offering in concurrent private placement, raising approximately $175 million in gross proceeds before deducting transaction fees and other offering-related expenses. Participants in the offering included some of the most respected blue chip institutional healthcare investors, which we believe further validate the great work that we have been able to achieve over the past year. Most importantly, this financing puts MindMed in its strongest financial position ever, and we expect that it will fund the company through important development milestones for MM120 and other programs in our pipeline. Finally, we announced several scientific posters and presentations that we have shared at various medical meetings. In April, we presented posters at the European Psychiatric Association's 2024 Congress in Budapest, Hungary, and the Anxiety and Depressions Association of America 2024 Conference in Boston. This month, we presented detailed results of the American Psychiatric Association's 2024 Congress and at the International Society for Pharmacoeconomics and Outcomes Research. These poster presentations covered data from our Phase IIb trial of MM120 and GAD, as well as studies related to the epidemiology and growing burden of GAD, which we believe remains underappreciated. Additionally, our collaborators from University Hospital Basel will be sharing one-year follow-up results from a Phase II investigator-initiated study of lysegide in the treatment of anxiety disorders at the Society of Biological Psychiatry 2024 Annual Meeting being held May 9th through 11th in Austin, Texas. Overall, increasing our visibility at these key scientific meetings represents an important strategic initiative for MindMed in 2024 as we look to expand awareness of our work and build MindMed's profile within the scientific community. Our progress comes at a crucial time with an urgent need for better treatments to address the 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 the 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. Our MM120 program in GAD has seen extraordinary progress over the past year. culminating in the four-week data from our Phase 2b trial that we announced in December 2023 and the subsequent positive 12-week follow-up data that we shared in March. Results have exceeded our target product profile for MM120, demonstrating a significant improvement in all analyzed endpoints for up to 12 weeks after just a single dose and without any additional therapeutic intervention. We believe these results demonstrate the fast-acting and durable clinical activity of MM120 along with its favorable tolerability profile. In the context of currently available therapies for GAD, these data represent a major step forward in a field that has suffered from practically no innovation in the past 20 years. The Cullens D standardized effect size 0.81 in the 100-microgram dose group at 12 weeks is more than double the estimated effect size in the current standards 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 MM120, as the trial was conducted in the absence of any other therapeutic intervention. We also reported results from our MM120 PK bridging trial, evaluating the MM120 orally dissolving tablet, or ODT formulation, that delivered upon our clinical aspirations for the new product formulation. The ODT formulation provides numerous benefits, including extending MM120's intellectual property profile, as well as product performance benefits, such as enhanced bioavailability and increased area under the curve at therapeutic concentrations that further differentiates MM120's clinical profile. Overall, the characteristics of the ODT formulation demonstrated in the PK bridging trial offer what we believe is compelling evidence for its differentiated clinical profile and supports our decision to progress the ODT formulation into Phase III development. With this exciting progress, we believe we have successfully achieved the goals of Phase II development for MM120 and expect to advance MM120 into pivotal Phase III clinical trials for GAD. We anticipate having an end-of-Phase II meeting with FDA in the second quarter of 2024 to align the scope of our Phase III development program and to initiate our Phase III clinical program in the second half of 2024. Additionally, based on the promising data we have observed for MM120 and indications beyond GAD, such as depression, we are actively evaluating additional clinical indications and believe the overall development program for MM120 may represent the best-in-class treatment for GAD and beyond. As we build momentum in development of MM120, we are also strategically enhancing our focus towards commercial planning. As you may recall from our analyst day in March, market research shows strong enthusiasm for MM120. with 74% of surveyed healthcare practitioners indicating that FDA-approved psychedelic treatments will change their approach to treating anxiety and depression. This positive sentiment aligns with the success of Johnson & Johnson's RIVATO, or intranasal ascetamine, which is rapidly approaching blockbuster status. RIVATO's impact extends beyond its own use case, as it has helped pave the way for the interventional psychiatry model. This established model includes well-defined patient care reimbursement pathways, RIMS documentation processes, and logistics infrastructure, all of which we believe can be readily leveraged for MN-120 if successful in clinical trials and ultimately approved by the FDA and marketed. Our second lead program is MN-402, which is the RN antimer of MDMA. We believe MN-402 holds promise for its potential prosocial effects and favorable tolerability profile versus racemic MDMA, or the SNM tumor. 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 increased prevalence of ASD, there are currently no approved therapies specifically targeted at its core symptoms. 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 one 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, our collaborators at UHB conducted a comparative phase one pharmacokinetics and pharmacodynamic trials, R, S, and racemic MDMA, with data anticipated in the second quarter of 2024. We believe that the results from this trial will expand and expedite our understanding of MM402's pharmacological profile as we progress into later stage clinical development. We'll now turn to our financial results for the quarter ended March 31st, 2024. As of March 31st, 2024, The company had cash and cash equivalents totaling $252.3 million compared to $99.7 million as of December 31, 2023. We believe that our cash and cash equivalents will be sufficient to fund our operations into 2026 based on our current operating plan. As the quarter ended March 31, 2024, net cash used in operating activities was $16.6 million, compared to $13.3 million for the same period in 2023. Research and development expenses were $11.7 million for the quarter ended March 31, 2024, compared to $12.6 million for the same period in 2023, representing a decrease of $0.9 million. This decrease was primarily due to decreases of $0.6 million in expenses related to our MM402 program, a decrease of $0.5 million in expenses related to preclinical activities, partially offset by an increase of $0.3 million in internal personnel costs as a result of increasing research and development capabilities. General and administrative expenses were $10.5 million for the quarter ended March 31, 2024, compared to $8.3 million for the same period in 2023, an increase of $2.2 million. The increase was primarily attributable increased stock-based compensation expense of $1.1 million and an increase of $0.7 million in personnel-related expenses due to an increase in headcount to support the growth of our business. Companies' net loss for the quarter ended March 31, 2024 with $54.4 million compared to $24.8 million for the same period in 2023. This increase was primarily due to changes in the fair value of the 2022 U.S. dollar financing warrants of $27.7 million. In conclusion, this is a very exciting time for MindMed. We believe that the data on MM120 and GAD that we shared validates our scientific understanding of MM120's mechanisms of action and shows the potential for an emerging best-in-class product profile compared to today's standard of care. We are excited to be on the cusp of moving forward into phase three with this program, which we currently expect in the second half of the year following our anticipated into phase two meeting with FDA. Before concluding our call, I want to extend my sincere appreciation and gratitude for the critical work and unmatched execution that has brought MindMed ever closer to realizing our mission. I would like to thank our highly talented and deeply committed team, our research collaborators and clinical investigator teams, our investors, and the many other individuals who have been supportive, including especially our patients and their families. We are working tirelessly to deliver on the therapeutic potential of our pipeline and to transform the treatment landscape for the many individuals living with brain health disorders.

With that, I'd like to thank you all again for joining us today, and I'm happy to take any questions.