Mind Medicine (MindMed) Inc.

Good morning and welcome to the Mind Medicine fourth quarter and year-end 2024 financial results corporate update conference call. Currently all participants are on 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. I would like to introduce Stephanie Fagan, Chief Corporate Affairs Officer of MindMed. Please go ahead.

Thank you, Operator, and good morning everyone. Thank you for joining us for our discussion of MindMed's fourth quarter and year-end 2024 business highlights and financial results. Leading the call today will be Rob Barrow, our Chief Executive Officer, and he will be joined by Dr. Dan Carlin, our Chief Medical Officer. After our prepared remarks, we will open the call for Q&A. An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call. 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 and the applicable Canadian securities regulators, including our annual report on Form 10-K 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 findings made with the SEC and the applicable Canadian securities regulators 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, March 6, 2025. MindMed disclaims any obligation to update such statements, even if management sees change except as required by law. With that, let me turn the call over to Rob.

Thank you, Stephanie, and everyone for joining our call today. 2024 marked a year of unparalleled progress for MindMed, underscoring our leadership in advancing new treatments for brain health. We successfully achieved key milestones positioning us to potentially deliver multiple clinical readouts from our MM120 Phase III program in 2026. A year ago, we announced positive results from our Phase 2b study of MM120 and generalized anxiety disorder, or GAD, which showed statistically significant and durable improvements in mean Hamilton anxiety scale, or HAM-A, and clinical global impression severity, or CGIS, scores for 12 weeks after a single dose of MM120. We also announced the results of a pharmacokinetic bridging study of our orally dissolving tablet formulation of MM120, are intended as commercial formulation, which we are also using in our phase three studies. Additionally, in 2024, we secured a new formulation patent on MM120-ODT, extending our intellectual property protection through at least 2041. Based on the strength of our data and the seriousness of GAD, FDA granted our MM120-GAD program breakthrough therapy designation, indicating its potential to represent a substantial improvement over currently available therapies. Our development approach prioritizes designing clean studies that yield clear results and are efficient to operationalize. This is exemplified by our bold decision early in development to study MM120 as a standalone treatment and our streamlined Phase III clinical trial designs, which aim to replicate the rapid, durable response observed in our Phase IIb study. Our pivotal program in GAD includes two Phase III studies, Boyage and Panorama. As we previously announced, we are very excited to have already successfully dosed patients in both studies, and we have seen strong enthusiasm from clinical sites and patients as recruitment has continued to ramp up. These sites include some of the highest performing enrollers from our Phase IIb study, and we are very encouraged by early enrollment trends. We are also on track to dose participants in eMERGE, our first Phase III study for the treatment of major depressive disorder, or MDD, in the first half of this year. This phase three program closely aligns with our GAD program with a protocol that allows for streamlined and efficient patient enrollment. These two indications, GAD and MDD, affect approximately 51 million adults in the U.S. and represent two of the most significant unmet medical needs in psychiatry. We believe MM120 could offer a differentiated and compelling option in both GAD and MDD, potentially positioning it as a best-in-class and first-in-class treatment option. We aspire to deliver a truly transformative treatment that has the potential to change the trajectory of the ongoing brain health epidemic. In fact, in our research with providers, they have shared their belief that the availability of psychedelics will radically transform treatment for GAD and MDD. Over the past year, we have been dedicated to broadening the awareness and understanding of these disorders and sharing our findings in a number of key medical meetings, such as the American Psychiatric Association's annual meeting, the International Society for Health Economics and Outcomes Research Annual Meeting, and the American College of Neuropsychopharmacology's Annual Meeting. We continue to generate evidence that underscores the significant economic and social burden of GAD in the United States, including higher healthcare utilization and costs, as well as reduced work productivity. These findings highlight the substantial impact of GAD, which has largely been underappreciated. I couldn't be more thrilled with the progress we've made this past year. As we look forward, 2025 will be a year of execution focused on our phase three programs in GAD and MDD and preparing for our three pivotal trial readouts in 2026. We have a strong dedicated team in place and continue to build a leading organization with best in class execution. Over the past year, we have also strengthened our financial position, having raised approximately $250 million in gross proceeds and gained the support of a number of top institutional investors. We expect our current cash and cash equivalents to provide sufficient funding into 2027 with a cash runway that extends at least 12 months beyond the first phase three top line data readout for MM120 and GAD. Now, let me turn the call over to our Chief Medical Officer, Dr. Dan Carlin. to discuss our clinical development programs in more detail. Dan?