Mind Medicine (MindMed) Inc.

Good afternoon and welcome to MindMedicine Third Quarter 2024 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. I would like to introduce Stephanie Fagan, Chief Corporate Affairs Officer at MindMed. Please go ahead.

Thank you, Operator. Good afternoon, everyone. Thank you for joining us today for a discussion of MindMed's third quarter, 2024 Business Highlights and Financial Results. Leading the call today will be Rob Barrow, our Chief Executive Officer. He will be joined by Dr. Dan Carlin, our Chief Medical Officer, and Francois Lowenthal, our Chief Commercial 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 details 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 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 and our Form 10-Q 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 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, November 7, 2024. MindMed disclaims any obligation to update such statements, even if management views change, except as required by law. With that, let me turn the call over to Rob.

Thank you, Stephanie, and to everyone for joining our call today. I'm pleased to share our progress for the third quarter, which builds upon our strong execution throughout the first half of the year. This has been an incredible year for MindMed, and we are even more excited about what lies ahead as we embark on our phase three programs for MM120 orally disintegrating tablet, or ODT, in generalized anxiety disorder, or GAD, and in major depressive disorder, or MDD. We remain on track to initiate our first phase three study of MM120, ODT, and GAD, called the VOYAGE study, by the end of this year. We also remain on track to initiate our second phase three study of MM120, ODT, and GAD, called the PANORAMA study, in our first phase three study of MM120ODT in NDD called the eMERGE study in the first half of 2025. These two indications, which together affect approximately 51 million adults in the U.S., have seen little innovation in the past quarter century and represent a significant unmet medical need. We believe MM120ODT represents a potentially transformational treatment for these populations. And if approved, could offer patients a differentiated and compelling option in both GAD and NBD, positioning it as a best-in-class and our vision of a first-in-class treatment option targeting two of the most significant unmet needs in psychiatry. We aspire to deliver a truly transformational treatment that we believe has the potential to change the trajectory of the ongoing brain health epidemic. As we progress toward the possibility of bringing MN120ODT to patients in need, we recognize and embrace the unique opportunities and challenges that lie ahead to deliver and scale this potential. While there is undoubtedly work to do in the coming years, our engagements with patients, prescribers, sites of care, and other key stakeholders have affirmed the broad recognition of the significant unmet medical need and the enthusiasm for the potential of MN120ODT if approved given the data we have generated to date. We are continuing to demonstrate this unmet need by producing strong evidence on the enormous impact that these disorders have on patients. For example, at the European College of Neuropsychopharmacology, or ECMP, Congress in September, we shared an analysis from the 2022 U.S. National Health and Wellness Survey showing that even small increases in the severity of GAD can significantly worsen the quality of life for patients. Additionally, last month, we presented a poster at the Academy of Managed Care Pharmacy Nexus 2024 meeting, highlighting the major economic burden of GAD represented by significant increases in hospitalizations, absenteeism, and reductions in overall productivity. As we progress our commercial plans, we intend to continue strengthening this body of evidence with the goal of enabling patient access and engaging with the key stakeholders needed to bring this potential into reality. Before turning the call over to Dan, I'd like to highlight a few key points about our Phase III development strategy for MM120-ODT, which leverages the strong Phase IIb results we presented earlier this year and our partnership with FDA under the Breakthrough Therapy Designation Program. A core principle of our development approach is to design clean studies that deliver clear results and are efficient to operationalize. This principle is exemplified by our bold and unique decision early in development to eliminate psychotherapy and by our streamlined Phase III clinical trial designs, which aim to replicate the rapid and durable response after a single dose of MM120 that we observed in our Phase IIb study. A methodological matter that has received a heightened amount of attention recently is functional and blinding and its impact on trials of psychedelics. To state the obvious, MM120-ODT and other drugs in the class have a clear perceptual effect for several hours after administration. While the qualitative nature of these effects may be unique, the reality of functional and blinding in psychiatry is common to virtually every approved psychiatric drug. Nonetheless, we have implemented several strategies intended to address this and other methodological considerations across our phase two and three programs. These include using central raters who are blinded to both treatment assignment and visit number, incorporating questionnaires to assess potential expectancy bias and unmasking, and in multiple of our studies, including additional control arms that are perceivable but not clinically active. Our continued interactions with the FDA further support alignment with the rigor and design of our approach, and we believe our development strategy can deliver clear and compelling evidence on the safety and effectiveness of MM120-ODT in both GAD and MDD. Operationally, We anticipate streamlined and efficient patient enrollment across both of our Phase III programs, given the closely aligned design of our protocols for both the GAD and MDD indications. Our operational efficiency is enhanced by the inclusion of many of our highest performing sites from Phase II and our Phase III program. Additionally, the planned sample size of Voyage is the same as our Phase IIb study, which we enrolled in approximately 12 months And Voyage will also benefit from having 50% more sites than our Phase 2b study. Our clinical protocols are designed with operational input from sites and specific attention to enabling enrollment so that we can rapidly recruit a representative sample of participants. Our clinical team and entire R&D organization continue to lead the field in quality and efficiency of execution, and we seek to build on that momentum going into our Phase 3 programs. We are invigorated by the enthusiasm expressed by patients, trial sites, and study investigators, and believe this broad enthusiasm will continue to support our goals of rapid progression and seamless execution in Phase 3. Now, let me turn the call over to Dr. Dan Carlin, Chief Medical Officer of MindMed, to discuss our clinical development programs in more detail. Dan?