Mind Medicine (MindMed) Inc.

Good afternoon, and welcome to the MindMed Second Quarter 2025 Financial Results and Corporate Update Conference Call. Currently, all participants are in a listen-only mode. This call is being webcast live on the Investors of Media section of MindMed's website at mindmed.com, and a recording will be available after the call. I would now like to introduce Stephanie Fagan, Chief Corporate Affairs Officer of MindMed. Please go ahead.

Thank you, Operator, and good afternoon, everyone. Thank you for joining us today for a discussion of MyMed's second quarter 2025 business highlights and financial results. Leading the call today will be Rob Vero, our Chief Executive Officer. He will be joined by Dr. Dan Carlin, our Chief Medical Officer, and Brandy Roberts, our Chief Financial Officer. After our prepared remarks, we will open the call for Q&A, and Matt Wiley, our Chief Commercial Officer, will also be available for questions. 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 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, July 31, 2025. MindMed disclaims any obligation to update such statements, even if management's views change, except as required by law. With that, let me turn the call over to Rob.

Thank you, Stephanie, and thank you, everyone, for joining our call today. I'm very pleased with our overall performance and execution through the first half of the year. We are currently on track with enrollment with our three pivotal phase three trials for our lead asset, MM120ODT, which is being evaluated in patients with generalized anxiety disorder, or GAD, and major depressive disorder, or MDD, the two most common psychiatric disorders in the U.S. We took a strategic approach in selecting GAD and MDD as the initial indications for MM120ODT, driven by the unmet medical need, clinical development feasibility, as well as the large commercial opportunity. Targeting both indications potentially provides us with the broadest label possible and enables us to reach a wider patient population. In the U.S., more than 60 million people live with GAD or MDD, and notably, more than 50% of patients with GAD also suffer from MDD. This creates a meaningful opportunity to address both conditions with a single therapeutic approach, particularly considering the limitations of current treatments. We believe MM120-ODT has the potential to offer a differentiated, novel, best-in-class treatment option for these patient populations. MM120 was granted breakthrough therapy designations from the FDA based on the results of our Phase IIb trial in GAD, which showed an effect size of 0.81 in the 100-microgram cohort, more than double that of standard treatments. And as a reminder, a single dose of MM120 demonstrated strong clinical remission rates with 48% of participants in the 100-microgram cohort achieving remission at week 12. Our Phase III trials were thoughtfully designed to build on the strong foundation of these successful Phase IIb results, while also positioning MM120-ODT for real-world implementation. A key advantage of our approach is the efficient single-visit treatment model, which we believe aligns with existing reimbursement pathways and supports full session coverage. This approach not only streamlines delivery, but also reduces the administrative burden on sites where MM120ODT may be delivered. Commercial opportunity for MM120ODT is significant, supported by strong provider interest. Our market research shows that 78% of interventional psychiatric providers believe the availability of psychedelic therapies will transform the treatment landscape for GAD and MDD. We remain focused on advancing our pivotal trials with urgency. Across all three studies, Voyage and Panorama in GAD and Emerge in MDD, enrollment trends remain strong with continued enthusiasm and engagement from clinical sites. As our pivotal trials continue to progress, we are actively laying the groundwork for commercial readiness. This includes building our organization and making strategic hires to support both near-term execution and long-term growth, ensuring we're well-positioned to capitalize on the opportunity ahead. We're incredibly excited about the leadership we've been able to bring to the company, including most recently our new CFO, Brandy Roberts, who joined our team last month. Brandy brings over 25 years of life sciences financial leadership experience and is uniquely positioned to lead our financial strategy during this critical growth phase. Most recently at Longboard Pharmaceuticals, she successfully led the company through its IPO and multiple financings, culminating in a $2.6 billion acquisition by Lundbeck, Her proven track record of scaling operations, supporting clinical development, and managing strategic investor relations brings tremendous value to our organization. On behalf of MindMed, I'd like to welcome Brandy to our team. In summary, with three of our pivotal phase three trials well underway and top line readouts for each of these trials anticipated in 2026, we're anticipating a catalyst-rich year as we progress MM120. With that, I'll turn the call over to Dan for an update on our clinical programs.