Mind Medicine (MindMed) Inc.

Good day and welcome to the Mind Medicine third quarter 2022 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. You may press star 1 at any time during the call if you'd like to ask a question. As a reminder, this conference call is being recorded. It is now my pleasure to introduce your host, Robert Barrow, Chief Executive Officer and Director at Mind Medicine. Mr. Barrow, you may begin your conference.

Thank you, operator, and good morning, everyone.

Welcome to MindMed's third quarter 2022 financial results and corporate update conference call. Prior to market open today, we issued a press release with a summary of our results for the third quarter of 2022. The press release reporting our financial results is available in the Investors and Media section of MindMed's website, and our quarterly report on Form 10Q for the quarter ended September 30, 2022, is planned to be filed today with the Securities and Exchange Commission. Joining me today is Sean Greenway, our Chief Financial Officer, Dr. Dan Carlin, our Chief Medical Officer, and Dr. Miriam Halperin-Wernley, our Executive President. During the course of today's call, I will provide an overview and update on our business. Then Sean will review financial results for the quarter ended September 30, 2022, followed by Q&A. Before we begin, let me remind you that during this conference call, we will be making forward-looking statements. The company's actual results may differ materially from those expressed in or indicated by such forward-looking statements. For a description of risks, please refer to our recent filings with the Securities and Exchange Commission. During the course of the third quarter, we continue to make significant progress across our business. beginning with MM120 or LSD Detartrate. In the third quarter, we dosed the first patient in our Phase IIb Dose Optimization Study of MM120 for the treatment of generalized anxiety disorder. Study enrollment has continued to progress according to plan, and we remain on target for a top-line readout in late 2023. In September, results from the LSD Assist Study, which is a Phase II placebo-controlled, investigator-initiated clinical trial of LSD, and the treatment of anxiety disorders that was conducted by our collaborators at University Hospital Basel was published in the peer-reviewed scientific journal, Biological Psychiatry. Top line results in 46 patients with clinically significant anxiety demonstrated the significant, rapid, durable, and beneficial effects of LSD and its potential to mitigate symptoms of anxiety and depression. Enrollment in our phase two proof of concept trial of low repeated administration of MM120 and ADHD has also continued to progress and remains on track for a top-line readout in late 2023. With respect to our MM402 or RMDMA program, we continue to progress preclinical R&D efforts in preparation for the initiation of a Phase I clinical trial in 2023. Additionally, through our collaboration with University Hospital Basel, in the third quarter, we initiated a Phase I pharmacokinetic and pharmacodynamic investigator-initiated trial of RMDMA S, and racemic MDMA in healthy volunteers. This study seeks to assess two dose levels of R-MDMA and one dose level each of racemic and S-MDMA, and we expect will provide valuable insights into the clinical activity of MM402 as we progress our sponsored development program targeting core symptoms of autism spectrum disorder. Additionally, Our external collaborations and early R&D activities have continued to progress, including the investigator-initiated study of LSD and the treatment of major depressive disorder being conducted at UHB. Our collaboration with the Leaky Lab at UHB continues to offer the opportunity to generate moderate, high-quality data demonstrating LSD's clinical activity in brain health disorders and continues to provide useful insights to inform the potential future directions in M120's development. We've continued the efforts disclosed in our second quarter earnings call to further streamline our operational and financial efficiency, and we continue to prioritize and focus our current development efforts and resources on MM120 and psychiatric indications in MM402. I would also like to take a moment to discuss our intellectual property position and strategy. As you are all aware, LSD in its freebase form was discovered in the 1930s by Sandoz chemist Albert Hoffman. Accordingly, IP is not available on LSD freebase. However, we believe we have made meaningful improvements and innovations on the original form of LSD and the development of our proprietary product candidate, MM120. This includes advancements both on the active pharmaceutical ingredient, LSD-Detartrate, and dosage forms of LSD-Detartrate that we believe are optimized to meet modern pharmaceutical standards. In the third quarter of 2022, we converted several non-provisional patent applications, which we believe could play a central role in the protection of MM120. Should the claims in those applications be granted, their first expiry date would be in 2042. We continue to retain all rights to our intellectual property, clinical data, and manufacturing rights that we have filed on our product candidates, and we'll continue to aggressively protect and expand our IP portfolio, seeking to maximize the protection of our product candidates should they eventually be approved for marketing. I'll now turn to our platform of digital medicine products, which is strategically aligned with our drug development programs and we believe has the potential to facilitate broad and diverse access to our product candidates. Under our MindMed Session Monitoring System, or MSMS, platform, we have continued to advance our clinical studies and regulatory engagement in the pursuit of eventual approval for elements of MSMS as a software as a medical device product. We look forward to providing further updates as we continue to progress our digital medicine strategy over the months ahead. We're incredibly pleased with the progress of our pipeline, and as we approach the end of 2022, we remain highly focused on the execution of our long-term plan and to reaching key value-driving milestones, which are anticipated in the upcoming year.