Mind Medicine (MindMed) Inc.

Good afternoon and welcome to the MIND Medicine first quarter 2023 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. For opening remarks, I would like to introduce Rob Barrow, CEO of MINDmed. Please go ahead.

Thank you and good afternoon, everyone.

Welcome to our first quarter 2023 financial results and corporate update conference call. The press release reporting our financial results is available in the investors and media section of myMEDS website. And our quarterly report on form 10Q for the quarter ended March 31st, 2023 will 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. Miri Halperin-Warnley, our executive president. During today's call, we'll be making certain forward-looking statements, including without limitation, statements about the potential, safety, efficacy, and regulatory and clinical progress of our product candidates, financial projections, and our future expectations, plans, partnerships, and prospects. These statements are subject to various risks, such as changes in market conditions, difficulties associated with research and development, and regulatory approval processes that are described in the filings made with the SEC, including the most recent annual report on Form 10-K and quarterly report on Form 10-Q. Forward-looking statements are based on the assumptions, opinions, and estimates of management of the date the statements are made, including the non-occurrence of the risks and the uncertainties that are described in the filings made with the SEC or other significant events occurring outside of IMED's normal course of business. We would caution not to place undue reliance on these forward-working statements, which were made as of today, May 4th, 2023. NIMA disclaims any obligation to update such statements, even if management's views change, except as required by law. I would like to begin by reiterating our deep commitment to advancing our organization and delivering new, life-changing treatment options to the many individuals living with brain health disorders. As we pursue our strategy to bring our lead product candidates to market, we believe we are laying the foundation to create lasting value for our shareholders. In the first few months of 2023, we continue to make steady progress across our pipeline, and we are well positioned to execute on our key priorities and reach multiple milestones throughout this year, including data readouts from our Phase 2B trial of MM120 for the treatment of generalized anxiety disorder, or GAD, as well as from our Phase 2A proof-of-concept trial of repeated low-dose MM120, and Intention Deficit Hyperactivity Disorder, or ADHD. Additionally, we expect to initiate the first clinical trial of MN402 later in the year. Before we dive further into our R&D and financial updates, I'd like to highlight the recently presented positive top-line data from the Phase II double-blind, investigator-initiated trial evaluating lysogyne in the treatment of major depressive disorder, or MDD. This trial was led by Professor Matthias Liechti and Dr. Felix Moeller, our collaborators at University Hospital Basel, or UHB, and the University Hospital of Psychiatry in Switzerland. As a reminder, we have exclusive global rights to data, compounds, and patents associated with the Liechti Lab's research evaluating lysergi and other psychedelic compounds. This includes data from numerous completed and ongoing investigator-initiated trials in both healthy volunteers and patient populations. Our collaboration has been particularly impactful by demonstrating and reinforcing the clinical potential of our drug development pipeline. Top-line data from this investigator-initiated trial demonstrated significant, rapid, durable, and beneficial effects of lysogide, which potentially mitigate symptoms of MDD. Patients in the study received a 100-microgram dose of lysogide on the first dosing day and a 200-microgram dose of lysogide on the second dosing day, which was separated by four weeks. An active small dose of 25 micrograms lysogide was used as a control line. The trial made its primary endpoint at six weeks, which was measured by the change in clinician-rated inventory of depressive symptomatology, or IDSC, scores. Further, the statistically significant improvement was maintained up to 16 weeks, which underscores the potential long-term benefits of lysogide treatment. Data from the secondary endpoints were also encouraging, and the investigational drug was generally well-tolerated. Given the high degree of comorbidity of MDD and GAD, the positive results and clinical activity of lysogide are particularly relevant to our MM120 program. I'm now trying to update on our R&D program, starting with our lead program, MM120, a proprietary, pharmaceutically-optimized form of lysogide detartrate in development for the treatment of GAD and ADHD. GAD is an often debilitating mental health disorder associated with excessive anxiety and persistent worry, which can lead to significant impairment in social, occupational, and other functioning. With very little innovation focused on the treatment of GAD, there's been a noted increase in the incidence and prevalence of individuals diagnosed with GAD in the U.S. and Europe over the past several years. Additionally, the number of patients who are not adequately treated by available therapies is also increasing. This is a result of the low rate of remission and multiple safety and tolerability challenges of SSRIs, SNRIs, antipsychotics, and benzodiazepines. The research we've conducted with patients and healthcare practitioners in the U.S. and Europe tells us that there's a significant demand for a new pharmacological class that could offer faster, more profound, and more durable efficacy responses, as well as favorable safety and tolerability. This is particularly true in the segment of patients who, despite having exhausted all available options, continue to experience intolerable anxiety. Given the need for new treatment options, we are extremely encouraged by the growing data that supports the therapeutic potential of MN120. Patient dosing and enrollment for our Phase IIb trial in GAD is progressing well across our 20 active sites, and we reiterate our expectation of reporting top-line results in late 2023. The trial plans will enroll a total of 200 participants, who will receive a single administration of up to 200 micrograms of MN120 or a placebo. The primary objective of the study is to determine the reduction in anxiety symptoms for up to 12 weeks after a single administration of MN120 across five treatment arms, with a primary endpoint measured at four weeks post-dosing. The results of this trial will guide the dose selection and development strategy for MN120 and GAD, as well as deepen our scientific understanding of its clinical effect and its underlying functional mechanisms of action. As mentioned, we are also evaluating MM120 for ADHD and expect to report top-line data for our Phase 2A trial in late 2023. Our Phase 2A trial is being conducted in collaboration with the University Hospital Basel in Switzerland and Maastricht University in the Netherlands and is designed to evaluate the therapeutic utility of repeated low doses of MM120 in adult patients with ADHD. Notably, this is the first study in which MM120 has been administered outside of the clinical setting. To date, no assays have been reported suggesting the real-world potential of this treatment regimen, as well as demonstrating our ability to deliver MM120 with innovative dose and frequency combinations. In this trial, we expect to enroll a total of 52 participants who will receive a 20-microgram dose of MM120 or placebo twice weekly for six weeks. The primary endpoint to the study are mean change from baseline and ADHD symptoms, and assessed by the AISRF after six weeks of treatment. This proof-of-concept trial is a component of our broader comprehensive NM120 clinical development strategy, which seeks to explore both session-based administration that harnesses perceptual effects of serotonin agonism, and innovative repeat administration regimen that harnesses neuropharmacological effects of recurrent serotonin agonism. The innovation of MM120 and its session-based delivery approach is driven by its mechanism of action as a potent teratonin receptor agonist, which leads to profound sustained psychological effects. We believe MM120 will be delivered as a single-dose pharmacological intervention that will only require occasional administration. We recognize the potential challenges in commercializing a product with such a revolutionary delivery profile and have embarked on robust pre-commercialization plans seeking to educate all external stakeholders of the clinical and economic value of NM120. This is why one of the key priorities we are advancing in 2023 is to develop an innovative market access strategy, document the clinical and socioeconomic burden of GAD and ADHD, and advance the generation of health economics and outcomes research data required to build a superior value proposition for our product candidates. As we progress our pipeline, we look forward to providing greater clarity on the commercial model and path forward for each program to maximize the reach of our novel product candidates. As a reminder, with respect to our intellectual property strategy, our patent portfolio includes 26 pending U.S. applications and 12 pending PCT applications. These include applications covering compositions, dosing, dosage formulations, and methods of treatment, among others, with projected expiration dates beginning in 2041. Additionally, we continue to retain all rights to our product candidates and are aggressively protecting and expanding our intellectual property portfolio as part of our comprehensive market protection strategy. Now I would like to turn to MM402, or RMDMA, which is a synthetic enantiomer of MDMA with potential prosocial effects and a favorable tolerability profile. MM402 is in development for the treatment of core symptoms of autism spectrum disorder, or ASD, which is characterized by atypical social communication and interaction, repetitive patterns of behavior, and restricted interest. Despite its significant and growing prevalence, there are no therapies approved to treat the core symptoms of ASD. MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. RMDMA is thought to increase levels of serotonin and, to a lesser extent, norepinephrine, and other neurotransmitters in the brain, resulting in feelings of increased sociability and interpersonal emotional warmth. Preclinical studies of RMDMA demonstrate its acute prosocial and pathogenic effects. While its diminished dopaminergic activity suggests that it could exhibit less stimulant activity, neurotoxicity, hyperthermia, and abuse liability risk compared to racemic MDMA or the asthmatic tumor. Our aim for MM402 is to demonstrate its ability to enhance social engagement and interaction rather than having a sedating or blunting effect, which is often a result of currently used off-label medications in the ASD population. Importantly, a late-breaking abstract on a preclinical study of MM402 and a model of ASD has been accepted for presentation at the 2023 American Society of Clinical Psychopharmacology Annual Meeting that is being held in Miami Beach, Florida from May 30th to June 2nd. With even further preclinical evidence to support our approach, we are extremely excited to initiate our Phase I clinical trial of NM402 later this year. This trial is intended to characterize the tolerability, pharmacokinetics, and pharmacodynamics of NM402, and we continue to explore all opportunities to generate early signs of efficacy as early as possible in development. We anticipate such data could be generated both in neurotypical healthy volunteers and in otherwise healthy individuals diagnosed with ASD. In parallel, through our research collaboration with University Hospital Basel, in 2022, we initiated and are currently enrolling healthy volunteers in a comparative phase one pharmacokinetics and pharmacodynamic study of R, S, and racemic MDMA. This study is designed to evaluate the tolerability, pharmacokinetics, and acute subjective physiological and endocrine effects of the three molecules. We believe that successful completion will accelerate our understanding of the pharmacological profiles and then forward to as we advance into later stage clinical development. Lastly, moving to our digital medicine update, our drug development strategy is closely complemented by a suite of digital medicine programs that have the potential to facilitate adoption, use, and access to our product candidates. By refining the techniques used to capture, model, and map the autonomic and behavioral outflow and other correlates of neural activity, we can improve the experience of clinicians and the outcomes for patients and the delivery of psychedelics and other perception-altering substances. Our digital medicine programs are oriented toward applications during two primary clinical periods, activities during a treatment session, referred to as intrasession, and activities between treatment sessions, referred to as intersession. Each digital medicine program consists of a platform that contains separate underlying components, some of which we anticipate will be within the scope of FDA's definition of medical devices and others which we anticipate will not be regulated as medical devices. For the medical device products, we intend to engage with the FDA and other international regulatory authorities to receive guidance along the development pathway towards a potential submission for regulatory clearance or approval. The ultimate goal of our digital medicine project is to develop applications that overcome frictional points of care delivery to encourage user adoption across patients, providers, and payers. Overall, we are very pleased with the progress to date. As we advance our key clinical programs and execute on our corporate objectives, we continue to further strengthen the leadership of MindMed. We are very excited by the recent addition of Mark R. Sullivan as our Chief Legal Officer and Corporate Secretary. Mark brings extensive legal and public company life sciences expertise and is a strong addition to our executive team. We believe Mark's experience, insights, and guidance will prove invaluable as we progress to the next stage of MindMed's evolution. I also have to highlight that as we approach our annual meeting in June, we are very excited about the potential of adding Dave Gwiska to our board. Dave brings invaluable insights from his 35 years of experience in the biopharmaceutical industry, including his service as CFO of two S&P 500 pharmaceutical companies, Insight and Celgene. Dave has also previously served on the board of GW Pharmaceuticals before its acquisition by Jazz Pharmaceuticals for $7.2 billion and serves on the board of Cgen, which recently agreed to be acquired by Pfizer for over $43 billion. Dave's nomination represents our ongoing commitment to board refreshment and ensuring we have the optimal mix of experience and perspectives in the boardroom to help the company create value. I believe Dave's involvement is an endorsement of the incredible people and organizations that we have built at MyMed, as well as the potential impact of our products on the millions of individuals suffering from brain health disorders. I'd also like to express the board's gratitude to Bridget Nakes, who notified us that she will not stand for reelection at the annual meeting, for her years of service to the early growth of the organization. Now is the time to radically transform how we treat brain health disorders, and we are deeply committed to realizing that potential for change. With that, I will now turn the call over to our CFO, Sean Greenway, to discuss our financial results. Sean? Thanks, Rob, and thank you all for joining us today. We will now turn to our financial results for the first quarter ended March 31st, 2023. As of March 31st, 2023, our cash and cash equivalents total $129.4 million compared to $142.1 million as of December 31st, 2022. We believe that our current cash and cash equivalents on hand positions us to accelerate our preparation for moving quickly into our pivotal studies for our lead program, MM120, and will be sufficient to meet our operating requirements beyond our key development milestones in 2023 and into the first half of 2025. Our net cash used in operating activities was $13.3 million for the quarter ended March 31st, 2023, compared to $12.9 million in the quarter end March 31st, 2022. Research and development expenses were $12.6 million for the quarter ended March 31, 2023, compared to $10.2 million for the quarter end March 31, 2022, an increase of $2.4 million. The increase was primarily due to increases of $2.9 million in expenses related to clinical research for the MM120 GAD study, $0.9 million in expenses related to our MM402 program and $0.2 million in internal personnel costs as a result of increasing research and development capabilities, which were offset by a decrease of $0.7 million in expenses related to our MM110 program and a decrease of $0.9 million in expenses in connection with various external RID collaborations. General and administrative expenses were $8.3 million for the quarter end March 31, 2023. essentially flat compared to the same quarter a year ago. Our net loss for the three months ended March 31st, 2023 was $24.8 million compared to $18.5 million for the same period in 2022. Lastly, I wish to reiterate that we are continuing to execute on a very efficient operation in terms of quarterly cash burn and headcount when compared to our peers in the space. As we have highlighted during our prior business update conference calls, We intend to continue to be thoughtful with our cash while also focusing and prioritizing our support for our most precious research and development activities directed toward our key value drivers. More specifically, we will review our discretionary expenses on a constant basis to ensure that we are seeking to capture value from operational efficiencies where we can. I will now turn the call back to Rob who will provide some closing comments. Thank you, Sean. We remain laser-focused on driving our key programs forward, which includes advancing our MM120 product candidate in GAD and ADHD to Phase II clinical readouts later this year, as well as initiating our first clinical trial of MM482. Additionally, our early R&D activities are progressing, and our collaboration with the University Hospital Basel continues to offer the opportunity to generate early clinical evidence to inform our pipeline's progression. I also want to extend my sincere appreciation and gratitude for the foundational work that has brought us closer to advancing novel treatments for brain health disorders. In particular, I would like to thank our highly talented and deeply committed team here at MindMed, our investors, and the many people who have been supportive along the way, including our research participants and their families. We are working tirelessly to deliver on our mission of transforming the treatment landscape for the many individuals living with brain health disorders who are underserved by today's available therapies. Finally, I'd like to remind everyone that the purpose of today's call is to discuss our first quarter updates and the progress of our business, and we will not be addressing matters related to our annual meeting. We encourage all of our shareholders to review our definitive proxy statement that has been filed with the SEC on CDAR and to visit www.protectmymed.com for updates pertaining to our proxy campaign. With that, I'd like to thank you all again for joining today, and I'm happy to take questions.