Mind Medicine (MindMed) Inc (MNMD) 2021 Q2 法說會逐字稿

Good afternoon, and welcome to MindMed's Q2 2021 Earnings Call. This is Collin Gage, VP of Corporate Development from MindMed. I will be coordinating today's conference.

I'd like to draw your attention to the fact that this conference call will contain forward-looking information, which may include, but is not limited to statements of (inaudible), business plans and strategies for MindMed. Forward-looking statements are made as of today's date and involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of MindMed to be materially different than the forward-looking statements. We draw your attention to the full disclaimer contained in our filings on SEDAR and EDGAR.

Leading the call today will be Interim MindMed CEO, Rob Barrow. Please e-mail any questions you may have to investors@mindmed.co. Rob, you may begin the call.

Thanks so much, Collin, and good afternoon. And welcome to MindMed's Q2 2021 Earnings Call as we continue our mission to discover, develop and deploy psychedelic-inspired medicines and therapies to alleviate suffering and promote mental health.

I'm Rob Barrow, Interim CEO of MindMed. I'm also joined today by our Chief Financial Officer, Dave Guebert.

Much has changed at MindMed over the past 1.5 years, however, our mission remains consistent. We will not waver from our mission to discover, develop and deploy innovative therapeutics through rigorous science and established regulatory pathways to address large problems in society, including the opioid crisis and in mental health.

We plan to further this mission by focusing on multiple generations of psychedelic-inspired therapies, including both classic psychedelics, such as LSD; and novel psychedelic-inspired therapies, such as our proprietary ibogaine conjugate, 18-MC. Given the potential revolutionary nature of this new class of therapeutics, we also recognized the critical need to build additional tools to facilitate the adoption, access and scalability of psychedelic therapies. To this end, we are advancing multiple projects through Albert, our digital medicine and technology division.

During the second quarter of 2021, we remained keenly focused on the advancement of our core drug and digital development programs as well as bolstering our pipeline with both internal and collaborative research development activities. Given the growth and advancements in our development, we also made great strides to continue building our internal infrastructure and attracting top talent from the pharmaceutical industry to lead our internal drug and digital development operations.

In this regard, we were honored to add a new board member to our Board of Directors, Dr. Sarah Vinson, who is a Triple Board-Certified physician specializing in adult, child and adolescent and forensic psychiatry. She is the founder of Lorio Psych Group, a group mental health care practice.

Dr. Vinson is an associate clinical professor of psychiatry and pediatrics at Morehouse School of Medicine, where she is the Program Director of the Child & Adolescent Psychiatry Fellowship and Adjunct Faculty at Emory University School of Medicine.

I am excited to work closely with Dr. Vinson as we go about designing platforms that can one day enable accessibility of mental health solutions and innovative therapeutics. Her experience and perspective will be invaluable through this process.

Furthermore, we are excited and honored to announce the additions of Dr. Maurizio Fava and Dr. Peter Bergethon to our Scientific Advisory Board. Dr. Fava is a world-leading expert in psychiatry and psychiatric clinical trials from Massachusetts General Hospital and the Harvard Medical School. Dr. Fava has been successful in obtaining more than $120 million of funding as principal or co-principal investigator from both the National Institutes of Health and other sources, and his prominence in the field is reflected by his role as a co-PI of the National Institute of Mental Health Sequenced Treatment Alternatives to Relieve Depression, or STAR*D study, the largest research study ever conducted in the area of depression; and of the RAPID Network, the NIMH-funded series of studies of novel, rapidly acting antidepressant therapies.

Dr. Peter Bergethon is the Vice President and Head of Digital and Quantitative Medicine at Biogen, where he leads the effort to transform clinical trials and humanize drug discovery by encouraging the transition of clinical trial measures from a qualitative to a quantitative discipline. The quantitative medicine transformation has advanced Biogen's leadership in neuroscience therapeutics and personalized medicine. Dr. Bergethon joined Biogen in 2017 from Pfizer Worldwide Research and Development, where he was Vice President and Head of the Pfizer Innovative Research Lab (sic) [Pfizer Innovation Research Lab] within the Early Clinical Development group.

Moving on to an overview of our drug development pipeline. Over the second quarter of 2021, we have continued to make considerable progress to advance our lead drug candidates and to expand our drug pipeline.

Project Lucy remains one of our key lead commercial drug development programs for the treatment of anxiety disorders with LSD. Our first planned clinical study under Project Lucy is a study of 200 patients with generalized anxiety disorder across 5 treatment arms, including the placebo, and will assess improvements in anxiety symptoms following a single administration of LSD or a placebo. The study will be the catalyst to select the final dose to be taken forward into Phase III pivotal clinical trials for LSD.

Additionally, based on the rigorous dose optimization design of this study, we believe it will significantly advance our scientific understanding of the underlying mechanisms of action that predict clinical response with LSD and other psychedelics. We continue to make progress in preparations for this study and submission of our IND, which we expect to file in late 2021, and to begin enrolling patients in late 2021 or early 2022.

Moving on to discuss project flow. We have also continued to make progress in preparations for our upcoming Phase II clinical trial of LSD in adult ADHD. Final regulatory review is ongoing, and we anticipate to start enrolling patients late this year.

Earlier this year, we also announced the launch of Project Angie under our pain franchise. We are advancing preparations to engage FDA to discuss our clinical development plans of psychedelics in pain, and remain on track to file a pre-IND meeting request later this year.

Switching to our addiction medicine program. We have also continued to make progress in advancing our clinical development program of 18-MC, which is a synthetic analog of the natural psychedelic substance, ibogaine. Dosing in our ongoing Phase I clinical trial of 18-MC in Australia has continued, and we anticipate completing the study by year-end. After that time, we intend to reengage FDA to discuss our Phase II development program and will thereafter begin to enroll patients in our planned Phase IIa study in early 2022.

We also continue to make progress with our Albert division of digital project projects and continue to drive these projects through our digital team, which has been fully integrated following our acquisition of HealthMode earlier in the year. We are progressing along 3 dimensions: inter-session monitoring, intra-session monitoring and modeling of the therapeutic process in the real world. We anticipate that several of these efforts have the potential to lead to software as medical device products. We are working to protect all relevant IP for these innovations and projects as we progress, and look forward to sharing further advancements in these efforts in the coming months.

We're excited to continue our relationship with the Liechti Lab at the University Hospital Basel. UHB has achieved a leading position in the academic and scientific realm with LSD, psilocybin, MDMA and other psychedelic research. Our strategy remains the same: translate the clinical and research work done by UHB and its leadership position into commercial drug trials conducted in compliance with FDA requirements and the requirements of other regulatory agencies.

As part of the extensive licensing agreement with the University Hospital Basel, we have acquired 16 completed studies, mainly with LSD and MDMA. Through this collaboration, we have -- with UHB, we have 5 ongoing Phase I studies, 3 ongoing Phase II studies and 3 Phase I studies nearing initiation, which are being conducted as investigator-initiated studies by Dr. Liechti and his team.

This includes a recently announced Phase I study of intravenous DMT, which will provide us with valuable insight into the pharmacokinetics and pharmacodynamics of this short-acting psychedelic, and can inform future assessments of its commercial drug development potential. Importantly, utilizing data out of this collaboration with UHB, we continue to file provisional patent applications to which MindMed has exclusive worldwide rights.

Through our collaboration with MindShift Compounds, a Swiss pharmaceutical discovery organization, we continue to explore the generation of novel psychedelic-inspired compounds that may have unique properties, such as onset and duration of action, receptor selectivity, potency and safety. A library of initial compounds has already been synthesized by MindShift, and related provisional patent applications have been filed by MindMed.

As you can see, we have many exciting projects underway and are making great progress in advancing these programs. With that, I would now like to transfer the call to Dave Guebert, our CFO, to give us an overview of the financials.

Thanks, Rob. Our financial statements for the second quarter of 2021 were reviewed by RSM Canada LLP and have been approved by our Audit Committee and our Board of Directors. The complete financial statements, along with related management discussion and analysis, can be found in the system for Electronic Document Analysis and Retrieval, the electronic filing system for the disclosure of documents of issuers across Canada at www.sedar.com, and also on EDGAR at sec.gov/edgar.

I will provide a brief summary of our quarter end financial statements. As a reminder, all figures are expressed in U.S. dollars.

MindMed continues to build its operating capabilities and to expand its clinical and research and development activities. The highlights of the quarter include the growth of our core team being assembled to execute on our strategic plan.

Our net and comprehensive loss for the 3 months ended June 30, 2021, was $36.3 million, made up primarily of research and development costs of $4.7 million; general and administrative expenses of $6.6 million; and noncash items, specifically share-based compensation of $21.8 million and amortization of intangible assets of $3.4 million. The increase in share-based compensation primarily related to transitioning of the CEO position.

Research and development expenses for the quarter were comprised of payroll and consulting fees of $2.5 million, clinical research and regulatory costs of $924,000, manufacturing-related costs of $589,000 and other R&D costs of $657,000. Research and development expenditures include all direct and indirect costs of the programs, compensation, licensing fees for intellectual property as well as manufacturing, clinical and regulatory costs. General and administrative expenses for the quarter consisted of payroll and consulting fees of $2.6 million, marketing and investor relations of $294,000, professional fees of $1.4 million, insurance of $645,000, public company-related costs of $408,000 and $1.1 million in other G&A.

Turning to the balance sheet. Our cash balance was $157 million, and our working capital was $147.8 million as of June 30, 2021. Our cash used in operations was $11.5 million during the quarter. Net proceeds from financing, preliminary option and warrant exercises was $7.9 million.

With that, I'll turn the presentation back to Rob.

Thanks, Dave. That completes today's earnings call. Please follow up with all questions to investors@mindmed.co. Thank you, everyone, for joining us, and we look forward to being in touch with you all soon.