MindMed Reports Full Year 2021 Financial Results and Business Highlights

“2021 was a year of major advancements across all aspects of MindMed, with significant growth in our organization, development programs and research collaborations. We established a regulatory pathway for MM-120 in the treatment of GAD and, with MM-402, launched a program to develop a novel treatment for core symptoms of autism spectrum disorder – both of which represent meaningful leaps forward in the field of psychiatry,” “We expect 2022 to be a transformational year in which we continue to drive substantial growth across our pharmaceutical and digital medicine pipelines. I am incredibly proud of our team’s achievements and I am more confident than ever in our ability to continue advancing our organization and development programs. We are keenly focused on our mission to deliver novel therapies to treat brain health disorders, leading to meaningful improvements in patient outcomes in these major areas of unmet medical need.

Robert Barrow, Chief Executive Officer and Director of MindMed

• In January 2022, the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application for the Phase 2b dose-optimization trial of MM-120 for the treatment of GAD.
  • Study MMED008, a Phase 2b dose-optimization study of MM-120 for the treatment of GAD, is expected to begin in Q2 2022.
• In December 2021, Study MMED007, a Phase 2a proof-of-concept study, was initiated for the treatment of ADHD. The study is designed to assess the safety and efficacy of repeated low-dose MM-120 administration.
• A clinical study of MM-120 in a chronic pain condition is expected to be initiated in Q4 2022.

• In January 2022, the USAN Council assigned the non-proprietary name “zolunicant” (pronounced: zoe lun’ i kant), to MM-110 or 18-MC.
• In December 2021, the Company completed a Phase 1 study of MM-110 with topline data expected in Q2 2022. These results will inform the design of the planned Phase 2a study in individuals undergoing standardized supervised opioid withdrawal, which is expected to commence in Q2 2022. The Phase 2a study will evaluate the safety, tolerability and efficacy of MM-110 in mitigating symptoms of opioid withdrawal and facilitating completion of detoxification.

• IND-enabling studies are currently ongoing and, through the Company’s collaboration with University Hospital Basel, a comparative Phase 1 pharmacokinetic/pharmacodynamic study of R(-), S(+) and + MDMA is expected to commence in mid 2022.

• In February 2021, the Company completed the acquisition of HealthMode and fully integrated its team to enable rapid progression of digital medicine and business operations functions.
• Having engaged in a productive Pre-Submission meeting with FDA in late 2021, in January 2022, the first subjects were enrolled into the Session Monitoring System (SMS-01) study evaluating the passive collection of sensory data during a consciousness-altering therapeutic session using the MindMed Session Monitoring System (MSMS).
• Anxiety Digital Diagnoses for Precision Psychiatry (ADDAPT, MMED-D001): A Natural History Study and our newly developed mobile application to support the study is expected to launch in private beta in Q2 2022.
• In September 2021, the first participants were enrolled by invitation in the Quantifying the Processes and Events of Psychotherapy at Scale (MM061302) study.

• University Hospital Basel (UHB): The Company continued to support the ongoing collaboration with the Liechti Lab at UHB in Switzerland. MindMed has exclusive worldwide rights to data, compounds and patent rights associated with the Liechti laboratory’s research with LSD and other psychedelic compounds, including data from preclinical studies and over 15 completed and 9 ongoing clinical trials.
  • In March 2022, the peer-reviewed publication of a double-blind placebo-controlled comparative study of LSD and psilocybin was published in Neuropsychopharmacology. The study demonstrated that the key differences between LSD and psilocybin are dose-dependent rather than substance-dependent. These findings have the potential to assist with dose-finding, trial design and inform future studies evaluating the therapeutic utility of psychedelics.
  • In November 2021, the peer-reviewed publication of a randomized, double-blind, placebo-controlled study evaluating the interacting effects of an SSRI and psilocybin in healthy volunteers was published in Clinical Pharmacology and Therapeutics. The study suggests psilocybin is safe to take in combination with an SSRI.
• Nextage Therapeutics Ltd: The Company entered into a collaboration with Nextage Therapeutics in April 2021 to explore the therapeutic potential of noribogine in a proprietary brain targeted liposome drug delivery technology system to mitigate risks of peripheral adverse effects.
• MindShift Compounds AG: The Company continued to progress its collaborative research and development activities with MindShift Compounds AG in Basel, Switzerland, focusing on the discovery and optimization of next generation compounds, including those with and without acute perceptual effects.
• The Chopra Foundation: The company ultimately did not reach a definitive agreement for a potential collaboration and discontinued the engagement.

• In December 2021, Robert Barrow was appointed as Chief Executive Officer and as a member of the Board of Directors. Mr. Barrow previously served as interim Chief Executive Officer and Chief Development Officer of MindMed and brings strategic expertise and deep industry insight to his role.
• In December 2021, Cynthia Hu, JD was appointed as Chief Legal Officer and Corporate Secretary.
• In November 2021, Carrie Liao, CPA was appointed as VP, Corporate Controller and Principal Accounting Officer.
• In September 2021, Carol Vallone and Andreas Krebs were appointed to the Board of Directors and were subsequently appointed as chair and vice chair, respectively.
• In May 2021, Sarah Vinson, MD was appointed to the Board of Directors.
• In February 2021, Daniel Karlin, MD, MA was appointed as Chief Medical Officer.

• Over the course of 2021, we made significant additions to our Scientific Advisory Board (SAB), including:
  • Robert C. Malenka, MD, PhD (Professor, Stanford University) – SAB chair
  • Maurizio Fava, MD (Psychiatrist-In-Chief, Mass General Hospital; Associate Dean and Professor of Psychiatry, Harvard Medical School)
  • Peter Bergethon, MD (President, Symmetry Research; formerly Vice President, Biogen)
  • Robert Dworkin, PhD (Professor, Rochester University; Director, ACTTION public-private partnership)
  • Bryan Roth, MD, PhD (Professor, University of North Carolina; Director, NIMH Psychoactive Drug Screening Program)
  • Maria Oquendo, MD, PhD (Chair and Professor of Psychiatry, University of Pennsylvania; Past President, American Psychiatric Association)