Full Press Release Details
Topline Data ODT PK Bridging Study Breakthrough Therapy Designation March 2024
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the entire referenced report or article. MindMed does not make any representation as to the accuracy of such information. Investor Presentation | March 2024 2
Today's Agenda Speaker Topic Rob Barrow Introductory Remarks Chief
Executive Officer, MindMed Rakesh Jain, MD, MPH KOL Perspective on Unmet Need in Clinical Professor of Psychiatry and Behavioral Sciences, Texas Tech University Generalized Anxiety Disorder (GAD) & School of Medicine - Permian Basin Phase
2b Trial Results Daniel R Karlin, MD, MA Summary of Full Topline Results from Phase 2b Chief Medical Officer, MindMed Trial of MM120 in GAD Francois Lilienthal, MD, MBA Commercial Opportunity Chief Commercial Officer, MindMed Rob Barrow Summary
Comments for MM120 Development Plan Chief Executive Officer, MindMed Closing Remarks and Questions & Answers (Q&A) All Presenters Investor Presentation | March 2024 3
Introductory Remarks Robert Barrow Chief Executive Officer
We Aim To Be A Global Leader In Brain Health Pipeline Management
Diversified pipeline of clinical Expertise in drug development programs targeting and commercialization significant unmet medical needs Research Expected Runway Leveraging decades of preclinical and clinical Expected cash runway through key research
with promising results in Phase 2b clinical readouts and into 2026* Market Protection Strategies IP and R&D strategies intended to maximize market exclusivity and protection *The company's cash and cash equivalents of $99.7 million as of
December 31, 2023 and committed credit facility are expected to fund operations into 2026. Investor Presentation | March 2024 5
Experienced Leadership with a Proven Track Record Strong Experience in 1
Brain Health Innovation 1. Includes Investor Presentation | March 2024 6
MM120 Has the Potential to Address a Large Unmet Need in GAD Opportunity
in Generalized Anxiety Disorder (GAD) 1 GAD is the 2nd most common mental disorder among adults , yet there Potential Best-in-Class are limited treatment options Therapy with Novel MOA Symptoms may be debilitating and treatment
inefficacy leads to incomplete remission and intolerable side effects. 1 Large Market 6.5 million do not respond to 13 million ~20 million US adults with GAD 3 1 2 first-line treatment receive treatment Opportunity 77% moderate to severe 1
SSRI/SNRIs : 50% failure rate with often undesirable side effects Benzodiazepines: addiction, tolerance risk; generally used in short-term Significant Need 4 for New Treatments Buspirone : poor efficacy Antipsychotics: short- and long-term risks;
poorly tolerated 1. Mental and Substance Use Disorders Prevalence Study (MDPSU): Findings Report 2023. 2. Kessler RC, Chiu WT, Demler O et al. Prevalence, Severity, and Comorbidity of 12-month DSM-IV Disorders in the National Comorbidity
Survey-Replication. 2005 Arch Gen Psychiatry; 62(6): 617-627. Investor Presentation | March 2024 7 3. Ansara, Management of Treatment-Resistant Generalized Anxiety Disorder, Ment Health Clin 2020 Nov; 10(6) 326-334) United States Census Bureau,
company calculations. 4. Garakani A, et al., (2020) Pharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options. Front. Psychiatry 11:595584. doi: 10.3389/fpsyt.2020.595584
MindMed Research & Development Pipeline Product Candidate Indication
Preclinical Phase 1 Phase 2 Phase 3 Registration Psychiatry Programs Generalized Anxiety MM120 1 Disorder (GAD) (Lysergide D-tartrate) Additional Psychiatric 2 Indication MM402 Autism Spectrum 1 Disorder (ASD) (R(-)-MDMA) Early Research &
Collaborations IITs 1 Various (UHB collaboration) Early Research Various (Mindshift collaboration) 1. Full trial details and clinicaltrials.gov links available at mindmed.co/clinical-digital-trials/ 2. Study in exploration and/or planning stage.
Investor Presentation | March 2024 8 LSD: lysergide; MDMA: 3,4-methylenedioxymethamphetamine. IIT: Investigator Initiated Trial (results are not anticipated to be used in our applications for regulatory approval); UHB: University Hospital
Key Highlights of MM120 Program Updates 1 Positive 12-Week Durability in
Phase 2b Trial of GAD Primary and secondary endpoints met with statistical significance 7.7-point improvement over placebo (d=0.81; p=0.003) 48% clinical remission rate at Week 12 Breakthrough Therapy Designation
Recognizes preliminary evidence of substantial improvement over SOC FDA organizational commitment and efficient development support Enhanced Product Profile of MM120 ODTs Results from PK bridging study demonstrate differentiated
profile Rapid absorption, better bioavailability & greater therapeutic AUC Commercial Model & Strategy for Scalable Launch Broad recognition of burden and unmet need in GAD Enthusiasm for MM120 as potential
game-changer Market Protection Strategies and IP Portfolio IP-driven R&D strategies to maximize market protection potential Advancing IP portfolio with recent and near-term key grants 1. Source: Study MMED008 internal study
documents and calculations. Investor Presentation | March 2024 9 2. Source: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
Results for MM120 in GAD Delivered on Target Product Profile after
Single Dose 1,2 with Significant Improvement in All Endpoints Fast Acting 1.8-point reduction in CGI-S within 24 hours (p<0.0001) 21.9-point improvement in HAM-A at Week 12 (p=0.003) represents Durable Activity further improvement from Week 4 3
Response / Remission 48% of participants in remission at Week 12 Favorable tolerability profile with most AEs limited to dosing Limited Side Effect Burden day Scalability, Access & Value Results achieved with no additional therapy 1. Source:
Study MMED008 internal study documents and calculations. 100 g dose group. 2. Represents all analyzed secondary endpoints in week 12 topline analysis, including HAM-A, CGI-S and MADRS. Investor Presentation | March 2024 10 3. p-values not
calculated for remission rates between groups. CGI-S: Clinical Global Impressions - Severity; HAM-A: Hamilton Anxiety Scale.
12-Week Durability Observed with Effect Size Over Double the Standard
of 1,3 Care Key Highlights of Phase 2b 12 Comparative Effect Sizes in GAD Week Results Maximum observed effect size of 0.81 2 MM120 100 g 0.81 is more than double the standard of 2,3 care 4 Benzodiazepines 0.38 Rapid and
durable clinical response 3 observed after single administration 4 SSRIs 0.36 Clinical activity observed with no psychotherapeutic intervention 4 Buspirone 0.17 beyond study drug 0 0.2 0.4 0.6 0.8 1. Source: Study MMED008 internal study
documents and calculations. 2. HAM-A scores based on ANCOVA LS Mean. in Study MMED008. Effect size based on post hoc calculation using LS Mean change between group and pooled standard deviation of week 12 HAM-A scores between groups. Investor
Presentation | March 2024 11 3. Based on 100 g dose group. 4. Source: RB Hidalgo, J Psychopharmacol. 2007 Nov;21(8):864-72.
FDA Has Designated MM120 a Breakthrough Therapy for GAD MM120 Granted
Breakthrough Benefits of Breakthrough Therapy 1 Therapy Designation Designation FDA organizational commitment Recognizes GAD as a serious condition involving senior managers Phase 2b results demonstrate Intensive
guidance on an efficient drug preliminary evidence that MM120 for GAD may have a substantial development program 2 improvement over available therapy Eligibility for Accelerated Approval and 3 Priority Review 4 Rolling Review of NDA
1. Additional details available at FDA website: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy 2. Based on clinically significant endpoint(s) 3. If relevant criteria are met
Investor Presentation | March 2024 12 4. Means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can
be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
PK Bridging Study Demonstrates Enhanced Product Profile for MM120 ODTs
1 Comparative PK Profile 2.5 MM120 Capsule Differentiated Performance of MM120 ODTs MM120 ODT 2 2 50% faster onset of action 1.5 3 17% improved bioavailability 1 4 0.5 23% increase in AUC at target conc. AUC 0 5 0 2 4 6 8 10 12 14 16 18 20 22 24
Reduced GI side effects Time (hours) 1. Company analysis of pharmacokinetic data from Study MM120-101. PK analysis based on n=24 subjects that completed both dosing sessions. 2. Based on time to reach target concentration of >1 ng/mL. 3. Based on
comparison of geometric mean ratio of total area under the curve. Investor Presentation | March 2024 13 4. Based on ratio of mean AUC . Target concentrations defined as level above which perceptual effects are present. >1ng/mL 5. Based on a
comparison between Phase 2b study of MM120 capsules in GAD versus PK bridging study of MM120 ODTs AUC: area under the curve; GI: gastrointestinal; ODT: orally dissolving tablet; PK: pharmacokinetics MM120 Concentration (ng/mL)
Compelling Commercial Opportunity for MM120 Driven by Significant Unmet
Need and Proven Pathways to Scale Significant Large unmet need market Significant Established Best-in-class reimbursement Commercial profile framework Potential Large and Strong growing value infrastructure proposition Investor Presentation | March
KOL Perspective on Impact and Unmet Need in GAD Rakesh Jain, MD, MPH
Clinical Professor of Psychiatry and Behavioral Sciences, Texas Tech University School of Medicine - Permian Basin
Perspective on Impact and Unmet Need in GAD GAD has a negative
impact on many aspects of patients' lives which Increases with severity GAD is chronic in nature, worsens with time and often precedes additional psychiatric disorders 1 Anxiety returning to focus as a major driver of brain
health disorders Patients are underserved by current medications 1 GAD patients express a desire for new treatment options 2 GAD has seen limited innovation in decades - Cymbalta last drug approved for GAD (February 2007)
Current treatments often aren't effective or tolerated and can require numerous cycles of switching and dosage adjustments 3 Decades of LSD Clinical Research in Psychiatric Disorders Supports its Unique Potential 1.
"Anxiety in Children and Adolescents: Screening" (2022). The United States Preventative Services Task Force; "Anxiety Disorders in Adults: Screening" Draft Recommendation (2022). The United States Preventative Services Task
Force. 2. Based on patient research conducted by MindMed in 2023. Investor Presentation | March 2024 16 3. https://investor.lilly.com/news-releases/news-release-details/fda-approves-cymbaltar-treatment-generalized-anxiety-disorder#. 4. Rucker 2016,
Gasset 2014, Holze,Gasser et al 2022, UHB presentation April 2023.
Overview of Generalized Anxiety Disorder Generalized Anxiety Disorder
(GAD) Epidemiology of Anxiety Prevalent disorder characterized by persistent 10% prevalence has tripled in past two decades and excessive worry about various aspects of life More prevalent in women than in men (~2:1)
Individuals with GAD often find it challenging to control their anxiety, leading to significant distress Onset typically in adolescence or early adulthood and impairment in daily functioning Common comorbid psychiatric conditions,
such as Typically manifests with restlessness, fatigue, major depressive disorder and other anxiety disorders difficulty concentrating, irritability, muscle tension, and sleep disturbances nd 2 most common mental disorder among
adults 18 to 65 years old Investor Presentation | March 2024 17