Definium Therapeutics, Inc. · NASDAQ:DFTX
Definium Therapeutics — Mind Medicine (MindMed) — Investor Presentation (August 2023)
32 slides from Definium Therapeutics's investor presentation, Aug 14, 2023
Slide 1: MindMed Investor Presentation August 2023
Company Logo MindMed Investor Presentation August 2023
Slide 2: Disclaimer
Disclaimer This presentation (the “Presentation”) has been prepared by Mind Medicine (MindMed) Inc. (“MindMed” or the “Company”) solely for informational purposes. None of MindMed, its affiliates or any of their respective employees, directors, officers, contractors, advisors, members, successors, r
Slide 3: MindMed at a Glance: A Global Leader in Brain Health
MindMed at a Glance: A Global Leader in Brain Health Using industry-leading drug development expertise to unlock the full therapeutic potential of psychedelics and other novel product candidates MM-120 Generalized Anxiety Disorder (GAD) & Attention-Deficit/Hyperactivity Disorder (ADHD) Well-characte
Slide 4: There is an Urgent Need for Better Treatments
There is an Urgent Need for Better Treatments Substantial opportunities exist to advance novel treatments for a wide range of brain health disorders GAD 10% 1-year prevalence of anxiety disorders in the US1 ADHD 4.4% estimated prevalence rate of ADHD among all US adults 2 ASD $461B economic cost of
Slide 5: Research & Development Pipeline
Research & Development Pipeline Our pipeline diversification offers potential opportunities across therapeutic areas and mechanisms of action PRODUCT CANDIDATE INDICATION PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 REGISTRATION Psychiatry MM-120 (LSD D-tartrate) Generalized Anxiety Disorder ADHD MM-402 (R(
Slide 6: Advancing the Field with Strong IP & Strategic Competitive Moats
Advancing the Field with Strong IP & Strategic Competitive Moats MindMed seeks to protect innovation and market potential through intellectual property-oriented R&D strategies Strategic Life Cycle Management & Late-Stage IP Development Can Significantly Extend Market Protection FDA-granted NCE exclu
Slide 7: Key Milestones
Key Milestones Anticipated Phase 2b in GAD Topline Data | Q4 2023 Phase 2a in ADHD Topline Data | Q4 2023 / Q1 2024 MM-120 LSD D-tartrate Company Logo MindMed Investor Presentation | August 2023 7
Slide 8: Lead Candidate with Evidence Across Multiple Therapeutic Areas
Lead Candidate with Evidence Across Multiple Therapeutic Areas Extensive evidence of clinical benefit and mechanistic rationale in psychiatry and other brain disorders Psychiatry ANXIETY SAFETY & PHARMACOLOGY Broad Applicability preliminary signs of efficacy across multiple diagnoses1 Long-Term Valu
Slide 9: Emerging Treatment Paradigm for Brain Health Disorders
Emerging Treatment Paradigm for Brain Health Disorders Image Image Image Image MM-120 is a potent serotonin agonist with potential applications to a broad range of brain health disorders1 Global Brain Connectivity Placebo Psychedelic drug Entropic brain activity Placebo (Low Entropy) Psychedelic Dru
Slide 10: Mechanism of Action Driving Potential Durable Clinical Response
Mechanism of Action Driving Potential Durable Clinical Response Unique mechanism of action increases brain connectivity, enabling rapid and durable effects Increased connectivity between brain regions Baseline connectivity between brain regions LSD activates serotonin-2A receptors LSD Serotonin-2A r
Slide 11: An Urgent Need for Better Anxiety Treatments
An Urgent Need for Better Anxiety Treatments Generalized Anxiety Disorder is underdiagnosed, underserved and has lacked innovation for decades GAD presents large and unmet patient need Prevalence of 10.0% among US adults1Ù 77% of patients present with moderate-to-severe GAD2Ù 50% of those treated fa
Slide 12: Extensive LSD Clinical Research in Psychiatric Disorders
Extensive LSD Clinical Research in Psychiatric Disorders MM-120 program builds on decades of clinical research of LSD, the most studied drug in its class Studies Indication(s) Sample Size KEY FINDINGS Anxiety Major Depressive Disorder 42 patients 61 patients HOLZE 2022 HOLZE 2023 21 Studies PRIOR TO
Slide 13: Modern Evidence in Anxiety Disorders
Modern Evidence in Anxiety Disorders Results from UHB’s LSD-Assist study support MindMed’s clinical development of MM-120 for GAD Rapid, durable and significant anxiolytic effects Reduction in anxiety and depression symptoms¬ durable at 16 weeks post-treatment vs. placebo (p<0.007 Clinical response
Slide 14: Phase 2b Generalized Anxiety Disorder (GAD)
Phase 2b Generalized Anxiety Disorder (GAD) PSYCHIATRY MM-120 (LSD D-tartrate) Indication: GAD PHASE 2B 180 participants total (n=36/arm) ADDITIONAL ENDPOINTS MADRS CGI-S/I PGI-S/C] SDS EQ-5D-5L PSQI ASEX Study MMED008 MM-120 for GAD A Phase 2b Dose Optimization Study of a Single Dose of MM-120 in G
Slide 15: Potential MM-120 Clinical Care Model
Potential MM-120 Clinical Care Model Advancing a delivery model that seeks to optimize outcomes Pre-Treatment Patient education, engagement, preparation Eligibility evaluation Care coordination with existing clinical team During Treatment Continuous monitoring by qualified session monitors Non-direc
Slide 16: Digital Unlocks Potential Opportunities Throughout the Product Lifecycle
Digital Unlocks Potential Opportunities Throughout the Product Lifecycle Generating data, insights, models, and tools from early development through market management Preclinical Research IND & Phases 1 - 3 Drug Launch Enhancement and Lifecycle Management Clinical Development Tools Patient education
Slide 17: Potential Pathway to Commercial Success for MM-120
Potential Pathway to Commercial Success for MM-120 Our approach seeks to leverage well-established pathways to bring novel therapeutics to patients at scale Submit Marketing Applications Seek approval for drug product candidates in major markets globally Collaborate with healthcare authorities to se
Slide 18: Phase 2a Attention-Deficit Hyperactivity Disorder (ADHD)
Phase 2a Attention-Deficit Hyperactivity Disorder (ADHD) Multi-faceted approach directly targeting the serotonin system Maximizing MM-120 value through study of various doses and schedules to optimize the drug across indications Serotonin is a critical and increasingly in psychiatry Creatively explo
Slide 19: Phase 2a ADHD Proof of Concept Study Design
Phase 2a Attention-Deficit Hyperactivity Disorder (ADHD) Proof of concept study design seeks to explore potential clinical response in ADHD PSYCHIATRY MM-120 (LSD D-tartrate) Indication: ADHD PHASE 2A 52 participants total (n=26/arm) Week 2 4 6 10 Prep Dosing Follow Up Secondary Endpoint AISRS MM-12
Slide 20: Key Milestones
Key Milestones Anticipated Phase 1 Study Initiation Q4 2023 Phase 1 IIT (UHB-Sponsored) Topline Data H1 2024 MM-402 R(-)-MDMA Investor Presentation August 2023 20 Company LOGO MindMed
Slide 21: Differentiated Mechanism of Action Targets Key Pathways
Differentiated Mechanism of Action Targets Key Pathways R-MDMA increases serotonin and oxytocin with potential prosocial and positive mood effects in patients with Autism Spectrum Disorder Company logo MindMed Investor Presentation | August 2023 21
Slide 22: No Approved Drugs for Core Symptoms of Autism Spectrum Disorder (ASD)
No Approved Drugs for Core Symptoms of Autism Spectrum Disorder (ASD) Growing prevalence and impact of ASD yields an urgent need for novel therapies that target core symptoms and align with patient preferences R(-)-MDMA Activity Aligns with Reported Needs and Desired Benefits for Individuals with AS
Slide 23: Preclinical Data Indicate Potential Enhanced Benefit/Risk Profile
Preclinical Data Indicate Potential Enhanced Benefit/Risk Profile Preclinical data suggest the R-enantiomer of MDMA has prosocial effects with reduced stimulant activity Translational preclinical data suggest that R(-)-MDMA may have: Strong prosocial effect Less stimulant activity compared to MDMA P
Slide 24: Clinical Data Support Opportunity for MDMA in ASD
Clinical Data Support Opportunity for MDMA in ASD Pilot clinical trial results of MDMA demonstrate acute and durable positive effects on social functioning in ASD population 1 MM-402 or R(-)-MDMA is a pharmaceutically optimized enantiomer of MDM Potential first-in-class therapy for core symptoms of
Slide 25: Collaborations & Early R&D
Collaborations & Early R&D company logo MindMed Investor Presentation | August 2023 25
Slide 26: External Collaborations Aim to Accelerate Discovery & Development
External Collaborations Aim to Accelerate Discovery & Development Leveraging key partnerships and collaborations with intent to accelerate drug discovery and de-risk clinical development NEW CHEMICAL ENTITY DISCOVERY ENGINE DISCOVERY & LEAD OPTIMIZATION ADVANCED DRUG DELIVERY NOVEL DOSAGE AND DELIVE
Slide 27: Exclusive Collaboration with Leading Researchers
Exclusive Collaboration with Leading Researchers MindMed’s exclusive collaboration with the Liechti Lab at UHB enables efficient evidence generation to support R&D strategy + LSD for Anxiety LSD for MDD LSD for Cluster Headache R-MDMA MDMA analogues Mescaline DMT Potential Strategic Value Rapid tran
Slide 28: Our Leadership Team
Our Leadership Team Our management has decades of successful leadership, product development, and commercialization in pharma and biopharma Robert Barrow Chief Executive Officer and Board Director Miri Halperin Wernli, PhD Executive President Daniel Karlin, MD, MA Chief Medical Officer Schond Greenw
Slide 29: Our R&D Leadership Team
Our R&D Leadership Team Our R&D team has decades of successful leadership, product development, and commercialization in pharma and biopharma Peter Mack, PhD VP, Pharmaceutical Development Bridget Walton, MS, RAC VP, Global Regulatory Affairs Robert Silva, PhD VP, Head of Development Carole Abel, MB
Slide 30: Our Team Has Significant Drug Development Experience
Our Team Has Significant Drug Development Experience Our Management and R&D team’s relevant experience overseeing the approval of drug candidates positions MindMed for success CNS Products Other Products company logo MindMed Investor Presentation | August 2023 30
Slide 31: Business Highlights
Business Highlights A leader in developing psychedelic product candidates to treat brain health disorders Diversified pipeline of clinical programs targeting significant unmet medical needs IP and R&D strategies intended to maximize market exclusivity and protection Leveraging decades of research on
Slide 32: MindMed
MindMed Company logo MindMed Investor Presentation | August 2023 32
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