Definium Therapeutics, Inc. · NASDAQ:DFTX
Definium Therapeutics — Mind Medicine (MindMed) — Investor Day (June 2023)
61 slides from Definium Therapeutics's investor day presentation, Jun 20, 2023
Slide 1: MindMed Investor Day 2023: MM-120 for Generalized Anxiety Disorder
MindMed Investor Presentation Investor Day 2023: MM-120 for Generalized Anxiety Disorder
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: Today's Agenda
Today’s Agenda SPEAKER TOPIC Rob Barrow CEO, MindMed Maria Oquendo, MD David Feifel, MD, PhD Experts and Management Team Michael Kobernick, MD W. Chad Shear, JD Rob Barrow Experts and Management Team Rob Barrow Opening Remarks Unmet Need & Patient Journey in Generalized Anxiety Disorder (GAD) Practi
Slide 4: MindMed at a Glance: A Global Leader in Brain Health
MindMed at a Glance: A Global Leader in Brain Health Advancing Proprietary Drug Candidates Across Psychiatric Indications MM-120 MM-402 Generalized Anxiety Disorder (GAD) & Attention-Deficit/Hyperactivity Disorder (ADHD) Well-characterized pharmacology Aelerated development potential Autism Spectrum
Slide 5: MM-120: Lead Candidate with Evidence Across Multiple Therapeutic Areas
MM-120 | Lead Candidate with Evidence Across Multiple Therapeutic Areas Psychiatry ANXIETY SAFETY & PHARMACOLOGY 1 preliminary signs of efficacy across multiple diagnoses benefit observed after acute dosing Rapid & Sustained 10,000+ patients treated in clinical trials 1 Long-Term Value through multi
Slide 6: Brain Health is One of the Fastest Growing Therapeutic Areas
Brain Health is One of the Fastest Growing Therapeutic Areas CNS Annual Sales ($ in Billions) CAGR: >11% CAGR: <1% 200 175 150 125 100 75 50 25 0 2012A 2022E 2023E 2024E 2025E 2026E 2027E 2027E Annual Sales Growth ($) from 2022E to 2028E CAGR Oncology cns immunomodulators dermatology endocrine cardi
Slide 7: US Market Revenue for GAD by Drug Class, 2022–2031
US Market Revenue for GAD by Drug Class, 2022 – 2031 ($ Million) Drug Class 2022 2031 (expected) cagr % (2022-31) Antidepressants SSRI SNRI Others Azapirones benzodiazepines Others TOTAL 1,675.7 787.6 737.3 150.8 117.6 823.1 323.4 2,939.8 2,370.9 1,153.4 1,058.1 159.3 137.0 1,154.2 366.6 4,028.7 3.9
Slide 8: Anxiety Returning to Focus as Major Driver of Mental Health Disorders
Anxiety Returning to Focus as Major Driver of Mental Health Disorders The United States Preventive Services Task Force (USPSTF) recently issued a recommendation for screening for anxiety for children and adolescents aged 8 to 18 years and issued a draft recommendation for adults under the age of 65.
Slide 9: GAD Pipeline is Far Less Crowded than MDD Pipeline
GAD Pipeline is Far Less Crowded than MDD Pipeline 6 FDA-approved drugs for GAD Key Players SSRIs/SORIs: Benzodiazapines: Paxil (GvKu) Effexor and Effexor XR (Pfizer-Viatris) Lexapro (Forest-AbbVie) Cymbalta (Eli Lilly) Xanax (Pfizer) Klonopin (Roche) Company Logo GAD Pipeline GRX 917 PH94B Zuranolo
Slide 10: Legacy of LSD Clinical Research in Psychiatric Disorders
Legacy of LSD Clinical Research in Psychiatric Disorders The Unique Opportunity of LSD LSD and Psilocybin Publications by Date Most researched compound in the psychedelic drug class 1 Compelling preliminary evidence in anxiety, depression, AUD and other indicationsy 2 Due to potency, unique opportun
Slide 11: Key Drug Candidate: MM-120 Program
Key Drug Candidate: MM-120 Program Proprietary drug candidate with evidence of clinical benefits across a broad range of brain health disorders We are positioned for two key data readouts this year and have recently reached an enrollment milestone in our Phase 2b trial for GAD with over 50% of patie
Slide 12: Advancing the Field with Strong IP & Strategic Competitive Moats
Advancing the Field with Strong IP & Strategic Competitive Moats Opportunities for Innovation & Strong IP Proactive Lifecycle Management Market Protection Strategies IP-Driven R&D Direction Strategic Life Cycle Management & Late-Stage IP Development Can Significantly Extend Market Protection FDA-gra
Slide 13: Table of Contents
Table of Contents 01 Opening Remarks 02 Unmet Need & Patient Journey in GAD 03 Practical Aspects of Monitored Therapies 04 Q&A for Sessions 2 and 3 Payer Considerations in New Medication Coverage 05 06 07 The IP Landscape Corporate Update 08 MindMed Q&A and Concluding Remarks Investor Day June 2023)
Slide 14: Unmet Need & Patient Journey in GAD - Maria Oquendo, MD
Unmet Need & Patient Journey in GAD - Maria Oquendo, MD Ruth Meltzer Professor and Chairman of Psychiatry at University of Pennsylvania Psychiatrist-in-Chief at the Hospital of the University of Pennsylvania President of the Board of Directors, American Foundation for Suicide Prevention Vice Preside
Slide 15: An Urgent Need for Better Anxiety Treatments
An Urgent Need for Better Anxiety Treatments GAD presents large and unmet patient needs 1-year rate of prevalence of 2.9% among US adults' 76% have moderate-to-severe GAD 2 Symptoms include: Clinically significant impairment at work and in social environments, restlessness, fatigue, concentration di
Slide 16: Anxiety Correlated with Significant Impairment
Anxiety Correlated with Significant Impairment Evidence of greater impairment for those with higher anxiety severity 1 An anxiety disorder is also associated with less accomplishment at work, reduced labor force participation2 Associated with significantly higher rates of cardiac disorders, hyperten
Slide 17: Need for Additional Treatment Options is Clear
Need for Additional Treatment Options is Clear. individual variations: GAD is not a once size fits all indication; it is a very diverse disorder Co-occurring conditions (e.g., depression or PTSD) may complicate treatment Treatment resistance: 50% fail first line (SSR.) treatment Side effects: Curren
Slide 18: Many Patients Change Treatments Due to Lack of Efficacy and/or Side Effects
Many Patients Change Treatments Due to Lack of Efficacy and/or Side Effects First Line Second Line Third Line Fourth Line + First Line Nearly all patients start on an SSRI (and titrate up` l Since most patients have MDD, this is effective for both MDD and GAD l Some augment with a benzo to help the
Slide 19: Patients are Underserved by Current Medications
Patients are Underserved by Current Medications Mechanism FDA Status in Anxiety Comments SSRI/SNRI 5-HT, NE (and DA) reuptake inhibitors Approved (fluoxetine, sertraline, escitalopram, paroxetine, duloxetine, venlafaxine) Generally front line, 50% failure rate, sexual side effects can be durable1 Be
Slide 20: Psychedelic Therapies Offer Promise
Psychedelic Therapies Offer Promise Evidence of rapid and d3rable impacts in anxiety and depression Lesser concern for chronic safety issue Monitored and infreq3ent dosing promises greater compliance Investor Day | June 2023 20
Slide 21: Table of Contents
Table of Contents 01 Opening Remarks 02 Unmet Need & Patient Journey in GAD 03 Practical Aspects of Monitored Therapies 04 Q&A for Sessions 2 and 3 05 Payer Considerations in New Medication Coverage 06 The IP Landscape 07 Corporate Update 08 Q&A and Concluding Remarks Investor Day | June 2023 21
Slide 22: Practical Aspects of Monitored Therapies – David Feifel, MD, PhD
Practical Aspects of Monitored Therapies – David Feifel, MD, PhD Founder and Medical Director, Kadima Neuropsychiatry institute l Professor Emeritus of Psychiatry, UC San Diego, where he was Director of the Neuropsychiatry and Behavioral Medicine Program and established world's first ketamine infusi
Slide 23: The Kadima Neuropsychiatry Institute
The Kadima Neuropsychiatry Institute Founded to more effectively pursue cutting edge, non-invasive treatments for neuropsychiatric disorders Specializing in depression, anxiety, PTSD, OCD, eating disorders and related conditions Providing ~75 ketamine treatments daily Clinical site for MindMed, Beck
Slide 24: Case Study – How Ketamine Therapy Works at Kadima
Case Study – How Ketamine Therapy Works at Kadima Initial Consult Medical and psychiatric history Discussion of treatment alternatives Ketamine Recommended? Six IV or IM treatments over a 3- week period` R Start at low dose R Gradually increase to find most effective dose R One preparation session w
Slide 25: Case Study – How Ketamine Therapy Works at Kadima
Case Study – How Ketamine Therapy Works at Kadima Investor Day | June 2023 25
Slide 26: Case Study – How Spravato (esketamine) Therapy Works at Kadima
Case Study – How Spravato (esketamine) Therapy Works at Kadima Initial Consult Clinic and Physician must be certified by Janssen G Medical and psychiatric history Discussion of treatment alternatives Spravato Recommended? Insurance prior authorization (failed 2 previous antidepressants and currently
Slide 27: Evolution of Spravato – FDA Approval and Launch, 2019 to Today
Evolution of Spravato – FDA Approval and Launch, 2019 to Today Spravto (esketamine): 2019 vs. 2023 2019 Not ready for primetime Insufficient billing codes Unprofitable Today Codes developed Covered by major insurers (Unite, Cigna, BC/BS, etc. Two business models: "Buy an Bill," Administration billin
Slide 28: The Experience with TMS Therapy
The Experience with TMS Therapy Deep Transcranial Magnetic Stimulation (TMS) therapy is a cutting-edge, non-medication treatment that is FDA approved for depression, anxiety, OCD and smoking addiction. TMS uses a pulsating magnetic field designed to stimulate nerve cells Neurons) in the specific bra
Slide 29: Potential and Promise of Psychedelic Therapy
Potential and Promise of Psychedelic Therapy Potential for rapid, long-lasting relief from a variety of symptoms we have years of experience and infrastructure for monitoring multiple sessions simultaneously through our work with ketamine and Spravato, as well as a participant in MindMed and Compass
Slide 30: Q&A for Sessions 2 and 3
MindMed Q&A for Sessions 2 and 3 Investor Day | June 2023 30
Slide 31: Table of Contents
Table of Contents 01 02 03 04 05 06 07 08 Opening Remarks Unmet Need & Patient Journey in GAD Practical Aspects of Monitored Therapies & Digital Medicine Q&A for Sessions 2 and 3 Payer Considerations in New Medication Coverage Corporate Update The IP Landscape Q&A and Concluding Remarks MindMed Inve
Slide 32: Payer Considerations in New Medication Coverage – Michael Kobernick, MD
Payer Considerations in New Medication Coverage – Michael Kobernick, MD Disclaimer: Opinions expressed are the speaker’s own and in no way reflect the opinions of Blue Cross Blue Shield of Michigan or any other organization. r Senior Medical Director, Blue Crosss/Blue Shield of Michigan Advises larg
Slide 33: Behavioral Health is a Leading Driver of Healthcare Costs
Behavioral Health is a Leading Driver of Healthcare Costs Estimated Health Care Spending by Payer and Type of Care 400 300 200 100 0 Neurological Disorders Behavioral Health Cardio-vascular Endocrine Disease Musculo- skeletal Billions of $ (Annual, 2016 USD) Source [1] HG Dieleman JL, et al. 2020; J
Slide 34: Depression and Anxiety are Most Prevalent Among US Adults
Depression and Anxiety are Most Prevalent Among US Adults Prevalence Among US Adults (%) 0 2 4 6 8 10 12 14 16 18 20 Schizophrenia OCD BPD Bipolar PTSD MDD Anxiety Percentage of US Adults, Annually Source: [1] 1. https://nami.org/mhstats. MindMed Investor Day | June 2023 34
Slide 35: Behavioral Health Issues Tend to Bring Higher Overall Healthcare Costs
Behavioral Health Issues Tend to Bring Higher Overall Healthcare Costs a 27% of patients who had a behavioral health condition in addition to other medical problems accounted for a Annual costs were for people who had a behavioral health condition such as anxiety, depression, or a substance abuse di
Slide 36: Behavioral Health is a Priority for Employers
Behavioral Health is a Priority for Employers All employers want to address solutions for behavioral health Seen as an important social determinant of health All new approaches being embraced Virtual Care Models Co-Care Models – PCP + Psychiatrist Interest in Ketamine and Psychedelics MindMed Invest
Slide 37: Factors For Medication Coverage Determination
Factors For Medication Coverage Determination FDA Approval Clinical Efficacy Peer Reviewed Publications Informative but not Decisive Specialty Society Guidelines Subject Matter Expert Opinion MindMed Investor Day | June 2023 37
Slide 38: Monitoring and Administration Coverage Codes Currently Exist
Monitoring and Administration Coverage Codes Currently Exist Observation Psychological Evaluation Evaluation and Management (EM) Precedents Spravato Sleep Studies MindMed Investor Day | June 2023 38
Slide 39: Table of Contents
Table of Contents 01 02 03 04 05 06 07 08 Opening Remarks Unmet Need & Patient Journey in GAD Practical Aspects of Monitored Therapies Q&A for Sessions 2 and 3 Payer Considerations in New Medication Coverage The IP Landscape Corporate Update Q&A and Concluding Remarks MindMed Investor Day | June 202
Slide 40: The IP Landscape – W. Chad Shear, JD
The IP Landscape – W. Chad Shear, JD Former principal in life sciences and pharmaceutical intellectual property (IP) at Fish & Richardson Led litigation on behalf of clients including Sunovion, Dainippon Sumitomo, Gilead Sciences, and Astellas Named an IP Trailblazer by The National Law Journal Form
Slide 41: Intellectual Property (IP) in Biotech – Basics: Patent Exclusivities
Intellectual Property (IP) in Biotech – Basics Patent Exclusivities PATENT TERN, 20 YEARS FROM FILING PTA, CALCULATED AT USPTO, TERM VERIES PTE, MAX 5 OR 14 YEAR FROM APPROVAL PED YEARS 17 20 23 28 Patent exclusivities Patent term – 20 years Patent term adjustment (PTA) Patent term extension (PTE) M
Slide 42: Intellectual Property (IP) in Biotech – Basics: Regulatory Exclusivities
Intellectual Property (IP) in Biotech – Basics Regulatory Exclusivities 5 YEARS OF DATE EXCLUSIVITY ANDA CAN BE SUBMITTED AT END OF YEAR 4 30-MONTH STAY EXTENDS THE EXCLUSIVITY TO 7.5 YEARS AFTER NDA APPROVAL CE PED QIDP sNDA 30-MONTH YEARS 4 10 Regulatory exclusivities New Chemical Entity (NCE) – 5
Slide 43: What Can be Patented?
What Can be Patented? New Compounds: These are new chemical compound or molecules that have never been described before Drug Formulations: Novel combinations, dosages, delivery systems, controlled-release formulations, or improved stability of the drug Manufacturing Processes: Novel synthesis routes
Slide 44: What are the Requirements for Patentability?
What are the Requirements for Patentability? Novelty: The invention should not have been previously known or used by others in any public form, such as in publications, patents, or public demonstrations Non-obviousness: The invention must involve an inventive step, meaning it must not be obvious to
Slide 45: Hatch-Waxman Act
Hatch-Waxman Act FDA Orange Book: Identifies dr7g prod7cts approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information 30-month stay: Gives the brand product sponso
Slide 46: Table of Contents
Table of Contents 01 Opening Remarks 02 Unmet Need & Patient Journey in GAD 03 Practical Aspects of Monitored Therapies 04 Q&A for Sessions 2 and 3 05 Payer Considerations in New Medication Coverage 06 The IP Landscape 07 Corporate Update 08 Q&A and Concluding Remarks MindMed Investor Day June 2023
Slide 47: We've Seen Positive Momentum Across the Business
We’ve Seen Positive Momentum Across the Business Meaningful Market Opportunity 21% 1-year prevalence of anxiety disorders in 21% the US1 4.4% estimated prevalence of ADHD among all US adults2 $461B economic cost of ASD in the US predicted by 20253 Significant Progress $129M 26 Cash on hand as of Q1
Slide 48: Our Leadership Team
Our Leadership Team Robert Barrow Chief Executive Officer and Board Director Miri Halperin Wernli, PhD Executive President Daniel Karlin, MD, MA Chief Medical Officer Schond Greenway, MBA Chief Financial Officer Mark Sullivan, JD Chief Legal Officer and Corporate Secretary Francois Lilienthal, MD, M
Slide 49: Our R&D Leadership Team
Our R&D Leadership Team VP, Pharmaceuticals Development Bridget Walton, MS, RAC VP, Global Regulatory Affairs Robert Silva, PhD VP, Head of Development Carole Abel, MBA VP, Programs & Portfolio Office (PPO) AstraZeneca Pearl Liquidia sunovion NOVARTIS Johnson & Johnson Wyeth ZOGENIX IPSEN Innovation
Slide 50: Research & Development Pipeline
Research & Development Pipeline 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(-)-MDMA) Autism Spectrum Disorder SUBSTANCE USE DISORDERS MM-110 (zolunicant HCl)* Opioid Withdrawal DISCOVERY
Slide 51: MM-120: LSD Increases Neural Connectivity and Activity
MM-120 | LSD Increases Neural Connectivity and Activity Baseline connectivity between brain regions LSD activates serotonin 2A receptors LSD Serotonin 2A receptor Increased connectivity between brain regions Transiently and powerfully alters perception, behavior, and mood Intensifies thoughts, emoti
Slide 52: MM-120: Legacy of LSD Clinical Research in Psychiatric Disorders
MM-120 | Legacy of LSD Clinical Research in Psychiatric Disorders Studies Indication(s) Sample Size KEY FINDINGS 21 Studies PRIOR TO 1974 Anxiety, depression & neurotic illnesses 1 512 patients Up to 95% reduction in symptoms Gasser 2014 Anxiety in terminal illness 12 patients Effect size of 1.1 wit
Slide 53: MM-120: Modern Preliminary Evidence in Anxiety Disorders
MM-120 | Modern Preliminary Evidence in Anxiety Disorders 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 (≥30% reduction) observed in 65% of LSD group vs 9% of placebo group £p
Slide 54: MM-120: Modern Preliminary Evidence in Depression
MM-120 | Modern Preliminary Evidence in Depression Significant, rapid, durable and beneficial effects on symptoms of MDD Reduction in depression symptoms; durable at 16 weeks post treatment Positive correlation between acute positive effect or mystical experiences and clinical outcome Generally well
Slide 55: MM-120: Phase 2b Generalized Anxiety Disorder (GAD)
MM-120 | Phase 2b Generalized Anxiety Disorder (GAD) PSYCHIATRY MM-120 (LSD D-tartrate) Indication: GAD PHASE 2B 200 participants total (n=40/arm) Study MMED008 | MM-120 for GAD A Phase 2b Dose Optimization Study of a Single Dose of MM-120 in Generalized Anxiety Disorder Key Entry criteria Men and W
Slide 56: MM-120: Phase 2b Enrollment Update
MM-120 | Phase 2b Enrollment Update Over 50% Patients dosed across 20 active sites1 Next Update Additional update on enrollment and timing of data during Q2 2023 earnings (August) 1 Dosing update as of May 17, 2023 MindMed Investor Day June 2023 56
Slide 57: MM-120: Potential Clinical Care Model
MM-120 | Potential Clinical Care Model Pre-Treatment During Treatment Post-Treatment Patient education, engagement, preparation Continuous monitoring by session monitors Follow-up psychosocial support Eligibility evaluation Non-directive psychosocial support Continuation of standard psychiatric care
Slide 58: MM-120: Digital to Complement Delivery Through the Patient Journey
MM-120 | Digital to Complement Delivery Through the Patient Journey Pre-Treatment During Treatment Post-Treatment Patient education, engagement, preparation In-session monitoring Real world monitoring of trends Deep digital diagnosis Clinician decision support Engagement in health maintenance Suppor
Slide 59: MM-120: Potential Pathway to Commercial Success
MM-120 | Potential Pathway to Commercial Success Soak approval for drug product candidates in major markets globally Collaborate with healthcare authorities t seek targeted labeling Strategic plans for long-term product life cycle management and market preservation Submit Marketing applications Revi
Slide 60: 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 7 Z Leveraging decades of researc
Slide 61: MindMed Q&A
MindMed Q&A MindMed Investor Day June 2023 61