Definium Therapeutics, Inc. · NASDAQ:DFTX

Definium Therapeutics — Mind Medicine (MindMed) — Investor Presentation (August 2024)

47 slides from Definium Therapeutics's investor presentation, Aug 12, 2024

  1. Slide 1: Corporate Presentation August 2024

    Corporate Presentation August 2024

  2. Slide 2: Disclaimer

    Corporate Presentation | August 2024 Disclaimer This presentation (the “Presentation”) has been prepared by Mind Medicine ( MindMed ) Inc. (“ MindMed ”, the “Company”, “we”, “our” or “us) solely for informational purposes. This Presentation does not constitute an offering of , o r a solicitation of

  3. Slide 3: We Aim To Be A Global Leader In Brain Health

    Corporate Presentation | August 2024 We Aim To Be A Global Leader In Brain Health 1. The company’s cash and cash equivalents of $252.3 million as of March 31, 2024 are expected to fund operations into 2026. Pipeline Diversified pipeline of clinical programs targeting significant unmet medical needs

  4. Slide 4: Experienced Leadership with a Proven Track Record

    Corporate Presentation | August 2024 Experienced Leadership with a Proven Track Record 4 Strong Experience in Brain Health Innovation 1 1. Representative of approved drugs developed by MindMed employees

  5. Slide 5: MindMed Research & Development Pipeline

    Corporate Presentation | August 2024 MindMed Research & Development Pipeline 1. Full trial details and clinicaltrials.gov links available at mindmed.co /clinical - digital - trials/ 2. Studies in exploration and/or planning stage. LSD: lysergide ; R( - ) - MDMA: rectus - 3,4 - methylenedioxymethamph

  6. Slide 6: Next Steps and Anticipated Milestones for R&D Pipeline

    Corporate Presentation | August 2024 6 2H2024 1H2025 2H2025 1H2026 Next Steps and Anticipated Milestones for R&D Pipeline 2H2026 MM120 - 300 for GAD Phase 3 initiation MM120 - 301 for GAD Phase 3 initiation MM120 - 300 for GAD Phase 3 Readout MM120 - 301 for GAD Phase 3 Readout Emerge MM120 - 310 fo

  7. Slide 7: MM120 ODT LSD D-tartrate Program Overview

    MM120 ODT LSD D - tartrate Program Overview

  8. Slide 8: Key Highlights of MM120 Program

    Corporate Presentation | August 2024 Key Highlights of MM120 Program 1. Source: Study MMED008 internal study documents and calculations. 2. Source: https://www.fda.gov/patients/fast - track - breakthrough - therapy - accelerated - approval - priority - review/breakthrough - therapy AUC: area under t

  9. Slide 9: MM120 Has the Potential to Address Large Unmet Needs in Major Brain Health Disorders

    Corporate Presentation | August 2024 MM120 Has the Potential to Address Large Unmet Needs in Major Brain Health Disorders 1. Based on results from Phase 2b Study MMED008. Comparisons to standard of care / other drug classes based on historical compa ris on not head - to - head comparison trial. 2. M

  10. Slide 10: Clinical Rationale and Mechanism of Action

    Corporate Presentation | August 2024 10 Clinical Rationale and Mechanism of Action

  11. Slide 11: MM120 ODT Program Overview

    Corporate Presentation | August 2024 MM120 ODT Program Overview 1. Studies will employ an adaptive design with interim blinded sample size re - estimation based on nuisance parameters (e.g. patient retention rate, variability of primary outcome measure) which allows for an increase of sample size up

  12. Slide 12: Strategies to Address Key Drug Class Methodological Considerations

    Corporate Presentation | August 2024 Strategies to Address Key Drug Class Methodological Considerations AE: adverse event; ECG: electrocardiogram; MOA: mechanism of action; TQT: thorough QT 12 Expectancy Bias & Functional Unblinding Cardiovascular Safety Adverse Event Collection • Blinded centralize

  13. Slide 13: MM120 | Multiple Layers of Intellectual Property and Protection

    Corporate Presentation | August 2024 +1y +2y +3y +4y +9y +5y +7y … 2043+ New Chemical Entity Exclusivity 30 - Month Stay 1. Section 505 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355. PK: pharmacokinetic; PD: pharmacodynamic MM120 Launch Potential Patent Protection Method of Use / Metho

  14. Slide 14: MM120 ODT LSD D-tartrate Phase 3 Program in GAD

    MM120 ODT LSD D - tartrate Phase 3 Program in GAD

  15. Slide 15: MM120 for GAD | Phase 3 Program Overview

    Corporate Presentation | August 2024 MM120 for GAD | Phase 3 Program Overview 15 1. Clinical study designs subject to ongoing regulatory discussion and review, including of Phase 3 clinical trial protocols 2. Primary endpoint in Phase 2b study was change from baseline to Week 4 3. Phase 2b study req

  16. Slide 16: Phase 2b Results in GAD Demonstrated 12-Week Durability with Effect Size Over Double the Standard of Care

    Corporate Presentation | August 2024 Phase 2 Results in GAD Demonstrated 12 - Week Durability with Effect Size Over Double the Standard of Care 1,3 1. Source: Study MMED008 internal study documents and calculations. Comparisons to standard of care/other drug classes based on his torical comparison n

  17. Slide 17: Phase 2b Results in GAD Delivered on Target Product Profile

    Corporate Presentation | August 2024 17 Phase 2 Results in GAD Delivered on Target Product Profile after Single Dose and Support Phase 3 Advancement 1,2 1. Source: Study MMED008 internal study documents and calculations. 100 µg dose group. 2. Represents all analyzed secondary endpoints in week 12 to

  18. Slide 18: MM120 for GAD | Phase 3 Study Designs

    Corporate Presentation | August 2024 Study MM120 - 301 Study MM120 - 300 MM120 for GAD | Phase 3 Study Designs 1. Studies will employ an adaptive design with interim blinded sample size re - estimation based on nuisance parameters (e.g. pati ent retention rate, variability of primary outcome measure

  19. Slide 19: Phase 3 GAD Part A Trial Schematics

    Corporate Presentation | August 2024 19 Phase 3 GAD Part A Trial Schematics: Two Pivotal Studies with Complementary Designs 1 1. Source: Study MM120 - 300 and Study MM120 - 301 internal study documents. 2. Study will employ an adaptive design with interim blinded sample size re - estimation based on

  20. Slide 20: Phase 3 GAD Part B Trial Schematics: Extension Phase

    Corporate Presentation | August 2024 20 Phase 3 GAD Part B Trial Schematics: Extension Phase 1. Source: Study MM120 - 300 and MM120 - 301 study documents. μ g: microgram; ePRO: electronic patient reported outcome; HAM - A: Hamilton Anxiety Rating Scale 4 5 6 7 8 9 10 11 12 Study Month Follow - up Ob

  21. Slide 21: Phase 3 GAD Part A Trials: Primary & Key Secondary Endpoints

    Corporate Presentation | August 2024 Phase 3 GAD Part A Trials: Primary & Key Secondary Endpoints 1 1. Clinical study designs subject to ongoing regulatory discussion and review, including of Phase 3 clinical trial protocols. 2. 100 µg dose group. 3. Based on assumption of n=85 evaluable subjects pe

  22. Slide 22: MM120 ODT LSD D-tartrate Phase 3 Program in MDD

    MM120 ODT LSD D - tartrate Phase 3 Program in MDD

  23. Slide 23: Decades of LSD Clinical Research in Psychiatric Disorders Supports its Unique Potential

    Corporate Presentation | August 2024 Decades of LSD Clinical Research in Psychiatric Disorders Supports its Unique Potential 1. Rucker JJ, Jelen LA, Flynn S, Frowde KD, Young AH. Psychedelics in the treatment of unipolar mood disorders: a systematic review. J Psychopharmacol . 2016;30(12):1220 - 122

  24. Slide 24: MM120 Antidepressant Potential Demonstrated in GAD Patients with Comorbid Depression

    Corporate Presentation | August 2024 24 MM120 Antidepressant Potential Demonstrated in GAD Patients with Comorbid Depression (MADRS) 1,2 1. Source: MindMed internal study documents and calculations. Full analysis set population. 2. Based on 100 µg dose group. 3. Significance achieved despite study n

  25. Slide 25: Emerge MM120-310 | MM120 for MDD Phase 3 Study Design

    Corporate Presentation | August 2024 Emerge MM120 - 310 MM120 for MDD | Phase 3 Study Design 1 1. Clinical study designs subject to ongoing regulatory discussion and review, including of Phase 3 clinical trial protocols. 25 N=70 N=70 Part A 12 Week Randomized, Double - Blind Part B 40 Week Extension

  26. Slide 26: Phase 3 MDD Trial Schematic: Emerge Study

    Corporate Presentation | August 2024 26 Phase 3 MDD Trial Schematic: Emerge Study 1 1. Source: Study MM120 - 310 study documents. Clinical study designs subject to ongoing regulatory discussion and review, including o f Phase 3 clinical trial protocols. 2. Select secondary endpoints. μ g: microgram;

  27. Slide 27: MM120 ODT LSD D-tartrate Phase 2b Results in GAD

    MM120 ODT LSD D - tartrate Phase 2b Results in GAD

  28. Slide 28: Phase 2b Trial of MM120 Utilized Standard GAD Design and Endpoints

    Corporate Presentation | August 2024 Phase 2b Trial of MM120 Utilized Standard GAD Design and Endpoints and was Aligned with FDA Draft Guidance for Drug Class 1 1. Source: Study MMED008 internal study documents and calculations. 2. FDA 2023 Draft Guidance: Psychedelic Drugs: Considerations for Clini

  29. Slide 29: Phase 2b Trial Schematic

    Corporate Presentation | August 2024 29 Phase 2b Trial Schematic 1 1. Source: Study MMED008 internal study documents. μ g: microgram; HAM - A: Hamilton Anxiety Rating Scale; MADRS: Montgomery - Asberg Depression Rating Scale; CGI - S: Clinical Global Impressions - Severity; PGI - S: Patient Global I

  30. Slide 30: Treatment Paradigm: Standalone Drug Effects with No Psychotherapeutic Intervention

    Corporate Presentation | August 2024 Treatment Paradigm: Standalone Drug Effects with No Psychotherapeutic Intervention 1 1. Source: Study MMED008 internal study documents. 2. FDA 2023 Draft Guidance: Psychedelic Drugs: Considerations for Clinical Investigations. • Dosing session monitors (DSMs) in

  31. Slide 31: Participant Disposition Aligned with Historical Expectations

    Corporate Presentation | August 2024 31 Participant Disposition Aligned with Historical Expectations 1 1. Source: Study MMED008 internal study documents and calculations. Safety population. 2. High dose groups include 100 and 200 µg dose groups. FAS: Full Analysis Set Randomized (n=198) 200 µg (n=40

  32. Slide 32: Participant Demographics and Baseline Characteristics Generally Balanced Across Groups

    Corporate Presentation | August 2024 32 Participant Demographics and Baseline Characteristics Generally Balanced Across Groups 1 1. Source: Study MMED008 internal study documents and calculations. Full analysis set population. Demographic (n=194) MM120 Placebo 25 µg (n=39) 50 µg (n=36) 100 µg (n=40)

  33. Slide 33: Statistically and Clinically Significant Reductions in HAM-A Score Continued at Week 12

    Corporate Presentation | August 2024 -25 -20 -15 -10 -5 0 LS Mean Change (SEM) in HAM - A score Placebo 25 µg 50 µg 100 µg 200 µg HAM - A Change from Baseline 33 Statistically and Clinically Significant Reductions in HAM - A Score Continued at Week 12 1,2 1. Source: Study MMED008 internal study docu

  34. Slide 34: Continued Response and Remission through Week 12

    Corporate Presentation | August 2024 HAM - A Remission Rate at Week 12 2 HAM - A Response Rate at Week 12 2 34 Continued Response and Remission through Week 12 with 65% Clinical Responder Rate and 48% Clinical Remission Rate 1 1. Source: Study MMED008 internal study documents and calculations. Full

  35. Slide 35: Primary & Key Secondary Analysis (MCP-Mod) Support Dose Response Relationship

    Corporate Presentation | August 2024 35 Primary & Key Secondary Analysis (MCP - Mod) Support Dose Response Relationship for MM120 in GAD 1 1. Source: Study MMED008 internal study documents and calculations. Full analysis set population. 2. Source: Novartis. “The MCP - Mod methodology – A statistical

  36. Slide 36: Rapid and Sustained Improvements in CGI-S Starting on Day 2

    Corporate Presentation | August 2024 CGI - S Scores at Week 12 2 36 Rapid and Sustained Improvements in Clinical Global Impressions – Severity (CGI - S) Starting on Day 2 and Continuing through Week 12 1 1. Source: Study MMED008 internal study documents and calculations. Full analysis set population

  37. Slide 37: MM120 was Well-tolerated with Mostly Transient, Mild-to-Moderate Adverse Events

    Corporate Presentation | August 2024 37 MM120 was Well - tolerated with Mostly Transient, Mild - to - Moderate Adverse Events Consistent with Drug Class Expectations 1 1. Source: Study MMED008 internal study documents and calculations. Safety population. 2. One serious adverse event (SAE) was observ

  38. Slide 38: Most Common TEAEs in High-Dose Groups Demonstrate Favorable Tolerability Profile

    Corporate Presentation | August 2024 38 Most Common (≥10%) TEAEs in High - Dose Groups Demonstrate Favorable Tolerability Profile 1,2 1. Source: Study MMED008 internal study documents and calculations. Safety population. 2. High dose groups include 100 and 200 µg dose groups. AFT: After Dosing Day;

  39. Slide 39: MM402 R(-)-MDMA

    <<) MindMed MM402 R(-)-MDMA

  40. Slide 40: Differentiated Mechanism of Action Targets Key Pathways

    Corporate Presentation | August 2024 Differentiated Mechanism of Action Targets Key Pathways 40

  41. Slide 41: Addressing the Urgent Need For Novel ASD Therapies

    Corporate Presentation | August 2024 increasing feelings of connectedness • MM402 is the serotonergic enantiomer of MDMA • Potential first - in - class therapy for core symptoms of ASD • Intend to develop for daily, at - home use reduced dopamine - related adverse effects 2 Enhanced pro - social eff

  42. Slide 42: Corporate Presentation | August 2024 42

    Corporate Presentation | August 2024 42

  43. Slide 43: Appendix

    <4) MindMed Appendix

  44. Slide 44: Investigator Initiated Trial of LSD for Depressive Disorders: Study Schematic

    Corporate Presentation | August 2024 Investigator Initiated Trial of LSD for Depressive Disorders 1. Source: Muller F. 2023, April 18. A Study on the Efficacy and Safety of LSD in Depressive Disorders [Conference presentation] . B asel, Switzerland. NCT03866252. BDI: Beck Depression Inventory; IDS -

  45. Slide 45: Investigator Initiated Trial of LSD for Depressive Disorders: Enrollment

    Corporate Presentation | August 2024 Investigator Initiated Trial of LSD for Depressive Disorders Source: Muller F. 2023, April 18. A Study on the Efficacy and Safety of LSD in Depressive Disorders [Conference presentation] . B asel, Switzerland. NCT03866252. 45 Investigator - Initiated Trial | Enro

  46. Slide 46: Investigator Initiated Trial: Primary Outcome Measure

    Corporate Presentation | August 2024 Investigator Initiated Trial of LSD for Depressive Disorders Source: Muller F. 2023, April 18. A Study on the Efficacy and Safety of LSD in Depressive Disorders [Conference presentation] . B asel, Switzerland. NCT03866252. IDS - C: Inventory of Depressive Symptom

  47. Slide 47: Investigator Initiated Trial: Secondary Outcome Measures

    Corporate Presentation | August 2024 Investigator Initiated Trial of LSD for Depressive Disorders Source: Muller F. 2023, April 18. A Study on the Efficacy and Safety of LSD in Depressive Disorders [Conference presentation] . B asel, Switzerland. NCT03866252. BDI: Beck Depression Inventory; IDS - C:

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