Definium Therapeutics, Inc. · NASDAQ:DFTX
Definium Therapeutics — Mind Medicine (MindMed) — Investor Presentation (January 2025)
28 slides from Definium Therapeutics's investor presentation, Jan 13, 2025
Slide 1: Corporate Presentation January 2025
Corporate Presentation January 2025
Slide 2: Disclaimer and Cautionary Note Regarding Forward-Looking Statements
Corporate Presentation | January 2025 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 an offer t
Slide 3: Transformational Innovation for Brain Health
Corporate Presentation | January 2025 Heather: the next slide is designed to convey a “bold” mission – I like the abstract image of the tree but open to your suggestions. This slide would follow our title slide. • We could also do something strictly scientific like how this image is used on this sli
Slide 4: Key milestones and expected clinical readouts
4 Corporate Presentation | January 2025 2024 1H2025 2H2025 1H2026 2H2026 MM120 - 310 for MDD Phase 3 Initiation MM120 - 310 for MDD Phase 3 Readout MM120 - 301 for GAD Phase 3 Readout MM120 - 301 for GAD Phase 3 initiation MM120 - 300 for GAD Phase 3 Readout Expected cash runway through key clinical
Slide 5: Advancing Our Pipeline with Broad Therapeutic Potential
Corporate Presentation | January 2025 Advancing Our Pipeline with Broad Therapeutic Potential 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 - methyle
Slide 6: Current Standard of Care is Failing Patients with GAD and MDD
Corporate Presentation | January 2025 Current Standard of Care is Failing Patients with GAD and MDD 1. Bystritsky A. Treatment - resistant anxiety disorders. Mol Psychiatry. (2006) 11:805 – 14; 2. Birkett MA, Shinday NM, Kessler EJ, Meyer JS, Ritchie S, Rowlett JK. Acute anxiogenic - like effects of
Slide 7: MM120 Has the Potential to Redefine Treatment for Patients
Corporate Presentation | January 2025 MM120 Has the Potential to Redefine Treatment for Patients 7 DESIRED FUTURE STATE Rapid & Durable Improvement CURRENT STATE Chronic Symptom Suppression • Cycles of medication failure • Delayed onset • Poor tolerability • Low remission rate • Loss of efficacy • S
Slide 8: …And Represents a Welcome Breakthrough for Providers
Corporate Presentation | January 2025 …And Represents a Welcome Breakthrough for Providers 1. Psychiatrists and Psychiatry Nurse Practitioners 2. Propietary MindMed Primary Market Research – Key Customer Perceptions Among Spravato® Providers and GAD Prescribers (February 20 24). Total Non - Spravato
Slide 9: MM120 ODT LSD D-tartrate Program Overview
MM120 ODT LSD D - tartrate Program Overview
Slide 10: Clinical Rationale and Mechanism of Action
Corporate Presentation | January 2025 Clinical Rationale and Mechanism of Action 10
Slide 11: The Impact of Generalized Anxiety Disorder
Corporate Presentation | January 2025 The Impact of Generalized Anxiety Disorder 1. National Health Statistics Report. 2024; 213:1 - 12; 2. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Association; 2013:222; 3.
Slide 12: The Impact of Major Depressive Disorder
Corporate Presentation | January 2025 The Impact of Major Depressive Disorder 1. SAMHSA. 2023 NSDUH detailed tables. Published July 2024; 2. APA. Diagnostic and statistical manual of mental disorders: DSM - 5 - TR. Fifth edition, text revision. ed. Washington, DC: American Psychiatric Association Pu
Slide 13: Aligned clinical trial designs across indications maximize operational efficiencies
Corporate Presentation | January 2025 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 to 50% to maintain statis
Slide 14: Maximum effect size d=0.81 more than double the standard of care
Corporate Presentation | January 2025 1. Study MMED008 internal study documents and calculations. Comparisons to standard of care/other drug classes based on histo ric al comparison not head - to - head comparison trial; 2. HAM - A scores based on ANCOVA LS Mean. in Study MMED008. Effect size based
Slide 15: MM120 Phase 2b Showed Significant Improvements on Anxiety and Depression Symptoms
Corporate Presentation | January 2025 -25 -20 -15 -10 -5 0 LS Mean Change (SEM) in HAM - A score Primary Outcome: HAM - A Change from Baseline MM120 Phase 2b Showed Statistically & Clinically Significant Improvements on Anxiety and Depression Symptoms 1,2 1. Source: Study MMED008 internal study docu
Slide 16: MM120 Phase 2b Produced Profound Changes in GAD Severity
Corporate Presentation | January 2025 MM120 Phase 2b Produced Profound Changes in GAD Severity 1. Source: Study MMED008 internal study documents and calculations. Full analysis set population. 2. Response is a 50% or greater improvement on HAM - A score; Remission is a HAM - A score of ≤ 7; p - valu
Slide 17: MM120 Phase 2b was Well-tolerated with Mostly Mild-to-Moderate Adverse Events
Corporate Presentation | January 2025 MM120 Phase 2b was Well - tolerated with Mostly Expected Transient, Mild - to - Moderate Adverse Events on Dosing Day 1. Source: Study MMED008 internal study documents and calculations. Safety population. 2. One serious adverse event (SAE) was observed in the 50
Slide 18: MM120 for GAD | Two Complementary Pivotal Phase 3 Study Designs
Corporate Presentation | January 2025 MM120 - 301 MM120 - 300 MM120 for GAD | Two Complementary Pivotal Phase 3 Study Designs 1 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 primar
Slide 19: MM120 for MDD | Phase 3 Study Design
Corporate Presentation | January 2025 Primary Endpoint MADRS at Week 6 MM120 - 311 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. 19 MM120 ODT 1 00 µg N=70 Placebo N=70 P
Slide 20: Regulatory Elements Supporting MM120 ODT NDA Filing Requirements
Corporate Presentation | January 2025 Today. Regulatory Elements Supporting MM120 ODT NDA Filing Requirements Study designs that demonstrate standalone drug effect FDA breakthrough therapy designation Phase 2b demonstrated substantial improvement over current therapies Phase 3 program in alignment w
Slide 21: MM120 ODT LSD D-tartrate Commercial Framework
MM120 ODT LSD D - tartrate Commercial Framework
Slide 22: Bold Strategy to Deliver on the Commercial Opportunity for MM120 ODT
Corporate Presentation | January 2025 Integrate MM120 ODT Delivery into Current Infrastructure Maximize Access and Reimbursement Educate Stakeholders about MM120 and Burden of GAD & MDD Bold Strategy to Deliver on the Commercial Opportunity for MM120 ODT 22 MM120 Value Proposition
Slide 23: Unique Opportunity to Deliver on the Quadruple Aim
Corporate Presentation | January 2025 Unique Opportunity to Deliver on the Quadruple Aim 23 Better Outcomes New mechanism of action may restore neural pathways for potential sustained remission Improved Patient Experience Potential for single administration with rapid onset of clinical activity , we
Slide 24: Potential Launch Can Leverage Rapidly Growing Interventional Psychiatry Infrastructure
Corporate Presentation | January 2025 Potential Launch Can Leverage and Expand on Rapidly Growing Interventional Psychiatry Infrastructure 1. As of 2Q2024; centers certified under the Spravato REMS 2. J&J Investor Day presentation, July 2024, Johnson & Johnson Spravato® website, July 2024. Compiled
Slide 25: Building on Existing Infrastructure, Practice Patterns & Reimbursement Pathways
Corporate Presentation | January 2025 Building on Existing Infrastructure, Practice Patterns & Reimbursement Pathways 1. HCP that is licensed to prescribe medications to patients. 2. HCP that is licensed to practice, which may include physicians, clinical psychologists, nurse practitioners, nurses,
Slide 26: Appendix
ee Appendix
Slide 27: MM120 for GAD | Phase 3 Study Design Leverages Phase 2b Results
Corporate Presentation | January 2025 27 MM120 - 301 250 participants (2:1:2) 2 Randomize Screen Dose Follow - Up MM120 ODT 1 00 µg (n=100) 2 MM120 ODT 50 µg (n=50) 2 Placebo (n=100) 2 MM120 - 300 200 participants (1:1) 2 MM120 ODT 1 00 µg (n=100) 2 Placebo (n=100) 2 Week - 30 to - 1 1 2 4 8 12 16 2
Slide 28: Strategies to Address Key Drug Class Methodological Considerations
Corporate Presentation | January 2025 Strategies to Address Key Drug Class Methodological Considerations AE: adverse event; ECG: electrocardiogram; MOA: mechanism of action; TQT: thorough QT 28 Expectancy Bias & Functional Unblinding Cardiovascular Safety Adverse Event Collection • Independent centr
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