Definium Therapeutics, Inc. · NASDAQ:DFTX
Definium Therapeutics — Mind Medicine (MindMed) — Investor Presentation (July 2025)
28 slides from Definium Therapeutics's investor presentation, Jul 31, 2025
Slide 1: Corporate Presentation August 2025
Corporate Presentation August 2025
Slide 2: Disclaimer and Cautionary Note Regarding Forward-Looking Statements
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, or a solicitation of an offer to purchase, securities of MindMed and under
Slide 3: MindMed: Transformational Innovation for Brain Health
Corporate Presentation | August 2025 MindMed: Transformational Innovation for Brain Health Strategic Focus on GAD and MDD The two largest drivers of psychiatric disease burden Late-Stage Pipeline Comprehensive Intellectual Property Strategy MM120 ODT: lead clinical program in three Phase 3 studies T
Slide 4: 2025 On Track and Executing
2025 On Track and Executing MM120-300 for GAD Phase 3 topline readout 1H 2026 ANTICIPATED MILESTONES MM120-301 for GAD Phase 3 topline readout 2H 2026 MM120-310 for MDD Phase 3 topline readout 2H 2026
Slide 5: Strong Execution Driving Upcoming Milestones
2024 1H2025 2H2025 1H2026 2H2026 MM120-310 for MDD Phase 3 Topline Readout MM120-301 for GAD Phase 3 Topline Readout Cash runway expected to extend into 2027 and at least 12 months beyond first Phase 3 topline data readout in GAD1 $250 million in equity investment Initiation of Phase 3 program for M
Slide 6: Advancing Our Pipeline with Broad Therapeutic Potential
Advancing Our Pipeline with Broad Therapeutic Potential Full trial details and clinicaltrials.gov links available at mindmed.co/clinical-digital-trials/ Studies in exploration and/or planning stage. LSD: lysergide; ODT: orally disintegrating tablet; R(-)-MDMA: rectus-3,4-methylenedioxymethamphetamin
Slide 7: Critical Gaps in Care Demand Innovation
Corporate Presentation | August 2025 Critical Gaps in Care Demand Innovation Fast onset Single intermittent administration Favorable tolerability 26 million U.S. adults live with GAD1 Last FDA approval in 2007 50% of patients failed by first-line pharmacological treatments2 Co-occurring MDD and GAD
Slide 8: Psychedelics: A Welcome Breakthrough for Providers
Psychedelics: A Welcome Breakthrough for Providers Psychiatrists and Psychiatry Nurse Practitioners Proprietary MindMed Primary Market Research – Key Customer Perceptions Among Spravato® Providers and GAD Prescribers (February 2024). Total Non-Spravato® Providers (n=125), Spravato® Providers (n=50).
Slide 9: Program Overview: MM120 ODT Lysergide D-tartrate
Program Overview MM120 ODT Lysergide D-tartrate
Slide 10: Clinical Rationale and Mechanism of Action
Clinical Rationale and Mechanism of Action Corporate Presentation | August 2025
Slide 11: Robust Phase 3 MM120 Development Program Aiming for Broad Label
Robust Phase 3 MM120 Development Program Aiming for Broad Label 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 5
Slide 12: MM120 Phase 2b Efficacy and Durability Support GAD Phase 3 Trial Plans
MM120 Phase 2b Efficacy and Durability Support GAD Phase 3 Trial Plans1,3 1. Study MMED008 internal study documents and calculations. Comparisons to standard of care/other drug classes based on historical comparison not head-to-head comparison trial; 2. HAM-A scores based on ANCOVA LS Mean. in Study
Slide 13: MM120 Phase 2b Showed Significant Improvements on Anxiety and Depression Symptoms
Primary Outcome: HAM-A Change from Baseline MM120 Phase 2b Showed Statistically & Clinically Significant Improvements on Anxiety and Depression Symptoms1,2 Source: Study MMED008 internal study documents and calculations. Full analysis set population. Based on 100 µg dose group. Based on observed MAD
Slide 14: MM120 Phase 2b Produced Profound Changes in GAD Severity
MM120 Phase 2b Produced Profound Changes in GAD Severity1 Source: Study MMED008 internal study documents and calculations. Full analysis set population. Response is a 50% or greater improvement on HAM-A score; Remission is a HAM-A score of ≤7; p-values not calculated. μg: microgram; HAM-A: Hamilton
Slide 15: MM120 Phase 2b was Well-tolerated with Mostly Expected Transient Adverse Events
MM120 Phase 2b was Well-tolerated with Mostly Expected Transient, Mild-to-Moderate Adverse Events on Dosing Day1 Source: Study MMED008 internal study documents and calculations. Safety population. One serious adverse event (SAE) was observed in the 50 µg dose group: panic attack on study day 98 that
Slide 16: MM120 for GAD: Two Complementary Pivotal Phase 3 Study Designs
MM120-301 MM120-300 MM120 for GAD | Two Complementary Pivotal Phase 3 Study Designs1 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) to maintain statistical power.
Slide 17: MM120 for MDD: Phase 3 Study Design
Primary Endpoint MADRS at Week 6 MM120-311 MM120-310 MM120 for MDD | Phase 3 Study Design1 Clinical study designs subject to ongoing regulatory discussion and review, including of Phase 3 clinical trial protocols. MADRS: Montgomery-Åsberg Depression Rating Scale; MDD: Major Depressive Disorder; ODT:
Slide 18: Regulatory Elements Supporting MM120 ODT NDA Filing Requirements
Today. Regulatory Elements Supporting MM120 ODT NDA Filing Requirements Studies designed to demonstrate standalone drug effect FDA Breakthrough Therapy Designation Phase 2b demonstrated substantial improvement over current therapies1 Phase 3 program in alignment with FDA guidance Phase 3 study desig
Slide 19: Commercial Framework: MM120 ODT LSD D-tartrate
Commercial Framework MM120 ODT LSD D-tartrate
Slide 20: Large, Identified, Accessible Opportunity for MM120 ODT
Large, Identified, Accessible Opportunity for MM120 ODT High Unmet Need Paradigm Shifting Clinical Profile Efficient Go To Market Strategy Significant Limitations of Existing Treatments MM120 ODT: Potential Best-In-Class Therapy Existing Referral an Administration Infrastructure Sustained clinical r
Slide 21: MM120 ODT Clinical Dosing Paradigm with Translatability to Real-World Delivery
MM120 ODT Clinical Dosing Paradigm with Translatability to Efficient Real-World Delivery1,2 Patients are supported by Dosing Session Monitors (DSMs), healthcare professionals who passively observe and offer comfort care such as assistance with food or restrooms breaks. Psychotherapy is not offered o
Slide 22: Positioned to Leverage Existing Delivery Infrastructure and Reimbursement Pathways
Corporate Presentation | August 2025 Positioned to Leverage Existing Delivery Infrastructure, Practice Patterns & Reimbursement Pathways HCP that is licensed to prescribe medications to patients. HCP that is licensed to practice, which may include physicians, clinical psychologists, nurse practition
Slide 23: Financial Summary & Upcoming Milestones
$250 million in equity investment Initiation of Phase 3 program for MM120 ODT in GAD (first patient dosed in Phase 3 Voyage study) MM120 Phase 2b results presented at APA Annual Meeting MM120 granted breakthrough designation by U.S. FDA Successful end-of-phase 2 meeting with U.S. FDA supporting pivo
Slide 24: MindMed
0) MindMed Nasdaq: MNMD
Slide 25: Appendix
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Slide 26: MM120 for GAD: Phase 3 Study Design Leverages Phase 2b Results
MM120-301 250 participants (2:1:2)2 Randomize Screen Dose Follow-Up MM120 ODT 100 µg (n=100)2 MM120 ODT 50 µg (n=50)2 Placebo (n=100)2 MM120-300 200 participants (1:1)2 MM120 ODT 100 µg (n=100)2 Placebo (n=100)2 -30 to -1 1 2 4 8 12 16 20 24 28 32 36 40 44 48 52 Corporate Presentation | August 2025
Slide 27: Strategies Addressing Key Drug Class Methodological Considerations
Strategies Addressing Key Drug Class Methodological Considerations AE: adverse event; ECG: electrocardiogram; MOA: mechanism of action; TQT: thorough QT Expectancy Bias & Functional Unblinding Cardiovascular Safety Adverse Event Collection Independent central raters blinded to treatment and visit nu
Slide 28: MM120: Multiple Layers of Intellectual Property and Protection
+1y +2y +3y +4y +9y +5y +7y … 2043+ New Chemical Entity Exclusivity 30-Month Stay MM120 | Multiple Layers of Intellectual Property and Protection Section 505 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355. PK: pharmacokinetic; PD: pharmacodynamic MM120 Launch Potential Patent Protection
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