Definium Therapeutics, Inc. · NASDAQ:DFTX
Definium Therapeutics — Mind Medicine (MindMed) — Investor Presentation (November 2025)
29 slides from Definium Therapeutics's investor presentation, Nov 6, 2025
Slide 1: Corporate Presentation November 2025
Corporate Presentation November 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 | November 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 ongoing Phase 3 studi
Slide 4: MM120 On Track and Executing: Anticipated Milestones
MM120 On Track and Executing ANTICIPATED MILESTONES MM120-300 for GAD Phase 3 topline readout 1H 2026 MM120-301 for GAD Phase 3 topline readout 2H 2026 MM120-310 for MDD Phase 3 topline readout Mid 2026 MM120-311 for MDD Phase 3 study initiation Mid 2026
Slide 5: Strong Execution Driving Expected Upcoming Milestones
2024 1H 2025 2H 2025 1H 2026 2H 2026 MM120-310 for MDD Phase 3 Topline Readout MM120-301 for GAD Phase 3 Topline Readout $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 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 | November 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 GA
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 | November 2025
Slide 11: MM120 Phase 2b Efficacy and Durability Support GAD Phase 3 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 12: Primary Outcome: HAM-A Change from Baseline
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 13: 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 14: MM120 Phase 2b was Well-tolerated
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 15: Comparative Clinical Activity of MM120 vs. Approved GAD Treatments
Corporate Presentation | November 2025 Comparative Clinical Activity of MM120 vs. Approved GAD Treatments1 1. The information presented in this slide is derived from multiple clinical trials, each conducted under distinct protocols and settings. As such, these data may not be directly comparable due
Slide 16: Robust Phase 3 MM120 Development Program Aiming for Broad Label
MM120-310 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 si
Slide 17: Rigorous Development Approach Addresses Key Regulatory Considerations
Rigorous Development Approach Addresses Key Regulatory Considerations Complementary clinical study designs intended to generate robust evidence Phase 2b and 3 studies intended to address key regulatory considerations for psychedelics 50 µg control dose in Panorama and Ascend intended to further miti
Slide 18: MM120 for GAD: Two Complementary Pivotal Phase 3 Study Designs
MM120-301 MM120-300 MM120 for GAD | Two Complementary Pivotal Phase 3 Study Designs 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 attempt to maintain statisti
Slide 19: MM120 for MDD: Two Complementary Pivotal Phase 3 Study Designs
Primary Endpoint MADRS at Week 6 MM120-310 MM120 for MDD | Two Complementary Pivotal Phase 3 Study Designs 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 Depressiv
Slide 20: Regulatory Elements Supporting MM120 ODT NDA Filing Requirements
Today. Corporate Presentation | November 2025 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 alignmen
Slide 21: Commercial Framework MM120 ODT
Commercial Framework MM120 ODT LSD D-tartrate
Slide 22: Large, Identified, Accessible Opportunity for MM120 ODT
Large, Identified, Accessible Opportunity for MM120 ODT High Unmet Need Potential Paradigm Shifting Clinical Profile Efficient Go To Market Strategy Significant Limitations of Existing Treatments MM120 ODT: Potential Best-In-Class Therapy Existing Referral and Administration Infrastructure Sustained
Slide 23: MM120 ODT Clinical Dosing Paradigm with Potential Translatability to Real-World Delivery
MM120 ODT Clinical Dosing Paradigm with Potential Translatability to Efficient Real-World Delivery1,2 Patients are supported by DSMs, healthcare professionals who passively observe and offer comfort care such as assistance with food or restrooms breaks. Psychotherapy is not offered or required but m
Slide 24: MM120 Durability of Effect Has Potential Best-in-Class Profile
If MM120 becomes FDA approved and marketed. Durability, tolerability and associated treatment interval assumptions based on demonstration of statistically significant reductions in HAM-A at week 12 in Phase 2b clinical trial MMED008. Assumes average 8-hour monitoring per dosing session of MM120. Bas
Slide 25: Positioned to Leverage Existing Delivery Infrastructure and Reimbursement Pathways
Corporate Presentation | November 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 practiti
Slide 26: Program Update MM402 R(-)-MDMA
Program Update MM402 R(-)-MDMA
Slide 27: MM402 Advancing into Phase 2a Study in Autism Spectrum Disorder
MM402 Advancing into Phase 2a Study in Autism Spectrum Disorder (ASD) Completed Phase 1 study in 2024 Single-ascending dose study in adult healthy volunteers characterized the tolerability, pharmacokinetics and pharmacodynamics of MM402 MM402 was well-tolerated at doses up to 255 mg with no SAEs or
Slide 28: 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 29: MindMed
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