Definium Therapeutics, Inc. · NASDAQ:DFTX
Definium Therapeutics — Q1 2026 Earnings Presentation
41 slides from Definium Therapeutics's earnings presentation, May 7, 2026
Slide 1: Corporate Presentation
May 2026 Corporate Presentation
Slide 2: Disclaimer
Disclaimer This presentation (the “Presentation”) has been prepared by Definium Therapeutics, Inc. (“Definium”, 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 Defini
Slide 3: Strategic focus on GAD & MDD
Strategic focus on GAD & MDD The two largest drivers of psychiatric disease burden Late-stage Experienced pipeline management team DT120 ODT: lead Proven track record clinical program in developing and in five Phase 3 commercializing novel Three Phase 3 readouts studies1 CNS therapies anticipated in
Slide 4: Advancing Our Pipeline with Broad Therapeutic Potential
Advancing Our Pipeline with Broad Therapeutic Potential PRODUCT CANDIDATE INDICATION PRECLINICAL PHASE 1 PHASE 2 PIVOTAL / PHASE 3 REGISTRATION Generalized Anxiety Disorder (GAD)3 Major Depressive Disorder (MDD)3 Lysergide tartrate DT1201 Posttraumatic Stress Disorder (PTSD) 4 Additional Indication(
Slide 5: Lysergide tartrate DT120 Program Overview
01 Lysergide tartrate DT120 Program Overview
Slide 6: Target Product Profile to Address Significant Unmet Need
Target Product Profile to Address Significant Unmet Need 1 5-8 12+ 50M Dose1 Hours in Weeks of US Adults with the Clinic2 Durability1 GAD & MDD3 1. Single dose regimen is being studied in pivotal clinical trials with primary and secondary outcome measures through 12 weeks after administration. Phase
Slide 7: DT120 Phase 2b Efficacy and Durability Demonstrates Potential Best-In-Class Profile
DT120 Phase 2b Efficacy and Durability Demonstrates Potential Best-In-Class Profile1,3 Comparative Effect Sizes in GAD Rapid and durable response after single administration3 1.8-point reduction in CGI-S within 24 DT120 100 µg2 0.81 Rapid hours (p<0.0001) 21.9-point improvement on the HAM-A Benzodia
Slide 8: DT120 Showed Statistically & Clinically Significant Improvements on Anxiety and Depression Symptoms
DT120 Showed Statistically & Clinically Significant Improvements on Anxiety and Depression Symptoms1,2 Primary Outcome: HAM-A Change from Baseline MADRS Change from Baseline 0 0 Change from Baseline2,3 Change from Baseline2 LS Mean Change (SEM) in MADRS score LS Mean Change (SEM) in HAM-A score ▪ We
Slide 9: DT120 Demonstrated Profound Changes in GAD Severity
DT120 Demonstrated Profound Changes in GAD Severity1 HAM-A Severity & Clinical Symptoms Median HAM-A Through Week 12 HAM-A Response & Remission at Week 122 Very Severe 35 Percent of Participants Meeting Criteria at Week 12 Symptoms are incapacitating % Responders % Remitters Severe (≥24) 30 Symptoms
Slide 10: DT120's Clinical Activity Stands Out Compared to Approved GAD Treatments
DT120’s Clinical Activity Stands Out Compared to Approved GAD Treatments1 DT120 2 Single Dose Duloxetine 3 Escitalopram 4 Paroxetine 5 Venlafaxine XR6 Buspirone 7 Alprazolam 8 (12 weeks) Chronic (9-10 weeks) Chronic (8 weeks) Chronic (8 weeks) Chronic (28 weeks) Chronic (8 weeks) Chronic (4 weeks) 0
Slide 11: DT120 Delivers Clinical Activity that Stands Apart from Latest Generation of Treatments for Depression
DT120 Delivers Clinical Activity that Stands Apart from Latest Generation of Treatments for Depression Symptoms1 DT120 (GAD) 2 Single Dose COMP360 (TRD) Spravato (TRD) Auvelity (MDD) Caplyta (BPD) Trintellix (MDD) (12 weeks) Two Doses (6 weeks) Chronic (4 weeks) Chronic (6 weeks) Chronic (6 weeks) C
Slide 12: Scientific Rigor in DT120 Phase 2b Provides Confidence for Phase 3 Program
Scientific Rigor in DT120 Phase 2b Provides Confidence for Phase 3 Program Key Findings Model-Based Dose-Response Curve1 7.0 ▪ Statistically significant dose response in Phase 2b 6.0 Placebo-adjusted HAM-A Change 5.0 ▪ Model supports 100 µg as optimal dose 4.0 3.0 2.0 ▪ Results not explainable by “f
Slide 13: DT120 was Well-Tolerated with Adverse Events Mostly Limited to Dosing Day
DT120 was Well-Tolerated with Adverse Events Mostly Limited to Dosing Day1 ▪ Virtually all (99%) adverse events (AEs) were mild-to-moderate in severity Favorable ▪ Minimal (2.5%) treatment emergent AEs (TEAEs) led to study withdrawal tolerability profile ▪ No drug-related serious AEs (SAEs)2 No SAEs
Slide 14: Anxiety & Depression
O02 Anxiety & Depression LE Se
Slide 15: Understanding the Patient Journey
Understanding the Patient Journey Impact on life, work, relationships Discuss 16-week Dose 12-week with PCP evaluation adjustment evaluation Impairment Symptoms takes hold Dose 10-week evaluation Suppressed Side effects “not adjustment worth it” First Present feelings Prescribed Hope Rx will SRI Not
Slide 16: Interplay Between GAD & MDD Highlights Opportunity for a Dual Intervention
Interplay Between GAD & MDD Highlights Opportunity for a Dual Intervention1 Severe MDD major depressive episodes GAD with inter-episode euthymia chronic background Anxiety anxiety burden Depression Moderate Between MDEs often characterized by residual anxiety Mild Remission 1. Conceptual illustratio
Slide 17: Clinical Outcome Assessments in GAD and MDD Share Many Domains
Clinical Outcome Assessments in GAD and MDD Share Many Domains Hamilton Anxiety Scale (HAM-A)1 Montgomery-Åsberg Depression Rating Scale (MADRS)2 Range: 0-56 Range: 0-60 1. Anxious mood – worry, fear 1. Apparent sadness 2. Tension – restlessness, inability to relax 2. Reported sadness 3. Fears – of
Slide 18: DT120 ODT Phase 3 Program
03 DT120 ODT Phase 3 Program Positioned for Success
Slide 19: Robust Phase 3 DT120 ODT Development Program Aiming for Broad Label
Robust Phase 3 DT120 ODT Development Program Aiming for Broad Label Posttraumatic Stress Generalized Anxiety Disorder (GAD) Major Depressive Disorder (MDD) Disorder (PTSD) n=2141 Target n=2001 n=149 Target n=1752 Target n=2002 1:1 randomization 2:1:2 randomization 1:1 randomization 2:1:2 randomizati
Slide 20: Multiple Programs with Shared Development Strategy
Multiple Programs with Shared Development Strategy Part A Part B PHASE 3 STUDY1 12 Week Randomized, Double-Blind 40 Week Extension with Opportunity for Open-Label Treatment Single Dose DT120 ODT 100 µg Up to four open-label doses of DT120 ODT 100 µg Placebo Follow-up Observation ePRO: biweekly Singl
Slide 21: SSREs Complete and Support Confidence in Decisive Phase 3 Outcomes
SSREs Complete and Support Confidence in Decisive Phase 3 Outcomes Phase 2b Study MMED0081,2 SSRE SSRE Observed Planned Planned Outcome Outcome Enrollment Target 200 200 250 200 Standard Observed: 7.8 Observed: 7.6 9.7 10.0 10.0 Deviation MMRM: 6.2 MMRM: 7.4 Non-evaluable 25% 15% 10% 15% 6% rate3 Po
Slide 22: DT120 ODT Treatment Paradigm: Standalone Drug Effects with No Psychotherapeutic Intervention
DT120 ODT Treatment Paradigm: Standalone Drug Effects with No Psychotherapeutic Intervention1 Pre-treatment During treatment Post-treatment ✓ Pre-treatment activities consist of a ✓ Continuous monitoring by DSMs ✓ Follow-up visits for assessment only comprehensive informed consent DT120 process ✓ Mu
Slide 23: Clinical Dosing Paradigm with Potential Translatability to Efficient Real-World Delivery
Clinical Dosing Paradigm with Potential Translatability to Efficient Real-World Delivery1,2 Hour 2-4 Hour 4-6 Hour 6-8 and post-session Transient Effects move to Ordinary perceptual, resolution perception, affect, affective, and Hour 5: Dosing Session and cognition cognitive drug Monitor (DSM) retur
Slide 24: Evolution of Patient Monitoring based on Clinical Evidence & Anticipating Real-World Setting
Evolution of Patient Monitoring based on Clinical Evidence & Anticipating Real-World Setting Phase 2 Study Pivotal-Stage Studies 23 Total Criteria 8 Item Scale Expansive Research-oriented Checklist Practice-oriented End of Session Checklist • Patient-reported physical status • EOSC intended to infor
Slide 25: Putting the Numbers in Perspective
Putting the Numbers in Perspective1 Minimum Detectable Latest Generation of Phase 3 Powering Phase 2b Results in GAD5 Difference2 Comparative Treatments Assumption2 GAD 1.8 – 2.4 3.2 3 4.0 5.0 7.7 Placebo adjusted changes in HAM-A 3.0 3.9 4 6.4 6 MDD Placebo adjusted changes in MADRS Improvement We
Slide 26: Why We Believe DT120 ODT Is Well Positioned for Phase 3 Success
Why We Believe DT120 ODT Is Well Positioned for Phase 3 Success Strong Phase 2b results with Phase 3 design enhancements effects on anxiety and support patient retention depression symptoms Existing and expanded key Continuous hands-on oversight research site relationships of trial execution Collabo
Slide 27: Accelerating DT120 ODT on a Disciplined Path to NDA Submission
Accelerating DT120 ODT on a Disciplined Path to NDA Submission Phase 2b demonstrated FDA Phase 3 Phase 3 Studies designed to substantial Breakthrough program in study designs demonstrate improvement Therapy alignment with mirror positive standalone drug effect over current Designation FDA guidance P
Slide 28: DT120 ODT Commercial Framework
04 Lysergide tartrate DT120 ODT Commercial Framework
Slide 29: The Near-Term Opportunity & Launch
The Near-Term Opportunity & Launch 4.2 million Large & Growing Unmet Need Failed by 2+ Rx 13 million Strong Patient Desire & Willingness Rx Treated 26 million Large & Expanding Treatment Network Diagnosed with GAD / MDD 50 million Payer Understanding & Intent US Adults with GAD / MDD Source: Ringeis
Slide 30: Launch is Only the Starting Point for a Broader DT120 Market Opportunity
Launch is Only the Starting Point for a Broader DT120 Market Opportunity 4.2 million Failed by 2+ Rx Removal of access barriers 13 million Rx Treated Increased treatment of mental health disorders 26 million Diagnosed with GAD / MDD Increased screening & awareness 50 million US Adults with GAD / MDD
Slide 31: Psychiatry Continues to Evolve Toward Faster, More Targeted Intervention
Psychiatry Continues to Evolve Toward Faster, More Targeted Intervention1-5 2020-Today 2005-2019 1980-Early 2000s 1950-1970 Pre-1950s Interventional Transformative care Office-based & digital emergence Pharmacology- Rapid-acting inpatient treatments Institution- psychiatry based treatment Directly t
Slide 32: Growing Psychiatrist Awareness and Positive Sentiment Support DT120 Adoption Potential
Growing Psychiatrist Awareness and Positive Sentiment Support DT120 Adoption Potential Psychiatrist Perception of Psychedelic Treatments2 Psychiatrist Perception of DT120 ▪ 58% HCPs surveyed have positive views of 5-7 Positive 52% DT120 profile1 ▪ HCPs cite quick onset of action, symptom 3-4 resolut
Slide 33: Strong In-Practice Intent Among High-Priority HCPs
Strong In-Practice Intent Among High-Priority HCPs DT1201 Esketamine1 I prescribe and administer this 26% treatment in my practice I would prescribe and administer 51% this treatment in my practice Refer out for esketamine 61% I would refer out this treatment 40% I would only discuss if a patient Re
Slide 34: Predictive Analytics Help Focus Resources Where Adoption Potential Is Highest
Predictive Analytics Help Focus Resources Where Adoption Potential Is Highest Priority GAD & MDD Prescribers Corporate Presentation | May 2026 34
Slide 35: Modest Adoption in Target Population Supports Blockbuster Revenue Opportunity
Modest Adoption in Target Population Supports Blockbuster Revenue Opportunity Potential Value ($B) for every 100,000 patients treated with DT1203 4.2 million patients At $28k annual price have been failed by $2.8B At $49k annual price 2 or more treatments1 At $70k annual price $4.9B $2 billion reven
Slide 36: R(-)-MDMA DT402 Program Update
05 R(-)-MDMA DT402 Program Update
Slide 37: DT402 Phase 2a Study in Autism Spectrum Disorder (ASD)
DT402 Phase 2a Study in Autism Spectrum Disorder (ASD) Completed Phase 1 study in 2024 ▪ Single-ascending dose study in healthy adult volunteers characterized the tolerability, pharmacokinetics and pharmacodynamics of DT402 ▪ DT402 was well-tolerated at doses up to 255 mg with no SAEs or TEAEs leadi
Slide 38: Summary
06 Summary
Slide 39: Value Creation Opportunity Shaped by Two Distinct Drivers
Value Creation Opportunity Shaped by Two Distinct Drivers1 Clinical & Regulatory Execution Voyage TLR Initial DT402 Data Ascend TLR in ASD Emerge TLR Panorama TLR Potential Pipeline Expansion 2026 2027 Value 2028 Creation Expanding Site of Care Accelerating Optimizing Patient Engagement & Scheduling
Slide 40: Financial Summary & Anticipated Milestones
Financial Summary & Topline Data Readouts Anticipated Milestones Emerge (MDD) Topline Readout | late 2Q 2026 Cash, Cash Equivalents & Investments $373.4 million Voyage (GAD) as of March 31, 2026 Topline Readout | early 3Q 2026 Credit Facility Panorama (GAD) Up to $120 million ($41 million outstandin
Slide 41: Definium
Definium THERAPEUTICS Precise science. Boundless impact.
Definium Therapeutics — Q1 2026 Earnings Presentation on 6ix