Definium Therapeutics, Inc. · NASDAQ:DFTX
Definium Therapeutics — Investor Presentation (September 2026)
48 slides from Definium Therapeutics's investor presentation, September 2026
Slide 1: Corporate Presentation September 2026
September 2026 Corporate Presentation
Slide 2: Disclaimer
Disclaimer This presentation (the “Presentation”) has been prepared by Definium Therapeutics, Inc. (“Definium”, the “Company”, “we”, “ou r” or “us") solely for informational purposes. This Presentation does not constitute an offering of, or a solicitation of an off er to purchase, securities of Defi
Slide 3: Strategic focus on GAD, MDD & PTSD
Strategic focus on GAD, MDD & PTSD Key drivers of psychiatric disease burden Three positive Experienced DT120 ODT management team Phase 3 studies Proven track record Differentiated late -stage in developing and profile in GAD & MDD commercializing novel CNS therapies Comprehensive intellectual Stron
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 DT120 ODT 1 Posttraumatic Stress Disorder (PTSD) 4 Additional Indication(s)
Slide 5: Program Overview: DT120 ODT lysergide
01 Program Overview DT120 ODT lysergide
Slide 6: DT120 ODT Target Product Profile to Address Significant Unmet Need
DT120 ODT Target Product Profile to Address Significant Unmet Need 1 5-8 12+ 50M Dose 1 Hours in Weeks of US Adults with the Clinic 2 Durability 1 GAD & MDD 3 1. Single dose regimen is being studied in pivotal clinical trials with primary and secondary outcome measures through 12 weeks after adminis
Slide 7: 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=214 n=245 n=149 Target n=165 1 Target n=200 1 1:1 randomization 2:1:2 randomization 1:1 randomization 2:1:2 randomization 1:1r
Slide 8: Multiple Programs with Shared Development Strategy
Multiple Programs with Shared Development Strategy 1 Part A Part B PHASE 3 STUDY 12 Week Randomized, Double -Blind 40 Week Extension with Opportunity for Open -Label Treatment ( OLTx )2 Single Dose DT120 ODT 1 00 µg Up to four OLTx of DT120 ODT 1 00 µg Placebo 3 Follow - up Observation Screening ins
Slide 9: Compelling Evidence Across Four Late-Stage Trials with Complementary Designs
Compelling Evidence Across Four Late -Stage Trials with Complementary Designs 1 Generalized Anxiety Disorder (GAD) Major Depressive Disorder (MDD) Phase 2b Study MMED008 Design 5 arms 2 arms 3 arms 2 arms Baseline HAM - A 30.2 27.9 28.0 17.1 Baseline MADRS 27.2 13.5 13.4 34.5 Pooled endpoint 11.1 7.
Slide 10: DT120's Efficacy Stands Out Against Approved GAD Treatments
DT120’s Efficacy Stands Out Against Approved GAD Treatments 1 0.99 1.0 0.96 0.88 0.81 0.81 0.8 0.64 0.6 Effect Size 0.4 0.38 0.36 0.2 0.17 0.0 2 3 4 2 3 4 Phase 2b Phase 2b 5 5 5 Benzodiazepines SRIs Buspirone Week 12 Week 4 DT120 effect size consistently larger than GAD standard of care 1) The info
Slide 11: 1,000+ DT120 ODT Dosing Sessions Demonstrated a Scalable Path to Clinical Practice
1,000+ DT120 ODT Dosing Sessions Demonstrated a Scalable Path to Clinical Practice 1 Time to End of Session Checklist (EoSC) Clearance Highlights 100% ▪ Consistent average time to 97% clearance of EoSC of ~6 hours 80% 87% across studies 1 60% 66% ▪ Two thirds of participants clear EoSC at hour 6 1 4
Slide 12: DT120 ODT 100 µg Has Demonstrated a Favorable and Consistent Tolerability Profile
DT120 ODT 100 µg Has Demonstrated a Favorable and Consistent Tolerability Profile Across Pivotal Readouts 1 ▪ AE profile consistent with prior studies and known pharmacology Favorable ▪ Most adverse events (AEs) mild -to-moderate in severity tolerability profile ▪ Most treatment emergent AEs (TEAEs)
Slide 13: DT120 ODT Program Oriented to Support NDA Strategy and Beyond
DT120 ODT Program Oriented to Support NDA Strategy 1 and Beyond Statistically FDA Consistent large Studies significant dose Breakthrough Program in effect size designed to response Therapy alignment with across demonstrate established in Designation FDA guidance complementary standalone Phase 2b stu
Slide 14: Positive Panorama Phase 3 Topline Data
02 Positive Panorama Phase 3 Topline Data DT120 ODT lysergide
Slide 15: Panorama Results Demonstrate Potential Best-in-Class Efficacy in GAD
Panorama Results Demonstrate Potential Best -in-Class Efficacy in Generalized Anxiety Disorder 1 ▪ All primary and key secondary endpoints highly statistically significant Rapid, robust and ▪ 5.1 point HAM -A improvement over placebo at week 12 primary endpoint (p<0.0001) durable efficacy ▪ 5.3 poin
Slide 16: Panorama - DT120 ODT 100 µg Showed Significant HAM-A Improvements
Panorama - DT120 ODT 100 µg Showed Statistically & Clinically Significant HAM -A Improvements at All Timepoints 1,2 Primary Endpoint: HAM-A Change from Baseline to Week 12 Highlights Change from Baseline2 0 100 µg 50 µg ▪ Week 1: -9.8 -10.3 -A score ▪ Week 4: -12.3 -8.8 -5 ▪ Week 8: -10.4 -8.1 LS Me
Slide 17: Panorama - Response and Remission Rates
Panorama - DT120 ODT 100 µg Effects Supported by Robust, Clinically Significant Response and Remission Rates 1 Remission Rate at Week 12 Mild or Better at Week 12 Response Rate at Week 12 60% Odds ratio: 4.2 60% Odds ratio: 2.6 60% Odds ratio: 2.9 50% 50% 50% 40% 40% 40% ** * 30% 35% 30% 30% 32% 20%
Slide 18: Panorama - Treatment Patterns in Part B
Panorama - Treatment Patterns in Part B Provide Early Insights into Paradigm beyond 12 Weeks 1 Summary of Cumulative DT120 ODT Doses through Week 28 DT120 ODT in Part A 2 100 µg n=62 n=54 n=43 n=35 Placebo ODT in Part A 2 n=68 n=55 n=44 n=43 Week 16 Week 20 Week 24 Week 28 Part A Dose only One OLTx
Slide 19: Panorama - HAM-A Scores Improved Further with Additional Treatments in Part B
Panorama - HAM -A Scores Improved Further with Additional Treatments in Part B HAM-A Scores through Week 281,2 Part A Part B 0 -2 First Open - Label Dosing Mean Change in HAM -A Score -4 -6 -8 -10 -12 -14 -16 Baseline Week 4 Week 8 Week 12 Week 16 Week 20 Week 24 Week 28 DT120 ODT, n= 96 92 89 87 66
Slide 20: Positive Voyage Phase 3 Topline Data
03 Positive Voyage Phase 3 Topline Data DT120 ODT lysergide
Slide 21: Voyage Results Demonstrate Potential Best-in-Class Efficacy in GAD
Voyage Results Demonstrate Potential Best -in-Class Efficacy in Generalized Anxiety Disorder 1 ▪ All primary and key secondary endpoints highly statistically significant Rapid, robust and ▪ 5.4 point HAM -A improvement over placebo at week 12 primary endpoint (p<0.0001) durable efficacy after single
Slide 22: Voyage - DT120 ODT 100 µg Showed Significant HAM-A Improvements
Voyage - DT120 ODT 100 µg Showed Statistically & Clinically Significant HAM -A Improvements at All Timepoints 1,2 Primary Endpoint: HAM-A Change from Baseline to Week 12 Highlights 0 Change from Baseline2 ▪ Week 1: -11.9 points -A score ▪ Week 4: -12.5 points -5 ▪ Week 8: -12.1 points LS Mean Change
Slide 23: Voyage - Response and Remission Rates
Voyage - DT120 ODT 100 µg Effects Supported by Robust, Clinically Significant Response and Remission Rates 1 Remission Rate at Week 12 Mild or Better at Week 12 Response Rate at Week 12 60% Odds ratio: 3.9 60% Odds ratio: 3.5 60% Odds ratio: 4.0 ** 50% 50% 50% 51% ** 40% 40% 40% 43% 30% 30% 30% 20%
Slide 24: Voyage - Treatment Patterns in Part B
Voyage - Treatment Patterns in Part B Provide Early Insights into Paradigm beyond 12 Weeks 1 Summary of Cumulative DT120 ODT Doses through Week 28 DT120 ODT in Part A 2 n=62 n=59 n=51 n=44 Placebo ODT in Part A 2 n=75 n=69 n=59 n=53 Week 16 Week 20 Week 24 Week 28 Part A Dose only One OLTx Two OLTx
Slide 25: Voyage - HAM-A Scores Improve Further with Additional Treatments in Part B
Voyage - HAM -A Scores Improve Further with Additional Treatments in Part B HAM-A Scores through Week 281,2 Part A Part B 0 First Open - -2 Label Dosing Mean Change in HAM -A Score -4 -6 -8 -10 -12 -14 -16 Baseline Week 0 Week 4 Week 8 Week 12 Week 16 Week 20 Week 24 Week 28 DT120 ODT, n= 107 101 98
Slide 26: Positive Emerge Phase 3 Topline Data
04 Positive Emerge Phase 3 Topline Data DT120 ODT lysergide
Slide 27: Emerge Results Demonstrate Potential Best-in-Class Efficacy in MDD
Emerge Results Demonstrate Potential Best -in-Class Efficacy in Major Depressive Disorder ▪ All primary and key secondary endpoints highly statistically significant Rapid, robust and ▪ 8.1 point MADRS improvement over placebo at week 6 primary endpoint (p<0.0001) durable efficacy ▪ 7.3 point MADRS i
Slide 28: Emerge - DT120 ODT 100 µg Showed Significant Improvements on MADRS
Emerge - DT120 ODT 100 µg Showed Statistically & Clinically Significant Improvements on MADRS at All Timepoints 1,2 Primary Endpoint: MADRS Change from Baseline to Week 6 Highlights 0 Change from Baseline2 ▪ Week 1: -17.6 points ▪ Week 4: -13.6 points LS Mean Change (SEM) in MADRS score -5 ▪ Week 6:
Slide 29: Emerge - Response and Remission Rates
Emerge - DT120 ODT 100 µg Effects Supported by Robust, Statistically Significant Response and Remission Rates 1 Remission Rate at Week 6 Response Rate at Week 6 60% 60% **** 60% 50% 50% *** 40% 40% 41% *** 30% 30% 35% ** 27% 20% 24% 20% 10% 13% 10% 3% 7% 0% 0% Remission 2 Mild or better Response Res
Slide 30: Emerge - Treatment Patterns in Part B
Emerge - Treatment Patterns in Part B Provide Early Insights into Paradigm beyond 12 Weeks 1,2 Summary of Cumulative DT120 ODT Doses through Week 28 DT120 ODT in Part A 3 n=50 n=45 n=38 n=32 Placebo ODT in Part A 3 n=44 n=39 n=35 n=28 Week 16 Week 20 Week 24 Week 28 Part A Dose only One OLTx Two OLT
Slide 31: Emerge - MADRS Scores Improve Further with Additional Treatments in Part B
Emerge - MADRS Scores Improve Further with Additional Treatments in Part B MADRS Scores through Week 281,2 Part A Part B 0 First Open - Label Dosing Mean Change in MADRS score -5 -10 -15 -20 Baseline Week 0 Week 4 Week 8 Week 12 Week 16 Week 20 Week 24 Week 28 DT120 ODT, n= 75 65 66 47 32 32 28 Plac
Slide 32: Commercial Framework
05 Commercial Framework DT120 ODT lysergide
Slide 33: 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: Ringei
Slide 34: Growing Psychiatrist Awareness and Positive Sentiment Support DT120 ODT Adoption Potential
Growing Psychiatrist Awareness and Positive Sentiment Support DT120 ODT Adoption Potential Psychiatrist Perception of Psychedelic Treatments2 Psychiatrist Perception of DT120 ▪ 58% HCPs surveyed have positive views of 5-7 Positive 52% DT120 profile 1 ▪ HCPs cite quick onset of action, symptom resolu
Slide 35: Strong In-Practice Intent Among High-Priority HCPs
Strong In -Practice Intent Among High -Priority HCPs DT120 ODT1 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 pati
Slide 36: 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 | September 2026 36
Slide 37: Modest Adoption Yields Significant Opportunity Given Large and Growing Delivery Ecosystem
Modest Adoption Yields Significant Opportunity Given Large and Growing Delivery Ecosystem 2 24 ~4,000 100K $5B patients per month patients per year interventional patients treated Potential Gross psychiatry clinics 1 Revenue Opportunity 2 1. Represents approximately half of estimated number of sites
Slide 38: Core Focus to Enable Commercial Impact & Success
Core Focus to Enable Commercial Impact & Success Patient Provider Site of Care Treatment Education Access Support Site Readiness Access & Navigation Reimbursement Support Operational Enablement Logistical Barrier Support Referral & Treatment Coordination Treatment -Day Logistics INTEGRATED COMMERCIA
Slide 39: Program Overview: R(-)-MDMA DT402
05 Program Overview R(-)-MDMA DT402
Slide 40: 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 lea
Slide 41: Summary
06 Summary
Slide 42: Building a Psychiatry Powerhouse with Two Distinct Drivers
Building a Psychiatry Powerhouse with Two Distinct Drivers 1 Clinical & Regulatory Execution Positive Voyage Initial DT402 Data Ascend TLR Topline Data in ASD Positive Emerge Panorama TLR 2026 NDA for Topline Data Topline Data DT120 ODT 2026 Value Creation 2027 2028 Expanding Site of Care Accelerati
Slide 43: Financial Summary & Anticipated Milestones
Financial Summary & Anticipated Milestones 2026 – Recent Completed Milestones 2027 – Anticipated Milestones Emerge (MDD) DT120 NDA Cash, Cash Equivalents & Investments Positive Topline Data | June 2026 Filing | 1H 2027 ~$1.1 billion Voyage (GAD) DT120 Commercial Day as of June 30, 2026 Positive Topl
Slide 44: Definium Therapeutics
Definium THERAPEUTICS Precise science. Boundless impact.
Slide 45: Appendix
Appendix
Slide 46: Clinical Outcome Assessments in GAD and MDD
Clinical Outcome Assessments in GAD and MDD 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 dark, str
Slide 47: Interplay Between GAD & MDD Highlights Opportunity for a Dual Intervention
Interplay Between GAD & MDD Highlights Opportunity for a Dual Intervention 1 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 illustrat
Slide 48: Clinical Dosing Paradigm with Potential Translatability to Efficient Real-World Delivery
Clinical Dosing Paradigm with Potential Translatability to Efficient Real -World Delivery 1,2 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) ret
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