Definium Therapeutics, Inc. · NASDAQ:DFTX
Definium Therapeutics — Investor Day (April 2026)
63 slides from Definium Therapeutics's investor day presentation, Apr 22, 2026
Slide 1: Investor & Analyst Day April 22, 2026
Investor & Analyst Day April 22, 2026
Slide 2: Disclaimer and forward-looking statements
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 Definium and unde
Slide 3: Today's Agenda
Investor & Analyst Day | April 2026 Topic Speaker(s) Timing Welcome & Introduction Definium Vision The Year Ahead Rob Barrow 5 min DT120 Program Overview Phase 2b Results Overview of Anxiety & Depression Phase 3 Program & Readout Expectations Rob Barrow & Dr. Dan Karlin 35 mins A Patient’s Perspecti
Slide 4: Speakers
Investor & Analyst Day | April 2026 Investor & Analyst Day Speakers Rob Barrow Chief Executive Officer Dan Karlin, MD Chief Medical Officer Matt Wiley Chief Commercial Officer Brandi Roberts, CPA Chief Financial Officer Andrew Penn, MS, PMHNP Brittany Albright, MD, MPH, DABOM Shannon Sarkar, PhD, LP
Slide 5: Definium Therapeutics
Definium THERAPEUTICS 4 ey Ss Lat rs 2 Precisescience./Boundless impact.”
Slide 6: Target Product Profile to Address Significant Unmet Need
Investor & Analyst Day | April 2026 Target Product Profile to Address Significant Unmet Need Single dose regimen is being studied in pivotal clinical trials with primary and secondary outcome measures through 12 weeks after administration. Phase 3 studies include 40 week extension phase to character
Slide 7: Understanding the Patient Journey
Investor & Analyst Day | April 2026 Understanding the Patient Journey AE: adverse events; MDE: major depressive episode; PCP: primary care physician; Rx: prescription; SGA: second generation antipsychotic; SRI: serotonin reuptake inhibitors (including selective serotonin and selective serotonin and
Slide 8: Bringing the field back to its origins
Investor & Analyst Day | April 2026 Receptor & Cellular Clinical Efficacy Neurocircuitry Psychological Bringing the field back to its origins in pursuit of best-in-class profile
Slide 9: Moving Psychiatry Forward at a Scale Reflecting the Unmet Need
Investor & Analyst Day | April 2026 Right Team, Right Experience Right Strategy Precise Science Boundless Impact Moving Psychiatry Forward – at a Scale Reflecting the Unmet Need
Slide 10: Phase 3 Program Built to Support a Broad Label
Investor & Analyst Day | April 2026 Phase 3 Program Built to Support a Broad Label Studies employ an adaptive design with interim blinded sample size re-estimation (“SSRE”) based on nuisance parameters (e.g. patient retention rate, variability of primary outcome measure) which allows for an adjustme
Slide 11: SSREs Complete and Support Confidence in Phase 3 Outcomes
Investor & Analyst Day | April 2026 SSREs Complete and Support Confidence in Decisive Phase 3 Outcomes Variable Planned SSRE3 Planned SSRE3 Enrollment 200 <200 250 <200 Standard deviation 10.0 Raw: 7.8 MMRM: 6.2 10.0 Raw: X.X MMRM: X.X Non-evaluable rate4 15% 10% 15% XX% Power for 5-point placebo-ad
Slide 12: Three Highly Powered Pivotal Readouts Anticipated in Next 6 Months
Investor & Analyst Day | April 2026 Three Highly Powered Pivotal Readouts Anticipated in the Next 6 Months Generalized Anxiety Disorder (GAD) Major Depressive Disorder (MDD) Complete n=214 Early 3Q 2026 No required increase No required increase Target updated to n=200 Late 3Q 2026 Screening Closed T
Slide 13: DT120 Phase 2b Results in GAD
DT120 Phase 2b Results in GAD
Slide 14: Key Phase 2b Efficacy and Safety Findings
Investor & Analyst Day | April 2026 Key Phase 2b Efficacy and Safety Findings Support Best-In-Class Potential of DT1201,3 Standardized effect size more than double the standard of care1,2,3 Comparative Effect Sizes in GAD Rapid and durable response after single administration3 Rapid Response & Remis
Slide 15: Dose Response in Phase 2b
Dose Response in Phase 2b Provides Confidence in Dose Optimization & Robustness of Response Statistically significant dose response in Phase 2b Model supports 100 µg as optimal dose Results not explainable by “functional unblinding” supporting robustness of drug effect R Robison, JAMA. 2025 Sep 4; e
Slide 16: Primary Outcome: HAM-A Change from Baseline
Primary Outcome: HAM-A Change from Baseline Source: Study MMED008 internal study documents and calculations. Full analysis set population. Based on 100 µg dose group. Based on observed MADRS score at each timepoint. Primary endpoint of the study was change in Hamilton Anxiety Scale (HAM-A) at week 4
Slide 17: DT120 Demonstrated Profound Changes in GAD Severity
Remission (≤7) Symptoms are absent, insignificant, or clearly due to causes other than anxiety Mild (8-15) Symptoms are infrequent, with no impairment and no more than mild distress Moderate (16-23) Symptoms are more frequent, with moderate distress or limited interference with usual activities Very
Slide 18: DT120 Phase 2b Results in Context
DT120 Phase 2b Results in Context
Slide 19: DT120 Clinical Activity vs Approved GAD Treatments
Investor & Analyst Day | April 2026 DT120 Delivers Clinical Activity that Stands Apart from 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 comp
Slide 20: DT120 vs Latest Generation Depression Treatments
Investor & Analyst Day | April 2026 DT120 Delivers Clinical Activity that Stands Apart from Latest Generation of Treatments for Depression Symptoms1 The information presented in this slide is derived from multiple clinical trials, each conducted under distinct protocols and settings. As such, these
Slide 21: DT120 Well-Tolerated with AEs Mostly on Dosing Day
DT120 was Well-Tolerated with Adverse Events Mostly Limited to Dosing Day1 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 was deemed not related to treatment. Suicidal
Slide 22: Anxiety & Depression
Anxiety & Depression
Slide 23: Interplay Between GAD & MDD
Interplay Between GAD & MDD Highlights Opportunity for a Dual Intervention1 Severe Remission Mild Moderate GAD chronic background anxiety burden Anxiety Depression Between MDEs often characterized by residual anxiety MDD major depressive episodes with inter-episode euthymia Investor & Analyst Day |
Slide 24: Diagnostic Definitions With Intersecting Symptoms
Investor & Analyst Day | April 2026 Diagnostic Definitions With Intersecting Symptoms Source: Diagnostic and Statistical Manual of Mental Disorders, 5th edition Text Revision (DSM-V-TR) 1. Restlessness or feeling keyed up/on edge 2. Being easily fatigued 3. Difficulty concentrating or mind going bla
Slide 25: Clinical Outcome Assessments in GAD and MDD Share Many Domains
Investor & Analyst Day | April 2026 Clinical Outcome Assessments in GAD and MDD Share Many Domains Montgomery-Åsberg Depression Rating Scale (MADRS)2 Range: 0-60 Hamilton Anxiety Scale (HAM-A)1 Range: 0-56 1. Apparent sadness 2. Reported sadness 3. Inner Tension 4. Reduced Sleep 5. Reduced Appetite
Slide 26: DT120 ODT Phase 3 Program
DT120 ODT Phase 3 Program
Slide 27: DT120 ODT Development Program Aiming for Broad Label
Investor & Analyst Day | April 2026 Phase 3 DT120 ODT Development Program Aiming for Broad Label Studies employ an adaptive design with interim blinded sample size re-estimation (“SSRE”) based on nuisance parameters (e.g. patient retention rate, variability of primary outcome measure) which allows f
Slide 28: Why DT120 ODT Is Well Positioned for Phase 3 Success
Investor & Analyst Day | April 2026 Why We Believe DT120 ODT Is Well Positioned for Phase 3 Success Strong Phase 2b results with effects on anxiety and depression symptoms Phase 3 design enhancements support patient retention Existing and expanded key research site relationships Alignment with FDA I
Slide 29: Multiple Programs with Shared Development Strategy
Multiple Programs with Shared Development Strategy Source: Definium internal study documents. ClinRO: clinician reported outcome; ePRO: electronic patient reported outcome; MADRS: Montgomery-Åsberg Depression Rating Scale; MDD: Major Depressive Disorder; ODT: orally disintegrating tablet DT120 ODT 1
Slide 30: Eligibility Process Supports Trial and Population Integrity
Investor & Analyst Day | April 2026 Eligibility Process in Phase 3 Supports Trial and Population Integrity Source: Definium internal study documents. CRO: contract research organization; MGH SAFER: Massachusetts General Hospital SAFER independent diagnostic interview 01 Site Diagnosis Comorbidities
Slide 31: DT120 ODT Treatment Paradigm: Standalone Drug Effects
DT120 ODT Treatment Paradigm: Standalone Drug Effects with No Psychotherapeutic Intervention1 Source: Study MMED008 internal study documents. DSM: dosing session monitor; EOSC: end of session checklist DT120 Patient Journey Pre-treatment activities consist of a comprehensive informed consent process
Slide 32: Clinical Dosing Paradigm with Real-World Translatability
Efficient single-visit model with full-session reimbursement streamlines administrative burden2 Investor & Analyst Day | April 2026 Clinical Dosing Paradigm with Potential Translatability to Efficient Real-World Delivery1,2 Dosing and monitoring paradigm based on Phase 3 clinical protocols. Required
Slide 33: Evolution of Patient Monitoring
Investor & Analyst Day | April 2026 Evolution of Patient Monitoring based on Clinical Evidence & Anticipating Real-World Setting 12-hour monitoring requirement based on inclusion of 200 µg dose of DT120 in Phase 2b The required monitoring period in pivotal studies of DT120 is 8 hours and requires th
Slide 34: Comments on Methodology & Research with Psychedelic Treatments
Investor & Analyst Day | April 2026 Few Comments on Methodology & Research with Psychedelic Treatments Functional Unblinding Comparator Controls Population
Slide 35: Accelerating DT120 ODT on a Disciplined Path to NDA Submission
Accelerating DT120 ODT on a Disciplined Path to NDA Submission 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. NDA: new drug application; ODT: orally disintegrating tablet
Slide 36: DT120 ODT Phase 3 Data Expectations
DT120 ODT Phase 3 Data Expectations
Slide 37: Preview of Emerge Topline Readout
Preview of Emerge Topline Readout Investor & Analyst Day | April 2026 Drug response : Placebo-adjusted change: Disposition, Demographics & Baseline characteristics Adverse events & suicidality (C-SSRS) Duration of session Time to inefficacy (i.e., return of moderate+ symptoms) Maintenance of MADRS i
Slide 38: Putting the Numbers in Perspective
Investor & Analyst Day | April 2026 Putting the Numbers in Perspective1 GAD Placebo adjusted changes in HAM-A MDD Placebo adjusted changes in MADRS The information presented in this slide on comparative treatments is derived from multiple clinical trials, each conducted under distinct protocols and
Slide 39: A Patient's Perspective on the DT120 Experience
A Patient’s Perspective on the DT120 Experience
Slide 40: Panel Discussion
Panel Discussion
Slide 41: Speakers
Investor & Analyst Day Speakers Investor & Analyst Day | April 2026 Dan Karlin, MD Chief Medical Officer Andrew Penn, MS, PMHNP Brittany Albright, MD, MPH, DABOM Shannon Sarkar, PhD, LPC, NCC Chief Medical Officer Definium Psychiatrist, Addiction Psychiatry Sweetgrass Psychiatry Medical University o
Slide 42: DT120 ODT Commercial Strategy
Matt Wiley, CCO DT120 ODT Commercial Strategy
Slide 43: Building Blocks for DT120 Commercial Success Are in Place
Investor & Analyst Day | April 2026 The Building Blocks for DT120 Commercial Success Are in Place Our Time to Execute Providers are Primed for Adoption Positive Payor Indications Patients Want Better
Slide 44: The Near-Term Opportunity & Launch
Investor & Analyst Day | April 2026 The Near-Term Opportunity & Launch Source: Ringeisen, H., et al. (2023). Mental and Substance Use Disorders Prevalence Study (MDPS): Findings Report, Zhou, Y,. Et al. (2017). Nature. Comorbid generalized anxiety disorder and its association with quality of life in
Slide 45: Launch is Only the Starting Point for a Broader Opportunity
Investor & Analyst Day | April 2026 Launch is Only the Starting Point for a Broader DT120 Market Opportunity 50 million US Adults with GAD / MDD 26 million Diagnosed with GAD / MDD 13 million Rx Treated 4.2 million Failed by 2+ Rx Increased screening & awareness Increased treatment of mental health
Slide 46: Psychiatry Continues to Evolve Toward Faster, More Targeted Intervention
Investor & Analyst Day | April 2026 Psychiatry Continues to Evolve Toward Faster, More Targeted Intervention1-5 Institution-centered care Limited care in asylums. Early ECT, sedatives Pharmacology-based treatment Medication options in outpatient setting. TCAs, MAOIs, antipsychotics Transformative ca
Slide 47: New Classes in Psychiatry Have Represented Major Market Opportunities
Investor & Analyst Day | April 2026 Despite Limitations, New Classes in Psychiatry Have Represented Major Market Opportunities $6.3B1 $ 6.2B1 $3-3.5B2 $ 5.4B1 $ 7.4B1 $ 6.6B1 $ 8.8B1 $ 4.3B1 Peak annual sales estimates. Peak sales from Evaluate Pharma, includes 3% annual inflation adjustment for dru
Slide 48: Limitations of Current SOC Leads to Medication Cycling
Investor & Analyst Day | April 2026 Limitations of Current SOC Leads to Medication Cycling and Patient Discouragement Sources: Clarivate analysis 2022 GAD Patient Journey, July 2022 (n=16 Clinicians n=24 Patients) Depression Patient Journey, November 2023 (n=16 Clinicians n=24 Patients) ECT: electro
Slide 49: Patients Are Not Satisfied With Efficacy of Their Medications
Patients With MDD and/or GAD Are Coping— They Are Not Satisfied With the Efficacy of Their Medications Source: Definium market research, on file. Investor & Analyst Day | April 2026
Slide 50: Most Patients Quit Current Treatments within Months
Investor & Analyst Day | April 2026 Most Patients Quit Current Treatments within 6 Months Source: Veeva Compass Patient - Claims Analysis Covering 2017-2025 All trademarks are property of their respective owners. Physicians contend with patients leaving treatment due to side effects, inefficacy, and
Slide 51: Growing Psychiatrist Awareness and Positive Sentiment
Growing Psychiatrist Awareness and Positive Sentiment Support DT120 Adoption Potential Psychiatrist Perception of DT120 1. GAD Demand Study 2024 Among Total HCP Respondents (n=273). Percentage based on top 3 box (scale 1-7) 2. DT120 Awareness and Perception Tracking: Wave 3, 2026. Total prescribers
Slide 52: Strong In-Practice Intent Among High-Priority HCPs
Strong In-Practice Intent Among High-Priority HCPs 1. GAD Target Validation Market Research, 2025. High-priority HCPs represent deciles 7-10 of GAD prescribers. In the conduct of market research, DT120 was blinded as “Treatment X” to respondents. D B I would prescribe and administer this treatment i
Slide 53: DT120 Appeal in Treatment-Experienced Patients
Investor & Analyst Day | April 2026 DT120 Appeal in Treatment-Experienced Patients Source: Definium market research on file.
Slide 54: Key Strengths of DT120 Value Proposition Align with Payer Preferences
One-time oral dosing DT120’s first-in-class anxiolytic MoA Rapid onset of efficacy + durability of effect Key Strengths of DT120 Value Proposition Align with Payer Preferences Source: Definium market research on file. Key Strengths Noted in Payer Engagements Investor & Analyst Day | April 2026 54
Slide 55: DT120 Reimbursement Outlook Anchored by Spravato Precedent
DT120 Reimbursement Outlook Is Anchored by Spravato® Precedent Source: Definium Market Research on File; Disclaimer: Definium finds it prudent to understand the economic ramifications of DT120 across multiple stakeholders. However, Definium has no intention of marketing the economic merits of its dr
Slide 56: Predictive Analytics Help Focus Resources
Predictive Analytics Help Focus Resources Where Adoption Potential Is Highest Priority GAD / MDD Prescribers Data-Driven Deployment Prioritizes the Highest-Value Prescriber Opportunities OR Investor & Analyst Day | April 2026
Slide 57: We Aspire to Provide the Best Support Patients Have Ever Experienced
We Aspire to Provide the Best Support Patients Have Ever Experienced Standard components of patient and HCP support services that are being considered for DT120 launch. HCP Field Infrastructure Medical Support Access Support Site of Care Support Patient Field Sales HUB Model REMS Patient Support Aff
Slide 58: Modest Adoption in Target Population Supports Blockbuster Opportunity
Modest Adoption in Target Population Supports Blockbuster Revenue Opportunity Investor & Analyst Day | April 2026 Source: Claims Analysis Data on File, 2026 Assuming median Spravato® surrogate pricing range; the price of DT120 has not been established. Range is based on Spravato surrogate low dose,
Slide 59: Building Long-Term Shareholder Value
Brandi Roberts, CFO Building Long-Term Shareholder Value
Slide 60: IP Strategy and Potential Patent Protection
Section 505 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355. Definium’s currently-pending applications related to DT120 ODT will, if granted, have 20-year expiration dates between 2042 and 2044, not accounting for any reductions or extensions term which may be applicable, such as termina
Slide 61: DT120 Represents a Transformational Opportunity
Investor & Analyst Day | April 2026 What We Believe Large market opportunities Patients want better options Ability to make an impact at scale First new GAD drug approval since 2007 Why We’re Positioned for Success Compelling Phase 2b results Rigorous Phase 3 program Differentiated strategy & execut
Slide 62: Value Creation Opportunity Shaped by Two Distinct Drivers
Value Creation Opportunity Shaped by Two Distinct Drivers1 Timing estimates subject to clinical progress and regulatory interactions. ASD: autism spectrum disorder; GAD: generalized anxiety disorder; TLR: topline data readout Clinical & Regulatory Execution 2026 2027 2028 Commercial Execution Value
Slide 63: Q&A Session
Q&A Session Key Anticipated Readouts: Emerge (MDD) Topline Readout | late 2Q 2026 Voyage (GAD) Topline Readout | early 3Q 2026 Panorama (GAD) Topline Readout | late 3Q 2026 Ask a Question