Definium Therapeutics, Inc. · NASDAQ:DFTX
Definium Therapeutics — Investor Presentation (May 2026)
42 slides from Definium Therapeutics's investor presentation, May 19, 2026
Slide 1: Corporate Presentation May 2026
Corporate Presentation May 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: Late-stage pipeline highlights
Late-stage pipeline DT120 ODT: lead clinical program in five Phase 3 studies1 Experienced management team Proven track record in developing and commercializing novel CNS therapies Three Phase 3 readouts anticipated in 2026 driving potential billion-dollar commercial opportunities in GAD and MDD Incl
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 Lysergide tartrate DT1201 Generalized Anxiety Disorder (GAD)3 Major Depressive Disorder (MDD)3 Posttraumatic Stress Disorder (PTSD) 4 Additional Indication(
Slide 5: Program Overview Lysergide tartrate DT120
Program Overview Lysergide tartrate DT120 01
Slide 6: Target Product Profile to Address Significant Unmet Need
Corporate Presentation | May 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 characteriz
Slide 7: DT120 Phase 2b Efficacy and Durability
DT120 Phase 2b Efficacy and Durability Demonstrates Potential Best-In-Class Profile1,3 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 & Remission Durable Standalone Drug Effect
Slide 8: 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 9: DT120 Demonstrated Profound Changes in GAD Severity
Remission (≤7) Symptoms are absent, insignificant, or clearly due to causes other than anxiety Mild (8-14) Symptoms are infrequent, with no impairment and no more than mild distress Moderate (15-23) Symptoms are more frequent, with moderate distress or limited interference with usual activities Very
Slide 10: DT120's Clinical Activity Compared to Approved GAD Treatments
Corporate Presentation | May 2026 DT120’s Clinical Activity Stands Out Compared to 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 du
Slide 11: DT120 Compared to Latest Generation Depression Treatments
Corporate Presentation | May 2026 DT120 Delivers Clinical Activity that Stands Apart from Latest Generation of Treatments for Depression Symptoms1 1) The information presented in this slide is derived from multiple clinical trials, each conducted under distinct protocols and settings. As such, these
Slide 12: Scientific Rigor in DT120 Phase 2b
Scientific Rigor in DT120 Phase 2b Provides Confidence for Phase 3 Program 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 Study MMED008 internal study documents and calc
Slide 13: DT120 Well-Tolerated with Adverse Events Mostly on Dosing Day
DT120 was Well-Tolerated with Adverse Events Mostly Limited to 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 was deemed not related to treatment.
Slide 14: Anxiety & Depression
Anxiety & Depression 02
Slide 15: Understanding the Patient Journey
Corporate Presentation | May 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 no
Slide 16: Interplay Between GAD & MDD Highlights Dual Intervention Opportunity
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 Corporate Presentation |
Slide 17: Clinical Outcome Assessments in GAD and MDD Share Many Domains
Corporate Presentation | May 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 6.
Slide 18: Positioned for Success DT120 ODT Phase 3 Program
Positioned for Success DT120 ODT Phase 3 Program 03
Slide 19: Robust Phase 3 DT120 ODT Development Program
Corporate Presentation | May 2026 Robust Phase 3 DT120 ODT Development Program Aiming for Broad Label Clinical study designs subject to change based on ongoing regulatory discussion and review, including of Phase 3 clinical trial protocols. DB: double blind; HAM-A: Hamilton Anxiety Rating Scale; MAD
Slide 20: Multiple Programs with Shared Development Strategy
Multiple Programs with Shared Development Strategy Source: Definium internal study documents. Parameters for treatment in the open label portion of Haven are still being determined. Clinical study designs subject to change based on ongoing regulatory discussion and review, including of Phase 3 clini
Slide 21: SSREs Complete and Support Confidence in Phase 3 Outcomes
Corporate Presentation | May 2026 SSREs Complete and Support Confidence in Decisive Phase 3 Outcomes Phase 2b Study MMED0081,2 Internal study documents. Robison, Reid et al. “Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial.” JAMA vol. 334,15 (2025
Slide 22: Eligibility Process in Phase 3 Supports Trial 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 23: 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 24: Clinical Dosing Paradigm with Real-World Delivery Potential
Efficient single-visit model with full-session reimbursement streamlines administrative burden2 Corporate Presentation | May 2026 Clinical Dosing Paradigm with Potential Translatability to Efficient Real-World Delivery1,2 Dosing and monitoring paradigm based on Phase 3 clinical protocols. Required m
Slide 25: Evolution of Patient Monitoring Based on Clinical Evidence
Corporate Presentation | May 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 that
Slide 26: Putting the Numbers in Perspective
Corporate Presentation | May 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 se
Slide 27: Why DT120 ODT Is Well Positioned for Phase 3 Success
Corporate Presentation | May 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 Ind
Slide 28: 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 29: Commercial Framework Lysergide tartrate DT120 ODT
Commercial Framework Lysergide tartrate DT120 ODT 04
Slide 30: The Near-Term Opportunity & Launch
Corporate Presentation | May 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 p
Slide 31: Launch Is Only the Starting Point for a Broader Market Opportunity
Corporate Presentation | May 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 di
Slide 32: Psychiatry Continues to Evolve Toward Faster, More Targeted Intervention
Corporate Presentation | May 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 care
Slide 33: 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 34: 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 35: Predictive Analytics Help Focus Resources Where Adoption Potential Is Highest
Predictive Analytics Help Focus Resources Where Adoption Potential Is Highest Priority GAD & MDD Prescribers Data-Driven Deployment Prioritizes the Highest-Value Prescriber Opportunities OR Corporate Presentation | May 2026
Slide 36: Modest Adoption in Target Population Supports Blockbuster Revenue Opportunity
Modest Adoption in Target Population Supports Blockbuster Revenue Opportunity Corporate Presentation | May 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, lo
Slide 37: Program Update R(-)-MDMA DT402
Program Update R(-)-MDMA DT402 05
Slide 38: DT402 Phase 2a Study in Autism Spectrum Disorder
DT402 Phase 2a Study in Autism Spectrum Disorder (ASD) Shaw KA, Williams S, Patrick ME, et al. Prevalence and Early Identification of Autism Spectrum Disorder Among Children Aged 4 and 8 Years — Autism and Developmental Disabilities Monitoring Network, 16 Sites, United States, 2022. MMWR Surveill Su
Slide 39: Summary
06 Summary Pai
Slide 40: 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 41: Financial Summary & Anticipated Milestones
Financial Summary & Anticipated Milestones Excludes 0.4 million pre-funded warrants outstanding as of April 30, 2026 ASD: autism spectrum disorder; GAD: generalized anxiety disorder; G&A: general & administrative; MDD: major depressive disorder; R&D: research and development Cash, Cash Equivalents &
Slide 42: Definium Therapeutics
Definium THERAPEUTICS Precise science. Boundless impact.
Definium Therapeutics — Investor Presentation (May 2026) on 6ix