Definium Therapeutics, Inc. · NASDAQ:DFTX
Definium Therapeutics — Technical Presentation (September 2026)
42 slides from Definium Therapeutics's technical presentation, Sep 14, 2026
Slide 1: Phase 3 Panorama Study Topline Data Readout
Phase 3 Panorama Study Topline Data Readout
Slide 2: Disclaimer and Cautionary Note Regarding Forward-Looking Statements
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 Definium and un
Slide 3: Opening Remarks
Opening Remarks Rob Barrow Chief Executive Officer
Slide 4: Thank you to our study participants, investigators and partners
Thank you to our study participants, investigators and partners who made Panorama possible
Slide 5: Significant need for innovation in the treatment of GAD
Significant need for innovation in the treatment of GAD 5 Population prevalence increased from 3% to 10% over last 20 years 1 No new drugs approved for GAD since 2007 Significant disease burden , with impairment in daily functioning, work productivity and quality of life Panorama Topline Results | S
Slide 6: Third Positive Pivotal Readout for DT120 ODT
Panorama Topline Results | September 2026 6 Third Positive Pivotal Readout for DT120 ODT 100 µg 1. Clinical study designs subject to change based on ongoing regulatory discussion and review, including of Phase 3 clinical tri al protocols 2. Includes the primary endpoint and all hierarchically contro
Slide 7: Panorama Results Demonstrate Potential Best-in-Class Efficacy in GAD
Panorama Topline Results | September 2026 7 Panorama Results Demonstrate Potential Best - in - Class Efficacy in Generalized Anxiety Disorder 1 Limited side effect burden Efficient session dynamics Rapid, robust and durable efficacy after single dose ▪ All primary and key secondary endpoints highly
Slide 8: DT120 Dose Response Relationship Highlights
8 Panorama Topline Results | September 2026 DT120 Dose Response Relationship Highlights 1. Based on Phase 2b best - fit prespecified dose response model (Emax) at week 4; per protocol population. 2. ITT population. Placebo - adjusted HAM - A at week 12 using a Mixed - Effects Model Repeated Measures
Slide 9: Benefit-Risk Highlights Differentiation of DT120 ODT 100 µg
Panorama Topline Results | September 2026 9 Benefit - Risk Highlights Differentiation of DT120 ODT 100 µg 1. Mechanism - based adverse event rates based on number of participants experiencing in Part A; safety population. Adverse event cat egories are a summary of MedDRA preferred terms that represe
Slide 10: DT120 Efficacy Stands Out Against Approved GAD Treatments
Panorama Topline Results | September 2026 10 DT120 100 µg Efficacy Stands Out Against Approved GAD Treatments 1 DT120 observed effect size consistently larger than GAD standard of care 1) The information presented in this slide is derived from multiple clinical trials, each conducted under distinct
Slide 11: Phase 3 Panorama Study Results Part A – Topline Results
Phase 3 Panorama Study Results Part A – Topline Results Dan Karlin, MD Chief Medical Officer
Slide 12: Panorama Trial Design
Panorama Trial Design 1. Source: Definium internal study documents. 2. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. ePRO: electronic Patient - Reported Outcome; GAD: generalized anxiety disorder; GAD - 7: a multipurpose instrume
Slide 13: Participant Disposition
13 1. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. ITT: intent to treat; ODT: orally disintegrating tablet Participant Disposition Panorama Topline Results | September 2026 Randomized n=245 DT120 ODT 100 µg n=96 DT120 ODT 50 µg
Slide 14: Demographics & Baseline Characteristics
14 1. Based on ITT population. 2. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. 3. Mean (SD). 4. The HAM - A is a 14 - item clinician - rated outcome measure assessing various domains of anxiety with a range of 0 - 56. In Panoram
Slide 15: Baseline Characteristics | Representative of GAD Patients
15 1. Based on ITT population 2. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. 3. Mean (SD) 4. Eligibility criteria required a baseline HAM - A score of 20 or greater; Moderate symptoms are defined as a HAM - A score of 16 – 23 .
Slide 16: Primary Endpoint: HAM-A Change from Baseline to Week 12
Primary Endpoint: HAM - A Change from Baseline to Week 12 16 1. Source: Panorama study documents. ITT population. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designe d o r powered for statistical comparisons. 2. Primary endpoint of the study was change in HAM - A at week 12 b
Slide 17: Key Secondary Endpoint: CGI-S Change from Baseline
Change from Baseline 2 Improvement over Placebo 2 17 1. Source: Panorama study documents. ITT population. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designe d o r powered for statistical comparisons. 2. Key secondary endpoints of the study was change in CGI - S at day 2 and
Slide 18: Robust Response and Remission Rates
18 DT120 ODT 100 µg Effects Supported by Robust, Clinically Significant Response and Remission Rates 1 Panorama Topline Results | September 2026 Remission Rate at Week 12 Response Rate at Week 12 1. Source: Panorama study documents. ITT population. Pre - planned secondary endpoints. HAM - A: Hamilto
Slide 19: Treatment Effect Maintained Across Key Subgroups
19 1. Source: Panorama study documents. Subgroup analysis of ITT population; 100 µg and placebo groups only. 2. Data presented as Least Squares mean ± standard error. 3. For each subgroup, the change from baseline in HAM - A total score is analyzed using the same MMRM model as the primary efficacy a
Slide 20: DT120 ODT 100 µg Generally Well-Tolerated
DT120 ODT 100 µg was Generally Well - Tolerated and Consistent with Prior Clinical Experience 1 1. Source: Panorama study documents. Safety population in study part A (through week 12). 2. Participant suicidality assessment based on changes in C - SSRS. C - SSRS: Columbia - Suicide Severity Rating S
Slide 21: Adverse Events Were Generally Mild-to-Moderate in Severity
Panorama Topline Results | September 2026 21 Adverse Events Were Generally Mild - to - Moderate in Severity 1,2 Placebo ODT n=97 DT120 ODT 50 µ g control 3 n=51 DT120 ODT 100 µ g n=96 Adverse Event 61 (63%) 49 (96%) 91 (95%) Any TEAE 30 (31%) 29 (57%) 51 (53%) Mild 29 (30%) 19 (37%) 39 (41%) Moderat
Slide 22: Most Common TEAEs Demonstrated Favorable Tolerability Profile
22 Most Common TEAEs Demonstrated Favorable Tolerability Profile of DT120 ODT 100 µg 1,2,3 Panorama Topline Results | September 2026 After Dosing Day Dosing Day TEAEs with Incidence ≥10% Placebo ODT (n=97) DT120 ODT 50 µ g control 4 (n=51) DT120 ODT 100 µ g (n=96) Placebo ODT (n=97) DT120 ODT 50 µ g
Slide 23: Dosing Sessions Demonstrated a Scalable Path to Clinical Practice
23 1. Source: Panorama study documents. Safety population in study part A (100 µ g). Time at which participant first meets End of Session Checklist criteria. 2. Based on Interim analysis of EoSC as of September 10, 2026 from all dosing sessions in Emerge, Voyage and Panorama. ODT: orally disintegrat
Slide 24: Phase 3 Panorama Topline Results Part B – Interim Analysis
Phase 3 Panorama Topline Results Part B – Interim Analysis Dan Karlin, MD Chief Medical Officer
Slide 25: Part B Disposition
25 1. Based on interim analysis as of August 11, 2026. Interim analysis based on partial data and subject to change. 2. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or powered for statistical comparisons. ITT: intent - to - treat; ODT: orally disintegrating tablet Par
Slide 26: Part B Enrollment & Baseline Characteristics
26 1. Based on interim analysis as of August 11, 2026. Extension population. Interim analysis based on partial data and subject t o c hange. 2. ITT population who entered Part B. Data based on Week 12 in Part A. 3. Panorama included a DT120 ODT 50 µg control arm (n=52) that was not designed or power
Slide 27: Treatment Patterns in Part B
27 1. Based on interim analysis as of August 11, 2026. Extension population. Interim analysis based on partial data and subject t o c hange. 50 µ g cohort not included due to small n. 2. n is the number of participants in the Extension population who had the specified number of doses up to the corre
Slide 28: HAM-A Scores Improved Further with Additional Treatments in Part B
28 1. Based on interim analysis as of August 11, 2026. ITT Part A+B population with treatment policy strategy. Interim analysis b ase d on partial data and subject to change. 50 µ g cohort not included due to small n. 2. n is the number of participants in the ITT Part A+B population with non - missi
Slide 29: Subsequent Treatments Further Improved Response and Remission Rates
29 Subsequent Treatments Further Improved Response and Remission Rates through Week 28 1,2 Panorama Topline Results | September 2026 Mild and Remission Rates in Part B Response Rates in Part B 1. Source: Panorama study documents. Based on interim analysis as of August 11, 2026. ITT Part A+B populati
Slide 30: Next Steps
Next Steps Rob Barrow Chief Executive Officer
Slide 31: Compelling Evidence Across Four Late-Stage Trials
Panorama Topline Results | September 2026 31 Compelling Evidence Across Four Late - Stage Trials with Complementary Designs 1 1. The information presented in this slide is derived from multiple clinical trials, each conducted under distinct protocols and se ttings. As such, these data may not be dir
Slide 32: Development Program Supporting Plans for DT120 ODT NDA
Panorama Topline Results | September 2026 32 Compelling Development Program Supporting Plans for DT120 ODT New Drug Application 1. Registrational program represents studies anticipated to be required at the time of NDA submission; additional studies, inclu din g Part B of Phase 3 studies, are ongoin
Slide 33: Opportunity to Deliver Significant Impact and Value Creation
Panorama Topline Results | September 2026 33 Opportunity to Deliver Significant Impact and Value Creation 1 1. Ringeisen, H., et al. (2023). Mental and Substance Use Disorders Prevalence Study (MDPS): Findings Report, Zhou, Y,. Et al. (20 17). Nature. Comorbid generalized anxiety disorder and its as
Slide 34: Modest Adoption Yields Significant Opportunity
34 Modest Adoption Yields Significant Opportunity Given Large and Growing Delivery Ecosystem Panorama Topline Results | September 2026 Significant revenue potential requires only modest uptake across an established treatment network patients per month patients per year interventional psychiatry clin
Slide 35: Core Focus to Enable Commercial Impact & Success
35 Core Focus to Enable Commercial Impact & Success Panorama Topline Results | September 2026 Patient Treatment Education Access & Navigation Logistical Barrier Support Provider Access Support Reimbursement Support Referral & Treatment Coordination Site of Care Site Readiness Operational Enablement
Slide 36: Building a Psychiatry Powerhouse with Two Distinct Drivers
36 Building a Psychiatry Powerhouse with Two Distinct Drivers 1 1. Timing estimates subject to clinical progress and regulatory interactions. ASD: autism spectrum disorder; ODT: orally disintegrating tablet; NDA: new drug application; TLR: topline data readout Clinical & Regulatory Execution 2028 20
Slide 37: Maintaining Momentum with Multiple Milestones Ahead
2026 – Recent Completed Milestones Emerge (MDD) Positive Topline Data | June 2026 Voyage (GAD) Topline Readout | August 2026 Panorama (GAD) Topline Readout | September 2026 MDD BTD | September 2026 2026 – Anticipated Milestones DT120 NDA Pre - NDA Meeting | 4Q 2026 DT402 Initial Data in ASD | 4Q 202
Slide 38: Definium Therapeutics
Definium = THERAPEUTICS Precise science. Boundless impact.
Slide 39: Q&A Session
Q&A Session id ° 4 ‘ ‘ Definium TL THERAPEUTICS y id z :
Slide 40: Appendix
Appendix
Slide 41: DT120 Program is a Rare Example of Consistent Dose-Dependent Efficacy
41 1. Bar chart shows the percentage change between the high dose and lowest dose of drug studied in each clinical trial. 2. Phase 2b study: 100 µ g vs. 25 µ g; 3. Panorama: 100 µ g vs. 50 µ g; 4. Study 3: 84 mg vs 56 mg; 5. Study 2: 3 mg vs 1 mg; 6. Study 3+4: 4 mg vs 2 mg; 7. Study 5: 20 mg vs 10
Slide 42: Clinical Outcome Assessments in GAD and MDD
Panorama Topline Results | September 2026 42 Clinical Outcome Assessments in GAD and MDD 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
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