Definium Therapeutics, Inc. · NASDAQ:DFTX
Definium Therapeutics — Technical Presentation (June 2026)
33 slides from Definium Therapeutics's technical presentation, Jun 22, 2026
Slide 1: Phase 3 Emerge Study Topline Data Readout
Phase 3 Emerge 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 Emerge possible
Slide 5: 1. Single dose regimen is being studied in pivotal clinical trials with primary and
5 1. Single dose regimen is being studied in pivotal clinical trials with primary and secondary outcome measures through 12 weeks aft er administration. Phase 3 studies include 40 week extension phase to characterize durability of response beyond 12 weeks in participants up until the time of discont
Slide 6: First Pivotal Readout for DT120 ODT
Emerge Topline Results | June 2026 6 First Pivotal Readout for DT120 ODT 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 controlled key secondary endp
Slide 7: Emerge Results Demonstrate Potential Best-in-Class Efficacy in MDD
Emerge Topline Results | June 2026 7 Emerge Results Demonstrate Potential Best - in - Class Efficacy in Major Depressive Disorder Limited side effect burden Efficient session dynamics Rapid, robust and durable efficacy after single dose ▪ All primary and key secondary endpoints highly statistically
Slide 8: Putting the Numbers in Perspective
Emerge Topline Results | June 2026 Putting the Numbers in Perspective 1 8 GAD Placebo adjusted changes in HAM - A MDD Placebo adjusted changes in MADRS 1. The information presented in this slide on comparative treatments is derived from multiple clinical trials, each conducted un der distinct protoc
Slide 9: Phase 3 Emerge Study Results Part A – Topline Results
Phase 3 Emerge Study Results Part A – Topline Results Dan Karlin, MD Chief Medical Officer
Slide 10: Emerge Trial Design
Emerge Trial Design MADRS: Montgomery - Åsberg Depression Rating Scale; ODT: orally disintegrating tablet; PHQ - 9: a multipurpose instrument for screen ing, diagnosing, monitoring and measuring the severity of depression; µg: microgram DT120 ODT 1 00 µg n=75 Placebo n=74 Part A 12 Week Randomized,
Slide 11: Participant Disposition
11 ITT: intent to treat; ODT: orally disintegrating tablet Participant Disposition Emerge Topline Results | June 2026 Randomized n=149 DT120 ODT n=75 Placebo ODT n=74 ▪ 100% included in ITT population ▪ 85% completed Part A ▪ 100% included in ITT population ▪ 82% completed Part A
Slide 12: Demographics & Baseline Characteristics
12 1. Based on ITT population. 2. Mean (SD). 3. The MADRS is a 10 - item clinician - rated outcome measure assessing various domains of depression with a range of 0 - 60. In Emerge, MADRS ratings were assessed by central raters blinded to both treatment assignment and visit number. 4. The CGI - S is
Slide 13: Baseline Characteristics: Representative of MDD Patients with High Burden of Disease
13 1. Based on ITT population ITT: intent to treat; MADRS: Montgomery - Åsberg Depression Rating Scale; MDD: major depressive disorder; ODT: orally disintegrati ng tablet; SD: standard deviation Baseline Characteristics | Representative of MDD Patients with High Burden of Disease 1 Emerge Topline Re
Slide 14: Baseline Characteristics: Course of Illness
14 1. Based on ITT population ITT: intent to treat; ODT: orally disintegrating tablet; SD: standard deviation Baseline Characteristics | Course of Illness Consistent with Representative and High Burden Population 1 Emerge Topline Results | June 2026 Overall N=149 Placebo ODT n=74 DT120 ODT n=75 Diag
Slide 15: Primary Endpoint: MADRS Change from Baseline
Primary Endpoint: MADRS Change from Baseline to Week 6 15 1. Source: Emerge study documents. ITT population. 2. Primary endpoint of the study was change in MADRS at week 6 using a Mixed - Effects Model Repeated Measures (MMRM) statistical ana lysis with reference - based imputation. LS Mean: least s
Slide 16: Improvements on CGI-S at All Timepoints
16 1. Source: Emerge study documents. ITT population. 2. Key secondary endpoint of the study was change in CGI - S at week 6 using a Mixed - Effects Model Repeated Measures (MMRM) statistic al analysis with reference - based imputation. CGI - S: Clinical Global Impressions – Severity scale; LS Mean:
Slide 17: Robust Response and Remission Rates
17 DT120 ODT Effects Supported by Robust, Statistically Significant Response and Remission Rates 1 Emerge Topline Results | June 2026 24% 41% 3% 13% 0% 10% 20% 30% 40% 50% 60% Remission MADRS ≤ 12 Mild or better MADRS < 20 Remission Rate at Week 6 35% 60% 7% 27% 0% 10% 20% 30% 40% 50% 60% Response ≥
Slide 18: Treatment Effect Maintained Across Key Subgroups
18 1. Source: Emerge study documents. Subgroup analysis of ITT population. 2. Data presented as LSmean ± standard error. 3. For each subgroup, the change from baseline in MADRS total score is analyzed using the same MMRM model as the primary efficac y a nalysis. If the number of patients is small fo
Slide 19: DT120 ODT Generally Well-Tolerated and Consistent with Known Pharmacology
DT120 ODT was Generally Well - Tolerated and Consistent with Known Pharmacology 1 1. Source: Emerge study documents. Safety population in study part A (through week 12). 2. The one severe adverse event that occurred was a recurrence of chronic back pain occurring approximately 6 weeks after dosing .
Slide 20: Adverse Events Mild-to-Moderate with No TEAEs Leading to Discontinuation
Emerge Topline Results | June 2026 20 Adverse Events were Mild - to - Moderate in Severity with No TEAEs Leading to Discontinuation 1 Placebo ODT n=74 DT120 ODT n=75 Adverse Event 42 (57%) 74 (99%) Any TEAE 31 (74%) 45 (61%) Mild 11 (26%) 28 (38%) Moderate 0 1 (1%) 2 Severe 24 (32%) 74 (99%) Any Stu
Slide 21: Most Common TEAEs Demonstrate Favorable Tolerability Profile
21 Most Common (≥10%) TEAEs Demonstrate Favorable Tolerability Profile of DT120 ODT 1 Emerge Topline Results | June 2026 Placebo ODT (n=74) DT120 ODT (n=75) TEAEs with Incidence ≥10% After Dosing Day Dosing Day After Dosing Day Dosing Day 0 2 (3%) 0 48 (64%) Illusion 0 3 (4%) 0 22 (29%) Euphoric Moo
Slide 22: Dosing Session Duration Supports Translation into Clinical Practice
22 1. Source: Emerge study documents. Safety population in study part A. Time at which participant first meets End of Session Chec kli st criteria. ODT: orally disintegrating tablet; EoSC: End of Session Checklist DT120 ODT Dosing Session Duration Supports Translation into Clinical Practice 1 Emerge
Slide 23: Phase 3 Emerge Topline Results Part B – Interim Analysis
Phase 3 Emerge Topline Results Part B – Interim Analysis Dan Karlin, MD Chief Medical Officer
Slide 24: Part B Disposition
24 1. Based on interim analysis as of May 21, 2026. Interim analysis based on partial data and subject to change. 2. Extension population includes participants with at least one Part B visit completed. ITT: intent to treat; ODT: orally disintegrating tablet Part B Disposition Emerge Topline Results
Slide 25: Part B Enrollment & Baseline Characteristics
25 1. Based on interim analysis as of May 21, 2026. Extension population. Interim analysis based on partial data and subject to c han ge. 2. ITT population who entered Part B. Data based on Week 12 in Part A. CGI - S: Clinical Global Impressions – Severity Scale; ITT: intent to treat population; MAD
Slide 26: Treatment Patterns in Part B Provide Early Insights beyond 12 Weeks
26 1. Based on interim analysis as of May 21, 2026. ITT Part A+B population. Interim analysis based on partial data and subject t o c hange. 2. Only includes participants who received DT120 ODT in Part A. 3. n is the number of participants in the Extension population who had the specified number of
Slide 27: MADRS Scores Improve Further with Additional Treatments in Part B
27 1. Based on interim analysis as of May 21, 2026. ITT Part A+B population with treatment policy strategy. Interim analysis base d o n partial data and subject to change. 2. n is the number of participants in the ITT Part A+B population with non - missing MADRS score at Baseline and the respective
Slide 28: Subsequent Treatments Further Improve Response and Remission Rates
28 Subsequent Treatments Further Improve Response and Remission Rates through Week 28 1,2 Emerge Topline Results | June 2026 Remission Rates in Part B Response Rates in Part B 1. Source: Emerge study documents. ITT population. 2. Only includes participants who received DT120 ODT in Part A. MADRS: Mo
Slide 29: Next Steps
Next Steps Rob Barrow Chief Executive Officer
Slide 30: Building Potentially Practice-Changing Evidence
Emerge Topline Results | June 2026 30 Building Potentially Practice - Changing Evidence 1. Clinical study designs subject to change based on ongoing regulatory discussion and review, including of Phase 3 clinical tri al protocols DB: double blind; HAM - A: Hamilton Anxiety Rating Scale; MADRS: Montg
Slide 31: Opportunity to Deliver Significant Impact and Value Creation
Emerge Topline Results | June 2026 31 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 associati
Slide 32: Building a Psychiatry Powerhouse with Two Distinct Drivers
32 Building a Psychiatry Powerhouse with Two Distinct Drivers 1 1. Timing estimates subject to clinical progress and regulatory interactions. ASD: autism spectrum disorder; GAD: generalized anxiety disorder; MDD: major depressive disorder; ODT: orally disintegrating tab let; TLR: topline data readou
Slide 33: Definium Therapeutics
a Definium 2 THERAPEUTICS cience. Boundless impact.
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