Slide 1: Phase 3 Voyage Study Topline Data Readout
Phase 3 Voyage 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 Voyage 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 Voyage Topline Results | Aug
Slide 6: Second Positive Pivotal Readout for DT120 ODT
Voyage Topline Results | August 2026 6 Second Positive 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 se
Slide 7: Voyage Results Demonstrate Potential Best-in-Class Efficacy in GAD
Voyage Topline Results | August 2026 7 Voyage 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 statist
Slide 8: Continuing to Build Potentially Practice-Changing Evidence
Voyage Topline Results | August 2026 8 Continuing to Build Potentially Practice - Changing Evidence 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 directly comparable due to
Slide 9: DT120's Efficacy Stands Out Compared to Approved GAD Treatments
Voyage Topline Results | August 2026 9 DT120’s Efficacy Stands Out Compared to Approved GAD Treatments 1 DT120 effect size is more than double the GAD standard of care 1) The information presented in this slide is derived from multiple clinical trials, each conducted under distinct protocols and set
Slide 10: Phase 3 Voyage Study Results Part A – Topline Results
Phase 3 Voyage Study Results Part A – Topline Results Dan Karlin, MD Chief Medical Officer
Slide 11: Voyage Trial Design
Voyage Trial Design 1. Source: Definium internal study documents. ePRO: electronic Patient - Reported Outcome; GAD: generalized anxiety disorder; GAD - 7: a multipurpose instrument for screening, di agnosing, monitoring and measuring the severity of anxiety; HAM - A: Hamilton Anxiety Rating Scale; O
Slide 12: Participant Disposition
12 ITT: intent to treat; ODT: orally disintegrating tablet Participant Disposition Voyage Topline Results | August 2026 Randomized n=214 DT120 ODT n=107 Placebo ODT n=107 ▪ 100% included in ITT population ▪ 90% completed Part A ▪ 100% included in ITT population ▪ 88% completed Part A
Slide 13: Demographics & Baseline Characteristics
13 1. Based on ITT population. 2. Mean (SD). 3. The HAM - A is a 14 - item clinician - rated outcome measure assessing various domains of anxiety with a range of 0 - 56. In Voyage, HAM - A ratings were assessed by central raters blinded to both treatment assignment and visit number. 4. The CGI - S i
Slide 14: Baseline Characteristics Representative of GAD Patients with High Burden of Disease
14 1. Based on ITT population 2. Mean (SD) 3. Eligibility criteria required a baseline HAM - A score of 20 or greater; Moderate symptoms are defined as a HAM - A score of 16 – 23 . GAD: generalized anxiety disorder; HAM - A: Hamilton Anxiety Rating Scale; ITT: intent to treat; MDD: major depressive
Slide 15: Primary Endpoint: HAM-A Change from Baseline to Week 12
Primary Endpoint: HAM - A Change from Baseline to Week 12 15 1. Source: Voyage study documents. ITT population. 2. Primary endpoint of the study was change in HAM - A at week 12 using a Mixed - Effects Model Repeated Measures (MMRM) statistical an alysis with reference - based imputation. HAM - A: H
Slide 16: DT120 ODT Showed Significant CGI-S Improvements at All Timepoints
16 1. Source: Voyage study documents. ITT population. 2. Key secondary endpoints of the study was change in CGI - S at day 2 and week 12 using a Mixed - Effects Model Repeated Measures (MMR M) statistical analysis with reference - based imputation. CGI - S: Clinical Global Impressions – Severity sca
Slide 17: Robust, Clinically Significant Response and Remission Rates
17 DT120 ODT Effects Supported by Robust, Clinically Significant Response and Remission Rates 1 Voyage Topline Results | August 2026 14% 4% 0% 10% 20% 30% 40% 50% 60% Remission HAM - A ≤ 7 Remission Rate at Week 12 43% 16% 0% 10% 20% 30% 40% 50% 60% Response HAM - A ≥ 50% Improvement Response Rate a
Slide 18: Treatment Effect Maintained Across Key Subgroups
18 1. Source: Voyage study documents. Subgroup analysis of ITT population. 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 nalysis. If the number of patient
Slide 19: DT120 ODT was Generally Well-Tolerated and Consistent with Prior Experience
DT120 ODT was Generally Well - Tolerated and Consistent with Prior Clinical Experience 1 1. Source: Voyage study documents. Safety population in study part A (through week 12). 2. At the time of the analysis, a total of 13 participants reported a treatment emergent serious adverse event across all s
Slide 20: Adverse Events were Mild-to-Moderate in Severity
Voyage Topline Results | August 2026 20 Adverse Events were Mild - to - Moderate in Severity 1,2 Placebo ODT n=107 DT120 ODT n=107 Adverse Event 74 (69%) 106 (99%) Any TEAE 49 (46%) 65 (61%) Mild 24 (22%) 41 (38%) Moderate 1 (1%) 3 0 Severe 51 (48%) 102 (95%) Any Study Drug - Related TEAE 30 (28%) 1
Slide 21: Most Common TEAEs Demonstrate Favorable Tolerability Profile
21 Most Common TEAEs Demonstrate Favorable Tolerability Profile of DT120 ODT 1,2 Voyage Topline Results | August 2026 After Dosing Day Dosing Day TEAEs with Incidence ≥10% Placebo ODT (n=107) DT120 ODT (n=107) Placebo ODT (n=107) DT120 ODT (n=107) 0 2 (2%) 11 (10%) 80 (75%) Illusion 3 (3%) 3 (3%) 9
Slide 22: DT120 ODT Dosing Session Duration Supports Translation into Clinical Practice
22 1. Source: Voyage study documents. Safety population in study part A. Time at which participant first meets End of Session Chec kli st criteria. 2. Based on Interim analysis of EoSC as of August 10, 2026 from all dosing sessions in Emerge and Voyage and open - label dosing sessions in Panorama. O
Slide 23: Phase 3 Voyage Topline Results Part B – Interim Analysis
Phase 3 Voyage 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 July 15, 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 1 Voyage Topline R
Slide 25: Part B Enrollment & Baseline Characteristics
25 1. Based on interim analysis as of July 15, 2026. Extension population. Interim analysis based on partial data and subject to cha nge. 2. ITT population who entered Part B. Data based on Week 12 in Part A. CGI - S: Clinical Global Impressions – Severity Scale; HAM - A: Hamilton Anxiety Rating Sca
Slide 26: Treatment Patterns in Part B Provide Early Insights beyond 12 Weeks
26 1. Based on interim analysis as of July 15, 2026. Extension population. Interim analysis based on partial data and subject to cha nge. 2. n is the number of participants in the Extension population who had the specified number of doses up to the corresponding vis it. ITT: intent - to - treat; ODT
Slide 27: HAM-A Scores Improve Further with Additional Treatments in Part B
27 1. Based on interim analysis as of July 15, 2026. ITT Part A+B population with treatment policy strategy. Interim analysis bas ed on partial data and subject to change. 2. n is the number of participants in the ITT Part A+B population with non - missing HAM - A score at Baseline and the respectiv
Slide 28: Subsequent Treatments Further Improve Response and Remission Rates
28 Subsequent Treatments Further Improve Response and Remission Rates through Week 28 1,2 Voyage Topline Results | August 2026 Mild and Remission Rates in Part B Response Rates in Part B 1. Source: Voyage study documents. Based on interim analysis as of July 15, 2026. ITT Part A+B population. Interi
Slide 29: Next Steps
Next Steps Rob Barrow Chief Executive Officer
Slide 30: Compelling Evidence Across Three Late-Stage Trials
Voyage Topline Results | August 2026 30 Compelling Evidence Across Three Late - Stage Trials 1. Primary endpoint in Voyage is the change from baseline in HAM - A total score at Week 12; in Study MMED008 the primary endpoint wa s change from baseline in HAM - A total score at week 4. Primary endpoint
Slide 31: Opportunity to Deliver Significant Impact and Value Creation
Voyage Topline Results | August 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 associa
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
Slide 34: Q&A Session
Q&A Session ce) Definium THERAPEUTICS