Definium Therapeutics Inc (DFTX) Corporate presentation summary

Strategic focus and pipeline overview

• Late-stage pipeline includes DT120 ODT in five Phase 3 studies targeting GAD and MDD, the largest psychiatric disease burdens.

• Three Phase 3 readouts anticipated in 2026, representing potential billion-dollar commercial opportunities.

• Additional pipeline includes DT402 (R(-)-MDMA) in Phase 2a for autism spectrum disorder (ASD).

• Comprehensive intellectual property strategy with issued patents for DT120 ODT.

• Strong financial position with $373.4 million in cash and investments, runway into 2028.

Clinical efficacy and safety of DT120 ODT

• DT120 ODT demonstrated rapid, durable, and statistically significant improvements in anxiety and depression symptoms in Phase 2b.

• Effect size in GAD more than double standard of care; 48% remission at 12 weeks.

• Clinically meaningful improvements in both HAM-A and MADRS scores compared to placebo.

• Well-tolerated safety profile with most adverse events mild-to-moderate and limited to dosing day.

• No drug-related serious adverse events or suicidality signals observed.

Phase 3 program design and execution

• Five pivotal Phase 3 studies (Voyage, Panorama, Emerge, Ascend, Haven) with adaptive designs and robust powering assumptions.

• Studies feature single-dose, double-blind, randomized controlled designs with 40-week open-label extensions.

• Primary endpoints include HAM-A for GAD, MADRS for MDD, and CAPS-5 for PTSD.

• Phase 3 designs align with FDA guidance and incorporate enhancements for patient retention and trial execution.

• Standalone drug effect demonstrated without psychotherapeutic intervention.