Definium Therapeutics Inc (DFTX) Corporate presentation summary

Strategic focus and pipeline highlights

• Late-stage pipeline centers on DT120 ODT, a proprietary lysergide tartrate, in four Phase 3 studies targeting generalized anxiety disorder (GAD) and major depressive disorder (MDD), the largest psychiatric disease burdens.

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

• DT402 (R(-)-MDMA) is advancing in a Phase 2a study for autism spectrum disorder (ASD) after a successful Phase 1 trial.

• Strong financial position with $411.6 million in cash and investments as of December 31, 2025, and a cash runway expected into 2028.

• Comprehensive intellectual property strategy with issued patents covering DT120 ODT's formulation, manufacturing, and treatment methods.

Clinical efficacy and safety of DT120 ODT

• DT120 ODT demonstrated rapid, durable, and statistically significant improvements in anxiety and depression symptoms in Phase 2b, with effect sizes more than double standard of care.

• 48% of participants achieved remission at 12 weeks, with favorable tolerability and most adverse events limited to dosing day.

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

• Phase 2b established 100 μg as the optimal dose, supporting robust Phase 3 program design.

• Phase 3 studies are designed to address regulatory considerations, including functional unblinding and placebo response moderation.

Phase 3 program and regulatory alignment

• Four pivotal Phase 3 studies (Voyage, Panorama, Emerge, Ascend) are underway or planned, with adaptive designs and open-label extensions to optimize statistical power and participant retention.

• Primary endpoints are HAM-A for GAD and MADRS for MDD, with studies powered to detect clinically meaningful differences.

• Phase 3 designs mirror positive Phase 2b results and align with FDA guidance; DT120 ODT has received FDA Breakthrough Therapy Designation.