Definium Therapeutics Inc (DFTX) Corporate presentation summary

Strategic focus and pipeline overview

• Lead program DT120 ODT targets generalized anxiety disorder (GAD) and major depressive disorder (MDD) with five Phase 3 studies underway or planned.

• Pipeline includes DT402 (R(-)-MDMA) in Phase 2a for autism spectrum disorder (ASD) and exploratory indications.

• Intellectual property covers formulation, manufacturing, and treatment methods for DT120 ODT.

• Cash position of $373.4 million as of March 31, 2026, with runway into 2028.

• Experienced management team with CNS drug development expertise.

Clinical development and efficacy results

• Emerge Phase 3 trial in MDD met all primary and key secondary endpoints, showing rapid, robust, and durable efficacy after a single dose.

• DT120 ODT demonstrated an 8.1-point MADRS improvement over placebo at week 6 (p<0.0001) and 7.3 points at week 12.

• Remission and response rates at week 6 were significantly higher for DT120 ODT versus placebo.

• Phase 2b in GAD showed a 7.7-point placebo-adjusted improvement on HAM-A at week 12 (p<0.01), with a standardized effect size more than double standard of care.

• DT120 ODT outperformed approved GAD treatments in comparative analyses.

Safety, tolerability, and clinical operations

• DT120 ODT was generally well-tolerated, with 99% of adverse events mild-to-moderate and no serious adverse events or suicidality signals in Emerge.

• Average dosing session lasted 5.8 hours, with all participants cleared by 8 hours, supporting real-world clinical adoption.

• Monitoring requirements have evolved to an 8-item checklist, aligning with potential REMS and real-world use.

• Rigorous eligibility and diagnostic processes ensure trial integrity.