Definium Therapeutics Inc (DFTX) investor relations material

Clinical program updates

• Lead program DT120, a proprietary LSD formulation, targets generalized anxiety disorder (GAD) and major depressive disorder (MDD), with three pivotal studies reading out in 2026, building on strong phase II data published in 2024.

• Phase II data showed rapid, durable effects: a Cohen's d of 0.81, 21.9-point improvement on the Hamilton Anxiety Rating Scale, and a 48% remission rate at 12 weeks after a single dose.

• Dose-response studies identified 100 micrograms as optimal, with no added efficacy at 200 micrograms but increased adverse events.

• Phase III studies began in late 2024/early 2025, with identical designs for GAD and MDD, including open-label retreatment to assess long-term durability.

• Breakthrough Therapy designation was granted, and regulatory alignment with FDA has enabled a rapid development timeline, aiming for NDA submission within five years of IND opening.

Efficacy and safety insights

• DT120 demonstrated effects double or better than current standards, with rapid onset and sustained improvement over 12 weeks.

• Clinical outcomes were robust, with significant separation from placebo and no evidence that functional unblinding explained results.

• Adverse events were mostly mild to moderate, limited to dosing day, and resolved quickly; no drug-related serious adverse events or suicidality signals observed.

• Centralized, blinded raters were used in phase III to further mitigate bias.

Market opportunity and adoption

• GAD and MDD affect 50 million people in the U.S., with 27 million currently receiving medication; current treatments are often ineffective and poorly tolerated.

• Commercial strategy targets rapid adoption, leveraging 7,000 interventional psychiatry clinics and high enthusiasm among healthcare providers.

• Surveys show 70% of healthcare professionals intend to prescribe DT120 for GAD if approved.

• Even treating 100,000 patients (well under 1% of the market) would represent a multi-billion dollar opportunity at current pricing benchmarks.