Definium Therapeutics Inc (DFTX) investor relations material

Strategic focus and pipeline overview

• Lead program DT120 ODT targets generalized anxiety disorder (GAD), major depressive disorder (MDD), and posttraumatic stress disorder (PTSD) with five Phase 3 studies in progress or planning.

• DT120 ODT is a proprietary, pharmaceutically optimized form of lysergide, with patents covering formulation, manufacturing, and treatment methods.

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

• Strong financial position with ~$1.1 billion in cash and investments as of June 30, 2026, and a cash runway expected into 2030.

Clinical program highlights

• DT120 ODT demonstrated rapid, robust, and durable efficacy in GAD and MDD, with significant improvements over placebo in primary and key secondary endpoints.

• Voyage Phase 3 (GAD): 5.4-point HAM-A improvement at week 12, 7.7-point at week 1, and high remission/response rates; well-tolerated with no new safety signals.

• Emerge Phase 3 (MDD): 8.1-point MADRS improvement at week 6, 7.3-point at week 12, and strong remission/response rates; no serious adverse events or suicidality signals.

• Predictable dosing session duration (~6 hours) supports efficient, single-visit clinical delivery and potential for real-world adoption.

Commercial opportunity and market positioning

• Large addressable market: 50 million US adults with GAD/MDD, 26 million diagnosed, and 4.2 million failed by two or more treatments.

• Modest adoption in the target population could yield blockbuster revenue, with $2 billion opportunity per 1% market penetration at surrogate pricing.

• Growing psychiatrist awareness and positive sentiment toward DT120 ODT, with 58% of surveyed HCPs expressing positive views and intent to prescribe.

• Predictive analytics and targeted engagement strategies focus on high-priority prescribers to maximize adoption.