Definium Therapeutics Inc (DFTX) investor relations material

Executive summary

• Advanced late-stage clinical programs for DT120 ODT in major depressive disorder (MDD), generalized anxiety disorder (GAD), and planned expansion into PTSD, with three pivotal phase III readouts expected in 2026 and enrollment completed for key studies.

• Emphasized disciplined execution, robust trial design, and commercial readiness, targeting large, underserved psychiatric markets.

• Highlighted strong engagement with FDA, breakthrough therapy designation for GAD, and constructive regulatory progress.

• DT402 (R(-)-MDMA) is in Phase 2a for autism spectrum disorder (ASD), with initial data anticipated in 2026.

• Company changed its name from Mind Medicine (MindMed) Inc. to Definium Therapeutics, Inc. in January 2026.

Financial highlights

• Q1 2026 research and development expenses were $41.5 million, up from $23.4 million in Q1 2025, mainly due to increased DT120 program costs and expanded R&D personnel.

• General and administrative expenses rose to $17.7 million from $8.8 million year-over-year, reflecting investments in commercialization, organizational maturity, and higher stock-based compensation.

• Net loss for Q1 2026 was $77.1 million versus $23.3 million in Q1 2025, with a $20 million impact from warrant fair value changes due to share price increase.

• Cash, cash equivalents, and investments totaled $373.4 million as of March 31, 2026, providing runway into 2028.

• Accumulated deficit reached $659.8 million as of March 31, 2026.

Outlook and guidance

• Anticipates top-line data from Emerge (MDD) in Q2 2026, and from Voyage and Panorama (GAD) in Q3 2026.

• Plans to initiate the Haven study in PTSD in 2027, expanding DT120 ODT's potential indications.

• Expects sufficient capital to fund operations through multiple clinical milestones and into 2028.

• Expects continued increase in R&D and G&A expenses as clinical programs advance.