DFTX · Mind Medicine (MindMed) Inc.

This 8-K filing conveys a high-materiality clinical development update centered on Definium’s lead asset DT120 ODT (lysergide tartrate), with three imminent Phase 3 topline readouts across major depressive disorder (MDD) and generalized anxiety disorder (GAD). The Emerge study (MDD, n=149) is fully enrolled and positioned for late Q2 2026 readout—the earliest of the three—and will inform the initial regulatory strategy, including timing and scope of a potential NDA submission. The Voyage study (GAD, n=214) is also fully enrolled, with early Q3 2026 readout expected, while Panorama (GAD, updated target n=200) has closed screening and now targets late Q3 2026 for topline results—reflecting a refined statistical plan following blinded sample size re-estimation. These three readouts collectively represent de-risking milestones across two distinct indications and two different trial designs (1:1 and 2:1:2 randomization), strengthening the clinical evidence package for both labeling breadth and durability claims. Additionally, the announcement of the Phase 3 Haven study in PTSD—planned for 2027 initiation with ~200 participants and CAPS-5 as the primary endpoint—signals strategic portfolio expansion beyond core anxiety/depression indications into trauma-related disorders, broadening the long-term commercial and clinical scope. Management explicitly frames these events as 'important near-term catalysts' and ties them to an 'expeditious path to a potential NDA submission', underscoring their centrality to near-term value inflection. No financial results, guidance, or capital events are disclosed; materiality derives entirely from the timing, scale, and regulatory implications of these coordinated clinical milestones.