Definium Therapeutics Inc (DFTX) investor relations material

Strategic focus and financial position

• Focused on late-stage development of DT120 ODT for generalized anxiety disorder (GAD), major depressive disorder (MDD), and posttraumatic stress disorder (PTSD), with three positive Phase 3 studies in GAD and MDD.

• Experienced management team with a track record in CNS therapies and a comprehensive intellectual property strategy.

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

• Shares outstanding at 134.4 million as of July 30, 2026; credit facility up to $120 million, with $36.5 million outstanding.

• Second quarter 2026 operating expenses were $75.1 million, with $48.7 million in R&D and $26.4 million in G&A.

Clinical pipeline and trial results

• DT120 ODT demonstrated rapid, robust, and durable efficacy in GAD and MDD, with statistically significant improvements over placebo in all primary and key secondary endpoints across Phase 3 trials (Voyage, Panorama, Emerge).

• Effect sizes for DT120 ODT in GAD exceed those of standard-of-care treatments, with consistent large effect sizes across complementary trial designs.

• Favorable tolerability profile with most adverse events mild-to-moderate and no suicidality signal; 97% of participants cleared session safety criteria within 8 hours.

• Phase 3 studies include a 40-week extension phase, showing further improvement with additional treatments.

• DT402 (R(-)-MDMA) advancing in Phase 2a for autism spectrum disorder (ASD), with initial data expected in Q4 2026.

Regulatory and commercial outlook

• DT120 ODT program aligned with FDA guidance and has received Breakthrough Therapy Designation for GAD and MDD.

• NDA filing for DT120 ODT anticipated in the first half of 2027, with a pre-NDA meeting scheduled for Q4 2026.

• Commercial launch planned for GAD and MDD, targeting a large US adult population with significant unmet need.

• Predictive analytics and strong psychiatrist awareness support high adoption potential; 51% of high-priority HCPs would prescribe DT120 ODT.

• Modest adoption could yield significant revenue opportunity, with a potential gross revenue estimate of $5 billion.