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Definium Therapeutics Reports Third Quarter 2026 Financial Results and Recent Highlights

DFTX
  • Reported positive topline Phase 3 results for DT120 ODT in two generalized anxiety disorder (GAD) studies: Voyage (214 participants) & Panorama (245 participants), both meeting primary & key secondary endpoints with significant HAM-A score improvements.
  • Received FDA Breakthrough Therapy Designation for DT120 ODT in major depressive disorder (MDD) following positive Phase 3 Emerge study results.
  • On track for New Drug Application (NDA) filing for DT120 ODT in the first half of 2027.
  • DT402 demonstrated positive initial results in a Phase 2a trial for autism spectrum disorder (ASD), showing improvements in socialization, communication, rigidity, & anxiety; a Phase 2 study evaluating multiple dosing paradigms is planned for 2027.
  • Planning to initiate the Phase 3 Haven study for DT120 ODT in posttraumatic stress disorder (PTSD) in 2027 with approximately 200 participants.
  • Continuing enrollment for the Phase 3 Ascend study in MDD, with topline data expected in 2027.
  • Held approximately $1.05 billion in cash, cash equivalents, & investments as of September 30, 2026, which is sufficient to fund operations into 2030.
  • Reported a net loss of $51.0 million for the quarter ended September 30, 2026, compared to $67.3 million in the prior year period.
  • Research & development expenses increased to $46.1 million for the quarter, driven by personnel costs & DT120 development program expenses.
  • General & administrative expenses rose to $26.1 million for the quarter, primarily due to increased commercial-preparedness & corporate affairs costs.
  • Management scheduled a conference call for 4:30 p.m. EST on the reporting date to review financial results & business highlights.
  • Presented clinical data at multiple medical meetings, including Psych Congress 2026, where DT120 ODT study posters received finalist status & awards.
  • Advancing commercial readiness activities with a first Commercial Day planned for the first half of 2027.