Definium Therapeutics Announces Positive Topline Results from Phase 3 Panorama Study of DT120 ODT in Generalized Anxiety Disorder

Study met primary and all key secondary efficacy endpoints; Panorama is the second positive Phase 3 trial for DT120 ODT in GAD and the third positive Phase 3 trial for DT120 ODT

Participants receiving DT120 ODT 100 µg achieved a statistically significant reduction in Hamilton Anxiety Rating Scale (HAM-A) score, with a placebo-adjusted change of 5.1 points from baseline at Week 12 (p<0.0001, Cohen's d=0.64)

DT120 ODT 100 µg was generally well tolerated, with a safety profile consistent with prior clinical experience

Pre-NDA meeting scheduled in 4Q 2026; NDA filing anticipated in 1H 2027

Company to host webcast today at 8 am EDT

NEW YORK, September 14, 2026--Definium Therapeutics, Inc. (Nasdaq: DFTX) ("Definium" or the "Company"), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today announced positive topline results from Panorama, the Company's second Phase 3 study of DT120 (lysergide) Orally Disintegrating Tablet (ODT) in adults with generalized anxiety disorder (GAD). This is the Company's third positive Phase 3 readout for DT120 ODT, following the positive Emerge results in major depressive disorder (MDD) announced in June and the positive Voyage results in GAD announced in August.

Panorama met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12. The Least Squares (LS) mean change from baseline in HAM-A total score at Week 12 in participants who received DT120 ODT 100 µg was -9.8 compared with -4.7 for participants who received placebo, an LS mean difference of -5.1 points (p<0.0001), corresponding to a standardized effect size of d=0.64. Efficacy was rapid, with changes seen as early as Day 2 and sustained at all post-baseline timepoints in Part A.

"The Panorama results again met our high expectations and confirmed the unprecedented efficacy of DT120 in GAD," said Rob Barrow, Chief Executive Officer of Definium Therapeutics. "With strong positive results across four complementary studies, we have built a compelling body of evidence that increases our confidence in the potential best-in-class profile of DT120. Building on this momentum, we are advancing toward an NDA submission and look forward to aligning with the FDA at our upcoming pre-NDA meeting. We are deeply grateful to the participants, investigators, site personnel, and our team whose commitment and hard work made this progress possible."