Definium Therapeutics, Inc. (NASDAQ: DFTX) reported positive topline results from two Phase 3 studies of its orally disintegrating tablet (ODT) candidate DT120 in generalized anxiety disorder (GAD). The company also disclosed financial results for the fiscal quarter ended September 30, 2026.
Regarding DT120 ODT, the company reported positive results from the Phase 3 Voyage study, which randomized 214 participants to receive DT120 ODT 100 micrograms or placebo. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful placebo-adjusted improvement of 5.4 points in the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline at Week 12 (p<0.0001). The company also reported positive results from the Phase 3 Panorama study, which randomized 245 participants to receive DT120 ODT 100 micrograms, DT120 ODT 50 micrograms, or placebo. This study also met its primary endpoint, showing a placebo-adjusted improvement of 5.1 points in HAM-A total score at Week 12 (p<0.0001). In both studies, DT120 ODT was generally well tolerated, with no drug-related serious adverse events and no suicidality signal observed in Part A.
In addition to the GAD results, Definium announced that it has received Breakthrough Therapy designation from the FDA for DT120 ODT in major depressive disorder (MDD). The company received this designation following positive topline results from the Phase 3 Emerge study, which met its primary endpoint and all key secondary efficacy endpoints. The company is continuing enrollment for the Phase 3 Ascend study in MDD, which is expected to enroll approximately 165 participants and is anticipated to report topline data in 2027. The company also plans to initiate the Phase 3 Haven study in PTSD in 2027 with approximately 200 participants.
On the financial front, Definium reported cash, cash equivalents, and investments of approximately $1.05 billion as of September 30, 2026. This represents an increase from $411.6 million as of December 31, 2025. The company stated that its current cash balance is sufficient to fund operations into 2030. For the third quarter of 2026, the company reported research and development expenses of $46.1 million and general and administrative expenses of $26.1 million. The net loss for the quarter was $51.0 million.
Definium also provided an update on its DT402 program, which is being developed for autism spectrum disorder (ASD). The company reported positive initial results from a Phase 2a trial of DT402 in five adults with ASD. The study demonstrated improvements across several measures of socialization, communication, and functional outcomes, including reduced rigidity and fixation and increased engagement in social settings. Based on these findings, the company plans to further evaluate DT402 in a study investigating multiple dosing paradigms expected to begin in 2027.
