NEW YORK, August 6, 2026
Definium Therapeutics reported its second quarter 2026 financial results and recent business highlights, led by positive topline results from the Phase 3 Emerge study evaluating DT120 ODT in major depressive disorder (MDD). The company reported that the trial met its primary and all key secondary efficacy endpoints, with DT120 ODT demonstrating a statistically significant and clinically meaningful improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) scores. Definium also completed enrollment in two Phase 3 studies evaluating DT120 ODT in generalized anxiety disorder (GAD), with topline results from Voyage expected during the week of August 10, 2026, followed by Panorama results anticipated in September 2026. The company ended the quarter with approximately $1.1 billion in cash, cash equivalents, and investments, which it expects to support operations into 2030.
Phase 3 Emerge Study Delivers Positive MDD Results
The Phase 3 Emerge study enrolled 149 participants with major depressive disorder, randomized 1:1 to receive DT120 ODT 100 µg or placebo. The study met its primary endpoint and all key secondary efficacy endpoints with a high degree of statistical significance. At Week 6, DT120 ODT demonstrated an 8.1-point placebo-adjusted improvement in MADRS total score from baseline, with a Cohen’s d of 0.83 and p<0.0001. At Week 12, the treatment maintained a 7.3-point placebo-adjusted improvement in MADRS scores, also reaching statistical significance. DT120 ODT was generally well tolerated, with no serious adverse events and no observed suicidality signal reported in the study.
Additional Phase 3 DT120 ODT Readouts Approach
Definium has continued to advance DT120 ODT across multiple psychiatric indications. Enrollment was completed in the Phase 3 Voyage study in GAD, which randomized 214 participants to DT120 ODT 100 µg or placebo, with topline results expected during the week of August 10, 2026. The company also completed enrollment in the Phase 3 Panorama study, involving 245 participants, with topline data anticipated in September 2026. In MDD, Definium has initiated enrollment in the Phase 3 Ascend study, which is expected to enroll approximately 165 participants, with topline results anticipated in 2027. A Phase 3 Haven study evaluating DT120 ODT in posttraumatic stress disorder (PTSD) is expected to begin in 2027.
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Strong Cash Position Supports Clinical and Commercial Expansion
Definium reported approximately $1.1 billion in cash, cash equivalents, and investments as of June 30, 2026, compared with $411.6 million at the end of 2025. The company expects its current financial resources to fund operations into 2030. R&D expenses increased to $48.7 million in the second quarter of 2026 from $29.8 million in the prior-year period, primarily due to increased investment in the DT120 program and expanded research capabilities. G&A expenses rose to $26.4 million, reflecting higher personnel, stock-based compensation, corporate affairs, legal, and commercial-preparation costs. Definium reported a net loss of $159.0 million, which included an $86.2 million non-cash increase in the fair value of warrant liabilities associated with the company’s share-price appreciation.
Source:Definium Therapeutics, press release
