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Definium Therapeutics (NASDAQ:DFTX) used its full-year 2025 earnings call to highlight impending late-stage clinical catalysts for DT120 ODT, its oral disintegrating tablet formulation of lysergide tartrate, as well as to review higher operating expenses tied to advancing its pipeline and expanding commercial readiness.
Multiple phase III readouts expected in 2026
Chief Executive Officer Rob Barrow said the company is “rapidly” approaching pivotal readouts for DT120 ODT in generalized anxiety disorder (GAD) and major depressive disorder (MDD), describing 2026 as a “pivotal” year for both the company and the broader psychiatry landscape.
Definium’s pivotal DT120 program includes four phase III studies:
- GAD: Voyage and Panorama
- MDD: Emerge and Ascend
Definium said Emerge, its first pivotal MDD study, is fully enrolled and top-line data is expected in late Q2 2026. Barrow said the company expects Emerge to be the first phase III readout across the program, which he said could support regulatory discussions in both MDD and GAD.
In GAD, Definium said enrollment in Voyage is approximately 80% complete, with enrollment expected to conclude in the “coming weeks” and top-line data anticipated in early Q3 2026. Panorama enrollment was described as “rapidly progressing,” with top-line data expected in the second half of 2026.
Trial design and endpoint details
Chief Medical Officer Dr. Daniel Karlin reviewed the structure of the pivotal studies, which each include a 12-week randomized, double-blind, placebo-controlled period followed by a 40-week extension with opportunities for open-label treatment.
Karlin said the MDD trials use a primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at week six for DT120 ODT 100 µg versus placebo. He said the trials were designed with 80% power to detect a five-point improvement over placebo.
For GAD, the primary endpoint is change from baseline in the Hamilton Anxiety Scale (HAM-A) at week 12 for DT120 ODT 100 µg versus placebo. Karlin said the GAD trials were designed with 90% power to detect a five-point improvement over placebo.
Management also referenced results from the company’s phase IIb dose optimization study, which was published in JAMA in September, including placebo-adjusted improvements at week 12 of 7.7 points on HAM-A and 6.4 points on MADRS. Karlin added that DT120 showed a 21.9 point absolute reduction in HAM-A scores at week 12 in that study, alongside a 48% clinical remission rate and a 65% response rate, and an 18.7 point absolute reduction in MADRS scores at week 12 for comorbid depressive symptoms.
Blinded sample size re-estimation update for Voyage
A key operational update centered on Voyage’s pre-planned blinded sample size re-estimation. Barrow said that analysis is complete and no increase in the trial’s sample size is required.
Karlin provided details from the blinded assessment among the first 100 participants completing week 12. He said the original power calculation assumed a standard deviation of 10 points on HAM-A and a non-evaluable rate of 15% at week 12. In the interim blinded review, he said Definium observed a model-based standard deviation of 6.7 points and a non-evaluable rate of 10%. If those parameters hold, he said that would imply over 99% power to detect a five-point difference on HAM-A and that the minimum difference needed for statistical significance would be less than two points.
In the Q&A, management emphasized that the re-estimation was blinded, involved no unblinding or inferential testing, and did not provide information about comparative performance between DT120 and placebo.
Commercial readiness focus and monitoring logistics
Chief Commercial Officer Matt Wiley said the company has “comprehensively mapped” the provider landscape and prioritized key launch states. Wiley described Definium’s planned commercial model as “high-touch” and “white-glove,” with a focus on supporting providers with areas beyond product information, including REMS certification, regulatory requirements, operational integration, and reimbursement pathways.
Management also addressed questions related to patient monitoring and discharge timing on dosing days. Karlin said Definium is collecting “high granularity” data and conducts structured assessments hourly starting at hour five, while observing all patients through hour eight in the study. He said the company expects to characterize time to safe discharge, but indicated it was not ready to share detailed open-label insights yet.
Regarding open-label extension data (part B), management said it had not committed to a specific timing for disclosure and does not want to present data that is not yet representative, but said it intends to share durability insights as data mature.
DT-402 program initiated in autism spectrum disorder
Beyond DT120, Karlin said Definium initiated a phase II study of DT-402 (the R-enantiomer of MDMA) in autism spectrum disorder (ASD) in late 2025 and has dosed the first participant. He described DT-402 as having promising prosocial effects with a potentially favorable tolerability profile and said the company is targeting core ASD symptoms, particularly social communication. The phase IIa study is a single-dose, open-label design in up to 20 adults with ASD, with initial data expected later in 2026. Karlin said the company is using sensitive and granular measures to assess change over a dosing day, including components of established measures as well as “novel ways” of evaluating social interaction and communication, but did not name specific scales.
On the financial side, Chief Financial Officer Brandi Roberts reported R&D expenses of $117.7 million in 2025, up from $65.3 million in 2024, driven primarily by higher DT120 program costs and increased internal personnel expenses. G&A expenses were $48.6 million, up from $38.6 million, with increases attributed to professional services and pre-commercialization activities, personnel-related costs, and other items. Net loss for 2025 was $183.8 million versus $108.7 million in 2024, with Roberts noting that net loss can be impacted by changes in the fair value of 2022 USD financing warrants. Definium ended 2025 with $411.6 million in cash equivalents and investments and said it expects that balance to fund operations into 2028.
Looking ahead, Barrow reiterated that Definium expects three phase III readouts in 2026, with Emerge data first in late Q2, and said the company is preparing for potential NDA activities subject to trial outcomes.
About Definium Therapeutics (NASDAQ:DFTX)
Definium Therapeutics, Inc, a clinical stage biopharmaceutical company, develops novel products to treat brain health disorders. The company’s lead product candidates include MM120, which is in phase 3 for the treatment of generalized anxiety disorder and attention deficit hyperactivity disorder; and DT402, a R-enantiomer of 3,4-methylenedioxymethamphetamine, which is in phase 2a clinical trials for the treatment of core symptoms of autism spectrum disorder. The company was formerly known as Mind Medicine (MindMed) Inc and changed its name to Definium Therapeutics, Inc in January 2026.
