Definium Therapeutics Q2 Earnings Call Highlights

Definium Therapeutics (NASDAQ:DFTX) said it expects to report top-line results from its Phase III VOYAGE study of DT120 ODT in generalized anxiety disorder during the week of Aug. 10, following positive Phase III results in major depressive disorder reported in June.

Chief Executive Officer Rob Barrow said the company completed enrollment in both VOYAGE and PANORAMA, its two pivotal generalized anxiety disorder, or GAD, studies. Definium expects to release PANORAMA results in September. The company has also begun enrollment in ASCEND, its second Phase III study of DT120 ODT in major depressive disorder, with top-line data anticipated in 2027, and is preparing to start a Phase III post-traumatic stress disorder study, HAVEN, in 2027.

The company did not hold a question-and-answer session because of the planned VOYAGE data release.

Phase III Depression Results

Chief Medical Officer Dr. Dan Karlin reviewed results from the Phase III EMERGE study in major depressive disorder, which enrolled 149 participants with moderate to severe disease. Participants had a mean baseline Montgomery-Åsberg Depression Rating Scale, or MADRS, score of 34.5, and about half had previously failed two or more antidepressant treatments, according to Karlin.

Background antidepressant and anxiolytic medications were discontinued before randomization, and psychotherapy was not part of the study, allowing the company to assess DT120 as monotherapy, Karlin said.

EMERGE met its primary and key secondary endpoints, according to the company. DT120 ODT produced an 8.1-point placebo-adjusted improvement on the MADRS at week six, with a p-value of less than 0.0001 and an effect size of about 0.83. Karlin said the company believes this represents the largest treatment effect reported in a Phase III major depressive disorder trial.

He said efficacy was observed as early as week one after a single treatment and remained statistically significant at each subsequent assessment through week 12. The company also reported significant improvements across key secondary endpoints and what it characterized as a favorable tolerability profile.

Upcoming Anxiety Data and Pipeline Plans

Karlin said Definium’s Phase II GAD study showed rapid, clinically meaningful improvements that persisted through 12 weeks after treatment. VOYAGE and PANORAMA were designed to confirm those findings in separate controlled pivotal studies.

The studies were initially designed with roughly 90% power to detect a five-point placebo-adjusted treatment effect. Following a protocol-specified blinded sample-size re-estimation that considered variations in the primary measure and dropout rates, Definium said both studies would be expected to have more than 99% power to detect a five-point placebo-adjusted effect.

While the company powered the trials to detect a five-point difference, Karlin said it believes a placebo-adjusted improvement of four points or more at week 12 would compare favorably with available treatments and other investigational products. He also cited the lack of a newly approved GAD drug in nearly 20 years.

Beyond DT120, Definium said it continues to advance DT402 for autism spectrum disorder. Karlin said the program targets the core social-communication challenges associated with autism spectrum disorder, for which the company said no FDA-approved therapies directly address those symptoms.

Commercial Buildout and Financing

Chief Commercial Officer Matt Wiley said Definium is expanding its commercial organization and developing launch capabilities for DT120 if the product receives approval. The company is hiring across marketing, market access, sales and commercial operations, while working on promotional messaging, payer value narratives, distribution design and deployment planning.

Wiley highlighted the July launch of Definium’s “Wired for Worry” campaign, which aims to raise awareness of the burden and underlying neurobiology of GAD and help clinicians identify patients who could benefit from new treatment options. He said early feedback has been positive and the campaign is generating engagement ahead of the GAD data readouts.

Chief Financial Officer Brandi Roberts said Definium completed an upsized underwritten public offering in June that generated approximately $758 million in net proceeds. The company ended the second quarter with about $1.1 billion in cash equivalents and investments and said it expects that capital to fund planned operations into 2030.

Second-Quarter Expenses and Loss

• Research and development expense rose to $48.7 million from $29.8 million a year earlier, primarily due to DT120 program spending and added R personnel.
• General and administrative expense increased to $26.4 million from $11.1 million, reflecting stock-based compensation, corporate and government affairs activity, personnel costs and commercial-readiness investments.
• Net loss widened to $159 million from $42.7 million in the prior-year quarter.

Roberts said the quarterly net loss included an $86.2 million non-cash expense from changes in the fair value of the company’s 2022 U.S. dollar financing warrants. The expense primarily reflected an increase in Definium’s share price to $47.04 on June 30 from $18.90 on March 31.

Barrow said the company is continuing to prepare for a potential new drug application submission and potential launch of DT120 ODT while advancing its clinical programs and broader research pipeline.

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.

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