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Definium Therapeutics (NASDAQ:DFTX) Chief Financial Officer Brandi Roberts said the company is preparing for several key clinical and regulatory milestones for DT-120, including anticipated Phase III data in major depressive disorder later this quarter and ongoing Phase III work in generalized anxiety disorder.
Speaking at a conference, Roberts said the company is “really excited” for the Phase III Emerge study in major depressive disorder, or MDD, to read out later this quarter. She acknowledged that Definium does not have a standalone Phase II study in MDD, but said the company sees meaningful overlap between generalized anxiety disorder, or GAD, and MDD based on symptom scales.
MDD Readout and Placebo Response
Roberts said the company is watching placebo response closely. In Phase II, she said Definium saw a placebo effect that was 40% higher than typically seen in historical studies, along with a 25% dropout rate that was mostly on the placebo arm. She attributed that in part to patients being asked to remain in a 12-week study after being washed out of background medications.
Definium has added an open-label extension to its Phase III studies, allowing patients who receive placebo and still have moderate or worse symptoms to receive drug after the initial 12-week dosing period. Roberts said this has helped reduce dropout rates, with recently disclosed GAD dropout rates at 10% or less.
On what would be clinically meaningful in MDD, Roberts said the studies are powered to show a five-point difference on the MADRS scale, but the company has discussed a four-point placebo-adjusted change as an important threshold. She said a “four plus” placebo-adjusted change, combined with durability and safety, would be “dramatic.” The MDD primary endpoint is six weeks, with patients followed to 12 weeks.
GAD Program Advances
Roberts said Definium’s Phase II GAD study evaluated 25-, 50-, 100- and 200-microgram doses and supported 100 micrograms as the go-forward dose. In the Phase III GAD program, she said the company built in a sample size re-estimation after half of patients had completed the 12-week period to review dropout rates and standard deviation.
Both measures were lower than expected, Roberts said, giving Definium “99% greater confidence” in detecting a five-point placebo-adjusted change in the Voyage and Panorama studies. She also said Panorama has completed enrollment with 245 patients.
Roberts said Panorama includes a 50-microgram dose as a confounding dose, while the primary analysis remains 100 micrograms versus placebo. She said this design is intended to help address concerns about functional unblinding by informing patients that feeling drug effects does not necessarily mean they received the dose associated with clinical benefit in Phase II.
Differentiation, Durability and Retreatment
Roberts said DT-120’s differentiation among psychedelic therapies is based in part on durability. She pointed to Phase II results showing 12-week durability for 48% of the population after one dose. She said Definium is framing the treatment as a potential “mental health day,” with patients spending five to eight hours in a clinic for the possibility of relief lasting three months or longer.
The open-label portion of the studies will follow patients for up to one year and help determine how often retreatment is needed. Roberts said the company would “love to see” something in the range of two to four treatments per year, while noting that patients may vary significantly.
PTSD, Regulatory Strategy and Scheduling
Roberts said PTSD has long been on Definium’s list of potential indications, citing overlap with anxiety and depression symptoms. She said the company plans to start a PTSD study next year and referenced approximately 13 million U.S. patients struggling with PTSD.
On regulation, Roberts said Definium has been focused for years on scheduling preparations. She said the DEA currently has 90 days to schedule the drug after approval, while states follow different processes. Roberts said California and Massachusetts have automatic trigger laws and that Definium has recently worked with four additional states to create automatic triggers, with efforts ongoing in more states.
Roberts also said DT-120 has breakthrough therapy designation in GAD and that the company has had a collaborative relationship with the FDA. If the MDD data are compelling, she said Definium would like to discuss with the agency the possibility of filing for both MDD and GAD at the same time. She also said the possibility of a single-study filing for MDD as a follow-on indication with significant overlap would warrant discussion with regulators after Emerge data.
Commercial Planning and IP
Roberts said Definium has been building its commercial team for the past year and a half. She cited SPRAVATO as a commercial analog, noting that roughly 7,000 centers are signed up for its REMS program, with sales concentrated among about 500 to 700 sites. Roberts said Definium expects to focus not only on sales representatives but also REMS support, payer support and making the treatment experience easier for providers.
On pricing, Roberts said SPRAVATO costs roughly $30,000 to $70,000 per year depending on dose and frequency, and that payers have been open to considering it as an analog. She said durability and retreatment patterns will help determine where DT-120 could fall in that range.
Roberts said Definium’s intellectual property approach includes patents on salts, polymorphs and the oral dissolving tablet formulation, as well as methods of treatment for GAD and MDD. She also pointed to the REMS program, scheduling framework and provider buy-and-bill dynamics as additional barriers that could help protect the product from generic competition.
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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