Definium Therapeutics, Inc. Q1 FY2026 earnings call

Robert Barrow noted 2026 is a pivotal year with advanced late - stage clinical programs, near - term data readouts, and team building. Daniel Karlin updated on clinical programs: DT120 ODT has ongoing Phase III studies in MDD, GAD, and PTSD; EMERGE in MDD has completed enrollment and is on track for topline results later this quarter; VOYAGE and PANORAMA in GAD are near topline data readouts. DT402 in ASD Phase II study is advancing. Matthew Wiley discussed commercial strategy for DT120, targeting high - volume healthcare practitioners and the market opportunity. Brandi L. Roberts presented financial results: Research and development expenses were $41.5 million in Q1 2026 compared to $23.4 million in Q1 2025. General and administrative expenses were $17.7 million in Q1 2026 compared to $8.8 million in Q1 2025. Net loss for Q1 2026 was $77.1 million compared to $23.3 million in Q1 2025. Ended Q1 2026 with $373.4 million in cash, cash equivalents, and investments.

Anticipates multiple pivotal data readouts across the second and third quarters for DT120, with a focus on disciplined execution and moving towards potential commercial launch. The company is well - positioned with its financial position to support operations through anticipated clinical readouts into 2028.

Q: Assuming success in MDD and anxiety this year, speak to thoughts on long - term safety and retreatment data needed for approval and long - term exposure for safety.

A: Robert Barrow and Daniel Karlin discussed safety data, Part B of studies, and how it relates to informing FDA and the clinical community.

Q: In terms of patient experience and monitoring, how confident are you that only one dosing session monitor will be needed and thought process behind PTSD HAVEN study design.

A: Daniel Karlin addressed patient monitoring based on FDA direction and the rationale for the PTSD HAVEN study design.

Q: On patient journey, talk about what gets closer to five hours in Phase III vs eight and thoughts on placebo response in GAD and MDD Phase IIIs.

A: Robert Barrow and Daniel Karlin discussed factors in patient journey and placebo response.

Q: About PTSD program, convictions regarding dose and submission in MDD or GAD.

A: Robert Barrow and Daniel Karlin answered on PTSD dose and submission considerations.

Q: Overlap of MDD and GAD, probability of success, and placebo in GAD.

A: Daniel Karlin discussed MDD and GAD overlap, probability of success, and placebo in GAD.

Q: For MDD OLE, reason for redosing trigger at MADRS score of 20 or greater and preparations at clinics for DT120.

A: Daniel Karlin and Matthew Wiley answered on redosing trigger and clinic preparations.

Q: Economic incentives for clinics to modify capacity for DT120 and advantages over Spravato, and PTSD differentiated advantages.

A: Matthew Wiley and Daniel Karlin addressed economic incentives and PTSD advantages.

Q: Filing strategy, which indication more challenging, and real - world advantages/disadvantages of Commissioner’s National Priority Voucher.

A: Robert Barrow and Matthew Wiley discussed filing strategy, challenging indication, and voucher advantages/disadvantages.

Q: EMERGE readout granularity of patient time - to - discharge data and label with eight - hour treatment window.

A: Robert Barrow responded on EMERGE data granularity.

Q: DEA rescheduling time saving and DT402 in ASD metrics.

A: Robert Barrow and Daniel Karlin answered on DEA rescheduling and DT402 metrics.

Q: Data needed from Part B and market capacity for DT120.

A: Robert Barrow addressed data needed from Part B and market capacity.