Definium Therapeutics Inc (DFTX) investor relations material

Program overview and milestones

• Two clinical assets in development, with DT120 (an ODT LSD formulation) as the lead candidate targeting generalized anxiety disorder (GAD) and major depressive disorder (MDD).

• DT120 has breakthrough therapy designation for GAD and is approaching three pivotal readouts: two in GAD (Q3) and one in MDD (late Q2).

• Phase II data showed rapid, durable 12-week response after a single dose, with about half of patients in remission at 12 weeks.

• The upcoming MDD readout is expected at the end of the month, followed by GAD data in Q3.

• Filing for GAD is anticipated within 6–9 months after data, with MDD filing to follow after the second study reads out in 2027.

Clinical trial design and expectations

• Phase III studies are designed to demonstrate durable effects, with primary endpoints at week 6 (MDD) and week 12 (GAD).

• Open label extension phases allow for real-world-like retreatment patterns, with up to four treatments in 40 weeks.

• Retention rates improved significantly in GAD studies due to the extension phase design.

• Remission rates and functional improvement are key endpoints, with remission defined as MADRS ≤12.

• Average dosing is estimated at four times per year, potentially lower, based on durability seen in phase II.

Commercial and operational strategy

• Existing esketamine (SPRAVATO) treatment centers are seen as a logical launchpad for DT120, leveraging established infrastructure.

• DT120 may not require physiological monitoring, potentially allowing administration by non-medical staff and improving access.

• Reimbursement is expected to be favorable due to reduced total clinic time compared to SPRAVATO, despite longer individual sessions.

• Engagement with payers indicates understanding and acceptance of the new treatment paradigm.