Definium Therapeutics Inc (DFTX) investor relations material

Key clinical data and trial updates

• Anticipated phase III Emerge data for major depressive disorder (MDD) expected later this quarter, with focus on translatability from GAD to MDD due to overlapping symptoms and scales.

• Phase II studies showed a 6.4 placebo-adjusted change in MDD symptoms among GAD patients, with phase III expected to show greater impact due to higher baseline severity.

• Dropout rates in phase III have been reduced to 10% or less by introducing an open-label extension, compared to 25% in phase II.

• Phase III GAD studies (Voyage and Panorama) are fully enrolled, with 245 patients in Panorama and high confidence in detecting a five-point placebo-adjusted change.

• Durability of effect is a key differentiator, with 48% of phase II patients showing 12-week durability after a single dose.

Regulatory and policy landscape

• Recent executive order and increased federal focus on mental health have accelerated preparations for drug scheduling and state-level adoption, aiming to reduce post-approval timelines.

• Efforts underway to modernize state scheduling laws, with several states now having automatic trigger laws to expedite access.

• Breakthrough therapy designation for GAD, with plans to discuss simultaneous MDD and GAD filings with the FDA if phase III data are compelling.

• Ongoing dialogue with the FDA regarding potential for single-trial registration and concurrent filings for overlapping indications.

Commercial strategy and market positioning

• Commercial team expansion underway, leveraging learnings from SPRAVATO’s market trajectory and focusing on building strong site relationships.

• Targeting a concentrated network of treatment centers, with a projected 200-person field team providing comprehensive support beyond sales.

• Pricing strategy informed by SPRAVATO analog, with annual cost expected to be competitive and justified by durability and reduced retreatment frequency.

• Durability of effect and reduced need for frequent dosing positioned as key value propositions for payers.