Definium Therapeutics, Inc. Q4 FY2023 earnings call

• 2023 was a productive year for Mind Medicine, including positive Phase 2b results for MM120 in Generalized Anxiety Disorder (GAD). • MM120 Phase 2b trial met primary endpoint with significant reductions in HAM-A scores at 4 weeks, well-tolerated with mostly transient adverse events. • MM402 Phase 1 trial initiated in Q4 2023 for Autism Spectrum Disorder (ASD), focusing on tolerability, pharmacokinetics, and pharmacodynamics. • Collaboration with University Hospital Basel on pharmacokinetics studies for MM402 and racemic MDMA. • Financials: As of Dec 31, 2023, cash and cash equivalents were $99.7M; net cash used in operating activities was $64.4M; R&D expenses increased to $52.1M from $36.2M in 2022; net loss widened to $95.7M from $56.8M in 2022.

No detailed breakdown of financial performance by product segments with revenue contribution percentages provided in the transcript.

• Expect to finalize Phase 3 development program for MM120 and hold End-of-Phase 2 meeting with FDA in the first half of 2024, aiming to start Phase 3 clinical program in the second half of 2024. • Anticipate sharing one-year follow-up results from a study of lysergide in anxiety disorders conducted by University Hospital Basel. • MM402 Phase 1 trial ongoing, with pharmacokinetics and pharmacodynamics data expected in the first half of 2024.

• Changes in market conditions. • Difficulties associated with research and development and regulatory approval processes as described in SEC filings.

Q: About 12-week durability data, dropout rates, and ODT formulation PK expectations A: Rob Barrow discussed effect size expectations, noting an effect size over 0.4 as an improvement over standard of care, dropout rates to be shared at the upcoming investor event, and the importance of the ODT formulation's PK profile for Phase 3.

Q: Phase 3 trial design, sizing, and functional blinding A: Rob Barrow mentioned trial sizing considerations based on statistical power and generalizability, and discussed functional unblinding in line with clinical trial standards, stating no deviation from established gold standards.

Q: Commercial side, SPRAVATO learning, durability importance A: Rob Barrow compared with SPRAVATO, emphasizing rapid onset, durability, and remission as key factors, noting durability out to 12 weeks is a game-changer for patient care and payer value.

Q: MM120 development, cash runway A: Rob and Schond Greenway discussed MM120 data presentation plans and cash runway considerations, with Schond noting cash runway based on historical burn rate and milestone-based funding.

Q: Phase 3 trial design, placebo control, bridging study A: Rob Barrow discussed placebo-controlled studies as the gold standard, reserved final commentary on Phase 3 study design, and mentioned sharing PK bridging data for the ODT formulation at the upcoming investor event.