Mind Medicine (MindMed) Inc. Q3 FY2025 earnings call

• Rob Barrow noted the company delivered a solid quarter advancing clinical programs, with full Phase 2b trial results published in JAMA. Completed an underwritten public offering raising ~$259M, strengthening the balance sheet. Enrollment is strong in pivotal studies, with plans to accelerate development of NM120 and NM402. 2026 is set to be a pivotal year with Phase III data readouts expected.
• Daniel Rollings Karlin discussed the Phase 2b trial results in JAMA, detailing the robust randomized placebo-controlled trial of LSD in a psychiatric population. Outlined Phase III program details for GAD and MDD studies, including enrollment targets and study designs. Also shared plans to advance MM402 into a Phase IIa study for ASD by end 2025.
• Brandi L. Roberts provided financial results: ended Q3 with $209.1M in cash, cash equivalents, and investments. Highlighted R&D expenses increased to $31M in 2025, G&A expenses up to $14.7M, net loss at $67.3M, and details on warrant exercises and potential funding.

No detailed segment performance with revenue contribution percentages provided in the transcript. The focus is on clinical programs and financials rather than product segment revenue breakdowns.

• Anticipate top-line results from VOYAGE and PANORAMA (GAD programs) in 2026, and EMERGE (MDD program) in mid-2026 (previously second half 2026) due to faster enrollment. - Plan to initiate ASCEND, the second Phase III study of MM120 in MDD, in mid-2026. - Aim to initiate a Phase IIa study of MM402 in ASD by the end of 2025.

• Changes in market conditions. - Difficulties associated with research and development and regulatory approval processes.

Q: Gavin Clark-Gartner from Evercore asked about blinded sample size re-estimation and if the trial is being upsized.

A: Rob Barrow stated they haven't disclosed sample size re-estimation and are on track for readouts next year but didn't comment on upsizing.

Q: Pete Stavropoulos from Cantor Fitzgerald asked about enrolling patients in psychedelic studies and MM402's rationale in ASD.

A: Daniel Rollings Karlin mentioned aiming for representative samples in studies, and Rob Barrow discussed MM402's potential use as a drug taken daily or as needed for ASD, targeting enhanced social awareness and communication.

Q: Brian Corey Abrahams from RBC Capital Markets asked about EMERGE study acceleration vs GAD studies and initiating ASCEND trial.

A: Rob Barrow said enrollment is strong across all studies and they're on track for 2026 readouts, and they're positioned to accelerate with the recent financing but set timelines based on confidence.

Q: Matthew Herschenhorn from Oppenheimer asked about commercial management of patients and comparison to SPRAVATO.

A: Rob Barrow discussed leveraging infrastructure from SPRAVATO but highlighted MM120's long-lasting durable effects differing from SPRAVATO.

Q: Francois Brisebois from LifeSci Capital asked about market potential overlap in MDD and GAD and KOL education.

A: Daniel Rollings Karlin explained overlap between the disorders, and Rob Barrow discussed high enthusiasm from KOLs and practicing psychiatrists for new options like MM120.

Q: Amy Fadia from and Company asked about persistency rates in studies and dose response in PANORAMA and ASCEND.

A: Rob Barrow said they won't comment on ongoing study data, and emphasized dose response demonstration in Phase II and importance for efficacy.

Q: Sumant Kulkarni from Canaccord Genuity asked about durability of effect in MDD vs GAD and real-world usage.

A: Rob Barrow stated they're characterizing treatment responses and retreatment characteristics, and MM120 doesn't require psychotherapy in its development program.

Q: Patrick Trucchio from H.C. Wainwright asked about FDA alignment and NDA submission.

A: Rob Barrow discussed constructive FDA dialogue and alignment, and that they'll submit data as needed for NDA but didn't specify timeline for GAD NDA.

Q: Christopher W. Chen from Baird asked about safety monitoring and treatment session protocols.

A: Daniel Rollings Karlin explained safety monitoring is consistent with psychiatric drug development and doesn't involve psychotherapy, and Rob Barrow emphasized no psychotherapy in study protocols.