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Dec 31, 2023
MindMed Q4 2023 Earnings Report
MindMed reported its financial results for 2023 and provided a business update.
Key Takeaways
MindMed reported positive Phase 2b results for MM120 in treating adult patients with GAD and initiated Phase 1 clinical trial of MM402 in Autism Spectrum Disorder (ASD). The company's cash and cash equivalents totaled $99.7 million as of December 31, 2023, and are expected to fund operations into 2026, if certain milestones are achieved that unlock additional capital.
Announced statistically significant and clinically meaningful topline Phase 2b data for MM120 at 4 weeks in Generalized Anxiety Disorder (GAD).
Planned multiple milestones for MM120 in GAD, including 12-week Phase 2b data to be presented at March 7th investor event, and initiation of Phase 3 clinical program in second half of 2024.
Initiated Phase 1 clinical trial of MM402 in Autism Spectrum Disorder (ASD).
The Company will host a virtual investor event on March 7, 2024 to provide 12-week data from the Phase 2 program for MM120 being developed for the treatment of GAD.
MindMed
MindMed
Forward Guidance
MindMed anticipates several milestones, including one-year follow-up results from an investigator-initiated clinical trial of lysergide in anxiety disorders and working closely with the FDA to finalize Phase 3 development program for MM120 in GAD, expecting to hold an End-of-Phase 2 meeting with the FDA in the first half of the year to enable the initiation of Phase 3 clinical program in the second half of the year.
Positive Outlook
- The Company plans to share topline 12-week safety, efficacy, and durability results from the Phase 2b study and results from its pharmacokinetics bridging trial of the MM120 Zydis® ODT formulation, its intended commercial formulation of MM120, at an upcoming virtual investor event on March 7, 2024.
- The Company anticipates that full results from the Phase 2b trial of MM120 in GAD will be presented at a scientific meeting in 2024.
- The Company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and expects to initiate its Phase 3 clinical program in the second half of 2024.
- One-year follow-up data from a Phase 2 placebo-controlled investigator-initiated clinical trial of lysergide in the treatment of anxiety disorders is anticipated in 2024.
- UHB is currently conducting a Phase 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S- MDMA in healthy adult volunteers, with topline results expected in the first half of 2024.
Challenges Ahead
- The Company has a history of negative cash flows.
- The Company has a limited operating history.
- The Company expects to incur future losses.
- The Company faces difficulty associated with research and development.
- The Company faces risks associated with clinical trials or studies.