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Mar 31, 2024
MindMed Q1 2024 Earnings Report
MindMed reported financial results for Q1 2024 and provided a business update.
Key Takeaways
MindMed announced positive Phase 2b clinical trial results for MM120 in Generalized Anxiety Disorder (GAD), demonstrating clinically and statistically significant activity through 12 weeks after treatment. The FDA granted Breakthrough Therapy Designation to MM120 for the treatment of GAD in adults. The company's cash and cash equivalents totaled $252.3 million as of March 31, 2024.
Announced positive Phase 2b clinical trial results for MM120 in Generalized Anxiety Disorder (GAD), demonstrating clinically and statistically significant activity through 12 weeks after treatment.
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to MM120 for the treatment of GAD in adults.
The Company completed an underwritten offering and concurrent private placement for $175.0 million in gross proceeds before deducting transaction fees and other offering related expenses.
Cash and cash equivalents of $252.3 million as of March 31, 2024.
MindMed
MindMed
Forward Guidance
MindMed expects to hold an End-of-Phase 2 meeting with FDA in the second quarter of 2024 and is on track to initiate its Phase 3 clinical program of MM120 Zydis® ODT for the treatment of GAD in the second half of 2024. The Company believes its available cash and cash equivalents will be sufficient to fund its operations into 2026 based on its current operating plan.
Positive Outlook
- Phase 3 program of MM120 in GAD on track to initiate in the second half of 2024.
- The Company plans to hold an End-of-Phase 2 meeting with FDA in the second quarter 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 will be presented at the Society of Biological Psychiatry (SOBP) 2024 Annual Meeting being held May 9-11 in Austin, Texas.
- Topline results from UHB’s Phase 1 investigator-initiated clinical trial of R(-)-MDMA, S(+)-MDMA and R/S- MDMA are anticipated to be presented in the second quarter of 2024.
- The Company believes its available cash and cash equivalents will be sufficient to fund its operations into 2026
Challenges Ahead
- MindMed 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 is subject to risks associated with clinical trials or studies.