MindMed Announces Q3 2024 Financial Results and Business Updates

Mind Medicine (MindMed) Inc., a clinical-stage biopharmaceutical company, announced its financial results for the quarter ending September 30, 2024, alongside a business update. CEO Rob Barrow highlighted the significance of the company's progress, particularly as they gear up to launch the Voyage Phase 3 study for MM120 ODT in Generalized Anxiety Disorder (GAD). MindMed is also preparing two additional Phase 3 studies: the Panorama study, their second GAD trial, and the Emerge study, their first trial of MM120 ODT in Major Depressive Disorder (MDD). These efforts reflect the company's strategic utilization of high-performing clinical trial sites and aligned protocols to expedite enrollment, aiming to address conditions affecting approximately 51 million adults in the U.S.

For the MM120 program targeting GAD, MindMed plans to initiate the Voyage study in Q4 2024. This study will have a 12-week double-blind period with top-line results expected in the first half of 2026. The Phase 3 clinical program for MM120 in GAD includes both the Voyage and Panorama studies, each featuring a 12-week randomized, double-blind, placebo-controlled trial followed by a 40-week open-label extension period. The primary endpoint for these studies is the change in Hamilton Anxiety Rating Scale (HAM-A) score at week 12. The Panorama study, involving participants from the U.S. and Europe, is set to begin in the first half of 2025, with results anticipated in the second half of 2026.

Additionally, MindMed is advancing MM120 ODT for MDD through the Emerge study, which, similar to the GAD studies, features a 12-week randomized, double-blind period followed by a 40-week extension. This study will enroll at least 140 participants and aims to assess changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at week 6. The Emerge study is expected to start in the first half of 2025, with results projected for the second half of 2026. The company plans a second Phase 3 study in MDD, pending progress updates and regulatory discussions.

MindMed also completed a Phase 1 study of MM402, a proprietary form of R(-)-MDMA, aimed at treating Autism Spectrum Disorder (ASD). This study assessed the tolerability, pharmacokinetics, and pharmacodynamics of MM402 in adult healthy volunteers, setting the stage for further investigations into its potential for ASD treatment.

Financially, MindMed reported a robust cash position with $295.3 million in cash and cash equivalents as of September 30, 2024, up from $99.7 million at the end of 2023. This financial buffer is expected to sustain operations into 2027, extending at least 12 months beyond the first Phase 3 topline data readout for MM120 in GAD.

For the nine months ending September 30, 2024, net cash used in operating activities was $53.8 million, compared to $43.8 million in the same period in 2023. Research and development expenses for the quarter were $17.2 million, up from $13.2 million in the prior year, reflecting increased spending on the MM120 and MM402 programs and associated personnel costs. General and administrative expenses decreased slightly to $7.6 million from $8.4 million in 2023, primarily due to reduced legal and commercial expenses despite higher stock-based compensation costs.

MindMed's net loss for the quarter was $13.7 million, a reduction from $17.9 million in the same period in 2023, mainly due to changes in the fair value of warrants issued in a previous financing round, offset by increased R&D expenses.

MindMed remains committed to its mission of transforming the standard of care for brain health disorders, leveraging its strong financial position and strategic clinical development plans.