Mind Medicine (MindMed) Inc. announced positive topline results from its Phase 2b clinical trial of MM-120 (lysergide d-tartrate) in generalized anxiety disorder (GAD). The trial met its primary endpoint, with MM-120 demonstrating statistically significant and clinically meaningful dose-dependent improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4. MM-120 was administered as a single-dose in a monitored clinical setting with no additional therapeutic intervention. MM-120 100 µg ­ the dose achieving the highest level of clinical activity ­ demonstrated a 7.6- point reduction compared to placebo at Week 4 (-21.3 MM-120 vs.

-13.7 placebo; p<0.0004; Cohen's d=0.88). Clinical Global Impressions - Severity (CGI-S) scores on average improved from 4.8 to 2.4 in the 100 ug dose group, representing a two-category shift from `markedly ill' to `borderline ill' at Week 4 (p<0.001). This clinical activity was observed to be rapid and durable beginning on Day 2 and continuing through Week 4 with no loss of activity observed on either HAM-A or CGI-S. Additional secondary and exploratory endpoints included in the primary topline results included HAM-A response and remission rates and Clinical Global Impressions - Severity (CGI-S) scores.

Clinical response (50% or greater improvement in HAM-A) at Week 4 was achieved in 78% of participants treated with MM-120 (100 µg or 200 µg) compared to 31% for placebo. Clinical remission (HAM-A 7) at Week 4 was achieved in 50% of participants treated with MM-120 100 µg. CGI-S scores demonstrated a statistically significant and clinically meaningful improvement compared to placebo in the 100 µg (p0.001) and 200 µg (p0.01) dose groups. On average, participants receiving MM-120 (100 µg or 200 µg) experienced a 2-unit improvement in the CGI-S score at Week 4, with statistically significant improvements observed as early as one day after treatment and continuing at all evaluated timepoints through Week 4. MM-120 was generally observed to be well tolerated, with mostly transient mild-to-moderate adverse events (AEs) that appear consistent with the pharmacodynamic effects of MM-120.

The overall four-week completion rate in the trial was approximately 90% and was 97.5% in the high dose groups, and no participants in the high dose groups discontinued due to an adverse event through Week 4. The most common adverse events (at least 10% incidence in the high dose groups) occurred on dosing day and included illusion, hallucinations, euphoric mood, anxiety, thinking abnormal, headache, paraesthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis. The Company expects that results of this study will support the advancement of MM-120 into Phase 3 clinical development for GAD. The Company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and expects to initiate Phase 3 clinical trials in the second half of 2024.

The Company expects to present additional topline 12-week data from the study in the first quarter of 2024 and to present full results at a scientific meeting in 2024.