Mr. Robert Barrow reports

MINDMED ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE 2B TRIAL OF MM-120 IN GENERALIZED ANXIETY DISORDER

Mind Medicine (MindMed) Inc. has released positive top-line results from its phase 2b clinical trial of MM-120 (lysergide d-tartrate) in generalized anxiety disorder (GAD). The trial met its primary end point, with MM-120 demonstrating statistically significant and clinically meaningful dose-dependent improvements on the Hamilton Anxiety rating scale (HAM-A) compared with 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 micrograms -- the dose achieving the highest level of clinical activity -- demonstrated a 7.6-point reduction compared with placebo at week 4 (minus-21.3 MM-120 versus minus-13.7 placebo; p less than 0.0004; Cohen's d equals 0.88). Clinical global impressions-severity (CGI-S) scores on average improved from 4.8 to 2.4 in the 100 microgram dose group, representing a two-category shift from "markedly ill" to "borderline ill" at week 4 (p less than 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.

"We are excited by the strong positive results for MM-120 in GAD, particularly given that this is the first study to assess the stand-alone drug effects of MM-120 in the absence of any psychotherapeutic intervention. These promising findings represent a major step forward in our goal to bring a paradigm-shifting treatment to the millions of patients who are profoundly impacted by GAD," said Robert Barrow, chief executive officer and director of MindMed. "We look forward to sharing additional study results in the coming months -- including top-line 12-week results in the first quarter of 2024 -- and working closely with FDA as we finalize the phase 3 development program for MM-120 in GAD. I would like to thank all of the participants in the study, as well as the study investigators and our clinical development team, whose dedication made this important milestone possible."

Daniel Karlin, MD, MA, chief medical officer of MindMed, said: "Generalized anxiety disorder is a common condition associated with significant impairment that adversely affects millions of people and there remains a serious unmet need for this patient population. The pharmaceutical industry has largely ignored GAD over recent decades as it has proved extremely difficult to target. Few new treatment options have shown robust activity in GAD since the last new drug approval in 2004, making the strong, rapid and durable clinical activity of a single dose of MM-120 observed in the trial particularly notable. We believe this study is the first to rigorously assess the efficacy of a drug candidate in this class in the absence of a concurrent therapeutic intervention, which brings hope to the millions of people suffering from GAD and provides additional evidence that MM-120 may play an important role in revolutionizing the treatment of brain health disorders."

Additional secondary and exploratory end points included in the primary top-line results included HAM-A response and remission rates and clinical global impressions-severity (CGI-S) scores. Clinical response (50 per cent or greater improvement in HAM-A) at week 4 was achieved in 78 per cent of participants treated with MM-120 (100 micrograms or 200 micrograms) compared with 31 per cent for placebo. Clinical remission (HAM-A less than or equal to seven) at week 4 was achieved in 50 per cent of participants treated with MM-120 100 micrograms. CGI-S scores demonstrated a statistically significant and clinically meaningful improvement compared with placebo in the 100-microgram (p less than or equal to 0.001) and 200-microgram (p less than or equal to 0.01) dose groups. On average, participants receiving MM-120 (100 micrograms or 200 micrograms) experienced a two-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 time points 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 per cent and was 97.5 per cent 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-per-cent incidence in the high-dose groups) occurred on dosing day and included illusion, hallucinations, euphoric mood, anxiety, thinking abnormal, headache, paraesthesia, dizziness, tremour, 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 top-line 12-week data from the study in the first quarter of 2024 and to present full results at a scientific meeting in 2024.

Conference call and webcast

MindMed management will host a conference call at 8:30 a.m. ET today to discuss the results of MM-120 in GAD. Individuals may participate in the live call via telephone by dialling 877-407-3982 (domestic) or 201-493-6780 (international). The webcast can be accessed live on the news and events page in the investors section of the MindMed website. The webcast will be archived on the company's website for at least 30 days after the conference call.

About study MMED008

Study MMED008 is a multicentre, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial enrolled 198 participants who were randomized to receive a single administration of MM-120 at a dose of 25 micrograms, 50 micrograms, 100 micrograms or 200 micrograms, or placebo. The full analysis set (FAS) for the trial included 194 subjects, those that had at least one valid postbaseline Hamilton anxiety rating scale score. Subjects enrolled in the trial presented with severe GAD symptoms (average baseline HAM-A scores of approximately 30). The primary objective of the study was to determine the dose-response relationship of four doses of MM-120 versus placebo as measured by the change in HAM-A from baseline to week 4. Secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability, as well as other measures of efficacy and quality of life. More information about the trial is available on the MindMed website or on the Clinical Trials government website (identifier NCT05407064).

About MM-120

Lysergide is a synthetic tryptamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A (5-HT2A)) receptors. MindMed is developing MM-120 (lysergide D-tartrate), the tartrate salt form of lysergide, for GAD and ADHD (attention deficit hyperactivity disorder).

About generalized anxiety disorder

GAD is a brain health disorder that results in fear, persistent anxiety and a constant feeling of being overwhelmed. It is characterized by excessive, persistent and unrealistic worry about everyday things. Approximately 10 per cent of United States adults, representing around 20 million people, currently suffer from GAD, an underdiagnosed and underserved indication that is associated with significant impairment, less accomplishment at work and reduced labour force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2004.

About Mind Medicine (MindMed) Inc.

MindMed is a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders. The company's mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. MindMed is developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.

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