MindMed Reports First Quarter 2024 Financial Results and Provides Business Update

MindMed Reports First Quarter 2024 Financial Results and Provides Business Update

Abstract:

MindMed (NASDAQ: MNMD), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its financial results for the quarter ended March 31, 2024, and provided a business update.

Building on a highly productive 2023, we were pleased to start the year by announcing that our Phase 2b trial of MM120 in Generalized Anxiety Disorder (GAD) hit its key secondary endpoint with clinically and statistically significant activity observed through 12 weeks after treatment, said Rob Barrow, Chief Executive Officer of MindMed. Additionally, the results we shared from our Phase 1 pharmacokinetics bridging trial support the advancement of our MM120 oral dissolving tablet (ODT) formulation into pivotal clinical trials, with our Phase 3 program of MM120 in GAD on track to initiate in the second half of 2024. We also presented at several recent medical meetings highlighting the continued unmet need, burden and increasing prevalence of GAD. With a strong balance sheet expected to fund operations through numerous key milestones, we look forward to providing additional updates on our GAD program, as well as on our pipeline as we advance MM402 for the treatment of autism spectrum disorder (ASD), and potentially expand into additional indications for MM120.

Business Update:

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.

The Company voluntarily delisted its common shares from Cboe Canada. The Company's common shares continue to be listed and tradable on Nasdaq under the symbol MNMD.

Program Updates and Anticipated Milestones:

MM120 (lysergide D-tartrate) for GAD:

In March 2024, the Company announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to MM120 for the treatment of GAD in adults.

In March 2024, the Company announced that its Phase 2b study of MM120 in GAD met its key secondary endpoint with data demonstrating rapid, robust, and durable activity, which was clinically and statistically significant through Week 12.

MM120 100 μg " the dose with optimal clinical activity observed in the trial " demonstrated a 7.7-point improvement over placebo at Week 12 (-21.9 MM120 vs. -14.2 placebo; p<0.001; mean baseline CGI-S score of 4.8). Clinical Global Impressions - Severity (CGI-S) scores, on average, improved from 4.8 to 2.2 in the 100 μg dose group, representing a two-category shift from "markedly ill" to "borderline ill" at Week 12 (p<0.001).

In March 2024, the Company announced results from its pharmacokinetics (PK) bridging study to support the advancement of the MM120 Zydis â ODT formulation into pivotal clinical trials.

In the trial, the Zydis â ODT formulation demonstrated 50% faster onset of action and meaningful improvements in both the overall area under the curve and the area under the curve above target or therapeutic concentrations compared to the non-ODT formulation.

We believe the Zydis â ODT formulation offers numerous product performance, clinical, and intellectual property benefits.

The Company presented detailed results from its Phase 2b study of MM120 in GAD, as well as multiple presentations describing the epidemiology and growing burden of GAD at the following conferences:

European Psychiatric Association (EPA) 2024 Congress

Anxiety & Depression Association of America (ADAA) 2024 Conference

American Psychiatric Association (APA) 2024 Congress

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 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.

This trial was conducted by the Company's collaborators at University Hospital Basel (UHB) in Switzerland and extends on the previously reported positive findings from the LSD-Assist study presented in May 2022.

The Company plans 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 â ODT for the treatment of GAD in the second half of 2024.

MM402 (R(-)-MDMA) for ASD:

The Company initiated its first clinical trial of MM402 (R(-)-MDMA), a single-ascending dose trial in adult healthy volunteers in Q4 2023. This Phase 1 trial is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics

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