MindMed Reports First Quarter 2024 Financial Results and Provides Business Update

MindMed Reports First Quarter 2024 Financial Results and Provides Business Update


MindMed (MNMD) 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.

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<.001; mean baseline CGI-S score of 4.8).

On average, CGI-S scores 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<.001).

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

In the trial, the Zydis α 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 the target or therapeutic concentrations compared to the non-ODT formulation.

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 α 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 of MM402. It should enable further clinical trials to characterize the effects of repeated daily doses of MM402 and the exploration of early signs of efficacy in the ASD population.

University Hospital Basel (UHB) has conducted a Phase 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S- MDMA in healthy adult volunteers. This trial was designed to assess the tolerability, pharmacokinetics and acute subjective, physiological and endocrine effects of the three molecules. Topline results are anticipated to be presented in the second quarter of 2024.

First Quarter 2024 Financial Results:

Cash Balance: As of March 31, 2024, MindMed had cash and cash equivalents totaling $252.3 million compared to $99.7 million as of December 31, 2023. The Company believes its available cash and cash equivalents will be sufficient to fund its operations into 2026 based on its current operating plan.

Net Cash Used in Operating Activities: For the quarter ended March 31, 2024, net cash used in operating activities was $16.6 million, compared to $13.3 million in the quarter ended March 31, 2023.

Research and Development (R&D) Expenses: R&D expenses were $11.7 million for the quarter ended March 31, 2024, compared to $12.6 million for the quarter ended March 31, 2023, a decrease of $0.9 million. The decrease was primarily due to decreases of $0.6 million in expenses related to our MM402 program

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