MindMed Closes Out 2023 with Positive Phase 2b Results for Generalized Anxiety Treatment

Mind Medicine (MindMed) Inc. (Nasdaq: MNMD) has announced its financial results for the year ended December 31, 2023, closing out a “highly productive” year with positive Phase 2b results for MM120 in the treatment of adult patients with generalized anxiety disorder (GAD).

Rob Barrow, Chief Executive Officer and Director of the Company, said, “We believe the initial data we shared validates our scientific understanding of MM120’s mechanism of action and shows the potential to have a best-in-class product profile compared to today’s standard of care. Looking further into 2024…we will be working closely with the FDA to finalize our Phase 3 development program for MM120 in GAD and expect to hold our End-of-Phase 2 meeting with the FDA in the first half of the year. This is intended to enable the initiation of our Phase 3 clinical program in the second half of the year.”

Highlights

In December 2023, MindMed announced statistically significant and clinically meaningful topline 4- week data from the 198-patient Phase 2b dose-optimization trial of MM120 for the treatment of 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 its Phase 3 clinical program for MM120 in the second half of 2024.

In Q4 2023, MindMed initiated a single-ascending dose trial of MM402 in adult healthy volunteers in Q4 2023. This Phase 1 trial is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM402 which is being developed as a potential treatment for autism spectrum disorder (ASD).

R&D expenses were $52.1 million for the year ended December 31, 2023, compared to $36.2 million for the year ended December 31, 2022, an increase of $15.9 million.

Net loss for the year ended December 31, 2023 was $95.7 million, compared to $56.8 million for the year ended December 31, 2022.

As of December 31, 2023, MindMed had cash and cash equivalents totaling $99.7 million.

MindMed is developing MM120 (lysergide D-tartrate) for generalized anxiety disorder (GAD) and other psychiatric indications, and MM402, (rectus-3,4-methylenedioxymethamphetamine), for the treatment of core symptoms of autism spectrum disorder (ASD).

About MindMed

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine, and acetylcholine systems.