Mr. Rob Barrow reports

MINDMED REPORTS 2023 FINANCIAL RESULTS AND BUSINESS UPDATES

Mind Medicine (MindMed) Inc. has released its financial results for the year ended Dec. 31, 2023, and has provided a business update.

"Two thousand twenty-three was a highly productive year for MindMed, which concluded with positive phase 2b results for MM120 in the treatment of adult patients with GAD," said Rob Barrow, chief executive officer and director of the company. "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. We look forward to sharing 12-week safety, efficacy and durability data and results from our phase 1 pharmacokinetics bridging trial to support the advancement of our MM120 oral dissolving tablet (ODT) formulation into pivotal clinical trials at our virtual investor event in March. Looking further into 2024, we anticipate several additional milestones, including one-year follow-up results from an investigator-initiated clinical trial of lysergide in anxiety disorders conducted by our collaborators at University Hospital Basel. We will be working closely with the FDA [Food and Drug Administration] 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."

Business update

The company will host a virtual investor event on March 7, 2024, to provide 12-week data from the phase 2 program for MM120 being developed for the treatment of GAD. Senior management and key opinion leaders will discuss the treatment landscape, market potential and commercial opportunity for MM120 in GAD and other psychiatric disorders.

Program updates and anticipated milestones

MM120 (lysergide D-tartrate) for GAD

In December, 2023, the company announced statistically significant and clinically meaningful topline four-week data from the 198-patient phase 2b dose-optimization trial of MM120 for the treatment of GAD.

MM120 100 microg -- the dose achieving the highest level of clinical activity -- demonstrated a 7.6-point reduction on the Hamilton Anxiety rating scale (HAM-A) compared with placebo at week 4 (minus 21.3 MM120 versus minus 13.7 placebo; p<004; Cohen's d effect size=0.88), which is more than double the effect sizes seen with the current standards of care1.

Clinical response (50 per cent or greater improvement in HAM-A) at week 4 was achieved in 78 per cent of participants treated with MM120 (100 microg or 200 microg) compared with 31 per cent for placebo.

Clinical remission (HAM-A<= 7) at week 4 was achieved in 50 per cent of participants treated with MM120 100 microg compared to 18 per cent for placebo.

The company plans to share topline 12-week safety, efficacy, and durability results from the phase 2b study and results from its pharmacokinetics bridging trial of the MM120 Zydis ODT formulation, its intended commercial formulation of MM120, at an upcoming virtual investor event on March 7, 2024.

The company anticipates that full results from the phase 2b trial of MM120 in GAD will be presented at a scientific meeting in 2024.

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 in the second half of 2024.

One-year follow-up data from a phase 2 placebo-controlled investigator-initiated clinical trial of lysergide in the treatment of anxiety disorders is anticipated in 2024. This trial was conducted by the company's collaborators at University Hospital Basel (UHB) in Switzerland and completed in Q3 2023.

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 and 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.

In October, 2023, the company presented results from a non-clinical study in a model of ASD, titled "MM402 demonstrates better efficacy than S(+)-3,4-MDMA or (plus or minus)-3,4-MDMA in Fmr1 knockout mice, an animal model of autism spectrum disorder" at the 36th Annual European College of Neuropsychopharmacology (ECNP) congress.

UHB is currently conducting a phase 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S- MDMA in healthy adult volunteers. This trial is designed to assess the tolerability, pharmacokinetics and acute subjective, physiological and endocrine effects of the three molecules. The company anticipates topline results to be presented in the first half of 2024.

2023 financial results

• Cash balance: As of Dec. 31, 2023, MindMed had cash and cash equivalents totalling $99.7-million compared with $142.1-million as of Dec. 31, 2022. The company believes its available cash and cash equivalents, as well as its committed credit facility, are expected to finance operations into 2026, if certain milestones are achieved that unlock additional capital.
• Net cash used in operating activities: For the year ended Dec. 31, 2023, net cash used in operating activities was $64.4-million, compared with $50.1-million for the year ended Dec. 31, 2022.
• Research and development (R&D): R&D expenses were $52.1-million for the year ended Dec. 31, 2023, compared with $36.2-million for the year ended Dec. 31, 2022, an increase of $15.9-million. The increase was primarily due to increases of $16.1-million in expenses related to clinical research and product development for the MM120 GAD phase 2b clinical trial, and $2.6-million in internal personnel costs as a result of increasing research and development capacities, offset by a decrease of $700,000 in expenses related to our MM402 program, a decrease of $800,000 in expenses related to various external research and development collaborations, and a decrease of $1.2-million in expenses related to preclinical activities and the MM110 program.
• General and administrative (G&A): G&A expenses were $41.7-million for the year ended Dec. 31, 2023, compared with $30.2-million for the year ended Dec. 31, 2022, an increase of $11.5-million. The increase was primarily attributable to professional services fees and expenses related to the proxy contest in connection with its 2023 annual general meeting of shareholders and costs to support the growth of our business.
• Net loss: Net loss for the year ended Dec. 31, 2023, was $95.7-million, compared with $56.8-million for the year ended Dec. 31, 2022.

Conference call and webcast reminder

MindMed management will host a conference call at 8 a.m. EST today to provide a corporate update and review the company's 2023 financial results. Listeners can register for the webcast on-line. A replay of the webcast will be available through the investor relations section of the MindMed website and archived for at least 30 days after the webcast. Those who plan on participating are advised to join 15 minutes prior to the start time.

About Mind Medicine (MindMed) Inc.

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

We seek Safe Harbor.