Mr. Rob Barrow reports

MINDMED ANNOUNCES BUSINESS UPDATE AND ANTICIPATED MILESTONES FOR 2024

Mind Medicine (MindMed) Inc. has provided a corporate update and outlook for 2024.

"Our strong progress in 2023 culminated in the delivery of statistically and clinically significant top-line results for our lead program (MM-120) in our phase 2b study of GAD. These positive results reinforce our scientific understanding of the mechanism of action for MM-120 and emphasize the critical role we believe the perceptual effects of MM-120 play in driving clinical outcomes," said Rob Barrow, chief executive officer and director of MindMed. "We are excited to enter 2024 with an enhanced focus on our lead program. In 2024, we plan to continue working diligently and efficiently to advance our MM-120 program into phase 3, bringing us one step closer to potentially providing a new treatment option to the millions of patients suffering from GAD. We anticipate several key data milestones for our MM-120 program in 2024, including full 12-week results for MM-120 in GAD, results from our phase 1 pharmacokinetics bridging study to support advancement of our MM-120 ODT formulation into pivotal clinical trials and additional results from our collaborator University Hospital Basel's one-year follow-up study of lysergide in anxiety disorders. We will be working closely with the FDA to finalize our phase 3 development program for MM-120 in GAD and expect to hold our end-of-phase 2 meeting with FDA in the first half of the year with initiation of our phase 3 clinical program in the second half of the year."

Business update:

• MindMed's management team will participate in the BIO Partnering at the J.P. Morgan Healthcare Conference in San Francisco that is being held from Jan. 8 to 11, 2024.
• The company expects to host an analyst and investor day in the first half of 2024, at which the company plans for its senior management, a physician expert and other leading key opinion leaders to provide an update on the company's lead development program MM-120 and discuss the treatment landscape, potential market and commercial opportunity for MM-120 in generalized anxiety disorder (GAD) and other psychiatric disorders.

Development program updates and anticipated milestones

MM-120 (lysergide D-tartrate):

• Generalized anxiety disorder (GAD): In December, 2023, the company announced statistically significant and clinically meaningful top-line four-week results from the 198-patient phase 2b dose-optimization study of MM-120 for the treatment of GAD.
  • MM-120 100 micrograms -- 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 MM-120 versus minus 13.7 placebo), which is more than double the effect sizes seen with the current standards of care;
  • 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 7) atw week 4 was achieved in 50 per cent of participants treated with MM-120 100 micrograms.
• The company plans to share top-line 12-week results from the phase 2b study by the end of the first quarter of 2024, and present full results at a scientific meeting in 2024.
• The company intends to share results in the first quarter of 2024 from its pharmacokinetics bridging study of the MM-120 Zydis orally disintegrating tablet (ODT) formulation, its intended commercial formulation of MM-120 formulation that may enhance intellectual property and market protection with a potentially differentiated biopharmaceutical profile.
• The company plans to hold an end-of-phase 2 meeting with the Food and Drug Administration 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 are anticipated in 2024. This study was conducted by the company's collaborators at University Hospital Basel (UHB) in Switzerland.
• Attention-deficit/hyperactivity disorder (ADHD): The company's 53-patient phase 2a proof-of-concept trial in ADHD was designed to assess the safety and efficacy of repeated subperceptual dose (20 micrograms) lysergide administration and did not meet its primary end point. In conjunction with the findings from its study of MM-120 in GAD, the company believes that these results support the critical role of perceptual effects of MM-120 in mediating a clinical response. The company intends to continue prioritizing development of its MM-120 program in GAD and other psychiatric indications, using the single perceptual dose (100 micrograms or greater) regimen that has shown strong positive results in numerous studies.

MM-402 (R(-)-MDMA) for autism spectrum disorder (ASD):

• The company initiated its first clinical trial of MM-402 (R(-)-MDMA), a single-ascending dose study in adult healthy volunteers in Q4 2023. This phase 1 study is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM-402 and will enable further clinical studies 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 MM-402 non-clinical study in a model of ASD, titled "MM-402 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 top-line results to be presented in the first half of 2024.

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) receptors. MindMed is developing MM-120 (lysergide D-tartrate), the tartrate salt form of lysergide, for GAD and other psychiatric indications.

About MM-402

MM-402 is the company's proprietary form of R(-)-MDMA (rectus-3,4-methylenedioxymethamphetamine), which it is developing for the treatment of core symptoms of autism spectrum disorder (ASD). MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. Preclinical studies of R(-)-MDMA demonstrate its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggests that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared with racemic MDMA or the S(+)-enantiomer.

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.