Mr. Robert Barrow reports

MINDMED INITIATES PHASE 2A LSD TRIAL FOR THE TREATMENT OF ADULT ADHD

Mind Medicine (MindMed) Inc. has begun a phase 2a proof-of-concept (POC) trial of lysergic acid diethylamide (LSD) in adult patients with attention deficit hyperactivity disorder (ADHD). The first site has been activated and patient enrolment is expected to start imminently. The POC trial will be conducted in collaboration with University Hospital Basel in Switzerland and Maastricht University in the Netherlands and is designed to evaluate the therapeutic utility of repeated low doses of LSD.

"We are pleased to activate our first site and excited to initiate patient enrolment of our ADHD proof-of-concept trial," said Robert Barrow, chief executive officer and director of MindMed. "The study builds on the growing evidence demonstrating LSD has the potential to improve mood and selective cognitive processes. Further, low doses of LSD have been shown to be safe, well tolerated and have minimal effects on physiological parameters. In collaboration with our renowned clinical researchers and team of leading investigators, we look forward to driving this exploratory trial forward as part of our broader comprehensive LSD clinical development strategy."

Dr. Matthias Liechti, from the University Hospital Basel and co-primary investigator of the trial, commented: "Psychedelics, including LSD, have shown beneficial and lasting effects on mood when given at single doses producing psychedelic effects. There is anecdotal evidence for possible benefits of low to very low doses of psychedelics given repeatedly. This is the first controlled study to validly evaluate therapeutic effects of very low doses of a psychedelic in patients."

"We are very much looking forward to initiating our ADHD trial with repeated low doses of LSD, which will be conducted at two top European clinical therapeutic sites," said Dr. Miri Halperin Wernli, executive president of MindMed. "We have designed a robust, randomized clinical trial to replicate and extend the promising findings of previously conducted smaller, open-label trials. This trial will evaluate our therapeutic regimen in a rigorously controlled setting and will help optimize the dosing schedule, compound selection and clinical management. Further, this trial will provide additional insight into the mechanisms by which psychedelics exert their therapeutic effects."

Phase 2a trial design

This is a multicentre, randomized, double-blind and placebo-controlled phase 2a trial evaluating the safety and efficacy of low-dose LSD as treatment for ADHD in adults. The trial plans to enroll a total of 52 patients that will receive 20 micrograms of LSD or placebo for six weeks (dose schedule: twice a week on a three/four-day schedule (plus or minus one day)). The primary end points are mean change from baseline in ADHD symptoms, as assessed by the AISRS after six weeks of treatment. The AISRS total score consists of 18 items from the original attention-deficit/hyperactivity disorder -- rating scale (ADHD-RS), which were derived based on DSM-5 criteria for ADHD. The ADHD-RS includes nine items that address symptoms of inattention, and nine items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.

The trial will be led by Dr. Matthias Liechti, at University Hospital Basel, Switzerland, and Dr. Kim Kuypers, at Maastricht University, the Netherlands.

About Mind Medicine (MindMed) Inc.

MindMed is a clinical-stage psychedelic-medicine biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed's approach to developing the next generation of psychedelic-inspired medicines and therapies.

MindMed trades on the Nasdaq under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

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