Robert Barrow, CEO Delivers 2021 Shareholder Update

R&D Pipeline

MM-110

• A proprietary Ibogaine mimetic, alpha-3 beta-4 nicotinic cholinergic receptor antagonist, tested extensively in preclinical models and designed for substance abuse disorders.
• Opioid crisis is worsening in this post-pandemic world – 75k lives lost in 2021 in USA alone. There is a massive unmet need for a therapy that subsides withdrawal symptoms and reduces the rate of relapse.
• MM-110 has extensive preclinical efficacy data - reduced signs of opioid withdrawal and self-administration of nicotine, opiates, and alcohol. Importantly, the drug also demonstrated a good safety profile – no pro-arrhythmic or neurotoxic activity (Ibogaine use has been historically shadowed by these safety concerns).
• Phase 1 initiated in 2021 – measured safety, PK, and cognitive effects – single and multiple ascending dose trials (4-325mg 2x/day 1 day, 2-90mg 2x/day for up to 7 days).
• Phase 2a trial in opioid withdrawal is planned for 2Q22.

MM-120

• A proprietary, optimized form of LSD currently being tested in human clinical trials for general anxiety disorder (GAD), ADHD, and (upcoming 2022) chronic pain.
• In Jan 2022 the FDA cleared the IND for Phase 2b dose optimization trial of MM-120.
• Phase 2b will commence 2Q22 and end in late 2023 – 200 participants single dose of up to 200ug MM-120 or placebo. - 12 week follow up across 5 treatment arms.
• This Phase 2b is the first large, commercially sponsored clinical trial for LSD in over 40 years. HUGE catalyst for the entire industry.
• In parallel, Phase 2a enrollment is currently being conducted for a proof of concept study for MM-120 as a treatment for ADHD in adults (rate of ADHD has increased over 120% amongst adults… 10M adults with this condition).
• The University Hospital Basel (UHB, Switzerland) and Masstricht University (Netherlands) are coordinating the Phase 2a trial - 52 participants, single 20ug dose MM-120 follow up in 6 weeks.
• MM-120 chronic pain study upcoming in 2022.

MM-402

• A purified, r-enantiomer of MDMA (r-MDMA) being developed for autism spectrum disorder (ASD).
• No currently approved therapies for ASD, only available treatments address co-morbid disorders or behavioral control.
• The goal is to enhance social engagement and interaction rather than just numb patients to stimuli.
• The observed pro-social affects and reduced dopaminergic activity suggest that MM-402 will have a favorable safety profile compared to racemic (equal mix r- and s- enantiomers) and s-MDMA enantiomers.
• Preclinical studies to start in 2023.
• UHB collab – will initiate comparative Phase 1 PK/PD r- s- and racemic MDMA in 2022.

Digital Health

• The company is working on digital medicine products to facilitate adoption of psychedelic therapeutics.
• In Feb 2021 they acquired a digital medicine platform with a team in place.
• Pre-submission meeting with FDA late 2021, Jan 2022 patients enrolled SNS01 study – passive collection of sensory data during psychotherapy session using Minded Monitoring System.
• The MindMed Monitoring System will be used to support novel analyses of psychiatric care data collected during trips, which will be used to improve psychiatric outcomes.
• The digital health platform captures, models, and maps autonomic (brain activity) and behavioral outflow under the effects of psychedelics.

Partnerships and Collaborations

Dr. Miri Halperin Wernli, Executive President, discussed academic partnerships and collaborations that play a critical role in MindMed's drug development program.

• Lieschti Lab – UHB (Switzerland) – MindMed owns the exclusive worldwide rights to the data, compounds, and patents coming out of the LSD and MDMA research conducted at UHB. The collaboration has been extended mescaline. There are currently 17 completed preclinical and seven ongoing trials. A recent publication showed the key differences between LSD and psilocybin are dose dependent, not substance dependent [Press Release].
• Maastricht University (Netherlands) – evaluating benefits of LSD on cognitive performance, sleep quality, mood, emotional regulation, and immune system response. Safety study initiated Q4 2021 and continues to progress.
• MindShift Compounds AG (Basel, Switzerland) - focusing on the discovery and optimization of next generation compounds, including those with and without acute perceptual effects.
• Nextage Therapeutics Ltd: - collaboration to explore the therapeutic potential of noribogine in a proprietary brain-targeted liposome drug delivery system to mitigate risks of peripheral adverse effects.

Financial Highlights

Robert Barrow, CEO – 2021 Financial highlights

Cash Balance. As of December 31, 2021, MindMed had cash totaling $133.5 million compared to $80.1 million as of December 31, 2020. MindMed believes its available cash and cash equivalents will be sufficient to meet its operating requirements beyond its key development milestones in 2023 and into 2024.

Net Cash in Operating Activities. The net cash used in operating activities was $45.8 million for the year ended December 31, 2021, compared to $23.6 million for the same period in 2020.

Research and Development (R&D). R&D expenses were $34.8 million for the year ended December 31, 2021, compared to $18.6 million for the year ended 2020. The increase was primarily due to an increase of $2.7 million in expenses related to our MM-120 clinical research, $2.3 million in expenses related to our MM-110 clinical research, $3.5 million in expenses related to preclinical and other research programs, offset by a $3.5 million decrease of expense in connection with various external R&D collaborations. Internal costs increased $11.1 million primarily related to an increase in non-cash expenses of $6.6 million of stock-based compensation expenses and $2.6 million of amortization of our developed technology.

General and Administrative (G&A). G&A expenses were $59.1 million for the year ended December 31, 2021, compared to $14.4 million for the year ended 2020. The increase was primarily due to an increase of $28.9 million in non-cash stock-based compensation expenses of which $21.9 million related to the modification of stock options and RSUs. Other contributors to the increase included higher professional services including accounting, audit, legal, compliance, director and officer insurance, and investor and public relations and personnel costs to support the growth of the company.

The net and comprehensive loss for the year ended December 31, 2021 was $92.3 million, compared to $33.7 million for the year ended 2020.

Q&A

Shareholder #1:

MM-120 - questions about trial design and Phase2b dose optimization in anxiety. How was dose of 200ug selected? How many preparations and integration therapy sessions and how will they by conducted? What is the placebo? Also, Is MM-110 safer than Ibogaine?

Robert Barrow's response:

Doses selected based on past studies on LSD – titration up to 200ug PK/PD characterized. 10-fold difference in exposure maximizes statistical power.

Placebo – 25ug LSD dose serves as a sub-perceptual dose of LSD and can be thought of as a control.

Sessions – psychotherapy critical for care of patients, but this study protocol does not involve therapy. Some consultation prior to dosing to ensure patients understand the process and what to expect. None of these protocols are psychotherapy.

Ibogaine’s main safety issue is cardiovascular. MM-110 Phase 1 study will focus on this. No biomarkers for clinical efficacy. Will monitor CNS activity as an indication of disease modifying effects.

Shareholder #2:

Details on patient enrollment for MM-120 ADHD trial? Levers to accelerate enrollment? Enough compound / purity for Phase 2b (GAD) outside of US?

Robert Barrow's response:

We don’t usually disclose enrollment publicly.

Controlled substances slow down enrollment.

2H23 readout for MM-120 ADHD Phase 2a trial.

Enrollment for studies driven at the site level. Centralized recruitment efforts can muddy the waters… huge volume, but screening for eligibility can be difficult.

All quality data included in IND submissions, which was cleared by the FDA. Will progress into Phase 2b MM-120 study in 2Q22.

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Disclosure

Author owns MindMed shares at the time of publishing and may choose to buy or sell at any time without notice.