Last Monday (3/28/22), Robert Barrow, MindMed CEO delivered a 2021 year end shareholder update via webinar (recording here). Accompanied by Dr. Dan Karlin, CMO, and Dr. Miri Halperin Wernli, Executive President, Barrow's analysis of the company's R&D was illuminating and instilled strong confidence in MindMed's ability to accomplish its 2022-2024 milestones and bring the first LSD analog to market.
Dr. Miri Halperin Wernli, Executive President, discussed academic partnerships and collaborations that play a critical role in MindMed's drug development program.
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.
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.
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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