Mind Medicine Archives - Green Market Report

Debra BorchardtMay 25, 2023


The battle over the board of psychedelic company Mind Medicine (NASDAQ: MNMD) continues with the latest volley being shot by the current company roster. MineMed published a report by Greenleaf Health, Inc. assessing the company’s MM-120 (lysergide D-tartrate) development strategy. The report’s main focus is to refute the claims by the group FCM MM Holdings that the company doesn’t need to engage in a Phase 2 study for MM-120.

In its battle to take control of the board, FCM MM Holdings which is affiliated with Jake Freeman, Scott Freeman and Chad Boulanger the group has put forth its own slate of board members that would be friendly to its plan. FCM believes that the company can pass Phase 2 for MM-120 in GAD and move directly into Phase 3, largely by relying on prior academic studies of LSD. The 2023 annual meeting for Mindmed shareholders is June 15, 2023.

Greenleaf Report

The analysis – led by the former Director and Deputy Director of the Office of New Drugs at the U.S. Food and Drug Administration (FDA) and paid for by the current board of MindMed specifically focuses on MindMed’s strategy for MM-120 and its ongoing Phase 2b trial in patients with generalized anxiety disorder. The findings support MindMed’s view that this trial is essential to the development of MM-120 and contradicts the claim by FCM that the trial isn’t needed. The trial plans to enroll up to 200 participants who will receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120 or placebo. Topline results are expected to be announced in late 2023.

MM-120 is a semisynthetic product of lysergic acid or LSD. The report wrote that prior published human and nonclinical experiences with LSD have primarily been with an LSD free base solution, while MindMed is developing the tartrate salt of D-lysergic acid diethylamide for solid oral administration. The study cited several previous LSD studies but noted that neither of the clinical trials referenced were dose-ranging studies. The report stated it was aware of no modern data demonstrating clinical response to doses of LSD other than 20 or 200ug. The study concluded:

“After review of the MM-120 regulatory history, relevant regulatory precedent, and applicable regulations and guidance, Greenleaf believes the ongoing Phase 2b dose-ranging clinical trial is an essential component to the development program for MM-120.”

MindMed continued to hit back at FCM’s claim by pointing out that the report said that to support FDA approval, the MM-120 program will need at least one, and more likely two, positive, adequate and well-controlled trials. The authors wrote, “The decision by MindMed to first initiate a dose-ranging Phase 2b study is appropriate and sound from a clinical and regulatory perspective.” It added, “The FDA’s feedback on the proposed developed program in no way suggests that it would accept a development program that skips important learnings from a well-designed and conducted Phase 2b trial in favor of moving directly to a large Phase 3 pivotal program.”

The authors went on to say that streamlining the process and moving straight to Phase 3 would substantially increase the chances of a failed trial and/or uninterpretable results. It also pushes back on using previous LSD studies describing them as informative but lacking detail.

“As we have consistently said, our regulatory strategy for MM-120 is the right one and was formulated over several interactions with FDA. Our ongoing Phase 2b study answers critical clinical and regulatory questions that will enable us to maximize the speed, efficiency and likelihood of success of our Phase 3 program,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “Dr. Jenkins’ and Dr. Kweder’s extensive experience as senior officials inside FDA, and their objective analysis validating our approach, reinforces that there is no credible basis for FCM’s misplaced claim that MindMed could skip its Phase 2 study of MM-120 in GAD and go directly into Phase 3. Further, it underscores that by supporting this strategy of FCM’s, our shareholders would be putting not just the future of MM-120, but also their investments, at significant risk.”



StaffMay 17, 2022


Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED) reported its financial results for the first quarter ending March 31, 2022. At this time, MindMed does not have any revenue to report. The net and comprehensive loss for the quarter was $18.5 million, compared to $13.8 million for the same period in 2021.

The net cash used in operating activities was $12.9 million for the quarter versus $10.0 million for the same period in 2021.  R&D expenses were $10.2 million for the quarter versus $6.8 million for the same period in 2021. MindMed said the increase of $3.4 million was primarily due to $4.4 million of internal expenses related to compensation costs for an additional headcount of $2.0 million and an increase in non-cash expenses of $1.7 million of stock-based compensation expenses.

“The outset of 2022 was marked by significant progress across all aspects of the company that propelled our business forward, as we continued to advance and de-risk our three lead product candidates: MM-120 for the treatment of generalized anxiety disorder, MM-402 for the treatment of core symptoms of autism spectrum disorder, and MM-110 for the management of opioid use disorder,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We anticipate multiple upcoming catalysts and further growth across our drug development pipeline as well as our enabling technologies. We look forward to building on this momentum and believe we are well-positioned to deliver on the therapeutic potential of psychedelics and other novel targets to transform the treatment of brain health disorders.”

Cash Levels

The company said it has cash of $120 million, down from $133 million for the first quarter in 2021. Despite the large amount of cash on hand, MindMed filed a prospectus for an at-the-market equity offering under which the company may offer and sell its Subordinate Voting Shares or common shares re-designated from the company’s Subordinate Voting Shares  for up to $100 million in aggregate sales proceeds in “at the market” transactions.

The company has a deficit of $156 million and said in it’s last filing, “We expect that it will be several years, if ever, before we have a commercialized product and generate revenue from product sales. Even if we succeed in receiving marketing approval for and commercializing one or more of our product candidates, we expect that we will continue to incur substantial research and development and other expenses in order to discover, develop and market additional potential products.”

Debra BorchardtMarch 28, 2022


Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED)  reported its financial results for the full year ended December 31, 2021. MindMed has no revenue at this time but did report that the net loss for the year was $92.3 million, compared to $33.7 million for 2020.

MindMed did note that it had cash totaling $133.5 million compared to $80.1 million as of December 31, 2020. The company said this will be enough capital to meet its operating requirements beyond its key development milestones in 2023 and into 2024. That means investors have to look at how the company is spending its money.

G&A Spending

MindMed reported that G&A expenses were $59.1 million for the year versus $14.4 million for 2020. The company attributed part of the increase to $28.9 million in non-cash stock-based compensation expenses of which $21.9 million was related to the modification of stock options and RSUs. The net cash used in operating activities was $45.8 million for the year, compared to $23.6 million for the same period in 2020.

R&D Spending

R&D expenses were $34.8 million for the year compared to $18.6 million for 2020. The company said the jump was primarily due to an increase of $2.7 million in expenses related to its MM-120 clinical research, $2.3 million in expenses related to its 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.

“2021 was a year of major advancements across all aspects of MindMed, with significant growth in our organization, development programs and research collaborations. We established a regulatory pathway for MM-120 in the treatment of GAD and, with MM-402, launched a program to develop a novel treatment for core symptoms of autism spectrum disorder – both of which represent meaningful leaps forward in the field of psychiatry,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We expect 2022 to be a transformational year in which we continue to drive substantial growth across our pharmaceutical and digital medicine pipelines. I am incredibly proud of our team’s achievements and I am more confident than ever in our ability to continue advancing our organization and development programs. We are keenly focused on our mission to deliver novel therapies to treat brain health disorders, leading to meaningful improvements in patient outcomes in these major areas of unmet medical need.”

Chopra Deal Is Off

The company said it ultimately did not reach a definitive agreement for potential collaboration with the Chopra Foundation and discontinued the engagement.

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