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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 24, 2023


The Daily Hit is a recap of the top financial news stories for May 24, 2023.

On the Site

Massachusetts Cancels Cannabis Lounge Pilot Program to Aid Openings

Massachusetts marijuana regulators on Monday decided to cancel a long-planned pilot program for the rollout of cannabis consumption cafes, a move they hope will get such lounges open sooner instead of later. Read more here.

Delaware Allocates Money, Staff to Establishing Adult-Use Cannabis Market

Delaware lawmakers this week took the first step toward implementing the state’s new recreational marijuana market by allocating $2.2 million and 34 staff members to the job in the upcoming annual budget. Read more here.

NY Cannabis Authorities: ‘No Historical Precedent’ for Lawsuit Claims

Cannabis regulators in New York asked a state court to dismiss a lawsuit filed by a group of medical operators. The group, known as the Coalition for Access to Regulated & Safe Cannabis, said the state has not done enough to suppress unlicensed marijuana sales. Read more here.

Michigan Regulators Propose Stripping Licenses from Companies that Don’t Pay Vendors

In proposed rules released this month, Michigan’s Cannabis Regulatory Agency is seeking authority to deny licenses to businesses found in court to have not paid vendors. It’s a move that would set the industry apart from nearly every other industry in the state. Experts in the industry, however, believe the rule could create havoc in an industry already under financial pressure due to low prices. Read more here.


Cresco Labs Stays Locked on Columbia Care Megadeal Amid Mixed Results
Slang’s Investment in Vermont Pays off as Revenues Rise

In Other News

PRODUCT RECALL: Green Trees Medicinals

Colorado’s Marijuana Enforcement Division has announced a recall for marijuana from Green Tree Medicinals, a dispensary in Berthoud, because of potentially dangerous levels of the mold aspergillus. The recall, issued May 23, includes three recreational harvest batches and one medical batch of flower, shake or trim sold at Green Tree from Jan. 5 through March 30. Read more here.

Dama Financial

A marijuana financial services company has revised its testimony on a congressional cannabis banking bill following pushback over remarks made at a Senate committee hearing this month where a compliance officer suggested a “pause” to further amend the legislation. Read more here.

Lowell Farms

Lowell Farms Inc. (CSE:LOWL; OTCQX:LOWLF) closed a sale leaseback transaction with New Wilston Associates LLC pursuant to which Lowell SR LLC, a subsidiary of the company, has sold its drying and midstream processing facility in Monterey County California for aggregate consideration of $19.4 million, including the buyer’s assumption of the existing mortgage on the facility. Read more here.

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