LSD 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.”



Dave HodesMay 2, 2022


“Psychedemia” is a mix of “psychedelic” and “academia”—meaning the integration of psychedelics into academia—and is a term coined by LSD research pioneer Humphry Osmond in 1957. 

It has been used since 2012 as the title for a grassroots collaborative psychedelics conference organized to “foster novel contributions to this burgeoning field,” and to “consider data from new research with an open mind.” 

The three-day psychedemia conference in 2012 was organized by the University of Pennsylvania, the Penn Medicine Neuroscience Center, the Perelman School of Medicine, the Graduate and Professional Student Assembly, the School of Arts and Sciences Student Government, and several other departments was a grand gesture ten years ago to not only raise the awareness of psychedelics but give the whole industry a shot in the arm. 

It represented a sort of full-circle path of academia for psychedelics after academia abandoned psychedelics when Harvard University psychology professor Timothy Leary derailed the industry in the 60s after doing experiments with psilocybin and LSD that “lacked scientific rigor”

Now academia is reclaiming psychedelics and putting more university brainpower into it than ever before.

The psychedemia conference is still going on, with the next one scheduled in August 2022, as a partnership with the newly founded Center for Psychedelic Drug Research and Education at Ohio State University. It will be presented on the campus.

But academia-inspired conferences and the founding of university-related psychedelics studies centers are just the tip of the iceberg in the huge rush by academia to embrace and better understand psychedelics. 

Masters Degrees

Universities are creating master’s degree level psychedelics classes, attracting world-class scientists to help find novel psychedelics therapeutics, and pushing to create a broader and deeper intellectual base for psychedelics study and research that is just gaining traction.

Here’s a quick look at five developments of note among the reported 100-plus U.S. universities researching psychedelics: 

  1. The Stanford University School of Medicine began an introduction to psychedelics as a speaker series in 2018 and is now an official course at the school, “PSYC 215: Introduction to Psychedelic Medicine.”
  2. In January 2021, the Center for Psychedelic Psychotherapy and Trauma Research was launched at Mount Sinai Health System with the James J. Peters Department of Veterans Affairs Medical center, to examine the therapeutic potential of psychedelic compounds for post-traumatic stress disorder (PTSD) and other trauma-related symptoms. Mount Sinai Health System is New York City’s largest academic medical system, made up of eight hospitals, a medical school, and a network of ambulatory practices throughout the greater New York region.
  3. In July, 2021, Tryp Therapeutics (OTC: TRYPF) partnered with the University of Michigan to work on part of a series of upcoming studies performed with the Chronic Pain and Fatigue Research Center and the Center for Consciousness Science in the Department of Anesthesiology at the University of Michigan. The series is designed to explore the relationship between a psilocybin-induced increase in neurophysiological complexity and indices of pain in a preclinical model for chronic central pain.
  4. In August, 2021, the University of Wisconsin–Madison opened the doors to its Transdisciplinary Center for Research in Psychoactive Substances to support research and educational activities about psychedelic drugs and related compounds. The center also supports the university’s master’s degree program, “Psychoactive Pharmaceutical Investigation.”
  5. In March, 2022, the Yale School of Medicine announced that physician-scientists at three major U.S. medical schools will collaborate to develop a curriculum to train psychiatrists in the practice of psychedelic medicine. The project, a collaboration between Yale School of Medicine, Johns Hopkins University School of Medicine, and New York University Grossman School of Medicine, will be funded by a $1 million grant provided by a group of donors, according to a press release.

Brian Pace, a scholar at Ohio State University who teaches psychedelics studies at the university, and is one of the organizers of the 2022 Psychedemia conference to be held at Ohio State, told Open Foundation, a Netherlands non-profit think tank, that the new-agey, cultish stuff they see around psychedelics now, with tuning your chakras and merging souls or whatever, is their fault. “That’s an abdication of the responsibility to investigate interesting questions and to chase down data: to find out how things work,” Pace said. “So where we are now is a very timid and late re-entry to the subject, more so for education than research. Psychedelic research didn’t end when the universities and governments abandoned it. It continued in the underground. The role of the university courses on psychedelics is to identify and evaluate high-quality information on the topic. We have a lot of catching up to do and I think that should be done with humility.”

Debra BorchardtDecember 15, 2020


Mind Medicine (MindMed) Inc. (NEO: MMED) (OTCQB: MMEDF) entered into an agreement with Canaccord Genuity Corp. to purchase, on a bought deal basis an aggregate of 11,364,000 units of the company at a price of C$4.40 per unit for gross proceeds of C$50 million. the company said the net proceeds will be used for investment in Project Lucy, Albert (the company’s digital medicine division), additional microdosing research and development, Project Layla (18-MC) as well as general working capital.

MindMed also announced the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of lysergic acid diethylamide (LSD) assisted therapy for anxiety disorder. This FDA meeting is an important milestone for the company and provides regulatory clarity and confidence as MindMed advances its lead clinical development program in the U.S. The psychedelic drug company also said it plans to open the IND with the FDA in August 2021, with a Phase 2b clinical trial evaluating experiential doses of LSD in an anxiety disorder.

MindMed Co-Founder & Co-CEO J.R. Rahn said “The FDA is one of the most impactful organizations for regulated drug development globally. We look forward to working through the FDA pathway on psychedelic-assisted therapies in strict compliance with their proven drug development guidelines and commencing our Phase 2b trial for Project Lucy in 2021.”

While Project Lucy focuses on LSD, Project Layla has been tagged as an addiction treatment program evaluating the ibogaine derivative 18-MC. The preliminary data from the Phase 1 Multiple Ascending Dose (MAD) and Single Ascending Dose (SAD) study has shown that the drug is safe and well-tolerated at the doses tested to date and that no serious side effects have been reported.

MindMed’s clinical team and 18-MC’s Medical Director, Dr. Judy Ashworth, have decided to continue dose escalation in the study to gather higher dosing data. The company has said that once that additional data has been reviewed, MindMed will directly thereafter initiate the Phase 2a proof of concept study. A meeting with the FDA has been confirmed to continue discussions regarding the 18-MC clinical development plan.

Latest Offering

In addition to raising C$50 million, each unit shall consist of one subordinate voting share and one-half of one Subordinate Voting Share purchase warrant of the company. The statement said that each Warrant shall be exercisable to acquire one Subordinate Voting Share at an exercise price of C$5.75 per Subordinate Voting Share for a period of 3 years from the closing of the Offering, subject to a Warrant acceleration right exercisable by the company if the daily volume-weighted average trading price of the Company’s Subordinate Voting Shares on the NEO Exchange is greater than C$9.00 per Subordinate Voting Share for the preceding 5 consecutive trading days.

Get the latest cannabis news delivered right to your inbox

The Morning Rise

Unpack the industry with the daily cannabis newsletter for business leaders.

 Sign up

About Us

The Green Market Report focuses on the financial news of the rapidly growing cannabis industry. Our target approach filters out the daily noise and does a deep dive into the financial, business and economic side of the cannabis industry. Our team is cultivating the industry’s critical news into one source and providing open source insights and data analysis


Recent Tweets

Back to Top

Get the latest cannabis news delivered right to your inbox

The Morning Rise

Unpack the industry with the daily cannabis newsletter for business leaders.