Psychedelics Archives - Green Market Report

Adam JacksonJune 1, 2023

The companies expect a third-quarter close.

Debra BorchardtMay 31, 2023

Spravato is a ketamine-based drug, while COMP360 is a psilocybin drug.

Debra BorchardtMay 31, 2023

Compass Pathways plc (Nasdaq: CMPS) announced that Co-founder and Chief Innovation Officer Dr. Ekaterina Malievskaia will step down from her executive role effective June 16, 2023. She will remain a member of the Compass Pathways Board of Directors, while her executive responsibilities will be carried forward by the existing executive team.

Dr. Ekaterina Malievskaia said, “I am grateful for the opportunity I had to co-found Compass Pathways and to work alongside such talented and dedicated people. We had a steep learning curve, building the company from a tiny start-up, through our initial public offering, and now to our phase 3 program. I am excited to take this experience forward into new opportunities in philanthropy and business to help change patients’ experience with mental health care and address significant unmet needs. Onward!”

Together with George Goldsmith and Lars Wilde, Katya co-founded Compass Pathways in 2017, determined to bring much-needed innovation to the field of mental health care. She helped oversee the growth of Compass and provided critical executive leadership to the company both before and after its initial public offering in 2020. During her tenure, she oversaw the development and execution of the groundbreaking phase 2b trial of COMP360 psilocybin for patients with treatment-resistant depression, started and helped build critical functions such as R&D, Digital Health, AI and Machine Learning, and Clinical Care Innovation. She also developed the company’s psychological support model and built its network of trained therapists.

Ekaterina received her medical degree from St Petersburg Medical Academy in St Petersburg, Russia, and then moved to the US where she completed her Internal Medicine residency training. She worked in private practice, academic medicine, and public health for more than 15 years in the greater New York area. She was a Clinical Instructor of Medicine at Mount Sinai School of Medicine, as well as a Research Professor at City University of New York. After moving to London in 2011, Ekaterina worked in global health and medical philanthropy, focusing on improving outcomes in maternal and child health.

Kabir Nath, CEO, of Compass Pathways, said, “Katya leaves an indelible mark on the company she helped found. COMPASS today reflects both the rigor and precision one would expect from a scientist and the compassion for and commitment to patients that one would expect from a physician. Her influence extends well beyond our company to the fields of psychedelic medicine and mental healthcare. We are closer to meaningful breakthroughs in care for patients thanks to her dedication, hard work, and leadership. We are pleased that we will continue to benefit from her experience and insights as she remains on the board.”

Watching Cash Levels

While the company has a large cash cushion, it is also spending quite a bit. In the company’s recent earnings call, CFO Mike Falvey said, “Our cash balance decreased by $26 million in the first quarter of 2023 due to using $27.7 million in operating cash, partially offset by $1.1 million provided by financing activities due primarily to the sale of shares under our ATM facility and a change of $0.7 million due to exchange rates impacts. The movement in operating cash is primarily driven by our net loss, partially reduced by noncash charges. Regarding guidance, we expect the second quarter net cash used in operating activities to be between 22 million and 30 million and the full year to be between $85 million and $110 million.”

He added, “The size of the second quarter range is due to the challenge in predicting the precise timing of cash outlays to support our phase 3 program in its early stages. As the trial reaches steady-state enrollment, we expect to offer a narrower quarterly and annual range. Compass continues to maintain a strong financial position with cash and cash equivalents of $117.1 million on March 31st, 2023, compared with $143.2 million on December 31st, 2022. In addition to our first-quarter cash balance, in the second quarter, we have received net proceeds of $26.9 million through the share — sale of shares under our ATM facility, which has further strengthened our cash position and extended our runway.”

Debra BorchardtMay 26, 2023

Irwin Naturals has defaulted on its debt.

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.”

Adam JacksonMay 24, 2023