Psychedelics Archives - Green Market Report

Video StaffMay 14, 2021

2min4030

This is Psychedellux, the week’s top business headlines in the psychedelics industry.

 COMPASS Pathways plc (Nasdaq: CMPS) reported its financial results for the first quarter of 2021 as the company continues to plug away at research. The net loss was $12.7 million, but Compass was granted 2 patents during the quarter and continues to have a generous cash cushion of $179 million. 

Havn Life Sciences Inc. (OTC PINK: HAVLF) reported this week its research team has developed a rapid testing method that enables precise and accurate measurement of psilocybin content in under 5 minutes. The fast test allows the Company to quickly experiment with and validate new extraction processes, which is essential for internal process development and maintaining quality control and accurate dosing of psychedelic compounds.

Numinus Wellness Inc. (TSXV: NUMI) and Optimi Health Corp. (CSE: OPTI) (OTC: OPTHF) developers of a functional mushroom brand have submitted a pre-clinical trial application to Health Canada for review and comment. The application includes the investigational product’s chemical constituents, genotype, and formulation as well as procedures and processes to produce a consistent dosage from Psilocybe mushrooms.

And finally, Wesana Health Holdings Inc. (CSE: WESA) began trading on the Canadian Securities Exchange this week under the ticker symbol “WESA.”

Psychedellux is brought to you by the Green Market Report.


StaffMay 13, 2021
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3min4530

COMPASS Pathways plc (Nasdaq: CMPS) reported its financial results for the first quarter of 2021. The net loss was $12.7 million, or $0.35 loss per share (after including non-cash share-based compensation expense of $1.7 million), versus $8.6 million, or $0.93 loss per share, during the same period in 2020 (after including non-cash share-based compensation expense of $1.7 million)

Research & development (R&D) expenses were $6.9 million versus $5.2 million during the same period in 2020. Compass said that $1.4 million reflected increased development activities, including hiring additional staff, as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “Our recent financing gives us additional resources to work even faster and to expand our efforts, grow our team, and focus on developing new indications, new compounds and new technologies, building on our leadership position in psilocybin therapy and mental health care. Far too many people are suffering with mental health challenges today. We are focused on developing evidence-based therapies that can make a difference and be accessible to as many patients as possible who might benefit. The COMP360 data published in the New England Journal of Medicine showed promising signals in a small investigator-initiated study. We are approaching the completion of our phase IIb trial of COMP360 psilocybin therapy for treatment-resistant depression, and on track to report data by the end of the year.”

The company still has plenty of cushion as it develops its products. Pro-forma cash and cash equivalents were $179.5 million as of March 31, 2021, compared with $190.3 million on December 31, 2020. On May 4, 2021, following the end of the reporting period, COMPASS completed a public offering of 4,000,000 American Depositary Shares at a price of $36.00 per ADS for total gross proceeds of $144 million.

Granted Patents

Two new patents were granted by the US Patent and Trademark Office for Compass. The patents cover oral formulations of COMPASS’s synthetic psilocybin in the treatment of MDD and Compass’s high-purity crystalline psilocybin (including the form used in COMP360), pharmaceutical formulations containing crystalline psilocybin, and methods of treating MDD with crystalline psilocybin. Compass’s innovation has now been recognized with six granted patents, including three in the US, two in the UK, and one in Germany


Video StaffMay 7, 2021

3min4890

This is Psychedellux – the leading recap of the week’s top news in the psychedelics industry.

The Multidisciplinary Association of Psychedelic Studies (MAPS) released data from its Phase III trial with the FDA for the use of MDMA (ecstasy) to treat PTSD. MDMA showed efficacy for treating PTSD in six MAPS Phase II trials, providing a cost-saving and clinically beneficial treatment for those with severe or extreme chronic PTSD resulting from any cause. The Phase III trial data revealed that 67% of the group who received MDMA no longer qualified for a PTSD diagnosis after three treatment sessions

Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) reported its net loss was $26.9 million for the year ending December 31, 2020.  Subsequent to the year-end 2020, the company raised approximately $30 million.

Psychedelic clinic companies have been expanding quickly as more patients are seeking alternatives to traditional prescription drug treatments. Field Trip Health Ltd. (OTCQX: FTRPF)  opened its fifth location in the United States in the city of Houston, TX. Novamind Inc. (OTC PINK:NVMDF) reported it would open four new Cedar Psychiatry clinics, doubling its network to eight total locations. 

Revive Therapeutics Ltd.(OTC: RVVTF) has entered into a sponsored research agreement with the University of California, San Francisco to explore the utility of Bucillamine as a treatment for severe COVID-19. 

Champignon Brands Inc. (CSE: SHRM) (FWB: 496) (OTCQB: SHRMF) has changed its name from “Champignon Brands Inc.” to “Braxia Scientific Corp.” and its ticker symbol will change from “SHRM” to “BRAX” on the Canadian Securities Exchange (the “CSE”).

Field Trip Health Ltd. (OTCQX: FTRPF)  announced that its common shares are now eligible for electronic clearing and settlement through The Depository Trust Company (“DTC”) in the United States

 


Julie AitchesonMay 5, 2021
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5min12240

The Multidisciplinary Association of Psychedelic Studies (MAPS) has worked for the last 35 years to shift the perception around psychedelics as a treatment tool for mental health issues. Now, with the release of data from its Phase III trial with the FDA for the use of MDMA (ecstasy) to treat PTSD, MAPS’ work has coalesced into findings that could change the mental health treatment landscape as we know it. 

MDMA is on the cusp of FDA approval to treat PTSD, not just for military veterans, but for an array of people who have suffered from abuse and other trauma-inducing events. In 2017, the FDA granted MDMA “breakthrough therapy status” in anticipation of approving it as a medication for mental health, and the release of MAPS’ latest statistically significant findings constitutes a huge leap towards legalization. 

The conversation around the legalization of psychedelic drugs is not new to the mental health community. Trials testing the efficacy of psychedelics such as LSD for mental illness began as early as the 1950s. By the 1960s more than 1,000 papers had been published about LSD as a treatment for depression, alcoholism, schizophrenia, and as an adjunct to psychotherapy. These trials lacked the scientific rigor necessary for legitimacy in the eyes of the FDA, but due in no small part to the work of MAPS, legitimacy is no longer the stumbling block it once was.

 MDMA showed efficacy for treating PTSD in six MAPS Phase II trials, providing a cost-saving and clinically beneficial treatment for those with severe or extreme chronic PTSD resulting from any cause. The Phase III trial is the first of any psychedelic-assisted therapy. It was a randomized, blinded study designed under an FDA-approved Special Protocol Assessment. 90 patients with severe, chronic PTSD were enrolled in the trial and randomized to receive either MDMA or a placebo. The results, according to the lead author of the paper, Jennifer Mitchell, Ph.D., were significant. “People with the most difficult-to-treat diagnosis, often considered intractable, respond just as well to this novel treatment as other participants. In fact, participants diagnosed with the dissociative type of PTSD experienced a greater reduction in symptoms than those without the dissociative subtype.”

The Phase III trial data revealed that 67% of the group who received MDMA no longer qualified for a PTSD diagnosis after three treatment sessions (compared to 32% of the placebo group). 88% of participants in the MDMA sessions experienced a clinically significant reduction in symptoms, as opposed to 60% of the placebo group who received therapy alone. Mitchell attributes MDMA’s effectiveness to its role as a catalyst in therapy, which often involves recalling, and frequently reactivating, previous trauma. “The unique ability of MDMA to raise compassion and understanding while tamping down fear is likely what enables it to be so effective.”

Researchers are currently enrolling participants in a second Phase III trial and MAPS is formulating plans for additional studies to evaluate MDMA’s efficacy for mental health conditions not yet explored, as well as other protocols beyond one-on-one sessions, including group therapy and cognitive behavioral therapy focused on couples. The fact that MDMA is currently classified as a Schedule I drug and defined as having “no medical benefit” means that the only way to receive MDMA-assisted therapy right now is through clinical trials. However, the FDA has given its blessing to an expanded access program so that 50 patients can access MDMA-assisted therapy before it is approved and MAPS has committed to confronting accessibility and equity issues from its own side of the table. While not a sure thing, with MAPS’ latest data and continued efforts in alignment with FDA requirements the hoped-for 2023 FDA approval of MDMA-assisted therapy for PTSD is closer to becoming a reality than ever before.


StaffMay 4, 2021
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5min5550

Psychedelic clinic companies have been expanding quickly as more patients are seeking alternatives to traditional prescription drug treatments. Both Field Trip Health and Novamind announced news of their expanding clinics across the country.

Field Trip

Field Trip Health Ltd. (OTCQX: FTRPF)  opened its fifth location in the United States in the city of Houston, TX. Located in the River Oaks District, the Houston location is the second Field Trip Health center to open this year. Field Trip also announced that it has entered into leases and has commenced, or will soon commence, construction to build Field Trip Health centers in San Diego, CA, San Carlos, CA, Seattle, WA, Washington DC, and Fredericton, NB.

“Every week, new evidence about the safety and efficacy of psychedelic therapies is being published. The academic data matches closely with what we are seeing in our Field Trip Health centers — that psychedelic-assisted therapy is a safe and effective treatment for depression, anxiety, and other mental health challenges,” commented Dr. Ben Medrano, Field Trip’s Senior Vice President, and U.S. Medical Director. “It is great to see academic journals like The New England Journal of Medicine as well as former Governor Rick Perry adding their voices to the conversation.”  The company noted that many peer-reviewed studies have shown the efficacy and safety of psychedelic-enhanced therapies as powerful and effective treatments for mental health challenges like depression, anxiety, and PTSD, as well as to promote mental and emotional health and well-being. In addition, according to new research from the New England Journal of Medicine, there is evidence indicating that psychedelic substances boost divergent thinking and creative ability in the long term.
Field Trip said that the design of the Houston location was heavily influenced by its local aesthetic, honoring Houston’s charm. It features Southwestern-inspired rugs, soft recycled leather couches, a beautiful moss wall, and most notably a zen rock box stretching almost the entire length of the hallway. With seven treatment rooms, a large group therapy room, and a beautiful light-filled integration lounge, the Houston location is calm, bright, and inviting. Each treatment room features custom photography of clouds taken all over the world, included to provide a relaxing atmosphere and to allow the mind to drift into a peaceful quiet space.
Novamind

Novamind Inc. (OTC PINK:NVMDF) reported it would open four new Cedar Psychiatry clinics, doubling its network to eight total locations. The expanded capacity from the New Clinics is forecasted to increase Novamind’s patient volume from 20,000 client visits recorded in 2020 to approximately 65,000 client visits anticipated in 2021.

“We are doubling the size of our clinic network six months ahead of schedule, with the added capacity enabling us to scale to 65,000 client visits in 2021,” said Yaron Conforti, CEO and Director of Novamind. “Expect continued and aggressive growth as we expand Novamind’s clinic network and clinical research infrastructure ahead of the FDA’s anticipated approvals of MDMA and psilocybin.”

Novamind said it has begun construction on three of the New Clinics and leased a fourth additional property. Scheduled to open between July and September 2021, the New Clinics represent the initial phase of Novamind’s national expansion strategy whereby the Company is replicating the successful operating track record of its current clinics in Utah, at scale, ahead of its expansion into other American states in 2021.


Video StaffApril 30, 2021

3min7470

This is Psychedellux – the week’s top psychedelic industry headlines.

MindMed (NASDAQ: MNMD) shareholders have been taken on quite the trip over the last few days as the company uplisted from the Over The Counter Market to the big time at the NASDAQ. The stock jumped to over $5 a share in its last days at the OTC Markets, only to move to midtown Manhattan and see the shares plunge 29% in its debut. The stock closed at $4.02 on Tuesday. 

Numinus Wellness Inc. (TSXV: NUMI) announced that it has formed a partnership with KGK Science, a leading contract research organization with expertise in natural products, to undertake a new Psilocybin extraction clinical trial. The Phase 1 trial will enroll 14 human volunteers and assess the safety and psychoactive properties of a Psilocybe mushroom product extracted and formulated at the Numinus Bioscience lab. The company also said it was listing its warrants on the TSX Venture Exchange

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has filed a provisional patent application with the U.S. Patent and Trademark Office outlining the novel use of ketamine as a potential treatment for Type 2 diabetes and obesity, based on the evaluation of the company’s drug repurposing artificial intelligence platform. PharmaTher recently used this platform to discover novel uses of psilocybin in the potential treatment of certain cancers, which led to the sale of the company’s psilocybin intellectual property portfolio to Revive Therapeutics Ltd. (OTC: RVVTF) for a consideration of up to C$10 million.

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the launch of a proposed public offering of 4,000,000 American Depositary Shares (“ADSs”), each representing one ordinary share.


Video StaffApril 23, 2021

3min9340

This is Psychedellux – the week’s top business headlines for the psychedelics industry

 Atai Life Sciences plans to raise $100 million in an IPO. The company has built a pipeline of 10 therapeutics and six enabling technologies. 

Lots of medical updates this week. 

Aion Therapeutics Inc. (CSE: AION) announced that its proprietary and patented combinatorial mushroom preparations showed high efficacy in killing HER2+ breast cancer cells, ER+/PR+ breast cancer cells, and triple-negative breast cancer cells by direct cytotoxicity. The company said it plans to begin initiating clinical trials.

Revive Therapeutics Ltd. (CSE: RVV, USA: RVVTF) announced the successful completion of the research results and filing of a U.S. provisional patent application with The United States Patent and Trademark Office on its oral thin-film delivery system with psilocybin 

Cybin Inc. (OTCQB:CLXPF)  announced that it has successfully demonstrated Proof of Concept for its deuterated tryptamine programs, CYB003 and CYB004, for the treatment of depression and addiction. Cybin is working to shorten the length of time that psilocybin treatments take and this program is part of that research. 

NeonMind Biosciences Inc. (OTC:NMDBF)  said that it is establishing a medical services division for the delivery of evidence-backed innovative treatments for a variety of mental health needs. This will include psychedelic modalities and other newer treatments for mood disorders such as depression. NeonMind has appointed Ernie Ho as VP, Corporate Development, with his initial focus to be the development of the team to build out medical services as well as to identify and assess partnership and acquisition targets.

 


StaffApril 19, 2021
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7min42861

While most people in the cannabis industry are gearing up for the high holiday of April, 20 or 420, our good friends in the psychedelic industry have their own day of celebration. It’s called Bicycle Day and it falls on April 19. The history is that on April 19, 1943, Albert Hofmann, the Swiss father of psychedelic medicine, dropped lysergic acid diethylamide (LSD) at 4:20 pm, interestingly enough, and went on a bike ride, becoming the first human to trip on LSD.

According to Wikipedia, “Hofmann’s condition rapidly deteriorated as he struggled with feelings of anxiety, alternating in his beliefs that the next-door neighbor was a malevolent witch, that he was going insane, and that the LSD had poisoned him. When the house doctor arrived, however, he could detect no physical abnormalities, save for a pair of incredibly dilated pupils. Hofmann was reassured, and soon his terror began to give way to a sense of good fortune and enjoyment, as he later wrote…”

“… Little by little I could begin to enjoy the unprecedented colors and plays of shapes that persisted behind my closed eyes. Kaleidoscopic, fantastic images surged in on me, alternating, variegated, opening and then closing themselves in circles and spirals, exploding in colored fountains, rearranging and hybridizing themselves in constant flux. It was particularly remarkable how every acoustic perception, such as the sound of a door handle or a passing automobile, became transformed into optical perceptions. Every sound generated a vividly changing image, with its own consistent form and color”

Hofmann realized he had made a significant discovery: a psychoactive substance with extraordinary potency, capable of causing significant shifts of consciousness in incredibly low doses. Hofmann viewed the drug as a powerful psychiatric tool; because of its intense and introspective nature, he couldn’t imagine anyone using it recreationally.

The celebration of Bicycle Day originated in DeKalb, Illinois, in 1985, when Thomas B. Roberts, then a Professor at Northern Illinois University, invented the name “Bicycle Day” when he founded the first celebration at his home. Several years later, he sent an announcement made by one of his students to friends and Internet lists, thus propagating the idea and the celebration. While this holiday isn’t as widespread as 420, a series of events honoring the day is beginning to happen.

Events

The Inside Guide

Jazmin Hupp, author of The Inside Guide celebrates the day with a special online event. Register at https://theinside.guide/bicycleday

Salt Lake City – Northeast Pavilion at Liberty Park from 5:00-7:00pm

Join Salt City Psychedelic Therapy & Research (SCPTR) along with other pro-psychedelic organizations in the Salt Lake City area to celebrate Bicycle Day with other like-minded individuals throughout Utah. This FREE event is a celebration of all psychedelics, appreciation for the cultures and people throughout history that have made the psychedelic experience possible for us today, and increased consciousness globally.

MAPS – A lineup of events

To commemorate the 78th anniversary of Dr. Hofmann’s discovery, the Multidisciplinary Association for Psychedelic Studies (MAPS) is proud to present a list of curated offerings hosted by the psychedelic community. Like Visionary Art with Alex Grey and Allyson Grey, 2:00 PM – 3:30 PM (PST). Immerse yourself in the world of psychedelic art in a journey guided by visionary artists Alex Grey and Allyson Grey, the founders of the Chapel of Sacred Mirrors (CoSM), featuring a conversation with MAPS Founder Rick Doblin, Ph.D.

The Macrodose: Take A Course

If you’re new to the idea of exploring consciousness through psychedelics, up your game with DoubleBlind’s brand new introductory course, DB 101: How to Take Shrooms & LSD.

“Of all the things people have asked us about since we started DoubleBlind, we’ve received the most questions about how to take shrooms and LSD,” write the founders about their latest offering. “It’s important to us that people are never excluded from accessing resources they need to embark on their journeys.” The limited-time course will be available for one week and is being offered at a discounted rate.

Next month on May 12 at 3 pm Green Market Report is hosting a virtual event titled “The State of Psychedelic Investing.” You can register here.


Video StaffApril 16, 2021

2min6530

This is Psychedellux – the week’s top business news in the psychedelics industry. Cybin said it was Starting the IND-enabling trials for CYB003 and CYB004 which is a step forward for Cybin to study these molecules. Our team hopes to produce a robust submission to the FDA that will advance its path forward to clinical trials. Once the studies have been completed,the company plans to file IND applications, targeting treatment-resistant psychiatric disorders and certain forms of addiction, in 2021

 

Red Light Holland to purchase 80% of Happy Caps Urban Gourmet Mushroom Farm, specializing in quality ‘grow your own mushroom kits’, mushroom plug spawn and fresh mushrooms for the wholesale market

 

 Dimensions Health Centres (“Dimensions”), a psychedelic treatment company, officially announced the company formation and subsequent closure of an initial, oversubscribed round of funding. The company did not disclose the size of the round.

 

EMPOWER CLINICS INC. (OTC PINK:EPWCF) announced it is now eligible for Depository Trust Company (“DTC”) services in relation to Empower’s listing on the OTC.

 

A new study published in the New England Journal of Medicine tested the use of psilocybin for depression treatment. Unfortunately for the psychedelic community, the results weren’t overwhelmingly different for psilocybin and the ultimate result was a suggestion for a larger study. 


StaffApril 15, 2021
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4min12100

A new study published in the New England Journal of Medicine tested the use of psilocybin for depression treatment. Unfortunately for the psychedelic community, the results weren’t overwhelmingly different for psilocybin.  The goal of the study was to compare the effects of psilocybin with a six-week course of escitalopram, which is a selective serotonin reuptake inhibitor (SSRI), for MDD. The Journal wrote that this trial did not show a significant difference in antidepressant effects between psilocybin and escitalopram in a selected group of patients. On a positive note, secondary outcomes generally favored psilocybin over escitalopram, but the report said that the analyses of these outcomes lacked correction for multiple comparisons.

The study was funded by the Alexander Mosley Charitable Trust and Imperial College London’s Centre for Psychedelic Research; ClinicalTrials.gov number, NCT03429075. opens in new tab. It did suggest that larger and longer trials are required to compare psilocybin with established antidepressants.

“In a field of research where it is very difficult to separate treatments in head-to-head comparative efficacy trials, this study found signals favoring psilocybin therapy over escitalopram. This is an encouraging investigator-initiated study that supports the need for additional clinical investigations in larger, well-powered studies to more accurately determine the efficacy of COMP360 psilocybin in MDD”, said George Goldsmith, CEO, and Co-founder of COMPASS Pathways (NASDAQ: CMPS). “At COMPASS, we are already committed to a full clinical development program of psilocybin therapy in treatment-resistant depression, and we know there is much more work to be done so that we can bring evidence-based innovation to patients who have run out of options in a number of mental health illnesses.”

The Study

A total of 59 patients were enrolled; 30 were assigned to the psilocybin group and 29 to the escitalopram group.  Patients were assigned in a 1:1 ratio to receive two separate doses of 25 mg of psilocybin 3 weeks apart plus 6 weeks of daily placebo (psilocybin group) or two separate doses of 1 mg of psilocybin 3 weeks apart plus 6 weeks of daily oral escitalopram (escitalopram group); all the patients received psychological support. The primary outcome was the change from baseline in the score on the 16-item Quick Inventory of Depressive Symptomatology–Self-Report (QIDS-SR-16; scores range from 0 to 27, with higher scores indicating greater depression) at week 6. There were 16 secondary outcomes, including QIDS-SR-16 response (defined as a reduction in score of >50%) and QIDS-SR-16 remission (defined as a score of ≤5) at week 6.


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