Psychedelics Archives - Green Market Report

Dave HodesJune 30, 2022

8min4270

Field Trip Health Ltd. (NASDAQ: FTRP) reported fiscal fourth-quarter and full-year 2022 results for the period ending March 31, 2022, and provided a business update today. All results are reported in Canadian dollars. For the quarter, Field Trip earned patient services revenues of $1,724,102 from its twelve clinics in operation, an increase of $1,197,667 or 228%, over the fourth quarter ended March 31, 2021.

Analysts put earnings estimate at -$.72/share for 2022, steady to -$.72/per share in 2023. Revenue estimates are encouraging, with analysts predicting 2023 year-end revenue to reach a little over $12 million from $4 million now (an increase of $3,899,234 or 406% over the prior fiscal year), with a projected sales growth of 197 percent. Four of five analysts have positioned Field Trip as a buy for now, as they predict it’s heading toward a price target of $12.84/share. 

 Field Trip reported a net loss of $14,170,285 which was mostly attributed to total operating costs of $14,323,644. This compares with a net loss of $7,950,590 in the fiscal fourth quarter of 2021. The increase from the prior year primarily reflects the company’s focus on growing the clinic’s business and continued investment in its drug development pipeline. Net loss for the comparative prior fiscal year was $23,117,607. 

The company is still working to resolve an issue with NASDAQ that it was not in compliance with the minimum bid price requirement ($1 per share) which is necessary to allow it to continue to be listed on the NASDAQ Global Select Market, one of three tiers of the NASDAQ stock market. The company went below $1 per share on May 4, 2022. Volume spiked on that same day (803,000) to its second-highest level since the stock was first listed on July 29, 2021. It has until December 31 to raise its stock price and regain compliance. The stock price hit a low of $.76 on May 11, and has struggled to rise much above that level ever since.

Earnings Call

On the company earnings call were Joseph del Moral, co-founder and CEO; Ronan Levy, co-founder and executive chairman; and Donna Wong, chief financial officer. Paula Amy Hewitt, vice president and general counsel, and Dr. Nathan Bryson, chief scientific officer, also joined in.

Del Moral talked first about the strategic review of the company. “The strategic review confirmed that both divisions of Field Trip are equipped and ready to successfully operate as independent companies, with distinct strategies, dedicated management teams and the capital resources required to execute on the respective business priorities.”

Other highlights included:

– The District of Columbia clinic began generating revenues in March 2022. On a year over year comparative basis, revenue of $526,435 in Q4 2021 was generated from the Toronto, New York, Santa Monica, Chicago and Atlanta clinics. The quarter over quarter revenue increase was in part due to the one additional clinic as compared to the prior quarter. 

– Total operating expenses in the fiscal fourth quarter were $14,323,644 and were comprised of the following: general and administrative expenses of $7,432,602, patient services expenses of $2,691,335, research and development (R&D) expenses of $2,333,724, depreciation and amortization of $1,124,854, sales and marketing expenses of $434,781 and occupancy costs of $306,798. 

– Total operating costs for fiscal year 2022 were $57,902,159 compared with $20,055,929 in fiscal year 2021.

– As of March 31, 2022 Field Trip had unrestricted cash and cash equivalents and restricted cash of $64,496,653.

– During the fiscal fourth quarter, Field Trip continued to advance its drug discovery work which is focused on the research and development of its novel molecule, FT-104, as well as other molecules under development, specifically the FT-200 series.

Levy said that, over the coming months, there will be an evolution in the business strategy for the clinic’s division as it becomes Fieldtrip Health and Wellness. “The focus today has been on validating that psychedelic assisted therapies can be safely, effectively, and reliably offered as a therapeutic option for the millions of people who struggle with mental health challenges,” he said. “We will continue to build upon our strong foundation as a leader in the industry, with a focus on growth and client numbers but also implementing further operational improvements to scale our physical footprint efficiently.” 

He said that there will be a new emphasis on expanding the Field Trip ecosystem in a capital-efficient manner, including building on the launch of their Field Trip at Home program, plus a greater emphasis on their digital tools, particularly the Trip app. “It will start to play a much more central role as the conversation around psychedelics emerges from a third line treatment to a much more social and cultural conversation. The opportunities in the psychedelic industry as it continues to evolve are near boundless. With Field Trip Health and Wellness, we plan to be at the forefront of the most exciting ones.”


Dave HodesJune 30, 2022
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8min5781

Microdosing psychedelics is quickly becoming a trendy new mental and physical wellness event that athletes, celebrities, and everyday business people are doing it as a daily ritual that is sometimes even encouraged by their bosses

In fact, the very term “microdosing” is working into common usage as just another way of saying you tried some thing, or attended some event, or ingested some substance—but just not a lot of it.

The term came into play as a common part of the work of drug researchers and scientists who measure what could or what should be an allowable, safe and effective dose of any psychedelic for human consumption, focusing mainly on psilocybin but inclusive of other psychedelics. 

The term actually comes from pharmacological drug development and guidelines from the Food and Drug Administration (FDA). Scientists report that, in the case of LSD and MDMA, psychedelic microdosing would be 5–10 percent of a usual psychoactive dose. Typical doses can be as small as one-twentieth of a typical recreational dose, sometimes even less. 

For example, a microdose of LSD might be 6–25 micrograms, or a microdose of psilocybin might be .1 to .5 grams of dried mushrooms.

To be sure, consuming a microdose of psychedelics combined with coffees or teas is also becoming popular—but just not the tested and approved coffees and teas you can get online or in any store. You have to actually get your psychedelic substance du jour from whatever trusted (illegal) source you have, and mix your own versions of a what you hope to be a measured, safe and effective microdosed concoction.

Yes, there are psilocybin microdose products (magic truffles) available in some countries, such as the iMicrodose kit from Red Light Holland (OTC: TRUFF), growing their truffles in Holland and selling kits in other countries where it is allowed. 

There is also Earth Resonance, a company also based in the Netherlands, also selling packages of microdoses of magic truffles that they recommend taking in the morning blended in a smoothie, chewed raw or put in morning tea.

But what’s going on in this country where psilocybin, LSD and MDMA are still illegal? It’s a do-it-yourself, wait and see attitude, with entrepreneurs lining up and ready to go. 

One example: The CEO of Denver-based CBD coffer maker Strava Coffee, Andrew Aamot, announced that they were envisioning bringing microdosed psilocybin-infused coffee and tea products to market. This was in July 2019, just months after the decriminalization of psilocybin was approved in Denver in May, 2019. But since that announcement, no updates have been published.

There are the important practicalities of microdosing to be better understood. When you are doing your own microdosing, be careful. There are still a lot of unknowns. There are many different kinds of psychoactive mushrooms with different strengths of hallucinogenic qualities. One study stated that the effects of microdosing “remain anecdotal,” and in the absence of quantitative research on microdosing psychedelics, “it is impossible to draw definitive conclusions on that matter.”

Another study found that, while most anecdotal reports focus on the positive experiences with microdosing, “future research should also focus on potential risks of (multiple) administrations of a psychedelic in low doses. To that end, (pre)clinical studies including biological (e.g. heart rate, receptor turnover and occupancy) as well as cognitive (e.g. memory, attention) parameters have to be conducted and will shed light on the potential negative consequences microdosing could have.”

And there is yet another study that showed that the effects of microdosing psychedelics versus using a placebo were about the same. In other words, participants in the research believed they felt better mentally even without taking the psychedelic substance that was being studied. 

What researchers are saying is that you’re taking some serious health chances doing your own microdosing until they can do more studies and figure microdosing out—as the psychedelics renaissance proceeds full steam ahead. 

So OK—it’s likely that the evolution of the revolution will soon reveal a solution to your motion for a potion. Microdosing is a full-fledged consumer trend introduced and promoted by the hip and connected that is slowly but surely trickling down to the everyday citizen as the psychedelics industry picks up momentum and broadens its appeal. 

The message today seems to be microdose at your own risk, but let the researchers hash out the details for a safer experience tomorrow—if you can wait that long.


Dave HodesJune 27, 2022
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10min11640

In Oregon, when voters approved Ballot Measure 109 calling for the legalization of psilocybin in November 2020, there was a silent hurrah throughout the state among people who took magic mushrooms for fun that went something like this: “Now we can go in to a psilocybin store and get a few grams of ‘shrooms—or maybe a handful—for the next concert.”

But that wasn’t the case. The measure was created to provide psilocybin for mental health therapy. It was strictly medicine. Wasn’t it?

Sometime early next year, if all goes according to plan, anyone over 21 will be able to go into a store in the state and buy magic mushrooms. But then they would have to sit through an “administration session” as a client of the facility, where they would consume and experience the effects of psilocybin under the supervision of a licensed psilocybin service facilitator. An “integration session” would follow where the client and a psilocybin service facilitator would discuss the experience.

It’s all pretty much just an extended doctor’s office visit, and brings into sharp focus what some believe to be the hollow victory of the state’s recreational psilocybin legalization: They are not for recreation at all.

Right now, the state is still in the process of setting up all the details of this psilocybin buying/selling/experiencing program. This includes: establishing rules by the end of the year; securing and customizing a product tracking system; creating an equity and justice centered approach to background checks; continuing to hire licensing and compliance teams; supporting the Oregon Psilocybin Advisory Board and subcommittees; creating education and training for their regulatory community and the public; and more.

But people looking for recreational fun with ‘shrooms don’t want to go to a medical clinic, or whatever these facilities will be morphing into as the regulations are developed and they begin operations. 

And outside of the concert or the dance club, people are beginning to use psilocybin as a smidgen of a bit of ‘shroom in their morning coffee, for example, to help set up a relaxing and productive day. That’s a trend that is catching on, rooted in Silicon Valley enterprises.

So the questions remain: Is legalized recreational psilocybin strictly medicine? Or can it also be a daily brain treat like some sort of advanced specialized brain health supplement? Or is it—will it become—a whole new recreational experience once people began tinkering with it outside of clinical studies and beyond the scope of any new regulations?

Not even the current Oregon state regulatory body can figure that out. Microdosing was not addressed, meaning that, even though recreational psilocybin is legal, microdosing is illegal right now. 

And there is confusion and debate around how medical Oregon’s psychedelics program will be structured. “I think there’s been a disconnect in what voters were told to expect when they voted and now. People will want mental health treatment but it’s not medical,” said Kimberley Golletz, a licensed psychologist and member of the Oregon Psilocybin Advisory Board giving guidance on the rules, as quoted in an article by Stat, a health and life sciences publication.

Real recreational legalization is part of the goal of Red Light Holland (OTC: TRUFF), an Ontario-based company that offers microdoses of magic truffles in their iMicrodose kit. A magic truffle is the fruiting body below the ground of the psilocybin mushroom. Magic truffles and magic mushrooms are both parts of the same organism that creates psilocybin, and have the same trippy effects after ingestion (though truffles’ effects are reportedly milder). Due to a loophole in Dutch law, magic truffles are legal but magic mushrooms are not. No therapists. No integration sessions. Just responsible adults going about their business buying magic truffles and enjoying their psilocybin experience.

Red Light Holland has been working on getting their products to other countries, such as Brazil and Canada, from their grow operations in The Netherlands. 

The company was created around the production, growth and sale of magic truffles to the legal, recreational market within the Netherlands, in compliance with all applicable laws. 

In an interview with The Street, an investment information company, Red Light Holland director and CEO Todd Shapiro said that he believes that magic truffles are a consumer goods product that is poised to cross more international borders. “We’re doing this because people are getting it anyway,” he said. “There are illicit markets anywhere you look. If people want to get access to this anyway, why not do it legally, why not do it carefully, and responsibly, and provide them that education that we are doing now. The careful use is the most important thing.”

So psilocybin is medical, but not… it’s illegal everywhere, except where it’s not… it’s turning into something like an uplifting food and beverage supplement to be combined with yoga or meditation, but that’s not really it either. It’s morphing, it’s evolving, it’s a moving target.

Perhaps the best thing that recreational psilocybin legalization has done is put more focus on achieving better brain health in general. According to results from an AARP survey, nearly one-quarter of adults age 18 and older currently take a supplement to maintain or improve brain health or delay or reverse dementia. That means that 58 million Americans (30 million age 50+) buy supplements believing it will help their brain health. Nine million adults age 50+ (8 percent) are taking a dietary supplement thinking it will actually reverse dementia.

Bottom line? There actually is no defined bottom line. But keep an eye on Oregon’s program, which could become the model of recreational psilocybin for other states as decriminalization continues—if all goes according to plan.


StaffJune 27, 2022
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6min7250

Revive Therapeutics Ltd. (OTCQB: RVVTF) (CSE: RVV) gave an update last week on the company’s U.S. Food & Drug Administration (FDA) Phase 3 clinical trial  (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.

Following Revive receiving positive comments from the FDA in regards to the company’s request to determine and agree on the Study’s potential new primary efficacy endpoints and the company’s submission of a Data Access Plan (“DAP”) to the FDA, the FDA has accepted the DAP to allow for the unblinding of the pre-dose selection data. The company will now proceed to unblind the pre-dose selection data to potentially support the amended Study protocol with the new primary efficacy endpoints. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization.

Despite the pandemic seemingly waning, the company believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant, there is an urgent need to treat symptom resolutions in addition to preventing hospitalizations. Revive made sure to note that it is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

Medical Mushrooms

According to a study, medicinal mushrooms have documented effects on different diseases, including infections and inflammatory disorders. “The related Basidiomycota Agaricus blazei Murill (AbM), Hericium erinaceus (HE), and Grifola frondosa (GF) have been shown to exert antimicrobial activity against viral agents, Gram‐positive and Gram‐negative bacteria, and parasites in vitro and in vivo. Since the mechanism is immunomodulatory and not antibiotical, the mushrooms should be active against multi‐drug resistant microbes as well. Moreover, since these Basidiomycota also have anti‐inflammatory properties, they may be suited for the treatment of the severe lung inflammation that often follows COVID‐19 infection.”
“An AbM‐based mushroom extract (Andosan), also containing HE and GF, has been shown to significantly reduce bacteraemia and increase survival in mice with pneumococcal sepsis, and to improve symptoms and quality of life in IBD patients via an anti‐inflammatory effect. Hence, such mushroom extracts could have prophylactic or therapeutic effect against the pneumonic superinfection and severe lung inflammation that often complicates COVID‐19 infection. Here, we review antimicrobial and anti‐inflammatory properties of AbM, HE and GF mushrooms, which could be used for the battle against COVID‐19.”

The Center for East-West Medicine, at the University of California Los Angeles (UCLA) applied to the US Food and Drug Administration (FDA) in April 2020 for approval to conduct 2 randomized phase 1 trials. According to the JAMA Network, the double-blind, placebo-controlled studies would evaluate the safety and feasibility of treating mild to moderate COVID-19 with either medicinal mushrooms, which have a long history as natural therapeutics for pulmonary disease, or a Chinese herb formulation that’s widely used there as a COVID-19 remedy. JAMA reported that the FDA ultimately sanctioned the MACH-19 (Mushrooms and Chinese Herbs for COVID-19) trials, which are now underway at UCLA and UCSD and are supported by the Krupp Endowed Fund. Meanwhile, a third MACH-19 trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.

“Researchers are currently conducting in vitro and animal studies with natural products to evaluate direct antiviral activity or to address COVID-19 sequelae,” D. Craig Hopp, PhD, deputy director of the Division of Extramural Research at the National Center for Complementary and Integrative Health (NCCIH), said in an interview. But the MACH-19 treatment trials are unique, he noted, because they’re evaluating natural products among humans with acute SARS-CoV-2 infection.”


Dave HodesJune 24, 2022
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13min6070

About one in eight people in the world live with a mental disorder, according to World Health Organization (WHO), and nearly a billion people around the world live with a diagnosable mental disorder.

But modern psychiatry is about to be deluged with more cases of depression, anxiety, paranoia and other mental health issues as a result of the pandemic and other worries among many countries, especially the U.S. 

In a recently published report, WHO estimated there was a rise in both anxiety and depressive disorders of about 25 percent during the first year of the pandemic.

It’s clear that mental health practitioners have to step up their game, in a manner of speaking, and should be ready to treat more people. But they should also be ready to utilize alternative treatments such as those offered by psychedelics-assisted therapy.

Easier said than done, it turns out.

Psychiatrists Wait & See

Psychiatrists are still watching and waiting on psychedelics to prove what they say they can do. They want better science on psychedelics. They want better clinical trials, complaining that results of MDMA trials, for example, are “durable” but that participant followup about the effects of their psychedelics use had “no statistical significance.”

It wasn’t always like this. Psychiatrists and other scientists were very enthusiastic about psychedelics in the 1950s. 

Then a social movement in the late 1960s killed it. Discussion of psychedelics by psychiatrists in the mid-1960s, and into the early 1970s, became a carefully avoided topic, as the U.S. government and some mind-freeing social forces came to blows, resulting in criminalizing psychedelics starting with LSD. 

Before LSD was banned, the U.S. National Institutes of Health funded more than 130 studies exploring its clinical utility, with positive results in a range of disorders but particularly anxiety, depression, and alcoholism.

Later, in the late 1970s, a rediscovery of psychedelics commenced, according to author and Harvard psychiatrist professor Lester Grinspoon in his 1979 book “Psychedelic Drugs Reconsidered.” 

Grinspoon wrote: “There have been few serious attempts to make theoretical sense of the full range of psychedelic experiences in terms that do justice to the understanding of those who undergo them. Psychologists and psychiatrists have chosen to ignore and dismiss most of this impressive clinical material, possibly because it seems so hard to incorporate into any acceptable theory of the mind. But we should not treat an experience as meaningless or demanding no explanation just because our present explanatory powers are inadequate to it.”

A review of the book noted that it should convince many skeptics that the “scandal” of psychedelic drugs is not that they are popular and a common item of illicit commerce, but that “their proper scientific study has been made impossible for completely unscientific reasons. The net result of their prohibition is that the substances seem to be available everywhere except where they should be, in the research institutions and hospitals as well as the practices of qualified psychologists and psychiatrists.”

The reviewer added that the reason the psychedelic drugs are not now “working” to bring about beneficial change is that “we are collectively using them all wrong — instead of creating a situation in which those interested to use them must incur risks and ostracism in no way connected with correct use but rather with their irrational prohibition, we should by now have structured our institutions to provide for these persons.”

That brings us to today… and psychiatrists are still skittish about psychedelics.

A United Kingdom National Health Services (NHS) pilot survey of 83 psychiatrists in 2021 found that, although 77.2 percent felt that there should be a role for controlled or therapeutic use of psychedelics, trainees appeared better informed than non-training grade psychiatrists. Psychiatrists of all grades did not feel prepared to participate in the delivery of psychedelic-assisted psychotherapy. 

NHS UK psychiatrists responded that they were positive about the potential for psychedelic-assisted therapy to advance psychiatric practice. “However, psychiatrists are lacking in confidence or preparedness to implement this treatment should it become a mainstream option,” the survey concluded, “and significant training needs were identified. Thematic analysis highlighted the need for societal shifts as well as professional ones.”

Psychiatrists in the U.S. had a slightly different take. A 2018 survey was sent to 1,000 members of the American Psychiatric Association—250 resident-fellows and 750 attending psychiatrists. Respondents tended to perceive hallucinogens as potentially hazardous and appropriately illegal for recreational purposes. But a large minority expressed optimism about the potential use of hallucinogens for psychiatric treatment.

Other researchers point to the risk of psychosis when using LSD. Until that risk is evaluated and quantified, in larger clinical studies, they report that the drug should remain under strict regulatory controls. “The long-term potential for addiction, dependence, psychosis and suicidal risk needs to be well defined before the clinical use for use in psychiatric disorders,” a Virginia doctor reported. “The small number of patients they have referenced are not supportive of the claim of long-term tolerability and long-term outcome is needed before embarking on regular use of these drugs in clinical care of patients.”

But today, there are also more rigid psychedelics clinical trials organized and run by well-respected scientists working with larger groups of participants, all of which have offered encouraging results that are turning heads in the psychiatrist community.

And academia is chipping away at the obstacles to bringing together psychiatry and psychedelics. One example is the Center for the Neuroscience of Psychedelics at the Massachusetts General Hospital, using an interdisciplinary approach to bring together “leaders in psychiatry, chemical neurobiology, and neuroimaging.” 

Mass General’s psychiatry department is highly respected as one of the best in the country. The department has 60 specialty clinics and research programs, and the largest clinical research program at Mass General. Advisors include Michael Pollan, who is a true pioneer in psychedelics development the best-selling author of the popular psychedelics book, “How to Change Your Mind”; and Rick Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS).

Dr. David Luke, senior lecturer in psychology at the University of Greenwich, said that academic and scientific enthusiasm around psychedelics has been increasing amid exasperation over the lack of advancement in psychiatry. As reported in The Guardian November, 2021, Luke said that psychedelics “has not progressed as a field of medicine relative to others for decades, and many psychiatrists have been deeply frustrated.” Yet there appears to be a set of long-ignored tools to treat causes rather than simply addressing symptoms, and psychedelics could do for psychiatry what the microscope did for biology, he said.

Perhaps psychedelics can help usher in new era of psychiatry to help explain how the brain executes the higher functions that are the actual focus of psychiatric practice—the generation of thought and behavior. “This knowledge gap has been responsible for psychiatry’s own split personality—historically swinging back and forth between a biological focus on the brain and a psychological focus on the mind,” psychiatrist Dr. Paul Minot, assistant medical director of psychiatry with Maine General Health and clinical assistant professor of psychiatry with Tufts University School of Medicine, writing in an issue of Psychiatric Times. “Just as physics sought a unified ‘theory of everything’ to incorporate the mystery of gravity, this missing piece of science has eluded psychiatry since its inception.”


Dave HodesJune 23, 2022
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11min9440

Say you want a quick microdose of an uplifting substance this morning and decide to turn to one of a handful of companies promising a “magic” experience with their mushroom concoctions—such as Mudwtr. 

A little psilocybin buzz should do the trick, right? Oops… better look closer.

On their website, Mudwtr attempts to clarify what is in their product while adding a tongue-in-cheek bit of confusion: “The mushrooms in Mud are magic … but they’re not that kind of magic. Nothing in Mud will cause a psychedelic trip.” They describe their mud product as a “dynamic product meant for creativity.”

Mudwtr delivers much of what psilocybin promises, according to users’ reviews – energy, focus, calming moments, relaxation. A sort of mellow brain boost without that jittery coffee caffeine effect. 

But what you are really getting in the mud is whole mushroom powders with mycelium and fruiting bodies, mixed with masala chai, chaga, reishi, cordyceps, Lion’s Mane, cacao, turmeric, cinnamon, sea salt, and yes, a microdose of caffeine for good measure (in Mudwtr’s morning ritual starter kit).

And no, you do not get psilocybin or MDMA or LSD or DMT or any other real psychedelic in this product or any legally sold product today. 

In fact, you can’t legally get any psychedelic substance to consume in place of your coffee, or in your coffee, or in anything you eat or drink, anywhere from anyone. It’s all illegal in the U.S. and most of the rest of the world except where it’s used in therapeutic settings such as the recreational model they are planning in Oregon.

What you may have bought into as a consumer of these psychedelic-not-psychedelic products is a classic marketing sleight of hand—a kind of innocent bait and switch if you will, capitalizing on the psychedelics renaissance that is all the rage today. 

There are other mushroom-based products beginning to flood the market that lean into the microdosing psychedelics mindset as well. 

SuperMush, a mushroom-based mouth spray, promises a “festival in a bottle” with a “daily dose of good vibrations,” adding on their website that “psychedelic and functional mushrooms are from the same kingdom, and both deserve a seat at the table in the wellness conversation.”

There there is Lifted Made. Their “Psilly” psychedelic gummies conjures up a psilocybin-infused candy product. But it’s really a combination of kava root, an intoxicating pepper that acts like alcohol on your brain; a leaf from the shrub called damiana, claimed to be used as an aphrodisiac; and green tea caffeine.

Lifted Made also offers “Shroomy” gummies, a combination of the reishi mushroom used to treat diabetes and cold sores; the Lions Mane mushroom, used to treat dementia and stomach problems; cordyceps, a fungus that lives on caterpillars and is used for helping the immune system; and chaga, a fungus that grows on tree trunks used to stimulate the immune system.

There’s also another psychedelic-not-psychedelic product out there now: psychedelic water.

According to a press release, the makers of this TikTok darling claim that psychedelic water’s popularity and rising reputation as the “influencer juice” is “fueling the creatives and risk-takers with a state of happiness, mental clarity, and creative bliss.” 

The company claims that it is the “first legal psychedelic brand of its kind built on the ethos that psychedelics are more than something you consume.” 

But there is no psychedelic substance in psychedelic water. It is created with, once again, kava root, damiana leaf, and green tea leaf extract, creating a “psychoactive, lightly carbonated blend that creates a sense of euphoria for a hangover-free experience.” 

The company doubles-down on the psychedelic-ness of their product as part of a new social movement, writing in the press release that the disrupters behind psychedelic water “welcome retailers to contact them directly to join their psychedelic movement.”

A coffee company, Four Sigmatic, makes mushroom coffee featuring Lion’s Mane and chaga ingredients. One of the Q&A’s on their website asks: Are these magic mushrooms? “We think so. They help your body do many things, but hallucinate is not one of them.”

To be sure, true psychedelics seekers can find real natural sources of plants offering an actual psychedelic experience, the so-called “herbal highs” that are mostly still legal with varying levels of safety and efficacy. They include mad honey, an intoxicating folk medicine from Nepal used as an aphrodisiac; lisergamide (LSA), the morning glory seed that produces effects similar to LSD; and amanita muscaria mushrooms, a dangerous mushroom that can cause hallucinations, but also coma and death.

So there is the real prospect of a legal psychedelic experience with some natural substances for people wanting that sort of thing, as they wait on the more well-known psychedelics now in clinical trials (MDMA, LSD, psilocybn, DMT) to make it into mainstream medicine by, well, 2023 at the earliest.

For now, marketers and “disruptive” startups are capitalizing on the psychedelics renaissance, and reeling in the curious who may think that the special “magic mushroom” drink they are taking daily is helping them somehow hallucinate their way to better health.


Dave HodesJune 21, 2022
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8min9850

The stock market has been tough over the last month, as has most of the U.S. economy.

The Federal Reserve raised interest rates by 0.75 percent on Wednesday, June 15, and that reduces the amount of money in the economy. 

Besides mortgages, rising interest rates impact the stock and bond markets, credit cards, personal loans, student loans, auto loans, and business loans according to Forbes. It’s the third hike this year and the largest since 1994. The move is aimed at countering the fastest pace of inflation in over 40 years. Another rate hike could come in July, according to Fed Chairman Jerome Powell.

The stock market reacted instantly. For example, GE’s stock price was down on Friday, June 17, from $69.64 Wednesday to $64.96 a share. Amazon was down from $108.36 a share on Wednesday to $102.42 a share on Friday. Apple was down from $136.61 Wednesday to $129.54 on Friday.

Many of the psychedelic stocks dipped briefly as well, but appear to be recovering as of this writing, basically going against the latest economic trend… even as most of them still are not showing any significant revenue yet.

What’s driving the ability of some psychedelics companies to survive—even thrive—amidst this economic turmoil: Cash on hand? Results of clinical trials? Insider buying? Yes, yes, and yes.

Let’s take a look at three examples:

  1. Good cash runway. Atai Life Sciences (NASDAQ:ATAI). Its stock was up 4.5% percent on June 17. Analysts are not worried about this company that finally showed a bit of revenue as of March 2022, in part because of a strong cash runway. A company’s cash runway is calculated by dividing its cash hoard by its cash burn. Atai reported $335 million in cash that it held as of March 2022. “Importantly, its cash burn was $73 million over the trailing twelve months,” analysts reported. “So it had a cash runway of about 4.6 years from March 2022. A runway of this length affords the company the time and space it needs to develop the business.”

The company is also showing strong execution of its clinical pipeline, anticipating several clinical milestones in 2022 and beyond, including data from the Phase 2 proof-of-concept study of a potential at-home-use therapy in treatment-resistant depression. The company is also expecting other Phase 1 and Phase 2 results on other compounds this year. “It’s a testament to our phenomenal team that we anticipate having 10 compounds in the clinic,” Srinivas Rao, chief scientific officer and co-founder of Atai, said in a May 16th press release.

  1. Clinical trial moves. Cybin, Inc. (NEO:CYBN) (NYSE:CYBN) stock was up 5 percent on June 17. According to Tip Ranks, based on three Wall Street analysts offering 12-month price targets for Cybin in the last 3 months, the average price target is $9.00 with a high forecast of $10.00 and a low forecast of $7.00. The average price target represents a 1453.06% change from the last price of $0.58. Analysts rate it as a strong buy.

But what is really driving this analyst frenzy is Cybin’s announcement of the first human clinical trial of their psilocybin compound—and it’s a big deal. 

On May 31, Cybin announced an investigational new drug application to the U.S. Food and Drug Administration for its Phase 1/2a first-in-human clinical trial evaluating CYB003 sometime in mid-2022, a proprietary deuterated psilocybin analog being developed for the treatment of the major depressive disorder.

The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating people with moderate to severe major depressive disorder. Human subjects will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at Week 3 (after a single dose) and at Week 6 (after receiving a second dose).

  1. Insider buying. Seelos Therapeutics (NASDAQ:SEEL). It’s stock was up 5.69 percent as of June 17. The stock is rated a buy or strong buy by analysts

Analysts also report that multiple insiders are buying stock, sending out a positive message to the company’s shareholders. For example, in the last twelve months, the biggest single purchase by an insider was when Founder Raj Mehra bought $57,000 worth of shares at a price of $0.85 per share. So it’s clear an insider wanted to buy, even at a higher price than the current share price (being $0.64). “While their view may have changed since the purchase was made, this does at least suggest they have had confidence in the company’s future,” according to analysts at Simply Wall Street. “In our view, the price an insider pays for shares is very important. As a general rule, we feel more positive about a stock if insiders have bought shares at above current prices, because that suggests they viewed the stock as good value, even at a higher price.”


Dave HodesJune 20, 2022
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15min10590

Now that psychedelics have taken hold in the consciousness of medicine as an approach to better mental health—with psychedelics-assisted therapy showing mostly positive results in more clinical trials by more companies—maybe now is the time to accelerate the building of an infrastructure for getting it to people that need it.

Some companies primarily focused on research and development are building on a strategy of infrastructure development by establishing clinic networks and digital platforms to build the infrastructure for clinical trials and the delivery of psychedelic-assisted psychotherapies. 

A report by LEK, a business development consultancy, included a quote from Lars Wilde, president, CEO, and co-founder of Compass Pathways (NASDAQ: CMPS), a mental health care company accelerating patient access to evidence-based innovations in mental health with its psilocybin therapy: “The big hurdle to the success of psychedelics is now in their commercialization and delivery,” Wilde said. “You need to have the physical spaces to deliver psychedelic therapy, and this poses a different challenge from country to country. Some companies are using digital platforms to explore how we can improve therapy and this is an interesting approach.”

One way to build those pathways to commercialization and delivery is to organize professional associations whose members can collaborate about what they need as an industry, and how to go about getting it while presenting a sort of unified voice to achieve such goals as infrastructure development together. 

A Unified Voice

For example, there is the American Psychedelic Practitioners Association (APPA), endorsed by Multidisciplinary Association for Psychedelic Studies (MAPS), the California Institute of Integral Studies (CIIS), the Psychedelic Research and Training Institute and others. 

The APPA’s mission is to “support practitioners and beneficiaries in developing and integrating safe, effective and accessible psychedelic medicine services for the advancement of healthcare and collective wellbeing.”

CIIS’ Center for Psychedelic Therapy and Research does its own work to educate the public and professionals about the research and clinical use of psychedelic medicine, offering a certificate in psychedelic-assisted therapies and research to educate licensed psychotherapy and medical professionals on the use of psychedelic medicine in FDA-approved clinical studies. CIIS also offers lectures and programs to the public on psychedelic medicine and therapies several times a year.

The National Psychedelic Practitioner Certification Board (NPPCB) is another organization creating board certification for psychedelic medicine practitioners and educating practitioners, the health care system, and potential consumers about the inherent value of the certification process. “As an emerging field in healthcare, psychedelic medicine has no current metrics to assess skill and competency,” according to the NPPCB. “This certification will be used by healthcare systems, insurance companies, and even state regulators to assess a professional level of competency for practitioners in this arena.”

Infrastructure Development

More psychedelics companies are throwing their collective hats into the infrastructure development ring.

Enthea is partnering with Dr. Bronner’s Soap to provide psychedelic therapy as an employee healthcare benefit for Dr. Bronner’s Soap (David Bronner, the CEO, is also a MAPS board member). 

Enthea is a non-profit benefit plan administrator that provides health plan benefit riders and single case agreement services for psychedelic healthcare. It’s the first-ever partnership between a health plan administrator and leading U.S. company to offer employee coverage for ketamine assisted therapy to promote mental health, according to the press release announcing the partnership. “We hold practitioner wellbeing and equitable access to psychedelic healthcare as central, guiding tenets to our mission and vision,” according to Enthea’s mission statement. “Enthea will be on the cutting edge of providing access and affordability of psychedelics-assisted therapy. In so doing, we will pave the way for other companies to follow, putting infrastructure in place for them to leverage.”

There are other companies who realize that it’s time to focus on commercializing and distributing access to psychedelics therapy to help accelerate the growth of the industry in general. 

For example, Numinus, a Vancouver-based company working on the  integration of psychedelic-assisted therapies into mainstream clinical practice, recently acquired Novamind in a deal expected to close this month (June). Novamind is a mental health company enabling safe access to psychedelic medicine (ketamine) through a network of clinics and clinical research sites. 

The combined Numinus/Novamind company will operate 13 wellness clinics in focused geographies across the U.S. and Canada, and “will continue developing and scaling innovative psychedelic therapy protocols and procedures for screening, preparation, dosing and integration targeting difficult-to-treat mental health conditions, including post-traumatic stress disorder (PTSD), COVID-19 burnout, depression, addiction and eating disorders,” according to the press release.

How this combination of two companies benefits the psychedelics industry infrastructure development is by its use of a centralized client care center for managing client inquiries, scheduling clients with appropriate providers, coordinating physician referral intakes, fulfilling prescription requests, and facilitating insurance authorizations. 

The combined company will also operate four clinical research sites and a bioanalytical laboratory, all of which are currently supporting leading drug developers in psychedelic medicine with critical infrastructure and services.

“What we want to establish is the real-world help, create the real-world infrastructure,” Payton Nyquvest, CEO of Numinus, said during an interview that also featured MAPS founder and executive director Rick Doblin. “There are lots of clinical trials going on. There’s lots of research on all different kinds of things. And I think for Numinus, our focus has really been around accessibility. What does this really, really look like at the end of the day? We’re really focused on the person that is going to, in a real-world context, come through the doors of a Numinus facility. And what does that look like and how can we do the best job for those people? I think if we look at the space, down the road, ultimately the groups that are really, really focused on client or patient outcomes are going to be successful.”

Another Vancouver-based company, Mindcure, a life sciences company focused on innovating and commercializing new ways to promote healing and improve mental health, has developed software-as-a-service digital therapeutics and psychotherapy clinics, working on a model of establishing clinic networks and digital platforms alongside pharmaceutical R&D that also contributes to the infrastructure development for the industry. 

Mindcure is positioning its software program, called iSTRYM, as the industry’s distribution network for science-based, evidence-backed protocols and artificial intelligence data systems. They released the minimum viable product (MVP) version of iSTRYM into partner clinics across North America, and plan to begin full commercial deployment by mid-2022.

Another infrastructure development example is MAPS and Vine Ventures, announcing the creation of a novel, social impact Special Purpose Vehicle (SPV), called the Regenerative Financing Vine (RFV), that will infuse $70 million into patient access infrastructure and research for MDMA-assisted therapy for PTSD.

There are already dozens of ketamine infusion clinics in most states across the U.S. (ketamine was approved by the FDA in February 1970), offering an early glimpse into how a psychedelics infrastructure works. 

All of these actions are driving where psychedelics is going, how it’s going to get there, and what that delivery infrastructure looks like. It’s a sort of Psychedelics 2.0 gaining momentum across the globe. 

For example, Australia is looking for organizational help going to this next phase of psychedelics industry development. Australia proposes the establishment of a multidisciplinary Australian Advisory Committee for Psychedelic Therapies, representing research, clinical, regulatory, industry, and community interests that would provide guidance to government, professional organizations, and other stakeholders in training and accreditation, infrastructure development, community education, and regulatory matters.

With this ongoing infrastructure development, there is some concern that it could be outpacing what is really happening in the labs. Is the industry jumping the gun and getting ahead of the science? 

A viewpoint article in the Journal of the American Medical Association’s Psychiatry publication in January 2022, spells it out: “There may be tension between avid advocates of this class of compounds and the deliberately slower pace of adoption encouraged by the scientific method, but rigorous research is necessary to more fully understand the risks and benefits involved in any presumptive clinical application,” the report’s authors noted. “The first wave of psychedelic research was disrupted by conflict between cultural and political forces. The current wave of psychedelic research could be susceptible to an emerging conflict between entrepreneurial enthusiasm and scientific deliberation.”


Debra BorchardtJune 17, 2022
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11min7260

 At the recent World Economic Forum in Davos Switzerland got to experience the Psychedelic Medicine House. An event hosted by psychedelic investment company Tabula Rasa Ventures and Energia. One of the discussions held at the house covered employment and psychedelics. What happens when work and tripping collide?

Dr. Bronner’s

Some in the industry think it’s a great idea to have employers instruct insurance companies to cover experimental psychedelic treatments for mental health. One is example is the 150-year-old soap company Dr. Bronners. The family-owned and operated business was pretty basic until the 1960s and 1970’s when the company moved to California and embraced a message of peace for the planet. The company is also known for its organic products and promotion of hemp, less known is that the original Bronner was never a real doctor, he just began calling himself Doctor and the name stuck.

Fast forward to today and Dr. Bronner’s products are sold everywhere. Its early adoption of hemp-based products put it squarely in the camp of using plant-based products for a variety of solutions. Dr. Bronner’s showed it had no fear of thinking outside the box and is continuing that trend with its decision to expand its mental healthcare benefits to include ketamine-assisted therapy. The company sees this as a first step in providing access to psychedelic-assisted therapy to employees to promote mental health. According to a company statement, “This innovative benefit plan is administered by Enthea, a nonprofit healthcare organization responsible for medical policy development, provider network management, and benefit plan administration. Enthea establishes high quality of care standards for the treatments offered, including credentialing and managing a network of specialty providers.”

However, allowing an FDA-approved drug to be used by employees is one thing, psilocybin mushrooms, LSD or ayahuasca is a whole different level of treatment. The drugs are not FDA-approved and are still undergoing numerous studies. Still, some company CEOs after experiencing a psychedelic trip want to share that with their employees and that’s where opinions diverge.

Pro Psychedelics

Those in the industry are all for it. They hope these enlightened CEOs will generate lots of business for their companies as employees begin signing up for treatments. Retreats, clinic visits, and microdosing are all ways for these emerging companies to earn revenue. The CEOs that had great experiences truly just want to share that with their employees. I.e. if it was so life-changing and eye-opening for them, imagine what it could do for others. The stress of today’s world with climate change, wars, and a post-pandemic landscape has affected people’s mental health so if this can help then why not. 

There have been many anecdotal stories out of silicon valley about workers using tiny amounts of psilocybin mushrooms each day or microdosing. Just enough to get the positive effects but not enough to detach from reality. Despite there being no studies on the long-term effects of microdosing, people are doing it anyway.

One executive in Davos spoke about how his life was a mess until he tried psychedelics and afterward found true love with a new partner and new meaning to his work. If it could do this for him, why wouldn’t he want others to have this too? Another executive also shared a story about how psychedelics changed his career path and that all people should be released from their self-imposed work rigors to find their true calling in their work life.

These stories all sound so amazing and positive, but the truth is that companies suggesting psychedelic experiences can be problematic.

Psychedelic Negatives

In the discussion that followed, several negatives were discussed that the workplace would have to grapple with if employers decided to offer these types of treatments. One was abandoning regular life. One psychedelic company executive told a story about explaining his position to another executive who was very much against it. Why? He said after several of his executives tried psychedelics, they all quit. The pro-psych people say this is a good outcome. Leaving behind what isn’t working and moving towards what is working. The negatives say that it is detaching from the real world. Walking away from jobs, companies, and investors with no warning isn’t always seen as productive or healthy.

One well-documented example was a story about an early cannabis company called Tradeiv whose CEO had an LSD trip in Alaska. The company CEO Aaron TK said God spoke to him during the trip and suggested a different career path so he came back and shut down the company. Leaving investors and employees completely blindsided as he jumped ship. With little known about this type of response on a large scale, it’s impossible to know whether these career escapes turn out to be great moves or impulsive decisions that actually jeopardize the individuals and their families. 

Not every experience in psychedelics is a good one. This is an issue that lots of people in the psychedelic industry avoid discussing. Bad trips happen and can be just as disturbing and profound as good trips. Does an employer want to be responsible for sending an employee to a dark place, one that could potentially have long-lasting effects? Pro psych people say bad trips are just a sign of deep-rooted negative experiences that are getting purged from a person’s psyche. But some people report getting totally derailed from their lives after a bad trip, what employer would want to be saddled with that responsibility?

Just Say No?

Another potential unwanted outcome could be an employee’s decision to reject the suggestion of a psychedelic trip. Psychedelic experiences go way beyond that of cannabis. In Davos, some executives saw rejection as an employee not being a team player. These pro-psych people are such huge believers in the benefits of the treatment, they truly want the best for their workers and think this is a massive gift to give. To them, it’s like offering a week’s paid vacation or salary bonus. It’s an amazing gift to give. Plus, they feel like an employee that doesn’t partake can’t relate to the others that have. To them, it’s like a company golf outing that one employee decides isn’t worth doing or participating in and rains on everyone else’s parade. One even said, “I wouldn’t want that person working for me.”

However, a psychedelic experience isn’t the same as a traditional corporate retreat.  To some employees, it may feel like the boss is making you take shots when you don’t drink alcohol. It’s hard to see how a company could force a person to engage in a psychedelic experience, but office politics are what they are and certainly, there could be an instance of a worker feeling like if they don’t participate, they could lose their job.

Drug Testing

The relationship between the workplace and drugs normally centers around an employee being impaired on the job and the employer testing for those drugs.  Current drug screen tests are called the 5-panel test or screen. The federal drug screen tests for metabolites of marijuana, cocaine, opiates (codeine and morphine), phencyclidine (PCP), heroin, and various amphetamines. There isn’t a screen for psychedelics at this time. If employers were against psychedelic treatments, they aren’t able to test their workers. If employers wanted to be sure a worker completed treatment, they are equally unable to confirm it.

In Closing

Cannabis consumption and the workplace has gone through years of debate. States that legalized medical marijuana found that those laws didn’t matter when it came to the workplace. Employers generally win lawsuits regarding drug use and jobs. In other words, employers can decide they don’t want their employees to use any cannabis whether its a medical treatment or not. 

Psychedelics though have flipped the narrative the other way around. Can an employer push for a treatment that an employee may not want? This debate is only beginning and is sure to warrant strong emotions on both sides. 

 


Dave HodesJune 16, 2022
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9min7660

One of Hollywood director Adrian Lyne’s most popular movies (he was the guy who directed “Fatal Vision”), was “Jacob’s Ladder,” a trippy pseudo-horror movie that was based on an experiment with a strong hallucinogenic 100 times more powerful than LSD that the Army was allegedly testing on unsuspecting U.S. Army soldiers in Vietnam. 

Whether that actually happened or not was left for the viewer to think about as the end titles rolled. But other documented experiments using LSD by the Army during the late 1950’s and 60’s were designed to find out how psychedelics could perhaps be used as a chemical weapon.

Psychedelics, it seemed, were the toy of the evil government scientist. They were weapons of war.

Fear about psychedelics lingered even after scientists and psychologists started doing more experiments in the mid-60s. But they worked to slowly demystify psychedelics such as LSD as they uncovered the good in them. 

Then Harvard University psychology professor Timothy Leary, who supported the recreational use of LSD, created the “tune in, turn on, drop out” negative social media explosion that effectively freaked out the establishment. The U.S. government, under guidance from President Richard Nixon, quickly criminalized LSD (and cannabis) in 1970, and put a hold on any psychedelics research until now—the so-called psychedelics renaissance.

The discussion about medicalization has re-emerged because now, some would argue, psychedelics have become part of a process in which mental health conditions and behaviors are labeled and treated as medical issues.

Medicalization

Medicalization has been described as “defining a problem in medical terms, usually an illness  or disorder, or using a medical intervention to treat it.” It’s often about new diagnoses, “based on a widened understanding of the human situations that usually benefit from medical involvement.” That describes precisely what is happening with psychedelics today.

Psychedelic substances today are increasingly being identified as medicines by an assemblage of scientific research groups, media institutions, government drug authorities, and patient and consumer populations, according to a study.

But medicalization has its downsides.

Medicalization is often presented as the societal and individual burden of unnecessary medical expansion. And seeking medicalization of cannabis was often depicted as a ruse to get recreational cannabis legalized in the late 1990s.

Medicalization can also lead to problems where, when a new condition is identified as having a medicalized treatment for it, suddenly everyone seems to have it. And sensing an opportunity, Big Pharma begins promoting it.

One example is restless leg syndrome. People did not complain about restless leg syndrome, or it was misdiagnosed, for years. But now that medications are available to treat it, nearly 12 million Americans have been diagnosed with it and are taking drugs to treat it, according to New York University Langone Health, which, by the way, is one of the leading academic institutions researching psychedelics at their Center for Psychedelic Medicine.

Consider the case of alcohol dependence. Once seen as a deviant social behavior that some individuals chose to engage in, the American Psychological Association (APA) now defines it as alcohol use disorder (AUD)—a genetically inheritable, medical illness. Alcoholism has been effectively medicalized. 

Another recent medicalization example is Attention Deficit Hyperactivity Disorder (ADHD), which is now one of the most commonly diagnosed behavior disorders of childhood—but under the suspicion that it’s because Big Pharma companies have heavily marketed their ADHD drug treatment programs and have found a new disease to help them build profits. 

One investigative journalist suggests that perhaps two thirds of the children diagnosed with ADHD do not actually suffer from the disorder, and that it is a “manufactured epidemic.”

So now we come to psychedelics like psilocybin, MDMA and LSD, all being medicalized to be made into a new pharmaceuticals to treat mental health illnesses such as PTSD and treatment resistant depression. 

But it’s also being researched as a medicine for the treatment of alcoholism, drug addiction, even gambling addiction—all now medicalized because of the work of researchers finding that psychedelics can effectively treat these mental health conditions. 

So is the medical community in favor of medicalizing psychedelics because it can help mental health patients live a better life with one or two treatments of psychedelics-assisted therapy, and broaden the use and success of alternative therapies, instead of a lifetime of drug-taking which appears to be the Big Pharma model?

Greg Kearns, a healthcare strategist, in a newsletter for the Multidisciplinary Association of Psychedelic Studies (MAPS), wrote that as psychedelic medicines are ushered into the health care system, “it will be especially interesting to see which other integrative wellness modalities (yoga, meditation, breath work, acupuncture, etc.) are embraced more fully. It is my personal hope that the introduction of psychedelic-assisted therapies, delivered in coordination with other primary and preventative health services, may be what it takes for us to finally transform the U.S. health care system from one that is more focused on the treatment of disease, to one that is focused on holistic wellness and the advancement of thriving individuals and communities.”

Amen to that.


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