Business Archives - Green Market Report

Dave HodesJune 27, 2022
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10min2440

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.


Debra BorchardtJune 27, 2022
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13min2520

 How does a company raise millions, make millions, but then basically go out of business in just a few years? It seems to happen more and more in the cannabis industry. ManifestSeven is one such company. Too much debt and bloated salaries conspired to bring the company down.

M7 started as MJIC and was one of the original cannabis platform companies. It published the MJIC Marijuana Index, a site that has since been pulled down and hosted some of the first cannabis business conferences. There were big plans for expansion into tech platforms and other cannabis operations. Green Market Report reached out to the company and received no response to our inquiries.

In 2019, the company officially changed its name to ManifestSeven (M7) and embarked on plans to go public. Throughout 2020 M7 went on an acquisition spree buying a dispensary called Healthy Healing Holistic Options (H3O) for $6 million, a delivery business, and a 1-800-cannabis phone number.  Fun fact, M7 paid $300,000 for the 800 number. Everything was looking rosy. 

Raising Millions

Money was also flowing in via various fundraises. In September 2020, ManifestSeven closed on an aggregate of $10.2 million in gross proceeds raised via three private placements of equity and convertible debt in 2020.

 At the time CEO Sturges Karban said, “Today’s announcement is a resounding affirmation of M7’s business model and corporate resilience in the face of economic headwinds, making us one of the few cannabis companies to raise capital in this environment successfully. We are truly encouraged by this level of financial backing from the investment community, which solidifies M7’s position as one of the leading operators in the legal cannabis market. This injection of capital allows M7 to continue expanding our seamless, compliant omnichannel across California, and eventually evaluate other markets in North America as opportunities arise.”

The company began trading on the CSE using the symbol MSVN in September 2020 through a reverse takeover with a company called P&P Ventures. It truly looked like this small company was building something – raising money, making acquisitions, and going public. However, one month after the RTO, M7 noted in its third-quarter earnings announcement in October 2020 that it was on a cost-cutting plan. It could be argued that it was prudent to review the cost structure as the company had gone on a buying spree, however, it also doesn’t make sense to be cutting costs while the company was also in expansion mode. 

Expansion Mode

In November 2020, M7 received another $2.31 million ($3.0 million CAD) from a noteholder in fulfillment of a subscription to the company’s 17.5% Subordinated Secured Convertible Notes. By February 2021, M7 announced the opening of its fully-licensed, multi-purpose facility in Brisbane, California, located directly south of San Francisco. The Brisbane facility marked a significant strategic milestone for M7 as it expanded its cannabis operations.

The following month March 2021, M7 announced that it has more than tripled the size of its fleet of distribution vehicles, augmenting the company’s logistics and transport capabilities of the company’s business-to-business division, Highlanders Distribution. M7 also brought in more funds that month when the company completed a non-brokered private placement resulting in gross proceeds of approximately C$3,314,605 ($2.5 million). 

However, another red flag went up when M7 refinanced the secured promissory note related to the Weden dispensary in Santa Ana, California, extending the note’s maturity date to January 1, 2022, with the ability to extend the maturity date by an additional 12 months upon the satisfaction of certain conditions. To be fair, this was smack dab in the middle of the pandemic and lots of companies were pushing out debt payments. Yet, knowing how this story ends, these signs were pointing to problems. Cutting costs and delaying making debt payments were all signs of trouble ahead.

Sales Decline

As the company moved into April 2021, M7 reported its fiscal first-quarter 2021 earnings. M7 said it generated consolidated revenue of $3.8 million during the first fiscal quarter, which fell from $4.1 million for the same prior-year period. M7 said “This decrease was primarily due to a decline in revenue generated from ancillary product sales due to a disruption in one of the company’s third-party e-commerce distribution channels that caused extended delays in the delivery time of products to customers and was partially corrected following the conclusion of the first fiscal quarter.” At least the company was generating revenue. 

Strategic Review

By July 2021, the party was essentially over not even a year after going public. M7 reported its fiscal second-quarter earnings with revenue of $3.8 million, essentially flat but more importantly, M7 said it had initiated a strategic review. That’s Wall Street talk for things are not going well and we’ve got to figure a way out of this mess. Maximizing shareholder value is code for selling assets. More importantly, the company said it was working with its creditors about making debt payments. So, within 18 months of raising millions, the company was already unable to make debt payments. As of August 31, 2021, the company only had $170,704 in cash. The company had a net working capital deficit of $28,251,574.

Despite the trouble, Sturges Karban, M7’s Chief Executive Officer told shareholders in July, “While we work to maximize the organic growth potential of the regulated infrastructure we have developed across California, the world’s largest and most vibrant cannabis market, we also continue to evaluate potential acquisitions and joint ventures to expand M7’s market share, while also enhancing its bottom line. As we look to the second half of 2021, we see significant opportunities to grow the physical and commercial footprint of our core B2B and B2C operations in California and, eventually, outside of our home state, as well.”

A few months later in October 2021, M7 told investors that it was in default of certain debt obligations from prior periods and continued to be in default as of the date of that report. The company had total liabilities of $33 million.  The company announced a modification to the terms of the New H3O Note on July 26, 2021. The company did not make interest payments due on the New H3O Note on July 1, 2021. The note was due January 2022 and carried a whopping 18% interest rate. H3O was the dispensary M7 bought in 2019.

Even as the company was saying it was cutting costs, over a nine-month period with revenues of $11 million, salaries were $5 million. Plus, it spent over a million dollars on consulting fees to tell the company how to cut costs. 

In November 2021, M7 reported revenue in the third quarter of $4.2 million, said it was still cutting costs and was still in default on its debts. The company also agreed to sell the dispensary Health Healing Holistic Options (H3O) for $6.7 million to a company called Stachs LLC, a subsidiary of Eaze. This was announced in December and at the time, M7 said it was going to focus on its distribution business. This was also about the time that Hardcar distribution thought M7 might merge or buy the company, but that didn’t happen. By February 2022, M7 said it was also discontinuing its distribution business. 

In March 2022, the company said that the discontinued cannabis distribution operations accounted for $3.32 million of revenue and a net loss of $2.76 million during the three quarters that ended August 31, 2021. “Eliminating these operations reduces the company’s cash needs on a go-forward basis and minimizes the accrual of additional liabilities associated with those operations.“ The company said it would continue to operate its ancillary e-commerce platforms and subscription services, including Rolling Paper Depot, Hippie Butler, and Puff Pack. 

At the end of March M7 said it was in serious financial difficulty. Despite this, it completed the first tranche of a non-brokered private placement of units of the company at a price of C$0.07 for gross proceeds of up to $2,100,000. All purchased by CEO Karban. 

Follow the Money

Green Market Report has reached out to the company to verify some of this information but received no response. The last published earnings were from October 2021 when the quarter ending in August was posted and since then no financials have been provided. The stock was briefly traded on the OTC Markets, but no financials were provided to that exchange either. The third-quarter earnings were announced in a press release in November 2021, but not a formal financial filing. The company’s auditor left in March 2022 and since there have been no financial filings, the stock has ceased to trade on the CSE. 

In April 2022, Dilshad Kasmani tendered his resignation as President and Chief Legal Officer of the company. The company was also suspended from trading in April on the CSE (Canadian Stock Exchange). The OTC Market has the stock designated for Expert Market only meaning the stock is not eligible for proprietary broker-dealer quotations. “All quotes in this stock reflect unsolicited customer orders. Unsolicited-Only stocks have a higher risk of wider spreads, increased volatility, and price dislocations. Investors may have difficulty selling this stock.”


StaffJune 27, 2022
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6min3140

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.”


StaffJune 27, 2022
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5min2710

The Northern Lights Acquisition Corp. (NASDAQ: NLIT), a special purpose acquisition corporation, rescheduled its special meeting of stockholders to Monday, June 27, 2022 at 4:00 pm ET. The vote was originally planned for June 24 in order to approve Safe Harbor Financial as the qualifying transaction for the SPAC. The deal is valued at $185 million or 9.1x 2023 EV/EBITDA vs. 9.7x peer group average according to Northern Lights. The enterprise value of the IPO is 2.0x versus the cannabis SPAC average of 3.0x. Once complete, the company will begin trading on the Nasdaq stock exchange under the ticker “SHFS”.

Protecting the SPAC

Last week, Northern Lights said that it had entered into a redemption backstop arrangement in the form of an OTC Equity Prepaid Forward Transaction agreement for up to $50 million with Midtown East Management NL LLC. Midtown East has agreed not to sell any public shares it purchases in connection with the planned business combination. Northern Lights anticipates that the shares purchased in connection with the agreement will help ensure the maximum redemption threshold condition in the business combination agreement will be met. The redemption backstop arrangement is in addition to the $60 million PIPE commitment from certain accredited investors previously announced on February 14, 2022.

Safe Harbor was founded in 2014 and is a first mover in providing a variety of banking services to cannabis businesses including, but not limited to, managed deposit accounts and commercial lending through its affiliation with Partner Colorado Credit Union. Since legislation protecting cannabis companies’ access to standard banking actions hasn’t been enacted, companies like Safe Harbor continue to fill a need in the industry. Safe Harbor says it is well-positioned to expand its compliance solutions and other service offerings with a proven track record for repeatedly enduring the tests of regulatory scrutiny.

Loan Provider

Recently Safe Harbor Financial closed on a $5 million senior secured loan to Solar Cannabis Co., an established vertically-integrated cannabis operator headquartered in Somerset, Massachusetts. Solar Cannabis said it would use the funds to further accelerate its growth. The transaction marked the evolution of Safe Harbor’s senior secured lending program, which was established to provide loans to cannabis operators in states in which cannabis is legal. Solar Cannabis’ loan is the first extended by Safe Harbor outside of its home state of Colorado.

Safe Harbor, through its predecessor entity, began offering loan services in 2020 with the buildout of its commercial lending program in late 2021 to help cannabis operators overcome their historic reliance on expensive, non-traditional forms of capital. Since initiating the program, the company has developed an actionable pipeline of approximately $500 million across nine states from both new as well as existing clients.

 


Debra BorchardtJune 24, 2022
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5min8710

Cannabis deal tracker Viridian Capital Advisors is looking at the second half of the year to see what’s in store for the industry. Director of Equity Research Jonathan DeCourcey wrote, “The outlook is bearish for investor returns in the near term as the key catalyst on everyone’s mind, federal legislation, is unlikely to come, and thus valuations will remain depressed for the remainder of the year with further stock declines likely in connection with broader market weakness.” With that said, DeCourcey thinks investors will have to wait until next year for a return to a positive market in the sector. For now, though he has come up with five predictions for cannabis for the back half of 2022. 

Viridian’s Five Predictions are as follows:

  • Federal legislation won’t happen
  • Stock prices will remain depressed
  • Companies may beat earnings estimates
  • California consolidation will continue
  • Smaller companies will outperform larger ones

Despite hopes for a banking bill, it is unlikely that anything will happen in 2022. DeCourcey wrote, “There is insufficient bi-partisan support for Chuck Schumer’s full legislative proposal to pass (requiring 10 Republican votes and full Democrat support) and, as we have said before, the timing is too tight for a stand-alone SAFE Act to be possible this year given the Democrats will first await the Schumer proposal to make the rounds.” Schumer’s proposal is expected to come in August, but that doesn’t give it much time before the midterm elections. 

New legislation could have been the catalyst to jump-start stock valuations. Take that off the table and there isn’t anything really big to move the needle. The overall broader market has been beset with recession fears and interest rate hikes. That also doesn’t help stock prices. However, depressed stock prices could combine next year with strong company earnings and that could lead to a recovery, but those hopes are pushed into 2023. 

Companies struggled with revenues and earnings at the beginning of 2022. Lingering Covid issues, wholesale price declines, and integration issues for newly combined companies caused some strong headwinds. DeCourcey thinks that these challenges are winding down, but cautions that there could be lingering inflation pressures. Still, expectations have been reset and if the New York market actually opens in 2023 then next year could see some strong growth. Plus, companies are going to be able to start reporting New Jersey sales figures, which are looking very good. Those New Jersey numbers could spark some earnings beats and that would be welcome news. 

“The proposed elimination of the California cultivation tax, which we expect to take effect next month, is a game-changer for California cannabis companies reducing the cost of production on outdoor growers by as much as 50%,” said the report. DeCourcey thinks the additional cash will lead to more transactions and motivation for M&A. The improving tax situation could also entice larger MSO’s to come to the market. “For investors, we expect the easier operating conditions and looming consolidation will result in outperforming returns for California-centric stocks in the second half and into next year.”

Finally, the report noted that scale does not necessarily equate to winning. Large companies get the attention, but the smaller and mid-size companies could have better growth potential with the likelihood of getting acquired. Smaller company stocks also outperformed the larger ones by declining by a smaller percentage. Dropping 47% on average versus 55% declines for larger companies. “Our top picks for 2H investment fall within the category of smaller and medium-sized companies. These names include Ascend (OTC: AAWH), AYR Wellness (OTC: AYRWF), Cansortium (CNTMF), Lowell Farms (LOWLF) and Schwazze.”


Dave HodesJune 24, 2022
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13min5180

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.”


Debra BorchardtJune 24, 2022
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9min7360

The Food & Drug Administration (FDA) decided to ban the popular vape product Juul and issued a marketing denial orders (MDOs) to JUUL Labs Inc. for all of its products currently marketed in the United States. That’s a long-winded way of saying the products are now banned. The company must stop selling and distributing these products. The ban doesn’t mean that people who continue to use Juuls or have them in their possession will get into trouble, the product just can’t be sold. 

In addition, those currently on the U.S. market must be removed, or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol-flavored pods at nicotine concentrations of 5.0% and 3.0%. 

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, M.D. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

What trigged the FDA response was the company’s lack of data regarding the toxicological profile of the products. “In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”

Cannabis Industry Worries

Vaping products in the cannabis industry are hugely popular, so the ban has attracted a great deal of attention among producers. Seattle-based data-analytics firm Headset recently reported that vapes were the second-largest category by revenue behind flower in the U.S. cannabis market during 2020 and 2021. The category logged nearly $2.6 billion in retail sales across six adult-use markets last year. Vape pens are also growing with sales rising 28% in 2021. Despite the sustainability issues, disposable vapes are proving to be very popular as well growing by 64%. Likely because disposable vape products tend to be cheaper. 

Arun Kurichety, chief operating officer and general counsel of Petalfast said, “ While the FDA’s decision to prohibit Juul from marketing its products in the US does not directly impact the cannabis industry, it suggests we may continue to expect scrutiny on all vaping products — nicotine and cannabis alike. For licensed businesses in the highly regulated cannabis industry, this shouldn’t be huge news. Rather than prohibition, this further highlights the need for consumer education regarding the risks of obtaining vape products in the illicit markets where product testing for safety is non-existent.”

E-cigarettes were originally hailed as an effective way for nicotine-addicted consumers to inhale with fewer terrible side effects. Tobacco companies all created versions for their tobacco-smoking customers with limited success. Yet, when Juul began marketing cotton candy flavored nicotine vapes, teens and young adults swarmed the products. Instead of helping already addicted adults, it created a whole new generation of Juul-addicted consumers. Parents complained and the FDA jumped in to address the situation. At first, it was just a clamp down on the flavors, but now it is banning the entire product line. 

Cannabis vapes also proved to be a nice option for consumers who didn’t want to smoke regular flower. Cannabis vapes were discreet, easy to carry, and didn’t create the distinct smell that burned flower did. They could be expensive, but cannabis consumers were willing to spend money for the convenience of being able to pop a vape in their pocket and ramble on. 

Arnaud Dumas de Rauly, CEO and co-founder of the Blinc Group said, “If the FDA took the time to look at the science surrounding vaping instead of having knee jerk reactions to statistics over youth consumption, they would see that vaping has been beneficial to countless individuals looking to quit smoking. For years, the European markets have embraced vape as such a necessary tool for the cessation of smoking that they offer health insurance breaks to those who vape.”

He went on to add, “If you look down the road to what this decision could mean for the cannabis vape industry, the federal illegality of cannabis will keep the space safe for now since the FDA is unwilling to regulate the industry while it remains a schedule one drug. However, this doesn’t mean that will be the case forever. I would hope when that time comes that the FDA will recognize that vape is considered one of the safest consumption methods, particularly for medical patients who are looking for the purest stream of cannabinoids and terpenes, and the absence of combustion means less hazardous substances and it’s easier on the lungs.”

A Post Juul World

One company that the trouble has already impacted in the Juul market is Greenlane (NASDAQ: GNLN). At one point in 2019, Greenlane was selling almost $50 million worth of Juul products. With the first ban on flavored products, sales fell over 30% to $33 million in 2020. Just this week, Greenlane noted that it was selling off assets in order to generate cash. The company has been weaning itself off its Juul dependence, but $50 million is a big number to make up elsewhere. 

In Closing

Juul has said it will appeal the ban and try to keep its products on the shelves while it fights the ban. Cannabis vapes may luck out purely due to the fact that the FDA can’t decide what to do about the federally illegal product.  Since the FDA can’t seem to make a decision on CBD products, tackling cannabis vape pens seems unlikely. Cannabis consumers haven’t been complaining about the product as evidenced by the growing sales. Like Dumas noted, the FDA was mostly reacting to angry parents of Juul-addicted teens. In the cannabis industry, not many people are complaining and that seems to have kept the product off the radar for now.


StaffJune 23, 2022
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7min4720

The Daily Hit is a recap of the top cannabis business stories for June 23, 2022.

ON THE SITE

IGC Makes Progress on THC for Alzheimer’s

India Globalization Capital, Inc. (IGC) (NYSE: IGC) announces its financial results for the fiscal year ending March 31, 2022. IGC reported that its revenue was approximately $397 thousand and $898 thousand for Fiscal 2022 and Fiscal 2021, respectively. The net loss for Fiscal 2022 for IGC was approximately $15 million or $0.30 per share, compared to approximately $8.8 million or $0.21 per share for Fiscal 2021. Adjusting for approximately $5.3 million in one-time and non-cash expenses, the net loss is approximately $9.7 million in Fiscal 2022. Read more here.

Selling the Psuedo-Psychedelic Sizzle

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. Read more here.

Executive Spotlight: Dave Choulpek

Juva Life (OTC: JUVAF) is a life sciences research company with an immense background in cannabis, allowing the company to cultivate and to derive small molecule compounds that target inflammation in the human body. Currently Juva Life is working with Juva-019 and Juva-041, which are non-cannabinoid molecules found to be naturally occurring in the cannabis plant. Juva Life’s assets include one micro business, one cannabis cultivation facility and two cannabis delivery companies in California. Read more here.

IN OTHER NEWS

Khiron Life Sciences Corp.

Khiron Life Sciences Corp. (TSXV: KHRN) (OTCQX: KHRNF) (Frankfurt: A2JMZC), a global medical cannabis company throughout Latin America and Europe, announced the results of its 2022 Annual General and Special Meeting of shareholders held on June 23, 2022. Read more here.

Auxly Cannabis Group Inc.

Auxly Cannabis Group Inc. (TSX: XLY), a consumer packaged goods company in the cannabis products market, announced that it has amended and restated the unsecured convertible debentures in the capital of the company issued under its standby facility with an institutional investor, which was previously announced on April 28, 2020. Read more here.

Nabis Cannabis, Teamsters Local 630

Drivers and fleet maintenance workers at Nabis Cannabis have voted overwhelmingly to ratify their first contract with Teamsters Local 630. It is the first collective bargaining agreement at the rapidly-growing cannabis distribution company. “I’m incredibly proud of the tenacity and courage that was demonstrated by this group of workers,” said Lou Villalvazo, Local 630 Secretary-Treasurer. “What they have done at this company can serve as a model for successful organizing and bargaining throughout the California cannabis industry moving forward.” Read more here.

Item 9 Labs Corp.

Item 9 Labs Corp. (OTCQX: INLB) — a vertically integrated cannabis dispensary franchisor and operator announced today that its new 20,000 square-foot, state-of-the-art cultivation and lab facility in Pahrump, N.V. is nearing completion and expected to be fully operational by end of 2022. Read more here.

CannTrust Holdings Inc.

CannTrust Holdings Inc. (unlisted), minority investor in Phoena Holdings Inc. (formerly CannTrust Equity Inc.) today announced that it is seeking an order from the Ontario Superior Court of Justice extending the time for the company to call the next annual meeting of its shareholders. The company also provided an update concerning its board of directors’ review of strategic alternatives. Read more here.

CryoMass Technologies Inc.

CryoMass Technologies Inc. (OTCQX: CRYM) announced that CryoMass begins trading today on OTCQX under the symbol “CRYM.” Christian Noël, CryoMass CEO, stated, “We are pleased to reach this important milestone, as OTCQX is the highest tier of the OTC markets. Of more than 12,000 securities traded on the OTC Markets, only 644 (as of May 31, 2022) have met the requirements for trading on the OTCQX® Best Market. The upgrade to the OTCQX will increase CryoMass’s accessibility to U.S. investors and will allow our shareholders to trade more effectively. This also reflects our continued commitment to responsible corporate governance.” Read more here.

Akanda Corp.

Concerned shareholders of Akanda Corp. have today replaced a majority of the board of directors of the Corporation, with highly-qualified and motivated directors. The concerned shareholders of the corporation collectively own or control 16,556,779 common shares of the corporation (representing approximately 54.1% of the issued and outstanding common shares of Akanda), and yesterday passed a written resolution of the shareholders of the corporation pursuant to the provisions of the Business Corporations Act (Ontario) removing each of Louisa Mojela, Philip van den Berg, Charles Kié, Gila Jones, Gugu Dingaan and Bridget Baker as directors of the Corporation effective immediately. Read more here.


StaffJune 23, 2022
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7min5610

Juva Life (OTC: JUVAF) is a life sciences research company with an immense background in cannabis, allowing the company to cultivate and to derive small molecule compounds that target inflammation in the human body. Currently Juva Life is working with Juva-019 and Juva-041, which are non-cannabinoid molecules found to be naturally occurring in the cannabis plant. Juva Life’s assets include one micro business, one cannabis cultivation facility and two cannabis delivery companies in California. The company was founded by Doug Chloupek in 2018, with the ultimate goal of bringing together a hand-picked team of cannabis industry veterans and leading, highly-respected medical researchers to create rigorously-tested, consistent, quality products built on research and a retail system that fosters informed customers through education and science. 

Doug has an immense background in both medical and adult-use cannabis, and was the visionary, co-founder, and COO of BAS Research. BAS Research (BAS) was California’s first licensed medical cannabis manufacturing and research group, dedicated to developing breakthrough pharmaceutical-grade cannabis products. He is a strong believer that standardized dosing and research is the first step to confirming the effectiveness of medical cannabis. The pharmaceutical industry follows an existing set of processes, and takes many different pathways to achieve an ultimate goal. Juva Life is taking a chemical approach to research versus a biological one, and is using modern tools to identify potential answers. In short, cannabis is known to anecdotally reduce pain and inflammation – Juva Life’s goal is to identify how and why this works, and isolate the specific molecules responsible for positive pain management effects in humans. 

Full name: Doug Chloupek 

 

Title: Founder, CEO, and Chairman of the Board

 

Company: Juva Life

 

Years at current company: 4

 

Education profile: I took an atypical route – I graduated high school 2 years early, and college wasn’t for me. I worked hard as a young person, homeschooled myself and have been working a 40/hr week job since age 15. 

 

Most successful professional accomplishment before cannabis: 

Over the past 12 years, I have led and created seven successful cannabis businesses, including the operation of cannabis retail businesses for 9 of those years, cultivation businesses for 8 of those years, and manufacturing businesses for 6 of those years. Prior to joining the cannabis industry, I acquired an additional 12 years of experience in marketing, brand creation, and advertising. I had been in media sales for about a decade, launched an online advertising/marketing firm for attorneys back in 2005, and had an entertainment company booking entertainers for local venues. Unlocking the health benefits hidden in cannabis was the motivating and all-consuming factor to create Juva and has brought us to where we are today. 

Company Mission: 

The Company’s mission is to leverage its unique knowledge of the chemistry and anti-inflammatory properties contained within cannabis to develop safe and effective therapeutics. We believe there are unappreciated small molecules identified by Juva and found in the cannabis plant that hold the keys to regulating inflammation in the human body. Our team of scientists are doing the much-needed research to validate our findings using established pharmaceutical assays to prove their efficacy.

Company’s most successful achievement:  

The discoveries of proprietary non-cannabinoid molecules, JUVA-019 and JUVA-041.

Juva-019 is a molecule found and derived from cannabis. It is a non-cannabinoid molecule, which is a naturally occurring molecule that is different from THC and CBD, with no psychoactive effects. Juva Life’s research team discovered Juva-019 by screening the whole library of compounds in cannabis using standard pharmaceutical assays, looking for compounds that stood out for their anti-inflammatory properties. 

Juva-041 is unique in that it actually inhibits multiple cytokines, which are responsible for inflammation in the human body. Juva Life’s researchers expect Juva-041 to have a potentially broader application than Juva-019, and have identified a process for straightforward, inexpensive synthesis of this molecule, without having to cultivate cannabis.

Has the company raised any capital (yes or no)? If so, how much?:

Yes, $36 million to date

Any plans on raising capital in the future?

Yes

Most important company 5 year goal: 

Juva Life’s goal is to unlock the secret of cannabis’ relationship with inflammation and pain management. Our team’s deep research background brings together top experts across multiple disciplines to apply a level of science and rigor not historically seen in the cannabis industry. At the core of its research, Juva Life is embarking to discover why and how cannabis works, and who it works for. With the recent discoveries of JUVA-019 and JUVA-041, we believe we are well on track to accomplish this goal. 

 


StaffJune 23, 2022
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4min5080

India Globalization Capital, Inc. (IGC) (NYSE: IGC) announces its financial results for the fiscal year ending March 31, 2022. IGC reported that its revenue was approximately $397 thousand and $898 thousand for Fiscal 2022 and Fiscal 2021, respectively. The net loss for Fiscal 2022 for IGC was approximately $15 million or $0.30 per share, compared to approximately $8.8 million or $0.21 per share for Fiscal 2021. Adjusting for approximately $5.3 million in one-time and non-cash expenses, the net loss is approximately $9.7 million in Fiscal 2022.

In Fiscal 2022 and Fiscal 2021, revenue was primarily derived from the Life Sciences segment, which involved sales of in-house brands and alcohol-based hand sanitizers, among others. In Fiscal 2022, the company de-emphasized the manufacturing and sale of low-margin hand sanitizers and shifted its focus to higher-margin white label services and the sale of products under its brands. This increased the gross margin from 12% in Fiscal 2021 to 48% in Fiscal 2022. The infrastructure segment had lower revenue in Fiscal 2022 due to the continued impact of the COVID-19 pandemic.

The company has roughly $10 million in cash on hand. SG&A expenses increased by approximately $5.3 million or 68% to $13.2 million for Fiscal 2022, from approximately $7.9 million for Fiscal 2021. The increase is attributed to one-time expenses, which include law-suit settlement expenses of approximately $264 thousand; impairment of facility of $833 thousand; net realizable value (NRV) adjustment of $1.7 million for its hemp crop; approximately $475 thousand in provisions for advances paid; approximately $1.7 million in provisions against inventory that was stolen at our vendor’s facility; and an increase of approximately $1.3 million attributable to non-cash expenses. Adjusting for approximately $5.3 million in one-time and non-cash expenses, the SG&A for the fiscal year 2022 was lower year over year by approximately $500 thousand.

R&D

Research and Development expenses were attributed to the Life Sciences segment. The R&D expenses increased by approximately $1.4 million or 151% to $2.3 million in Fiscal 2022, from approximately $929 thousand for Fiscal 2021. The increase is attributed to the now completed Phase 1 clinical trial on Alzheimer’s. “We expect R&D expenses to increase with progression in Phase 2 trials on IGC-AD1 and pre-clinical trials on TGR-63.”

Alzheimer’s

IGC completed the first-in-human safety and tolerability trial on its tetrahydrocannabinol (THC) based investigational new drug IGC-AD1. During the trial, the company discovered positive signals for improving several neuropsychiatric symptoms including agitation in dementia associated with Alzheimer’s. “Based on these signals, we are initiating a larger efficacy trial to test IGC-AD1 as a symptom modifying agent, specifically on agitation in dementia due to Alzheimer’s disease.”

On June 7, 2022, the USPTO issued a patent (#11,351,152) to IGC titled “Method and Composition for Treating Seizures Disorders.” The patent relates to compositions and methods for treating multiple types of seizure disorders and epilepsy in humans and animals using a combination of cannabidiol (CBD) with other compounds. Subject to further research and study, the combination is intended to reduce side effects caused by hydantoin anticonvulsant drugs such as phenobarbital, by reducing the dosing of anticonvulsant drugs in humans, dogs, and cats.


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


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