Dave Hodes, Author at Green Market Report

Dave HodesJune 30, 2022

8min3570

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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8min4881

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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10min11010

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.


Dave HodesJune 24, 2022
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13min5990

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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11min9300

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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8min9660

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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15min10480

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.”


Dave HodesJune 16, 2022
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9min7600

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.


Dave HodesJune 14, 2022
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8min7270

Editors Note: This story was originally published on June 13, but due to some technical problems we had to reset the website and as a result, the story got erased. This is the same story but republished.

 

Biotechnology is always a dicey business to create, run, and make profitable. Psychedelics add a difficulty factor of 10 to that equation.

Currently, there are many psychedelic companies still working their compound through clinical trials—with no actual product to market and sell for years.

Much of the real success of any psychedelic business hinges on the completion of clinical trials and Food and Drug Administration (FDA) approval, which takes serious time and money and is never guaranteed. 

And with any startup business, there is always risk: internal threats, external threats, workforce issues such as illness or theft, fraud, market changes, facility damage, rent increase—it’s a fairly exhaustive list.

An SBA financial education course presents a sort of Business Risks 101: Good risk management will help a business continue in operation. Mitigated risk leads to better cash flow and greater stability. Creditors will see this stability and good cash flow reflected in a company’s financial reports. Greater stability will mean the company will last into the future. 

The rewards of risk management are all linked together: good cash flow leads to stability, which leads to good credit, which leads to longevity.

Even before the startup business really gets off the ground, an investor should have done their due diligence on the risk they could be exposed to by the business, and do an analysis of an investment’s returns compared to its risk, with the expectation that a greater degree of risk is supposed to be compensated by a higher expected return.

There are computations and equations for determining risk using statistical methods that are historical predictors of investment risk and volatility, such as standard deviation, Sharpe ratio, value at risk, conditional value at risk, and others.

But all that cool analysis may or may not work in the hot, complicated world of the psychedelics industry, even with the news that nearly 50 psychedelic companies have gone public. Going public can offer a more secure investment because it helps a company raise capital to invest in future operations, expansion and acquisition.

Due diligence for a public company in the U.S. also means checking the U.S. Securities and Exchange Commission (SEC) filing of any company they are considering. 

The SEC filing can show how some psychedelics companies are still scrambling to organize their operations—even as investor money pours in seemingly oblivious to the danger at hand.

Take the sure thing as one example: Atai Life Sciences (NASDAQ: ATAI) . The company has eight lead investors, and has gone through 10 funding rounds since mid-2018, raising a total of $347.1 million. 

It’s one of the most closely watched psychedelics companies by investors. But the stock has been experiencing a steady decline since November, 2021, from just over $17/share to less than $4/share.

And company executives admitted in the company’s SEC filing that the company did not design and maintain formal accounting policies, processes and controls related to complex transactions necessary for an effective financial reporting process. “These deficiencies constitute material weaknesses in the design of our internal controls over financial reporting,” they said in their filing (pg. 60). “As a result of the material weaknesses, we have relied, in part, on the assistance of outside advisors with expertise in these matters to assist us in the preparation of our consolidated financial statements and in our compliance with SEC reporting obligations and expect to continue to do so while we remediate these material weaknesses.” 

As of March 31, 2022, those weaknesses had still not been remediated… but the company reported it had $335 million in cash as of that same day, the day of its first quarter reporting.

All that cash, all those funding rounds, and a crashing stock price.. under a management structure the company admitted had “material weaknesses.” 

Still too risky? Most investors would agree. 

But then there’s the 400 pound gorilla in the room: Predictions of a global psychedelic drugs market are very encouraging to say the least. Data Bridge Market Research says that the global market is expected to reach $6.4 billion by 2029, up from $2.4 billion in 2021.

Positive signs one day, red flags the next, all coming amidst projections of a wildly profitable industry just gaining its footing and attracting more startups. What’s the end game here?

There’s always risk in any business. But as the saying goes: Let the buyer beware.


Dave HodesJune 14, 2022
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13min10220

One of the most important benefits of psychedelics research and development is how it has employed the newest approaches of medical technology to find out exactly how and what psychedelics do inside the human body. 

Most of what psychedelic compounds research is about today are how psychedelics target the human serotonin 2A receptor used to treat neuropsychiatric diseases in the brain for such conditions as treatment-resistant depression, PTSD, and a host of other mental health conditions.

There’s still a lot to learn, and precision medicine is becoming a trusted guide in discovery and treatment.

Precision medicine is defined as an approach to medical care in which disease prevention, diagnosis, and treatment are tailored to the genes, proteins, and other substances in the human body, according to the National Cancer Institute.

Precision medicine primarily uses genetic testing to identify changes in gene sequence such as deletions, additions, or misspellings; genome sequencing to accurately diagnose diseases that are difficult to diagnose using clinical or laboratory criteria alone; and biomarkers. 

Biomarkers

Biomarkers are almost any measurement reflecting an interaction between a biological system and a potential hazard, which may be chemical, physical, or biological, including everything from pulse and blood pressure through basic chemistries to more complex laboratory tests of blood and other tissues.

Genetic testing can determine that some people have inherited conditions that make them more likely to get a disease. For example, women with a BRCA1 or BRCA2 gene mutation are more likely to get breast or ovarian cancer, and men with a BRCA1 or BRCA2 gene mutation have an increased risk for breast cancer as well (and prostate cancer).

Precision medicine has been used in pharmaceutical development since it was first investigated beginning in 2011. Researchers suggested a framework for creating an information system of disease that integrates the rapidly expanding range of information on the causes of disease and allows researchers, healthcare providers, and the public to share and update the information. 

The idea behind the framework is that, by analyzing connections between information sets (for example between the genome and environmental exposures) scientists would be able to formulate and test disease mechanisms, and clinicians could develop new treatments based on unique features of a disease and tailored to each patient. The availability of more diverse information about each disease would allow insurers and health care providers to more precisely define disease subtypes.

When it comes to psychedelics, there are unique challenges for precision medicine and the ongoing search for how they work in the human brain. Molecular imaging studies with positron emission tomography (PET) or single-photon emission computer tomography (SPECT) are being used to depict the uptake and binding distribution of certain hallucinogenic compounds in the brain. Functional magnetic resonance imaging (fMRI) is helping researchers understand how specific psychedelics such as psilocybin and LSD work in the brain.

Researchers are coming up with improved precision medicine efforts to get a comprehensive understanding of the lasting effects of psychedelic treatment. To do that, they can employ a personalized patient care approach. 

One example of a personalized care approach is discussed in a recently published paper offering an evaluation of the synergistic use of virtual reality (VR) and psychedelic-assisted psychotherapy (PAP), providing recommendations on how clinicians and research organizations can best utilize VR integrated into a robust PAP protocol. It outlines contextual VR design specifications. 

The research demonstrates that VR can simultaneously allow a further glimpse into psychological and neurological mechanisms that are at play during an altered state. 

The authors of the paper suggest that VR can be utilized for its ability to mitigate psychological side effects through enhancing the state of relaxation; encouraging entering the inner world of experience by inducing a mindful presence, and; strengthening resilience around facing challenging experiences.

More explorations into personalized precision medicine for psychedelics come from Beckley Psytech Limited, a company addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, which partnered with Empatica, Inc., medical wearables and digital biomarker company offering continuous, passive monitoring for patients with neurological conditions to support the collection and analysis of behavioral and physiological data in Beckley Psytech’s future clinical trials.

The partnership allows Empatica’s EmbracePlus wearable device and associated software to identify and measure passive behavioral and physiological signals in the upcoming Phase 2 studies evaluating the use of 5-MeO-DMT (DMT) in combination with psychotherapy in the treatment of treatment-resistant depression (TRD). “The digital enhancement of the psychedelic treatment pathway aims to support patients before, during, and after treatment through the application of novel, predictive biomarkers which will potentially identify early signals of patient response and relapse,” according to a press release.

Another example is Ehave, Inc. (OTC Pink: EHVVF), a healthcare services and technology company, that just announced its KetaDASH subsidiary will begin using precision medicine techniques to improve patient outcomes through its partnership with HaluGen Life Sciences Inc. psychedelics genetic test kit. 

KetaDASH will use HaluGen’s expanded psychedelics genetic testing panel to test patients. The panel analyzes a series of relevant DNA biomarkers and utilizes pre-screening mental health surveys to provide insights into an individual’s risk and potential of adverse reactions with the use of ketamine. 

For example, the gene mutation CYP2B6 can influence the metabolism of ketamine for the 10-20 percent of people that carry a specific CYP2B6 gene variant. And the HTR2A gene mutation, which is carried by approximately 20 percent of the population, can impact how a person responds to serotonin, which is the primary mechanism of action for serotonergic psychedelics such as psilocybin, LSD, and DMT

For now, advancing precision medicine for psychedelics is all about collecting more data through other research sources following a broader agenda. At the Johns Hopkins’ Center for Psychedelic and Consciousness Research, researchers are focusing on how psychedelics affect behavior, mood, cognition, brain function, and biological markers of health, and say that they hope to create precision medicine treatments tailored to the specific needs of individual patients.

Beyond just psychedelics, utilizing precision medicine for all types of healthcare needs is the goal behind the National Institutes of Health’s (NIH) “All of Us” research program. It’s designed to gather health data from one million or more people living in the United States to accelerate research that may improve health by collecting data on biology, lifestyle and environment to help with any and all drug formulation. 

The program is working through 29 institutions and an integrated NIH database of nearly 100,000 genome sequences, survey responses from nearly 330,000 participants, and information from 214,000 electronic health records, alongside physical measurements and wearable device data.

The next digital frontier in precision medicine is quantum computing (QC), according to a McKinsey and Company report. “The molecules (including those that might be used for drugs) are actually quantum systems; that is, systems that are based on quantum physics. QC is expected to be able to predict and simulate the structure, properties, and behavior (or reactivity) of these molecules more effectively than conventional computing can,” according to the report. “Quantum computing could be the key to the exponentially more efficient discovery of pharmaceutical cures and therapeutics as well as to hundreds of billions of dollars in value for the pharma industry.”


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