psychedelics Archives - Green Market Report

StaffFebruary 3, 2023
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3min2890

Origin Therapeutics Holdings Inc. (CSE:ORIG) is buying Safe Supply Streaming Co. Ltd. as per a binding LOI with a formal agreement expected by the end of February. Origin is an investment issuer that has historically focused on making equity investments in psychedelics-industry-related. It should be noted that in December 2022 Origin announced that its board of directors had initiated a review process to consider, review and evaluate strategic alternatives for the company.

Safe Supply will complete an arm’s length equity financing of at least $3 million and no greater than $4 million subscription receipts ultimately exchangeable into Resulting Issuer Shares. The proceeds from the Private Placement will be used to fund working capital and general corporate purposes, including potential streaming investments.

Upon closing of the Private Placement, the Resulting Issuer will have more than $6 million in cash to execute its business plan. Origin has agreed to lend up to $500,000 as interim financing to Safe Supply to allow Safe Supply to execute near-term business objectives.

Safe Supply is a pharmaceutical streaming and investment company tackling the global safe supply ecosystem. Safe Supply has a portfolio of potential letters of intent for investments across the value chain from narcotics licenses to laboratories to clinics and more.

Recently, Health Canada and British Columbia’s provincial governments moved to decriminalize certain schedule 1 narcotics marking the third and the final wave of de-scheduling in Canada in its movement to fight the healthcare crisis. The safe supply of cannabis and legalization started in 2013 in Canada. Following the success of cannabis legalization, in 2019 the Canadian government launched the second wave of de-scheduling narcotics with psychedelics and psychedelic-assisted therapy. The company said in a statement, “This third and final wave of de-scheduling marks a monumental period for the country and presents a unique opportunity for investors and commercial operators to work with the Canadian government to advance their efforts.”


Dave HodesJanuary 31, 2023
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7min7040

Most psychedelics clinical trials have some degree of failure in that there are people in the trial who simply can’t tolerate psychedelics as a therapeutic option—usually called adverse events. Common adverse events include headaches, nausea, vomiting, diarrhea, and anxiety. Researchers expect that there are more serious adverse events that go unreported.

Indeed, these adverse events have not been well studied, even as researchers focus on harm reduction during clinical trials in the hopes of bringing in larger groups of participants.

Future studies should describe the timing and severity of effects more extensively, one study concluded, adding that full transparency about adverse events is “a responsibility of clinicians, particularly in a nascent field fueled by the enthusiasm of pioneering researchers.”

One well-known adverse event is the so-called “flashback” from LSD use. But it is considered rare and occurs almost exclusively in the context of illicit recreational use in patients with anxiety disorders, and it typically will have a limited course of months to a year.

But exactly how a certain psychedelic affects any one patient is still a bit of a mystery, according to one study. “Larger studies need to validly define the benefits of using hallucinogens as an adjunct to psychotherapy and the patient characteristics that may predict such additional benefits of hallucinogens. Unclear are the aspects of the acute response to hallucinogens that best predict good long-term therapeutic outcomes.”

Outside of clinical trials, patient tolerance of psychedelics, and the benefit they get from psychedelic therapy, are issues that have been addressed numerous times, mostly with positive results, such as in the 2015 study published in the Journal of Psychopharmacology.

Using a data set of 135,095 randomly selected United States adults, including 19,299 psychedelic users, the associations between psychedelic use and mental health were studied, resulting in no significant associations between lifetime use of psychedelics and increased likelihood of past year serious psychological distress, mental health treatment, suicidal thoughts, suicidal plans and suicide attempt, depression and anxiety. “We failed to find evidence that psychedelic use is an independent risk factor for mental health problems,” the study concluded. “Psychedelics are not known to harm the brain or other body organs or to cause addiction or compulsive use; serious adverse events involving psychedelics are extremely rare. Overall, it is difficult to see how prohibition of psychedelics can be justified as a public health measure.”

Much of the newer science and research by psychedelics companies is aiming at identifying and controlling the hallucination effect from psychedelics in the hopes of scaling up psychedelics therapies to a broader demographic of people seeking mental and physical help.

For example, a genetically encoded biosensor to detect hallucinogenic compounds has been developed by researchers at the University of California, Davis, called the psychLight. Researchers can use psychLight to see how naturally occurring neuromodulators like serotonin, or hallucinogenic drugs, act on different parts of the brain.

Another approach gaining acceptance is to try carefully measuring a micro-dosage of the psychedelic treatment as a method of avoiding any profound hallucinogenic experiences—Algernon Pharmaceuticals’ (OTC: AGNPF) DMT treatment for stroke is one example.

A more recent discovery helps shed new light on who can use psychedelics and who cannot.

University of North Carolina School of Medicine researchers, led by Dr. Bryan Roth, MD, who also leads the National Institutes of Health Psychotropic Drug Screening Program, reported in a study in July that one reason for treatment disparity could be common genetic variations in one serotonin receptor.

Their study results indicated that some gene variations—even ones far from the exact location where the drug binds to the receptor—alter the way that the receptor interacts with the psychedelic drugs.

“Based on our study, we expect that patients with different genetic variations will react differently to psychedelic-assisted treatments,” Roth said. “We think physicians should consider the genetics of a patient’s serotonin receptors to identify which psychedelic compound is likely to be the most effective treatment in future clinical trials.”

The researchers worked with psilocybin, DMT, mescaline and LSD. The research was financed in part by The National Institutes of Health (NIH) and the Defense Advanced Research Projects Agency (DARPA).

“This is another piece of the puzzle we must know when deciding to prescribe any therapeutic with such dramatic effect aside from the therapeutic effect,” Roth said. “Further research will help us continue to find the best ways to help individual patients.”


Dave HodesJanuary 3, 2023
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9min22770

With all the twists and turns coming from the U.S. federal government, decriminalization and legalization of psychedelics advancing all across the country, and companies scrambling to secure patents on novel molecules, predictions about the future of an industry as new as psychedelics can be tricky at best. 

There are no sure answers to how the various psychedelics businesses are going to do this year. Some say the psychedelic businesses exist within a hype bubble. The truth is that revenue growth will still be iffy this new year. Psychedelic stocks experience crashes, then revive, in an unpredictable cycle. 

Funding expensive research and development is still creating growth restraint even as it uncovers more positive results for treating mental health conditions. 

But for some industry watchers and business developers, and even in some respected mainstream publications like The Economist, it’s beginning to look like 2023 may be the year when the world starts paying more attention to what is going on in the psychedelics industry. 

And even with the uncertainties, no one is backing down from predictions about a multi-billion dollar psychedelics industry developing over the next few years.

Psychedealia talked to three psychedelics business leaders to get their take on what might happen in 2023:

Greg Mayes, President, and CEO, of Reunion Neuroscience Inc. (NASDAQ: REUN), said, “I think we’re all excited that larger studies have begun to report more robust data supporting the efficacy of many compounds in later stage development in the treatment of depression and post-traumatic stress disorder. In 2023, I think everyone expects that we should be at or extremely close to the first regulatory approval for medicine for mental health use of a psychedelic backbone. From my perspective, that’s incredibly exciting and great news for patients and investors. And I think it’ll ultimately encourage further clinical development and maximization of the opportunity that psychedelics present for treatment options for mental health conditions.

“I think what we’ll see in 2023 is the first potential approval, or being on the cusp of the first approval, which I think will really put to rest any regulatory concerns or overhang over the space. I think that the concerns of regulatory overhang have dissipated. I think what we saw in 2022 was what I call a warming experience or the opportunity for regulators to finally start to say that they are going to designate a couple of companies and programs with breakthrough designation status. They are going to help move companies into phase three pivotal programs. That’s a huge help. I think what’s really driving the regulatory agencies—and what is driving me to get out of bed every day—is that we’re dealing with a mental health crisis in this world. And the agencies want to help companies like Reunion Neuroscience develop safe and efficacious molecules where there’s been no innovation in close to 35 years.

“But what I’d like to also add for 2023 is that I think that psychedelics will continue to be a mainstream therapeutic. They will start to really become part of the vocabulary when people think about mental health, depression and anxiety, potentially addiction, and the potential for other indications, which is truly exciting.”

Dr. Hans Eriksson, chief medical officer, HMNC Brain Health said, “I think there will be new data coming out. We know that there will be phase three data coming out from MAPS, at least. So it seems as if these first studies are aiming at sort of establishing the fact that psychedelics do work. They are followed by larger clinical trials. From our own perspective, we have an ongoing phase two study with prolonged release ketamine conducted in three countries in Europe, where we are using the take-it-home approach. Just the first dose of these medicines are given under physician supervision. So we are already taking the first steps in bringing ketamine out from the physician’s office.”

James Lanthier, CEO, Mindset Pharma commented, “I think what we’re doing is directly tied to trying to piggyback off of the really important work that’s been done over the last few years around what we call first-generation psychedelic drugs. 

“So 2022 for us was really the year where Mindset went from being this high-level concept for a lot of folks, as we were able to articulate it as a business, executing on what we described—which is what we’ve been saying all along has been a major opportunity—is trying to discover and develop novel drugs that hopefully will be optimized and make up for some of the shortcomings in first generation drugs.

“I think 2023 is going to be a really great year because we’re getting ever closer to approval for first-generation drugs. And I think the closer we get, the more we’ll start to see the infrastructure get developed on the clinic side and get more questions answered. There should be a lot of progress with MDMA, the phase three pivotal trials for psilocybin are going to be underway. So all of that is really great because I think that that will just continue to attract more institutional capital to the companies in the space that are doing serious work. I think it’ll continue to attract more real pharma interest to the space. The whole kind of psychedelic medicine moves from being this idea that’s really interesting to talk about, that’s backed by some really great science, to being close to being an on-the-ground reality and an option for patients.”


Adam JacksonOctober 10, 2022
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2min16570

Psychedelic drug maker Reunion Neuroscience (Nasdaq: REUN), formerly known as Field Trip Health, announced that Ronan Levy has stepped down from the board and resigned his post as director.

Levy co-founded Field Trip Health.

The company’s corporate secretary and general counsel, Paula Amy Hewitt, also resigned.

“The company wishes both Ronan and Paula much success in their future endeavors and greatly appreciates the contributions that they made to support Reunion as it transitioned to a stand-alone entity,” a spokesperson told Green Market Report.

The news follows Reunion’s recent tapping of Greg Mayes as president and CEO. Mayes has been poised to replace Levy since the Sept. 28 announcement.

A company spokesperson said that Hewitt served Reunion as corporate secretary, but “was not employed by the company.”

“As such, Reunion needed to align its board support with an existing employee,” the spokesperson added.

CFO Donna Wong will fill Hewitt’s post as legal advisor.


StaffOctober 6, 2022
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8min9140

The Daily Hit is a recap of cannabis business news for October 6, 2022.

ON THE SITE

Biden To Pardon Marijuana Convictions, Calls For Classification Review

President Joe Biden on Thursday announced a sweeping directive that would alter the laws surrounding cannabis and its classification as a dangerous substance, as well as grant pardons to those who suffered from the War on Drugs. In a statement, the president stated that he plans to pardon all prior federal offenses and begin an administrative review alongside Justice Department to process pardons for simple marijuana possession. Read more here.

Floridians Stocked Up On Cannabis Ahead Of Hurricane Ian

Florida operators that had to temporarily shutter last week amid Hurricane Ian’s wrath are coming back online, though some companies are still reeling from its violent landfall. With the Sept. 30 cutoff date for the fiscal third quarter, some companies could see some additional padding to earnings reports, as patients throughout the state flocked to stores early last week to stock up on medicine ahead of the storm’s arrival. Read more here.

Agrify To Help Three Companies’ Grows Go Vertical

Agrify Corporation (Nasdaq: AGFY) said that three companies have decided to operate their cultivation businesses using the company’s rapid deployment packs (RDPs) — a prepackaged, quick-to-deploy alternative to traditional grow facilities. Prairie State Cannabis LLC in Illinois, LowKey LLC in Massachusetts and MediFlora Cultivation LTD in South Africa have all elected to use the tech, which the company said is able to provide “best-in-class” cultivation capabilities in potentially as little as 60-90 days. Read more here.

Recreational Psychedelics Enters The Conversation

The medical psychedelics decriminalization efforts are growing, with now 20 different states (or cities and counties within states) either decriminalizing or working on decriminalizing psychedelics. There have been pushbacks, with complaints that some decriminalization efforts include making them the “lowest law enforcement priorities,” a ruling that still effectively criminalizes psychedelics. That same ruling applied to the decriminalization of cannabis. Read more here.

Zynerba Gets Patent For Fragile X Drug

Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, today announced that the U.S. Patent and Trademark Office has issued Patent No. 11,458,110, titled “Treatment of Fragile X Syndrome With Cannabidiol,” which includes claims directed to methods of treating Fragile X syndrome with cannabidiol. Read more here.

Green Thumb Industries Sees Board Shakeup

Three of four independent board members of Green Thumb Industries (OTC: GTBIF), including Dorri McWhorter, resigned over what the marijuana company said was “a disagreement as to the company’s policies and practices related to personal misconduct.” Read more here.

IN OTHER NEWS

Agrify Corporation

Agrify Corporation (Nasdaq : AGFY), a provider of cultivation and extraction solutions for the cannabis industry, today issued the following statement relating to the default of its customer Bud & Mary’s Cultivation, Inc. under a construction loan facility extended by Agrify to Bud & Mary’s associated with an Agrify Total Turn-Key Solution project and the lawsuit brought by Bud & Mary’s in response to the default notice. Read more here.

Bespoke Extracts, Inc.

Bespoke Extracts, Inc. (OTCQB: BSPK) today announced that the Colorado Marijuana Enforcement Division (MED) has approved Bespoke’s application for “suitability”. This approval enables Bespoke to acquire, subject to final state and local approval, any business licensed by the MED. Read more here.

Merchants & Marine Bank, CannaFirst Financial

Merchants & Marine Bank, a century-old Mississippi-based banking institution, has launched CannaFirst Financial, the first banking division dedicated to business owners in Mississippi’s quickly emerging cannabis industry. CannaFirst will serve clients in platform integration, online and mobile banking, cash transport, and treasury solutions. It is overseen and staffed by seasoned banking professionals with significant experience and certifications in emerging markets and industries. Read more here.

Neuraxpharm Group, Panaxia

Neuraxpharm Group, a European specialty pharmaceutical company focused on the central nervous system, and Panaxia (TASE: PNAX), a global pharmaceutical company that develops, manufactures and markets advanced medical cannabis products of pharmaceutical quality, today announced the signing of two addendums to their agreement to expand their collaboration into the Czech and Swiss markets. Read more here.

F1SeedTech, NewBreedSeed

F1SeedTech and NewBreedSeed (NBS) announced that they have entered into a definitive agreement, with F1SeedTech acquiring 100% of the shares of NBS. The merger creates the industry leader in F1 hybrid varieties of cannabis, combining the day-neutral breeding activities of NBS and the short-day breeding activities of F1SeedTech in Israel and the Netherlands, respectively. Read more here.

Optimi Health Corp.

Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, is applauding the government of Alberta’s decision to regulate some psychedelics for therapeutic use in the province. Read more here.

Cybin Inc.

Cybin Inc. (NEO:CYBN) (NYSE AMERICAN:CYBN), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics®, provided an update on its intellectual property progress in support of its research and development strategy. The company continues to prioritize the development of in-house IP and licensing opportunities that support its active development programs and future novel drug candidates. Read more here.


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