The company is funded through 2026.
The company is funded through 2026.
The company received approval in the Netherlands to start dosing humans with one of its compounds.
The Daily Hit is a recap of cannabis business news for Jan. 11, 2023.
Connecticut Recreational Cannabis Sales Top $250,000 on Day One
According to Biotrack, the cannabis technology platform Connecticut uses to trace marijuana inventory from seed to sale, those seven retailers passed the $250,000 mark by 5 p.m. after just seven hours of sales, bringing crows of victory from state regulators. Read more here.
More from Connecticut’s Adult-Use Cannabis Launch:
Algernon Pharmaceuticals Looks to Advance DMT Stroke Research
Treating stroke with DMT (N, N-Dimethyltryptamine) is a novel idea being pursued by Algernon Pharmaceuticals (CSE: AGN) (FRANKFURT: AGWO) (OTCQB: AGNPF), a Vancouver-based clinical stage drug development company. The opportunity is big, with the global stroke treatment market is expected to reach $15 billion by 2027. Read more here.
REITs on the Downslope?
The REIT trend appears to be cooling down, according to data from Cannabiz Media. In the third quarter of last year, just four deals were solidified for a total value of $90 million, down from a high of nine deals worth $305 million in the fourth quarter of 2019. Read more here.
Kaya Group (OTC: NUGL) announced its Kaya Extracts subsidiary plans to enter the legal psilocybin market in Jamaica where the laws are relaxed, targeting the multibillion-dollar industry for the development, marketing, and distribution of psilocybin mushrooms. Read more here.
Grown Rogue International
Grown Rogue International Inc. (CSE: GRIN) (OTC: GRUSF), a craft cannabis company operating in Oregon and Michigan, issued a total of 200,000 common shares, at the current market price, to an owner of Golden Harvests LLC. The common shares were issued pursuant to an option agreement relating to the prior acquisition of a 60% controlling interest in Golden Harvests by Canopy Management LLC in May 2021. Read more here.
In a Monday bid to dismiss claims that they misclassified drivers as independent contractors in violation of the Fair Labor Standards Act and the Pennsylvania Minimum Wage Act, FarmaceuticalRX and five other companies said that there was no indication that they operated jointly or that any of them employed their accusers. Read more here.
Algernon wants to use psychedelics as a therapy for stroke victims.
More groups are researching the effect of psychedelics on TBI.
Canadian clinical stage drug development company, Algernon Pharmaceuticals Inc. (CSE: AGN) (OTCQB: AGNPF), has entered a clinical trial agreement with Yale University to study DMT for the treatment of depression.
Algernon will provide DMT for the study in return for intellectual property rights with Yale around the clinical use of the drug. The company will also have the option to negotiate licenses to both IP developed jointly and IP developed solely by Yale — subject to rights reserved by the US government in conjunction with publicly funded research.
“The study may enhance our current understanding of the dosing regimen in the subjective effects induced by DMT,” said Deepak D’souza, the trial’s principal investigator and professor of psychiatry and director of Schizophrenia Neuropharmacology Research Group at the Yale University School of Medicine.
D’Souza is an experienced researcher with DMT and other controlled substances.
Algernon will also receive data from the study that it could use for its DMT stroke research program.
“After careful consideration, we chose to support Dr. D’Souza’s clinical DMT study and work with Yale University,” said Christopher Moreau, CEO of Algernon Pharmaceuticals. “Although the treatment of psychiatric disorders with DMT is not the company’s current focus, we have patents pending on novel forms of DMT which could potentially be used across a broad range of diseases. In addition, we believe the data generated from this study may help inform Algernon’s stroke research program.”
“A rising tide lifts all boats, and we feel a corporate responsibility as well to improve global awareness and support psychedelic medicine research when possible. It is in that spirit that we also chose to become the lead sponsor of Wonderland, the world’s largest conference on psychedelic medicine to be held November 3-5 in Miami.”
N, N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD and psilocybin. DMT occurs naturally in many plant species and animals including humans and has been used in religious ceremonies as traditional spiritual medicine by indigenous people in the Amazon. DMT can also be synthesized in a laboratory.
The “double-blind, placebo-controlled, crossover-controlled” study will compare different bolus and constant infusion dosing regimens of DMT in healthy control participants and individuals with depression.
Algernon has active research programs for idiopathic pulmonary fibrosis (IPF) with chronic cough, chronic kidney disease and a psychedelic program investigating a proprietary form of DMT for stroke.
The psychedelics industry is attracting more attention from less scrupulous operators who see the reward as worth the risk.
GH Research PLC (Nasdaq: GHRS) reported financial results for the second quarter ended June 30, 2022 and gave updates on its business. The company has no revenue at this time and is focused on developing its DMT drugs for mental health issues. The company also said it does not expect to have revenue for several years. GH Research has $265.4 million in cash as of June 30, 2022, compared to $276.8 million as of December 31, 2021. The company said it believes that has enough capital to fund its operating expenses and capital expenditure requirements into 2025.
GH Research reported a net profit of $0.3 million, or $0.006 earnings per share, for the quarter versus a net loss of $2.1 million, or $0.053 loss per share, for the same quarter in 2021. This was due to the foreign exchange gain in the quarter.
R&D expenses were $4.2 million for the quarter versus $2.0 million for the same quarter in 2021. The increase was primarily due to increased activities relating to the company’s technical development and clinical trials and increases in employee expenses to support these activities. G&A expenses were $2.5 million for the quarter versus $0.7 million for the same quarter in 2021. The increase was primarily due to an increase in insurance costs, as well as increased employee expenses.
Small Pharma (OTC: DMTTF), a London-based neuropharmaceutical company focused on psychedelic-assisted therapies, made big news recently with the announcement of the first clinical trial in February 2021, using N, N-Dimethyltryptamine (DMT) to treat major depressive disorder. “We’re doing it in combination with psychotherapy, because we have reasons to believe that what psychedelics really do is enhance the potential for psychotherapy to improve the condition,” Small Pharma CEO Peter Rands told Psychedealia.
“We conducted a phase 1 clinical study in 2021, completed in September, that assessed four different dose levels of DMT in 32 psychedelic naïve volunteer subjects because the majority of major depression sufferers will be psychedelics naïve,” Rands said.
DMT is a very short and intense experience and is given by interjection, that lasts about 20 minutes. “What we’re trying to demonstrate with the patient study, and where we’ve taken the sort of optimal base, is to give a fully psychedelic experience to everyone that participated,” he said. “They would have a full psychedelic experience and a very good tolerability, which was largely what we’re trying to assess in psychedelic subjects, as well as DMT being their first psychedelic experience.”
They are in the next phase of the clinical study, initiating the blinded, randomized, placebo-controlled, proof-of-concept Phase IIa study in 42 patients with major depressive disorder.
That study is being held at two UK clinical trial sites—Hammersmith Medicines Research and MAC Clinical Research—and has been modeled on an ayahuasca case study, Rands said. DMT is often associated with ayahuasca because it is the brew’s main psychoactive ingredient.
Results are anticipated sometime this year. “The critical difference is that ayahuasca creates a long-lasting psychedelic experience, which is made orally available,” he said, noting that DMT is not normally orally active, but it can be drunk. “If we’re successful, then we will take this to phase 2b, and we will progress our pipeline,” Rands said.
Small Pharma began in 2015 when Rands and his team were looking for viable projects they could initiate based on known active ingredients with some sort of proprietary and innovative profile. “That took us to mental health, and specifically the role of ketamine in treating depression,” Rands said. “We discovered reading in the literature that there was very promising preclinical data supporting a rapid-acting antidepressant quality of one of the ketamine metabolites. It didn’t have the same abuse potential that ketamine has, which at the time was a big question about the commercial viability of ketamine as a treatment.”
He said that they started with that project, but two years later, with the data coming out about psychedelics, they switched focus. “We thought what would really change patients’ outcomes will be the psychedelic space not the sort of non-psychedelic headspace, as it were.”
Why the name Small Pharma? Rands wrote on the company website that they called themselves Small Pharma because they “knew more what we weren’t than what we were. We weren’t deep-pocketed or well known, which meant we were unencumbered by legacy pipelines or mismanaged expectations.
He explained further: “We are focused at the stage of development where Big Pharma typically struggles to innovate these days,” he said. “We don’t consider ourselves different, fundamentally, from Big Pharma. It’s all the same people who work in these companies,” Rands said. “What does separate us is the mission. So we can and should work on higher risk programs, that if they succeed, we’ll have a very strong value increase up until the stage where it can be passed on to big pharma company.”
Rands said that while Small Pharma hasn’t partnered with any big pharma companies yet because they feel that there is more clinical work they can do before entering a deal. But that it’s “always been on our radar.”
The psychedelic world was caught by surprise when boxer Mike Tyson admitted using DMT (5-MeO-DMT) on a dare for the first time in 2017—a powerful psychedelic derived from the venom of the Sonoran Desert toad (and other plant species). Tyson was looking for help with problems in his life at the time. He claims DMT changed everything for the better.
He has now tripped on this strong version of DMT over 53 times, and reportedly has a nursery of Sonoran Desert toads at his ranch in Desert Hot Springs, California.
What Tyson is taking is DMT that 4 to 6 times stronger and more intense than the other plant-based version, N,N Dimethyltryptamine, which is the active ingredient of the psychoactive drink, ayahuasca. There is also a DMT derivative found in certain marine sponges.
People who experience DMT talk about entering “hyperspace” in a private “ritual-like” personal experience. It is known to produce out-of-body states and profound changes in sensory perception.
It works fast—if smoked or injected, DMT peaks within a few minutes, and is over within an hour.
Lab research is limited, but the first field study of DMT was done in late 2021 with experienced DMT users observed during their non-clinical use of the DMT at home, and later interviewed after their experience. They reported profound and highly intense experiences, including encounters with other beings, and experiences of going into other worlds.
Those intense experiences from DMT—some reportedly akin to alien abduction and near death—are part of the reason that DMT has, until recently, been low on the list of psychedelics researchers. They are trying to figure out the best way to use it for human health conditions, generally working with small groups of people who are experienced using DMT. But as the Tyson story demonstrates, DMT curiosity among the general public is growing. Researchers today are finding more first-time users signing up for studies.
The first human experience with pure DMT was in April 1956, when Hungarian chemist and psychiatrist Stephen Szara self-administered it intramuscularly and reported sensations such as “brilliantly colored oriental motifs and wonderful scenes altering rapidly.”
There have been just a few other studies since the mid-1990s concentrating on the hyperspace effect, and descriptions of the alien entity encounters and descriptions.
But the pace of studies is quickly changing.
Researchers believe that something significant can be done with a substance where people who use it experience “breaking through” to other immersive worlds that are hyper-vivid, intricate and impossible, as well as interacting with other beings such as aliens, fairies, or even clowns.
It is believed that the DMT experience can help increase a person’s worldview, decrease death anxiety, aid the personal connection with oneself—all of which are the positive basic goals of psychedelic research using other substances.
Other studies find that DMT naturally occurs in mammals, and may be made and secreted in the human pineal gland.
There is an expanding list of uses of both N,N-Dimethyltryptamine and 5-MeO-DMT that go beyond mental health issues—from recovering motor and sensory function after a spinal cord injury, to preventing tooth loss, to treating food allergies and even as a “novel rodent control agent” in a study by the National Institutes of Health and Harvard College.
Yale University is studying DMT to treat headaches; Applied Biology Inc., headquartered in Irvine, California, a biotechnology company specializing in hair science, is studying DMT as a topical agent to treat hair loss; Rejoy, also based in Irvine, California, is studying DMT for a topical application treating female sexual dysfunction.
Researchers are intrigued by the stronger version of DMT because it works much faster than psilocybin, making it easier to use as a method to treat depression and anxiety, according to Alan Davis, an adjunct assistant professor in the Psychedelic Research Unit at Johns Hopkins University. “Because 5-MeO-DMT is short-acting and lasts approximately 30-90 minutes, it could be much easier to use as an adjunct to therapy because current therapies usually involve a 60–90-minute session,” Davis said.
Researchers always caution using DMT recreationally or in any uncontrolled setting because of its strong and overpowering effect. But DMT apparently has found its way into the psychedelics underground, with nicknames such as Dimitri, fantasia, businessmen’s trip, businessmen’s special, 45-minute psychosis floating around.
There is still much to find out about DMT, according to a 2018 study about its role and function as a therapeutic. “At present, the data arguing for the use of DMT as a therapeutic, particularly via administration, is thin,” the study stated. “There have been proposals that DMT might be useful to treat substance abuse, inflammation, or even cancer. However, at this point, the necessary data to support such proposals have not been presented and it would be premature to propose that DMT will become commonly used for clinical purposes.”
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