Here’s What You Missed in Cannabis, Psychedelics This Week

In this week’s “Rising High,” The Fly’s recurring series focused on cannabis and psychedelic stock news, The Fly looks back on an entry into an adult-use market, a certification grant and a strategic investment.

ACREAGE LAUNCHES NEW YORK ADULT-USE OPERATIONS: Acreage Holdings (ACRHF) announced Wednesday that it has launched adult-use operations in New York. “We are tremendously proud to officially become an adult-use wholesale distributor in New York,” said Dennis Curran, CEO and Chairman. “As a New York-headquartered company and long-time medical operator in the state, we have been anxiously awaiting the launch of our adult-use operations here. We believe there is immense growth potential in the Empire State, with it expected to become one of the largest cannabis markets in the country, representing an incredible opportunity for us to dramatically increase our total addressable consumer base. We have built strong relationships in New York and are well prepared for this long-anticipated AU launch, with our team having identified key partners for sales. For years, our high-quality products have only been available to medical-use patients, and we are excited for adult-use consumers to now learn why so many patients choose The Botanist.” Specifically, The Botanist’s full product line, which includes flower, infused pre-rolls, edibles, capsules, and tinctures, is now available for wholesale purchase to eligible adult-use dispensaries across New York. Products are anticipated to hit participating dispensary shelves the week of January 8, 2024. On December 8, NYCANNA, a wholly owned subsidiary of Acreage, received approval to enter New York’s adult-use market from the New York Cannabis Control Board. In addition, the CCB further approved NYCANNA to operate up to three, co-located dispensaries. (read more)

CLEVER LEAVES GRANTED AUSTRALIAN GMP CERTIFICATION: Clever Leaves Holdings (CLVR) announced Wednesday it has been granted Australian GMP certification for its facilities in Colombia by the Therapeutic Goods Administration. This certification authorizes Clever Leaves to manufacture cannabis products for patients in Australia. The company said, “Similar to the stringent standards of the EU-GMP certification, the Australian GMP certification from the TGA ensures the delivery of the highest quality medicinal cannabis to patients. It safeguards against product contamination, variations in compound concentrations, mix-ups, incorrect labeling, and other potential issues. This certification is a prerequisite for the manufacturing and commercialization of cannabis products in the Australian market. This achievement underscores Clever Leaves’ commitment to maintaining premium and high-quality standards in its production processes.” (read more)

ATAI LIFE SCIENCES INVESTS IN BECKLEY PSYTECH: atai Life Sciences (ATAI) announced Thursday a strategic investment in Beckley Psytech, a private clinical-stage biotechnology company dedicated to transforming short-duration psychedelics into effective and rapid-acting medicines for neuropsychiatric conditions. The company said, “This strategic investment and collaboration aims to accelerate the development of Beckley Psytech’s two clinical-stage, patent-protected, short-duration psychedelic candidates, BPL-003 and ELE-101, by adding them to atai’s mental health innovation platform.” BPL-003 is a novel, short-duration, intranasal formulation of 5-methoxy-N,N-dimethyltryptamine and ELE-101 is a novel intravenous formulation of psilocin, the primary moiety of psilocybin. BLP-003 is currently in development for two indications: Treatment Resistant Depression and Alcohol Use Disorder, with three clinical trials underway. Beckley Psytech’s second candidate ELE-101 is being developed for the treatment of Major Depressive Disorder. Initial results from the current ELE-01 Phase 1/2a study are anticipated in the first half of 2024. Under the terms of the investment Beckley Psytech will remain an independent, privately-owned company and atai will own 35.5% of Beckley Psytech. This is based on a $50M total investment, with a $40M direct investment into the company to fund ongoing research programs, and an additional $10M in secondary share purchases from existing shareholders. Upon closing, atai will receive 1:1 warrant coverage at a 30% premium on the primary issuances. atai will also have the right to appoint and hold three of the nine seats in Beckley Psytech’s Board of Directors, and will hold a time-limited right of first refusal on a future sale of the company, asset sales or other transfer of commercial rights, as well as an indefinite right of first negotiation for BPL-003 and ELE-101. (read more)

Additionally on Tuesday, atai announced results from its Phase 1 study evaluating orally administered EMP-01, the R-enantiomer of MDMA. The goals of this Phase 1 study were to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of EMP-01. The four-cohort, single-ascending dose, randomized, double-blind, placebo-controlled study enrolled 32 healthy participants who received 75mg, 125mg, 175mg or 225mg of EMP-01 or placebo in a 6+2 design. EMP-01 was well-tolerated, and treatment-related adverse events were all expected and generally dose dependent. There were no study discontinuations, and no serious or severe AEs were observed in the study. Non-clinically significant increases in blood pressure and heart rate were observed, though such changes showed limited dose dependency. Further, the peak body temperatures observed fell within the normal range. Finally, bruxism was observed in only 1 of 24 subjects that received EMP-01. The PK profile of EMP-01 was dose-proportional. The PD measures included both subjective reports and blood-based biomarkers. Significant, consistent and dose-dependent changes were seen on several of these exploratory PD measures. EMP-01 administration resulted in a differentiated subjective experience compared to racemic MDMA on standard psychedelic experience questionnaires. Further, dose dependent changes on measures of emotional breakthrough, a phenomenon thought to be a key mediator of the long-term psychological changes associated with psychedelics, were noted in this healthy volunteer population. (read more)

IM CANNABIS CONCLUDES CONSTRUCTION LEGAL PROCEEDINGS: IM Cannabis (IMCC) announced Tuesday that the construction proceedings against Focus Medical Herbs, were concluded on December 28. The company maintains “de facto” control of Focus Medical. Focus Medical was indicted and a fine of C$129,000 has been imposed. The cultivation facility, which was the focus of the proceedings, was closed in June 2022 in alignment with the company’s strategic shift towards import and sales. “The company continues to operate as usual. The importation and sale of our premium brands remain unaffected. Under the circumstances this is the best outcome we could have obtained, and we can look at this as an achievement,” said Oren Shuster, CEO. (read more)

VILLAGE FARMS LAUNCHES BRANDS IN UK: Village Farms International (VFF) announced Wednesday the first shipment and launch of two cannabis brands in the United Kingdom. The company’s Pure Sunfarms and The Original Fraser Valley Weed Co. brands will be distributed by 4C LABS, a UK medical cannabis company. The launch includes three of Village Farms’ most popular strains in Canada: Pink Kush, Jet Fuel Gelato and D. Burger. “This launch of our leading BC-grown cannabis brands is a game-changer for patients in the UK, the third most populated country in Europe,” said Michael DeGiglio, CEO. “We are proud to launch brands and products in the UK that have driven our top-three market share performance in Canada, while also proving successful in other international markets.” (read more)

CANNABIS/PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Aleafia Health (ALEAF), Audacious (AUSAF), Aurora Cannabis (ACB), Avant Brands (AVTBF), Ayr Wellness (AYRWF), Awakn Life Sciences (AWKNF), Body and Mind (BMMJ), BZAM (BZAMF), Cannara Biotech (LOVFF), Canopy Growth (CGC), Chicago Atlantic (REFI), Clearmind (CMND), CordovaCann (LVRLF), Cresco Labs (CRLBF), Cronos Group (CRON), Columbia Care (CCHWF), Compass Pathways (CMPS), CURE Pharmaceutical (CURR), Curaleaf (CURLF), CV Sciences (CVSI), Cybin (CYBN), Delic Holdings (DELCF), Delta 9 (DLTNF), Entourage Health (ETRGF), Enveric Biosciences (ENVB), Fire & Flower (FFLWF), Flora Growth (FLGC), Trees Corporation (CANN), Goodness Growth (GDNSF), Greenlane (GNLN), Green Thumb (GTBIF), GrowGeneration (GRWG), Hemp (HEMP), High Tide (HITI), India Globalization Capital (IGC), Indiva (NDVAF), Innovative Industrial Properties (IIPR), InterCure (INCR), Wellbeing Digital (KONEF), Khiron Life Sciences (KHRNF), Lowell Farms (LOWLF), Lotus Ventures (LTTSF), Lucy Scientific Discovery (LSDI), MediPharm (MEDIF), MedMen (MMNFF), MindMed (MNMD), NewLake Capital (NLCP), Numinus (NUMIF), Organigram (OGI), Planet 13 (PLNHF), Reunion Neuroscience (REUN), Revitalist (RVLWF), RIV Capital (CNPOF), Relmada (RLMD), RYAH Group (RYAHF), Safe Harbor Financial (SHFS), Small Pharma (DMTTF), SNDL (SNDL), Sproutly (SRUTF), Skye Biosciences (SKYE), Stem Holdings (STMH), Sunniva (SNNVF), TerrAscend (TRSSF), Tetra Bio-Pharma (TBPMF), Tilray (TLRY), Trulieve (TCNNF), Tryp Therapeutics (TRYPF), Verano (VRNOF), Wesana Health (WSNAF), Zynerba (ZYNE) and 4Front Ventures (FFNTF).