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 a bill advancement, a product launch and a CFO departure.

SENATE COMMITTEE ADVANCES CANNABIS BANKING BILL: A U.S. Senate committee voted to advance The Secure and Fair Enforcement Regulation Banking Act bill, increasing hope that the cannabis industry will get access to regular banking services, Reuters’ Arunima Kumar and Sourasis Bose reported Wednesday. The bill, which was introduced by a bipartisan group of senators, will now proceed to the Senate floor and comes as most U.S. banks do not serve the cannabis sector as the plant remains federally illegal. The bill seeks to ensure that all businesses, including cannabis businesses, have access to deposit accounts, insurance and other financial services. (read more)

MEDIPHARM LAUNCHES NEW PRODUCTS IN AUSTRALIA: MediPharm Labs (MEDIF) announced Wednesday that Canadian produced GMP Beacon Medical cannabis oil and inhalation cartridges have now been launched in the Australian medical market. The cannabis oil portfolio is comprised of a high CBD Isolate oil, a balanced oil and a THC dominant full spectrum oil made with Beacon’s medical flower strains. The inhalation cartridges include flavour-forward options and strain-specific full spectrum cartridges that utilize flower varieties already favored by Beacon Medical patients. With Beacon Medical’s Pink Kush and GSC products now available in flower, oil and inhalation formats, the company provides physicians and patients with three unique delivery methods to consume the same full spectrum strains. Deliveries of inhalation cartridges to patients began this week, and cannabis oils are scheduled to ship from Canada this week. (read more)

GOODNESS GROWTH CFO DEPARTS: Goodness Growth Holdings (GDNSF) announced Tuesday that the company’s CFO John Heller will depart, effective September 30, to accept a new external opportunity. Interim CEO Josh Rosen will assume the additional role of Interim CFO. Rosen said, “The strength of the team John has established, combined with our increasingly less complex organization give us confidence that we can fulfill our CFO responsibilities with existing internal resources. We’re excited to see some of the talent that John helped develop take on greater responsibility including Joe Duxbury, Aaron Garrido, and Brandon Van Asten, who have been instrumental in supporting our push toward more decentralized operations.” (read more)

SMALL PHARMA REPORTS SPL026-SSRI INTERACTION DATA: Small Pharma (DMTTF) announced Tuesday safety, tolerability and efficacy data from its Phase Ib study exploring the interaction between selective serotonin reuptake inhibitors and SPL026, native N, N-dimethyltryptamine, in patients with Major Depressive Disorder. The purpose of this study was to build upon the previously reported Phase I/IIa safety and efficacy profile of SPL026 with support therapy, to assess whether SPL026 can be safely administered with or without SSRIs. In the Phase I/IIa SPL026 study, patients were required to be withdrawn from SSRIs, which can be a disruptive experience. Through the SPL026-SSRI drug interaction study, Small Pharma aimed to address this requirement, which could enable broader patient recruitment on future large-scale studies, and potentially accelerate the clinical development pathway. Additionally, removing the requirement to be withdrawn from SSRIs may facilitate patient access to SPL026 earlier in the MDD treatment journey, if approved. This open-label study investigated the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of a single 27.5 mg intravenous infusion of SPL026, alone or in combination with SSRIs, in 171 patients, together with support therapy. The test cohort consisted of patients currently on a stable treatment course of SSRIs, which have been ineffective in fully relieving their depression symptoms. The control cohort consisted of patients not currently using any pharmacological treatment to treat their depression symptoms. Patients were recruited with moderate-severe MDD as defined by a Hamilton Depression Rating Scale score of >14. Efficacy was assessed using the Montgomery-Asberg Depression Rating scaleto measure any change in patients’ depression symptoms from baseline. Additional exploratory endpoints include the Beck Depression Inventory to assess patients’ self-reported depression. SPL026 was well-tolerated by all patients in both the SSRI Cohort and Non-SSRI Cohort, with no apparent differences between cohorts. No drug-related serious adverse events reported. A small number of drug-related adverse events reported. Majority of drug-related AEs were resolved during the dosing visit. The results reaffirmed the efficacy initially demonstrated in the Phase IIa SPL026 study. However, a marked improvement was observed between the antidepressant effect of SPL026 treatment in the SSRI Cohort compared to the Non-SSRI Cohort. While the efficacy observed in the Non-SSRI Cohort was comparable to the efficacy data previously observed in the Company’s SPL026 Phase IIa clinical trial, the antidepressant effects observed in the SSRI Cohort were of a greater magnitude, suggesting a potentially enhanced efficacy effect when SPL026 is administered in combination with SSRIs. (read more)

CYBIN, FLUENCE PARTNER FOR EMBARK TRAINING: Cybin (CYBN) announced Tuesday an agreement with Fluence to support the streamlining and scaling of Cybin’s EMBARK facilitator training program in preparation for a multi-site, global Phase 3 trial of CYB003, its proprietary deuterated psilocybin analog in development for the potential treatment of major depressive disorder. This streamlined model of psychedelic facilitation training, known as EMBARK for Clinical Trial, is designed for individuals with existing experience, knowledge, and skills in psychedelic facilitation. Under the terms of the agreement, Fluence will support Cybin in the selection and training of facilitators for the planned Phase 3 trial. Fluence will also create supplemental video content and provide asynchronous and synchronous training in service of augmenting and verifying facilitator competencies. (read more)

CANNABIS/PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Aleafia Health (ALEAF), Acreage (ACRHF), Atai Life Science (ATAI), 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), Clever Leaves (CLVR), CordovaCann (LVRLF), Cresco Labs (CRLBF), Cronos Group (CRON), Columbia Care (CCHWF), Compass Pathways (CMPS), CURE Pharmaceutical (CURR), Curaleaf (CURLF), CV Sciences (CVSI), Delic Holdings (DELCF), Delta 9 (DLTNF), Entourage Health (ETRGF), Enveric Biosciences (ENVB), Fire & Flower (FFLWF), Flora Growth (FLGC), General Cannabis (CANN), Greenlane (GNLN), Green Thumb (GTBIF), GrowGeneration (GRWG), Hemp (HEMP), HEXO (HEXO), High Tide (HITI), India Globalization Capital (IGC), Indiva (NDVAF), Innovative Industrial Properties (IIPR), InterCure (INCR), IM Cannabis (IMCC), Wellbeing Digital (KONEF), Khiron Life Sciences (KHRNF), Lowell Farms (LOWLF), Lotus Ventures (LTTSF), Lucy Scientific Discovery (LSDI), MedMen (MMNFF), MindMed (MNMD), NewLake Capital (NLCP), Numinus Wellness (NUMIF), Organigram (OGI), Planet 13 (PLNHF), Reunion Neuroscience (REUN), Revitalist (RVLWF), RIV Capital (CNPOF), Relmada (RLMD), RYAH Group (RYAHF), Safe Harbor (SHFS), 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), Village Farms (VFF), Wesana Health (WSNAF), Zynerba (ZYNE) and 4Front Ventures (FFNTF).