In this week's "Rising High," The Fly's recurring series focused on cannabis and psychedelic stock news, The Fly looks back on a paid membership program, a trial commencement and partnerships.
HIGH TIDE LAUNCHES CABANA ELITE PAID MEMBERSHIP: High Tide (HITI) announced Tuesday the launch of Cabana Elite, an optional paid membership upgrade for Cabana Club members. The company expects that ELITE will extend the Cabana Club membership program, attract new customers and instill even greater customer loyalty. High Tide anticipates that further discounts, benefits and promotions will be regularly added to ELITE.
"I am delighted to finally announce the launch of ELITE, the next evolution in our innovative discount club model and a huge milestone for High Tide. The continuous innovation from our team has positioned us as a top-performing Canadian cannabis company, and ELITE is the natural result of this success. By leveraging the strengths of our diversified cannabis ecosystem, we are providing additional value to ELITE members by offering discounts on High Tide's global online consumption accessories platforms. We see this as a big step towards building our loyalty program into a global cannabis community as we continue to convert price-conscious consumers from the illicit market into our legal cannabis ecosystem," said CEO Raj Grover.
IGC COMMENCES PHASE 2 TRIALS OF IGC-AD1: India Globalization Capital (IGC) announced Thursday that it has begun “A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Trial of the Safety and Efficacy of IGC-AD1 on Agitation in Participants with Dementia due to Alzheimer’s Disease”. The company has commenced the Phase 2 study at two U.S. sites with plans to add between three to five additional sites in the United States, Canada, and possibly South America to increase population diversity, promoting both the inclusion of underrepresented populations and helping the company to better understand the impact of IGC-AD1 on the population of the Americas. The trial will enroll 146 patients with one half, the treated group, receiving IGC-AD1, and the other half, the control group, receiving a placebo. The goal of the trial is to evaluate and establish the efficacy of IGC-AD1 in helping patients with Alzheimer’s dementia reduce neuropsychiatric symptoms such as agitation, which affects 76% of individuals with Alzheimer’s. IGC-AD1 relies on low-doses of THC, a psychoactive cannabinoid, and another compound as active agents in trials for Alzheimer’s. The formulation has recently completed Phase 1 of clinical trials required by the FDA and demonstrated in Alzheimer’s cell lines the potential to be effective in suppressing or ameliorating a key protein that is responsible for Aβ plaques.
CORDOVACANN PARTNERS WITH JACKSON BEVCO: CordovaCann (LVRLF) announced Wednesday it has entered into a non-binding letter of intent with Jackson BevCo to execute a managed services agreement to facilitate the opening and operation of cannabis retail stores within or beside convenience stores owned and operated by Jacksons. Jacksons owns and operates 65 convenience stores in the western United States under the Big Smoke and Tobacco Connection brand names. Jacksons is wholly-owned by Jacksons Food Stores and stores are predominantly located in Washington, Oregon, California, Arizona and Idaho. Pursuant to the terms of the LOI, Cordova will facilitate the opening of cannabis retail stores in all aspects requested by Jacksons, but with primary focus on regulatory process, compliance, training, security, inventory selection and inventory procurement. The cannabis retail stores opened under the MSA will be owned and operated by Jacksons, and Jacksons will pay Cordova a royalty based on a percentage of revenues generated by these cannabis retail stores. Cordova and Jacksons expect to have the MSA executed by January 2023. Cordova expects to launch the first cannabis retail stores within the Jacksons footprint in 2023. The initial locations currently being discussed by Cordova and Jacksons are in Washington, Oregon and Arizona.
GREENLANE, WILD GREEN CANADA ENTER COLLABORATION: Greenlane Holdings (GNLN) announced Tuesday its strategic partnership with Wild Green Canada to streamline business-to-business processes and increase Greenlane's product reach into Canada. The partnership with Wild Green Canada aligns with Greenlane's focus on accelerating growth and a path towards profitability. Through its B2B website, outside salesforce, and leadership team, Greenlane's partnership with Wild Green Canada will expand Greenlane's product reach to a wider base of retail stores in Canada, ultimately increasing visibility and Greenlane's growth.
ZYNERBA ANNOUNCES PUBLICATION OF CONNECT-FX STUDY DATA: Zynerba Pharmaceuticals (ZYNE) announced Monday that the results from the Phase 3 CONNECT-FX study of Zygel for the treatment of behavioral symptoms in children and adolescents with Fragile X syndrome were published in the Journal of Neurodevelopmental Disorders. The paper titled, “A Randomized, Controlled Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome,” details how Zygel was well tolerated in patients with FXS and demonstrated efficacy with a favorable benefit risk profile in patients with ≥90% methylation of the FMR1 gene, in whom gene silencing is most likely, and the impact of FXS is typically most severe. CONNECT-FX was a randomized, double-blind, multinational, 14-week study to evaluate the efficacy and safety of Zygel in children and adolescents aged 3 to 17 years. A total of 212 patients were randomized to 12 weeks of Zygel or placebo, as add-on to standard of care. The trial was conducted at 21 investigational centers in the U.S., Australia and New Zealand. The primary endpoint assessed change in social avoidance measured by the Aberrant Behavior Checklist–Community Edition FXS SA subscale in the full cohort of patients with full mutation FXS, regardless of the FMR1 gene methylation status. Ad hoc analyses assessed efficacy in patients with ≥90% and 100% methylation of the promoter region of the FMR1 gene, in whom FMR1 gene silencing is most likely. Although statistical significance for the primary endpoint was not achieved in the full cohort, significant improvement was demonstrated in patients with ≥90% methylation of FMR1, representing 80% of the overall study population. This group also achieved statistically significant improvements in Caregiver Global Impression-Change in SA and Isolation, Irritable and Disruptive Behaviors, and Social Interactions. Similar results were seen in patients with 100% methylation of FMR1, representing 65% of the study population. Zygel was generally well tolerated. All treatment-emergent adverse events were mild or moderate. The most common treatment-related TEAE was application site pain.
“CONNECT-FX provided evidence that a biologically identifiable and clinically responsive population of patients with FXS, who are defined by both full mutation and greater than or equal to 90% methylation of the FMR1 gene, benefited from treatment with Zygel,” said CEO Armando Anido. “Given these findings, our follow-on pivotal Phase 3 trial, RECONNECT, is underway to confirm the results observed in this population. We believe having patients with complete methylation of their FMR1 gene as the primary analysis population improves our chance of success and we look forward to topline results from RECONNECT in the second half of 2023 and believe the results, if positive, will be sufficient to support the submission of a New Drug Application in the U.S. and Marketing Authorization Application in the EU for Zygel in patients with FXS.”
CANNABIS/PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Acreage (ACRHF), Akerna (KERN), Aleafia (ALEAF), Atai Life Sciences (ATAI), Audacious (AUSAF), Aurora Cannabis (ACB), Awakn Life Sciences (AWKNF), Ayr Wellness (AYRWF), Body and Mind (BMMJ), Canopy Growth (CGC), Cannara Biotech (LOVFF), Chicago Atlantic (REFI), Clever Leaves (CLVR), Columbia Care (CCHWF), Compass Pathways (CMPS), Cresco Labs (CRLBF), Cronos (CRON), Curaleaf (CURLF), CURE Pharmaceutical (CURR), CV Sciences (CVSI), Cybin (CYBN), Delic Holdings (DELCF), Delta 9 (DLTNF), Entourage Health (ETRGF), Fire & Flower (FFLWF), Flora Growth (FLGC), General Cannabis (CANN), The Green Organic Dutchman (TGODF), Green Thumb (GTBIF), Goodness Growth (GDNSF), GrowGeneration (GRWG), Hemp (HEMP), HEXO (HEXO), Indiva (NDVAF), Innovative Industrial Properties (IIPR), InterCure (INCR), IM Cannabis (IMCC), Khiron (KHRNF), Wellbeing Digital (KONEF), Lowell Farms (LOWLF), Lotus Ventures (LTTSF), MediPharm Labs (MEDIF), MedMen (MMNFF), Neptune Wellness (NEPT), NewLake Capital (NLCP), Organigram (OGI), Planet 13 (PLNHF), Reunion Neuroscience (REUN), Revitalist (RVLWF), RIV Capital (CNPOF), Relmada (RLMD), RYAH Group (RYAHF), Safe Harbor (SHFS), SLANG Worldwide (SLGWF), Sproutly (SRUTF), Stem Holdings (STMH), Small Pharma (DMTTF), Skye Biosciences (SKYE), SNDL (SNDL), Sunniva (SNNVF), TerrAscend (TRSSF), Tetra Bio-Pharma (TBPMF), Tilray (TLRY), Trulieve (TCNNF), Tryp Therapeutics (TRYPF), The Valens Company (VLNS), Verano Holdings (VRNOF), Village Farms (VFF), Wesana Health (WSNAF), and 4Front Ventures (FFNTF).