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 earnings, a market entry and Phase 1 study data.

TILRAY REPORTS Q2 EARNINGS: On Tuesday, Tilray (TLRY) reported second quarter adjusted earnings per share of 0c on revenue of $194M, which compared to analyst estimates of a loss per share of (6c) on revenue of $195.1M. Irwin Simon, CEO, stated, “Tilray Brands is a major force at the forefront of innovation, disrupting the global CPG industry across medical and adult-use cannabis, wellness foods and snacks, and craft beverages. Our Q2 financial results demonstrate the strength of our brands, our global team, and our diversified growth strategy. We grew revenue, enhanced our capital structure, and realized operating synergies while strengthening Tilray Brands’ position as the #1 cannabis operation and brand portfolio in Canada by sales volume and market share, the European market leader in medical cannabis, and the leader in branded hemp products. We have also emerged as a disruptor in the craft beverage-alcohol industry by assembling a portfolio of highly sought-after brands that are dominating key regions across the U.S. in the Northeast, the Pacific Northwest, and the Southeast. Tilray is now uniquely positioned to become a top 12 beer and alcohol beverage company in the U.S.” The company also expects total cost savings related to the HEXO and Truss integration to amount to $30M-$35M in this fiscal year and sees 2024 adjusted EBITDA between $68M-$78M. In addition, the company continues to expect to generate positive adjusted free cash flow. (read more)

CRONOS ENTERS AUSTRALIAN CANNABIS MARKET: Cronos Group (CRON) announced Tuesday it is expanding distribution into the Australian market with its first shipment of cannabis flower to Vitura Health. Cronos owns approximately 10% of the common shares of Vitura, formerly known as Cronos Australia, and will supply cannabis for Vitura. “Supplying the Australian market, which has grown significantly in the past three years, is a great milestone for Cronos as we aim to enter and expand within international markets,” said CEO Mike Gorenstein. “We look forward to working closely with our partners at Vitura to provide patients with high-quality cannabis products and establish our presence in Australia as a trusted cannabis partner.” Cronos intends to help Vitura grow market share and help establish Vitura as a leading cannabis brand in Australia by leveraging the company’s success in flower within the Canadian, Israeli, and German markets. (read more)

CYBIN REPORTS CYB004, SPL028 DATA: On Monday, Cybin (CYBN) announced safety, pharmacokinetic and pharmacodynamic data from its Phase 1 studies of CYB004 and SPL028in healthy volunteers. CYB004 and SPL028 are proprietary deuterated DMT molecules within the company’s DMT program in development for the treatment of generalized anxiety disorder. Results from the Phase 1 studies in the CYB004 and SPL028 programs demonstrated PK and PD profiles with the potential to bridge data across these molecules, and the PK profiles for both molecules demonstrated concentrations in the effective range. Both IV and IM administration routes were safe and well-tolerated, with potential for IM dosing to provide a more convenient dosing method for patients when compared to IV infusion. IM dosing of SPL028 produced robust psychedelic effects lasting a short duration in the majority of subjects, a finding that supports IM administration as a well-tolerated and effective dosing method that is highly scalable. “The positive data from our Phase 1 studies of CYB004 and SPL028 are highly encouraging with the combined data from these studies enabling us to prioritize our 2024 development plan for our deuterated DMT program. Importantly, these are the first-in-human studies of deuterated DMT in healthy participants. We are pleased that both the IV and IM administrations produced robust psychedelic effects and were safe and well-tolerated. We are especially encouraged that the IM route produced psychedelic effects in the majority of subjects, with a short-duration psychedelic experience from a single administration of SPL028,” said Doug Drysdale, CEO. “These results for IM dosing of deuterated DMT are highly promising and will help inform dosing in future clinical trials, saving time and resources by eliminating the need for further formulation studies of other methods such as subcutaneous dosing.” (read more)

CLEARMIND COMPLETES TYPE A MEETING: Clearmind Medicine (CMND) announced Wednesday it has completed a Type A meeting with the U.S. Food and Drug Administration to discuss the company’s clinical trial of its proprietary MEAI-based, CMND-100 compound, for the treatment of Alcohol Use Disorder using its novel psychedelic- based therapy.  “We’re pleased to report we recently met with the FDA to align on the content of our IND resubmission for CMND-100,” said Dr. Adi Zuloff-Shani, CEO. “The meeting was informative and productive, and we’re eager to advance the U.S. regulatory process and potentially bring a new hope for millions suffering from AUD by providing an innovative approach to overcome the challenges associated with the current available treatments to date.” (read more)

TRYP RECEIVES HREC APPROVAL: Tryp Therapeutics (TRYPF) announced Monday a significant milestone in its clinical trial program for TRP-8803. The company has received approval from the Human Research Ethics Committee in Australia to commence Phase 1 clinical trial of TRP-8803 in healthy human volunteers. This study is designed to determine the optimal blood levels of psilocin needed to achieve the targeted psychedelic state. The trial, titled “A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of a Single Intravenous Infusion of TRP-8803 in Healthy Adult Participants,” is set to be performed at the CMAX Phase 1 unit in Adelaide, Australia. This study is designed to provide a major advance in psychedelic medicine by aiming to optimize the doses and infusion rates of IV-administered psilocin to achieve targeted blood levels of psilocin. Uniquely, the study will also collect real-time electroencephalogram data from all nine human volunteers to monitor changes in EEG patterns associated with the psychedelic state, providing invaluable insights into the correlation between psilocin levels and the depth and duration of the psychedelic experience. (read more)

CANNABIS/PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Acreage (ACRHF), Aleafia Health (ALEAF), Audacious (AUSAF), Aurora Cannabis (ACB), Atai Life Sciences (ATAI), 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), Clever Leaves (CLVR), CordovaCann (LVRLF), Cresco Labs (CRLBF), 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), Trees Corporation (CANN), Goodness Growth (GDNSF), Greenlane (GNLN), Green Thumb (GTBIF), GrowGeneration (GRWG), Hemp (HEMP), High Tide (HITI), India Globalization Capital (IGC), Indiva (NDVAF), IM Cannabis (IMCC), 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), SNDL (SNDL), Sproutly (SRUTF), Skye Biosciences (SKYE), Stem Holdings (STMH), Sunniva (SNNVF), TerrAscend (TRSSF), Tetra Bio-Pharma (TBPMF), Trulieve (TCNNF), Verano (VRNOF), Village Farms (VFF), Wesana Health (WSNAF), Zynerba (ZYNE) and 4Front Ventures (FFNTF).