Delta 9 Cannabis has sent its first bulk dried cannabis flower shipment to an undisclosed Australian customer, making it the Canadian company's debut export of the product to an overseas market.
The company has also obtained seven more export permits from Health Canada and plans to complete "multiple shipments" to Australia in the first half of 2023, expected to include approximately 100kg of dried flower and 6kg of distillate.
Delta 9 described the expansion as a significant milestone as it moves into the global cannabis market.
CEO John Arbuthnot added: "This shipment is our first step of many planned sales into the Australian medical cannabis market.
"We see significant emerging opportunities in international markets playing out over the next several years and anticipate that exports of cannabis products will become a key growth driver for us."
Delta 9 expressed confidence that a growing number of markets around the world will refine their regulations, "allowing for lower-barrier access to high-quality cannabis products produced by trusted suppliers from Canada".
Little Green Pharma
Little Green Pharma's psychedelic subsidiary, Reset Mind Services, has been granted ethics approval to conduct a clinical trial examining the safety and efficacy of psilocybin-assisted psychotherapy.
The single-centre, randomised, open-label, two-arm trial is scheduled to run over 12 months and will focus on treating depressive-related conditions.
Patients' family members will also be involved, participating in therapy sessions following psilocybin administration.
The 60-participant trial will be conducted at the Harry Perkins Institute of Medical Research in Perth.
The approval arrives two weeks after the TGA announced it will allow approved psychiatrists to prescribe psilocybin and MDMA for treatment-resistant depression and post-traumatic stress disorder from July 1.
Zelira Therapeutics
Zelira Therapeutics has received a binding term sheet from Cantheon Capital to provide an initial US$8.6 million in funding to carry out FDA Phase II and Phase III clinical trials of its Hope 1 cannabinoid-based medicine for Autism Spectrum Disorder through a special purpose vehicle (SPV).
Zelira will contribute Hope 1 product, IP and real-world data in exchange for a 55% equity stake in the SPV, while cash investors will contribute approximately US$35m for a cumulative equity interest of 45%.
Zelira will manage the SPV as part of its business platform.
Cantheon's US$8.6m contribution accounts for approximately 25% of the total US$35 million US FDA trial cost to be raised for the SPV. It is structured as a convertible note that can be converted into a maximum of 12.93% of the SPV's common stock.
Zelira has also executed a mandate with SW4 Advisors to raise the remaining approximately US$26 million required on standard commercial terms.
The SPV has appointed Ingenu as its contract research organisation to lead the clinical validation and regulatory registration of the study product with the US FDA through the submission of an Investigative New Drug (IND) application.
Ingenu will also work with the SPV to drive the execution of clinical trials and pivotal studies needed for the approvals and licences required for commercialisation.
Emyria
Emyria has obtained a supply of clinical-grade MDMA for an initial group of Australian patients through Canadian manufacturer PharmAla, with the arrangement facilitated by Mind Medicine Australia.
The move comes ahead of the rescheduling of certain psychedelics by the TGA from July 1, when the regulator will permit approved psychiatrists to prescribe psilocybin and MDMA for treatment-resistant depression and post-traumatic stress disorder.
Emyria is building a network of research-focused therapists and psychiatrists and working to prepare their sites and care teams to deliver MDMA-assisted therapy — through ethics-approved clinical trials and the Authorised Prescriber pathway — to patients with appropriate diagnoses.
The company will also examine licensing models that would allow specialist groups to access its MDMA supply and care model.
Managing director Dr Michael Winlo said: "Emyria has expertise delivering treatments to patients with substances listed under Schedule 8 and 9 while generating real-world evidence to support care-model improvement and novel drug development.
"To support its partners to provide MDMA-assisted therapy from July 1, Emyria has secured a short-term supply of patient-ready MDMA that can be provided within a comprehensive care model together with appropriately trained and reputable care providers.
"Our approach of participating in care delivery also supports our analogue program."
