Delta 9 Cannabis has completed its first shipment of bulk dried cannabis flower to an unnamed Australian customer, marking the Canadian firm’s first export of the material to an international market.
The company has also received seven additional export permits from Health Canada and intends to complete “multiple shipments” to Australia in the first half of 2023, anticipated to include around 100kg of dried flower material and 6kg of distillate.
Delta 9 said the expansion marks a significant milestone for the company as it enters 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 said it was optimistic that an increasing number of global markets will refine 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 received ethics approval to run a clinical trial to test the efficacy and safety of psilocybin-assisted psychotherapy.
The single-centre, randomised, open-label, two-arm trial will take place over 12 months for the treatment of depressive-related conditions.
Family members of patients will also participate in the trial by taking part in therapy sessions after the psilocybin has been administered.
The trial, which will involve 60 participants, will be held at the Harry Perkins Institute of Medical Research in Perth.
The approval comes two weeks after the TGA said 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 funding to conduct FDA Phase II and Phase III clinical trials of its Hope 1 cannabinoid-based medicine for Autism Spectrum Disorder via a special purpose vehicle (SPV).
Zelira will contribute Hope 1 product, IP and real-world data for 55% equity ownership of the SPV. Cash investors will contribute around US$35m in exchange for a cumulative equity interest of 45%.
Zelira will manage the SPV as part of its business platform.
Cantheon’s US$8.6m contribution represents ~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 ~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 partner with the SPV to drive the execution of clinical trials and pivotal studies for the approvals and licences required for commercialisation.
Emyria
Emyria has secured a supply of clinical-grade MDMA for an initial cohort of Australian patients through Canadian manufacturer PharmAla, facilitated by Mind Medicine Australia.
The move comes in advance of the rescheduling of some psychedelics by the TGA from July 1, when the regulator will allow approved psychiatrists to prescribe psilocybin and MDMA for treatment-resistant depression and post-traumatic stress disorder.
Emyria is establishing a network of research-oriented therapists and psychiatrists and helping to prepare their sites and care teams to provide MDMA-assisted therapy – via ethics-approved clinical trials and the Authorised Prescriber pathway – to appropriately diagnosed patients.
It will also explore licensing models for 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.”
