Clever Leaves
Colombia-based cannabis company Clever Leaves has secured Australian GMP certification for its Colombian manufacturing facilities, opening the door to producing cannabis products for the Australian market.
The Therapeutic Goods Administration (TGA) granted the GMP status, which the company says makes it the first medicinal cannabis firm in the world to hold GMP certifications from the European Union, Colombia, Brazil, and Australia simultaneously.
Clever Leaves chief executive Andres Fajardo called the certification a "major milestone" for the business.
"[It] further highlights our commitment to producing high-quality and safe cannabis products in one of the fastest growing and largest medicinal cannabis markets globally," he said. "We will continue distributing through our partners, with whom we are already distributing finished cannabis products to patients in the country."
The company noted that GMP standards protect against product contamination, inconsistent compound concentrations, and incorrect labelling.
Since July 1 2023, GMP certification has been a mandatory requirement for the manufacturing and sale of cannabis products in Australia.
Cronos/Vitura
Cronos Group has sent its first shipment of cannabis flower to Australian distributor Vitura Health, marking the Canadian company's entry into the Australian market. Cronos Group holds approximately a 10% stake in Vitura, which previously operated as Cronos Australia.
Cronos Group chairman, president and CEO Mike Gorenstein said: "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.
"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."
InhaleRX
InhaleRX has chosen breakthrough cancer pain (BTcP) as the primary focus for the phase 2 clinical trial of its synthetic THC compound, IRX211.
The company's medical team had originally considered complex regional pain syndrome (CRPS) as the main indication before shifting focus to BTcP.
A patent application has been filed with the Australian Patent Office.
Chief scientific officer Rob Jenny said targeting BTcP gives the company access to a considerably larger patient population.
"We believe IRX211 will find its way to market more rapidly via a clinical program involving the BTcP population and will underpin further product extensions targeting other similar pain indications, including CRPS," he said.
A phase 1 clinical trial of IRX211, an inhaled fixed-dose treatment, has already produced "pleasing preliminary results" for pharmacokinetics, safety and tolerability in patients experiencing acute episodic breakthrough pain, according to the company.
InhaleRX closed out 2023 with A$714k in cash reserves after spending $242k on operating activities during the final quarter.
The company drew $546k through a financing facility with Radium Capital, which allowed early access to a portion of its R&D tax incentive claim for 2023.
Emyria
Emyria has received an R&D tax incentive refund of A$2.53 million for research conducted during FY23.
CEO and MD Dr Michael Winlo said the refund "reflects Emyria's deep investment into mental health research and development over the past financial year and follows our key specialist psychiatrist obtaining Authorised Prescriber status last week.
He added: "The period was marked by significant milestones in our quest to develop and deliver innovative mental health treatments for the large number of patients who are not able to find relief through conventional care."
CannMart/Aura Therapeutics
CannMart, a subsidiary of Canadian med-tech company Lifeist Wellness, has entered into an agreement with Aura Therapeutics to begin supplying cannabis products to Australia.
Under the deal, Aura Therapeutics — which rebranded from Endoca Australia last October — will import a range of medicinal concentrates, live resin vapes, bulk flower, and other refined concentrates. The arrangement is CannMart's first move into international markets, and also the debut of its in-house brand, Roilty, outside Canada.
"We are excited to bring a diverse range of CannMart products to the Australian market in 2024," said Aura Therapeutics CEO Tom Fay.
"We have confidence in the anticipated growth of the Australian medical cannabis sector in the coming year and believe our collaboration with CannMart will enable us to capitalise on this expansion by offering an extended range of high-quality products to Australian patients."
CannMart CEO Daniel Stern said the agreement will help diversify the company's revenue streams and build an international profile for both CannMart and its Roilty concentrates brand.
Cann Group
Cann Group has appointed Tony Di Pietro as its incoming chief financial officer, filling the role left vacant after Deborah Ambrosini's departure before Christmas.
Di Pietro will also take on the role of joint company secretary alongside head of legal and regulatory affairs Steven Notaro.
He comes to Cann Group from med-tech company Genetic Technologies, where, as CFO, he led a US$5 million capital raise from US investors and managed due diligence and compliance obligations with the ASX and NASDAQ.
Cann Group CEO Peter Koetsier said Di Pietro has a "brilliant track record of helping to oversee the successful evolution of smaller companies into established successful operations that generate outstanding profits".
Greenfern Industries
Greenfern Industries (GFI) has satisfied New Zealand's regulatory minimum quality standards required to commercialise its first cannabis harvest at its cultivation, drying, and packaging facility in Taranaki.
Managing director Dan Casey said the achievement was "testament to all the hard work and research that our team have diligently put together over the last few years".
"We are looking forward to finalising our first batch in preparation for export and look forward to even more wins in the near future," he said.
The harvest is being prepared for export to the EU and UK via Greenfern's partner Ampyl Sciences.
Casey added: "Despite the journey to get here, which has been a slow and complex industry pathway for all domestic players, some of whom have not survived, GFI has achieved something worth celebrating and we feel excited that this is just the start of our cultivation vision.
"We will now look to make sure we continue to bring the best quality medicinal cannabis to the international and, in time, the New Zealand markets."
LGP/Reset Mind Sciences
Reset Mind Sciences, the psychedelics-focused subsidiary of Little Green Pharma, has begun a clinical trial examining the safety and efficacy of psilocybin-assisted therapy that involves family members, enrolling 60 patients with treatment-resistant major depressive disorder.
Participant screening is underway, with the trial expected to run for 12 months. Professor Sean Hood, an academic and consultant psychiatrist from the University of Western Australia, will act as principal investigator.
Separately, an extraordinary general meeting to consider the demerger of Reset Mind Sciences from LGP has been scheduled for January 17.
The demerger is contingent on completing a capital raise of up to A$2 million through the issue of up to 10,000,000 ordinary Reset shares at $0.20c per share.
UPDATE (January 17, 2024): The closing date for the capital raise has been extended to February 20 to "enable international investors to obtain regulatory investment approval and make a final investment decision".
The EGM will now take place the following day (February 21).
