AusCann accelerates path towards commercialisation with capsules released for clinical evaluation in December Quarter
Highlights
Completed development of hard shell capsule ready for the next phase of clinical evaluation and commercialisation.
Completed construction of AusCann’s product development facility.
Board renewal process finalised.
30 January 2020 – Medicinal cannabis pharmaceutical company AusCann Group Holdings Limited (ASX: AC8) (‘AusCann’ or ‘the Company’) is pleased to provide an overview of its activities for the three months ended 31 December 2019.
AusCann had a cash balance at the end of the quarter of circa $26m. Net cash outflows for the quarter were $6.405m due primarily to construction costs of $3.426m in respect to the product development facility, and operational costs of $2.871m including R&D costs of $0.979m. AusCann expects cash outflows next quarter of approximately $4.678m.
The Company remains well funded to reach its key milestones and will focus its capital on its core R&D program including clinical evaluation, product manufacturing and commercialisation.
Hard Shell Capsules Released for Clinical Evaluation
AusCann reached a major milestone during the quarter announcing on 18 December 2019 finalising the successful development, manufacturing and testing of its proprietary cannabinoid-based hard-shell capsules.
Testing of the capsules was completed according to standardised validated tests used across the pharmaceutical industry to ensure product quality, dose reliability and consistent performance through the shelf life of the product.
The Company is working to develop a commercially focused, short clinical evaluation. AusCann's solid fill capsule formulation is a unique presentation for cannabinoid medicines, and the clinical evaluation goal is to provide key exposure information to inform dose selection, bioavailability and safety.
AusCann is targeting to have the hard-shell capsules commercially available for physicians to prescribe in Australia through the Therapeutic Good Administration (TGA) special access scheme and authorised prescriber scheme during the first half of CY 2020.
The capsule is manufactured by PCI Pharma and a three-year agreement was executed with TGA licensed Aspen Pharmacare Australia (Aspen) to provide cost-efficient packaging of the capsules in consumer-ready packs at its Australian facility.
Product Development Site
During the quarter AusCann completed the next stage of its facility based in Perth, Western Australia. The site construction was completed on time and on budget with $4.5m spent to date and additional capital spend to be deployed within the original $6m budget the company announced on 25 January 2019. The site provides AusCann with a state of the art R&D facility that will assist in the development of innovative cannabinoid-based medicines pipeline.
The Company has recently moved its administration headquarters to the new facility.
Change in Substantial Shareholder
During the quarter long term investor Merchant Funds Management Pty Ltd acquired a 13.2% interest in AusCann from Canopy Growth Corporation. Merchant is a financial services firm with extensive experience in the medical cannabis sector.
Board Renewal Process Completed
The Board renewal process was completed in December with the appointment of Mr Max Johnston as a Non-Executive Director of AusCann on 19 December 2019 and Chairman of the Company effective 19 January 2020.
Ms Krista Bates was appointed as a Non-Executive on 20 December 2019 and brings over 18 years of legal expertise to the Board, and Mr Chris Mews was appointed as Merchant’s Board nominee on 1 December 2019.
AusCann CEO, Mr Ido Kanyon said the last few months were pivotal for AusCann with the completion of preclinical product development, commercial manufacturing and release of the Company’s hard-shell capsules for clinical evaluation.
“The team at AusCann had been working relentlessly towards this milestone with manufacturing and testing successfully completed and meeting the strictest pharmaceutical quality and conformance standards. Finding the right packaging partner was also of critical importance. AusCann has signed a three-year agreement with leading global pharmaceutical packaging company Aspen.
“There is a lack of quality clinical evidence for medicinal cannabis pharmaceuticals in the industry and that is why we are generating the evidence to demonstrate the uniqueness and consistency of our capsules while building medical acceptance with Australian-based physicians.
“This is an exciting time for AusCann as we establish the Company as a trusted pharmaceutical player with a reliable, stable and standardised product. We are committed to making our capsules commercially available for prescription to patients in Australia during the first half of 2020.”
ENDS
This ASX announcement was authorised for release by the Board of AusCann.
