OSOROJO
4 years ago
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.
LoserTrying2Win
4 years ago
AusCann on a high with cannabis capsule release
Shares in WA medical cannabis company AusCann have skyrocketed on the release of its cannabinoid-based hard-shell capsules for clinical evaluation.
AusCann chief executive Ido Kanyon said the successful manufacture, testing and release of a commercial-sized batch of the capsules marked a critical milestone for the company.
Cannabinoids tend to degrade over time when not protected but AusCann said its capsules, which have now passed Australian Therapeutic Goods Administration standards, are designed to perform consistently throughout the shelf life of the product.
AusCann shares were up 9.5¢, or 52.8 per cent, to 27.5¢ at 11.45am.
Mr Kanyon said he hoped to make the capsules available for physicians to prescribe in Australia during the first half of next year.
“Now with this stage of our R&D program complete, we are accelerating our path toward commercialisation with full confidence in our ability to consistently provide reliable, stable and standardised pharmaceutical products which address unmet medical needs,” he said.
The news comes just months after the arrival of activist shareholder Merchant Group heralded a shake-up of AusCann’s board that included the departure of founder and chairman Mal Washer.
Former Liberal MP Dr Washer stepped down from the board in October and was replaced as chairman by non-executive director Cheryl Edwardes, who will also leave early next year.
Merchant bought out Canada’s Canopy Growth last month to become AusCann’s biggest shareholder with a 12.4 per cent stake.
Merchant, which drove the revival of medical cannabis company HAPA Pharm, is believed to have argued board changes were necessary if AusCann was to regain its momentum and capitalise on its initial promise as one of Australia’s first cannabis companies.
https://thewest.com.au/business/health/auscann-on-a-high-with-cannabis-capsule-release-ng-b881414901z
LoserTrying2Win
4 years ago
Why did the AusCann share price rocket higher today?
Investors have been buying AusCann’s shares following the release of an update in relation to its proprietary cannabinoid-based hardshell capsules.
According to the release, AusCann has completed manufacturing and testing of the hard-shell capsules and released the hard-shell capsules for clinical evaluation. Management advised that the clinical evaluation goal is to provide key exposure information to inform dose selection.
The release explains that its testing was conducted in accordance to standardised validated tests used across the pharmaceutical industry. This is to ensure product quality prior to release of products to market.
The hard-shell capsules were tested and found to meet all applicable pre-defined criteria set by the Australian Therapeutic Goods Administration, relevant International Pharmacopoeial standards, and the company’s own quality assurance and control procedures.
AusCann is now targeting hard-shell capsules availability for patients in Australia during the first half of calendar year 2020.
AusCann CEO, Mr Ido Kanyon, was pleased with the development.
He said: “AusCann had the vision to provide patients and healthcare professionals with a high quality pharmaceutical product which addresses patients’ unmet needs. AusCann’s manufacturing, operational processes and test results are up to global pharmaceutical standards which is great news for patients, healthcare professionals and AusCann’s investors.”
“Now with this stage of our R&D program complete, we are accelerating our path toward commercialisation with full confidence in our ability to consistently provide reliable, stable and standardised pharmaceutical products which address unmet medical needs.”
“We remain focused on making AusCann’s capsules available for prescription to patients in Australia during the first half of 2020. Our goal is to provide high-quality medicine and to obtain detailed, data-driven evaluations regarding the outcomes of AusCann’s pharmaceutical treatment. These results will build the clinical evidence supporting the unique benefits of AusCann’s capsules necessary to open a large market for the Company,” he concluded.
The post Why this ASX cannabis share rocketed 35% higher today appeared first on Motley Fool Australia.
https://au.finance.yahoo.com/news/why-asx-cannabis-share-rocketed-003043523.html
LoserTrying2Win
5 years ago
AusCann Group Holdings Limited
AusCann Group Holdings Limited (ASX: AC8) is in the business of medicinal cannabis product cultivation, manufacturing and delivery. The company is also involved in distribution activities across Australia through established pharmaceutical distribution channels as well as unregistered product pathways.
Recent Updates:
The company, on 23 July 2019, issued 50,000 fully paid ordinary shares at $ 0.21 per share on exercise of 50,000 unlisted options, scheduled for expiry on 19 January 2020.
On 01 July 2019, AC8 notified the market about signing an agreement with Tasmanian Alkaloids (TasAlk). Under the deal, AusCann will secure high-quality cannabis raw material from TasAlk. The company will use the material for cannabinoids-based pharmaceuticals development and production. The strategic alliance between the two was undertaken in 2017 to benefit from each other’s abilities with regards to cannabis plant cultivation along with manufacturing and marketing of cannabis products.
On 8 March 2019, S&P Dow Jones Indices announced the March 2019 quarterly rebalance of the S&P/ASX Indices. The company was added to All Ordinaries, effective at the open on 18 March 2019.
March Quarter 2019 Updates: The company appointed Mr. Ido Kanyon as new Chief Executive Officer during the period. Further, AC8 inked an agreement for purchasing cannabis resin from MediPharm Labs, which is the largest supplier of purified, pharmaceutical grade cannabis extracts in Canada.
The company bought a R&D (Research & Development) facility of 7,300 square metres to further improve its product development capabilities. The facility is based in Perth, the capital city of Western Australia. The consideration price for the facility was $ 5.25 million, which was fully funded from existing cash reserves on the balance sheet and the anticipated completion of the facility is CY 2019.
1H FY19 Results Review (ended 31 December 2018): The company, in July 2018, accomplished a share placement program and raised A$ 33.5 million. An amount of A$ 1.9 million was further raised in August 2018 through a share purchase plan. AC8 posted a loss of $ 4,438,372 in 1HFY19 as compared to $ 4,829,822 in the prior corresponding period. On balance sheet, net assets rose to $ 43,255,881 at the end of 1H FY19 from $ 14,112,032 at 30 June 2018. Total current liabilities at the end of the period stood at $ 592,819, slightly lower as compared to $ 600,139 at the end of June 2018. Accumulated losses at the end of 1H FY19 were $ 31,810,379 as compared to $ 27,372,007 at the end of 1H FY18.
1H19 Results Highlights (Source: Company Reports)
Key Focus Areas for FY2019: The company intends to launch solid hard-shell capsules to treat chronic pain which is likely to be released for clinical trials in 2019. The company plans to continue with diversifying and boosting cannabis raw material supply base. With regards to the product development, the company is progressing towards the development of a new AusCann R&D facility in Western Australia. The facility will be engaged in cultivation, extraction and new product development activities. AC8 is likely to invest a further capital of ~$ 6 million in the upcoming time for the customisation of the site.
AC8 stock was trading at $ 0.510 on 29 July 2019 (AEST 02:41 PM), up 7.368% from its previous closing price. The company has a market cap of $ 150.57 million and 317 million outstanding shares. The stock gave a negative return of 26.36% in the past six months.
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