Bod Australia : Quarterly activities report and Appendix 4C
07/27/2022 | 07:18pm EDT
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Quarterly Activities Report: Bod continues to progress clinical trial pipeline
ahead of multiple new product launches
Initial participants recruited for phase IIB clinical trial into the efficacy of a new, unique Schedule 3 (pharmacist only) CBD formulation on symptoms associated with insomnia - a major step towards commercialisation of Bod's over-the-counter (OTC) low-dose CBD product for the Australian market
First patients enrolled for study investigating the efficacy of CBD-dominant medicinal cannabis on symptoms associated with long-COVID. Study will provide Bod with an opportunity to commercialise a product that can alleviate long-COVID symptoms and unlock another large market
Completion of proof of concept study into the safety and efficacy of a cannabigerol (CBG) dominant cannabis extract lays foundation for new product launch. Bod will be the first company to introduce a new CBG cannabis product into the Australian and UK markets in coming weeks
Steps undertaken to launch new low dose CBD product through Australian SAS-B channels - provides Bod with another sales channel and additional delivery format for consumers ahead of OTC launch
Receipts from customers up 65% on the previous quarter to $1,070,000 (Q3 FY2022: $647,000) and total sales
rose to $943,608, highlighting 46% growth on last quarter (Q3 FY2022 sales: $645,918)
Sydney, Australia - 28 July 2022: Cannabis focused drug development and product innovation company Bod
Australia Limited ("Bod" or "the Group") (ASX: BOD) is pleased to provide the following update on activities for the quarter ended 30 June 2022 (Q4 FY2022).
First patients enrolled for clinical trial to commercialise a Schedule 3 CBD product for the Australian market: The Group secured first patient enrolments for itsAustralian-basedPhase IIB clinical trial, which is investigating the efficacy of a new, unique Schedule 3 (pharmacist only) CBD formulation on symptoms associated with insomnia.
Bod's clinical trial is being undertaken at the Woolcock Institute for Medical Research, Australia's leading sleep and respiratory research organisation. It is a double blind, randomised and placebo-controlled investigation on the effect of administering a 50mg and 100mg oral CBD product per day, versus a placebo, over an 8-week period with over 200 participants.
Upon completion of the trial, Bod is confident that it will have sufficient data to progress product registration for a Schedule 3 low dose CBD product with the Therapeutic Goods Administration (TGA) and for the final product to be added to the Australian Register of Therapeutic Goods (ARTG). This would provide Bod with the opportunity to become one of the first Australian companies with a unique CBD product that can be sold over-the-counter (OTC) by pharmacists to Australian consumers without the requirement of a prescription.
First patients enrolled for long-COVID study investigating the efficacy of CBD-dominant medicinal cannabis:
Bod successfully completed the first enrolment of patients for its UK-based open label clinical trial in collaboration with Drug Science UK ('Drug Science') (www.drugscience.co.uk) to explore the effectiveness of Bod's medicinal cannabis product, MediCabilis® CBD 5% ('MediCabilis') on symptoms associated with the long term impact of SARS- CoV-2('COVID-19'), commonly referred to as long-COVID.
Long-COVID is an emerging condition, which refers to ongoing or new symptoms that develop in the eight weeks from an initial COVID-19 infection. Some common symptoms include shortness of breath, fatigue, loss of concentration, chronic pain, anxiety and insomnia. Many of the aforementioned symptoms are amenable to treatment with cannabis-based medicines, which underpins a significant opportunity for the Group.
Bod's planned study will recruit 30 participants over the age of 18 that are suffering from long-COVID. Under a clinical trial setting, each patient will be administered MediCabilis on a daily basis over a six-month period while self- reporting and assessing common symptoms associated with the condition. The collective results will determine the
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feasibility of Bod's medicinal cannabis product in the treatment of the condition and whether it is effective and safe for use.
The outcomes from the initiative will allow Bod to continue its efforts to commercialise a product that can alleviate the symptoms of long-COVID. This also provides the Group with additional evidence for the use of MediCabilis and can assist Bod in advancing potential licencing agreements with pharmaceutical partners in Australia and overseas for its unique extract.
Proof of concept study completed into the safety and efficacy of a new medicinal cannabis product:
Bod completed a proof-of-concept study into the safety and efficacy of a cannabigerol (CBG) dominant cannabis extract, which has shown very promising results. The study will form the basis for the launch of a new medicinal cannabis product that will be sold under Bod's existing MediCabilis brand.
CBG is a non-intoxicating compound taken from cannabis plants. It has the potential to hold significant therapeutic benefits across multiple applications. Early research has shown that CBG has unique pharmacological actions and can potentially address alternative therapeutic uses to CBD and THC. CBG has been identified as part of the treatment strategy for fibromyalgia, inflammatory bowel disease and irritable bowel syndrome (IBS) amongst others.
The study was undertaken over a three month period to assess the use of MediCabilis CBG in patients suffering from symptoms associated with fibromyalgia, inflammatory bowel disease and anxiety. During the trial, participants were administered 50mg/ml of the product twice daily, orally and asks to rate the improvement of symptoms on a scale of one to ten, with one being nothing and ten being the best improvement.
A comprehensive review of the data showed that 74% of trial participants highlighted a noticeable improvement in symptoms within two to four weeks of using the product. When using the scale of one to ten, 64% of participants reported a rating above six.
The Group has shared a detailed report highlighting trial data with doctors and approved prescribers in Australia and the UK, which is expected to assist with ongoing educational and business development initiatives prior to the product launch. Bod also continues to advance the product launch through Special Access Scheme Category B (SAS-
channels in Australia. The introduction of the new product will cement the Group's position as the first company to have a pharmaceutical grade CBG product in the Australian and UK market, providing another opportunity to grow sales.
Bod to launch new low dose CBD product through Australian SAS-B channels:
The Group also progressed steps towards launching a new low dose CBD product into the Australian market, scheduled for July. The product will be sold as Bod Bio-Absorb 100™ and is made up of a uniquely developed CBD formulation in a soft gel delivery format. The product is the same one currently being tested in Bod's phase II clinical trial and following the potential successful completion of the clinical trial, will be introduced to over-the-counter markets in Australia.
The launch of Bio-Absorb 100™ expands the Group's medicinal cannabis range, provides consumers with a new delivery format and will provide Bod with valuable consumer feedback prior to the proposed launch through OTC channels.
Receipts from customers increased by 65% on a quarter-on-quarter basis to $1,070,000 (Q3 FY2022: $647,000) but
decreased when compared to the previous corresponding period ('PCP' (Q4 FY2021: $2,246,000) due to increased cash collections during Q4 FY2021. Total sales for the quarter also rose to $943,608, highlighting 46% growth on last quarter (Q3 FY2022 sales: $645,918), however decreased on the PCP (Q4 FY2021: $1,173,498).
Quarter-on-quarter growth was underpinned by increased cash collections from H&H Group, as well as sales of the Group's medicinal cannabis products during the period. The decline on a year-on-year basis reflects the Company's ongoing focus towards the delivery of its R&D pipeline which is anticipated to unlock a number of growth initiatives
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in the coming months, provide Bod with a suite of underlying intellectual assets and present future revenue generating opportunities.
Net cash used in operating activities was $826,000. This was higher than the last quarter's operating cash outflow of $290,000, due to the receipt of an R&D tax incentive refund of $1,098,000 during Q3 FY2022 but was lower than Q4 FY2021 ($1,179,000) and each of the first two quarters of FY2022. The Group's Board and management remain focused on streamlining expenditure across the Group.
Bod made payments totalling $0.15m to related parties during the quarter, representing remuneration paid to directors. The Group had $3.67m cash at bank as at 30 June 2022.
Board & Management transition:
During the quarter, the Group advised that Mr Simon O'Loughlin retired as a Non-Executive Director and was replaced by Mr David Baker effective 4 April 2022. Mr O'Loughlin was instrumental in Bod's ASX-listing and growth trajectory. The Group significantly benefitted from his guidance.
Mr Baker is a commercial advisor and company director with over 40 years' experience in law, investment banking, public company leadership and corporate governance. He has strong industry knowledge across a range of sectors and a sophisticated understanding of financial markets. Mr Baker is a co-founder of Baker Cook Advisory, a boutique provider of outsourced legal, commercial and governance advice and mediation services for corporations and government agencies. He is also a longstanding shareholder in Bod.
Subsequent to this, Non-Executive Chairman Mr Mark Masterson resigned due to personal reasons and was replaced by Mr Baker in the role of Non-Executive Chairman. Mr Masterson joined Bod in September 2019 and his expertise across product development and clinical trials has been instrumental in the Group's journey. Bod would like to thank Mr Masterson for his contribution.
Bod is focused on a number of value-accretive opportunities during FY2023, including:
Completion of the phase IIB clinical trial and additional steps to launch a low dose schedule 3 CBD product into the Australian market;
Completion of the study investigating the efficacy of medicinal cannabis when used to alleviate symptoms of long-COVID;
Ongoing R&D initiatives to unlock further uses and benefits of Bod's CBD extract to broaden the Group's underlying asset base;
Securing additional purchase orders to drive sales growth of medicinal cannabis and CBD wellness products; and
Partnership agreements and licencing opportunities to underpin sales growth.
CEO Ms Jo Patterson said: "During the period, Bod continued to execute on a number of milestones that underpin the Group's clinical trial pipeline. This included the commencement of patient recruitment for two trials, which have the potential to provide considerable data and new product launches and sales growth. The results of Bod's proof- of-concept study have also laid a solid foundation for the launch of an innovative CBG product that will allow Bod to introduce the first pharmaceutical grade product utilising this compound in Australia and the UK.
"Over the next few months, the Group remains focused on patient recruitment to advance our clinical trials. These are important steps for Bod, as each development provides additional evidence for the use of CBD products across a range of widespread conditions. We look forward to providing additional updates as developments materialise."
This announcement has been approved by the Board of Bod Australia Limited.
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About Bod Australia:
Bod Australia Limited (ASX:BOD) Bod is a cannabis focused drug development and product innovation company.
Bod is focused on progressing R&D and a defined clinical trial pathway to commercialise and deliver premium, scientifically proven and trusted products for the consumer and medical markets.
The company has a number of existing partnerships with large corporate groups and collaborations with leading research partners to advance the use of CBD.
For more information please contact:
Chief Executive Officer
Six Degrees Investor Relations
+61 2 9199 5018
+61 431 271 538
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Quarterly cash flow report for entities subject to Listing Rule 4.7B
Name of entity
Bod Australia Limited
Quarter ended ("current quarter")
89 601 225 441
30 June 2022
Consolidated statement of cash flows
Year to date
Cash flows from operating activities
Receipts from customers
research and development
(b) product manufacturing and operating
advertising and marketing
(f) administration and corporate costs
Dividends received (see note 3)
Interest and other costs of finance paid
Income taxes paid
Government grants and tax incentives
Net cash from / (used in) operating
Cash flows from investing activities
Payments to acquire or for:
(c) property, plant and equipment
ASX Listing Rules Appendix 4C (17/07/20)
+ See chapter 19 of the ASX Listing Rules for defined terms.
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