Zelira Therapeutics Ltd (ASX:ZLD, OTCQB:ZLDAF) continues to focus on the expansion of commercialisation activities and revenue generation from its new clinically tested products, with the strategy expected to lead to the launch of a suite of new cannabinoid-based products over FY22.
Commercialisation plans are focused on generating revenues from the multiple products it has launched into the Australian and US markets.
The company plans to continue to launch new product lines while expanding into new geographies such as the UK and Germany.
During FY21, the company significantly progressed its growth strategy, achieving key milestones set by the new leadership team.
It also brought forward future development and commercialisation milestones following successful capital raisings.
➢ Cardiovascular Solutions of Central Mississippi (CVSCM) deal
Zelira entered into a binding product development agreement with US-based CVSCM to develop products that target symptoms associated with Peripheral Arterial Disease (PAD) - the leading cause of non-traumatic amputations in the US.
➢ Phase 1 dose-escalation study in chronic pain
The Phase 1 dose-escalation trial in chronic pain patients on long-term high-dose opioid treatment met its primary and secondary endpoints for safety and efficacy. These trial results informed the design of the trial being undertaken with Levin Health targeting retired athletes with chronic pain and also accelerate plans to expand Zelira's portfolio of chronic pain products, supported by clinical trial data.
➢ HOPE™ launched in Louisiana
Zelira launched HOPE™ 1 & 2 in Louisiana, USA, through licensee Advanced Biomedics and hopes to repeat the success of HOPE in Pennsylvania, where it has established itself as one of the top-selling medicinal cannabis products.
➢ Zenivol™ launched in Australia
Following its successful clinical trial, Zenivol™, Zelira’s proprietary cannabinoid medicine, was approved by the Therapeutics Goods Administration (TGA) for prescription to patients in Australia via its Special Access Scheme.
➢ Real-world data agreement for insomnia drug Zenivol
Real-world data collected from patients will complement the existing clinical data-pack for Zenivol and will be used to inform further clinical development and, evaluation of the path to product registration.
➢ HOPE autism products launched in Australia
Zelira’s proprietary cannabinoid medicines HOPE 1™ and HOPE 2™ were made available for prescription to patients in Australia through the TGA Special Access Scheme and via authorised prescribers.
➢ Emyria partnership for autism observational trial for HOPE products
Zelira partnered with Emyria to undertake an observational trial in patients diagnosed with ASD treated with the HOPE range of products - one of the largest medicinal cannabis studies ever undertaken involving a specific range of products in patients diagnosed with ASD.
➢ SprinJene® partnership
Zelira launched its proprietary CBD toothpaste in the US in partnership with SprinJene®, a leader in natural oral care products.
SprinJene was launched in the UK in June 2021, and discussions are ongoing to access SprinJene’s global distribution networks in France, Russia, Singapore, Ukraine, China, Morocco, UAE, Saudi Arabia and Sudan Shoprite.
➢ Transfer of leadership
As part of a strategic consolidation of its operations, leadership was transferred to the US-based team and Dr Oludare Odumosu assumed the role of global managing director, allowing Zelira to optimise its exposure to the rapidly expanding US cannabis sector while also continuing to grow its revenues in ex-US markets.
➢ National Cannabis Round (NCR) table
Zelira was appointed to NCR’s Board of Directors and is being represented by managing director Dr Oludare Odumosu.
A non-partisan advocacy group focused on federal cannabis reform in the US, NCR is seeking to balance respect for state-legal cannabis programs with common-sense federal regulation in the US, to realise the full potential of the legal cannabis industry.
➢ HOPE range of autism spectrum disorder products in Washington DC
Since May 2021, Alternative Solutions LLC, a licensed grower, manufacturer, and distributor of medical cannabis products, has been distributing Zelira’s HOPE range of products in the District of Columbia (Washington DC).
Washington DC has reciprocity with 32 other States in the US with approved medical cannabis programs and as such, the market for the HOPE range is far larger than just the population of the District of Columbia.
➢ CBD toothpaste launch in the UK
It signed a five-year exclusive distribution agreement with Health House International Limited (ASX:HHI) in the UK, which further expands the availability of Zelira’s SprinjeneCBD toothpaste brand beyond the US.
The UK market provides significant growth opportunities for Zelira’s clinically validated, hemp-derived oral care products.
➢ Levin health licensing and management agreement
It licensed a proprietary cannabinoid formulation to Levin Health Limited to undertake a clinical trial to test the efficacy of the formulation in treating sports-related chronic pain experienced by retired professional and amateur athletes.
➢ Significant uptake of CBD into the brain
Its funded team of researchers at Curtin University (Australia) developed a new technology to improve the delivery of cannabidiol-based drugs into the brains of mice at a rate up to 40-times more than has previously been delivered. The technology has the potential for cannabinoid-based therapies to treat neurological disorders such as Alzheimer’s disease, multiple sclerosis, and traumatic brain injury.
The research was published in the leading peer-reviewed open access scientific journal PLOS ONE.
➢ Zenivol results published in SLEEP
The clinical trial results of Zenivol were published in the prestigious peer-reviewed journal SLEEP® while the trial results of the University of Western Australia’s investigational team that undertook the double-blind, placebo-controlled, cross-over trial of Zelira’s ZTL-101 (on market as Zenivol) in chronic insomnia patients were published in the Sleep Research Society’s peer-reviewed journal for all sleep-related conditions.
Zelira received IRB approval for its 12-week observational clinical study to evaluate the efficacy, safety and tolerability of its proprietary, patent-protected product against a multi-billion-dollar Big Pharmaceutical company drug.
Zelira had successfully navigated a unique regulatory path for this trial and looks forward to the results of the study, which are anticipated in the first half of 2022.
Strongly supported fundraising
The company significantly strengthened its balance sheet In August 2020 with a strongly supported and oversubscribed A$8.75 million placement before costs at an offer price of $0.05 per share.
A further A$2 million placement was made to Thorney Investment Group in September 2020, which increased their interest to become a substantial shareholder with a 5.2% stake in the company.
Subject to shareholder approval at Zelira’s Annual General Meeting in November 2021, the company will issue Thorney a one-for-one free attaching unquoted option, exercisable at A$0.07 and expiring two years from the date of issue.
The capital raised has enabled Zelira to accelerate commercialisation, launch five products into global markets, and leverage its unique ‘Launch, Learn and Develop’ model to launch products, generate revenues, and progress the development of clinically validated medicines.
Healthy working capital ratio
The net assets of the consolidated group increased by A$3,282,714 from A$34,546,925 at June 30, 2020, to A$37,829,639 at June 30, 2021,
The group maintained a healthy working capital ratio, with working capital rising from A$1,162,501 as at June 30, 2020, to A$5,014,801 at June 30, 2021.