Summary
- Amid social distancing measures, several clinical studies have been suspended; the limited number of cannabis studies suggest not many were affected.
- Medicinal cannabis deemed as an essential service, underling the importance of cannabis-based medicines.
- Cannabis is under the spotlight as it can be effective against stress and anxiety, which is common among the general public during this pandemic.
- Amid COVID-19, AC8 commenced clinical evaluation of cannabinoid capsules; ZLD completed the clinical trial in insomnia, with expected launch inH2’20; Medlab’s NanaBis™, a Phase 3 candidate, is currently recruiting, unaffected during the time of disruption.
Medicinal cannabis, also identified as medicinal marijuana, has seen a shift in usage from being a criminalised product to be a legal medicinal product being studied for multiple indications. Cannabis is used across various countries, either for improving disease symptoms or treatment of different chronic medical conditions.
Medicinal Cannabis Industry Australia, or MCIA, announced that medicinal cannabis falls under the ‘essential service’ category underlying its importance according to the federal and state governments.
The industry has seen a significant demand during the coronavirus pandemic, and market participants seem to be keenly following cannabis stocks. Further, an increasing number of cases of people citing stress and anxiety issues is likely to put the industry under the spotlight as medicinal cannabis is known to be beneficial to address these mental health disorders.
Cannabis players have not stayed behind either, eager to make the most of the opportunity at hand. They have been active with clinical trials ongoing despite the social distancing measures being followed to prevent the spread of the virus. With thousands of clinical studies being suspended or even cancelled, cannabis studies have fared significantly better.
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With this backdrop, let us have a look at few ASX-listed cannabis stocks that continue their clinical studies despite the social distancing challenges:
Medlab Clinical Limited (ASX:MDC)
Medlab Clinical Limited is a medical research and development company engaged in the formulation and commercialisation of therapeutic pathways for obesity, depression and pain management. The Company manufactures cannabis-based medicines for pain management and anxiety.
MDC is currently recruiting for the following clinical studies:
- An observational study assessing the safety, efficacy, and tolerability of NanaBis™ in patients with cancer or non-cancer associated pain.
- Randomised, placebo-controlled study to investigate the role of probiotics + magnesium orotate to manage depression.
Source: Company Presentation
Medlab receives an initial batch of NanaBis™ from Tasmanian Alkaloids
On 3 June 2020, Medlab announced the delivery of first three batches of NanaBis™ (Patented cannabis-based medicine) from Tasmanian Alkaloids (TasAlk). This announcement led to a jump in the share price by 7.317% at the end of the day. The commercial agreement between Medlab and TasAlk was announced on 29 January 2020, to ramp up manufacturing, enhance product quality and robust manufacturing compliance for TGA, FDA and EMA.
Source: Company presentation
Highlights from Quarter Ended 31 March 2020
The completion of the trial at Royal North Shore hospital of a cannabis-based medicine (NanaBis™) with significant results has allowed Medlab to focus primarily on the designing of Phase 3. The study met its primary endpoints indicating that the medicine is efficacious, safe, and tolerable. The drug also showed meaningful pain reduction with a specific subset (prostate or breast cancer with bone metastasis) showing a 40% improvement in pain scores from baseline.
During the quarter, NanaBis™ sales jumped up by ~217% over the previous corresponding period. Also, for the first time, sales volume crossed 2,000 bottles. COVID-19 did cause disruptions in the supply chain across nutraceutical and pharmaceutical businesses, and Medlab has taking actions to minimise disruption to one month.
On 5 June 2020, MDC stock ended the day’s trade at AU$0.210, in line with the previous close.
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Zelira Therapeutics Limited (ASX:ZLD)
Zelira Therapeutics Limited (formerly Zelda Therapeutics) is a global therapeutic medicinal cannabis company with a focus on the development of branded cannabis products for treating various medical conditions such as insomnia, autism, and among others.
ZLD completed the trial of insomnia Phase 1a/2b successfully, as announced on 7 April 2020.
Zelira and Tasmanian Alkaloids sign a Commercial Supply Agreement
ZLD signed an agreement with Tasmanian Alkaloids (TasAlk) on 26 May 2020, under which, the latter will have exclusive rights for manufacturing ZLD’s Insomnia and HOPE™ medicinal cannabis formulations. The agreement will ensure ZLD remains on-track to launch Insomnia and HOPE™ products in Q3 2020 in Australia. After the launch of these two products, Zelira will be transformed into revenue-generating, commercial Company across the US, and Australia market.
Source: Company Website
In February 2020, Zelira successfully completed a placement to raise AU$4,642,759 (before costs), thus increasing its cash position to approximately AU$5,788,500 before costs. The funds to be applied to expedite ZLD’ plans of launch in various products across the globe in the second half of 2020.
At the end of 31 March 2020, Zelira had cash of AU$4.02 million.
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On 5 June 2020, ZLD stock ended the day’s trade at AU$0.062, down 7.463% compared to the previous close.
AusCann Group Holdings Ltd (ASX:AC8)
A leading pharmaceutical company based out of Australia, AusCann focuses on developing and selling cannabinoid-based pharmaceuticals across Australia and globally.
In April 2020, the Company had announced that it had completed the recruiting process and had begun an open-label, randomised, Phase 1 trial to assess the pharmacokinetics of two different formulations of THC/CBD combination administered orally in healthy individuals.
AC8 had analysed its budget in light of COVID-19, and operational rightsizing was undertaken to reduce costs. However, the capital was allocated to R&D, which includes clinical evaluation and customer-facing elements of AC8’s business.
During the quarter ending 31 March 2020, AusCann’s hard-shell capsules were made commercially available in Australia for a prescription through the TGA special access scheme and authorised prescriber. Also, the capsules were released in a low-dose presentation confirming the ability of AC8 in customising cannabinoid dosing for personalised patient treatment.
AusCann signed a new distribution agreement with Clifford Hallam Healthcare (CH2) that opens up an Australia-wide channel for storage and distribution of cannabinoid medicines. Also, CH2 was shipped with these commercial medicines for nation-wide sales.
At the end of 31 March 2020, AusCann had cash of AU$24.7million, and net cash outflows stood at AU$1.4 million.
On 5 June 2020, AC8 stock ended the day’s trade at AU$0.170, in line with the previous close.