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MoneyTalks is Stockhead’s regular recap of the ASX stocks, sectors and trends that fund managers and analysts are looking at right now.
Today we hear from Paul Hart, executive director of Canary Capital.
Incannex is a clinical stage pharmaceutical company focused on developing unique medicines combining medical cannabis with off patent drugs as well as psychedelic medicine therapies.
They’re one of several stocks on the ASX set to benefit from the Therapeutic Goods Administration’s (TGA) recent approval of psychedelic substances used in magic mushrooms and MDMA.
From 1 July this year, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by authorised psychiatrists in Australia for treating certain mental health conditions.
“A world first Phase 2A trial treating patients with generalised anxiety disorder (GAD) using a unique combination of specialised psychological therapy alongside psilocybin dosage sessions is currently halfway through,” Hart said.
“The trial involving a total of 72 people is expected to conclude later this year, however, the company is due to report on the interim assessment from the first 29 patients, which is being completed by an independent Data Safety Monitoring Board before the end of March 2023.”
“Canary Capital eagerly awaits this interim report, and if it is positive, we expect the market to react very positively.
“Given the significant number of people suffering from anxiety globally, any safe and highly effective treatment for GAD has the potential to have a substantial impact on the community, and to the prospects of the company.”
Last week, Hart visited the site of the PsiGAD1 clinical trial with Dr Paul Liknaitzky in the BrainPark facility at Monash University – and he’s pretty impressed with the set-up.
“Each participant on this trial undergoes a total of 11 sessions: two dosing psilocybin and nine psychotherapy sessions.
“We also discussed the protocols behind the design and the execution of the trial, which aims to make real and lasting improvements in the wellbeing of participants.”
Hart also highlighted that the company has a multitude of projects aimed at developing new medicines for conditions with an unmet needs in a range of billion dollar markets including:
Nyrada specialises in the discovery and development of small molecule drugs to address unmet medical needs in cardiovascular disease and stroke and Traumatic Brain Injury (TBI) – and is about to enter an interesting phase with two clinical trials expected to commence during the first half of this year.
“The first trial aims to demonstrate that the company’s small molecule PCSK9i inhibitor lowers cholesterol,” Hart said.
“According to the World Health Organisation (WHO), cardiovascular disease is the largest cause of death globally, taking the lives of an estimated 17.9m people every year.
“One of the major causes of the disease is a build-up of LDL cholesterol in arteries which can cause heart attack and stroke.
“Nyrada aims to prove that its PCSK9i inhibitor, which is taken orally, lowers LDL cholesterol levels.
“The drug would be an ideal solution for patients who respond poorly to statins.”
Notably, results from a second preclinical trial in a specialised transgenic mouse model have shown cholesterol levels reduced by 46%, and reduced by 65% when given in combination with the statin Lipitor – which alone only achieved a 27% reduction.
For contex, Lipitor is the leading cholesterol drug owned by global giant Pfizer, and has been the best-selling drug of all time having generated more than US$160 billion in sales since its launch in 1997.
Despite being off patent, it still generates annual sales of around US$2 billion.
“There is no doubt that this new cholesterol drug has the potential to generate significant global sales if the clinical trial is successful,” Hart said.
The second drug development program involves the development of a neuroprotectant drug to reduce the impact of secondary brain injury in patients following a stroke or TBI.
Every year there are 4.1 million TBIs in the United States, United Kingdom, Europe and Japan – and there is no US Food and Drug Administration (FDA) approved drug available.
Biome Australia is focused on targeted probiotics (live-biotheraputics), with its flagship brand Activated Probiotics.
“What sets this them apart from others in the space is the level of clinical evidence behind many of the products backed up by data from clinical trials,” Hart said.
“Biome works in partnership with some of the world’s leading organisations in microbiome research and development.
“Biome also develops, licences and distributes a scientifically formulated organic nutraceutical range called Activated Nutrients and a sports performance and recovery range targeting professional athletes under the brand Activated X Performance.”
The company recently released a FY23 trading update with record quarterly sales of $1.8m, up 103% from the prior corresponding period.
First half revenue was $3.4m, up 87% on the H1 FY22.
“Importantly, the company’s gross margin has been maintained above 58%,” Hart added.
“H1 revenue was 48.5% of the $7.0m total revenue forecast for FY2023 which provides a level of confidence that the full year target will be achieved.
“If sales continue to grow at a fast pace, it is only a matter of time before the market takes notice of Biome.”
The views, information, or opinions expressed in the interviews in this article are solely those of the interviewee and do not represent the views of Stockhead.
Stockhead does not provide, endorse or otherwise assume responsibility for any financial product advice contained in this article.
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