Slow progress of acceptance in legal and medical circles globally has seen ASX cannabis stocks face volatility
\nMGC Pharmaceuticals says after a \u201csignificant transformation\u201d in recent years, it\u2019s distancing itself from\u00a0 cannabis classification
\nBioxyne is looking to submit its first clinical trial to a human research ethics committee (HREC) in January 2024<\/p>\n
There was a time when pot stocks were an investor favourite on the ASX.\u00a0 Much as lithium has become a market darling in the energy transition,\u00a0 demonised cannabis and psilocybin were seen as transitioning from an illegal drug substance to a legal one with greater potential use in the medicinal sphere.<\/p>\n
However,\u00a0 slow progress of acceptance in legal and medical circles worldwide has seen ASX cannabis stocks face volatility.\u00a0 Australia legalised the use of medicinal marijuana in 2016, but recreational use remains illegal except in the ACT.<\/p>\n
Meanwhile, the Victorian Government is looking to commence a trial to assess the driving abilities of medicinal cannabis users<\/a>.<\/p>\n From July 1, 2023\u00a0 changes by the Australian Therapeutics Administration (TGA) saw psychiatrists authorised to prescribe products containing 3,4\u2011methylenedioxy\u2011methamphetamine (MDMA) and psilocybin for use in psychedelic-assisted psychotherapy to treat specific mental health conditions, including post-traumatic stress disorder (PTSD) treatment-resistant depression (TRD)<\/p>\n Worth reading \u2013 MDMA and magic mushrooms have arrived: Australia lets psychs find a new way for happy to fight sad<\/a><\/strong><\/p>\n In the US \u2013 the world\u2019s largest healthcare market \u2013 the Department of Health is recommending a downgrade of marijuana\u2019s scheduling. Additionally, a bipartisan group of US senators<\/a> is advocating for state-legalised cannabis businesses to access finance through the SAFER Banking Act.<\/p>\n While developing medicines incorporating cannabinoids or psilocybin as active pharmaceutical ingredients (API) there are ASX companies trying to shake the categorisation as a merely a pot stock, whether to counter social stigma, regulatory ambiguities or broaden their appeal to investors. Here\u2019s Part One of the ASX pot stocks that want to be known for much more.<\/p>\n \u00a0<\/p>\n MXC managing director and CEO Roby Zomer told Stockhead<\/em> the European-based biopharma has undergone a significant transformation in recent years, distancing itself from the classification of a cannabis company, \u201cwhich is still prevalent in the Australian market\u201d.<\/p>\n \u201cIn a series of announcements, we have eliminated non-core activities and removed the legacy of cannabis from our operations,\u201d he says.<\/p>\n \u201cWhile we do produce medicines that incorporate cannabinoids as active pharmaceutical ingredients alongside non-cannabinoid APIs, it\u2019s essential to understand that this doesn\u2019t categorise us as a cannabis company.\u201d<\/p>\n MXC is currently undertaking a dose-finding study for CimetrA, which is a phyto medicine based ingredients from curcumin and Boswellia serrata that has demonstrated effectiveness in arresting the cytokine storm in Covid-19 patients in late-stage trials.<\/p>\n It is also progressing Phase II studies of its phyto medicine based on phytocannabinoids called CannEpil, for the treatment of refractory epilepsy, which accounts for ~25% of the people diagnosed with epilepsy.<\/p>\n MXC\u2019s strategic focus includes an initial entry into the lucrative US market by submitting IND applications for CimetrA and CannEpil to the US FDA.<\/p>\n Zomer says the decision to move away from the cannabis industry was driven by the observation that much of the sector remained focused on adult use rather than evolving into the pharmaceutical realm.<\/p>\n \u201cThis shift made it challenging for doctors to confidently provide patients with the medical remedies they require,\u201d he says.<\/p>\n \u201cIn response, MGC has redirected its efforts to leverage our knowledge, experience, and field results, working closely with doctors and patients to develop medicines that undergo rigorous clinical trials and, ultimately, receive marketing authorisation.\u201d<\/p>\n Zomer says it\u2019s important to note that the cannabis industry is not fading away; it continues to serve people\u2019s needs as access improves.<\/p>\n \u201cHowever, MGC\u2019s focus is on being a pharmaceutical provider rather than a part of the traditional cannabis industry,\u201d he says.<\/p>\n \u201cThis strategic shift aligns us with other pharmaceutical companies, emphasising our commitment to delivering medicinal solutions.\u201d<\/p>\n \u00a0<\/p>\n CEO Sam Watson told Stockhead<\/em> BXN subsidiary Breathe Life Sciences hope to become the first company certified by the TGA in Australia to manufacture psilocybin and MDMA medicines under good manufacturing practice (GMP), not just for clinical trials but for commercial supply to patients via special access pathways.<\/p>\n \u201cWe have our GMP inspection and site audit end of this month, and following this we hope to receive manufacturing licences for the above and also various cannabis products,\u201d he says.<\/p>\n Watson says BXN is also working with medicos and health practitioners to submit its first clinical trial to a human research ethics committee (HREC) in January 2024.<\/p>\n \u201cOur trials, if approved by HREC, will be the some of the first revenue generating large population (500-1000 participants) interventional study of psilocybin in patients with cancer related depression and treatment resistant depression,\u201d he says.<\/p>\n \u201cWe hope to show significant efficacy from just a single dose of psilocybin, repeated every six months.\u201d<\/p>\n The company then intends to compare the efficacy and safety of psilocybin versus selective serotonin reuptake inhibitors (SSRIs) in patients with general depression.<\/p>\n \u201cIf we can demonstrate a single dose administered alongside guided therapy once every six months works better than daily SSRIs, the plan will be to work quickly to get our psilocybin drug registered on the ARTG as an approved treatment,\u201d Watson says.<\/p>\n \u201cThis is potentially a multi-billion-dollar opportunity, and will put us years ahead of the US biotechs and psychedelic companies.\u201d<\/p>\n In medical cannabis BXN is already supplying high dose THC suppositories for investigation and treatment of colon, rectal and prostate cancer.<\/p>\n And in Japan BXN has been providing its CBD to epileptic children for the last few years as a sponsor and partner in the Green Zone Japan, Midori No Wa project.<\/p>\n In the UK BXN is a leading supplier of raw materials, novel food and consumer health products such as CBD and nootropic mushrooms. The company is also in advanced talks to acquire a plant-based food business that produces their own plant-based meat alternatives for quick service restaurant and retail.<\/p>\n \u201cWe believe that life sciences is not just about drugs and medication, treating disease, but about preventing it,\u201d Watson says.<\/p>\n \u201cOur brands symbolise alternate, new age, natural, botanical wellness.\u201d<\/p>\n Watson says BXN wants to be a global leader in longevity, health, and lifestyle with medical studies showing the efficacy of their treatments.<\/p>\n He says BXN is a small high growth company, that has demonstrated profitability, is globally positioned, ahead of the curve on novel therapeutics, but trading at a tiny fraction of its potential.<\/p>\n \u201cLooking at our US peers like Compass Pathways, atai Life Sciences, they\u2019re trading at multi-hundred million valuations with little or no revenue,\u201d he says.<\/p>\n \u201cWe\u2019re trading at only ~2x and I think this is because people haven\u2019t heard of us yet, which we are working on changing.\u201d<\/p>\n \u00a0<\/p>\n \ufeff<\/span><\/span>\u00a0<\/p>\n At Stockhead, we tell it like it is. While MGC Pharmaceuticals and Bioxyne are Stockhead advertisers, they did not sponsor this article.<\/em><\/p>\n <\/span><\/p>\n The post Why these ASX firms are shying away from the \u2018pot stock\u2019 label \u2013 Part One<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"MGC Pharmaceuticals (ASX:MXC)<\/strong><\/a><\/h2>\n
Bioxyne (ASX:BXN)<\/strong><\/a><\/h2>\n
The MXC and BXN share price today:<\/h2>\n\n