Hi Scott, I’m still not quite sure I understand what your main concerns are but I’ll try and address them as best I can.
Firstly, CannPal did not have debt associated with it prior to the acquisition. In-fact, it brought in a cash balance, as well as an R&D refund of which AusCann will be the beneficiary. It also brought in research assets which can be used to advance human cannabinoid-based drug candidates (such as GLP toxicological and safety studies) as well as provide AusCann revenue opportunities through animal product registrations which are quicker to market. FDA registered veterinary medicines can generate the same kind of revenues as many human drugs, and AusCann is the only Company to have commenced the submission of a registration dossier for a veterinary medicine in Australia, or hold an open INAD with the FDA.
Respectfully, your comment that Neuvis® will disappear is inaccurate.
Neuvis® is a product made with proprietary SEDDS technology and presently sold through the SAS-B pathway which is a special access pathway that was designed for the compassionate use of unregistered medicines in Australia. At present, the SAS-B is not a scalable commercial pathway for most Companies, because it wasn’t designed for that. And for that to change, the regulatory landscape will need to evolve.
To re-iterate for perspective, the total market for medicinal cannabis in Australia is worth an estimated $200m (40% in flower) and is shared across 220+ products available in the market.
Where-as GW Pharmaceuticals had 1st year revenues of US$300m for a single cannabinoid-based medicine after FDA registration and is expected to reach peak sales of over US$1b.
The comment you’re referring to in the market update, is in relation to AusCann undertaking a review of all internal assets, including our self-emulsifying drug delivery technology (SEDDS) which can be used to deliver cannabinoids in the current presentation (1:1 ratio of CBD:THC) as well as other novel formulations for human product registration opportunities, which has always been the goal for AusCann.
As GW has shown, one highly valuable commercial product opportunity in an area of unmet medical need with IP protection, can create significant value for the Company, and the patients that we serve.
We are focused on creating the most value for our patients and shareholders by developing differentiated cannabinoid-based medicines that meet real medical needs. Neuvis® in the current presentation (1:1 ratio of THC:CBD) may still go down the path of product registration to achieve that outcome, just the same as other formulations we have may also go down that path, using the SEDDS platform.
But it’s important to remember that the key intellectual property is in the delivery system, and the purpose of the work we are undertaking is to identify which formulations are the most therapeutic and commercially attractive using our unique delivery system, and what internal research data can we leverage to accelerate the development pathway.
As far as the SAS-B pathway, we will continue to operate in this channel for now, as it is a great opportunity to generate insights on our SEDDS technology as well as our different cannabinoid-based formulations. But at present, we need to prioritise our resources, and that is on the commercialisation of our first potential registered veterinary medicine, and identifying high ROI opportunities for human registration.
Layton
