OncoSil Medical Limited (ASX:OSL) Managing Director & CEO, Daniel Kenny provides an update on the company's EU commercialsation plans, including its CE Mark Certification and Global Pancreatic Cancer programs.
Rachael Jones: Hello I’m Rachael Jones for the Finance News Network. Joining me today from OncoSil Medical Limited (ASX:OSL) is Managing Director and CEO Daniel Kenny. Daniel, welcome back.
Daniel Kenny: Thank you Rachael, good to be back.
Rachael Jones: First up Daniel, can you start by giving us an introduction to your company?
Daniel Kenny: OncoSil Medical is an ASX listed medical device company. The company was listed in 2013. The current market capitalisation is $80 million. But more importantly, the company’s developed a unique platform technology, already a therapy device, for the treatment of pancreatic and primary liver cancer.
Rachael Jones: Now to your technology. How does it work and what are the advantages?
Daniel Kenny: The OncoSil device comprises microparticles, it’s a fusion of silicon and phosphorus, the phosphorus P-32 is radioactive. We directly inject the microparticles into the tumour and being radioactive, it breaks down the cancer DNA from within. In terms of an advantage, we’re able to deliver through this radiotherapy device, a high dose of radiation, used in conjunction with chemotherapy. But the key thing here is we’re able to deliver a high dose, without impacting healthy surrounding tissue. The radiation that’s implanted into the tumour only irradiates the tumour; it does not migrate or leave the tumour, in any shape or form.
Rachael Jones: Does that work on all tumours?
Daniel Kenny: The OncoSil device is a platform technology that can be used theoretically, in all solid tumours. But to date, we’ve only trialled the device in pancreatic cancer and in primary liver cancer.
Rachael Jones: OncoSil recently completed a capital-raising plan for commercialisation for the EU. What can you tell me about that?
Daniel Kenny: The company’s delighted with the support it’s received from the market, both institutional investors and retail investors with those share purchase plan. And the funds raised will be used by the company wisely to capture EU commercialisation, to drive early revenues following what we anticipate, a CE mark later this year.
Rachael Jones: What can you tell me about the global pancreatic cancer programs?
Daniel Kenny: We have two current studies operating. We have the PanCO trial, which is running in Europe and Australia, which we ultimately will recruit 45 patients. And that will underpin our CE mark filing for later this year. In fact, we’ll be filing our data package for CE marking at the end of May 2018. We also are running a study in the United States, called the OncoPaC-1 program. We’re hoping to recruit 20 patients from a number of prestigious US centres. So the overall global program looks to recruit 65 patients from two studies, from 15 prestigious centres. And the data from these studies will be used to secure EU regulatory approval, which we expect at the end of 2018.
Rachael Jones: Now to a more general question Daniel. What is the company’s strategy and the market opportunity?
Daniel Kenny: Excellent question Rachael, the company strategy is very clear. Secure EU regulatory approval, which we expect in the latter half of 2018. On the basis of that and the emerging data that we have generated, to secure a significant strategic partner, to help capture early commercial revenues. The market opportunity for pancreatic cancer exceeds $2 billion globally.
Rachael Jones: Last question Daniel. What can investors look forward to in the terms of news flow over the next quarter and beyond?
Daniel Kenny: In terms of news flow, the first major catalyst would be the filing of our CE mark data package, at the end of May. We expect CE mark approval by the end of 2018, so that’s something investors should be looking out for. And finally, we would be continuing to provide updates to the market on our clinical data package. And the readouts from the data we’re getting from our PanCO study in Europe and Australia, and the OncoPaC-1 study, which is being conducted in the United States.
So it’s an exciting time with OncoSil Medical, with regulatory approval in Europe imminent, early sales from Europe happening in 2018 and the latter end of 2018. And of course, continuing to update the market on important emerging clinical data.
Rachael Jones: Daniel Kenny, thanks for the update.
Daniel Kenny: Thank you.