OncoSil Medical (ASX:OSL) gets CE approval


by Ortenzia Borre

OncoSil Medical Limited (ASX:OSL) Managing Director and CEO Daniel Kenny talks about the significance of the company's CE Marking approval for its lead product OncoSil, which helps treat pancreatic, liver and biliary duct cancer.

Ortenzia Borre: Hello, I'm Ortenzia Borre for the Finance News Network. And joining me from OncoSil Medical is Managing Director and CEO Daniel Kenny. Daniel, welcome back.

Daniel Kenny: Thank you, Ortenzia.

Ortenzia Borre: First up, could you comment on the significance of the CE Mark approval for your device?

Daniel Kenny: The significance of the CE Mark is tremendous for the company. It allows us to now commercialise the device in the UK and Europe. It's a further validation of our technology, and we will look to having first revenues later this year, but more importantly, the CE Mark significance allows us to also file in other key geographies, such as Asia, which recognises the CE Marking.

Ortenzia Borre: And can you remind us about the treatment options for people with pancreatic cancer and the market opportunity?

Daniel Kenny: The global market opportunity for unresectable locally advanced pancreatic cancer exceeds US$3 billion. The treatment options are essentially surgery, chemotherapy, or a combination of chemotherapy and radiotherapy. For unresectable locally advanced pancreatic cancer patients, the treatment options don't lead to good outcomes. The median overall survival for those patients is less than eight months, and the five year survival is less than 5 per cent. So with the introduction of the OncoSil device, we believe it could be a paradigm shift in the way we treat pancreatic cancer. Early this year, the USFDA granted breakthrough device designation, and so did the European authorities with the CE Marking. So coming back to the significance of the CE Marking, it's a recognition of the capabilities of the technology to improve overall survival, but also to potentially downstage patients from inoperable status to operable status. And with that, we feel that this device can actually make a difference to the way we treat these patients who have this insidious cancer.

Ortenzia Borre: And to the CE Mark in more detail, can you tell us more starting with how your device helps to treat locally advanced pancreatic cancer?

Daniel Kenny: Essentially, the device is microparticles that are injected directly or implanted directly into the pancreatic tumor using ultrasound guided endoscopy. So the company is pioneered a unique way to deliver a radiotherapy device in a very difficult to treat cancer. The device is approved for unresectable locally advanced pancreatic cancer, and the benefits that we've seen from the trials that have been conducted is a prolongation of survival was showing a doubling of overall survival from eight months to 16 months. And we expect that that maturing survival data will be further emphasised as we go forward. In addition, we're showing a compelling and exciting and highly encouraging rate of surgical downstaging, taking patients who have an inoperable tumor and downstaging them to being able to take them into surgery with curative intent.

Ortenzia Borre: That's fantastic. Now tell us about your European launch program?

Daniel Kenny: Well, COVID-19 has come at a time to basically delay our launch preparedness and our launch, but we are confident by putting our training program online to be able to launch later this year, COVID-19 pandemic permitting. So we do have five sites already established in Europe, part of our original R and D program. So those sites are when hospital access improves would be able to start treating patients later this year. So just to recap, the COVID-19 pandemic has clearly delayed our launch preparedness, but we're quietly confident that at later this year, the sites that are already established, who have already treated patients under our trial program, will start treating patients. So we'll just have to assess the situation as we move forward.

Ortenzia Borre: And could you update us on the approvals for other jurisdictions?

Daniel Kenny: Yes. The exciting developments this year with the USFDA granting breakthrough device designation, the Europeans doing the same. And of course the CE Marking gives us a tremendous regulatory platform in which to seek approvals and other key geographies. We have already filed in Malaysia, Singapore, and Hong Kong. We expect to be able to file with the TGA shortly. So on the basis of the regulatory success of the past few months, we believe that further approvals are forthcoming.

Ortenzia Borre: Now to the finances and your share price. Could you give us an update?

Daniel Kenny: Yes. As of yesterday we completed a $19 million capital raising program, comprising $14 million of institutional placement, where we brought on board high quality international and domestic institutions. So we've effectively institutionalised the stock on the back of our recent regulatory success. And at close of business yesterday, we concluded a entitlement offer, or rights issue, valuing $5 million. So we've raised effectively another $19 million on the back of our regulatory success. We have proforma cash reserves now approaching $24 million, which gives the company a tremendous working capital reserve to move forward, to accelerate further R&D, secure new approvals, and of course commercialised when COVID-19 pandemic permits.

Ortenzia Borre: That's wonderful news. Congratulations. And lastly, Daniel, is there anything else you'd like to add?

Daniel Kenny: I think the company has had a tremendous success this year with FDA breakthrough designation and CE Marking. So we look forward to now moving into revenue generation, but this is not possible without a really strong management team. And we've recently brought on board Nigel Lang, who was the previous President of Sirtex Europe and drove tremendous commercial success for Sirtex in Europe. And he has now recently been appointed to OncoSil to be the President of OncoSil Medical Europe, and we look forward to Nigel generating equally a great success with the OncoSil device in Europe. We also have Charles Rowland heading up US OncoSil, and we are hoping to file next month... Well, actually without question, there's no "hope" here. We will be filing for bile duct cancer indication with the USFDA next month. And Charles will be a big part of that process as we move forward. So that's the other key highlights moving into bile duct cancer in the United States with a filing next month, a new management coming on board to drive our commercial program.

Ortenzia Borre: Daniel Kenny, thank you so much for the update.

Daniel Kenny: Thank you very much.