Telix Pharmaceuticals (ASX:TLX), Chief Business Officer, David Cade talks about its prostate cancer imaging product, diagnostic and therapeutic products, partners and key priorities for 2020.
Rachael Jones: Hello. I'm Rachael Jones from the Finance News Network. Joining me from Telix Pharmaceuticals today is chief business officer, Dr. David Cade. David, welcome to the Finance News Network.
Dr. David Cade: Right. Nice to be with you Rachael, and thank you for that gracious introduction.
Rachael Jones: Now Telix Pharmaceuticals is a nuclear medicine company focused on molecularly targeted radiation for the diagnosis and treatment of prostate, renal, and brain cancer. Can you tell us how progress is?
Dr. David Cade: Well, Rachael, great opening question. I think for a company that's founded five short years ago, it's got five late clinical stage assets for the imaging and treatment of prostate, kidney, and brain cancer. Normally to be at this stage, it may be typically a 10 year journey. So Telix truly has moved at a very rapid pace and is shortly to be filing with FDA it's first a commercial product for prostate cancer imaging.
Rachael Jones: Thanks David. Now 2020 is shaping up as a pivotal year for the company. What are your key priorities?
Dr. David Cade: Well, the first priority and particularly so in the current environment, Rachael, with the pandemic in and amongst our midst, is to get to revenue. We are very well funded. We have cash reserves through to the middle of 2021. And they can certainly be extended should the need arise through to the end of 2021. But our acute focus is on getting to revenue and that involves submitting our first new drug application to the US Food and Drug Administration in the current quarter, Q2, of 2020. And we expect a very significant possibility of marketing authorization prior to this year end.
Rachael Jones: And now let's talk about your portfolio. Can you tell us more starting with prostate cancer?
Dr. David Cade: It is our most advanced program and within that program we have two key assets. One for the diagnostic imaging of prostate cancer, which is the most common cancer in men. And the other asset is for the treatment of prostate cancer. By far and away the most advanced of those two assets is the former, the prostate cancer imaging agent. That has completed all of it's data. We have submitted those data to the FDA just after Christmas, a few months back. And in late February had very positive feedback from FDA indicating that the safety and the efficacy data in their view was sufficient to approve the product. And hence we are moving rapidly to submit our new drug application in this quarter.
Rachael Jones: And what can you tell me about kidney or renal cancer?
Dr. David Cade: Yeah, so kidney cancer, specifically renal cell carcinoma, is the form of kidney cancer that we are seeking to develop our assets for. Again, the kidney program has two key assets. One for the diagnosis of kidney cancer and the other one for the treatment of kidney cancer. The most advanced asset is our imaging product for kidney cancer. And that is currently in the last stage of clinical development known as phase three development in our so-called ZIRCON trial, which is currently recruiting patients. That is a 250 patient phase three trial being conducted at multiple institutions globally, including sites in the United States. And we expect that to complete it's recruitment before the end of 2020.
Rachael Jones: Thanks David. Now let's talk about glioblastoma or brain cancer.
Dr. David Cade: Well Rachel, glioblastoma is the most common form of primary malignant brain cancer. It's quite a catastrophic diagnosis unfortunately for those folks unfortunate to be told by their physician that they have glioblastoma.There's of the order of 11,000 new cases diagnosed each year in the United States. And while treatment in the first instance principally consists of surgery and radiation therapy and some chemotherapy, it's almost invariably the case that everyone with glioblastoma will experience relapse, meaning that it comes back. And unfortunately the median survival for folks diagnosed with glioblastoma is of the order of 12 to 14 months. So it's a catastrophic diagnosis. Upon recurrence, which as I mentioned, almost everyone unfortunately experiences, there is very scant available additional effective treatments.
Dr. David Cade: So we are developing our glioblastoma asset, TLX101, for recurrent glioblastoma. It is an earlier stage asset, currently in phase one development. However, because there are very few treatments, most regulators take a pragmatic view and endeavor wherever possible to help get these therapies on the market should the data warrant that.
Rachael Jones: Thanks David. And now to the financials, can you provide us with a snapshot?
Dr. David Cade: Yes certainly. So to date, Telix has raised 103 million. The first raise was a small raise of eight million in the pre-IPO rounds back in 2017. The company went on to do a initial public offering in November of 2017 and raised $50 million. And then it did a third round of 45 million in July of last year, so nine months ago. At the moment it remains very well-funded and very well supported by its long-term shareholders. We have cash runway, as I mentioned earlier, through to the middle of 2021, which we deem sufficient for our first two commercial product launches. Which entails that the opportunity to generate revenue. And should we need to, based on the current uncertainty brought about by the COVID-19 pandemic, we can certainly extend our cash reserves through cost control through to the end of 2021 should the need arise. But we're very comfortable. We have made certain moves to preserve our cash. And as I said at the outset, we are acutely focused on getting to revenue as a priority to ensure that our financial situation is stewarded very well.
Rachael Jones: Dr. David Cade, thanks so much for the update.
Dr. David Cade: All right, thank you Rachael. Much appreciate your time and lovely as always to speak to you. Thank you, Rachael.