Telix Pharmaceuticals Limited (ASX:TLX) Chief Business Officer, Dr. David Cade talks about the company's product pipeline, financials and strategy. Dr. David Cade:Thanks, Clive, and I appreciate the very gracious introduction. I'd like to extend a very warm welcome to everybody on today's call, and look forward to talking to you today about Telix. Just by way of brief introduction, I've joined Telix in October last year, I've been at Telix now for six months. I'm an Australian trained physician by background, and previously spent many years in medical roles with local companies, including Sirtex Medical and more recently Cochlear.
So Telix is just over four years old. It was founded late 2015, it has an advanced clinical stage pipeline of molecularly-targeted radiation products, for patients with advanced forms of prostate, kidney, and brain cancers. The previous speaker, James Gunn, spoke very eloquently, I thought, about glioblastomas, so some of the preliminary information is exactly applicable to that type of cancer that I mentioned there.
We currently have eight clinical trials in progress, and quite uniquely for a clinical stage biotech company, we had 11 and a half thousand doses of our prostate cancer imaging product, which is known as TLX591-CDx denoting companion diagnostic, delivered and administered to patients in 2019. And that was done under a clinical trialed use, special access scheme use, and other magisterial use, in Europe.
We currently have extensive logistics capabilities. We're able to ship product to 65 countries. We have a clinical and regulatory footprint in 17 countries now, and cash reserves under full program spend to take us through the mid 2021, which we deem sufficient for two commercial product launches of those two commercial products, and should we need to, we can extend that current cash balance out to the end of 2021, should the need arise. We currently have just over 60 folks, located predominantly in Australia and in Belgium, with a small team in the United States and in Japan, and highly experienced chairman, board and management.
Next slide, please.Current market capitalization of just over a 300 million Australian. The company's undertaken three capital raises for a total of 103 million raised so far. It commenced in early 2017 with a pre-IPO round of 8 million, followed by a $50 million capital raise at RPO in November of 2017, and then a further, third capital raise in July last year at a dollar 30, raising another 45 million. Current cash balance just over 34 million as at 31st of March, and as I mentioned earlier, the potential to extend if need be, that cash run right out to the end of 2021.
Corporate head office, as Clive mentioned, is in Melbourne, Australia. I'm located in Sydney, and the company has regional offices in Indianapolis, in Indiana, Liège, Belgium, and Kyoto in Japan, and presently board and management hold about 30% of the securities of the company.
Next slide, please.So, since the capital raise just over nine months ago, in July of last year at a dollar 30 a share, Telix really has achieved all of its major commercialization milestones that it has set out to achieve, on a somewhat relentless path towards commercialization of its first product. The color coding here denotes the color of our programs. So light blue is the color we use for prostate, just like pink is the color for breast cancer, and similarly orange is the color for kidney cancer.
So I would like to focus on the blue program, our prostate cancer program, and we see that at the bottom of the slide there, just after Christmas, a few months back, we submitted our new drug application clinical briefing package to the USFDA for the first product, TLX591, our prostate cancer imaging product. And 60 days later we were delighted to receive very positive feedback from FDA at the end of February, indicating that the safety data and the efficacy data that we intend to use to support that application is deemed sufficient, and we expect to finally submit that full new drug application in this quarter. And I'll talk about that in a moment.
More recently, earlier this month we entered a commercial distribution agreement with Cardinal Health, a Fortune 20 company that is the largest medical products supplier to US hospitals, and Cardinal Health has taken on the rights to distribute that prostate cancer imaging product upon launch.
Next slide, please.So, molecularly-targeted radiation delivers radiation very precisely to cancer cells. Historically we can classify the way we treat cancer really into four main domains, surgical intervention, chemotherapies, radiation therapy, and more recently immunotherapies, that use the host's immune system to treat cancer. Really, what MTR drugs do is they deploy radiation therapy, which has been proven over many decades, specifically to the sites of cancer. So here on the left, we see an MTR drug comprising its two main components. First of all, a radioactive isotope that serves as the treatment payload. And secondly, a small molecule or an antibody that specifically seeks out and binds to a protein that is expressed on a prostate cancer, or a kidney cancer or a glioblastoma cell. So we have a specific target on the cancer cell that is identified, and this essentially serves as the address to which that radioactive isotope is then delivered.
The drugs are administered in a very usual way, intravenously, and they then circulate within the bloodstream and identify and bind to cancer cells wherever they are, including small or micro metastatic disease, that may not be visible using standard imaging. Once located at a target cancer cell site, small doses or low doses of the radiation may be used to generate images of a patient's cancer. In other words, see the cancer, for a radiologist or a nuclear medicine doc to identify the size and the location of the patient's cancer, and then subsequently higher doses of radiation may be employed to destroy and thus treat the cancer.
Next slide, please.So Telix's program is an advanced program, focusing on three main therapy areas, prostate, kidney and brain cancer. For the first two, prostate and kidney. Each of those has both an imaging and a therapeutic agent in development, and in each of those areas the imaging agent is the most advanced. Telix's prostate cancer imaging agent just about to be submitted to FDA, and our kidney cancer imaging agent in phase three development. For brain cancer or glioblastoma, which was previously in the earlier presentation, very nicely described, we have an earlier stage asset known as TLX101, which is currently in phase one to develop.
Next slide, please.So looking at the first commercial product of Telix, our prostate cancer imaging agent, this comprises specifically an isotope known as Gallium-68, which enables images or pictures to be obtained in a PET camera. And a PET camera is a significant piece of capital equipment, that is ubiquitous in the nuclear medicine departments of large metropolitan hospitals. And the targeting molecule is known as PSMA-11, or prostate specific membrane antigen, which identifies a specific protein on prostate cancer cells and thereby takes the Gallium-68 isotope to its location.
On the right, you see this is what the actual kit for the generation of this drug looks like. So these are the components that Telix provides to a nuclear medicine department in a hospital, they use the Gallium-68, which is produced by a generator within the nuclear medicine department, and the kit, to formulate the final drug product and that is then supplied and injected into the patient about to go for PET imaging.
Next slide, please.Very interestingly, for a drug that is as yet unapproved by any major regulatory authority around the world, including FDA, over the last year and really just in the last few months, PSMA-based PET imaging for prostate cancer patients has emerged as the new standard of care. And so on the left we see an article from just last month, published in the prestigious Lancet Medical Journal, which was reporting the results of a somewhat landmark randomized controlled trial, run at 10 sites in Australia by Professor Michael Hofman from the Peter MacCallum Cancer Center in Melbourne and collaborators, that showed that PSMA-based PET imaging is significantly more accurate and better than current day conventional imaging, which uses a CT scan and a bone scan for identifying where a new patient's disease is located when they first present with prostate cancer.
And interestingly the results were so strong that the authors of this landmark paper went so far as to suggest that the current clinical practice guidelines should be reviewed and updated in line with these findings. So no doubt the guidelines will be updated to include this new information. Furthermore, back in January, ASCO, or the American Society of Clinical Oncology, updated their clinical practice guidelines for prostate imaging, recommending the, what they call next generation imaging modalities, which include PSMA PET imaging, the new standard of care for imaging men presenting with prostate cancer. So it's clearly in the guidelines, and this is quite a unique situation when a drug has not actually been approved yet.
Next slide, please.So as I mentioned, the first indication that Telix will be submitting for is for its prostate cancer imaging product to be used in men suspected of having a recurrence of prostate cancer after they'd been treated with curative intent. So what that means, is that a male patient with prostate cancer can either undergo prostatectomy, where they have the prostate removed by a surgical urologist, or they have radiation therapy with the intent to cure them and cure is established.
But unfortunately, for a very significant number of men, in this case in the United States, we use those figures by way of example, 70,000 men who are treated with curative intent for their prostate cancer unfortunately have a rising blood test in subsequent months and years, suggesting that their prostate cancer has recurred. And the limitation of present day imaging with CT or MRI is that it's difficult, because of the lack of resolution, to identify early on where that disease may be coming back. And of course what that results in is that it's impossible then to take early intervention to endeavor to reestablish cure in these patients. So clearly very important to be able to identify early recurrence early on when it occurs, so that treatments may be undertaken to reestablish cure in these men.
Of course that's the first indication, there are three potential future additional indications, which are substantially larger in size than that first indication. They are, as reported in that Lancet paper, primary staging in men newly diagnosed with high risk prostate cancer, a thirdly patient selection for folks who are undergoing locally targeted radiation which is also known as radio ligand therapy, and then fourthly monitoring of response to treatment, in men undergoing therapy for advanced prostate cancer, to ascertain whether their treatments are working.
Next slide, please.So, we are in a very unprecedented times and despite these challenges that have been wrought by COVID-19 across all sectors of business, unfortunately cancer is not something that waits for these types of matters in any way. And so we are grateful that Telix, from Telix's point of view, we expect to achieve all of our key 2020 objectives, and we'll just focus on these in conclusion.
So for the prostate cancer imaging product, TLX591 CDX, we expect to submit our new drug application to the FDA during the current quarter. Similarly, we'll be making our European submission for our marketing authorization to our European competent authority, which is the Danish Medicines Authority. Also in the second quarter, although we would expect a longer approval timeframe in Europe.
Current feedback from the FDA has been very positive, and we know that our safety and our efficacy data have been deemed sufficient, so we expect the likelihood of an approval for our prostate cancer imaging agent in the US to be particularly high between now and the end of 2020. And so we could foresee a US commercial launch in the first quarter of next year, should that approval come through.
Prostate cancer therapy, TLX591, we will be having our consultation with the FDA via a pre-investigational new device, or IND meeting, or our phase three randomized controlled trial, which we will have as our registration trial. We'll be having that consultation with FDA also during this quarter.
And then finally, our kidney cancer imaging product, TLX250 CDX. We are currently recruiting, as previously communicated, to our ZIRCON phase three registration trial, and we expect completement of approvement to that trial to occur during 2020.
So with that, I would like to thank everybody on the call, and would welcome any questions. I've provided my details and would absolutely welcome reach-outs to me, to address any questions that folks on the call may have.
