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Oncolytics Biotech, Inc. (ONCY)
2013 Annual Meeting of Shareholders Conference Call
May 9, 2013 5:15 pm ET
Robert L. Kirkman, MD — President & CEO
Matt Coffey, PhD – Director
Unidentified Company Representative
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Thank you. And after I finish the presentation, I would urge you to direct anything of interest from a question perspective to me in anything difficult towards my colleague Matt. And anything financial towards Kirk, unfortunately, Kirk, you’ll have to speak for the first time. But thank you for that. And I would ask you to leave your questions to me at the end of the presentation. I won’t be taking all that much of your time.
What I’m wondering today is to give you a brief update of the years achievements and take a little bit of time talking more detail about three specific clinical studies, our two lung studies, and our head and neck clinical study. I think those are things of interest that people should be gotten your attention to.
Before I begin, I would like to bring your attention to our forward-looking statements and I will do my first (inaudible) share, where we draw your attention to our forward-looking statements and with the SEC, our registration statements and with the 13 securities commissions in Canada, I believe despite Ontario’s best efforts to have a single securities commission we still have 13. I’m a big fan of the Alberta Securities Commission. So I’m actually a fan of keeping at the way that I want to say that my one clinical statement for today.
Today, I’ll be talking about the last year, I’ll be talking about our financial status. I’ll be talking about briefly about some intellectual property developments, just talk about our manufacturing program, which is a critical program, and to be talking and to get some more depth on mostly about advances in our clinical trial program. And I would encourage you to pay close attention to that particular part of the conversation. I’ll also be talking briefly about the year ahead and then we’ll entertain questions and comments.
So let’s just start here with financial. As many of you know, we are a development stage biotech company, which means we don’t revenues and certainly don’t have revenues to cover our cash burn costs. And so it’s important for us to maintain sort of an ongoing financing activity that allows us to fund other operations of the company. And it’s always been our sort of operation to attempt to have at least a year of cash on balance at any time. And so when we drift down close to the year, we always anticipate doing a financing to push that time on well beyond that particular time.
So a year ago at this time or year ago at the end of Q1, we had a little over $40 million in cash. We spent money mostly on our Phase III study candidly. We had a very heavy expense year with respect to clinical trail programs last year. And as a result of that we then kept our eyes open for opportunities to do financing. We did so earlier this year.
And so what you have at the cash balance that reflects very closely to where we were last year. It’s a little higher, and that gives us cash operation certainly till end of 2014, inarguably to early 2015 by the guidance that we provided to the market. But it’s critical for everybody to remember that that is how biotech companies operate until they actually have revenues and sales.
With respect to intellectual property and this a very short slide for a very large amount of activity. But we maintain a very vigorous and aggressive IP program inside this company, and this isn’t just patents, it’s also trademarks, it’s also confidential information that’s kept that way trade secrets. And as reflected in output, upfront what you see, which is patent being issued on a regular basis, but not just here in North America and Canada and United States, but around the world. We have a very aggressive worldwide filing strategy and (inaudible) spearheads up program for us. And I have to say, it’s a real strength in this company and has been annoyed will be, we will continue to maintain our efforts in this particular area.
Manufacturing and sometimes it doesn’t do justice to give this one slide, but to do much more than that would telling things that we’re not supposed to talk about candidly. But we’re very, very late in the development stage of our manufacturing process. Again, we view this is a major strength of the company. Imagine a scenario where we demonstrated in real lives and works and then we can’t make it a little beyond embracing I would have to say or can make it, but it doesn’t meet regulatory scrutiny also a problem.
And there are more products that failed registration at agencies like the FDA because of manufacturing issues than there are because of clinical data issues. And so this is a program that we don’t talk about that often, but I think it’s absolutely critical that we’ve recognized the effort and the achievement of this particular activity. In this coming year, we’ll see the last elements of that fall in place. And I have to say that this has a major strength by other entities taking a look at Oncolytics on both non-commercial and commercial.
With respect to the clinical program I think the things the highlight is from a major activity perspective, it is actually looking at the first stage of our REO 18 head and neck study. We completed and expanded the enrollment, which was about twice the original anticipated enrollment in this study quite expeditiously. And we actually released initial data of the very, very early preliminary data that was available from the study just before Christmas last year. And I think this was a critical milestone for us to anticipate and a critical milestone for us to look forward to in this particular study. And I’ll be going into more depth about that data and also be explaining widely to this analysis, because I think it’s very important for people to understand how, I think, new launch, the analysis of this particular study has become.
This is our randomized clinical program, just as a placeholder let you know what we’re doing. I don’t have all the clinical studies that Oncolytics is involved with on this particular slide, that would take another slide or two. We have a very broad-based clinical program now looking at a number of different indications, different types of cancer. And I think the key thing for us in the last year has been moving into a very broad randomized, which means we have a control and test group within the same study program looking at most of actually the major indications in oncology.
And this is a result, of course, of our belief that REOLYSIN actually is broadly active against most cancers. And this is the result of that. And this slide really just gives you an indication of the breadth of the activity and the number of patients in each one of those studies. I just like to note that those last six studies was randomized Phase II studies represent about as many patients as we’ve enrolled in total for the entire history of the company in our previous studies including our – the REO 18 head and neck study.
And most of those program costs are being supported by outside agencies. The equivalent to that 600 plus patients is in essence the cost of a single study test as a corporation. Now, what does those comprise of, there’s actually four randomized studies now ongoing in Canada. These are actively enrolling in Canada and just very briefly, we are looking at castration-resistant prostate cancer and a very interesting study. Our first study looking at what I think it was a new age targeted therapeutic and combination with REOLYSIN, which is colorectal cancer in combination with the vast and then a drug combination called FOLFOX6.
Looking at actually two both types of lung cancer both adenocarcinoma lung and (inaudible) lung in the second line setting either study here kind of randomized in the essence two studies and one is actually four arms in the study. And finally, a study that’s I think very important just to take a look at real finally in randomized setting looking at breast cancer. And all these studies are being run by NCIC here in Canada, it’s International Cancer Research Institute of Canada, which now just NCIC is done along with the contraction of their future name.
We still have and these are further advanced two studies going on in the United States, one for later stage ovarian and reproductive stage cancers in women. (inaudible) colleague company of ours here in Canada, who was in ovarian study many of years ago and got a query from Health Canada wondering about the gender and balance in those study (inaudible), but we have not got that question about this particular study, every time I look at that study, I think it’s only – I can’t tell that.
And our colleague (inaudible) who unfortunately died of pancreatic cancer actually round that study. And the other study being a very interested study in pancreatic cancer, and just to note that these are first line patients, but they are actually getting standard of care, currently which is about the change is gemcitabine for first line patients in the United States and in Canada and we’re not actually using that in first lien patient. So it’s kind of an interesting study, and both of those are sponsored for and mostly paid by the MCI and GOG, Gynecologic Oncology Group, is actually running the ovarian study.
So between those two jurisdictions, fixed studies who will need to be substantially rolled or completely enrolled in this calendar year. And so next year when we are standing here, I’m hoping to be able to be describing early data, I would like to form on most of these studies. It’s a very significant step forward for Oncolytics and it’s really, if you think of head neck of the tip of the iceberg for Oncolytics, this is the bulk of the iceberg underneath the water. These are represented literally most of the major indications from a numeric perspective for number of patients in oncology to-date, very critical be thinking in that term. This is Oncolytics future in these six studies.
Now, I want to talk briefly in more detail about three studies as I indicated and that’s our two lung study, single ARM lung studies, one for (inaudible). I think it is very critical, because they do lead into a number of our existing study, because we already have that second lien study. But probably I think one of these two studies is a candidate for our own next larger randomized study.