Oncolytics Biotech Inc. (ONCY)

[onco_investor]

Oncolytics Bio CEO & Investor Conference Transcript

This is not a full transcript, but only some parts that RJC found either new, or particularly interesting.

CEO Brad Thompson's presentation date: 2/14/2011

You can currently hear the webcast at:
http://www.veracast.com/webcasts/bio/ceoinvestor2011/61114431.cfm

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Miscellaneous H&N selections:
- We currently have 20 [Phase III H&N] centers enrolling right now, and should have between 45 and 50 centers enrolling by summertime.

- We anticipate being fully enrolled (in the full 280 patients), some time in calendar year 2012

- What we've powered this study for is looking at a maximum 10% response rate and a control arm median PFS of 2 months and we actually powered it for 2 different survivals … 4 1/2 months (which is what we expect, and 6 months survival. So if you look at that 200 patient outcome that is most likely in the second stage, it's actually powered against the 6 month potential survival and the control arm, which gives us quite a bit of latitude in case the patients do better, which they often do

- If we duplicate [the UK Phase II H&N results] in the Phase III, it could be statistically significant at 80 patients, but we'll continue to run patients under that Study even if they are, as it's not a large enough safety package.

Squamous Cell Carcinoma Lung
{11:25} The key thing looking at squamous cell is not so much tumor regression, but whether you're getting bleeding post tumor regression … which has been an issue with some of the other studies that have been done. So far we haven't seen that. Again, it's early days and while this is typical of what we're
seeing, I wouldn't want to predict necessarily that's typical in the end.

NSCLC Trial:
In the section starting at {12:25} where Brad says that "We're running a single arm Non-Small Cell Lung study, which should now report near mid-year.", he follows with the well chosen words that "… we're quite looking forward to getting this data out".

Texas Gemzar/Reo pancreatic
{13:20} We're looking at a single-arm study involving Reolysin in combination with current standard of care (which is Gemzar) … just to show you how low the bar is in this particular area. It's a "Simon two-stage" design, and we needed 3 or more Stable Diseases in the first 17 patients to proceed on to a second Study which could either be the same Study expanded, the same Study with the addition of a taxane, or a randomized Study. We're in the midst of thinking what exactly we want to do there. We met that end point and actually in 6 patients there was a Partial Response, 3 Stable Diseases by RECIST, a Stable Disease patient who was within his last 2 days of therapy to get to 12 weeks and he decided he wanted to go on to something else, and 1 Progressive Disease. So quite encouraging, even though early.

NCI Carbo/tax/Reovirus pancreatic
{14:09} The other Study that we're working on (which is starting up now), is an interesting randomized Study that the NCI is actually sponsoring (which is I suspect how they got FDA Approval to run a non-standard of care Study in First Line), where they're looking at carbo/tax in combination with Reolysin versus carbo/tax. It's a very very interesting Study given that it excludes Gemzar.

On pancreatic imaging
{14:50} The tumors are mostly normal tissue … 75-80% of the tumors are normal strata so it's very hard to see what's underneath. You could completely get rid of the tumors in some cases and still end up only having Stable Disease by RECIST, so it's a bit of a challenge and us and other people are trying to incorporate imaging to get to these end points but of course again you have to worry about the FDA and if they'll accept them with the PFS end-point or not.

Manufacturing
{17:30} We're currently producing at the 100 liter scale which produces over 100,000 IV doses, so a 100 liter facility is actually well comfortable for us to do a launch with. We're actually finishing off the final validation this year, then we're going to start stockpiling product in anticipation of launch.

Stock
{17:55} Our trading volumes are about 55% NASDAQ, 45% Toronto. We're about 40% institutionally held. Most of that is outside of the US. From a cash basis, our anticipated burn this year is between 2 and 2.2 million [per month], and lower next year actually as we finish Phase III enrollment, and so with the cash as of Jan 24, we had about 2 years of cash. We're just a little under 2 years right now. So this takes us past our data read-out on our Phase III Study, and allows us to finish up all the other Studies that we're conducting right now.

Summary
{18:35} Something to look forward to. Early Phase III data by year end, or early next year and we've got the other two randomized Studies that be finishing enrolling early next year and we continue to develop our IP portfolio and have leapt over the hurdle of manufacturing which for this particular biologic was a very important milestone.

Q&A
Question on partnering strategy …
{19:20} Given that we're not that far away from a first early Phase III data read-out … it's always been our intention to partner before we ran large registration studies in big indications. I can handle Head and Neck, but a large thousand patient registration Study in the other indications I think is
beyond our capability. We're pursuingpartnering. We're in active discussions with quite a few people, and I would expect however that we'll either partner very soon, or after the first part of the Phase III data comes out. There will be a peak and then a trough and then a peak again.

Unheard Question
{22:00) It'll be later this year that it will be done. It's a very specific subset, and as my colleague Dr Matt Coffey says "We don't want to rush to failure", and we want to make sure we get a pure patient population. It's really a function of the number of sites. If we're focusing our time and attention on getting site numbers up, and getting as broad a country representation as possible, we're probably 8 or 9 countries on by mid-year, and doubling and a half our current sites (which are around 20) … so we should have it done later this year. It's a very specific sub-patient type though. We're being very very particular about keeping the enrollment criteria narrow.

Survival for lung or pancreatic cancer
{22:00] Brad answers something like it's too early to tell, but then says "We're seeing responses we need, certainly higher than Gemzar alone." If you Inject locally will you get better responses

{22:50} You actually do on a tumor specific basis. We did local therapy when we started out for a variety of reasons, and you overcome delivery issues by doing it local. There's two things. There's the immune system between the injection site and the tumor, and then getting into the tumor, and both are issues
depending on which virus you're using. For us, the immune system isn't much of an issue, but certainly the tumor interface is an incredibly important issue, and that's where the taxanes and radiation really are key when we're using them together because they make the tumor's very porous or the virus will actually get through the tumor in the presence of those agents than it does without.

When we did intertumoral, we got very close to the theoretical response rates. We usually expect around 2/3 response rate and that's what we did on the tumors. We did see some tumor to tumor transmission of the virus. It's just in that particular case it takes it out of a general clinic use basis and turns it into
a surgical technique. A lot of tumors are just inaccessible. To do stereotactic delivery intertumorly, it's necessary [inaudible] of certain type so we've just gone the route of IV, but we needed to conquer those delivery issues.

If we hadn't, then intertumoral would be the better case. Needing to be aware of the issues is new for us as well. For the whole group of us that are working in virology, we didn't actually understand what the issues were until we got into the clinic, and I think we do now.

Immune Response question
{24:40} You have to have a time frame for an immune response to occur. With more aggressive tumors and with more aggressive metastatic disease, I think you need to lean towards something that's more of a cytotoxin than an immune response. I think that immune therapies will work in the First Line … I know they do … there are certain homes that are better for certain types of cancers, and with us working on these more aggressive ones, I think you need a cytotoxin.

With some of the slower ones, I think that immune therapy is a great approach, and we're seeing that in the clinic with other people's agents.

Thanks to rjc for the transcribing and posting the best parts.