Good morning. My name is Sharon and I’ll be your conference operator today. At this time, I would like to welcome everyone to the Oncolytics Biotech’s Third Quarter Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker’s remarks, there will be a question-and-answer session for analysts and institutional investors. [Operator Instructions] I will now turn the call over to your host, Michael Moore, Vice-President, Investor Relations and Corporate Communications. Mr. Moore, please go ahead.

Thank you, Sharon. Good morning, ladies and gentlemen and thank you for joining us on our third quarter 2018 financial results and corporate update call. With me on the call this morning from Oncolytics are Dr. Matt Coffey, President and Chief Executive Officer, and Kirk Look, Chief Financial Officer. On today’s call, Dr. Coffey will review our progress in the third quarter, provide an update on our clinical development plans and strategy including our program in metastatic breast cancer that consists of our window of opportunity study and the planned phase through registration study. We will also review the other combination studies we are conducting or plan to conduct over the next 12 months to 18 months. Kirk will review our financial result and activity for the third quarter. I’d like to point out certain statements made on this call such as those relating to our clinical development plans and business development plans are forward-looking within the meaning of applicable security laws. Please refer to our third quarter press release and MD&A from important assumptions and cautionary statements related to forward looking information. I will now turn the call over to Dr. Matt Coffey. Matt?

Thanks Mike. Good morning everyone and thanks for joining our call today. I will just direct you to our forward-looking statements, and we will be making a number of these forward-looking statements. And I wanted to start the call by just reminding everyone of what a tremendous year it’s been 2018 in terms of making progress. It sets the stage for what we believe will be a transformation in the company in 2019. We wanted to provide an overview on our thinking now that we’ve had more feedback on the Phase 3 with KOLs, pharma partners and our current thinking about biomarkers and how we think we’ve identified potential markers that will predict for overall survival in various patient populations by better measuring the immune response to the lysis for the tumors. We’ll give an update on our metastatic breast cancer program and how we are positioning it for the Phase 3, some guidance on our immune checkpoint program and why we think it’s such a pivotal time in oncolytic viruses and how pharma is trying to position these agents as we move to registration. Now the emerging role of Pelareorep, I wanted to start off, we’ve had a lot of questions, people have asked me, you know, Matt why are you not using REOLYSIN anymore as the name of the product. And the reason for this is, in our interactions with the FDA during our special protocol assessment; it came to their attention or one of the reviewer’s attention that’s the name REOLYSIN rhymes with the existing chemotherapeutic bleomycin, so REOLYSIN/bleomycin. The concern was this may lead to dosing errors, transcriptional errors if the pharmacist misread REOLYSIN to bleomycin there was a chance that it would lead to misdosing the patients. What the FDA requested is that we use…

Thanks Matt. And welcome to the call everyone. I'll provide an overview of our financial results and invite you to review our news release and MD&A for additional information. R&D expenses for the third quarter of 2018 were $1.9 million compared to $1.7 million for the third quarter of 2017. Increase in R&D for the quarter is primarily related to foreign exchange losses due to the translation of our U.S. currency partially offset by the stabilization of our clinical trial expenses. In the current quarter our clinical trial activities are mainly related to closing out certain fully enrolled clinical trials, safety data management and updating regulatory documents connected to our clinical program. G&A expenses for the third quarter of 2018 are $1.5 million compared to $1.3 million for the third quarter of 2017. With the rise in expenses relating to our continued investment in our U.S. operations as we've expanded our office space in Santiago, California, and incurred additional personnel costs. Net loss for the third quarter of 2018 was $3.3 million or $0.20 per share compared to a net loss of $3 million or $0.20 per share post consolidation for the third quarter of 2017. As of September 30, 2018, we had cash and cash equivalents of $16.2 million, a $4.4 million increase over the $11.8 million we had on December 31st, 2017. With the window of opportunity study, a very quick and reasonably inexpensive study being the only study Oncolytics is currently sponsoring, our burn rate has stabilized and we can now advance our collaborative studies into 2020. This includes all of our collaborations along with some of the important clinical and data milestones to come from these studies. We were also active in the third quarter and subsequent to the quarter’s end securing financial strength for Oncolytics. We announce a dedicated equity purchase agreement with Lincoln Park Capital in late September and an at the market facility towards the end of October. As outlined in the announcements, these are both at our discussion and do not create dilution until used, but they do create financial strength which is something very important to us as we approach an important time of negotiations in 2019. Finally, a high priority for us remains the funding required for our phase 3 program which we believe we can do through a partnership that allows us to maintain at least a co-promote scenario in North America. As Matt alluded to earlier, we believe our overall clinical development program provides data that it enhances the potential for successful registration program and successful partnering activities. As we see the emerging data from these open label studies and negotiate from a position of financial strength with potential pharma partners, we will be able to determine the best funding options at that time. With that, I will now turn the call back over to Matt before we open it up for Q&A.

Thanks, Kirk. We've accomplished so much in 2018 and I think that's going to pay out to what happens in 2019 for the company. We're running and are preparing for a total of five combination studies with large pharma. We anticipate that this data will ultimately lead to the strategic alliance that we’ve been looking to get in place over the last 12 to 18 months. These studies will generate new and important data that will advance our partnership discussions and provide critical information that these potential partners need for their investment and partnering decisions. It also I think will significantly de-risk the phase 3 program by allowing us to identify those patients likely to respond at baseline but further to identify those patients who are responding to treatment. We believe we can identify this as early as cycle two. Now we've created a competitive environment for potential partners while we generate this data all of it in real-time and all of it open-label, all while we drive to our phase 3 registration program in metastatic breast cancer. 2019 should prove to be the most valuable year in the company's history with significant catalyst, value inflection points throughout the year. Now with this operator, we'll opening for questions.

[Operator Instructions] And your first question comes from Wangzhi Li with Ladenburg. Your line is open.

Hi, good morning.

Hi, Wangzhi.

Hey, good morning. Thanks for taking my question.

Thanks for calling.

And maybe just – yes, just a little bit color further on the window of opportunity study, what specific biomarker you could expect and - or do the biomarker Assay that were established in case it's positive you want to implement in the phase 3, are they ready to go or we need to do some further work to really make it Phase 3 ready biomarker?

We, without being too coy, we submitted this for presentation next quarter. We did see a correlation between this biomarker and an overall survival benefits. It looks quite good, although the end was small and this is why we want to run it for the AWARE program. Without giving away too much detail, basically it's a measure of adaptive response. This came to us actually by way of some of our strategic alliances. It's an Assay that they've very readily used for checkpoint blockade. They thought it would be adaptable to our situation. We worked with one of their recommended vendors and actually out of the box it was it appears to be predictive. So, we'll give a full account on this, hopefully in a poster or a presentation section at next AACR, but it does look very robust. We're working with one of our potential partners to further gate this. This is something that they have a lot of experience with and they think it's even a very attractive biomarker to run with basket studies because we can verily quickly identify especially with checkpoint blockade, those patients responding and those who aren’t. So, we don’t have to necessarily wait for the OS data we think we can detect immunological changes much earlier than that which is a good way to get rid of failed arms or expand those, that looks successful. But there'll be -- assuming it gets accepted, there'll be a full presentation. But it is robust. It is accepted. And it is something our partners are using.

Okay. Got it. Thank you. And also, maybe if you can - I know you already talked quite some in detail, but maybe friend potential outcome from the window of opportunity study. What's the top potential scenarios and how that affects the Phase 3 study? And if you added this IDO combination arm, how that would affect the SPA with FDA, will that still be in effect or will be changed?

It's a great question. Thank you for asking that. The AWARE-1 study it’s not as you point out the population that we ran the randomized Phase 2, but the benefit of it is we actually get the entire tumor tissue. So, it allows us to better characterize the immune response. We believe what we will see though is inflammation certainly in the hormone receptor positive HER-2-negative group. What we hope the biomarker will do is allow us to basically identify those patients who have more inflammation, who have more recognition of new epitopes and basically use that as the potential biomarker going forward. Now, because we have the whole tissue, and because only half the patients are going to get access to Tecentriq, if we see an increase in cellularity, or what that means is if we see an increase in the inflammatory cells in the tumor, it could potentially recommend a role for Tecentriq in a very broad market that they have not yet envisioned. If that's the case, I think we would look to run this with a strategic alliance, so it would be a three arm study, we would potentially could go back to FDA to inform them that we now have a biomarker or we believe we have a biomarker that potentially checkpoint blockade is recommended. But in speaking with potential partners about this, what's nice if we do see a signal coming out of checkpoint blockade and breast cancer, we could simply add an arm to the study and it would be Standard of Care, Standard of Care virus, Standard of Care with the checkpoint inhibitor. What's nice about this is with the biomarker if we're not seeing any benefit at all with checkpoint blockade, we can drop that arm and move ahead as we did. If we are seeing a betterment with the triplet, it allows for a three arm comparison, it allows us two potential ways to win either with the checkpoint blockade or without it. So, it becomes very attractive clinical design for us and potential partners because potentially it expands checkpoint franchise into an area that has not been successful for checkpoint blockade to-date. And if it doesn't, then that would hopefully a multi-billion dollar product that's applicable on second line breast cancer.

Got it. Thank you. Last question is, have any of the investigators provide any guidance in terms of timing for data reports whether Phase 2 Keytruda combo trial in pancreatic cancer, and the Keytruda and Nivolumab combo study in multiple myeloma?

These are ISTs, so I mean investigators have control over when the data get presented but Deva Mahalingam -- and I should have pointed this out, Deva Mahalingam is a very good investigator and a very good colleague. Dave actually ran the study with reovirus and gemcitabine. And what he demonstrated there was no change in PFS but landmark survival in pancreatic cancer a 50% at one year and close to 25% at two which is unheard of. I have never seen reports beyond 4% or 5% at two year in pancreatic cancer, especially in the patient population that was enrolled into that study. Now, as part of that work and as part of Deva's thinking that this was checkpoint blockade, he added Keytruda, that was actually his study design, so that small Keytruda study that we did was again Deva's thinking, and the results there was sufficiently positive that he was able to get Merck design an IST and provide Keytruda for the study that he's now running at Northwest University. So, he's taken lessons learnt from the small Keytruda study, refined it and has run it in his program. The other nice thing about Deva is Dave likes to present his data even when it’s not final. He has had a history of presenting interim results, we’re hopeful that he continues to do this. Likewise, the gentlemen running the multiple myeloma study at Emory and at the Norris Cancer Center they've all presented interim data. I mean, I think this is a good chance to get some biomarker data out, some response data and certainly with the bone marrow smears and pro-inflammatory cytokine response and enhancement of inflammation in the bone marrow. So, we strongly encourage these guys to present data early and often and to-date they've been happy to do so.

Okay. Got it. Thanks, very much.

Your next question comes from John Newman with Canaccord. Your line is open.

Hi guys, thanks for taking the question. I wonder if you can talk a little bit about the recent abstract that you released regarding the multiple myeloma combination data that we’ll see at ASH? Thanks.

Yes. That was actually work done by Craig Hofmeister and Doug Sborov. They're actually the gentlemen that are involved with the Opdivo study with BMS. What they found there is patients who had and we've seen this with other studies as well. There was very good response rates in patients who had not been very heavily previously exposed to proteasome inhibition. Those patients who respond, they were able to see an uptick in PD-L1 expression. The very heavily pre-treated group that had just failed the proteasome inhibitor had less impressive results. So, again it solidifies our thinking that the virus really benefits from a cellular stress response that this allows the virus to propagate more easily, to spread more easily, and as a result of this, get much better inflammation. Now, I should point out the slide that we used with the checkpoint inhibitors that shows the inflammation, this is actually Dr. Hofmeister work. And what's interesting about this is he's demonstrated that this massive inflammation is much enhanced by having susceptibility to the proteasome inhibitor. He looked at this as a monotherapy and we do see inflammation but it's not as striking as this. Likewise, when the patient has just failed carfilzomib and we get inflammation but it's not as dramatic as someone who has some susceptibility to the proteasome inhibitors. So, it does seem that the virus does benefit from active cytotoxicity. We've seen this on our breast cancer response. What we found in subset analysis, patients who had received taxanes very recently did not do as well as those who had not received taxanes in the previous 12 months. So, it does seem that the washout period really benefits the results of this. And this is going to be presented early December at ASH. There's some really nice figures in that. I think again it strongly supports a role for reovirus being a standardized backbone in checkpoint blockade.

And you mentioned that it seems like the patients that had not had heavy prior exposure to proteasome inhibitors should a better response when the reovirus was added. Have you seen any correlations one way or the other regarding prior IMiD reatment?

That's a good question. And I'm not sure that we've looked at that. If you're at assay, strongly encourage you to bend Dr. Hofmeister's ear, he’ll be a much better person to give you that answer.

Okay, great, thank you.

Thank you.

Your next question comes from Rahul Sarugaser with Paradigm Capital. Your line is open.

Good morning, gentlemen. Thanks for taking my question. So, thanks for the additional color on the window of opportunity study, so, just a couple of questions here. So, you mentioned that you will be biopsying based on a mastectomy after. And so, I wanted to clarify how many patients do you expect to enroll in this study? And then what is the time from administration of pelareorep to the mastectomy and biopsy?

Great question. This will look at triple negative, hormone receptor positive, HER2-negative, and HER2-positive patients, its roughly 12 patients per subset. Patients are biopsied at baseline. They are treated for a three week period, 21 days plus or minus five days from the mastectomy. So, the patients can get it's, well basically 21 days up to about 26 days. So, there's a window there to allow for the surgery to get in. With the full mastectomy we can get the full biopsy with immunohistochemistry. So, it's more than just a biopsy. It’s a actual disease we can look at the entirety of the mass, the normal surrounding tissue. And again what we're hoping to see is much more double stranded RNA and much more inflammation and much more lysis in the hormone-receptor-positive. We're hoping Tecentriq actually enhances this benefit. And again we're hoping to see a safety signal. We don’t expect there would be any toxicities with Tecentriq based on our limited data with Keytruda in our animal experiments. But until you do the experiment, you don’t know.

Great, that's very helpful. And in terms of then progressing to selection of biomarker and then taking that to the FDA for an amendment on the SPA. Do you have an estimate on sort of what that will take? What that process will look like and the amount of time that that would take?

And, we can start sharing the biomarker work now. As I said, we’re significant -- we're happy enough that we submitted for publication. It's done in collaboration with another group. So, we were hoping to present a little bit earlier but we had to get it through all the legal to get the press, the abstract out. I think the FDA will look at this positively. I mean, they were the group that strongly encouraged us to identify the biomarker. They provided guidance that in this area that looking at innate and adaptive responses are more easily quantifiable and have often been correlated with patient benefit. So, we looked at this with a lot of our archival tissue and actually we're able to demonstrate in an indication that this biomarker would predict for overall survival as early as cycle two-day-one. We do need to verify this in breast, but the biochemistry is the biochemistry. We're just looking at innate and adaptive response. In terms of adding that third arm, it would really be I think up to our potential strategic alliance whether we wanted to go back and do another SPA or an amendment to the SPA. The SPA typically is not required when you have an overall survival endpoint. It's more typical to see an SPA when we have a surrogate endpoint. We would still recommend the overall survival as the primary. If we were to file an amendment as I said these studies are open label. We could be seeing data here at March/April timeframe. We could be amending this SPA during the conduct of the AWARE-1 so that as soon as we had the final study reports, we hopefully would have the SPA in hand. But again, this would be -- we believe done in collaboration with our strategic partner. So, this would be in conjunction with them. So, the thinking of whether an SPA was required and the timing of any amendment to it could be as early as during the conduct of AWARE, right after but typically these SPA's have a 30 to 60 turnaround time, so, no more than two months.

Great. Thank you very much. That’s very helpful.

For them, I mean they've agreed to the activity of the agent in the phase 2. They've agreed that the results were significant enough that only a single study was made. So, it basically be their review time on adding a biomarker that will be in discussion with them and whether or not third arm is recommended.

Great. And then, one last question. And in terms of driving a partnership because you talked about that discussion happening in parallel with the FDA. So, in terms of having that enough evidence to re-incentivize the pharma partners, that you’re talked about earlier, what sort of timeline are you looking at based on the data generation from the window of opportunity study, and after that I’ll leave it there? Thank you.

You know I think there’s enough historical examples. I mean, I would point everyone to the Viralytics story. I mean they entered into the IST. They generated some results and were acquired shortly thereafter. If you look at the other one that was actually preceded by, I think the mezzanine financing, I want to say, Boehringer, I think actually participated in a mezzanine financing of viral therapeutics and acquired them within 18 months. And those are preclinical results. Pharma spend big money for these assets right now. They’re also spending big money on very limited data. The only group that really had later stage data was T-Vec and it was during the conduct of a Phase 3. So it would be very difficult to figure out what was going on. So, I think the real time data. I think, Rahul, that the biomarker results we just received them as a later or earlier this month, and they were striking enough that we were able to pull an abstract together very very quickly. We’re just communicating this now with potential partners, because again, this was something that I think everyone thought was critical to be involved in a Phase 3 program, because again it’s just significantly de-risks it. And the signal here is very very good. Whether or not, it’s going be applicable across all indications or if it’s going to be seen in the indication that where we are reporting it in yet to be seen. But I mean, it’s immune activation. So it should be applicable to all of our indications.

All right. Thank you very much.

And we are currently out of time. At this time, I will turn the call over to the presenters.

Thanks everyone. We appreciate everyone being on the call today, and look forward to updating you on our future progress. As I said, keep an eye out for us at ASH and then leading into the New Year. We’re starting the Pancreatic Cancer study imminently. We’ll be starting the Opdivo study here imminently. It’s an exciting time for us. We’re generating the data that we need for our strategic alliances, and we’re very appreciative of the patients, their families, our KOLs, and our pharma partners in moving us to the point that we are now and into a very exciting 2019

This concludes today’s conference call. You may now disconnect.