Good day, ladies and gentlemen. My name is Kat and I’ll be your conference operator today. At this time, I would like to welcome everyone to the Oncolytics Biotech’s Third Quarter 2019 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. I will now turn the call over to your host, Michael Moore, Vice-President, Investor Relations and Corporate Communications. Sir, the floor is yours.

Thanks Kat. Good afternoon, ladies and gentlemen, and thank you for joining us on our call today to discuss our third quarter and corporate update including our updated catalysts and milestones. With me on the call this afternoon from Oncolytics are Dr. Matt Coffey, President and Chief Executive Officer, Kirk Look, Chief Financial Officer; and Andrew de Guttadauro, Global Head of Business Development. On today’s call, Dr. Coffey will review our clinical and operational progress including a recap of catalysts and milestones; Andrew will touch on our business development progress and our growing relationships with pharma and big biotech; and Kirk of course will then speak to our financial position. 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 for important assumptions and cautionary statements related to forward-looking information. I will now turn the call over to Dr. Matt Coffey. Matt?

Hello everyone and welcome to our third quarter 2019 and corporate update conference call. The quarter was marked by continued clinical execution as well as even more validation of our unique oncolytic virus and specifically our entry in this route of delivery, which I believe feed vastly undervalued differentiator and will be something to come back to a few times on today's call. It's just that important. We remain on track to report a steady cadence of values driving catalysts across our robust and growing development pipeline, before the end of this year and extending into the middle of 2021. I'll describe these important value inflection points later on this call, but first let me provide a quick overview of our lead program and update on recent highlights from the quarter. As everyone following Oncolytics, now, we're focused on advancing pelareorep in the lead indication of metastatic breast cancer, and we're conducting two key clinical studies with industry leaders that will determine design of the Phase 3 registration program for pelareorep in this indication. We haven't approved study design for the Phase 3, but we believe these two studies named AWARE-1 and BRACELET-1 will provide data supporting the addition of a checkpoint inhibitor to this registration study as well as the biomarkers that we believe increases the chance of success in this critical study. AWARE-1, our window of opportunity study in early stage breast cancer with Roche’s Tecentriq sensor is ongoing and we expect to announce additional data before the end of the year. The BRACELET-1 study for which we have a co-development agreement with Pfizer and Merck KGaA focusing on metastatic breast cancer will begin enrolling Q1 of next year with our recently announced clinical partner PrECOG. Last quarter, we announced encouraging results from the safety run in AWARE-1,…

Thank you, Matt. As I mentioned on our last call, we've seen renewed interest among large pharma and gained access to oncolytic viruses to potentially combine with their immuno-oncology asset. This interest is reflected by deals executed by Merck, BMS, J&J, Boehringer Ingelheim and others over the past two years. The majority of these deals were preceded by initial clinical collaborations designed to first evaluate the viability of the combination of the oncolytic viruses in question with the acquiring companies own immuno-oncology assets. That's exactly what Oncolytics doing with our ongoing studies designed to demonstrate potential synergies with Bavencio, Tecentriq, Keytruda and Opdivo. Potential partner's interest is firstly driven by demonstrating pelareorep's potential to synergize with a range of checkpoint inhibitors and tumor types. That said, we're seeing partners are also excited by the systemic effect and attendant IV route of administration as the ladder allows for nurses to administer pelareorep with chemotherapy suite much the same way to do other infuse cancer therapies. Pelareorep ease of administration is attractive to potential partners because it addresses a major drawback for most of these, which require intratumoral administration, which is an uncommonly used approach by which to treat oncology patients and carries commercial drawbacks, not experience with IV administration. In addition, pelareorep systemic effect allows it to directly impact metastatic disease, a critical therapeutic aspect that IV administered OVs have yet to prove that can similarly impact. Pelareorep systemic effect therefore allows pelareorep to impact cancer across a broader range of its lifecycle to include it critical metastatic stage. As Matt previously mentioned, we're also excited about pelareorep's emerging potential synergized with the CDK 4/6 therapies, one of the fastest growing drug class in oncology, with 2019 worldwide sales projected to exceed 4 billion. Our goal is to strike a licensing agreement with either company which checkpoint assets or a company recognizing the significant clinical and commercial potential inherent in a therapy capable of being safely and efficaciously combined with multiple checkpoints to treat a range of tumor targets with unmet clinical need. With that, I'll turn the call back over to Matt.

Thanks, Andrew. Before I hand the call to Kirk for a quick review of our finance position, let me recap our guidance over the next two years in terms of upcoming catalyst, as discussed on our most of recent conference call that highlighted our robust set of catalyst and milestones for the first time. Within our press release that went out earlier today, and on the call, we touched on preclinical data demonstrating the synergies between pelareorep as well as another oncology drug class called CDK 4/6 inhibitors. We're also on track to announce additional AWARE-1 data before the end of the year. Our planned Phase 2 study of pelareorep in combination with Merck's Keytruda in multiple myeloma is in the hands of our lead investigator, Dr. Kevin Kelly at USC Norris Cancer Center. Dr. Kelly is negotiating with the FDA to finalize the protocol and we await updates from Dr. Kelly on the study initiation. Now looking at the first half of 2020, we expect to complete enrollment in AWARE-1 and initiate the BRACELET-1 study and report final data from AWARE -1 as logged interim data from our ongoing Phase 2 study in second line pancreatic cancer with Merck's Keytruda in Q2, 2020. The study should also complete enrollment around the same time. Now the second half of 2020 will include final data from the Phase 2 pancreatic study and interim data from both multiple myeloma studies with Opdivo and Keytruda as well as finally data from our previously mentioned NCI sponsored multiple myeloma study combining pelareorep and Amgen's Kyprolis. We expect BRACELET-1 to complete enrollment in the second half of 2020 as well as report interim data before the end of the year. Final data from BRACELET-1 study is expected in the first half 2021. Now, this is without question the most robust set of data catalyst of any company in the Oncolytics BioSpace and so why we're so excited about the future. I will now turn the call to Kirk Look our CFO to discuss our financial results for the quarter.

Thank you, Matt, and hello everyone. At September 30, 2019, we report cash and cash equivalent of $12.3 million to fund our continued operations. This includes gross proceeds of $3.7 million from our underwritten public offering, which importantly added a full quarter to our run rate giving us a stronger financial position. Our net loss for the third quarter of 2019 was $3.5 million compared to $3.3 million in the third quarter 2018, equating to a loss of $0.16 per share in 2019 compared to a loss of $0.20 per share in 2018. Research and development expenses for the third quarter of 2019 were $1.6 million compared to $1.9 million in the third quarter of 2018. In the current quarter, our R&D activities centered on the continued enrolment in our AWARE-1 study, preparing for the first patient to be enrolled in our BRACELET-1 study which continuous to track towards Q1 next year and supporting our other checkpoint inhibitor combination trials. Our operating expenses for the third quarter of 2019 were $1.8 million compared to 1.5 million in the third quarter of 2018. The increase in operating expenses primarily due to transaction costs related to our August 2019 public offering and our continued investments in our investor relations and business development activities. Subsequent to the end of the third quarter and as announced in this morning's press release, we have seen some warrants exercised with proceeds of over $1.25 million on the back of the recent share price appreciation, which is more than doubled in the last month. With our cash on hand along with the proceeds from our warrants and our ATM, Oncolytics is positioned to capitalize on our catalysts and milestones. With that, I will turn it back to management.

Thanks, Kirk. Now before we take questions, I want to reiterate just how highly differentiated we are within the oncolytic virus world, which is Andrew highlighted is an area that is very attractive to large pharma. Now almost all of these developments including the only approved to OB in North America are genetically modified and required intratumoral delivery, and therefore cannot reach metastatic disease. We're the only OB with meaningful data demonstrating efficient and selected viral replication within the tumor following systemic delivery. Now, this is supported by multiple scientific publications and highlighted by the recent meta-analysis presented IOVC. We also feel that this is still significantly underappreciated and believe will be a great source of value as we build our critical mass of data continuing to confirm our intravenous systemic delivery. Pelareorep remains the only viral agent to show survival benefit in late stage metastatic breast cancer. Now, these outstanding results have generated multiple big pharma partnership opportunities where discussions remain very active. As we continue to advance our lead clinical program in breast cancer, our goal is to continue expanding our pipeline to access additional markets with an unmet need and to explore combination therapies with checkpoint inhibitors and other drug classes in oncology. As I described, Oncolytics is entering a rich period of data catalyst over the next 21 months. We look forward to achieving these milestones in line with our guidance and guidance supplied by data by clinical investigators and to build additional value for our company and its shareholders. Now, before we go to Q&A, I'd like to touch on a couple things. First, I'd like to say welcome to our news covering analyst, Jerry Isaacson at Roth Capital, happy to see the interest in Oncolytics and OB space. Second and a very important, I know it's been on many people's minds. Today was the 10th day in a row that we closed above $1 on NASDAQ, and expect to receive formal notification from them as soon as being back in full compliance. We always knew that we would compliance issue, but happy to have it addressed as quickly as we did. I now like to open the lines to take some brief questions, operator.

Thank you. The floor is now open for questions. [Operator Instructions] And our first question comes from John Newman from Canaccord. Go ahead, John.

You've mentioned I think at the beginning of the call that you will be presenting some additional data for AWARE-1 by the end of this year. Just wondering, if you could talk a little bit more about that? Thanks.

Yes, John, thanks for the question. And sorry everyone, I got a cough, I had a cold all days so I sound absolutely terrible, my apologies. So AWARE-1, just to remind it for everyone, AWARE-1 is the window of opportunity study. So these are women who are otherwise healthy but they have a very small primary breast cancer lesion. Now going into this study, we first did note the virus would actually access primary disease. So, we were delighted that it did. But the other thing is we're very concerned about is Tecentriq is it can be toxic and this is exacerbated, if your immune system is completely healthy. You can imagine ramping up your immune system, could potentially be harmful to the patient. So, fortunately, it was tolerated in the patients, when we presented all that initial data. The next safety cohorts are in hormone receptor positive patients only standard of care in virus and this cohort I think almost all of them have either undergone surgery or about to in the next week. So we'll do a similar analysis looking at cell tailor, inflammatory cell count, T cell characterization, both CDA positives as well as using multiplexes to show whether T regs are entering or exiting the tumor. And so, we should have a pretty good stems from these first group of patients whether we see this diminishment of T reg in the presence of checkpoint inhibitors or if the virus can do it on itself. The number of clones, we're very interested to see whether or not the Tecentriq is expanding those as well as just looking at the cytokines profile and response to these patients. So, we're hoping to have that out hopefully in December, if we can get everything on test quickly enough, but there'll be a DSMB meeting, review of the safety of this combination as well. So we'll have that out to the marketplace with fuller data provided first quarter next year. And we're still hoping that this will be presented at ASCO 2020.

And our next question comes from Wangzhi Li from Ladenburg. Go ahead.

Hi, thanks for the question. Just one clarification on the SITC presentation for three patients you have biopsies screening base 3 surgery. For the base 3 is a biopsy taken before the Tecentriq or is after Tecentriq?

It's definitely before and this is how we know that the virus is able to stimulate new T cell expansion as well as some existing. This existing T cell population becomes further expanded in the presence of the checkpoint inhibitor, but the hundreds of new clones is as we're measured and by day 3 is before addition of checkpoint blockades that we're very comfortable on saying that this is definitive proof that the virus can elicit T cell expansion in a primary breast cancer patient.

One question, previously which virus infection in the tumor usually the 10% to 20%, but in these two patients even before the Tecentriq it looks like you've got 60% to 70%. So why much higher in these two patient, any color?

It's interesting, we recently come to understand that it's the creation and accumulation and maintenance of double-stranded RNA in the cell from the virus replication that’s really driving the adjuvant effected virus. In most of our studies, we're only seeing viral protein produced. You know, at the time points, we're looking that in maybe 20% to 30% of the patient. Now, we don't know why the breast cancer patients are seeing double or triple this number, but keep in mind breast cancer is one of the few indications where we have single agent activity. There was paper by [Gul Ahmandi] that demonstrated women with anthracycline refractory breast cancer having a partial response after six months of treatment. We do see tumor marker responses as a mono-therapy, but the only objective responses with improvements in PSF and OS we've ever seen is breast cancer. So, we don't know if breast cancer for biochemical reason, we don't fully understand. It's just way more susceptible, but we were very surprised to see that amount of viral protein propagation because we don’t see it multiple myeloma. We haven't seen it in GI indications. So breast cancer certainly does look like a standout, but again the next cohort of patients will confirm whether this is enhanced by Tecentriq, the next group of patient will have them, and we can start making decisions and plan that Phase 3 as early as later this year.

And one clarification question, you said it will be continued enrollment in our AWARE-1 first quarter next year. So complete enrollment in all cohorts or in a certain cohorts, whether the current enrollment there because you have five cohorts right. So, you're going to complete the enrollment for all five cohorts in the next quarter or just clearly one?

All enroll by Q2 next year, but the follow-up here Wangzhi Li because there's where it's by chemical test, the follow-up is only three weeks, it's from time to get the first injection surgery and because there is first line patients, there are lot of these patients and going to rolling I think its total of 15 centers. So the enrollment should go very separately.

You need all cohorts at same time or there is a sequential enrollment from different cohort?

Right now, we're doing the safety cohort focusing on hormone receptor positive, that cohorts a total of 5 plus 5 and then at its open enrollment for everybody else. Hormone receptor positive is bar far most common, but again because these are primary care patients and because breast cancer is so sadly ubiquitous. There is no shortage of patients.

But right now you are enrolling to cohort the one, right?

Yes.

Not to that open enrollment to all the cohorts and each of them presenting enrollments whether you can complete the enrollment next quarter or second quarter next year?

That's correct. Yes.

And our next question comes from Jerry Isaacson from Roth Capital. Go ahead, Jerry.

Thanks guys for taking the question. So, talking about the biomarker…

You've microphone, Jerry?

Right, talking about the biomarker a little bit, I'm wondering to what extent from what you've seen so far, that's going to limit the number of patients that are available for enrollment. And, will that slow down enrollment as a trial at all?

It's not a critical factor for SME studies and what we're hoping for the Phase 3 revenue threshold level of T cell clonality will be an entrance criteria. And then after cycle 1, it'll be used to stratify patients that have been vaccinated efficiently versus those that have not been. Right now, we're seeing quite impressive expansion in the majority patient certainly greater than 75%. And at baseline, it looks like in this patient population, we're anticipating a screen failure of no more than sort of one and eight. We have moved this to -- the plan for the Phase 3 is to do it in patients who've just come off IBRANCE, so they are chemo naive so they haven't been as beaten up, if you will. So, they still have immune systems that are quite intact.

Okay, thanks. So I wonder if you could also talk a little bit more about the multiple myeloma program and kind of what you see is, has potential path to market there? Well, I know to me, we would be targeting things like that.

Okay, well, this is convenient. Currently, right now, Flavio is going to be presenting some biochemical data that the abstract is online for the ASH Conference. And we have a CI program ongoing right now with carfilzomib and reovirus where we're actually just putting together a paper with reovirus and bortezomib that was run by Kevin Kelly. Both of these what we're seeing from preclinical, is it would seem as though the proteasome inhibitor was actually increasing the activity of T-cells, and it seems to help with the entry and replication of the virus. So we're planning on having Dr. Craig Hofmeister and Dr. Pichiorri do a teaching in December on is our current plan. So, you'll be able to ask us right from the guys who are doing the work and in planning that the development, but it's interesting because it is -- I don't think anyone's ever considered a proteasome inhibitor and something that can enhance immunotherapy. So it's a fascinating outcome. And certainly we're seeing some very impressive responses in that NCI study. And I think it's only got about three patients left to go. So it'll be finished, hopefully here in the very near term. It's enrolling at Emory and the Huntsman Center in Utah. So, it's Craig Hofmeister and Doug Sborov running that study. So, stay tuned and you can ask them what their plans are forward in early December.

Just one more thing, ramping up on clinical activity going into next year, I just wondered if you could talk a little bit about the use of resources that you expect going forward compared to recent quarters?

Certainly, the relationship with Pfizer with Merck with Roche have certainly I think improved our thinking around them. The IFC that were running the co-development is a very cost-effective way of doing this because we're sharing responsibility with an industry partner. And the goal here is obviously to lead to a partnership for the Phase 3. We're not anticipating the change in our burn because we have adopted this strategy, it is very cost-effective and Andrew is on the BD side. So, hopefully, we'll have more updates for you in the coming quarters. And again, the move towards hopefully our alliance partners has allowed us to keep the steady cost to achieve.

At this time, there are no more questions. So, I would like to turn it back to management for any closing remarks.

Yes, I just want to thank everyone again for joining us on our call and webcast and taking the time to listen to our updates. Again, I apologize for this horrible cough, and we look forward to rolling out the reverse set of data catalyst and keeping everyone updated along the way.

Thank you. This does conclude today's webinar. We thank you for your participation. You may disconnect your lines at this time. And have a wonderful day.