Good morning and welcome to Oncolytics Biotech's Third Quarter 2021 Conference Call. All participants are now in a listen-only mode. There will be a question-and-answer session at the end of the call. Please be advised that this call is being recorded at the company's request. And I would like to turn the call over to Jon Patton, Director of Investor Relations and Communications. Please go ahead.

Thank you, operator and good morning, everyone. Earlier today, Oncolytics issued a press release providing financial results and corporate updates for the third quarter of 2021. A replay of today's call will be available on the Events & Presentations section of the Oncolytics website approximately two hours after it's completion. After remarks from company management, we will open the call for Q&A. As a reminder, various remarks made during this call contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of pelareorep, including statements regarding the company's focus, strategy and objectives, company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the design, aims and anticipated benefits of the company's current pending clinical trials, the company's plans and expectations regarding a potential registrational study, the company's plans regarding the expansion of pelareorep's market and business development potential and other statements related to anticipated developments in the company's business. These statements are based on management's current expectations and beliefs and are subject to a number of factors which involve known and unknown risks, delays, uncertainties and other factors not under the company's current control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or expectations implied by these forward-looking statements. Many forward-looking statements in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis but there can be no assurance that the statement or expectation or belief will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions by regulatory agencies and those other factors detailed in the company's filings with SEDAR and the SEC. Oncolytics does not undertake any obligation to update these forward-looking statements except as required by applicable laws. Now, I'll turn the call over to Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. Matt?

Thanks, Jon and thanks to all who are joining us today to discuss our third quarter corporate update. Now, in addition to Jon, I'm joined by Tom Heineman, our Global Head of Clinical Development and Operations; Andrew de Guttadauro, our Global Head of Business Development; and Kirk Look, our Chief Financial Officer. These past months were an important period of execution for Oncolytics. We achieved key objectives that advanced pela down a clear path of a registrational breast cancer study, while simultaneously furthering its development as an immunotherapy backbone that can enable the success of a wide range of agents across multiple indications. One of the most exciting recent highlights from these past months was actually announced earlier today and relates to new biomarker data from the first two cohorts of AWARE-1 breast cancer study. As a reminder, AWARE-1, together with our ongoing BRACELET-1 trial in f HR+/HER2- breast cancer was designed to achieve three key objectives in order to answer questions that were posed by regulators and partners regarding the survival benefit observed in IND-213, our prior randomized Phase 2 study that showed a near doubling of overall survival with pelareorep in f HR+/HER2- metastatic breast cancer patients. These objectives were to confirm that pelareorep works through an immunotherapeutic mechanism of action as suggested by the survival benefit in IND-213 which became apparent about 10 months after the start of treatment. Second, determine the checkpoint inhibitors synergize with pelareorep; and third, determine the changes in peripheral blood T-cell populations could potentially serve as a novel blood-based biomarker to predict patient response to pelareorep therapy. Now, on our recent earnings call, we walked through data showing that AWARE-1 had accomplished its primary goals and validated our broader clinical strategy by confirming pela's immunological mechanism of action and demonstrating the synergy…

Thanks, Matt and thanks to all those listening on the call today. I'd like to start by first discussing the compelling AWARE-1 biomarker analyses, Matt mentioned, the results of which we announced for the first time today. These analyses focused on how pelareorep treatment, both with and without a checkpoint inhibitor, drive changes in peripheral blood T-cell populations and how these changes correlate with CelTIL score and tumor-infiltrating CD8+ T-cells, two metrics that are associated with favorable clinical outcomes. The goal of these analyses was to identify a potential blood-based biomarker that could be used to quickly identify patients most likely to respond to pelareorep, either before therapy or after an initial treatment cycle. I'm pleased to say that this goal was accomplished and that we've identified potential biomarkers that will be evaluated further in our Phase 2 BRACELET-1 trial. Now, I'll dive into the specifics of the latest data which, as Matt mentioned, include all patients from AWARE-1's first two cohorts. As a reminder, these cohorts enrolled patients with HR+/HER2- breast cancer. Cohort 1 patients were treated with pelareorep and hormonal therapy, while Cohort 2 patients received the same treatment regimen plus the checkpoint inhibitor atezolizumab. A pooled analysis across cohorts showed a statistically significant decrease in peripheral blood T-cell diversity post-treatment due to the expansion and generation of new antiviral and anti-tumor T-cell clones. To provide some context on what this means, you can think of T-cell diversity as a measure of population heterogeneity. At baseline, there are many types of T-cell clones that are represented in about equal numbers, each program to attack a different target when activated. When diversity has decreased, this means a larger proportion of the T-cell population consists of a limited number of clones designed to attack a select number of specific targets.…

Thanks, Tom and thanks to all who have joined us on today's call. Before I elaborate further on Tom's point, I'd like to first discuss some of our work leveraging collaborations with industry leaders to expand pelareorep's potential therapeutic impact by developing it in combination with checkpoint blockade and indications beyond HR+/HER2- breast cancer. This work is embodied by several ongoing trials. These include our trial with BMS, evaluating pelareorep Opdivo combination therapy multiple myeloma, IRENE which is a Phase 2 study, evaluating pelareorep in combination with Insight's PD-1 checkpoint inhibitor, retifanlimab in metastatic triple-negative breast cancer; and GOBLET, our phase 1/2 trial, evaluating pelareorep in combination with Roche's PD-L1 inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal and advanced renal cancers. We are very pleased with the progress we've seen in each of these studies. Patient dosing was initiated in GOBLET last week, while IRENE and our multiple myeloma study are on track for interim safety updates by the end of the year. With each of these trials, we aim to leverage the immunotherapeutic effects pelareorep is demonstrated AWARE-1 and other clinical studies. These effects can reverse to tumor defense mechanisms that limit the efficacy of checkpoint inhibitors. By doing this, we believe we can address a pressing unmet need and tap into a large commercial opportunity as the checkpoint inhibitor market is expected to reach $55 billion by 2025 despite less than one in five patients responding to these therapies. The combination of unmet need and the commercial opportunity for agents that can enhance the efficacy of checkpoint inhibitors has driven large pharma's growing interest in this space. This interest bolsters our efforts to execute on our BD strategy as we work towards the goal of securing a global clinical and commercialization partnership. By engaging large pharma…

Thanks, Andrew and good morning, everyone. It's my pleasure report that Oncolytics continues to remain in a strong financial position as we advance our lead breast cancer program towards a registrational study and execute on additional clinical and corporate objectives. Our cash and cash equivalents as of September 30, 2021, was $48.1 million compared to $31.2 million as of December 31, 2020. Based on our current projections, we expect our financial runway will extend into the middle of 2023. Now, our operating expenses for the third quarter of 2021 were $2.9 million compared to $2.5 million in the third quarter of 2020. This change is largely due to a higher non-cash share-based compensation and Investor Relations activities. Research and development expenses for the third quarter of 2021 were $3.3 million compared to $3.9 million for the same period last year. Now, this change was largely due to lower manufacturing-related expenses as we completed a cGMP production run in the third quarter of 2020. This was partially offset by higher R&D compensation-related expenses in support of our expanded clinical program and increased research collaboration activities, including CAR T therapy and biospecific antibody. The net loss for the third quarter of 2021 was $4.9 million compared to $6.7 million in the third quarter of 2020 which included an FX gain of $1.2 million for the third quarter of 2021 compared to a loss of $0.5 million for the third quarter of 2020. This equated to a net loss of $0.09 per share for the 2021 period and a net loss of $0.16 per share for the 2020 period on a consolidated basis. With that, I'll hand it back to Matt. Matt?

Thank you, Kirk. Now, before we move on to Q&A, I'd like to reiterate how impressed I have been by the talent, the dedication and the nimbleness of the Oncolytics team over the past few months. Since the pandemic continued to evolve with the surge of the delta variant this past summer, they were able to seamlessly adapt and keep our development programs efficiently moving forward. Thanks to their efforts, we're heading towards 2022 with positive momentum and robust clinical and preclinical data sets that demonstrate pelareorep's vast immunotherapic effect. By leveraging these effects, we believe we can develop pelareorep as a backbone therapy that will combine synergistically with checkpoint inhibitors and a broad array of additional immuno-oncology units. As we work towards this goal, we will remain primarily focused on our lead breast cancer program, while selectively engaging partners and collaborators to announce our efforts in other areas. We expect this to allow us to maintain an optimal benefit risk balance and achieve our regular cadence of catalysts. These include reporting interim safety updates from IRENE and from our multiple myeloma trial evaluating pela in combination with carfilzomib inhibitor later this year as well as the completion of enrollment in BRACELET-1 which is expected in late 2021 or in the first quarter of 2022. Looking ahead, I remain excited about our prospects as we head towards the end of the year. Our lead program is advancing down a clear path towards a registrational study, while several other clinical and preclinical programs advance in parallel. We have a strong team that has consistently executed under the ever-evolving circumstances of the pandemic and we are well positioned to generate value for our shareholders as we work towards our ultimate goal of improving the lives of cancer patients. With that, I'd now like to open the lines and take some questions. Operator?

[Operator Instructions] And your first question will be from John Newman at Canaccord. Please go ahead.

Hi guys, thanks for taking my questions. Congrats on all the progress here. I just had two this morning. The first one is, could you describe how you might incorporate the biomarker analysis from AWARE-1 that you discussed today into some of your other ongoing studies? And second question on GOBLET-1, just wondered if you could remind us of the dosing duration here and any potential color you could give us on timing of the clinical data in the future.

So, the data today, just to kind of contextualize it. When we talk about diversity of our T-cell repertoire, really, if you could just imagine an aquarium full of multi colored fish, so you have red fish, blue fish, yellow fish, green fish, white fish, black fish, if they're equally represented, it's pretty diverse. Like you look into it and it's like, wow, it's a spectrum of what have you. Now, all of a sudden, the red fish population it flows by like a 100 fold, those -- clones of those red fish just amp up the diversity drop and that's really what this data is telling us. We get a massive increase in the clonality of these red fish that to carry on the illusion, these are our anti-tumor clones. So, the clonality shoots up and the diversity drops. What this allows us to do with a simple blood draw is we can do a three mill draw at as early as two to three weeks and if we see this drop in diversity and this increase in these new T-cell clones, this is correlating very strongly with positive CelTIL. We've demonstrated it correlates very positively with overall survival in pancreatic cancer. So what that allows us to do is stratify these patients. So, basically, this is a very easy way to enrich or follow-up on the patients that are deriving benefit. And really, this will be verified with BRACELET but we've now seen this in breast cancer and pancreatic after and it really becomes the focus of the GOBLET study as well. So what it allows us to do in the clinical testing phase is to run much smaller studies that are much more nimble because we can follow the patients that are having the desired immunological effect.…

So, yes, so keep in mind that the GOBLET study is a platform study in which we are treating patients with four different types of GI cancers. And so the treating regimens -- the treatment regimens are a little bit different depending on the type of cancer. So, patients will be treated with either pela -- all patients will be receiving pelareorep and atezolizumab. In a couple of the cohorts, patients, for example, with pancreatic cancer or with third line colorectal cancer will also be receiving standard of care chemotherapy. And so the treatment regimens vary a little bit. Patients will be receiving pelareorep weekly and atezolizumab according to its normal administration schedule and then chemotherapy is appropriate and they will continue to be treated on the study as long as the investigators believe they are deriving benefit from the treatment.

Okay, great. Thank you.

Sure.

Any further questions, Mr. Newman?

No, that's all. Thank you.

Thank you. Your next question will be from Patrick Trucchio at H.C. Wainwright. Please go ahead, Patrick.

Hi, good morning and congrats on all the progress. I have a follow-up question on the potential for a combination of pela plus CAR T. I'm wondering if there is a preference for moving forward with autologous CAR T-cells or allogeneic CAR T-cells? And secondly, what tumor type or types do you believe would be ideal for this combination of pela plus CAR T? And finally, what's the status of any discussions around our potential collaboration?

We're actually exploring both autologous and allogeneic CAR T. And the reason for that is, I think, the recent CRISPR data with allogenic looks fantastic. But I think for the next 5 to 10 years, autologous CAR Ts are going to be dominant in this field. So, I think we're running things in parallel. In terms of targets, we're looking really at the solid tumor market. I think we're speaking with potential partners around hematopoietic indications as well because of the ability of the virus to ramp things up so dramatically in the CAR T setting. Professor Vile presented data earlier this year that the problem with CAR Ts is they are very short lived. What he demonstrated is loading the CAR T-cells with virus would increase their activity and their persistence. And importantly, as they started to diminish, you could give a booster of the virus to basically reengage or repopulate those CAR T populations. So that has implications, obviously, in solid and liquid tumors. So, we are really looking at that both. In terms of our solid tumor targets, the study that we're doing, AWARE-1 really allows us to look at whether the virus is active in breast cancer beyond HR+ disease. So, really, the focus now is looking at HER2+. The work that we did with biospecifics with Leiden University really pointed to the fact that targeting HER2 was a very good area for us. So, I think not only beyond the CAR T, I think you will likely see us move into HER2+ biospecific approach with the CAR Ts. In terms of our discussions, we have active collaborations with multiple parties in the CAR T space. We're looking to get additional information out in the form of a manuscript here in the very short term. But…

That's helpful. Thank you very much.

Thank you.

Thank you. And at this time, I would like to turn the call back over to Dr. Coffey. Please go ahead, sir.

I just wanted to thank everyone for their time and attention. We're very excited about what we're seeing in the clinic. We're very excited about our partnership with Adlai Nortye now that they've taken our results and have move them into one of the fastest growing oncology markets. We're very pleased with the GOBLET study. It hit the ground running, like you wouldn't believe. We're approaching the end of BRACELET-1 which will give us a readout next year, final data on AWARE-1. The AWARE-1 data, I think, exceeded our expectations in terms of the biomarker, the ability to demonstrate that it is killing cell through an immunological mechanism. So, we're looking forward to the next 12 months and we're very excited about keeping everyone up-to-date with the progress as it becomes available. [Call ends abruptly]