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

Thank you, operator. And good afternoon, everyone. Earlier today, Oncolytics issued a press release providing financial results and corporate updates for the second quarter of 2021. A replay of today’s call will be available on the Events and Presentations section of the Oncolytics website approximately two hours after its 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 development and commercialization of pelareorep, including statements regarding the Company’s focus, strategy and objectives, the 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 or pending clinical trials, our plans for collaborations and other business development activities, our financial position and runway and other statements related to the 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 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. In any forward-looking statement, 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, 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 will turn the call over to Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. Matt?

Thanks, Jon. And thanks to all listening, for joining us on the call today to discuss our second quarter 2021 corporate update. In addition to Jon, I'm joined by Tom Heineman, our Global Head of Clinical Development and Operations, Andrew de Guttadauro, Global Head of Business Development and Kirk Look, our Chief Financial Officer. We recently wrapped up a highly productive quarter, during which we achieved key clinical and scientific milestones that have advanced our lead breast cancer program towards registration, and further position pelareorep [ph] to have a broad impact across multiple indications. Chief among these milestones was the completion of two critical cohorts in AWARE-1 with data showing that we achieved the trials primary endpoint. This positive result represents both validation of our hypothesis and a major advancement for our lead breast cancer program. AWARE-1 was designed to answer key questions that were posed by regulators and partners regarding the survival benefit, observed in IND-213, our prior Phase 2 study that showed a near doubling of overall survival, with pelareorep treatment in HR positive, HER2 negative metastatic breast cancer patients. And I'm pleased to say it did just that, it's accomplishing a goal. Looking ahead, pelareorep is now on a clear path towards a registrational study in HR positive, HER2 negative breast cancer. The last major tasks we need to accomplish before advancing to our study is the completion of our ongoing Phase 2 trial BRACELET-1. Tom will speak a bit more about BRACELET in a bit, but I'm pleased to say now that the trial remains on track for enrollment in the fourth quarter. Now before I hand it off to Tom to provide some more details on our recent clinical and scientific accomplishments, I'd like to take a moment to emphasize some of the broader implications…

Thanks, Matt. And thanks to all those listening on the call today. It's been a very exciting past few months at Oncolytics, and we achieved multiple clinical and scientific milestones. Importantly, we have been working to advance our clinical programs, and positioning ourselves for a steady cadence of upcoming catalysts. In our lead breast cancer program, we reported data at AACR from all patients in AWARE-1s first two cohorts, which examined the effects of pelareorep treatment with or without anti-PDL1 checkpoint inhibitor therapy, in patients with HR positive, HER2 negative breast cancer. Evaluation of these cohorts is the core objective of AWARE-1 with HR positive, HER2 negative breast cancer is a subtype in which we saw the most pronounced survival benefit in IND-213. And it is also the subtype we intend to evaluate in a future registrational study. That Matt alluded to earlier, the purpose of AWARE-1 was to build on the IND-213 results, and advance pelareorep for the registrational study by answering two key questions that were posed by partners and regulators. First, does pelareorep have an immunotherapeutic effect, as was suggested by the survival benefit in IND-213, which became apparent about 10 or 12 months after the start of treatment. And second, is there a synergy between pelareorep and checkpoint inhibitors in breast cancer? In other words, as the addition of a checkpoint inhibitor enhance pelareorep's efficacy, and ability to induce anti cancer immune responses? To answer these questions, we utilized paired biopsies to collect data on T cell infiltration into tumors, tumor expression of PDL1, and CelTIL score, which is AWARE-1s primary endpoint and a measure of tumor cellularity and inflammation that is significantly correlated with event free and overall survival in breast cancer. Excitingly, the data showed that AWARE-1 second cohort which included the pelareorep and…

Thanks, Tom. And thanks to all who have joined us on today's call. As Tom mentioned, we are leveraging collaboration with Roche and AIO to further develop pelareorep in combination with checkpoint inhibition in pancreatic and other GI cancers. We're doing this through our Phase 1/2 GOBLET trial, which is designed to evaluate pelareorep, plus Roche's anti PDL1 checkpoint inhibitor Tecentriq in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers. We continue to make progress in GOBLET and recently received approval from regulators in Germany. Now that we have the blessing of the German regulators and the study manager, AIO, we have opened the trial for enrollment and are working with sites to commence enrollment as soon as possible. The GOBLET studies representative of the broader strategy we're executing to expand pelareorep's potential therapeutic impact by focusing its development in highly prevalent indications beyond our lead, HR positive, HER2 negative breast cancer program. This strategy is represented by additional ongoing trials, including IRENE, which is our Phase 2 study evaluating pelareorep in combination with insights - anti PD1 checkpoint inhibitor, retifanlimab in triple-negative breast cancer, and by our ongoing study with BMS evaluating pelareorep [indiscernible] combination therapy, in multiple myeloma. These collaborative trials leverage the growing interest from large pharma and biotech companies and improving the efficacy of checkpoint inhibitors. Such interest is driven by a large commercial opportunity and the high unmet need. 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 low response rates of checkpoint inhibitors are due to several different resistance mechanisms that can be addressed by the immunotherapeutic effects pelareorep is demonstrating AWARE-1 and other clinical trials. This leads us well positioned as we execute on our…

Thank you, Kirk. Before we move on to the Q&A, I'd first like to say how proud I am of the Oncolytics team. When the pandemic began almost a year and a half ago, they immediately adapted to the challenges posed to keep the company and our clinical programs on track. They continue to build on this momentum every month since and thanks to these efforts. We've clinically demonstrated immunotherapeutic effects of pelareorep, which augment checkpoint blockade and are the cornerstone for multiple oncology treatments. Their hard work has also left us poised to achieve a steady stream of value creating milestones, including the dosing of the first patient in our GOBLET study. They're reporting to the final AWARE1 biomarker data for cohorts 1/2, which is expected in the second half, completion of the BRACELET-1 enrollments and interim safety update for IRENE and the reporting of interim safety data from her multiple myeloma trial evaluating pelareorep in combination with Kyprolis and BMS is Opdivo, which is expected in the fourth quarter. Moving forward, the talent and dedication consistently displayed by the Oncolytics team gives me confidence that we will continue to build on our positive momentum as we work towards these milestones. This will allow us to continue generating 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 to take some questions. Operator?

Thank you. [Operator Instructions] Your first question comes from John Newman with Canaccord. John, please go ahead.

Hi, guys. Thanks for taking the question. Just wondered on the BRACELET study, Matt, if you could sort of walk us through what they see there before proceeding to a pivotal study? And then just in terms of [indiscernible] design, just kind of curious as to how you're thinking about that at the moment? Thanks.

Thanks for the question, John. So what AWARE is teaching us is that we - with or without checkpoint blockade get a pro inflammatory events. And this is why we think we see these long survival tails on our breast cancer program and our PEG [ph] program, in all of our programs, really. What BRACELET is really there to accomplish is largely biochemical or immunological signal changes. What we're looking for is that ratio between CD8 to T regs. So CD8 are the positive inflammatory cells, T regs are negative, viral infections can cause both. So they can antagonize each other. But what we found from AWARE the addition of the checkpoint blockade largely eliminated that T reg. So again, we're looking for this confirmation that we can skew the CD8 to T reg balance. You know, we're planning for the Phase 3 now. And I think what we're really looking at is the addition of checkpoint blockade into our Phase 3 program, as well as the addition of our biomarkers. Tom, is there anything you'd like to add to my response?

No, Matt, I think that's right. I mean, we obviously want to look at the BRACELET data as it comes in and be informed by the data. But as I think the expected and most likely scenario is exactly what you described.

Okay. Thank you.

Thank you. Your next question comes from Patrick Trucchio with H.C. Wainwright. Patrick, please go ahead.

Hi, thanks. Good morning. I was just wondering on the AWARE-1 outcome with the final biomarker data, what additional data would you be expecting there to be generated to kind of help you as you're forming the pivotal trial design? And then just regarding the IRENE trial, the interim safety update, would there be any additional signs of efficacy in this initial data? Or is that more 2022 events?

First, first question first, with the AWARE-1, AWARE-1 is a treasure trove for us, it really is because we have so much tissue over a three week course. So a lot of the work that we're doing now is we're looking at [indiscernible] analysis, which - what that does is using appropriate labeling for immunological cells or cancer cells. It lets us see physically how the virus is drawing the immunological cells into the tumor, what we're hoping to see is those patients who had the highest CelTIL score score have the closest proximity of the inflammatory cells to the cancer cells. And [indiscernible] that really show you immunologically what's happened at a cellular level. So that's one thing. And what we're obviously hoping to see is checkpoint blockade continues to restrict these t regs, while getting this positive CD8 and inflammatory event. We're also doing analysis at the molecular level, where we're actually looking for changes in gene expression, to really see how this is being driven. What pathways are being turned on is, you know, interferon type 1, type 2, are we seeing cell [ph] 9,10 and 11? Are we seeing more of it in the presence for the checkpoint blockade and without, so it really allows us to characterize exactly what's happening so that we can better design future go forward treatments, because, again, you know, if we're activating a pathway in non-responders, you know, maybe we can use an inhibitor to that pathway to allow a greater response or if alternatively, if we're getting there very positive proinflammatory accumulation and signalling, is there something we can use to make that even greater. So it gives us a great deal of information and really decides how we want to move forward in breast cancer and beyond. And…

That's helpful. Thank you very much.

Well, thanks, Patrick.

Thank you. There are no further questions at this time. Mr. Coffey, you may proceed.

I just wanted to thank everyone for dialing in and participating. And thank you for the questions and we look forward to moving this program further. Thanks, everybody.

Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation. You may now disconnect.