Oncolytics Biotech Inc.

Good morning and welcome to Oncolytics Biotech's third quarter 2021 conference call. All participants are now in 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 John Patton, Director of Investor Relations and Communication. Please go ahead.

Thank you, Operator, and good morning, everyone. Earlier today, Oncotics 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 and presentation section of the Oncotics 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 the development and commercialization of Pella Rear Rep. including statements regarding the company's focus, strategy, and objectives, the company's belief as to the potential and mode of action of Pell Area Rep 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 Pell Area Rep'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, They 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. In any forward-looking statement in which Oncologics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith, Our beliefs have 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 CDAR and the SEC. OnClinics 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, John. And thanks to all who are joining us today to discuss our third quarter corporate update. Now, in addition to John, I'm joined by Tom Heinemann, our Global Head of Clinical Development and Operations, Andrew DiGadadaro, 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 Pella 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 our most exciting recent highlights from these past months was actually announced earlier today in relation 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 on HR-positive HER2-negative 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 INV213, our prior randomized Phase II study that showed a near doubling of overall survival with Pellarerep in HR-positive HER2-negative metastatic breast cancer patients. These objectives were to confirm that Pellarear Rep works through an immunotherapeutic mechanism of action as suggested by the survival benefit in IND213, which became apparent about 10 months after the start of treatment. Second, determine if checkpoint inhibitors synergize with Pellarear Rep. And third, determine if changes in peripheral blood T cell populations could potentially serve as a novel blood-based biomarker to predict patient response to Pellarear Rep 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 Pella's immunological mechanism of action and demonstrating the synergy between Pella rear rep and checkpoint inhibition. With the data we are announcing today, which Tom will discuss in more detail, we have further support for these earlier conclusions and evidence that changes in peripheral blood T cell populations may be predictive of patient response to Pellarear Rep. This is an exciting finding that could potentially improve our chances of success in subsequent studies by allowing us to quickly identify the patients who are most likely to respond to Pellarear Rep therapy. It also has us well on our way to achieving the last of the three objectives I just laid out, which we expect to complete as part of our ongoing Bracelet One study. One important point to emphasize about the AWARE-1 data we have presented to date is that includes all patients in the first two cohorts, which evaluates Pella with and without checkpoint inhibition in patients with HR-positive HER2-negative breast cancer. Evaluation of these cohorts was the core objective of AWARE-1 as HR-positive HER2-negative is the breast cancer subtype we intend to examine in future registrational studies. As I alluded to earlier, the data from these cohorts has allowed the site to meet its primary objective, which has our lead program advancing down a clear path towards a registrational study. The last task we need to accomplish before advancing to such a study is the completion of bracelet one, which Tom will discuss shortly. As we look ahead for wear one, we have amended the protocol to keep all ongoing and future cohorts focused on evaluating Pella in patients with HER2 positive breast cancer. We are thus not proceeding with the where's one triple negative cohort, as we expect to generate an abundance of data in this breast cancer subtype for our ongoing IRENE trial, which evaluates Pellary Rep in combination with Insight's PD-1 checkpoint inhibitor, retifanilamab, in the metastatic setting, which is a less common subtype. This will allow us to advance our breast cancer program with efficiency while collecting data in each subtype of the disease. Beyond our lead program, we continue to strategically leverage collaborations with industry leaders and academia to unlock additional value by executing unstated milestones in our other clinical trials, such as IRENE and GOBLET, which also evaluate Pella in combination with a checkpoint inhibitor. Our efforts towards this goal are bolstered by the robust clinical data set demonstrating Pella's ability to act as an immunotherapeutic agent that trains immune cells to fight cancer. while simultaneously enabling their success by weakening or reversing the tumor defense mechanisms that drive checkpoint inhibitor resistance. Taking a broader view, this differentiated and broadly applicable mechanism of action positions Pella as a potentially immunotherapy backbone that can be an enabling technology for a range of immuno-oncology agents even before checkpoint inhibitors such as CAR T cells and bispecific antibodies. This provides a multiple of opportunities to further expand Pella's market and business development potential. In order to efficiently pursue these opportunities, we plan on utilizing a partner strategy. This will allow us to keep our primary internal focus on advancing Pella Rare Rep towards a registration in HR positive, HER2 negative, and metastatic breast cancer. We believe this strategy represents the best way to maximize the value Pella Rare Rep can generate for shareholders and patients. while ensuring we devote the necessary resources to our lead program. This will position the company to minimize risk as we work to efficiently execute on stated clinical objectives. With that, I'll now hand it off to Tom to talk a bit more in detail about our recent data and progress of our clinical programs. Tom?