Oncolytics Biotech Inc.

Good afternoon and welcome to Oncologics Biotech's fourth 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. And I would like to turn the call over to John Tatton, Director of Investor Relations and Communication. Please go ahead, sir.

Thank you, Operator, and good afternoon, everyone. Earlier today, Onclytics issued a press release providing recent operational highlights and financial results for the fourth quarter and full year 2021. A replay of today's call will be available on the events and presentation section of the Onclytics 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 our business prospects and the development and commercialization of Pella Rear Rep. including statements regarding our focus, strategy, and objectives, our belief as to the potential and mode of action of Pellery Rep as a cancer therapeutic, design, aims, expectations, and anticipated benefits of our current and pending clinical trials, our plans and expectations regarding a potential registrational study, our plans regarding the expansion of Pellery Rep's market and business development potential, our plans for collaborations with industry leaders, our financial runway, 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 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 OnCodex expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith, are believed to 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, risk associated with intellectual property protection, financial projections, actions by regulatory agencies, and other factors detailed in the company's filings with CDAR and the SEC. Oncologics does not undertake any obligation to update these further 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 Oncologics Biotech. Matt?

Thanks, John, and thanks to all who are joining us today to discuss our fourth quarter corporate update. Now, in addition to John, I'm joined by Tom Heinemann, our Chief Medical Officer, Andrew D. Gadadaro, our Global Head of Business Development, and Kirk Luck, our Chief Financial Officer. I'm pleased to say that we had a very strong 2021 and have continued to build on our momentum in the early part of 2022. If you've not had a chance, I would encourage our investors to read the letter to shareholders that we distributed as a press release on January 11th. In it, we walk you through why what we saw in 2021 is significant and why we're excited about 2022 and our upcoming milestones. We are advancing toward potential value inflection points across our pipeline with a strong historical foundational data set that demonstrates Pella's ability to deliver a statistically significant survival benefit, as was shown in our randomized Phase II metastatic breast cancer trial, generate a profound and concerted innate and adaptive anti-cancer immune response, and synergize with multiple oncology treatments. Now, the most significant of our expected 2022 milestones is the top-line data announcement from Bracelet 1. Our randomized Phase II trial evaluating PELA in combination with checkpoint inhibition in HR-positive HER2-negative metastatic breast cancer. Bracelet 1 is being conducted with collaboration with Pfizer and Merck-Sorono and is designed to expand upon our prior positive phase 2 results in this indication by generating critical data requested by the FDA and our global pharma collaborators. Data that confirms the overall survival benefit we saw in IMD 213 would serve to de-risk our lead breast cancer program and broader pipeline And we believe that data represents the last major step on Pella's path to a registrational breast cancer study. As we work towards this data readout, we intend to begin discussing our plans for a registrational study with the FDA and other regulators so that we can advance the programs with efficiency. While Tom will be speaking more about bracelet one and our lead breast cancer program in a bit, I will say now that the trial remains on track for full enrollment in late Q1, early Q2 with top line data in Q4. assuming no or limited impact from COVID-19. Beyond our lead program, Pella's ability to generate an innate and adaptive immune response, thereby weakening tumor defense mechanisms, continues to spark collaborations with industry leaders and academia. These collaborations include those underlying our ongoing trials in triple negative breast and gastrointestinal cancers, both of which recently reported interim updates that further demonstrate the favorable safety profile of Pella checkpoint inhibitor combinations. These positive updates are notable because the lack of toxicity in these large indications provides additional opportunities to expand the potential market of pellet checkpoint inhibitor combinations. The opportunity for expanding beyond checkpoint inhibitors has been evident in data we reported during the 2021 year. Promising combination therapy data readouts involving CAR-T, bispecific antibodies, PARP, and CDK4-6 inhibitors are evidence of Pella's differentiated and broadly applicable mechanism of action. We believe leveraging Pella REAREP in this fashion could address unmet needs across a spectrum of target indications, and we expect to report clinical updates supporting this hypothesis in both multiple myeloma, GI, and glioblastoma at upcoming conferences. Looking ahead, we plan to utilize a partnership strategy to pursue the multitude of market and business development opportunities offered by Pella REAREP and its potential to act as an immunotherapy backbone. This will allow us to operate efficiently as we devote our primary focus and resources towards the advancement of Pella Rear Rep to registration in HR-positive HER2-negative metastatic breast cancer. With that, I'll now hand it off to our Chief Medical Officer, Tom Peidemann, who I should also congratulate on his well-deserved recent promotion to provide a bit more detail on Bracelet 1 and our recent highlights. Tom?