Oncolytics Biotech Inc.

Good morning and welcome to Oncolytics Biotech's third quarter 2022 conference call. All participants are now in the 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 Patton, Director of Investor Relations and Communications. Please go ahead, sir.

Thank you, Operator, and good morning, everyone. Earlier this morning, Onclytics issued two press releases, one announcing interim results from the pancreatic cancer cohort of the company's Phase 1-2 goblet trial, and a second providing recent operational highlights and financial results for the third quarter of 2022. The announcements and highlights provided in these press releases will be the topics of today's call. A replay of which 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 the company's business prospects and the development and commercialization of Pelleria Rep, including statements regarding the company's focus, strategy, and objectives, the company's belief as to the potential and mode of action of Pelleria Rep as a cancer therapeutic, the design, aims, and anticipated benefits of the company's current pending clinical trials, and the anticipated timing of the release of additional data, the company's plans and expectations regarding potential registrational studies, the company's business development plans and strategies, 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 being 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 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 other factors detailed in the company's filings with CDAR and the SEC. Oncolitics does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Speaking on today's call will be Oncolitics Chief Executive Officer, Dr. Matt Coffey, Chief Medical Officer, Dr. Tom Heinemann, Global Head of Business Development, Andrea DiGuttadaro, and Chief Financial Officer, Kirk Look. With that, I'll now turn the call over to Matt. Please go ahead.

Thank you, John, and good morning to all who have joined us today. I'll begin by getting right to the exciting news reported earlier this morning, which came when an abstract with interim data from our GOBLET trial was published as part of the CITSE annual meeting. These data showed an objective response rate, or ORR, of 70% in 10 valuable pancreatic cancer patients treated with a combination of Helirep, the checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nabpaclitaxel. This ORR is nearly three times greater than the average ORR seen in historical control trials, which is about 25%. These remarkable results have brought our pancreatic cancer program to a pivotal trial readiness, as we are now planning to advance Pella Rea Rep, or Pella as we'll refer to it, into a registrational study for this indication pending discussions with regulatory authorities. With our pancreatic cancer program now representing a second near-term registrational opportunity to go alongside our breast cancer program, we believe we have transformed Pella's value proposition and are at a true inflection point in the company's history. We arrived here guided by a clear strategic focus and commitment to data-driven approach that had us collaborating with industry leaders to selectively pursue therapeutic opportunities beyond our lead program. This approach enables us to keep our efforts in breast cancer on track while simultaneously building a robust proof of concept data set in pancreatic cancer. We now have two pillars upon which we can build our registration program going forward. With regards to our breast cancer program, we are increasingly enthusiastic about its prospects and upcoming milestones. Chief among these potential value drivers will be the disclosure of an expansive data set from bracelet one at a major medical meeting in the first half of next year. As a reminder, Bracelet 1 is a randomized phase 2 trial in HR-positive HER2-negative metastatic breast cancer. It includes cohorts evaluating paclitaxel monotherapy, paclitaxel plus Pella, and paclitaxel plus Pella in combination with a PD-L1 checkpoint inhibitor. Those of you familiar with Oncolytics have likely heard me refer to Bracelet 1 as Pella's last major step on its path to a registrational breast cancer study. The data generated by bracelet 1 are expected to inform the design of a pivotal trial while simultaneously validating our prior data in HR-positive HER2-negative breast cancer, which provides a robust foundation for the program. These include the results of the randomized phase 2 trial in IND213, which showed a statistically significant near doubling of overall survival in HR-positive HER2-negative breast cancer patients treated with Pella combined with Paclitaxel versus those treated with Paclitaxel alone. These data showing Pella's ability to drive a meaningful clinical benefit contributed to a special protocol assessment from the FDA, which means IND213 counts as one of the two pivotal studies required for approval. Additional data forming the foundation of our HR-positive HER2-negative breast cancer program include Phase I results demonstrating Pella's single-agent activity, as well as results from AWARE-1 trial demonstrating and characterizing its immunological mechanism of action. Prior to reporting Bracelet 1's findings, we also expect to report additional data from Wear 1, as well as the results of our Chinese partner, Adelaide Norte's bridging trial in HR-positive HER2-negative breast cancer. Both of these announcements are expected later this quarter. As we move forward in 2023 and beyond, we will aim to replicate our recent success by maintaining a core focus on our near-term registration opportunities in HR-positive HER2-negative breast cancer and pancreatic cancer, while selectively exploring additional indications, primarily through partnerships or collaborations. Our team is engaging with regulators and seeking regulatory input on the registration program for breast cancer, which we expect to be able to discuss in more detail in the first half of 2023, as breast cancer will remain a crucial part of Oncolytic's story and a value proposition going forward. We believe we are closing in on our goal of delivering treatments that improve the lives of cancer patients and are excited for what's ahead. Having completed that high-level overview of HR-positive HER2-negative breast cancer and pancreatic cancer, two programs we expected to primarily focus on going forward, let me hand the call over to Tom to provide some more insights on the new pancreatic cancer data. And after that, Andrew will dig into what this means for our business development. Tom?