Oncolytics Biotech Inc.

Welcome to Oncolytics Biotech's fourth quarter and full year 2022 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 will now like to turn the call over to John Patton, Director of Investor Relations and Communications. Please go ahead.

Thank you, Operator, and good morning, everyone. Earlier this morning, Oncolitics issued a press release providing recent operational highlights and financial results for the fourth quarter and full year of 2022. A replay of today's call will be available on the events and presentation section of the Oncolitics 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 Pallad 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 Pallad Rear Rep as a cancer therapeutic, the design, aims, and anticipated benefits of the company's current pending clinical trials, and 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, the company's 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 none other than risk, 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 four looking statements. and a new 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 those factors detailed in the company's filings with CFR and the SEC. Oncolytics does not undertake any obligation to update these forward-looking statements except as required by applicable laws. Speaking on today's call will be Oncolytics Chief Executive Officer, Dr. Matt Coffey, Chief Medical Officer, Dr. Thomas Heinemann, Global Head of Business Development, Andrew D. Gododaro, and Chief Financial Officer, Kirk Look. I will now turn the call over to Matt to begin management's remarks. Please go ahead, Matt.

Thanks, John, and thanks to everyone joining us this morning. Looking back over the past year, it's clear that 2022 was a transformational time for our pipeline and company, and one that has set us up for another exciting year in 2023. Emboldened by the accomplishments that you'll be hearing about on today's call, we are advancing a pipeline that now includes two high-value registrational opportunities for Pella Rea Reb, or Pella as we'll call it, with each representing a core pillar of our business and foundation for growths. The first and longest standing of these pillars is of course our HR positive HER2 negative breast cancer program. Last year we completed enrollment in the program's second randomized phase two trial, bracelet one, which is approaching a crucial data rate out that we anticipate sharing at a major medical meeting next quarter. We expect this readout, which Tom and Andrew will discuss in more detail, to provide key data that will validate the program's prior positive results and help inform the design of subsequent registrational trial. Just to provide some additional company history, our breast cancer program's prior positive results come from IND213, a randomized phase two trial that counts as one of the two pivotal studies required for regulatory approval of Pella in breast cancer, per a special protocol assessment agreed with the FDA. IND213 showed a statistically significant and clinically meaningful near doubling of overall survival in HR-positive HER2-negative breast cancer patients who received Pella plus Paclitaxel compared to those who received Paclitaxel alone. These data build upon Phase I results demonstrating Pella's single-agent activity in HR-positive HER2-negative breast cancer and also inspired the AWARE-1 study, which met its primary endpoint and demonstrated how Pella remodels the tumor microenvironment and trains the immune system in ways that may enhance the efficacy of a wide range of oncology treatments. With all these data in place, we believe a successful outcome from Bracelet 1 would represent a key inflection point for our breast cancer program, as it would clear the way for Pella's advancement into a registrational study and bolster our business development activities. I'll turn to our pancreatic cancer program, which emerged as our second core pillar late last year following some remarkable proof-of-concept data from our Phase I-II goblet study presented at the 2022 CITSE annual meeting. The pancreatic cancer cohort reported a 69% objective response rate, including a confirmed complete response in 13 valuable patients treated with a combination of Pella, the checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nabpaclitaxel. These results generated excitement from our team and key opinion leaders in the field because the average response rate observed in relevant historical control trials in pancreatic cancer is only about 25%. The 69% objective response is nearly three times what would have been expected. Based on the strength of these data, as well as discussions with key opinion leaders and potential partners, we believe the most prudent next step for our pancreatic cancer program is to determine the optimal registration enabling pathway as expeditiously as possible. To do this, we continue to engage with the FDA, who granted Pella fast-track designation in pancreatic cancer in the fourth quarter, and other key stakeholders to align on the optimal design for such a study, which Tom will discuss further. Looking ahead, advancing our pancreatic and HR-positive HER2-negative breast cancer program towards regulatory approval will be our primary focus. Alongside these efforts, we will selectively continue to evaluate Pella's therapeutic potential in additional indications through collaborations with leading industry players and academics, as this was the strategy that allowed us to maintain momentum in our breast cancer program while bringing our pancreatic cancer program forward as our pipeline's second core pillar. And with that, let me turn the call over to Tom and Andrew for a more in-depth discussion of our clinical programs and business development efforts. We will start with you, Tom.