Oncolytics Biotech Inc.

Good afternoon and welcome to Oncolytics Biotech's first quarter 2024 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 John Patton, Director of Investor Relations and Communication. Please go ahead.

Thank you, Operator, and good afternoon, everyone. Earlier today, OnClinic's issued a press release providing recent operational highlights and financial results for the first quarter of 2024. A replay of today's call will be available on the event section of the OnClinic's 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 Pellegrino Rep. Including statements regarding the company's mission, the company's belief as an essential and mechanism of action of Pellery Rep as a cancer therapeutic, our belief that we are positioned to begin registrational track studies in breast and pancreatic cancer, and our strategies and upcoming milestones in connection therewith. Our critical objectives for 2024, the anticipated timing and the release of additional data, the company's belief that it has sufficient cash to achieve these milestones, 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 unnoticed delays, uncertainties, and other factors not under the company's control that may cause actual results, performance, or achievements of the company to be mutually different from the results, performance, or expectations implied by these forward-looking statements. In any forward-looking statement in which Oncologics expresses 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 could 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 linking statements except as required by applicable laws. I'm joined by several members of the OncoLynx management team to review our first quarter 2024 results and corporate updates, including Chief Executive Officer, Dr. Matt Coffey, Chief Financial Officer, Kirk Look, and Chief Medical Officer, Dr. Tom Heinemann. Dr. Coffey will begin our discussion today. Matt, please take it away.

Thank you, John. Good afternoon and welcome to OncoLynx first quarter conference call. Oncolytics' mission is to improve the lives of people with cancer by bringing our proprietary immunotherapeutic product candidate, Pella Rear Rep, or Pella as we'll refer to it, to patients as quickly as possible. We are taking the next steps to make that happen as we transition to become a late-stage cancer company by progressing Pella in our two lead indications, breast cancer and pancreatic cancer. As we'll discuss throughout the call, we are building the necessary foundation to begin registrational track studies for both of these indications for which there is urgent need for new or alternative therapies. We have organized today's call to provide you with a comprehensive update on our progress and upcoming milestones. I'll spend a few moments sharing what excites us about Pella and touch on our recent developments, upcoming milestones, and key corporate messages. After that, I will ask Tom to provide an update on the breast cancer program the new goblet pancreatic cancer cohort, the expansion of the goblet anal cancer cohort, and initial plans for the registrational tract pancreatic cancer study. Then I'll ask Kurt to review the financials. And finally, we will end by taking your questions. I'll start with a brief note on what makes Pella such a compelling immunotherapy candidate. In a nutshell, it's all about results. Pella is delivered intravenously and works systemically. it is able to selectively replicate its tumors and introduce double-stranded RNA into these cancer cells. This results in generating, recruiting, and training immune cells to begin identifying cancer cells to enable cancer cell killing in addition to remodeling the tumor microenvironment to activate immune cells. This has made Pella unique because the responses Pella generates have led to synergies with multiple cancer treatments, including chemotherapy, immune checkpoint inhibitors, CAR-T cell therapy, and others. These synergies come from two randomized breast cancer studies, multiple studies in pancreatic cancer, and recently there's been an intriguing efficacy signal in the anal cancer cohort of our goblet study, which included a complete response even in the absence of standard cytotoxic chemotherapies. In these clinical trials, Pella was used in combination with chemotherapy drugs like napaxitaxel or immune checkpoint inhibitors like atezolizumab. Compelling data from these studies showed that the treatment with Pella produced meaningful clinical responses with favorable comparisons to historical controls, as in the case of Goblet, or in randomized control trials, as we've demonstrated in breast cancer. It's demonstrated a positive association between increases in tumor-infiltrating lymphocytes, or TILs, and tumor responses, and it was well-tolerated by patients. Taking together these data formed the basis of our enthusiasm for Pella as a novel, differentiated immunotherapeutic agent. and supports our plans to move ahead with registration track studies. 2024 is off to a promising start. We're building on our compelling clinical databases and continuing our transition to become a late-stage oncology company. A few notable milestones have marked our year-to-date progress. We've been granted a type C meeting with the FDA for a Q2 2024 meeting to discuss our planned registration enabling study in breast cancer. Defining this registration path for palliative breast cancer is a pivotal clinical goal for the year. We expanded enrollment for the anal cancer cohort of the GOBLET study to strengthen the already promising signal of efficacy. This is important because it could open the door to a new registration indication and accelerate approval for pathways. We received regulatory clearance to begin enrolling patients in the new pancreatic cancer cohort in the GOBLET study. This cohort will evaluate Pella in combination with a widely used chemotherapy regimen called modified fulferinox with and without atezolizumab. The study is supported by a U.S. $5 million grant from the Pancreatic Cancer Action Network, also known as PANCAN, which provides additional positive validation for Pella. We have firm plans to report overall survival data from the Phase II Bracelet Breast Cancer Study in H2 2024. While we have reported overall survival response data for pelopaclitaxel, that is three times paclitaxel monotherapy, overall survival data continues to mature. This has the potential to be a major catalyst as we have already had another metastatic breast cancer study called IND213 overall survival . We know that two abstracts related to clinical and translational data were selected for presentation at the annual meeting of the American Society for Clinical Oncology, or ASCO, 2024, which we'll be able to discuss in more detail later this month. We continue to maintain an active dialogue with our clinical collaborators and potential strategic partners. These discussions provide valuable perspectives that have shaped and enriched our registration study plans. Looking ahead, we remain laser focused on our critical objectives for 2024. In H1 2024, we intend to provide guidance on the registration path for Pella and breast cancer. Over the coming months, we expect to enroll the first patient in cohort five of the GOBLET study, which is evaluating Pella plus modified falferinox with and without atezolizumab in pancreatic cancer patients. Also in H2 2024, we expect to report overall survival data from the BRACE-01 breast cancer study. Now, before I turn the call over to Tom to provide you with an update on our clinical programs, I'd like to thank everyone in the Oncolytics organization and our collaborators for the dedication that you bring to our mission every day to improve the care of patients with cancer. Your work and unwavering commitment is critical to advancing the development of Pella. Tom?