Oncolytics Biotech Inc.

Good morning and welcome to Oncolytics Biotech's third quarter 2023 conference call. All participants are now in a 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 morning, everyone. Earlier this morning, Onclytics issued a press release providing recent operational highlights and financial results for the third quarter of 2023. A replay of today's call will be available on the events 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 Pellery Rep, including statements regarding the company's mission, strategy, and objectives, the company's belief as to the potential mechanism of action, and benefits of Pellery Rep as a cancer therapeutic, our clinical pipeline, and our belief that we are on track for licensure-enabling studies in metastatic breast cancer and metastatic pancreatic cancer, the company's plans and expectations regarding the release of additional results, and or updates in respect of its ongoing clinical 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 to be materially different from results, performance, or expectations implied by these four living statements. In any forward-looking statement in which on-credits 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 protections, actions by regulatory agencies, and those other factors detailed in this company's filings with CDAR and the SEC. Oncletics does not undertake any obligation to update these forward-looking statements except as required by applicable laws. Now, I'll bring on CEO, Dr. Matt Coffey, for his overall highlights and to introduce the rest of the management team who will be speaking today. Matt?

Thank you, John. I'll open by saying that Oncletics has made substantial progress since our last quarterly update, and I want to say thank you for joining us for today's call to hear about these operational highlights and third quarter 2023 financial results. During the call today, our Chief Medical Officer, Tom Heinemann, our Global Head of Business Development, Andrew DiGiudicaro, our Chief Financial Officer, Kirk Look, and I will present an update on a clinical program, summarize the data we presented at ESMO and other recent and upcoming medical meetings, discuss how recent data readouts and other opportunities bolster our business development efforts and potential, outline our upcoming milestones, and provide you with our outlook on our cash runway and summarize third quarter financial results. Then we'll open the call up for questions. Oncolytic intends to deliver on its mission to improve the survival of patients with cancer by investigating the novel immunotherapy, Pella rear rep, or Pella as we'll refer to it, in carefully selected indications and treatment regimes that will leverage its unique mechanism of action to provide the most meaningful clinical benefits. This is measured by improvements in overall survival and progression-free survival supported by an improved T-cell profile. The data presented at the European Society for Medical Oncology, or ESMO, from the pancreatic and colorectal arms of the goblet study are a highlight of 2023. I'd like to underscore a few observations, and Tom will take you through the detailed results. First, we have now met the Simon two-stage success criteria in two consecutive goblet cohorts evaluating Pella in patients with first-line pancreatic and third-line colorectal cancer. Importantly, this is the third indication where we've seen Pella combined with atezolizumab provide encouraging results in patients. These are breast cancer with the AWARE study, plus pancreatic and third-line colorectal cancer in the GOBLET study. We also continue to see the combination of Pella and chemotherapy providing response compared to historical controls, demonstrating its potential as an immune therapy backbone. Additionally, we've seen the expansion of tumor infiltrating lymphocytes, or TIL clones, correlated with tumor response and a strong correlation between T cell clone expansion and improvements in the tumor microenvironment, or TME, consistent with Pella's differentiated mechanism of action. Critically, Pella treatment continues to be well tolerated, which is important as we continue to evaluate additional indications and potential oncology treatment combinations, and finally, In addition to meeting the success criteria for both the pancreatic and colorectal cancer cohorts, the data are compelling, especially for pancreatic cancer, where we saw objective response rates, progression-free survival rates, and rates of overall survival that exceed historical control trials. Taken together, these data show how PELLA's mechanism of action facilitates synergy with both chemotherapy and checkpoint inhibitors in multiple indications. Furthermore, the results expand that data set that forms the basis of a potentially compelling product profile for Pella and give us additional confidence in advancing our clinical program. We will use the results of both goblet segments presented at ESMO, combined with our analysis of the current treatment paradigm and competitive landscape, to map out our next steps for registration studies. As we review Oncolitic's third quarter, along with the company's recent operations, I believe there are three key take-home messages. First, We believe Pella has the potential to be a differentiated and effective immunotherapy that could improve the lives and overall survival of people with cancer. This is based on positive, consistent results in gastrointestinal and breast cancer, including data presented at ESMO 2023 for pancreatic cancer and colorectal cancer. The totality of our clinical data set shows significant improvements in tumor response and overall survival, coupled with highly correlated immunological responses. measured by an improved T-cell profile in the tumor microenvironment. Second, we are proud to be making the transition to a late-stage company running registrational trials with the upcoming start of the Phase III Precision PROMIS study in pancreatic cancer. Another important development is the recently award of a $5 million U.S. grant from PanCan to support a new Phase II combination study in pancreatic cancer. If this study generates the same responses we've seen to date in pancreatic cancer, it could result in another Pella-based combination therapy being selected for inclusion in the Precision Promise Phase 3 platform trial. Third, we are well-positioned to advance our clinical program based on a focus on capital efficiency with a strong balance of $40 million, including $17 million U.S. raised in an August public offering and the over-allotment, plus a $5 million U.S. PANCAN grant. Before I bring Tom on, I want to thank everyone on the OnClinics team for your unwavering dedication to our mission and your fine work. Now, I'd like to turn the call over to our Chief Medical Officer.