Oncolytics Biotech Inc.

Good morning and welcome to Oncolytics Biotech's second 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. And I would 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, Onclytics issued a press release providing recent operational highlights and financial results for the second quarter of 2023. 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 the company's business prospects, and the development and commercialization of Pella ReRap, including statements regarding the company's focus, strategy and objectives, the company's belief as to the potential and mode of action of Pella ReRap as a cancer therapeutic, the company's plans regarding precision promise and the anticipated timing of entering into a definitive agreement in connection therewith, 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 to be materially different from the results, performance, or expectations implied by these forward-looking statements. In any forward-looking statement in which Onclyx expresses an expectation or belief as to future results, such expectations or beliefs professing 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, which is 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-looking statements except as required by applicable laws. On our call today, we'll hear from Oncologics Chief Executive Officer, Dr. Matt Coffey, Chief Medical Officer, Dr. Thomas Heinemann, Global Head of Business Development, Andrew DiGutadaro, and Chief Financial Officer, Kirk Look. I'll now hand the call off to Matt to give a few highlights from this past quarter. Matt?

Thank you, John, and welcome to all who have joined us this morning. We are excited by the continued progress of our CARP programs for Pella Rear Rep, or Pella as we'll refer to it, in pancreatic and breast cancer that are accelerated towards registrational studies. In June, at the ASCO annual meeting, we presented results from our HR-positive, HER2-negative metastatic breast cancer program. Data from the randomized Bracelet-1 trial showed a 50% improvement in progression-free survival and a nearly threefold increase in confirmed overall response rate for Pella in combination with Paclitaxel versus Paclitaxel alone. This impressive data readout validated earlier Phase II results from IND213, which showed a statistically significant near-doubling of median overall survival in HR-positive HER2-negative metastatic breast cancer patients, meaning this program is now Phase III ready. The company will now prioritize progressing swiftly to a registrational trial of Pella Paclitaxel combination therapy in HR-positive HER2-negative metastatic breast cancer. Our second registration program in pancreatic cancer has generated compelling data and is clearly attracting attention among thought leaders in the community. This is evidenced by Pella being selected as a new investigational treatment in Precision Promise, an innovative, adaptive phase three clinical trial designed to accelerate registration pathways for pancreatic cancer therapies and expected to reduce phase three costs by about 50% compared to a traditional trial. The study, if successful, is expected to support approval of Pella in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nabpaclitaxel for the treatment of first-line metastatic pancreatic ductal adenocarcinoma. Pella's inclusion in Precision Promise is supported by prior pancreatic cancer clinical data that suggests it synergizes with checkpoint inhibition and chemotherapy. As a reminder, our Phase I-II goblet study data has almost tripled the average historical objective response rate by combining Pella with nabpaclitaxel, gemcitabine, and atezolizumab in first-line advanced pancreatic cancer. However, in total, we have data from over 120 pancreatic cancer patients we have treated across multiple studies with and without chemotherapy and checkpoint inhibitors, which Tom will discuss a bit later. Our plan for this indication is to finalize agreements with the Precision Promise team by the fourth quarter of this year, and we expect to open the investigational treatment of Pella, a checkpoint inhibitor, gemcitabine, and nalpaclitaxel in early 2024. At the end of July, we announced the U.S. $15 million equity offering, which closed last week and was led by a healthcare-focused institutional investor. Our HR-positive HER2-negative metastatic breast cancer and metastatic pancreatic cancer programs both represent meaningful registration opportunities, and this additional funding further strengthens our position to advance Pella into registrational trials. We plan to provide guidance on the registration enabling pathway for both of these programs later this year. Now I will turn the call over to Tom and Andrew for a more detailed discussion of our clinical programs and business development efforts. We will start with you, Tom.