Oncolytics Biotech Inc.

are ongoing business development initiatives, 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 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 four looking statements. In any forward-looking statement in which oncologists express an expectation or belief as to future results, such expectations or beliefs are expressed in good faith, and our beliefs 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 other factors detailed in the company's filings with CDAR and the SEC. Unclaims does not undertake any obligation to update these forward-looking statements except as required by applicable laws. Now, I'm pleased to introduce the members of our management team who are joining me to discuss the important progress we made during the third quarter. These are Chair of Unclaims Board of Directors and Interim CEO, Wayne Pisano, Chief Medical Officer, Dr. Tom Heinemann, Chief Financial Officer, Kirk Look, and Vice President of Business Development, Christophe Degois. Wayne will start our conversation this morning, so I'll hand it off to him. Wayne?

Thank you, John. Good morning. Also, thanks to everyone who's joining our call today, especially because we've had several meaningful news events since our last update. Following my brief introduction, Tom will provide a recap of the Bracelet One data and our plans for a clinical trial designed to support the accelerated approval of Pell-O-Rio Rep and metastatic breast cancer. He will also expand upon our plans for Pell-O-Rio Rep and gastrointestinal cancers. Christoph will discuss our large, addressable market opportunities and partnership efforts. Kirk will review the financials. And finally, we will end by taking your questions. In the third quarter of 2024, we reached a critical milestone in our development of Pella-Riorep, or Pella as we often call it, our leading immunotherapeutic agent. The BraceFoot1 breast cancer study reported its final data and the combination of Pella plus Paclitaxel showed substantial improvement compared to Paclitaxel monotherapy in critical metrics like progression-free survival, overall survival, and 24-month overall survival rate. Progression-free survival and the 24-month overall survival rate nearly doubled, while overall survival showed an approximate 14-month benefit. We believe these data provide us the opportunity to significantly impact the lives of patients with HR-positive, HR-negative metastatic breast cancer, and we believe the next appropriate step is a registration-enabling study utilizing Bracelet 1 outcomes as the basis for an accelerated approval development path. Now, before Tom provides a more comprehensive update, I would also like to highlight that we are continuing enrollment in the safety run-in phase of Goblet Cohort 5 in newly diagnosed patients with metastatic pancreatic destructal adenocarcinoma, supported by the Pancreatic Cancer Action Network. Additionally, we continue to work with GCAR on finalizing the master protocol and seeking FDA feedback for the registration-enabling study in pancreatic cancer. With the potential for two registrational studies ahead, we believe 2025 will be an exciting year for Pella and for Oncolytics. Now, I'd like to turn the call over to Tom to provide a more detailed update. Tom?

Thank you, Wayne. Just to quickly refresh anyone who hasn't heard our story for a while or is new to what we're doing, Pella is an intravenously delivered immunotherapeutic that acts systemically. It introduces double-stranded RNA into the tumor, which promotes an inflammatory response that makes the tumor visible to the immune system. At the same time, it stimulates anti-tumor cellular immune responses that can attack the now-visible tumor. Our main priorities are to advance our planned registrational studies in breast and pancreatic cancer, so that is where we will focus our discussion today. Starting with our breast cancer program, we recently shared efficacy results from the BRACE-LOOK-1 study, which exceeded our expectations across the board, including both progression-free survival, PFS, and overall survival, OS. The median PFS nearly doubled from 6.4 months in the control arm to 12.1 months in the Pella arm. Similarly, while median OS was 18.2 months in the control arm, it could not even be calculated in the Pella arm because more than half the patients were still alive at the end of the study. Nonetheless, using the conservative assumption that all the Pella patients would have passed away at the time of their next clinic visit, the median OS would have been 32.1 months, well more than a year longer than the control patients. Perhaps even more telling, the proportion of patients who lived two years or longer nearly doubled from 33% in the control arm to 64% in the Pella arm. It's important to note that the patient populations were well-balanced across the study groups with no substantial differences that would be expected to bias results in favor of Pella. Safety results from the BRACE-L1 study were in line with Pella's well-understood and favorable safety profile based on more than 1,100 treated patients. The next question is where we go from here. After discussions with key opinion leaders, our biopharma collaborators, and the FDA, we have identified an approach that can generate primary endpoint results within two years of the start of patient enrollment. Accordingly, our next planned breast cancer study is anticipated to be a registration-enabling large Phase II study of around 180 HR-positive, HER2-negative metastatic breast cancer patients. We would use progression-free survival as a primary endpoint and would power the study to achieve a Phase III level of success if the expected clinical benefit is achieved. If Pella-based therapy demonstrates a progression-free survival benefit comparable to that seen in bracelet one, we anticipate seeking licensure, potentially through the accelerated approval pathway. This approach has been used to achieve the initial approvals of other breast cancer treatments, including Pfizer's, Ibran's, and Daiichi's, and HER2. We believe this is a cost-effective and efficient strategy for the development of Pella in breast cancer. I would now like to move to the Goblet study and our opportunity in gastrointestinal cancers. So far, we have evaluated Pella-based therapies in first-line metastatic pancreatic ductal adenocarcinoma, or PDAC, third-line metastatic colorectal cancer, and second-line or later, later anal cancer. Despite the difficulty of treating these specific cancers, Pella-based combination therapy met the initial predefined efficacy success criteria for each of these indications. Our highest priority in GI cancers is pancreatic cancer. We've seen exciting efficacy signals in previous studies, and the objective response rate we reported in the pancreatic cancer cohort of the GOBLET study was more than double historical objective response rates. The strength of these results attracted the attention of multiple potential partners. One of these collaborators is the Global Coalition for Adaptive Research, or GCAR, which specializes in the design and conduct of cost-effective, innovative, adaptive clinical trials intended to support licensure. We are currently collaborating with GCAR to develop an adaptive registrational enabling study to evaluate Pella-based combination therapy and metastatic PDAC, and we expect to seek, with GCAR, FDA guidance on the study design. We look forward to continuing our collaboration with GCAR on this exciting opportunity, and we will provide an update as this program advances. As a compliment to our work with GCAR, we also received a $5 million grant from the Pancreatic Cancer Action Network, also known as PANCAN, to evaluate a different Pella-based combination therapy in PDAC. Historically, the two most common standards of care in metastatic pancreatic cancer are the chemotherapy regimens of gemcitabine nabpaclitaxel or modified fulfirinox. The gemcitabine nabpaclitaxel regimen is the focus of our work with GCAR, while the PANCAN grant is funding the evaluation of Pella combined with modified fulfirinox. This is an attractive opportunity because if Pella-based therapy demonstrates benefit when combined with both commonly used chemotherapy regimens, it may lead to improved therapeutic options for nearly all metastatic pancreatic cancer patients. Earlier this year, we announced the dosing of the first patient in the new Goblet cohort evaluating Pella combined with modified Fulfironox. Enrollment into this cohort of the Goblet study is ongoing, and we will provide additional updates when they become available. Did the combination of Pella and modified Fulferinox produce a positive outcome if it resulted in another registrational opportunity for Pella in this challenging indication? Before I turn the call over to Christoph to expand on our business development efforts as well as our most recent commercial assessments, I would like to briefly summarize our immediate priorities. First, we plan to pursue an accelerated approval pathway for Pella in HR-positive, HER2-negative metastatic breast cancer to a large registration-enabling study that compares paclitaxel plus Pella to paclitaxel alone. Since we've already demonstrated Pella's clinical benefit in two prior randomized studies, we are confident in this approach. Secondly, we are working with GCAR to finalize the protocol for the metastatic pancreatic cancer trial, evaluating Pella, gemcitabine, nabpaclitaxel, and atezolizumab, and we will seek guidance from the FDA on this approach, which we believe will open another registrational pathway for Pella. And finally, we continue to enroll patients into the Goblet Study cohort evaluating Pella combined with modified fulfirodox, which is in newly diagnosed pancreatic cancer patients. Our conviction in Pella's broad therapeutic benefits grows stronger with each positive dataset, as does our belief in Pella's potential to improve the lives of cancer patients. With that, I will turn the call over to Christoph to discuss Pella's market opportunity, our ongoing collaborations, and future partnership opportunities. Christoph?