Oncolytics Biotech Inc.

Good afternoon and welcome to Oncolytics Biotech's fourth quarter and full year 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 conference call over to John Patton, Director of Investor Relations and Communication. Please go ahead.

Thank you, Operator, and good afternoon, everyone. Earlier today, Oncleric's issued a press release providing recent operational highlights and financial results for the fourth quarter and full year of 2023. A replay of today's call will be available on the events section of the Oncleric'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 Palo Rio 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 Pellet Re-Rep as a cancer therapeutic, our clinical development plans for 2024, including initiation of our first registrational studies for Pellet Re-Rep, a manufacturing program, our cash 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 known and non-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 forward-looking statements. In any forward-looking statement in which Onclinix 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. There can be no assurance that the statement, expectation, or belief will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property production, financial projections, actions by regulatory agencies, and those factors detailed in the company's filings with CDAR and the SEC. Oncologics does not undertake any obligation to update these forward-looking statements except as required by applicable laws. The Oncologics Management Team is on the call today to review our fourth quarter 2023 and year-end results, including Chief Executive Officer, Dr. Matt Coffey, Chief Financial Officer, Kirk Look, Chief Medical Officer, Dr. Tom Heinemann, and Vice President, Product Development, Allison Hagerman. Now, I will turn the call over to Dr. Coffey. Matt.

Thank you, John. Good afternoon, and welcome to the Oncolytics Biotech fourth quarter conference call. 2024 marks the year that Oncolytics will become a late-stage cancer company. with the initiation of our first registrational studies for our proprietary immunotherapeutic product candidate, Pella-RioRep, or Pella, as we'll refer to it. This brings us closer to achieving our mission of improving the lives of patients with cancer, so we'll begin the year with significant enthusiasm. The transition to becoming a late-stage biopharma company reflects significant progress in positive clinical and translational data reported from our clinical programs in 2023. A key element of this transition is making smart investments in manufacturing, which is why Allison Hagerman will join us to talk about the steps we're taking so Oncolytics is set up for success as Pelham is closer to beginning registrational trials. During our call today, we would like to share some of the key highlights from the last several months, outline our clinical and strategic objectives for 2024, including the manufacturing, review our financial results for the fourth quarter and full year 2023, and take your questions. Positive clinical and translational data helped close 2023 on a high note. Starting with our clinical results, we reported positive clinical data from three cohorts in the Phase 1-2 goblet study in pancreatic cancer, colorectal cancer, and anal cancer. Each indication has achieved the predefined quote-unquote stage 1 success criteria, defined according to the Simon 2-stage study design. Data from the pancreatic and anal cancer cohorts demonstrated response rates that were nearly three times greater than published historical controls. Positive clinical results were supported by valuable translational data from further analysis of the AWARE-1 breast cancer study and from cohorts in the Goblet study. These data underscore Pella's mechanism of action as an immunotherapeutic agent. Importantly, the data demonstrated a positive correlation between response rates and PELL's ability to induce the expansion of T cell populations, measured by increases in the cell TIL score and the level of tumor infiltrating lymphocytes, or TILs, in the peripheral blood. TIL expansion could become an important biomarker of clinical outcomes that could be used in future clinical studies and to guide patient care. The positive data that we reported throughout 2023 include the Bracelet-1 breast cancer data reported in June, have also attracted interest and enhanced ongoing interactions with our clinical collaborators and potential strategic partners. The overall survival data for bracelet 1 continues to mature for patients receiving Pella and Paclitaxel. Overall survival is an important metric to potential partners and will likely serve as a catalyst to further our ongoing business development conversations. Additionally, these conversations have further informed our thinking on the design of future registrational studies. We've sharpened our strategic thinking thanks to the contributions of our board of directors, including our new director, Pat Andrews. Her experience in navigating registrational trials in oncology and completing transformational business development agreements complements and expands the strategic expertise of our board. We look to extend the transformational and strategic mindset in all of our discussions in 2024 and beyond. Now, as we look ahead, we are steadfast in our focus on achieving important objectives this year that move Pella forward on the regulatory pathway. These include, in the first half of the year, we intend to provide guidance on a registrational path for Pella in breast cancer. Also in 2024, we plan to initiate a registration study for Pella in pancreatic cancer using an adaptive design. I'd like to take a moment to expand on our thinking for each indication, starting with breast cancer. We expect our registrational strategy in breast cancer to focus on an evaluation of Pella in combination with Paxlitaxel compared to Paxlitaxel monotherapy in patients with metastatic disease who are HR positive, HER2 negative. As a reminder, we are continuing to follow patients in the bracelet one, HR positive, HER2 negative metastatic breast cancer study and expect to report overall survival data this year. That being said, The data we've reported so far are supportive of the statistically significant near doubling of median overall survival seen in the IND213 study. With respect to our plans for pancreatic cancer, we expect our registration study to focus on the evaluation of Pella in combination with apetalizumab, gemcitabine, and nabpaclitaxel compared to the combination of gemcitabine and nabpaclitaxel in patients receiving first-line treatment for pancreatic ductal adenocarcinoma, or PDAC. We continue to develop a study protocol that utilizes an adaptive design, building on the positive results from the goblet study. The registrational strategy for PDAC will incorporate learnings from our previous interactions with the Pancreatic Cancer Action Network, also known as PANCAN, and ongoing conversations with their newly announced alliance partner, the Global Coalition for Adaptive Research, or GCAR. As a result of these relationships, we've been able to collaborate with key opinion leaders in the pancreatic cancer community and their enthusiasm propels potential, and this indication reinforces our commitment to bringing new treatment options to patients. I'd also like to mention the expansion of the enrollment in the Goblet cohort focused on anal cancer. The American Cancer Society estimates that there will be about 10,500 new cases of this cancer in 2024. We recently announced plans to begin enrolling stage two of this cohort based on positive results in the first stage of the Simon two-stage program. reported at an international medical meeting in November of last year. The study will evaluate the combination of Pella and atezolizumab in patients with second-line or later disease. While inner cancer is very rare, there is no standard of care for these patients who have progressed to advanced disease, so positive results may provide an opportunity for a rapid regulatory pathway. We hope to report additional data in 2025. Before I turn the call over to Tom Heinemann, there are three key messages we would like you to take away from today's call. First and foremost, propelled by the encouraging clinical and translational data we unveiled in 2023, Pella is poised to embark on registrational trials for pancreatic cancer and breast cancer as early as 2024. The consistently positive outcomes from seminal studies such as BRACELET-1, AWARE-1, and GOBLET have captured the attention and deepening engagement of the clinical oncology community and potential strategic partners. Secondly, we eagerly anticipate the forthcoming release of overall survival data from the Bracelet-1 breast cancer study in 2024. This data represents an important milestone anticipated to serve as a significant catalyst in bolstering our registration endeavors for Pella and a focal point of interest for our prospective biopharma collaborators. Lastly, the compelling data stemming from the anal carcinoma cohort of the Goblet study advocates for the expansion of this cohort. With the potential for fewer than 20 additional patients to be enrolled, we could swiftly transition towards a registrational study in this critical unmet need area. Particularly noteworthy is the distinctive approach of excluding chemotherapy in favor of leveraging the demonstrated synergy between Pella and a checkpoint inhibitor, underscoring our commitment to pioneering novel and effective treatment modalities. Finally, as always, I'd like to thank everyone in the Oncolytics organization and our collaborators for your dedication to the mission to improve the care of patients with cancer. Your work to advance the development of Pella inspires me and everyone around us every day.