Oncolytics Biotech Inc.

Good morning and welcome to Oncolytics Biotech second quarter 2022 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 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 2022. 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 Pellaria Rep, including statements regarding the company's focus, strategy, and objectives, the company's belief as to the potential and mode of action of Pellaria Rep as a cancer therapeutic, the design, aims, and anticipated benefits of the company's current pending clinical trials, and the anticipated timing of the release of additional data, the company's plans and expectations regarding a potential registrational study, 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 current 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 Oncologics expresses an expectation or belief as a future result, such expectations or beliefs are expressed in good faith. 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 factors detailed in this company's filings with CDAR and the SEC. Oncolytics does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. I will now pass a call off to Oncolytics President and Chief Executive Officer, Dr. Matt Coffey. Please go ahead, Matt.

Thanks, John, and good morning to all listening. As usual, joining me on today's earnings call are a few fellow members of the Oncolytics leadership team, including Dr. Thomas Heinemann, our Chief Medical Officer, Andrew DiGadadaro, our Global Head of Business Development, and Kirk Look, our Chief Financial Officer. I'd like to begin today's call with a brief recap of our very strong second quarter, highlighting two clinical data readouts in our breast and pancreatic cancer programs that we find very encouraging. Each of these readouts further clarifies Pella Rear Rep's core value proposition, which is its ability to solve one of oncology's most prevalent and longstanding problems, the inability of the immune system to recognize and infiltrate tumors. This problem extends across many tumor types and is known to severely blunt the impact of many of the most widely used and commercially successful classes. To date, the problem posed by the inaccessibility of tumors to immune cells has yet to be broadly solved, due in a large part due to the multiple biological mechanisms perpetuating it. With Pella Rear Rep, or Pella as I'll call it, we believe we have a safe and versatile immunotherapeutic agent that can simultaneously address many of these various mechanisms and make tumors more amenable to successful treatment with complementary anti-cancer therapies. By doing this, we believe we could substantially broaden the commercial opportunity of these therapies by expanding their reach in large indications such as HR-positive HER2-negative metastatic breast cancer and pancreatic cancer, which affect approximately 114,000 and 62,000 patients yearly in the U.S., respectively. This belief is supported by data from multiple clinical studies, such as IND213, which showed a statistically significant near doubling of overall survival in HR-positive HER2-negative breast cancer patients when Pella was added on top of chemotherapy. It is also supported by AWARE-1, which provided a mechanistic explanation for IND213's results by establishing Pella's immunotherapeutic effects in HR-positive HER2-negative breast cancer patients. These findings were strengthened with new analysis presented at the ESMO breast cancer meeting in May, which showed Pella remodeling tumor microenvironments in a way that improved patient prognosis and long-term outlook. Another key finding from AWARE-1 was the demonstration of synergy between Pella and checkpoint inhibition, as combining Pella with Roche's atezolizumab led to an enhanced immunotherapeutic effect. This added to the massive data supporting our breast cancer program and provides a clear scientific rationale for the Phase 1-2 Goblet trial, which showed in June that the synergy observed in breast cancer may extend into pancreatic cancer. Notably, pancreatic cancer is a highly prevalent and challenging indication where checkpoint inhibitors have thus far not provided substantial clinical benefits. We were thus highly encouraged when Goblet's initial readout showed treatment with the combination of Pella, atezolizumab, and standard of care chemotherapy led to dramatic tumor shrinkage and partial responses per resist criteria in all patients in the pancreatic cancer cohort. Still early, we believe these data are indicative of Pella's potential as a platform molecule that can be used in a variety of indications to enable immune cell access to tumors. Pella's ability to do this contributes to its anti-cancer activity as a single agent and positions it as a broadly applicable combination partner that can drastically enhance the efficacy of a range of drug classes. Looking ahead, we plan to present additional data from Goblet's pancreatic cancer cohort at a major medical meeting later this year. With enrollment nearly completed in stage one of the cohort, we submitted an abstract that includes objective response data at week 16 on all valuable patients. This update includes follow-up on the three patients we've already reported on at ESMO GI this past June. If the early signal of efficacy observed with the first three patients persists in subsequent readouts, we believe it will open up new pathways towards registration that will de-risk our pipeline and increase our avenues for value creation. Tom and Andrew will be providing additional context on our pancreatic cancer program a bit later. I'd now like to turn our attention to an important announcement we made in our press release that was distributed early this morning. This was the completion of enrollment in Bracelet 1, a randomized phase 2 trial in HR-positive HER2-negative metastatic breast cancer. With Bracelet 1 enrollment finishing near the end of last quarter, the trial is now less than four months away from a complete dataset on its primary endpoint of week 16 overall response rate. Once we have cleaned and locked the database, we will provide our partners at Pfizer and Merck-Sorono with a report that will trigger the start of their 90-day period of exclusivity. during which the data could not be publicly announced. As we are already monitoring the data from this open-label study in real time, we're able to review the data as it develops, which allows us to engage investigators, cooperative groups, and regulatory consultants on a confidential basis. While a brief delay in Bracelet 1 enrollment, combined with the 90-day exclusivity period from our contractual obligations to Pfizer and Merck-Sorono, and the scheduling of major medical meetings, we have pushed our anticipated disclosure from the end of 2022 into Q2 2023. It's important to realize that this does not impede our lead program's momentum. We intend to take advantage of this 90-day quiet period to engage with regulators on a confidential basis during this time to discuss the optimal design for the future registrational study. This new study will be informed and supported by Bracelet One's results, as well as by Pella's robust safety database Phase 1 efficacy data demonstrating its single-agent activity and the aforementioned results from IMD 213, which notably counts as one of the two pivotal trials required for approval by the FDA. With regards to public disclosure of the data, our collaborators on our athletics team believe announcing Bracelet 1's full suite of clinical and translational data alongside emerging overall survival results at a major medical meeting will ultimately be more impactful. Instead of just piecemeal top-line data, this announcement will include an expansive set of clinical and translational data, including overall response rates, progression-free survival data, and evolving overall survival data from the trial's randomized cohorts. It will also provide important external validation and allow us to receive unbiased input from relevant experts and key opinion leaders. This feedback will be invaluable as we work to advance towards registration as efficiently as possible. As we've stated repeatedly, we expect Bracelet One's data to substantially de-risk our breast cancer program, bolster our business development prospects, and fuel Pella's advancement into registrational study by providing key learnings that will inform the trial's design. Nonetheless, we are still very excited about the breast cancer data we will have in the fourth quarter of this year at the San Antonio Breast Cancer Symposium in December, where we will be seeing clinical data from our Chinese partners HR Positive, HER2-negative breast cancer bridging trial, and additional AWARE-1 data. With that, I'll introduce Tom to provide some additional context around the recent announcements from AWARE-1 and Goblet.