Matt Coffey
Analyst · Roth Capital Partners
Thanks, Tom. And thanks to all listening for joining us on the call today to discuss our second quarter corporate update. Now in addition to Tom, I'm joined by Andrew de Guttadauro, our Global Head of Business Development; and Kirk Look, our Chief Financial Officer. As I begin today's call, I'd like to say how incredibly proud I am of all the members of the Oncolytics team. Their talents and unwavering dedication has allowed us to make truly remarkable progress over the last quarter, particularly in light of the unpredictable and industry-wide challenges posed by the COVID-19 pandemic. Through the efficient implementation of a robust business continuity plan, Oncolytics was able to achieve five clinical milestones, including three data readouts in the second quarter. Completion of these milestones has proved important clinical validation of our unique Oncolytics virus immunotherapy platform, while also advancing our lead breast cancer program towards the initiation of a registration study. Looking forward, we are well positioned to continue recording a steady cadence of value creating milestones across our diverse clinical pipeline. Now let's move on and provide some of our highlights from our productive quarter. We remain focused on the clinical advancement of pelareorep, our intravenously delivered immuno-oncolytic virus, towards a registrational study in HR positive and HER2 negative metastatic breast cancer. A substantial unmet need exists in this indication as currently approved therapies are unable to produce a meaningful survival advantage for the over 112,000 patients with the disease in United States alone. To address this unmet need, we continue to build on the results of our Phase 2 study IND-213, a metastatic breast cancer trial that showed a near doubling of overall survival with pelareorep treatments in HR positive HER2 negative patients. Encouraged by this data, we are conducting our AWARE-1 and BRACELET clinical studies, the completion of which will determine the design of our Phase 3 registrational program. Together these ongoing studies aim to achieve three objectives to facilitate the initiation of a Phase 3 trial. First, they aim to confirm pelareorep’s immunotherapeutic mechanism of action to support a promising efficacy data generated by IND-213. Seconds, is they aim validate the clinical utility of a novel blood-based biomarker measuring T cell clonality to predict patient response to pelareorep. And finally, they will evaluate pelareorep’s ability to enhance the efficacy of checkpoint inhibitors to improve patient outcomes, as there is a robust preclinical and clinical data set supporting the synergistic potential of pelareorep and checkpoint inhibitor combination therapies. With these objectives in mind, I'm happy to report that the second quarter features achievements have multiple key milestones, which continue to drive our sustained progress towards the registrational trial. The first of these milestones AWARE-1 window of opportunity studying early stage breast cancer. This study is being conducted by SOLTI in Spain and represents the first use of our clinical supply agreement with Roche. Following a recent expansion in the number of AWARE-1 trial sites, we are rapidly enrolling patients in the study thanks for doubling the number of study centers that coincided with Spain's reopening. Also, thanks for last week's successful safety committee review we once again verified pelareorep’s outstanding safety profile. The progress has been further bolstered by positive data generated such as the recently announced compelling data presented at the 2020 ESMO Breast Cancer Meeting. This data was also highlighted in a recent key opinion leader color, KOL call featuring Dr. Aleix Prat share SOLTI and the lead translation investigator of AWARE-1. During this KOL call, Dr. Prat spoke to how AWARE-1 data confirmed pelareorep’s immunotherapeutic mechanism of action support the critical utility of T cell clonality as a predictive and prognostic biomarker, and demonstrated pelareorep’s potential to synergistically combine with checkpoint inhibitors across multiple breast cancer subtypes. Specifically, the data show that systemic pelareorep administration was followed by tumor specific replication, which led to the creation and mobilization of tumor targeting CD positive T cell clones, and increased tumor PDL-1 expression. Notably, the AWARE-1 results also showed that pelareorep treatment leads to an increase in CelTIL, a measure of tumor information and the study's primary endpoint. Such data is particularly exciting when considering that patients with CelTIL scores have improved clinical outcomes. The Increase CelTIL also correlated with peripheral T cell clonality coordinates use of the biomarker which may allow us to select and stratify patients are more likely to respond to treatment and our clinical studies. Taken together previously reported results from AWARE-1, demonstrate the substantial progress made towards achieving the critical objectives necessary to move our lead breast cancer program into registrational studies. Looking ahead, we expected therefore this trial to continue in earnest. They're highly encouraged by this progress and will keep you up to date as the trial advances. Moving on now the breakup one, our Phase 2 trial evaluating the safety and efficacy of pelareorep combination therapy in HR+ / HER2- metastatic breast cancer patient. Like in AWARE-1 the exception work that Oncolytics team and its partners throughout the midst of this pandemic has a lot of achieve – critical milestones in the study. As we recently built our first patient following the opening with the first two sites in study. We expect to see an acceleration opening of additional sites over the next quarter as hospitals adapt to the running studies and COVID-19 pandemic environment. As a reminder, BRACELET design was developed in collaboration with Pfizer and Merck KGaA and is essentially identical to the study design that were prior IND 213 study exceptions. Firstly, the study focuses exclusively on HR+ / HER2- subsets of metastatic breast cancer patients, which is the patient population in which we saw the pronounced overall survival benefit in IND 213. Second, based on as an additional study to evaluate pelareorep in combination with Pfizer, Merck, anti-PDL-1 checkpoint inhibitors Bavencio. As mentioned earlier, this design was developed to support the overall survival advantage observed an IND 213, by demonstrating pelareorep’s ability to induce a robust anti-tumor immune response in an identical patient population. Additionally, the study aims to validate T cell clonality utility as a clinical biomarker and evaluate the efficacy of pelareorep checkpoint inhibitor combination therapy. Importantly, we believe that are AWARE-1 and BRACELET studies present multiple opportunities for value inflection points in the near future. Particularly given how prior data and regulatory interactions de-risk our overall breast cancer program. As those who have been following us for some time may know, we have previously received favorable feedback from the FDA and the phase 2 meeting, a favorable EMA Final Advice Letter, Fast Track Designation and a special protocol agreement for our metastatic breast cancer program. These regulatory achievements combined with our PrECOG and BRACELET-1 and compelling AWARE-1 showing that we are on track to meet the clinical objectives needed to initiate a registration study, demonstrate how the hard work of our employees, partners, patients and investigators have de-risk our lead clinical program instead of Oncolytics near and long-term success. Now I want to shift gears a bit and talk briefly about the recently announced expansion of a breast cancer program into new disease subtype triple-negative breast cancer. About a month ago, we announced our new IRENE study, which is a phase 2 investigator sponsored clinical trial designed to evaluate pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab. This trial aims to address a critical unmet medical need as there are over 460,000 triple-negative breast cancer patients in the U.S. alone. Importantly, well checkpoint inhibitor therapy is approved for the treatment of triple-negative breast cancer, that has significant limitation. Only about half of triple-negative breast cancer patients have the 1% PD-L1 expression level needed to become eligible for checkpoint therapy at this time, of those 40% are likely to respond to treatment. This represents a very interesting clinical and market opportunity for pelareorep, which is highlighted by the AWARE-1 data showed an ability to increase in tumor PD-L1 expression with pelareorep treatments across multiple breast cancer subtypes. These data highlights pelareorep potential to increase the number of patients that are eligible for and can respond to checkpoint inhibitors thereby helping to address this pressing unmet need in triple-negative breast cancer. Moving on, I'd now like to shift the discussion away from our primary focus on metastatic breast cancer and towards the progress made in hematological and gastrointestinal cancer indications. These programs demonstrate both the depth of our pipeline and the broad commercial opportunity offered by pelareorep continued advancement. Milestone to achieve in each of these programs in the second quarter as new clinical data from trials evaluating pelareorep in multiple myeloma and pancreatic adenocarcinoma were presented as part of the ASCO meeting held in May. We saw some [indiscernible] clinical proof-of-concept data in multiple myeloma, which is in-patient, where the incredible immunosuppressive nature of the cancer microenvironment has presented the success of checkpoint inhibitors. In patients that are multiple myeloma trial which treating with pelareorep, in combination with carfilzomib Kyprolis, we saw the activation of a profound inflammatory response accompanied by 50% overall response rates, and 83% clinical benefit rates. These will also include the first reported incidence of cytokine release syndrome associated with clinical response in multiple myeloma. The induction of cytokine release syndrome, which can be effectively managed with well established therapies, highlights the ability of pelareorep profolic [indiscernible]combination treatments to induce robust immune cell activation and tumor lysis in multiple myeloma patients. The compelling data seen here are even more noteworthy when considering that the trial was carried out in carfilzomib-refractory patients, who are notoriously just concentrates. Importantly when this recently announced data considered together with clinically reported trial results showing a dramatic increase in PD-L1 expression with pelareorep treatments, which strongly support the success of our ongoing clinical study evaluating pelareorep, trastuzumab and an immune checkpoint inhibitor therapy in multiple myeloma. Finally, before I hand off the call to Andrew to elaborate on our PD-L first, I'd like to give a brief update on our work with GI cancers. As in breast cancer multiple myeloma, we have compelling clinical data from our GI malignancies, demonstrating pelareorep’s potential to synergistically increase the effectiveness of immune checkpoint inhibitors. This includes data represented at ASCO from a trial evaluating pelareorep, Keytruda combination therapy in second-line pancreatic cancer patients. These data show that the therapy was well tolerated and resulted in tumor-specific replication, high degree T Cell repertoire turnover, and the creation of new T cell clones in the peripheral blood with these patients. Looking ahead, these recently reported results as well as the robust set of clinical data showing pelareorep stability to prime immune system across several types of GI cancers. Notably, this data itself is driving some very interesting discussions around potential industry and academic collaboration that may complement our existing relationships quite nicely. Now that you have some more of these, more about these exciting collaborations and other ongoing BD efforts, I'll hand the call over to Andrew.