Good afternoon, and welcome to Oncolytics Biotech's First Quarter 2022 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 Mr. Jon Patton, Director of Investor Relations and Communications. Please go ahead.

Thank you, operator, and good afternoon to all listening. Earlier today, Oncolytics issued a press release providing recent operational highlights and financial results for the first quarter of 2022. A replay of today's call will be available on the Events and Presentations section of the Oncolytics website approximately 2 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 our business prospects and the development and commercialization of pelareorep, including statements regarding the company’s focus, strategy and objectives, company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic, design, aims and anticipated benefits of our current and pending clinical trials, and anticipated timing of the release of the additional data. 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 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 Oncolytics 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, 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 SEDAR and the SEC. Oncolytics does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. I'll now pass the call over off to Oncolytics, President and Chief Executive Officer, Dr. Matt Coffey. Please go ahead Matt.

Thank you, Jon, and good afternoon, everyone. It's my pleasure to be speaking with you all today about our recent accomplishments and outlook for the next several months. Now, in addition to Jon myself, you will also be hearing from Dr. Thomas Heineman, our Chief Medical Officer; Andrew de Guttadauro, our Global Head of Business Development; and Kirk Look, our Chief Financial Officer. 2022 has thus been a highly productive year for Oncolytics. We reported a total of seven clinical updates on pelareorep, or pela as I will refer to it from five different clinical trials. Each of these updates is added to a robust clinical data set demonstrating pela’s anti-cancer activity immunological mechanism of action and favorable safety profile. Alongside these clinical achievements, we published compelling preclinical data into high impact peer reviewed journals, bolstering our efforts to expand pela’s commercial potential through collaborations and partnerships. Most importantly, we also continue to expect BRACELET-1, our randomized Phase II trial and HR+/HER2- breast cancer to report top line data by year's end. We expect this readout to be our most important milestone this year as a successful outcome would strengthen our business development prospects and move us forward into a registrational study. Taking a broader view of this recent progress, we can see the advantages of our corporate strategy. This strategy has us internally focused on bringing our lead breast cancer program into a registrational study and leveraging partnerships and collaborations to generate additional value to pela’s developments and other indications and geographies. We believe this strategy nicely aligns with pelareorep’s pharmacological profile, as its clinically demonstrated ability to stimulate anti-cancer immunity and weaken tumor defense mechanisms, positions it as an attractive immuno-oncology product in its own right, as well as the ideal combination partner for a wide array of…

Thanks, Matt. I'll begin by discussing some very interesting biomarker data from our AWARE-1 trial that were just announced yesterday in a poster at the ESMO breast cancer meeting and will then provide some context on how they support our lead programs advancement to a registrational study. These data are from AWARE-1s first two cohorts, which enrolled patients with early stage HR+/HER2- breast cancer. The subtype we plan to examine in a future registrational study. Patients in these cohorts were treated with pelareorep and letrozole with or without the checkpoint inhibitor atezolizumab, tumor samples were collected from patients both pre and post treatment. Gene and protein expression assays run on these samples demonstrated pelareorep's immunologic mechanism of action and its synergy with checkpoint inhibitors. Notably, they provided strong evidence of pelareorep's ability to deliver durable clinical benefits to HR+/HER2- breast cancer patients. This evidence came from two well established prognostic assessments based on PAM50 gene panel analysis. The first of these was the risk of recurrence score, which uses tumor gene expression profiling to assess the likelihood of a patient relapsing after an initial clinical response to therapy. The results showed that all valuable patients had a risk of recurrence score classified as low after treatment, while only 55% of patients had a low score prior to receiving the pelareorep-based therapy. The second prognostic metric featured in the ESMO breast cancer poster uses gene expression profiles to classify tumors into distinct molecular subtypes. Testing of pre and post treatment samples demonstrated that most tumors converted from the aggressive Luminal B subtype to the Luminal A subtype which is associated with improved clinical outcomes. In fact, all tumors from a valuable patients who receive pelareorep in combination with the atezolizumab were classified as Luminal A by 21 days following treatment. Collectively,…

Thank you, Tom, and good afternoon, everyone. From a BD perspective, we are very excited by the preclinical results presented in Science Translational Medicine, despite only being approved for a subset of cancer patients with hematologic malignancies. CAR T therapies generated more than a billion dollars in sales last year. pelareorep's potential to enable CAR T success in solid tumors therefore, represents an opportunity to greatly expand what is an already large market. To pursue this opportunity, we plan on using our preclinical data to engage with partners who are interested in licensing pelareorep and leading its development as an enabling technology for CAR T therapies. Having a partner assume the cost and development responsibilities here will allow us to participate in the upside of this lucrative CAR T commercial opportunity with minimal risk, and a continued focus on our current clinical programs in breast and other cancers. I'd like to mention the ongoing bridging clinical trial being conducted by our partner ally Adlai Nortye, who is working to develop and commercialize pelareorep in China and other Asian territories. This trial evaluates pelareorep, Paclitaxel, combination therapy in Chinese breast cancer patients. The trial recently advanced into its third and final dose escalation cohort after data from the first two cohorts showed the study combination was well tolerated and did not lead to any new safety signals. As a reminder, the trial second cohort evaluated a dosing regimen equivalent to what was administered in IND-213. While the third cohort regimen is equivalent to the pelareorep Paclitaxel cohort being evaluated in BRACELET-1. The bridging trial aims to accelerate Adali's development of pelareorep by allowing them to incorporate data from IND-213 and BRACELET-1 to inform plans for Phase-III studies designed for registration rapidly growing pharmaceutical markets. China alone recorded 416,000 cases of breast…

Thank you, Andrew. I'm happy to report that Oncolytics continues to be in a strong financial position, with cash and cash equivalents of 39.5 million as of March 31, 2022, compared to 41.3 million as of December 31, 2021. Based on our current projections, our existing financial resources leave us well capitalized into 2023. This is expected to provide runway through multiple clinical data readouts, including the upcoming announcement of BARCELET-1s top-line results. Our operating expenses for the first quarter of 2022 were $2.6 million, compared to 3.1 in the first quarter of 2021. This change was mainly due to lower investor relations activities and associated expenses. Now research and development expenses for the first quarter of 2022 were 3.7 million compared to 2.8 for the same period last year. This increase was due to the progression of the GOBLET study -- the completion of a product fill, higher manufacturing related process development activities and a higher compensation expense in support of our expanded clinical program. The net loss for the first quarter of 2022 was 6.8 million compared to 6.4 million for the first quarter of 2021. Equating to a net loss of $0.12 per share for the first quarter of 2022 and $0.13 per share for the first quarter of 2021. With that, I will now pass the call back to Matt for some concluding remarks, Matt?

Thanks, Kirk. Let me conclude by expressing my enthusiasm where I see Oncolytics headed. Thanks to thoughtfully designed clinical studies highlighted by IND-213 and it's supportive studies. We have established pela as a broader face of immunotherapeutic agents and demonstrated its ability to deliver a statistically significant and clinically meaningful survival benefit to breast cancer patients in a well-controlled randomized clinical trial. We have thoroughly characterized its immunological effects, including its ability to awaken innate and adaptive anti-tumor immunity and remodel tumor microenvironment by promoting the infiltration of cancer fighting immune cells and upregulating PD-L1 expression. We also showed that we can enhance these effects with checkpoint blockade. All this is clearly differentiated pela from competing agents. It has also strongly piqued the interest of thought leaders across industry and academia, allowing us to establish valuable relationships. We're leveraging these relationships to adapt the diverse pipeline and expect to achieve multiple clinical milestones by the end of the year. These include anticipated updates from the GOBLET study at the upcoming ESMA World Congress on gastrointestinal cancer meeting, as well as BRACELET-1 anticipated a top-line data readout in Q4. With BRACELET-1 upcoming readout, we are aiming to propel our lead program into a registrational study, while providing the necessary proof of concept for our broader clinical development strategy. A positive outcome in BRACELET-1 will establish the role of pela as an emerging immunotherapy and will likely bode well for a program like GOBLET, which is yet another example of a collaboration with an industry leader. We'd also emboldened our efforts to expand pela's therapeutic impact through partnerships that seek to develop it as a backbone of combination therapies and additional indications. As we adapt pela's development, we will continue to dedicate our primary focus and resources to our breast cancer program along with GI cancers through the GOBLET study. We believe this capital efficient approach represents the best strategy to maximize shareholder value, as we work to bring pela to cancer patients in urgent need of novel therapies. Finally, I'd like to briefly thank all those responsible for bringing Oncolytics where it is today starting with our shareholders, we greatly value your support, which is what makes our fight against cancer possible. I also need to extend my gratitude to our employees, partners and collaborators who have enabled an impressive collection of data highlighting pela's wide ranging therapeutic benefits. Lastly, and most importantly, I want to thank the patients who have participated in our clinical trials and their families. Its desire to improve the lives of patients that serves as the driving force behind all the work we are doing as a company. With that, I'll ask the operator to open it up for questions.

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] Your first question comes from John Newman with Canaccord. Please go ahead.

Hi, guys. Thanks very much for taking my question. I just wondered if you could talk a bit about future plans for pelareorep conjunction with CAR T. You've recently published some interesting information regarding loading CAR T cells with pelareorep. And I'm wondering if you could discuss potential future clinical plans there. Thanks.

Hey, John, how are you?

Good. Thank you.

So what's sort of transpired since this has become public, Andrew has been able to negotiate a number of MTAs and a number of companies are looking to see whether their constructs behave as well in a pre-clinical environment as Professor Vile worked at Mayo. As you know, various companies have various CAR T targeting various moieties. So what they want to be able to do is basically emulate the work that Dr. Vile had done. And then I think we could be looking at getting into number of clinical studies very, very quickly. Andrew, do you want to talk a little bit about the commercial strategy around the CAR T and how we see a way forward with this?

Yes. Obviously, something we don't want to develop organically. We're focusing on breast first and last and foremost, right now. So and the reason for that part is, if you read the paper, essentially, you have a prime and a boost dose of pelareorep. So it only sells each CAR T treatment would only sell two doses of pelareorep, which is negligible. But it would sell CAR T that go on the order of $400,000 to $500,000 a year. So we see the value for us financially being in getting a piece of the actual sale of that CAR T that would not be sold, were it not for the ability to treat that solid tumor that pelareorep conveys. So the way we see it is, we would want to get reasonable upfront, I won't go into what those numbers are, but it has to be something we feel comfortable with, some development milestone payments, and then when the product is approved, a certain percentage of each sale of a CAR T treatment.

Okay, great. Thank you.

[Operator Instructions] Your next question comes from Patrick Trucchio with HC Wainwright. Please go ahead.

Hi. Good afternoon. This is Jason on for Patrick. And I guess my first question is also just around the CAR T kind of building off the previous question. And what I'm wondering is, are there any plans in terms of moving into higher or larger organism for preclinical and kind of like producing for IND enabling studies?

That is ultimately the goal. What we'd like to do is work with these various partners in their preclinical model. It's interesting, we've discussed, how we potentially move this forward with some other partners, including the collaborators that may because so many of these CAR Ts are well understood now in the clinic, especially the [indiscernible] malignancy ones. And because the talks profile around pela's is well known. We're not sure if we would actually need to do higher organisms, stateside analogous monkeys or bagels or what have you, what we may be able to do is what we've done with the initial work done in checkpoint blockade, where we just run a safety run-in in three to six patients are a three-by-three design. So we might be able to forego any additional animal testing required to get into the clinic and that's generally the thinking we'll have that conversation, or our partners will have that conversation with the agency. But our current thinking is that would not be necessary.

Okay, great. Yes. That's really helpful to know. And then just one more question, if I may. So I know there wasn't any update today in terms of the [indiscernible] program, and especially with the positive results that you guys presented for the long-term at ACR early last month. So can you kind of give us an update of like, what is the next plan or like what is like the next update for this? And that's all for me for today. Thank you.

It's interesting, the emerging data that we're getting especially AWARE, and we anticipate, if the science holds, we should expect similar outcomes with BRACELET and GOBLET. There was a lot of interests around the GBM work, the virus did seem to provide a survival advantage at the high dose, as well as a PFS advantage at the high dose. Where we think this is likely to go is with the addition of checkpoint blockade. We actually have a number of animal models and publications in the space demonstrating that the virus can be very effective in the GBM space, and, of course, our more recent work with CAR T. This isn't on our critical path, though, in terms of what we would like to do in the clinic that really the goal is to get the results out of BRACELET and start that Phase-III three program in breasts in the context of a partner. We also believe that GOBLET could potentially lead to a second route to a registration study, allowing us to avoid any binary events in that Phase-III setting by running two different programs. What we think is very attractive though is, if we do partner with a company that has checkpoint blockade, in terms of their development path and lifecycle management, I think we've demonstrated very effectively that the virus can be used synergistically in GBM. And I think the next logical step would really be exploring that in the context of either CAR T checkpoint blockade and then that on a regulatory path.

Okay, great. Thank you so much.

There are no further questions at this time. Please proceed.

Again, I just want to thank everyone for taking the time to listen to our quarterly updates and I'd like to thank everyone for their questions. Have a lovely day.

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines. Have a great day.