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Good afternoon, and welcome to Oncolytics Biotech's First Quarter 2022 Conference Call. [Operator Instructions] 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 the company's 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 the company's current, pending clinical trials and anticipated timing of the release of 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 these 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 the 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 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 and 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 7 clinical updates on pelareorep or pela, as I'll refer to it, from 5 different clinical trials. Each of these updates has added to a robust clinical data set demonstrating pela's anticancer activity, immunological mechanism of action and favorable safety profile. Alongside these clinical achievements, we published compelling preclinical data in 2 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 in 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 the 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 development and other indications and geographies. We believe this strategy nicely aligns with pelareorep's pharmacological profile as its clinically demonstrated ability to stimulate anticancer immunity and weakened 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 therapeutic classes. This hypothesis has been repeatedly supported by clinical and preclinical data showing pela synergy with anticancer therapies, such as checkpoint inhibitors and CAR-T cells. By successfully executing our strategy, we have been able to maintain a strong cash position and report positive clinical updates in breast, pancreatic, colorectal, neurological and hematological cancer since the start of the year, all while keeping our lead program on schedule and advancing towards what we believe will be the crucial inflection point for the company. Long-term, we plan to continue executing the strategy by building upon existing partnerships with lead academic institutions and companies such as Pfizer, Roche, Merck Serono, Incyte, BMS and Adlai Nortye with the goal of building towards a late-stage pipeline that provides shots on goal in multiple indications. This will allow us to preserve our primary focus, resources and upside in breast cancer, while minimizing shareholder dilution and the risk of binary events in late-stage clinical trials. With that high-level overview completed, I'll recommend that anyone interested in reading more about our Q1 accomplishments, take a look at the most recent letter to shareholders posted on our website. And now I will hand it off to Tom to discuss our recent accomplishments in more depth. Please go ahead, Tom.
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-1's first 2 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 2 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 evaluable 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 evaluable patients who received pelareorep in combination with atezolizumab were classified as Luminal A by 21 days following treatment. Collectively, we believe these are very exciting results. They show that pelareorep drives changes in the tumor that leave patients more likely to benefit from therapy and less likely to see their cancer return following an initial positive clinical outcome. Also included in the ESMO poster were data showing statistically significant post-treatment increases in markers of tumor cell death and T cell activation, which further define the molecular mechanisms by which pelareorep delivers the exciting prognostic results I just mentioned as well as the clinical benefits we observed in earlier breast cancer studies. When viewed alongside the previously reported results from the very successful AWARE-1 study, these latest data add to a clear and compelling picture of pelareorep's multifaceted mechanism of action that explain its ability to offer clinical benefit in multiple indications and in combination with a wide variety of therapeutic partners. As you may recall, the previously reported results included pelareorep's ability to remodel the tumor microenvironment by upregulating PD-L1 expression and its ability to promote the generation, expansion and tumor infiltration of anticancer CD8-positive T cells. These effects were enhanced when checkpoint inhibition was added to the therapeutic regimen. The prior data also identified changes in peripheral blood T cell populations that may serve as potential biomarkers to identify patients most likely to respond to pelareorep treatment. Each of the immunologic effects observed in AWARE-1 serves to prime the immune system in its fight against cancer and improve the long-term survival of patients as evidenced by the prognostic classifications, which were improved following treatment as described in the ESMO poster. They are also linked to the successful achievement of AWARE-1 primary endpoint, a robust increase in CelTIL score. CelTIL score is another prognostic metric that's associated with improved overall progression-free survival in breast cancer patients. Taking a step back, I'd like to talk about how the AWARE-1 results fit within the broader data set supporting our lead HR+/HER2- breast cancer program and what they mean for the program going forward. They also have important implications beyond just breast cancer, but I'll let Andrew and Matt speak to those later in the call. For those of you who may be new to the Oncolytics stories, our earlier trials included a Phase I monotherapy study that demonstrated pelareorep's single-agent anticancer activity in HR+/HER2- breast cancer and IND-213, a randomized Phase II trial that showed a statistically significant near doubling of median overall survival in this indication when pelareorep was combined with paclitaxel. I'd like to take a moment to emphasize the importance of the IND-213 findings as they provide clear clinical evidence of pelareorep's ability to improve survival in a study that enrolled nearly 60 HR+/HER2- breast cancer patients. Based largely on the strength of these results, we received Fast Track designation and the special protocol assessment from the FDA, which suggests the agency views IND-213 as one of the 2 well-controlled pivotal trials that are typically required to support a regulatory approval. As part of our strategic planning to advance pelareorep to a registrational study, we began discussing the IND-213 result with potential biopharma partners. These discussions were ultimately the impetus behind our decision to collaborate with Roche, Pfizer and Merck Serono to supplement the IND-213 results through the AWARE-1 and BRACELET-1 trials. By conducting these trials in collaboration with industry leaders, we've been able to work together on navigating the best path to a future registrational study and strengthen our business development outlook. As we have consistently stated on past earnings calls, AWARE-1 and BRACELET-1 were designed to support and expand upon the IND-213 results by exploring pelareorep's mechanism of action and evaluating its potential synergy with checkpoint blockade. In addition, the trials seek to identify a biomarker that can predict patient response to pelareorep therapy. Thanks to the AWARE-1 results, we can confidently say that the strategy we laid out after IND-213 has thus far been a success. With these results in hand, the next potential catalyst for our breast cancer program is BRACELET-1's anticipated top line data readout in Q4. With randomized cohorts evaluating paclitaxel monotherapy, paclitaxel plus pelareorep and paclitaxel plus pelareorep in combination with a checkpoint inhibitor, we aim to support the clinical benefits seen in IND-213 and determine if we can further improve upon this benefit by adding a checkpoint inhibitor to the treatment regimen. We view the completion of BRACELET-1 as the last major step on pelareorep's path to a registrational study and expect the data generated to inform the design of this future trial. Now I'd like to briefly mention data from 2 separate investigator-sponsored studies that were featured in poster presentations at the annual AACR meeting last month. These studies in 2 difficult indications, relapsed refractory myeloma and glioblastoma showed promising survival and biomarker data when pelareorep was combined with chemotherapy. These combinations also stimulated innate and adaptive immune responses, which form the basis for the observed clinical responses. The learnings gleaned from these studies will help fuel our business development efforts and accelerate our ongoing clinical programs. Lastly, I'd like to discuss a peer-reviewed paper recently published in Science Translational Medicine that evaluated pelareorep's ability to enhance the efficacy of CAR-T cells and enable their success in solid tumors. CAR-T cells are produced by removing natural T cells from a patient and genetically engineering them to include a receptor that is specific for an antigen expressed on cancer cells. This directs CAR-T cells to the site of the cancer where they mediate tumor cell death. Since our initial development, CAR-T cells have been a transformative therapy and have been shown to generate long-term cures in patients with leukemia, lymphoma and other blood-based cancers. Unfortunately, the benefits of CAR-T cells have thus far been limited to the comparatively small subset of cancer patients with hematologic malignancies and their inability to effectively treat solid tumors remains a longstanding problem. This is largely due to 3 challenges. First, the immunosuppressive microenvironment of solid tumors restricts CAR-T cell infiltration into tumors and diminishes their effectiveness. Second, CAR-T cells have limited perseverance, which hampers their anticancer activity. And lastly, the heterogeneous nature of solid tumors leads to antigen escape, which allows tumors to evade killing by leaving CAR-T cells with nothing to target. The result published in Science Translational Medicine show that the addition of pelareorep overcomes each of these challenges as it reverses immunosuppressive tumor microenvironment, increases CAR-T cell perseverance and prevents antigen escape by creating dual specific CAR-T cells that take advantage of pelareorep's ability to replicate within the tumor. These dual specific cells are directed against the tumor, both by their engineered receptor targeting its specified tumor antigen and by a separate receptor that targets pelareorep replicating within the tumor. By overcoming each of these challenges, pelareorep was able to drastically improve the persistence and efficacy of CAR-T cells in murine models of skin and brain cancer. When compared to treatment with either pelareorep or CAR-T cells alone, CAR-T cells loaded with pelareorep led to statistically significant survival benefits. When pelareorep loaded CAR-T cells were followed by an intravenous pelareorep boost, we saw a further enhancement in efficacy with tumor cures observed in more than 80% of treated mice in each model. If these findings are translated to the clinic, they could have a profound therapeutic impact and alter treatment paradigms across many indications. According to the U.S. National Cancer Institute, approximately 90% of cancer cases diagnosed in 2021 were solid tumors. While these patients are currently unable to benefit from CAR-T therapy, the preclinical data featured in Science Translational Medicine point to pelareorep as the key to unlocking the potential of this revolutionary treatment modality for these patients. We believe this provides an excellent opportunity for business development, which I'll now let Andrew discuss. Andrew?
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 $1 billion 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 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, 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 2 cohorts showed the study combination was well tolerated and did not lead to any new safety signals. As a reminder, the trial's second cohort evaluated the dosing regimen equivalent to what was administered in IND-213, while the third cohort's regimen is equivalent to the pelareorep paclitaxel cohort being evaluated in BRACELET-1. The bridging trial aims to accelerate Adlai's development of pelareorep by allowing them to incorporate data from IND-213 and BRACELET-1 to inform plans for a Phase III study designed to support registration of rapidly growing pharmaceutical markets. China alone recorded 416,000 cases of breast cancer in 2020, and our partnership with Adlai provides a valuable opportunity to expand pelareorep's commercial prospects into important international regions. The last safety update I'll discuss today come from GOBLET, our Phase I/II gastrointestinal cancer trial being conducted in collaboration with Roche. This trial is evaluating pelareorep in combination with PD-L1 inhibitor, atezolizumab, in patients with advanced or metastatic pancreatic, colorectal and anal cancers. The trial has seen rapid progress since the first patient was dosed last November. Each of its 2 safety runnings have been successfully completed with no safety concerns noted during independent reviews by the trial's Data Safety Monitoring Board or DSMB. Following these positive DSMB reviews and authorization from Germany's regulatory body, all of the trial's 4 cohorts are now cleared for full enrollment. With each of the safety updates I just mentioned and the data from the presentations at AACR, we have added to an impressive database demonstrating pelareorep's ability to combine with a myriad of leading anticancer agents without causing unacceptable toxicities. This has been shown across many indications, which supports the case for pelareorep to be developed as an immunotherapy backbone that can enhance the efficacy of other agents. Pelareorep's safety database has thus proven to be a strong selling point in our conversations with potential biopharma partners interested in harnessing its immunologic effects to maximize the commercial impact of their drugs and therapeutic candidates. Next, I'd like to talk about how we envision our BD efforts progressing, particularly as we head towards BRACELET-1's anticipated top line data readout. As data matures from BRACELET-1 and factoring in the data we've already generated for IND-213 and AWARE-1, we'll be able to better leverage the full suite of immunotherapeutic effects of pelareorep and find the most advantageous strategy for partnership. With that in mind, we plan to be methodical in our efforts to seek a global clinical and commercialization partnership as we move towards registration. Given the number of relationships we've established with leading biopharma companies, including some who have already expressed interest in the BRACELET-1 study, we hope to generate competitive attention between potential partners to ensure we reach the best deal possible for our shareholders. Beyond breast cancer, we plan to continue utilizing partnerships with academic and industry leaders to advance pelareorep-based combination therapies. As Matt mentioned, we believe the strategy aligns well with pelareorep's pharmacologic profile. Data from AWARE-1 and other clinical studies have demonstrated pelareorep is both an active immunotherapy and a versatile backbone therapy with the ability to activate anticancer immunity and remodel the tumor microenvironment. As a backbone therapy, pelareorep can increase the efficacy and addressable patient populations of a variety of therapeutic modalities. We have already begun to prove out this strategy with checkpoint inhibitors, which comprise a multibillion-dollar market despite [ less than ] 1 in 5 patients adequately responding to these therapies. As discussed earlier, we are now working to solve this problem with breast and GI cancers with our BRACELET-1 and GOBLET studies. To efficiently replicate this approach across other indications and drug classes, we aim to have partners who will share the responsibility for these development efforts. This will allow us to maximize our opportunities for value creation without deviating from our core focus on breast cancer. And with that, I'll now let Kirk proceed with a discussion of our financial results. Kirk?
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 BRACELET-1's top line results. Our operating expenses for the first quarter of 2022 were $2.6 million compared to $3.1 million 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 million 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 for where I see Oncolytics headed. Based on thoughtfully designed clinical studies highlighted by IND-213 and its supportive studies, we have established pela as a broadly safe immunotherapeutic agent 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 an adaptive antitumor immunity and remodel tumor microenvironments by promoting the infiltration of cancer flooding immune cells and upregulating PD-L1 expression. We also showed that we can enhance these effects with checkpoint blockade. All this has 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 are leveraging these relationships to advance a 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 ESMO World Congress on Gastrointestinal Cancer Meeting as well as BRACELET-1's anticipated top line data readout in Q4. With BRACELET-1's 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. It would also embolden 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 advance 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 to 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. It's the 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.
[Operator Instructions] Your first question comes from John Newman with Canaccord.
I just wondered if you could talk a bit about future plans for pelareorep's conjunction with CAR-T. So 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?
So what 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 preclinical environment as Professor Vile's work did 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 a number of clinical studies 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. It's 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 2 doses of pelareorep, which is negligible. But it would sell CAR-Ts 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 not for the ability to treat that solid tumor that pelareorep conveys. So the way we see it is we would want to get a 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.
[Operator Instructions] Your next question comes from Patrick Trucchio with H.C. Wainwright.
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 preclinicals 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 can potentially move this forward with some other partners, including the collaborators at Mayo because many of these CAR-Ts are well understood now in the clinic, especially the heme malignancy ones and because the tox profile around pela is well known. We're not sure if we would actually need to do higher organisms, say, cynomolgus monkeys or beagles 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 3 patients to 6 patients or a 3x3 design. So we might be able to forgo 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 it would not be necessary.
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 ReoGlio program, I mean, especially with the positive results that you guys presented for the long-term at AACR early last month. So can you kind of give us an update of like what is the next plan? Or what is like the next update for this? And that's all for me for today.
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 interest around the GBM work. The virus did seem to provide a survival advantage at the high dose as well as the 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 this space demonstrating that the buyers can be very effective in the GBM space and of course, our more recent work with CAR-T. This isn't on a critical path though in terms of what we would like to do in the clinic. Really the goal is to get the results out of BRACELET and starts that Phase III program in breast 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 2 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 getting that on a regulatory path.
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.