Oncolytics Biotech Inc.

Good morning and welcome to Oncolytics Biotech's third quarter 2022 conference call. All participants are now in the 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. And I would like to turn the call over to John Patton, Director of Investor Relations and Communications. Please go ahead, sir.

Thank you, Operator, and good morning, everyone. Earlier this morning, Onclytics issued two press releases, one announcing interim results from the pancreatic cancer cohort of the company's Phase 1-2 goblet trial, and a second providing recent operational highlights and financial results for the third quarter of 2022. The announcements and highlights provided in these press releases will be the topics of today's call. A replay of which 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 Pelleria Rep, including statements regarding the company's focus, strategy, and objectives, the company's belief as to the potential and mode of action of Pelleria 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 potential registrational studies, the 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 being 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 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 other factors detailed in the company's filings with CDAR and the SEC. Oncolitics does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Speaking on today's call will be Oncolitics Chief Executive Officer, Dr. Matt Coffey, Chief Medical Officer, Dr. Tom Heinemann, Global Head of Business Development, Andrea DiGuttadaro, and Chief Financial Officer, Kirk Look. With that, I'll now turn the call over to Matt. Please go ahead.

Thank you, John, and good morning to all who have joined us today. I'll begin by getting right to the exciting news reported earlier this morning, which came when an abstract with interim data from our GOBLET trial was published as part of the CITSE annual meeting. These data showed an objective response rate, or ORR, of 70% in 10 valuable pancreatic cancer patients treated with a combination of Helirep, the checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nabpaclitaxel. This ORR is nearly three times greater than the average ORR seen in historical control trials, which is about 25%. These remarkable results have brought our pancreatic cancer program to a pivotal trial readiness, as we are now planning to advance Pella Rea Rep, or Pella as we'll refer to it, into a registrational study for this indication pending discussions with regulatory authorities. With our pancreatic cancer program now representing a second near-term registrational opportunity to go alongside our breast cancer program, we believe we have transformed Pella's value proposition and are at a true inflection point in the company's history. We arrived here guided by a clear strategic focus and commitment to data-driven approach that had us collaborating with industry leaders to selectively pursue therapeutic opportunities beyond our lead program. This approach enables us to keep our efforts in breast cancer on track while simultaneously building a robust proof of concept data set in pancreatic cancer. We now have two pillars upon which we can build our registration program going forward. With regards to our breast cancer program, we are increasingly enthusiastic about its prospects and upcoming milestones. Chief among these potential value drivers will be the disclosure of an expansive data set from bracelet one at a major medical meeting in the first half of next year. As a reminder, Bracelet 1 is a randomized phase 2 trial in HR-positive HER2-negative metastatic breast cancer. It includes cohorts evaluating paclitaxel monotherapy, paclitaxel plus Pella, and paclitaxel plus Pella in combination with a PD-L1 checkpoint inhibitor. Those of you familiar with Oncolytics have likely heard me refer to Bracelet 1 as Pella's last major step on its path to a registrational breast cancer study. The data generated by bracelet 1 are expected to inform the design of a pivotal trial while simultaneously validating our prior data in HR-positive HER2-negative breast cancer, which provides a robust foundation for the program. These include the results of the randomized phase 2 trial in IND213, which showed a statistically significant near doubling of overall survival in HR-positive HER2-negative breast cancer patients treated with Pella combined with Paclitaxel versus those treated with Paclitaxel alone. These data showing Pella's ability to drive a meaningful clinical benefit contributed to a special protocol assessment from the FDA, which means IND213 counts as one of the two pivotal studies required for approval. Additional data forming the foundation of our HR-positive HER2-negative breast cancer program include Phase I results demonstrating Pella's single-agent activity, as well as results from AWARE-1 trial demonstrating and characterizing its immunological mechanism of action. Prior to reporting Bracelet 1's findings, we also expect to report additional data from Wear 1, as well as the results of our Chinese partner, Adelaide Norte's bridging trial in HR-positive HER2-negative breast cancer. Both of these announcements are expected later this quarter. As we move forward in 2023 and beyond, we will aim to replicate our recent success by maintaining a core focus on our near-term registration opportunities in HR-positive HER2-negative breast cancer and pancreatic cancer, while selectively exploring additional indications, primarily through partnerships or collaborations. Our team is engaging with regulators and seeking regulatory input on the registration program for breast cancer, which we expect to be able to discuss in more detail in the first half of 2023, as breast cancer will remain a crucial part of Oncolytic's story and a value proposition going forward. We believe we are closing in on our goal of delivering treatments that improve the lives of cancer patients and are excited for what's ahead. Having completed that high-level overview of HR-positive HER2-negative breast cancer and pancreatic cancer, two programs we expected to primarily focus on going forward, let me hand the call over to Tom to provide some more insights on the new pancreatic cancer data. And after that, Andrew will dig into what this means for our business development. Tom?

Thanks, Matt. It's my pleasure to have the chance to discuss our new pancreatic cancer data, which, as Matt mentioned, were published in an abstract earlier today as part of the CITSE annual meeting. These data come from Goblet, a multi-indication phase 1-2 trial we are conducting in collaboration with Roche and AIO, which is an academic cooperative medical oncology group in Germany. The results published at CITSE are from the trial's first cohort that enrolled patients with first-line advanced or metastatic pancreatic cancer. Patients in this cohort received Pella in combination with atezolizumab and standard-of-care chemotherapy, gemcitabine and nabpaclitaxel. As of the abstract's July 28 cutoff date, seven of 10 of valuable patients in this cohort had achieved a partial response per resist criteria with two more achieving stable disease. This gave an objective response rate and clinical benefit rate of 70% and 90% respectively. We believe these results are striking and they markedly exceeded our expectations going into the study. For context, The pre-specified success criterion for efficacy in stage 1 of GOBLET's pancreatic cancer cohort was three objective responses in 12 evaluable patients. This landmark was actually achieved with the first three evaluable pancreatic cancer patients, and as of the CITSE abstracts cutoff date, we have more than doubled this initial goal in only the first 10 evaluable patients. Historical data from trials evaluating the combination of gemcitabine and nabpaclitaxel showed an average objective response rate of only about 25%, almost three times less than the objective response rate reported in our CITC abstract. Prior studies also showed that checkpoint inhibitors are unable to benefit the vast majority of pancreatic cancer patients as these agents only improve outcomes in persons classified as MSI-high. Unfortunately, MSI-high patients represent less than 1% of the total pancreatic cancer population. Given the limited efficacy observed in each of these aforementioned historical settings, Goblet's interim results strongly suggest that Pella synergistically combines with checkpoint inhibitors and chemotherapy to drive tumor responses in pancreatic cancer. This is noteworthy, as objective response rate is known to correlate with survival, and has even been used as a registrational endpoint in certain oncology indications. Moreover, prior clinical data in pancreatic and other cancers have demonstrated Pella's ability to activate an anti-cancer immune response and reverse the immunosuppressive microenvironments that limit the efficacy of checkpoint inhibitors. These earlier results collectively provide strong mechanistic support for Goblet's interim results increasing our enthusiasm for the pancreatic cancer program. Looking ahead for this program, we plan to discuss our results with regulators with the goal of enabling advancement into a registrational study rather than into Goblet's optional stage two expansion phase. We believe this approach represents the best strategy to address the urgent needs of pancreatic cancer patients given both the strength of our data and the limited efficacy of currently available therapies. Lastly, before handing it off to Andrew, I wanted to briefly preview our upcoming poster presentation at CIPSE later this week. The poster will include updated data from Stage 1 of Goblet's Pancreatic Cancer Cohort, which was designed to enroll a total of 12 evaluable patients versus the first 10 reported in the abstract today. These updated results will also be discussed during a virtual KOL event a week from today on Monday, November 14th which will give viewers the opportunity to hear expert commentary from three key opinion leaders on our data and on the current pancreatic cancer treatment landscape. It will also include a question and answer session and I highly encourage all listening now to join us next week using the link available on the events and presentations section of our website. I'll now turn it over to Andrew to discuss how our recent clinical results are driving our business development efforts and corporate strategy. Andrew?

Thanks, Tom. We are in the midst of a very exciting time for Oncolytics BD team as our recent data in pancreatic cancer have substantially enhanced Pella's potential licensing value proposition. Given the pancreatic readout and our existing clinical data set in breast cancer, we can now offer potential partners two near-term registration opportunities that we believe have a high likelihood of technical and regulatory success. Further, first-line metastatic pancreatic cancer and HR-positive HER2 breast cancer represent two highly attractive market opportunities, which I'll discuss in more detail now. Looking first at HR-positive HER2-negative breast cancer, estimates indicate that there will be approximately 300,000 drug-treatable cases in the U.S., major European markets in Japan by 2028. And despite the limited benefits current therapies can provide, drug sales in the HR-positive HER2-negative breast cancer subtype are expected to grow from 11 billion in 2020 to 31 billion by 2030. Thanks to IND213's results, we already have a randomized data set demonstrating Pella's ability to improve patient outcomes in this indication, and that will count as one of the two trials required by the FDA for registration. With Bracelet 1's upcoming readout, we aim to validate this finding with a second randomized data set which we believe would leave Pella well-positioned to capture a substantial portion of this market following a subsequent registrational study and potential approval. Turning our attention to pancreatic cancer, estimates indicate that there will be approximately 135,000 metastatic first-line drug-treatable cases in the U.S. major European markets in Japan by 2028. This represents the patient population being valued in our goblet trial. Beyond its prevalence, another aspect of pancreatic cancer that makes it valuable commercial and partnering opportunity is the significant unmet need and lack of past successful innovation in this indication. Pancreatic cancer patients are typically treated with regimens composed of older chemotherapeutic agents, such as gemcitabine and napaclitaxel. Unfortunately, only about one in four patients will respond to these regimens, and those that do respond see only modest survival benefits. For example, the combination of gemcitabine and napaclitaxel resulted in a median overall survival of less than nine months in a randomized phase III trial of over 860 metastatic pancreatic cancer patients. Despite the best efforts of researchers across academia, biotech, and pharma, these older, minimally effective treatment regimens currently remain the best option for the overwhelming majority of pancreatic cancer patients. Even PD-1 and PD-L1 checkpoint inhibitors, which have revolutionized the treatment of numerous cancers, are unable to effectively treat the 99% of pancreatic cancer patients who are not classified as MSI-high. Taking all this into consideration, one can appreciate the significance of our goblet data, which suggests Pella may be the key to unlocking the potential of checkpoint inhibitors in pancreatic cancer. Therefore, we believe Pella's successful development could transform the standard of care in this syndication. opening up a large new market opportunity and leading to drastically improved clinical outcomes for patients. To enable our efforts in pancreatic and breast cancer, our BD team is focused on securing a global clinical and commercialization partnership with a leading biopharma company. As we work towards this goal, we are fortunate to have established relationships with several industry leaders, including Pfizer, Roche, Merck-Sorono, Bristol-Myers Squibb, and Insight. collaborative trials with these major players have allowed each to become intimately familiar with Pella, which we believe will serve us well in any partnering discussion. While we can't predict the timing of any potential partnership, we will be thoughtful and diligent as we seek to achieve the best possible outcome for Oncolytics and its shareholders. Our plan is to pursue a single licensing deal for both of our breast cancer and pancreatic cancer programs that allows us to minimize our clinical and commercial risk, while providing upside through upfront payments, milestones, and royalties. By leveraging our current and maturing data from the IMD 213, Price at One, and Goblet trials, we intend to create competition among potential partners and drive continued interest. Given the clinical data we have generated and the attractive commercial opportunities offered by our breast and pancreatic cancer programs, we believe we are ideally positioned to execute on our BD objectives. We plan to provide additional updates as appropriate and look forward to moving forward with Pello's newly enhanced value proposition. Next, I'll turn the call over to Kirk to discuss our Q3 financial results.

Kirk? Thanks, Andrew. I'm pleased to say that Oncolytics continues to operate on a sound financial foundation with an anticipated cash runway beyond 12 months and through several important milestones based on our current projections. These milestones most notably include a readout on overall response rate, progression-free survival, and evolving overall survival data from bracelet one, which is expected in the first half of next year. Turning to our financial results, OncoDex finished the third quarter of 2022 with $32.4 million in cash and cash equivalents, compared to $41.3 million in cash and cash equivalents as of December 31, 2021. Now, general and administrative expenses for the third quarter of 2022 were 2.4 million compared to 2.9 million in the third quarter of 2021. This change was mainly due to lower investor relations activities as the current global business conditions have negatively impacted market sentiment for the biotech industry and the overall markets. Research and development expenses for the third quarter of 2022 were $3.7 million compared to 3.3 in the third quarter of 2021. This change was mainly due to our clinical development program primarily from a net increase in our clinical study costs. Compared to the third quarter of 2021, we saw higher goblet patient enrollment and sample analysis activities this quarter. This increase was offset by lower bracelet one patient costs as bracelet entered into the retreatment and follow-up phase upon reaching full enrollment at the end of the last quarter. The net loss for the third quarter of 2022 was 4.4 million compared to 4.9 million for the third quarter of 2021. This equates to a net loss of $0.08 per share for the third quarter of 2022 and $0.09 per share for the third quarter of 2021. Now, with that review of our third quarter financial results complete, I'll turn the call back over to Matt. Matt?

Thanks, Kirk. Before providing some brief closing remarks, I wanted to take a moment to recognize the recent appointment of Jonathan Rigby to our Board of Directors. Jonathan is a seasoned industry veteran with over 30 years of experience in the pharmaceutical and biotech sectors. He currently serves as the group's CEO of Revolo Biotherapeutics and was a co-founder of Zogenics, Inc., which was acquired by UCB earlier this year in a transaction valued up to approximately $1.9 billion U.S. dollars. We are confident that Jonathan's extensive commercial and business development expertise will be invaluable as we enter the next phase of our corporate evolution propelled by the new data from Goblet's Pancreatic Cancer Cohort. These data have added a second near-term registration opportunity to our pipeline, allowing us to de-risk our binary events in pivotal trials and improve our position as we pursue potential partnering discussions. Taking a step back, we can also appreciate how Goblet's data validate our overreaching clinical development strategy. The strategy seeks to leverage this Pella's multifaceted mechanism of action to address one of the longest standing problems in oncology, namely the inability of immune cells to recognize, infiltrate, and destroy tumors. In past earning calls, you've heard me speak about how data from trials such as WHERE1 demonstrated Pella's ability to generate immune cells that recognize and kill tumors while simultaneously remodeling tumor microenvironments to promote immune cell infiltration. This positions Pella as a platform molecule that can synergistically enhance the efficacy of a broad range of drug classes such as checkpoint inhibitors, chemotherapy, or CAR-T cells, enabling it to potentially improve the therapeutic outcomes in a wide range of indications. Moving forward, our near-term registration opportunities in breast and pancreatic cancer will be our primary focus, while efforts beyond these programs will be enabled predominantly through partnership or collaboration. This approach will allow us to operate with capital efficiency as we seek to further unlock Pella's expansive therapeutic potential. Finally, before opening up the call for Q&A, I just wanted to reiterate my excitement for where OncoLit exists today and thank all those who have brought us to this point. I'll start first and foremost with our clinical trial participants who remain a key source of inspiration for the company. I'll also express my gratitude for the support of our shareholders and the amazing work done by our employees, collaborators, and investigators. It's their contributions that allow us to advance Pella's development and pursue our mission of improving the lives of cancer patients. With that, we will begin the Q&A session. Operator?

Thank you, sir. Ladies and gentlemen, if you would like to ask a question, please press star followed by 1 on your touchtone phone. You will then hear a three-tone prompt acknowledging your request. And if you would like to withdraw your question from the queue, please press star 2. And if you're using a speakerphone, we do ask that you please lift the hands up before pressing any keys. Please go ahead and press star 1 now if you have any questions. And your first question will be from John Newman at Canaccord. Please go ahead.

Hi, guys. Good morning. Really interesting goblet data here. Just had a couple questions. Just curious, in terms of the next steps here going forward, what might a registration study look like, just roughly speaking in terms of clinical design? I'm just wondering if it would be sort of chemotherapy plus checkpoints plus or minus Pelleria rep or if maybe there's sort of some different designs and considerations that you've thought about over time here. Thanks.

Thanks very much for the question. This is something we've obviously debated quite a bit and we'll provide more color on during the KOL presentation next week. I'd like to remind everyone that we are hosting a KOL call. a week from today where that's exactly the type of question we'll be getting into. Tom, could you maybe provide a 10,000-foot sort of look at what we've generally discussed in terms of an adaptive design or a Phase 2-3 program, roughly what those numbers look like? Obviously, there's a number of stakeholders involved in this decision and what the ultimate study design will look like. I think Tom can give you an idea of what our general thoughts are. Tom, would you mind providing a little bit of color?

Yeah, sure. So as Matt said, there are a number of stakeholders and discussions that need to occur before we land on a formal final design. But our thinking now is running toward a phase 2-3 type of design in which we would have a two-arm study comparing standard of care to standard of care plus Pellerea rep plus a checkpoint inhibitor, just as in the goblet study. And when I say a 2-3 design, that would mean that we would have a look at the data at some appropriate time point with the endpoint trigger to determine whether or not we move on to the study based on the progress of the patients up to that time point. Now, this sort of design is not uncommon. And the goal is to allow a seamless progression towards completion of a licensure-enabling study while maintaining an appropriate risk level during the conduct of that study.

Interesting. Okay, great. We'll certainly have more questions at the KOL event next week. Thank you.

Thank you. Once again, ladies and gentlemen, if you would like to ask a question at this time, please press star followed by one on your touchstone phone.

And at this time, gentlemen, we have no further questions.

Please proceed with your closing.

Thanks to all who joined today to hear about our recent clinical data and progress. Before we go, I'll remind everyone that we're hosting a virtual KOL event a week from today to provide expert perspective on the extended pancreatic data being presented at CITSE. Those interested can find a link to the event on the events and presentations section of our website. Thanks again. Have a great day.

Thank you, sir. Ladies and gentlemen, this does indeed conclude your conference call for today. Once again, thank you for attending. And at this time, we ask that you please disconnect your lines.