Good afternoon, and welcome to Oncolytics Biotech's Fourth Quarter and Full Year 2023 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 Jon Patton, Director of Investor Relations and Communications. Please go ahead.

Thank you, operator, and good afternoon, everyone. Earlier today, Oncolytics issued a press release providing recent operational highlights and financial results for the fourth quarter and full year of 2023. A replay of today's call will be available on the Events section of the Oncolytics' 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 pelareorep, including statements regarding the company's mission, strategy and objectives, company's belief as to the potential mechanism of action and benefits of pelareorep as a cancer therapeutic our clinical development plans for 2024, including initiation of our first registrational studies for pelareorep, manufacturing program, our cash runway, 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, there can be no assurance that these statements or expectation or belief will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial protections, actions by regulatory agencies and those other factors detailed in this 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. Oncolytics management team is on the call today to review our fourth quarter 2023 and year-end results, including Chief Executive Officer, Dr. Matt Coffey; Chief Financial Officer, Kirk Look; Chief Medical Officer, Dr. Tom Heineman; and Vice President, Product Development, Allison Hagerman. Now, I'll turn the call over to Dr. Coffey. Matt?

Thank you, Jon. Good afternoon, and welcome to the Oncolytics Biotech fourth quarter conference call. 2024 marks the year that Oncolytics will become a late-stage cancer company with the initiation of our first registrational studies for our proprietary immunotherapeutic product candidate pelareorep or pela as we'll refer to it. This brings us closer to achieving our mission of improving the lives of patients with cancer, so we'll begin the year with significant enthusiasm. The transition to becoming a late-stage biopharma company reflects significant progress in positive clinical and translational data reported from our clinical programs in 2023. A key element of this transition is making smart investments in manufacturing, which is why Allison Hagerman will join us to talk about the steps we're taking, so Oncolytics is set up for success as pela moves closer to beginning registrational trials. During our call today, we would like to share some of the key highlights from the last several months, outline our clinical and strategic objectives for 2024, included in manufacturing, review our financial results for the fourth quarter and full year 2023, and take your questions. Positive clinical and translational data helped close 2023 on a high note. Starting with our clinical results, we reported positive clinical data from three cohorts in the Phase 1/2 GOBLET study in pancreatic cancer, colorectal cancer, and anal cancer. Each indication has achieved the predefined "Stage 1 success criteria" defined according to the Simon two-stage study design. In addition, data from the pancreatic and anal cancer cohorts demonstrated response rates that were nearly 3x greater than published historical controls. Positive clinical results were supported by valuable translational data from further analysis of the AWARE-1 breast cancer study and from cohorts in the GOBLET study. These data underscore pela's mechanism of action as an immunotherapeutic agent.…

Thanks, Matt. During today's call, I'd like to provide a snapshot of the key features of pela and an update on our ongoing clinical programs. Pela is administered intravenously, which allows it to work systemically by selectively infecting tumor cells wherever they may be in the patient. Some tumor cells are killed directly by pela infection. In other cases, pela infection results in the accumulation of double stranded RNA in the cancer cells. This induces a proinflammatory response in the tumor microenvironment that primes the tumor for immunologic killing. Specifically, pela infection results in increased T cell infiltration into the tumor, expansion of tumor infiltrating lymphocytes, also known as TILs, and stimulation of both innate and adaptive immune responses. We can assess the immunotherapeutic action of pela through clinical effects such as changes in tumor size, time to disease progression, and overall survival; in addition, we can assess the immunologic effects of pela treatment by such measures as the expansion of TILs in the blood. Data demonstrating a positive correlation between clinical response and TIL expansion support the potential use of this measure as a biomarker in future clinical trials and during patient care. In 2023, Oncolytics provided important clinical and translational data from the BRACELET-1 study, from multiple GOBLET study cohorts and from the AWARE-1 study. Based on these results, I will take you through our clinical plan for 2024. As Matt indicated, this year we expect to provide guidance on our registrational plans for pela in breast cancer, initiate a registrational study of pela in pancreatic cancer, and report the overall survival results from the BRACELET-1 breast cancer study. In addition, we plan to initiate a new pancreatic cancer cohort in the GOBLET study. The new cohort will evaluate pela plus modified FOLFIRINOX with or without atezolizumab in…

Thanks, Tom. I'm excited to share the progress we've made over these past few months. As Matt and Tom have just shared, 2024 is poised to be a very important year for Oncolytics as we advance pela to registrational study readiness. A key element of this advance is the cornerstone investment we will be making in the pela product supply. Throughout my discussion, you will hear me use the word product, product supply, and supply chain. These are all industry terms related to manufacturing and are not intended to denote an FDA approved product. I will also use the term drug substance meaning purified bulk pelareorep material, the active pharmaceutical ingredient. Drug substance is used in the manufacture of drug products, the finished dosage form packaged for patient administration. Key takeaways from my section are we have a well-established product supply chain for pela, we have made numerous batches of material at increasing scale and pela has a long shelf life. We have been working with a high quality contract manufacturing organization for some time and we are investing in optimized manufacturing scale up and validation so that we are ready to support product registration. For a bit of background, pela drug substance is produced in a simple eight step process and stored in bulk at -80 degrees Celsius. Finished drug product can be stored at -80 or -20 degrees Celsius. Pela material has a long shelf life with ongoing drug substance stability out pass 10 years plus an established drug product expiration period of six years from date of product filling. Pela is made by our Contract Development and Manufacturing Organization or CDMO MilliporeSigma SAFC located in the San Diego area. Master and working cell banks and virus banks are established and validated. All raw materials are sourced from…

Thanks, Allison, and good afternoon, everyone. In this segment of the call, I'd like to take you through our financial results. I will be providing data in Canadian dollars unless otherwise noted. Full summary of our financial results can be found on the Investors section of our website under filings and reports or in the press release issued earlier this afternoon. The company closed the year with $34.9 million in cash and cash equivalents, compared to $32 million in cash, cash equivalents and marketable securities as of December 31, 2022. We believe this will enable us to achieve the most critical near-term milestones set out in today's call. The net loss in the fourth quarter of 2023 was $3.9 million, compared to $8.6 million in the fourth quarter of 2022, equating to a net loss of $0.05 per share in the fourth quarter of 2023 compared to $0.14 per share for the same period of 2022. The net loss for the full year of 2023 was $27.8 million, compared to $24.8 million in the full year 2022, equating to a net loss of $0.41 per share for the 2023 period and a net loss of $0.43 per share for the 2022 period on a consolidated basis. The net loss for the fourth quarter and full year of 2023 included gains of $4.8 million and $5.3 million, respectively, mainly related to the change in fair value warrants issued as part of our 2023 public offering. General and administrative expenses for the fourth quarter of 2023 were $4.2 million, compared to $3.7 million for the fourth quarter of 2022. For the full year 2023, general and administrative expenses were $16.1 million, compared to $11.5 million for the full year of 2023. The changes between the fourth quarter and full year 2023 and…

Thanks, Kirk. The clinical data we reported in 2023 puts pela on a clear trajectory towards registration with metastatic breast cancer and metastatic pancreatic cancer as our highest priority indications. Our dedication to collaboration and engagement remains steadfast as we foster important discussions with the clinical oncology community and prospective strategic partners. Together, we are committed to expediting pela’s journey to markets, ensuring both swift progress and financial prudence every step of the way. This collective effort fuels our optimism and drives us towards a future where pela's transformative potential can positively impact countless lives. As we conclude today's call and embark on this New Year, we have a bright outlook for the development of pela and a hopeful outlook for patients with an unwavering dedication to our mission. Together, all of us, we're pioneering the path filled with hope, determination and the resolute belief that every step forward brings us closer to uplifting patients' lives and the reshaping of the landscape of cancer treatment. We look forward to updating you on our progress this year and thank you for taking the time with us today. Operator, I would now like to open the call for questions.

Thank you. Ladies and gentlemen, we will now conduct a question-and-answer session. [Operator Instructions]. Your first question comes from the line of Soumit Roy from Jones Research. Your line is now open.

Good afternoon, everyone, and thank you again for all the details on the progress, especially on the manufacturing front. A quick question on the breast cancer trial, trying to understand if you expect any change in the baseline patient characteristics, your BRACELET trial versus the potential pivotal trial in terms of or to status or companion treatments, any differences you expect. And also on the manufacturing front, as you have fairly clearly explained, there is a good transfer of technology between prior and current manufacturing. If the release criteria and everything, anything that could change the viral characteristics, any color would be appreciated.

Yes, sure, Tom Heineman here. I can speak to the first part of your question on the breast cancer study. The population will be very similar to the BRACELET study population. There will be some differences due to the evolving standard of care in the target population, in particular the approval recently of antibody drug conjugates. But it will be largely similar to the BRACELET population in that it will be in patients who have failed hormonal therapy, HR+/HER2- breast cancer patients who have failed hormonal therapy and who are now ready for their next stage of their treatment. And maybe I'll let Allison Hagerman speak to the next part of your question.

Thanks, Tom. With regard to the question related to technology transfer and any change in virus characteristics, no, there are no changes to the virus characteristics of the product either the direct substance or the product, the raw material inputs remain the same, including a master and working virus stocks and all products batches are tested, including identity testing, potency, purity and virus concentration to assure comparability and suitability for clinical use.

Your next question comes from the line of John Newman from Canaccord. Your line is now open.

Hi guys, thank you for taking my question. Just wondering if you could talk a little bit more about the design of the pivotal study in pancreatic cancer, including the potential endpoints that you could look at there. Thanks.

Hey John, it's Matt Coffey. What we're looking at is very similar to what we initially had planned with the PanCAN people. It's quite an innovative design in the sense that it uses adaptive. And what we really thought was clever about it is, it's an FDA approved protocol so that they're used to the idea of an interim look and an adaptive study. It allows us to more expediently get to an approval. Obviously, PanCAN is a tough indication, so lets us have an interim look as well to make sure that we're on the right track. Very similar to what you'd expect from the PanCAN. Looking at that, the primary endpoint would be overall survival, which is most meaningful in this patient population. And obviously in this patient population, it's an endpoint that we don't have to wait a very long time to get to. So it's attractive from that perspective in the sense that it can get us to approval much earlier. So, very similar to what we had historically done, we'd be looking basically to piggyback on a successful study design.

Your next question comes from the line of Patrick Trucchio from H.C. Wainwright. Your line is now open.

Hi everyone, this is Luis Santos in for Patrick. Just wanted to discuss a little bit more the expansion of the anal cohort. And if I think planned number of patients was about 20, perhaps that was going to be sufficient to match the efficacy signal observed to-date. And what is the timing -- approximate timing for that enrollments? Thank you.

Yes. Sure, Tom Heineman again. So, for the anal carcinoma cohort, the expansion will actually be 18 additional evaluable patients for a total of 28 evaluable patients, so 18 on top of the 10 in Stage 1 of the study. And we, of course, have worked with our statistician to determine appropriate success criteria to establish or to confirm a signal in that population. So what we're looking for in that population would be for a successful study would be seven or more responses out of the 28 evaluable patients, okay. And that would provide, I think, a great deal of confidence that the treatment we're evaluating is active at a level higher than what is seen with the standard of care checkpoint inhibitor alone. And then once we confirm that signal, then we can discuss about next steps and how to move forward as rapidly as possible in that patient population.

Thank you.

Did that answer your question or was there additional -- did you have an additional question?

Yes.

Okay. Thank you.

I was going to ask a little bit about the timing for enrollment of that.

Okay, timing, yes. I'm sorry. Yes. The study has been submitted. This study is a new cohort in the ongoing GOBLET study, which is being conducted in Germany with the AIO study group, which is a group of very well respected and expert KOLs, PIs in Germany. But because it is in Germany, the protocol has been submitted to the German regulatory authorities for their approval, we're not expecting any issues with that. And so we're hoping that enrollment will be able to start into that arm of the study probably sometime in May. But it will depend a little bit on the regulatory timelines of the German authorities.

Your next question comes from the line of Louise Chen from Cantor. Your line is now open.

Hi, good afternoon, everyone. This is Carvey on for Louise from Cantor. Thank you for taking our questions. On your OS data guidance of BRACELET-1 study this year, given the data percentage so far, can you help us frame expectations here how it might change the treatment paradigm? Our second question is on OpEx. Given all your clinical activities, can you talk about the push and pulls on OpEx for 2024? Thank you.

Carvey, we missed the second part of your question about OpEx.

Yes. We just like to know the push and pulls on OpEx for 2024 given your studies ongoing.

Sorry, for whatever reason, we have a terrible connection.

Yes. It's breaking up. Sorry.

Yes, maybe we can -- okay. Is this better or still the same?

Yes.

Okay. Like to know push and pulls on OpEx for 2024, any color there?

I -- Tom Heineman here. I cannot address the second part, but I can address the first part about the overall survival results. The -- in the BRACELET study per protocol, the study will end two years after the last patient was enrolled. So that will be late in the second quarter. And when that -- when that occurs, then we will be in a position to do the final database cleaning and the final calculations around the overall survival. So we expect to have overall survival results in the -- probably in the third quarter -- internally in the third quarter, but this will be reported later in the year. Does that answer your question related to the overall survival?

And given your hazard ratio that was provided earlier look last year, what are the expectations here? Given the population, how many months are we thinking of any -- how it might change the treatment paradigm? Any information would be helpful. Thank you.

Well, as we reported last year, the progression free survival showed a 50% to 100% benefit compared to the control arm in the BRACELET study, okay? And so we -- I don't want to speculate on the overall survival results until the -- until we have all the data and have an opportunity to review it appropriately per protocol. But we are optimistic that the overall survival will ultimately be in line with the -- and be -- why I say be in line, I don't mean necessarily month-for-month, but that the overall survival will ultimately validate the PFS benefit that we saw and reported nine months ago or so.

Awesome. That's great. I don't know if the management team was able to hear my technique question, but if not, that's all right too. Thank you.

No, just, what were you wanting to know about our operating costs?

Yes. So you guys have ongoing studies in 2024, but also initiating -- coming up with initiating new studies. So I just want to know how we should think about OpEx for this year.

Okay. So for 2024, just compared to 2023, we do see those coming off in terms of our operating costs, more in line with I think 2022's -- sorry, 2021's level on the OpEx. In terms of the R&D and clinical related costs will just be a function of how quickly we can move forward with our clinical plan, moving the pancreatic cancer program forward and into the clinic, and then what we hear from the FDA on the breast cancer study.

We have run out of time for additional questions. I will now hand the call over to Dr. Matt Coffey for closing remarks.

Once again, I would like to thank everyone for making time to hear about our recent progress and how we're planning to involve into a late-stage oncology company this year. The data supporting pela as a novel immunotherapeutic agent with the ability to improve patient outcome continues to grow, and we're setting the stage to add to that this year. I look forward to our next update and I wish everyone a wonderful evening. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.