ONCY

Good afternoon, and welcome to Oncolytics Biotech First Quarter Conference Call. All participants are in a listen-only mode. There will be a question-and-answer session at the end of the call. Please be advised that this call is being recorded at the Company's request. I would now like to turn the call over to Jon Patton, Director of Investor Relations and Communications. Please go ahead.

Thank you, operator. Today, we'll provide an update on the quarter and a review of our financials. 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 ongoing CEO search, or emission strategies and milestones, the Company's belief as to the potential and mechanism of action of pelareorep as a cancer therapeutic or potential registrational opportunities for pelareorep, and our plans and strategies related thereto; our plans to continue enrollment in GOBLET Cohort 5, our ongoing business development initiatives 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, unknown risk, 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, which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressing good faith and are believed to have a reasonable basis, but there can be no assurance that these statements or expectations or belief will be achieved. These factors include results of current pending clinical trials, risks associated with intellectual property production, 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. On today's call, I'm joined by Chair of Oncolytics' Board of Directors and Interim CEO, Wayne Pisano; Chief Medical Officer; Dr. Tom Heineman; VP Business Development; Christophe Degois; and Chief Financial Officer, Kirk Look. The team will be available for Q&A at the end of this call. And with that, I'll hand it over to Wayne.

Good afternoon, everyone, and thank you, Jon. I know it's only been a short time since we last provided a corporate update so today's call will be relatively brief. I'll run through the important developments from the quarter and then ask Tom to discuss our clinical progress and Christophe to share our business development update. Then Kirk will say a few words about our financials. To start, I want to let you know that our CEO search is active, and we've met several excellent candidates with an asset like pelareorep, which has potential in numerous consequential indications, we are aiming to find a leader who can steward pela with a laser focus on clinical trial execution. Our clinical data continues to exceed expectations and we believe the further development of pela will allow it to fulfill its potential as a value of treatment option for patients with several difficult-to-treat malignancies, including pancreatic cancer, breast cancer and anal carcinoma. All of which have a high unmet medical need. Additionally, the new CEO will provide invaluable leadership and strategic decision-making surrounding our plant registration-enabling study evaluating pela and paclitaxel in advanced or metastatic HR-positive/HER2-negative breast cancer. And I hope to be able to announce our new CEO in the near future. Pelareorep or pela, as we often call it, is a unique and versatile immunotherapeutic agent that we believe has tremendous potential to help a wide range of cancer patients. As discussed during a key opinion leader event in March, Professor, Alexander Eggermont described pela's benefits, including intravenous administration, the ability to be taken to tumor sites via monocytes and lymphocytes, and that it doesn't create anti-agent antibodies, allowing T cells to reach the tumor for long-lasting responses, all without infecting normal healthy cells. During the same call, Professor, Martine Piccart, a leading expert in breast cancer, shared her experience in the clinic and confirmed intravenous administration is much referred to any intratumoral interventions. She also discussed pela’s opportunity in breast cancer and the multitude of registrational opportunities for an asset like pela. She confirms support for the continued advancement of pela-based on two randomized studies confirming its ability to provide an overall survival benefit in breast cancer. She also discussed her belief that there could be an opportunity for pela to benefit patients at an earlier stage of treatment, possibly in a curative setting. Additionally, in the first quarter, we were able to showcase the versatility of pela in gastrointestinal cancers when we presented data at ASCO GI in both pancreatic and anal cancers. Tom will lead the discussion of that clinical data shortly. Looking forward, we'll be sharing pancreatic cancer data at this year's ASCO meeting, highlighting pela's unique mechanism of action, which stimulates both innate and adaptive immune responses. I'd now like to turn the call over to Tom for an update on our clinical progress and plans. Tom?

Thanks, Wayne, and thanks for teeing up the data that we have shared and we'll be sharing this year of medical conferences such as ASCO and ASCO GI. The impactful data that Wayne mentioned was presented in January of this year at the ASCO GI conference. Interim results from GOBLET Cohort 4, which investigates pela and atezolizumab in relapsed anal carcinoma showed a 33% objective response rate, including one patient with a complete response that lasted more than 15 months. We have expanded this cohort to Stage 2 in which an additional 18 patients will be enrolled. If the efficacy signal in this cohort persists, we will engage in discussions with our scientific advisory board and key opinion leaders to optimize the development of pela in this indication. While anal carcinoma is not as large a commercial opportunity as breast or pancreatic cancer, achieving regulatory approval in this indication would serve as an important validation of pela's potential in gastrointestinal cancers and could greatly benefit patients with a very high unmet medical need. In addition, GOBLET Cohort 5, which is funded by a $5 million grant from the Pancreatic Cancer Action Network, or PanCAN is currently enrolling newly diagnosed metastatic pancreatic cancer patients. This cohort is evaluating pela combined with modified FOLFIRINOX with or without atezolizumab. Enrollment into the safety run-in phase of this cohort was recently completed. After a review of the safety data by an independent data safety monitoring board in the German regulatory authorities, we received all necessary permissions to proceed with full enrollment, which is ongoing. This cohort has enrolled more than half of the patients required to complete Stage 1 of the study, which requires a total of 30 evaluable patients, 15 each in the arm with the atezolizumab and the arm without the atezolizumab. Upon completion of Stage 1 enrollment, the decision will be made whether to advance either one or both arms to Stage 2 enrollment. If the efficacy data are encouraging, this study could lead to yet another registrational opportunity. We expect to review initial efficacy data from this cohort later this year and shared publicly next year. In addition to the exciting progress in our gastrointestinal cancer studies, I'd also like to remind you of the compelling breast cancer results from two randomized Phase 2 studies, in which pela-based combination therapy substantially outperformed standard of care treatment. The first of these was the IND-213 study in metastatic breast cancer in which median overall survival in the pela group was nearly double that in the control arm. We followed IND-213 with the BRACELET-1 study to confirm the efficacy signal. In BRACELET-1, we evaluated patients with advanced or metastatic HR-positive/HER2-negative breast cancer who had progressed on hormonal therapy, including a CDK4/6 inhibitor. The BRACELET-1 data became available last fall and showed a substantial clinical benefit for pela combined with paclitaxel compared to paclitaxel monotherapy. This was based on a near doubling of both the median progression-free survival and the two-year survival rate a near tripling of the confirmed objective response rate and a median overall survival of more than a year longer than that in the control arm, with two randomized Phase 2 studies pointing to a meaningful clinical benefit as well as supportive mechanism of action data from several studies, including the AWARE-1 breast cancer trial. We believe we have largely derisked this program, setting the stage for continued development of pela in breast cancer. In the evolving breast cancer treatment landscape, we have a number of attractive options for the continued development of pela. These include a potential registration-enabling study designed to take advantage of the accelerated approval pathway which was successfully utilized by breast cancer drugs such as Pfizer's Ibrance and Daiichi’s in HER2. We also have the option to conduct studies in patients at different stages in the breast cancer treatment path including patients with inoperable disease who have failed antibody drug conjugate therapy and early-stage patients utilizing a neoadjuvant approach. This latter is one of the pathways suggested by key opinion leaders including Professor, Martine Piccart, who spoke at the KOL event, Wayne mentioned at the start of this call. Next, I would like to introduce Christophe, who will comment on our ongoing business development activities. Christophe?

Thanks, Tom. I'm happy to share an update on our BD activities in addition to development involving our current collaboration. As we discussed, the data presented at ASCO GI continued to show the versatility of pela in multiple indications, specifically pancreatic or anal cancer. One underappreciated aspect is a remarkable safety profile of pela. Pela has been administered to over 1,100 patients over the course of its development. While we are encouraged to see there remain no safety concern in anal cancer where pela is being evaluated with the checkpoint inhibitor atezolizumab is now being tested in combination with modified FOLFIRINOX in pancreatic cancer. This chemotherapy regimen has a different safety profile than gemcitabine plus nab-paclitaxel, the chemotherapy regimen from Cohort 1 of the GOBLET study. The fact that we are able to combine pela with multiple chemotherapies and checkpoint inhibitors while maintaining a favorable safety profile in pancreatic cancer makes it easier to engage in productive BD conversation. We had encouraging business development interaction in January at the JPMorgan Conference and will continue to meet with potential biopharma partners at ASCO in Chicago and Bio in Boston. We're also supported by key opinion leaders like Professor Martine Piccart and Professor Alex Eggermont, will continue to be enthusiastic supporters of pela's potential. During the previously discussed KOL event organized by H.C. Wainwright, both Professor Piccart and Professor Eggermont, highlighted the need for new treatment innovations such as pela that work to activate the immune system to recognize and kill cancer. Furthermore, we already have support from advocacy groups like PanCAN while funding Cohort 5 as a GOBLET study. As I mentioned on our previous calls, the accompanying data pela has generated across multiple indication serves us well. We have two randomized Phase 2 studies, showing pela's benefits in HR-positive/HER2-negative metastatic breast cancer, multiple pancreatic studies pointing to pela's meaningful impact and an emerging efficacy signal that's continued to persist in anal cancer. In summary, this continues to be an exciting time for pela as we evaluate the most efficient way to pursue regulatory approval and further demonstrate the potential of our unique immunotherapeutic asset as in helping improve the lives of cancer patients. I look forward to our next chance to update you on our BD opportunities and activities. I'll now turn the presentation over to Kirk, who will discuss our financials for the quarter. Kirk?

Thanks, Christophe, and good afternoon, everyone. I'd like to discuss our financial results for the first quarter of 2025, which will be provided in Canadian dollars unless otherwise noted. A full summary of our financial results can be found on the Investors section of our website on their filings and reports or in the press release issued earlier this afternoon. Turning to our financial results for the first quarter. As of March 31, 2025, we reported cash and cash equivalents of $15.3 million, providing runway through key value-driving milestones and through the third quarter of 2025. Net cash used in operating activities for the quarter were $6.5 million compared to $7.5 million in the same period last year. The decrease reflects lower net operating expenditures, partially offset by changes in noncash working capital. General and administrative expenses were $3 million for the first quarter, consistent with the prior year. Research and development expenses totaled $4.1 million, down from $5.7 million in Q1 of 2024. This decrease is primarily driven by reduced manufacturing and clinical trial costs, partially offset by increased personal-related and share-based compensation expenses associated with leadership transition activities. The net loss for the quarter was $6.7 million or $0.08 per basic and diluted share compared to a net loss of $6.9 million, $0.09 per share in Q1 of 2024. Finally, following the end of our quarter, we were pleased to announce a $20 million share purchase agreement with Alumni Capital. This agreement provides the Company with access to capital solely at our discretion, helping us extend our financial runway. Now, this concludes our financial review. We look forward to providing further updates throughout the year and encourage you to watch for our upcoming poster presentation on pela's mechanism election at ASCO. On behalf of the entire Oncolytics team, I'd like to thank our patients, caregivers, health care providers, employees and shareholders for their ongoing support. Now, I would like to open the call for Q&A. Operator?

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] Your first question comes from the line of Patrick Trucchio from H.C. Wainwright. Please go ahead.

Congrats on all the progress. Just first, regarding the anticipated start of the registrational trial in HR-positive/HER2-negative metastatic breast cancer. What can you share about the potential trial design for the study. Will PFS be a primary endpoint? And how are you incorporating feedback from regulatory agencies? And then separately, have there been any recent interactions with the FDA or other regulatory bodies regarding the pancreatic cancer program? And what feedback, if any of you received concerning potential registrational pathways.

Hi, Patrick, Tom Heineman here. Maybe I can answer those and others can step in if there's more to say. Regarding on the breast cancer side, we, as you know, have discussed the study with the FDA at a Type C meeting in second or third quarter of last year, right? We continue to -- beg your pardon, we continue to work towards the initiation of our next study in breast cancer. At the time that we discussed this with the FDA, we obviously discussed many elements of the study design, including the primary endpoint, which we do anticipate will be progression-free survival in our next breast cancer study. So that's on the breast cancer side. On the pancreatic cancer side, we have not had, I mean, we have -- the FDA is aware of our pancreatic cancer program, including having granted us fast-track approval in pancreatic cancer. We have been working with GCAR, as you may be aware, to develop a protocol in pancreatic cancer and those -- that activity is ongoing. Of course, we're talking to key opinion leaders and exploring all the best options in our pancreatic cancer program forward, but we have not had any additional discussions with the FDA recently, if we were to move forward with the registrational study through any means that would require an FDA meeting before we initiated that study, however. I hope that answered your question. Maybe if I forgot anything, let me know.

Yes, that's helpful. And then just a follow-up, if I may, on the business development activities. I'm wondering if there are specific areas like regional rights or co-development opportunities or other areas that are being prioritized? And then just given pelareorep's mechanism of action, are there plans to explore additional combination approaches maybe with immune checkpoint inhibitors or in other tumor types?

Hi, Patrick, this is Christophe. Yes, I'm happy to answer the first question. I think Tom can comment on the second part of the question because we're already doing that. Yes. What we're doing right now, as we mentioned, we've been busy at JPMorgan, we'll be at ASCO, we'll be at BIO. We are looking at different -- potential different partnership for us, what's very important is, as we discussed during this call, pela has potential multiple indications. So, we'd like to have obviously, breast and pancreatic being our top priorities. So, we'd like a partner that could help us maximize the value of the asset in this multiple indication. And that could be done either through a global partnership or more regional like European partnership. So, we are looking at both avenues right now. Does that answer your question?

Yes, that's helpful.

Tom, do you want to comment, yes, do you want to comment on the combination?

Yes, yes, sure. If you don't mind, Patrick, I'll just mention the combination with checkpoint inhibitors specifically. So, we've done a lot of work, translational work based on samples from clinical trials in a number of different indications, including breast and pancreatic cancer and have shown particularly in pancreatic cancer, but also in breast cancer, the pela clearly potentiates the activity of checkpoint inhibitors, right? Now in breast cancer, we have seen very strong efficacy data with pela without a checkpoint inhibitor. So, it's not necessarily essential in every context. But in pancreatic cancer, specifically, we have really solid clinical and translational data indicating a synergy with checkpoint inhibitors. So, this is something that we will continue to explore and leverage on an indication-by-indication basis.

[Operator Instructions] Your next question comes from the line of Michael Freeman from Raymond James. Please go ahead.

So, a few questions here. You mentioned on the metastatic breast program. You've previously discussed a registration path that might enable accelerated approval. And then I think I'm hearing for the first time discussion of treatment of patients at different stages of the treatment journey and leaning towards earlier-stage patients, if I'm hearing it -- if I heard it right. I wonder if you could discuss -- just like to dive into that a little more. Is this -- would this be an alternative to do a registration-enabling trial? Or would this be like a separate cohort along the treatment journey? Please discuss the rationale and different potential registration paths.

Yes, Tom here. So just to be clear, we're not trying to imply that we would be shifting towards earlier stage necessarily. I'm just trying to indicate that there are a lot of different populations in the breast cancer treatment path that could provide valuable information and advanced the overall program and one of those may be an earlier stage study in neoadjuvant patients. But the other thing to consider is that the antibody drug conjugates, as you're certainly aware, are changing the landscape in breast cancer. This provides us with a real opportunity because following antibody-drug conjugate therapy, the treatment for these patients is much less clear and is wide open for agents like pela-based combination therapy to step in. And so, they're in some discussing with key opinion leaders, there is a sense that one potential way to advance the program and derisk it and move it forward efficiently would be to specifically generate in patients who have who are -- these are not earlier-stage patients, but these are patients who have failed hormonal therapy and then also failed at antidrug conjugate. We have every reason to believe that pela would be a successful agent in that patient population and generating direct data in that population could be a very nice way to further derisk the program and also stimulate additional interest by potential partners, investors and so forth who are looking to understand as well as possible where pela could fit into the overall treatment path. I hope that answers your question, and I don't know if anyone else on the call may want to contribute to that answer.

Yes. That's helpful. Just a little more on that. I'm curious, like was that not similar to the what you had contemplated for the original registration-enabling trial like that it would line up after ADCs? Or is -- or are you now sort of considering a smaller cohort study that would exclusively look at post-ADC or like patients that had failed hormonal therapy and the ADCs?

Yes, we had anticipated that before. The reality of the matter is that at that time, it was more hypothetical because the ADCs had been approved as the first line therapy immediately following failure on hormonal therapy, right? Now with that approval, I don't remember when that was the first quarter of this year. With that approval now on the books, that opens up a slightly different population and leads us to expect that the ADCs are going to be used even earlier in the treatment path than had been obvious before, right? And so, provides us with some additional opportunity and motivation to further solidify that pela's efficacy in that population. You see what I'm saying, and if we were to go down that path, we certainly would do it in a smaller study, but we wouldn't do it in a tiny study. We definitely want to make sure that the data that we've generated there are robust enough to really move the program for us rapidly and with this little risk as possible.

Okay. All right. Great. I appreciate you guys being a dynamic of the landscape. Now, I have a question for Kirk. On the share purchase agreement. Congratulations on finding that access to capital. I wonder if you could describe just like the basic structure of this agreement, any terms, conditions, benefits to Alumni Capital? And just like the flexibility that offers you?

Yes, for sure, Michael. I think essentially, the share purchase agreement does provide us with access to capital at our discretion. Importantly, the minimum purchase notice is set at the 750,000 often what we see are smaller purchase notices moving forward. So, we felt that, that was important. The structure in terms of commitment fees. There was an upfront commitment fee that was granted and then there is an additional fee that's attached on a pro rata basis, as well in an effort to reduce the cost of capital, which we were pleased with. And so, it really allows us to -- based on kind of the market dynamics at the time allows us a source of capital that we can at our discretion, take advantage of and allows us to move the programs forward. Get us through our milestones, especially around the GOBLET study that's coming up here and get through this CEO transition and importantly, move the runway forward.

Okay. All right. That's helpful. Have you tapped that since announcing it?

We are -- yes, we've tapped it a little bit. But again, we're just making sure that it works as described, and we're doing it in a in a strategic manner.

Thank you. There are no further questions at this time. I would now hand the call back to Mr. Kirk Look for any closing remarks.

Well, thanks, operator. Once again, I would like to thank everyone for taking the time to hear about our recent progress and plans for the future. We continue to be excited about 2025 and how pela is positioned to positively impact the lives of cancer patients. Wishing everyone a great day. Thanks very much.

And this concludes today's call. Thank you for participating. You may all disconnect.

Good morning, and welcome to Oncolytics Biotech Inc.'s fourth quarter and full year 2024 conference call. All participants are in a listen-only mode. There will be a question and answer session at the end of the call. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Jon Patton, director of investor relations and communications. Please go ahead.

Thank you, operator. Good morning, everyone. Welcome to Oncolytics Biotech Inc.'s fourth quarter and full year 2024 earnings call. 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 milestones, the company's belief as to the potential and mechanism of action of pelareorep as a cancer therapeutic, our search for a new permanent CEO, our potential registrational opportunities for pelareorep, and our plans and strategies related thereto, the potential market for pelareorep in breast cancer, plans to continue enrollment in goblet cohort five, our ongoing business development initiatives, 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. These may cause actual results, performance, or achievements of the company to be materially different from results, performance, or expectations implied by these forward-looking statements. In any forward-looking statement in which Oncolytics Biotech Inc. expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith. Our beliefs have a reasonable basis, but there can be no assurance that these statements, expectations, or beliefs will be achieved. These factors include results of current or pending clinical trials, 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. Our clients do not undertake any obligation to update these forward-looking statements except as required by applicable laws. Joining me this morning to discuss our recent accomplishments, in addition to what we are looking forward to in 2025, are chairman of Oncolytics Biotech Inc.'s board of directors and interim CEO, Wayne Pisano, chief medical officer, Dr. Thomas Heineman, chief financial officer, Kirk Look, and vice president, business development, Christophe Degois. To get started, I would like to hand it to Wayne who will provide us with an introduction and overview. Wayne?

Thanks, Jon. And thanks everyone for joining our 2024 year-end conference call. First, I would like to reiterate my and the entire team's best wishes for Dr. Matthew Coffey, as he focuses full-time on his recovery. Many of you know that Matthew is a co-founder of the company and he has a passion for improving the lives of cancer patients. So this is not a decision that was taken lightly. Matthew's knowledge and expertise on pelareorep and immuno-oncology is impressive. He will always be a strong advocate of pelareorep and we anticipate that he will support Oncolytics Biotech Inc. in an advisory role later this year. We are actively searching for a chief executive officer to lead the company's advancement of our novel therapeutic agent pelareorep, or PELA as we refer to it. We believe the opportunity for PELA is very compelling as we see the potential for an accelerated approval pathway in HR-positive HER2-negative metastatic breast cancer. Our exciting work in gastrointestinal tumors continues to garner attention from collaborators like GCAR and PanCAN in addition to key opinion leaders in the field. I will leave it to Thomas to discuss our clinical data in more detail, but I would like to highlight that in 2024, we generated final data in the BRACELET-1 breast cancer study that not only met but exceeded our expectations. We also furthered our work in GI cancers with the ongoing goblet study. Initial safety and efficacy data in both pancreatic and anal cancers are positive. After Thomas, Christophe will provide us with an overview of our business development progress, and Kirk will discuss our financials. I would like to remind everyone that on our last call, Christophe provided a detailed analysis of the breast cancer market. Even with the introduction of the ADCs, breast cancer remains an unmet medical need for many patients. We estimate that as many as 55,000 breast cancer patients would benefit from pelareorep. The efficacy data generated in both breast and gastrointestinal cancer trials demonstrate the potential of pelareorep in hard-to-treat and very diverse tumor types. We remain focused on advancing the development of pelareorep for cancer patients and value generation for our shareholders. I will now turn it over to Thomas to discuss our clinical program updates. Thomas?

Thanks, Wayne. The recent impactful GI data that Wayne mentioned were presented in late January at the ASCO GI Conference. From goblet Cohort four, which investigates PELA and the checkpoint inhibitor atezolizumab in relapsed anal cancer, we reported a 33% objective response rate from the 12 evaluable patients, including a complete response that lasted more than 15 months. In addition, we reported translational data from this cohort showing the expansion of new and pre-existing tumor-infiltrating lymphocytes clones in the blood of patients who responded to treatment with pelareorep combined with atezolizumab. We also saw the upregulation of multiple cytokines, including IL-10 and IL-11, as well as PD-L1 and interferon gamma. These results from patients with relapsed anal cancer support PELA's immunologic mechanism of action as previously defined in other cancers. Specifically, they demonstrate PELA's ability to enhance antitumor T cell responses and its complementary effect of making tumors visible to the immune system. In addition, these findings provide evidence of PELA's ability to synergize with checkpoint inhibitors in cancers that have historically resisted immune therapies. We have begun enrollment into stage two of this Simon two-stage study, which will provide data from an additional 18 patients. We believe the confirmation of the efficacy signal from these patients would provide a strong foundation for a subsequent registrational trial in anal cancer. At ASCO GI this past January, we also presented safety results from goblet cohort five. In this cohort, patients with metastatic pancreatic cancer are being treated with PELA combined with modified FOLFIRINOX either with or without atezolizumab in two treatment arms. No safety signals were observed during the safety run-in period, and both an independent data safety monitoring board and the German regulatory authorities have approved the cohort to continue the full enrollment. We are now working towards achieving the next enrollment milestone, completion of enrollment into stage one of the Simon two-stage cohort, which consists of a total of 30 evaluable patients. We expect to review and report the initial efficacy results from this cohort by the end of the year. Note that this cohort is funded by a $5 million grant from the Pancreatic Cancer Action Network or PanCAN through their therapeutic accelerator award based on compelling prior pancreatic cancer results, including from cohort one of the goblet study in which patients treated with PELA combination therapy showed an objective response rate more than double historical results. While our GI cancer studies have provided results most recently, our top priority remains breast cancer, specifically metastatic HR-positive HER2-negative breast cancer, in which PELA has previously demonstrated a marked statistically significant near doubling of median overall survival in the IND-213 study. In light of this exciting result, we conducted the BRACELET-1 study to confirm the robust efficacy signal observed in IND-213 and to extend the evaluation of PELA to patients who had previously received CDK inhibitors, which are now part of the standard treatment regimen for patients with advanced or metastatic HR-positive HER2-negative breast cancer. This past fall, the final efficacy results from the BRACELET-1 study became available, and they once again pointed to a clinically meaningful benefit for patients treated with PELA-based combination therapy compared to those treated with chemotherapy alone. In fact, all efficacy measures favored patients in the PELA combination therapy arm compared to those in the chemotherapy alone arm. These included median progression-free survival, median overall survival, two-year survival rate, and confirmed objective response rate. With these results, we have now observed a substantial efficacy signal from two randomized trials that enrolled over 100 patients. We currently are planning to move directly to a large Phase 2 study of approximately 180 HR-positive, HER2-negative advanced or metastatic breast cancer patients that we anticipate will support an accelerated approval file submission. In this study, patients will be randomized to receive either PELA plus paclitaxel or control therapy of paclitaxel alone. The primary endpoint is expected to be reached within two years of the start of patient enrollment. The planning for this study is ongoing, and we aim to initiate the study in the second half of this year. In conclusion, the clinical data we have generated continue to exceed our expectations, provide extremely strong support for continued clinical development, and provide clear paths towards registration in breast, pancreatic, and anal cancer, all difficult-to-treat cancers with high unmet needs. Now I will turn the call over to Christophe who will provide an update on our ongoing business development activities and collaborations. Christophe?

Thanks, Thomas. I am happy to be here with you today to provide the latest update on our ongoing business development conversations. Since our last earnings call, we have continued to communicate to potential biopharma partners the substantial clinical benefit PELA has demonstrated across multiple hard-to-treat indications. However, breast cancer is our highest priority. This is because we have data showing patient benefit in two randomized breast cancer studies that exceed 100 patients. Also, after discussion with regulators and key opinion leaders, we know where PELA should be positioned in the ever-evolving breast cancer treatment paradigm. As for the clinical benefit and the final BRACELET-1 data reported this past fall, PELA combined with paclitaxel showed a greater than 12-month estimated advantage over paclitaxel monotherapy. However, as Thomas mentioned, we also saw meaningful benefit in objective response rates, PFS, and 12- and 24-month overall survival. Our expected positioning of PELA in the treatment paradigm is for it to follow hormonal treatment like endocrine therapy, CDK4/6 inhibitors, and targeted therapy. An antibody-drug conjugate like Enhertu. However, some patients may not be eligible for or cannot tolerate ADCs. So once a patient is eligible for chemotherapy, PELA would be a natural fit as our data with paclitaxel shows a robust benefit over paclitaxel monotherapy. As I discussed in great detail on our previous call, this is where we anticipate there will be 55,000 addressable breast cancer patients in the U.S. by 2027, and the potential for $2.4 billion in annual sales across the U.S. and major European markets by 2033. Another important aspect of our BD conversation centers around where we will take PELA next on the regulatory pathway. After multiple discussions with key opinion leaders and statisticians, we have designed a registration-enabling breast cancer study that could generate a PFS endpoint within two years of the start of patient enrollment and be eligible for an accelerated approval file submission. We believe this is reasonable because the PFS benefit we would aim to achieve is 4.3 months, but the BRACELET-1 benefit was 5.7 months. In our meetings, this is an aspect of our strategy that seems to be well understood and one that has already been used by other companies, including the approval of Ibrance for Pfizer and Enhertu for Daiichi Sankyo. Now in future meetings, we will also layer in the most recent developments that we presented at ASCO GI from our promising gastrointestinal programs. As these conversations progress, we will be sure to keep you updated. We are in the fortunate position to have compelling data in three indications: breast, pancreatic, and anal cancers. These three indications demonstrate the broad potential for pelareorep to help a large number of patients and provide a commercial opportunity that is appealing to potential biopharma partners. In the GI space, GCAR and PanCAN remain our valued collaborators. We are excited that Goblet Cohort five, funded by PanCAN, is continuing to progress as planned and is now ready for full enrollment given the DSMB and TEI synapse. As a reminder, PanCAN provided Oncolytics Biotech Inc. with a $5 million grant to fully fund Cohort five after an extensive vetting process and meeting with multiple pancreatic cancer key opinion leaders. As a highly regarded organization solely focused on pancreatic cancer, their vote of confidence in PELA's potential gives us confidence in the strategy to continue evaluation in this indication. PanCAN's continued interest in PELA is helping us to provide a more complete picture of PELA's potential in this extremely difficult-to-treat type of cancer. This is due to the fact that the treatment regimen in this cohort is evaluating treatment with a different chemotherapy than we have used in the past, modified FOLFIRINOX. This is one of the two most commonly administered to metastatic pancreatic cancer patients, the other being gemcitabine and nab-paclitaxel. The combination of PELA plus gemcitabine, nab-paclitaxel, and atezolizumab showed a 62% objective response rate, well above the usual 20-25% response rate that would be expected in a similar patient population. In turn, that data led to the relationship with PanCAN as well as a fast track designation from the FDA and the opportunity to collaborate with GCAR. We continue to engage with GCAR to finalize a master protocol for initiating a registration-enabling study that could eventually lead to regulatory approval for the PELA, gemcitabine, nab-paclitaxel, and atezolizumab combination. We look forward to sharing additional enrollment plan updates with you later this year. I now turn the presentation over to Kirk for a review of our financials. Kirk?

Thanks, Christophe. And good morning, everyone. I will now discuss our financial results for the fourth quarter and full year 2024, which will be provided in Canadian dollars unless otherwise noted. A 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 morning. Throughout 2024, we remained cautious with our cash resources. As of December 31, 2024, the company reported $15.9 million in cash and cash equivalents. Net cash used in operating activities for 2024 totaled $27 million compared to $28.4 million for 2023, reflecting non-cash working capital changes partially offset by higher net operating activities in 2024. Now, general and administrative expenses for the fourth quarter of 2024 were $3.9 million compared with $4.2 million for the fourth quarter of 2023. The decrease was mainly attributed to lower personnel-related expenses along with lower cash annual short-term incentive awards. The decrease is partially offset by higher share-based compensation expense. Research and development expenses for the fourth quarter of 2024 were $4.6 million compared to $4.7 million for the fourth quarter of 2023. The decrease was due to lower personnel-related expenses, related to lower cash annual short-term incentive awards, mainly offset by higher clinical trial expenses and share-based payment compensation expense. Net loss for the fourth quarter of 2024 was $8 million compared to a net loss of $3.9 million for the fourth quarter of 2023. The basic and diluted loss per share was $0.10 in the fourth quarter of 2024, compared to a basic and diluted loss per share of $0.05 in the fourth quarter of 2023. For the full year 2024, net loss totaled $31.7 million compared to $27.8 million in 2023, or $0.41 per share on a basic and fully diluted basis. As we look forward to 2025, we are confident in the vast potential that PELA holds for improving patient outcomes. We are making progress as shown by the recent data in pancreatic and anal cancers announced at ASCO GI, and we are dedicated to advancing PELA as effectively and efficiently as possible. Now before we wrap up today's call, I would like to thank everyone who continues to support our efforts, from patients, providers, and caregivers to our dedicated employees and most importantly, our steadfast shareholders. On behalf of the entire management team at Oncolytics Biotech Inc., thank you again for taking the time to join us today. Now, I would like to open the call up for Q&A. Operator?

Thank you. And ladies and gentlemen, we will now begin the question and answer session. To ask a question, you may press the star followed by the number one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, you may press the star followed by the number two. Once again, please press the star one to join the queue. One moment please for your first question. And your first question comes from the line of Michael Freeman with Raymond James. Please go ahead.

Hey. Good morning, Kirk, Wayne, Thomas, Christophe, Jon. Congratulations on closing out a strong year 2024, and looking like an action-packed 2025. So you are getting excited for this. I guess, one question I have is, as you get closer to launching the registration-enabling study in metastatic breast, I am wondering how you are thinking about the total cost of that trial, and I know you did provide some sort of detail around timing. But if you could provide as much color on launch timing and initial readout timing as you can, that would be terrific.

Sure. I can take that. So currently, we are working at getting the study registration, pardon me, enrollment ready. And so, you know, what that means is we have more or less finalized the protocol. We will be approaching the regulator just as a normal course activity. In the meantime, we are working with identified sites through feasibility and working with their process to get them on board. And then once we have those sites identified and ready to be put on board, we will look to bring them online and then we will be in a position to enroll. We are targeting to be in that position, you know, as things progress, it will probably be later half of the year now. Once enrollment starts, it is expected to be an 18-month enrollment period with a six-month data maturity to get to PFS readout. So in the interim, we are looking at putting in place a futility analysis, and we have to finalize that assessment, but our expectations right now is a futility analysis will take about 14 months from the first patient enrolled to get to that point, and then we can have the futility readout.

Okay. Great. And then any sharper estimations on total costs?

We are working through that, Michael. I think it is premature to speak to that in any great detail. But as we understand our sites and their enrollment rates, etcetera, we will be able to have more color on that.

Gotcha. Okay. Thank you. One more question. I have been noticing more news from oncolytic virus developers in the landscape. And I wonder if you are seeing increasing evidence that there is a bit of an oncolytic virus renaissance going on. And are you seeing increased interest from pharma as a result? Like, I point specifically to CG Oncology, you know, they were able to raise $200 million at the end of last year on good data. You know, and that is a live virus. Curious how you are seeing things. I am curious for your perspective on all this.

Christophe, do you want to speak to that as to what you have heard on your end? And I can follow-up and if others want to jump in, they can.

No. Happy to answer that. Yes. You are exactly right. I mean, you are talking about CG Oncology. We also, I do not know, you may have seen also Kendall, you know, who has done a raise, you know, at the end of last year. We definitely see more activities in that field. I think that is very beneficial for us. Because let us remember that we have significant advantages, you know, being injected, you know, instead of, I mean, IV injection. And not an intratumoral. And, you know, the intratumoral has been sometimes, you know, a little complicated for big pharma companies that do not really interested in that. So we, as I mentioned during the call, think we continue to have a conversation with potential partners, and we have seen that, you know, the fact how we position, you know, PELA in breast cancer, the multiple, you know, signal breast cancer, obviously, having very strong data, but also the strong signal we have seen in other indications. Pancreatic and anal. Resonating very well with potential companies. Kirk, do you want to add anything to that?

Yeah. And what we are noticing on, you know, kind of just discussions and presentations with investors is again more interest in the oncolytic virus space that we are seeing. We are seeing more dedicated, you know, clinicians, science experts from those investors sitting down and talking to us and, you know, walking through our data and our plan. And there have been some comments from their standpoint just seeing some white space opportunities to generate return for them. And so their focus is on that. They see some of them are seeing this as a real opportunity. So that in combination with what is going on in the industry, you know, I think there are some pretty big and important data readouts coming from our competitors that will be important to help those investors continue looking at the space. And, you know, we have seen a real shift in that. So we are excited to hopefully be part of that.

So I am yeah. I get a rising tide situation. I hope if I could shoehorn one last one in, I wonder on the pancreatic front, and your alignment with GCAR, I understand that you are working together to submit to get that master protocol together. First, will this be the first trial launched on the GCAR platform and just I recognize that it takes some time for this organization to unload and get together a master protocol. But I wonder if there is any way that this trial can be accelerated to launch.

Can you speak to us? Yeah. Yeah. I can speak to that, but, you know, we have been working, as Kirk mentioned, very actively with GCAR to finalize a licensure enabling study protocol. The next step would be, as would be typical in this sort of situation, to go to the regulators and get the FDA's thoughts and move on from there. And so it is really maybe a little early for us to say anything very specific about the timing until we talk to the FDA. But I can say with regard to accelerating it, that like, you know, we are working very actively with GCAR, and so we are moving things forward with them at the greatest possible pace.

Okay. Alright. Thank you very much. I look forward to seeing all your activity this year. I will pass it on.

Alright. Thank you. And once again, if you would like to ask a question, simply press the star one on your telephone keypad. Your next question comes from the line of Patrick Trupeau with H.C. Wainwright. Please go ahead.

Good morning, everyone. Thank you for taking our questions. Luis here in for Patrick. Congratulations on the latest presentations. We are curious to know what your thoughts are around the positioning, the commercial positioning of PELA given that ADCs seem to have shown and continue to show positive results in the same patient population. So you are probably going to focus on the patients that did not respond or are not eligible, as you said, for this kind of therapy. Is there any other population that you could target regarding the ADCs and you think that there is a potential also for a combination, not just a sequential treatment approach, but a combination with an HER2 and other ADCs?

Thank you. Okay. Sure. So I, Thomas here. I can start there, and then if Christophe or others want to jump in, they can. But you are right. We do want to target patients who are ineligible for or cannot tolerate ADCs. But in actuality, the largest population we expect to target will be patients who receive ADC therapy and then progress on ADC therapy, which is going to be a very large population. The ADCs have been extremely successful drugs and have benefited a lot of patients. But they are not cures. Right? And so once a patient takes an ADC at the appropriate time in their treatment path, they will eventually progress on that therapy and will at that point need the best possible treatment options. And so we think that we would very well provide an alternative there that would be very attractive. Right? And then I am sorry. What was the second part of your question, please?

We were wondering if there is any potential for combination with any of these therapies.

Yeah. Yeah. Sorry. So pelareorep, in general, has proven itself to be an agent that can potentiate the activity of other therapies, including chemotherapy and immunotherapies. I think it is a very logical thing to consider in the future. It is not our immediate path for a variety of reasons now, but I think at the appropriate time in the future, combination therapy with ADCs and other agents will certainly be something worth considering.

Great. Thank you. And yeah, this is Christophe. I can add a little color, you know, on the more on the numbers of patients for you. As you may recall, we discussed a total addressable patient population of 55,000 patients just in the U.S. And when you look at that, it is mostly, you know, for patients who would have been on Enhertu. And would have initially responded and then, you know, would relapse, which is, you know, as you look at Enhertu, I mean, your average PFS is 10 to 11 months. So we know that this patient at some point in time will need another better treatment. So, you know, when we build our forecast of that that totals more than $2 billion, that considers 55,000, you know, patients annually in the U.S. And then, you know, we take, you know, a very conservative approach with 15 to 20% market share, you know, in this population. So that is where we believe, you know, there is a significant market opportunity.

A follow-up question?

Thank you. That was very helpful. Great. Thank you.

And I am showing no further questions at this time. I would like to turn it back to Kirk Look for closing remarks.

Well, thanks to everybody who took the time to join our earnings call this morning. This is going to be an exciting year for PELA and Oncolytics Biotech Inc. with additional data readouts expected and the planning of registration-enabling studies that can move PELA closer to regulatory approval. Thanks again for your support, we will have more updates as soon as we can. Wishing everyone a wonderful day. Thanks very much.

Thank you, presenters. And ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect.

Good afternoon and welcome to Oncolytics Biotech's Third Quarter 2024 Conference Call. All participants are 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 call over to Jon Patton, Director of Investor Relations and Communication. Please go ahead.

Thank you, operator and thank you all for joining us. 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 milestones, the company's belief as to the potential and mechanism of action of pelareorep as a cancer therapeutic, our potential registrational opportunities for pelareorep and our plans and strategies related thereto, our plan to continue enrollment in GOBLET cohort 5, our ongoing business development initiatives 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 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 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. Now I'm pleased to introduce the members of our management team who are joining me to discuss the important progress we made during the third quarter. These are Chair of Oncolytics Board of Directors and Interim CEO, Wayne Pisano; Chief Medical Officer, Dr. Tom Heineman; Chief Financial Officer, Kirk Look; and Vice President of Business Development, Christophe DeGois. Wayne will start the conversation this morning, so I'll hand it off to him. Wayne?

Thank you, Jon. Good morning. Also thanks to everyone who's joining our call today, especially because we've had several meaningful news events since our last update. Following my brief introduction, Tom will provide a recap of the BRACELET-1 data and our plans for a clinical trial design to support the accelerated approval of pelareorep in metastatic breast cancer. He will also expand upon our plans for pelareorep in gastrointestinal cancers. Christophe will discuss our large addressable market opportunities and partnership efforts. Kirk will review the financials. And finally, we will end by taking your questions. In the third quarter of 2024, we reached a critical milestone in our development of pelareorep or pela, as we often call it, our leading immunotherapeutic agent. The BRACELET-1 breast cancer study reported its final data and the combination of pela plus paclitaxel showed substantial improvement compared to paclitaxel monotherapy in critical metrics like progression-free survival, overall survival and 24-month overall survival rate. Progression-free survival and the 24-month overall survival rate nearly doubled, while overall survival showed an approximate 14-month benefit. We believe these data provide us the opportunity to significantly impact the lives of patients with HR+/HER2- metastatic breast cancer and we believe the next appropriate step is a registration-enabling study utilizing BRACELET-1 outcomes as the basis for an accelerated approval development path. Now before Tom provides a more comprehensive update, I would also like to highlight that we are continuing enrollment in the safety run-in phase of GOBLET cohort 5 in newly diagnosed patients with metastatic pancreatic ductal adenocarcinoma, supported by the Pancreatic Cancer Action Network. Additionally, we continue to work with GCAR on finalizing the master protocol and seeking FDA feedback for the registration-enabling study in pancreatic cancer. With the potential for two registrational studies ahead, we believe 2025 will be an exciting year for pela and for Oncolytics. Now I'd like to turn the call over to Tom to provide a more detailed update. Tom?

Thank you, Wayne. Just to quickly refresh anyone who hasn't heard our story for a while or is new to what we're doing, pela is an intravenously delivered immunotherapeutic that acts systemically. It introduces double-stranded RNA into the tumor, which promotes an inflammatory response that makes the tumor visible to the immune system. At the same time, it stimulates antitumor cellular immune responses that can attack the now visible tumor. Our main priorities are to advance our planned registrational studies in breast and pancreatic cancer. So that is where we will focus our discussion today. Starting with our breast cancer program, we recently shared efficacy results from the BRACELET-1 study, which exceeded our expectations across the board, including both progression-free survival, PFS and overall survival, OS. The median PFS nearly doubled from 6.4 months in the control arm to 12.1 months in the pela arm. Similarly, while median OS was 18.2 months in the control arm, it could not even be calculated in the pela arm because more than half the patients were still alive at the end of the study. Nonetheless, using the conservative assumption that all the pela patients would have passed away at the time of their next clinic visit, the median OS would have been 32.1 months, well more than one year longer than the control patients. Perhaps even more telling, the proportion of patients who live two years or longer nearly doubled from 33% in the control arm to 64% in the pela arm. It's important to note that the patient populations were well balanced across the study groups with no substantial differences that would be expected to bias results in favor of pela. Safety results from the BRACELET-1 study were in line with pela's well-understood and favorable safety profile based on more than 1,100 treated patients. The next question is, where we go from here? After discussions with key opinion leaders, our biopharma collaborators and the FDA, we have identified an approach that can generate primary endpoint results within two years of the start of patient enrollment. Accordingly, our next planned breast cancer study is anticipated to be a registration-enabling large Phase II study of around 180 HR+/HER2- metastatic breast cancer patients. We would use progression-free survival as the primary endpoint and would power the study to achieve a Phase III level of success if the expected clinical benefit is achieved. If pela-based therapy demonstrates a progression-free survival benefit comparable to that seen in BRACELET-1, we anticipate seeking licensure potentially through the accelerated approval pathway. This approach has been used to achieve the initial approvals of other breast cancer treatments, including Pfizer's IBRANCE and Daiichi's in HER2. We believe this is a cost-effective and efficient strategy for the development of pela in breast cancer. I would now like to move to the GOBLET study and our opportunity in gastrointestinal cancers. So far, we have evaluated pela-based therapies in first-line metastatic pancreatic ductal adenocarcinoma, or PDAC, third-line metastatic colorectal cancer and second line or later anal cancer. Despite the difficulty of treating these specific cancers, pela-based combination therapy met the initial predefined efficacy success criteria for each of these indications. Our highest priority in GI cancers is pancreatic cancer. We've seen exciting efficacy signals in previous studies and the objective response rate we reported in the pancreatic cancer cohort of the GOBLET study was more than double historical objective response rates. The strength of these results attracted the attention of multiple potential partners. One of these collaborators is the Global Coalition for Adaptive Research or GCAR, which specializes in the design and conduct of cost-effective innovative adaptive clinical trials intended to support licensure. We are currently collaborating with GCAR to develop an adaptive registrational-enabling study to evaluate pela-based combination therapy in metastatic PDAC and we expect to seek with GCAR, FDA guidance on the study design. We look forward to continuing our collaboration with GCAR on this exciting opportunity and we will provide an update as this program advances. As a complement to our work with GCAR, we also received a $5 million grant from the Pancreatic Cancer Action Network, also known as PanCAN, to evaluate a different pela-based combination therapy in PDAC. Historically, the two most common standards of care in metastatic pancreatic cancer are the chemotherapy regimens of gemcitabine, nab-paclitaxel or modified FOLFIRINOX. The gemcitabine/nab-paclitaxel regimen is the focus of our work with GCAR, while the PanCAN grant is funding the evaluation of pela combined with modified FOLFIRINOX. This is an attractive opportunity because if pela-based therapy demonstrates benefit when combined with both commonly used chemotherapy regimens, it may lead to improved therapeutic options for nearly all metastatic pancreatic cancer patients. Earlier this year, we announced the dosing of the first patient in the new GOBLET cohort evaluating pela, combined with modified FOLFIRINOX. Enrollment into this cohort of the GOBLET study is ongoing and we will provide additional updates when they become available. Should the combination of pela and modified FOLFIRINOX produce a positive outcome, it would result in another registrational opportunity for pela in this challenging indication. Before I turn the call over to Christophe to expand on our business development efforts as well as our most recent commercial assessments, I would like to briefly summarize our immediate priorities. First, we plan to pursue an accelerated approval pathway for pela in HR+/HER2- metastatic breast cancer through a large registration-enabling study that compares paclitaxel plus pela to paclitaxel alone. Since we've already demonstrated pela's clinical benefit in two prior randomized studies, we are confident in this approach. Secondly, we are working with GCAR to finalize the protocol for the metastatic pancreatic cancer trial evaluating pela, gemcitabine, nab-paclitaxel and atezolizumab and we will seek guidance from the FDA on this approach, which we believe will open another registrational pathway for pela. And finally, we continue to enroll patients into the GOBLET study cohort evaluating pela combined with modified FOLFIRINOX, which is in newly diagnosed pancreatic cancer patients. Our conviction in pela's broad therapeutic benefits grow stronger with each positive dataset as does our belief in pela's potential to improve the lives of cancer patients. With that, I will turn the call over to Christophe to discuss pela's market opportunity, our ongoing collaborations and future partnership opportunities. Christophe?

Thanks, Tom. Since joining Oncolytics, I've focused on facilitating business development opportunities as well as working to articulate the broad opportunity we have with pela to potential strategic industry partners. We continue to have conversation with our current collaborators, Pfizer and Roche, in addition to potential biopharma partners. With the announcement of the final data from BRACELET-1, including a 5.7 months progression-free survival benefit and nearly 14 months overall survival benefit, I anticipate we'll be able to have enhanced discussion about pela going forward as this is an asset that is clearly ready to move to registrational setting. There are numbers of potential partner who could be interested in the progress we're making and in our plans for the future. We just completed a robust analysis of the HR+/HER2- metastatic breast cancer population and are encouraged by the potential pela may have in this indication. Using the assumption that pela could be ready for an accelerated approval in 2027, we anticipate an addressable population of around 55,000 patients in the U.S. at that time. We derived these numbers by factoring in patients who would have progressed on endocrine therapy and who are ineligible for, not responsive to, or progress on [indiscernible], which is an antibody conjugate is becoming part of the breast cancer treatment paradigm. If we then project sales going forward for the U.S. and Europe, assuming a 15% to 20% market penetration by the year 2033, we see the potential for $2.4 billion in annual sales for U.S. plus EU5. This would create a meaningful breast cancer drug franchise to just about any biopharma partners. And that is what we are offering in our discussion going forward, a multibillion- dollar potential drug with the potential for accelerated approval in a few years. While we are obviously very excited about the breast cancer data and opportunity, pela has shown exciting efficacy in multiple cancer indications. The pancreatic cancer data has been reported is very compelling as well. In the second quarter, we entered into a collaboration with GCAR and last year received funding from PanCAN via the Therapeutic Accelerator Award. Both of these strategic relationships provide external validation of the potential of pela-based combination therapy. GCAR selected the combination of pela, gemcitabine, nab-paclitaxel and atezolizumab for investigation in the inaugural pancreatic cancer program after a thorough vetting process, which included meetings with key opinion leaders and multiple committees. We're working with them to finalize the master protocol and have GCAR submitted to the FDA for guidance. Importantly, the GCAR alliance will provide access to trial sites, rapid patient enrollment and control arm drug supply. PanCAN is a nonprofit organization dedicated to fighting pancreatic cancer in a comprehensive way by advancing scientific research, building community, sharing knowledge and advocating for patients. PanCAN Therapeutic Accelerator Grant is funding cohort 5 of the GOBLET study, which is pela plus modified FOLFIRINOX with and without atezolizumab. As Tom mentioned earlier, modified FOLFIRINOX is the other chemotherapy backbone that is most often used besides gemcitabine plus nab-paclitaxel. So a meaningful response with the FOLFIRINOX combination would create significant opportunity to improve the treatment outcomes for a large number of patients. With that, I'll bring on Kirk to cover our Q3 2024 financial highlights. Kirk?

Thanks, Christophe and good morning, everyone. I'd like to discuss our financial results for the third quarter of 2024, which will be provided in Canadian dollars, unless otherwise noted. A 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 morning. As we start to ramp up our efforts to put pela on the path to registration, we continue to be efficient with our cash resources and keep our critical milestones in mind. As of September 30, 2024, the company reported $19.6 million in cash and cash equivalents. Net cash used in operating activities for the nine months ended September 30, 2024, was $19.1 million compared to $22.3 million for the nine months ended September 30, 2023. The decrease reflects non-cash working capital changes, partly offset by higher net operating activities in 2024. Our general and administrative expenses for the third quarter of 2024 were $3.1 million compared to $5.2 million for the third quarter of 2023. The decrease was primarily due to lower investor relations activities and transaction costs that were part of our 2023 public offering. Research and development expenses for the third quarter of 2024 were $6.8 million compared to $5.8 million for the third quarter of 2023. The increase was primarily due to higher manufacturing expenses and clinical trial expenses. Increased manufacturing expenses were related to completing a cGMP production run in the quarter, increased clinical trial expenses that were associated with our GCAR collaboration, BRACELET-1 study closeout costs and the clinical data management of legacy studies. This increase was partly offset by lower GOBLET study costs as we focus on enrolling cohort 5, which is supported by the PanCAN grant. The net loss for the third quarter of 2024 was $9.5 million compared to a net loss of $9.9 million for the third quarter of 2023. The basic and diluted loss per share was $0.12 in the third quarter of 2024 compared to a basic and diluted loss per share of $0.14 in the third quarter of 2023. Now we are very excited to move pela further along the path to registration and we are looking at multiple upcoming milestones. We are moving forward with our registration-enabling study in HR+/HER2- metastatic breast cancer based on the clinical benefits observed in IND-213 BRACELET-1 in addition to the feedback we received from the FDA. Our collaboration with GCAR is continuing to progress and we are nearing the finalization of the master protocol. Cohort 5 of the GOBLET study, the combination of pela and modified FOLFIRINOX with and without atezolizumab continues to enroll and we expect safety data in early 2025, followed by efficacy data later next year. We are also looking for updated efficacy data from cohort 4 of GOBLET next year. That is the cohort evaluating pela and atezolizumab in second-line or later anal cancer. So we always try to end our calls by expressing our gratitude to the people who are instrumental in helping us continue our mission of giving cancer patients the opportunity to live longer, better lives. This includes the entire Oncolytics team, our investors, our patients and their families. Now I would like to open the call for Q&A. Operator?

Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] First question comes from the line of Soumit Roy with Jones Trading. Please go ahead. Soumit, you may be on mute.

Hi. Good morning, everyone. Sorry, I was on mute. Congratulations on all the progress. And wanted to check on the upcoming San Antonio Breast Cancer update. Should we expect any closer data cut? Or what kind of detail should we expect there?

Yes. Hi, Soumit, Tom Heineman here, Chief Medical Officer. The data that we presented in this call are, in fact, the final results. Because of the timing and – of the meeting, we will not have anything – any update at San Antonio. But the results presented are, in fact, the final results. So there are – there is no more updated cut expected.

Got it. And a quick one on the HER2-status is – could you remind us, they were IHC 2 and below or...

Well, when this study was started, the antibody drug conjugates were not on the market and they were not being used, right? So there was no reason to test specifically the HER2 status. All of the patients in the study fell into the classic characterization, however, of HER2 low. So they were all two or lower according to the standard definition.

Got it. Thank you again for taking the questions.

Sure.

Next question comes from Louise Chen with Cantor. Please go ahead.

Hi. Good morning, everyone. Thank you for taking our questions. First, on your breast cancer registration-enabling study, can you provide additional color on the potential to achieve accelerated approval? How early will you able to achieve this? Or do we have to wait until the trial completion for regulatory action? And I do have a follow-up. Thank you.

Okay. Well, I'll start. It's Tom Heineman again. So the path for regulatory approval and accelerated approval is based on our prior feedback with the FDA and on precedent, right? And so we think that the study, as designed, will provide a clinically meaningful benefit. And if it does provide a clinically meaningful benefit comparable or even anywhere close to what we saw in the BRACELET study, that would result in a statistical level of p-value of less than 0.05, okay? And so in other words, with that study, we would hit all the main points that the FDA is looking for when they consider an approval. So one, we would have a clinically meaningful benefit. Two, we would have statistical – a highly statistically significant study; and three, if it performs as it has in all our previous studies, we would have a solid safety profile, which are the three main things the FDA is looking for, okay? So the FDA, of course, will never tell you in advance that they will approve anything before they see the data. But if this study performs as we expect it to, we would hit on all the points that we think would be compelling for the FDA to support a regulatory approval following in the precedent set by such – by many drugs but including such drugs as IBRANCE in HER2. And with regard to the timing, perhaps I can hand that off to Kirk to discuss the timing explicitly. If you don't mind, Kirk.

Yes. In terms of timing, we would – once we can get the study up and running and enrolling, we expect enrollment to happen over an 18-month period and then data maturity is expected to be six months after the last patient is on. And then we would expect to be in a – subject to the data, of course, we expect to be in a filing position after that point in time.

Great. Thank you. My follow-up question is on your first upcoming major milestone, which is finalizing the master protocol for your adaptive registration-enabling trial. Given this is for first-line PDAC patients, we're wondering how quickly will you be able to complete patient enrollment? Thank you.

Well, once the – so we need to finalize the protocol, as we mentioned, it will need to be discussed with the FDA. In other words, there are some upstream steps. Once that study starts enrolling, we would have to map out the timelines precisely based on the parameters of the study at that time. But we expect it to enroll quickly because this is a – this is not a rare disease. This is a, unfortunately, relatively common cancer and we would be expecting to work with all of – well, or many of the best, highest potential recruiting potential sites in the U.S. and maybe even elsewhere. So while I hesitate to put a precise timeline on it, we expect the study to enroll very efficiently. And Kirk, maybe you'd like to expand on that, I don't know.

No, no, I think that's exactly right.

Okay.

Great. That’s helpful. Thank you so much.

The next question comes from Michael Freeman with Raymond James. Please go ahead.

Hey, good morning, Wayne, Kirk, Tom, Christophe. First of all, congratulations on the sensational metastatic breast data. This is – it's truly impressive. So my question is, on the back of this overall survival data, I wonder, perhaps, Christophe, if you could describe your partnering and business development approach and algorithm as you have this powerful data in hand? And if you could describe – maybe just summarize how progress is going? And for instance, like have you seen an accumulation of pharmas in your data room? And then I'll have a follow-up after this.

Yes, sure. This is Christophe Degois. Yes, we last year – I mean, before I joined the company, last year, we had – when we presented the interim data, the PFS data, we had some interest from pharma companies but obviously, they wanted to see the final data. As explained during this call, we got this data very recently. So we are putting our [indiscernible] orders and starting to reengage pharma companies. Obviously, we've been talking, as mentioned before, we've been talking to our current partners but we're also expanding to other companies. I think the end of the year coming and JPMorgan, I think where we're really now preparing for a big outreach and a large outreach. And that will be with your typical big pharma partners that are interested in the solid tumor market but also potentially European or Asian companies for more regional partnership. We haven't decided yet of the best options. We are looking at the different options right now. So obviously, in the coming months, I think we will be very active.

Okay. Yes, that's helpful. I guess when you think about a partnership, how would you contemplate structuring that sort of a partnering deal or sort of business development deals, like the type of outreach you've just described, how do you expect the structure of an ultimate deal might be?

Again, this is a little early but we have definitely – if you look at what we've done so far, we've had the capacity to run the Phase II trial that Tom described in breast cancer. But there are also other opportunities, as we explained. Obviously, pancreatic cancer, even in breast, there may be other opportunities, early on opportunities. So I think our objective is going to bring a partner that's going to help us accelerate the development of the drug in breast, I mean, in metastatic breast cancer but potentially also in the other indication. We are a fairly small company. Our focus right now is definitely on bringing pela approved for breast cancer. But we cannot neglect the other opportunities in other solid tumors. So for us, I think the ideal partner is somebody who is going to get committed to help us accelerate that and also prepare for the launch of the drug. If we get accelerated approval, we want someone who is going to help, especially on the commercial side preparing the market for the drug. And that's where the big pharma or large biotech can really bring value.

Absolutely. And just very quickly, just one more. What pricing are you using in your – as you size these markets as you just did very well?

Yes, that's a very good question. We've made some assumption on that. And the pricing we're using is the pricing similar to [indiscernible], with a slight premium since we'll be coming post [indiscernible] for most of the patients. And we've looked at the pricing of [indiscernible] in the U.S. and outside the U.S. As you can imagine, the pricing outside the U.S. is slightly different.

Okay. Thank you very much. I will pass the line now.

Thank you.

There are no further questions, go ahead. Please continue.

Well, that concludes our call today. Again, I'd like to thank everyone who took the time to join us this morning and learn more about our recent progress in BRACELET-1 and our plans for registration in this indication. I hope everyone has a wonderful day. Again, thanks very much. Have a great day. Bye.

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