Oncolytics Biotech Inc.

Good afternoon, and welcome to OnClinic's Biotech's first quarter conference call. All participants are now in 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 John Patton, Director of Investor Relations and Communication. 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 Pella Rear Rep, including statements regarding the company's ongoing CEO search, our mission, strategies, and milestones, the company's belief as to the potential and mechanism of action of Pella Rear Rep as a cancer therapeutic, our potential registrational opportunities for Pella Rear Rep, 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 none and no known 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 in which Oncologics expresses an expectation or belief as to future results, Such expectations or beliefs are expressed in good faith, and our beliefs have a reasonable basis, but there can be no assurance that these statements or expectations or beliefs will be achieved. These factors include results of current or 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 CDAR and the SEC. OnClinics 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 OnClinic's Board of Directors and Interim CEO, Wayne Pisano, Chief Medical Officer, Dr. Tom Heinemann, VP of Business Development, Christophe Degas, and Chief Financial Officer, Kirk Loke. 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, John. 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 Christoph to share a 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 Pella RealRep, which has potential in numerous consequential indications, we are aiming to find a leader who can steward Pella with a laser focus on clinical trial execution. Our clinical data continues to exceed expectations, and we believe the further development of Pella will allow it to fulfill its potential as a valuable 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 planned registration-enabling study, evaluating Pella and Paclitaxel in advanced or metastatic HR-positive, HR-2-negative breast cancer. And I hope to be able to announce our new CEO in the near future. Pella Riorette, or Pella 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 Egermont described Pella's benefits, including intravenous administration, the ability to be taken to tumor sites via monocytes and lymphocytes, and that it doesn't create anti-aging antibodies, allowing T cells to reach the tumor for long-lasting responses, all without infecting normal healthy cells. During the same call, Professor Martine Picard, a leading expert in breast cancer, shared her experience in the clinic and confirmed intravenous administration is much preferred to any intratumoral interventions. She also discussed Pella's opportunity in breast cancer and the multitude of registrational opportunities for an asset like Pella. She confirmed support for the continued advancement of Pella 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 Pella 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 Pella and 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 Pella'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 will be sharing this year at 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 Pella 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 two 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 Pella 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 Pell'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 Pella combined with modified fulfirinox with or without atezolizumab. Enrollment into the safety run-in phase of this cohort was recently completed. After review of the safety data by an independent data safety monitoring board and 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 one of the study, which requires a total of 30 evaluable patients, 15 each in the arm with atezolizumab and the arm without atezolizumab. Upon completion of stage one enrollment, a decision will be made whether to advance either one or both arms to stage two enrollment. If the efficacy data are encouraging, this study could lead to yet another registration opportunity. We expect to review initial efficacy data from this cohort later this year and share it 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 two studies in which Pella-based combination therapy substantially outperformed standard of care treatment. The first of these was the IND213 study in metastatic breast cancer, in which median overall survival in the Pella group was nearly double that in the control arm. We followed IND213 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 pellet 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 more than a year longer than that in the control arm. With two randomized phase two 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 de-risked this program, setting the stage for continued development of Pella in breast cancer. In the evolving breast cancer treatment landscape, we have a number of attractive options for the continued development of Pella. 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, Ibrant's, and Daiichi's, and HER2. We also have the option to conduct studies in patients at different stages in the breast cancer treatment path, including patients with an operable 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 Picard, who spoke at the KOL event Wayne mentioned at the start of this call. Next, I would like to introduce Christoph, who will comment on our ongoing business development activities.

Christoph? 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 continue to show the versatility of PELA in multiple indications specifically pancreatic and anal cancer. One underappreciated aspect is a remarkable safety profile of PELLA. PELLA has been administered to over 1,100 patients over the course of its development. While we're encouraged to see there remain no safety concern in anal cancer, where PELLA is being evaluated with a checkpoint inhibitor, atezolizumab, it is now being tested in combination with modified folfrenox in pancreatic cancer. This chemotherapy regimen has a different safety profile than jebcitabine plus napaclitaxel, the chemotherapy regimen from cohort one of the Goblet study. The fact that we are able to combine Pella 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 J.P. Morgan 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 Martin Picard and Professor Lex Eggermont, who continue to be enthusiastic supporters of Pella's potential. During the previously discussed KOL event organized by H.E. Wainwright, both Professor Picard and Professor Eggermont highlighted the need for new treatment innovations such as Pella, that work to activate the immune system to recognize and kill cancer. Furthermore, we already have support from advocacy groups like PanCan who are funding cohort five of the Goblet Study. As I mentioned on a previous call, the compelling data PELLAS generated across multiple indications serves us well. We have two randomized phase two studies showing PELLAS benefits in HR-positive, O2-negative metastatic breast cancer. multiple pancreatic studies pointing to Pella's meaningful impact, and an emerging efficacy signal that has continued to persist in anal cancer. In summary, this continues to be an exciting time for Pella as we evaluate the most efficient way to pursue regulatory approval and further demonstrate the potential our unique immunotherapeutic asset has 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 now turn the presentation over to Kirk, who will discuss our financial 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 investor section of our website under 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 was $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 non-cash 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 was 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, or $0.09 per share in Q1 of 2024. Finally, following the end of our quarter, we were pleased to announce a $20 million U.S. dollar 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. So this includes our financial review. We look forward to providing further updates throughout the year and encourage you to watch for our upcoming poster presentation on Pella's Mechanism of Action at ASCO. On behalf of the entire OnClinics team, I'd like to thank our patients, caregivers, healthcare providers, employees, and shareholders for their ongoing support. Now, I would like to open the call for our Q&A. Operator?

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the one on your telephone keypad. You will hear a prompt that your hand has been raised, and should you wish to cancel the request, please press star followed by the two. If you're using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from the line of Patrick Truchot from H.C. Wainwright. Please go ahead.

Thanks, and good afternoon, and 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, have you received concerning potential registrational pathways? Yeah, hi, Patrick. Tom Heinemann here. Maybe I can answer those, and others can step in if there's more to say. Regarding the, on the breast cancer side, we, as you know, have discussed this study with the FDA at a Type C meeting in the second or third quarter of last year, right? 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 that activity is ongoing. Of course, we're talking to key opinion leaders and exploring all the best options for moving our pancreatic cancer program forward, but we have not had any additional discussions with the FDA recently. If we were to move forward with a registrational study through any means, that would require an FDA meeting before we initiated that study, however. I hope that answers your question. If I forgot anything, let me know. Yeah, that's helpful. And then just to 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, you know, given Pella Rear Rep's mechanism of action, are there plans to explore additional combination approaches, you know, maybe with immune checkpoint inhibitors or in other tumor types?

Hi, Patrick. This is Christophe. Yeah, 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. Yeah, what we're doing right now, as we mentioned, we've been busy at J.P. Morgan. We'll be at ASCO. We'll be at BIO. We're looking at different potential different partnerships. For us, what's very important is, as we discuss during this call, Peli has a potential multiple indication, so we'd like to 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 a 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 on the combination?

Yeah, 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, that Pella clearly potentiates the activity of checkpoint inhibitors. Now, in breast cancer, we have seen very strong efficacy data with Pella 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.

Thanks so much.

Thank you. Once again, should you have a question, please press star four by the one on your telephone keypad. Your next question comes from the line of Michael Freeman from Raymond James. Please go ahead.

Hey, good afternoon, Wayne, Kirk, Tom, Christoph, Tom. Just a few questions here. You mentioned on the metastatic breast program, You know, you've previously discussed a registration path that might enable accelerated approval. And then, you know, I think I'm hearing for the first time discussion of treatment of patients at different stages of the treatment journey and leaning toward, you know, earlier stage patients if I'm hearing it, if I heard it right. I wonder if you could discuss, just like dive into that a little more. Would this be an alternative to a registration enabling trial or would this be like a separate cohort along the treatment journey? If you could just discuss the rationale and different potential registration paths.

Yeah, 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 advance 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 pellet-based combination therapy to step in. And so in discussing with key opinion leaders, there is a sense that One potential way to advance the program and de-risk it and move it forward efficiently would be to specifically generate data in patients who have, these are not earlier stage patients, but these are patients who have failed hormonal therapy and then also failed an antibody drug conjugate. We have every reason to believe that Pella would be a successful agent in that patient population and generating direct data in that population would could be a very nice way to further de-risk the program and also stimulate additional interest by potential partners, investors and so forth who are looking to understand as well as possible where Pella 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.

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

Yeah, we had anticipated that before. The reality of the matter is that at that time it was more hypothetical because the ADCs had not yet 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, but first quarter of this year, with that approval now on the books, that opens up a slightly different population range 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, the appellate's efficacy in that population. You see what I'm saying? Yes. 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 were generated there are robust enough to really move the program forward as rapidly and with as little risk as possible.

Okay. All right. Great. I appreciate you guys being dynamic to the landscape. Now, a question for Kirk. On the share purchase agreement, you know, 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 it offers you.

Yeah, for sure, Michael. I think essentially this Share purchase agreement does provide us with access to capital at our discretion. Importantly, the minimum purchase notice is set at $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's 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 of 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?

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 strategic manner.

Okay. Thank you. That's all from me. Congratulations.

Thank you. There are no further questions at this time. I would now hand the call back to Mr. Kirk Gluck 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 Pella 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.