NASDAQ:ONCY Oncolytics Biotech Q2 2024 Earnings Report $0.59 +0.02 (+3.84%) Closing price 04/29/2025 03:59 PM EasternExtended Trading$0.59 +0.00 (+0.35%) As of 04/29/2025 05:38 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Oncolytics Biotech EPS ResultsActual EPS-$0.07Consensus EPS -$0.08Beat/MissBeat by +$0.01One Year Ago EPS-$0.09Oncolytics Biotech Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AOncolytics Biotech Announcement DetailsQuarterQ2 2024Date8/1/2024TimeN/AConference Call DateThursday, August 1, 2024Conference Call Time4:30PM ETUpcoming EarningsOncolytics Biotech's Q1 2025 earnings is scheduled for Thursday, May 8, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Earnings HistoryCompany ProfilePowered by Oncolytics Biotech Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 1, 2024 ShareLink copied to clipboard.There are 11 speakers on the call. Operator00:00:01To Oncolytics Biotech's 2nd Quarter 2024 Conference Call. All participants are now in a listen only mode. There will be a question and answer session at the end of this call. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Jan Patton, Director of Investor Relations and Communications. Operator00:00:26Please go Speaker 100:00:29ahead. Speaker 200:00:31Thank you, operator. Earlier today, OnClinics issued a press release providing recent operational highlights and financial results for the Q2 of 2024. A replay of today's call will be available on the Events section of the Onclinix website. And after remarks from company management, we will open the call for Q and 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 pelarep, including statements regarding the company's mission, strategy and milestones the company's belief as to the potential and mechanism of action of pelivirip as a cancer therapeutic our belief that we are positioned to execute on our key priorities and reach multiple milestones throughout the second half of the year and into 2025 our potential registrational opportunities for palivirap anticipated timing of the release of additional data, our cash runway and other statements related to anticipated developments in the company's business. Speaker 200:01:27These 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 of 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 belief will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions to our regulatory agencies and those other factors detailed in the company's filings with SEDAR and the SEC. Oncluence does not undertake any obligation to update these forward looking statements except as required by applicable laws. Joining me to discuss the substantial progress we made during the Q2 are a few members of the management team, including Chair of Oncolytics Board of Directors and Interim CEO, Wayne Pisano Chief Medical Officer, Doctor. Speaker 200:02:35Tom Heinemann Chief Financial Officer, Kirk Look Vice President, Business Development, Christophe DeGlois. And with that, it's my pleasure to turn the call over to Wayne. Wayne? Speaker 300:02:47Thank you, John. Good afternoon. I appreciate everyone taking the time to join us today. While I know you are accustomed to our CEO, Matt Coffey leading these presentations, personally and on behalf of the Board, I'd like to wish Matt a swift recovery. In the interim, the Board and I are highly confident in our tenured executive team's ability to continue executing our mission, achieve our strategic priorities and deliver on our long term goals and ultimately bringing pelareorep to patients with cancer. Speaker 300:03:20Following my brief introduction, Tom will provide an update on the clinical advancements, Christoph will discuss recent collaborations and partnership opportunities, Kirk will review the financials. And finally, we will end by taking your questions. In the Q2 of 2024, we continue to make excellent progress in advancing our potentially leading immunotherapeutic agent pelareorep or pellet as we often refer to it. We believe we are well positioned to execute on our key priorities and reach multiple milestones for the second half of the year and into 2025. Now before Tom provides a comprehensive update on our progress and how recent activities continue our mission to improve the lives of people with cancer, I would like to highlight a few important advancements. Speaker 300:04:12Notably, we held an extremely productive Type C meeting with the FDA and we are able to communicate what we consider to be the optimal path for pellet and breast cancer going forward. With input from the agency, we were able to align our key elements for the next steps we plan to take and are bolstered by compelling data from 2 randomized breast cancer studies showing the benefit of Pella combined with paclitaxel compared with paclitaxel monotherapy. This gives us confidence in TELUS potential to demonstrate a clinically meaningful benefit in a future registration enabling study. Importantly, we remain on track to report overall survival results from the BRACELE-one trial in the second half of twenty twenty four. Looking at the opportunity in pancreatic cancer, we dosed the 1st patient in the modified polferonox cohort of the goblet study. Speaker 300:05:11This represents an exciting opportunity to evaluate the combination of PELLA with another first line pancreatic cancer chemotherapy regimen that could result in a second registration program in this indication. As you may recall, this opportunity came about as a result of positive data demonstrating that the combination of Pella, cislelizumab, gemcitabine and nab paclitaxel in pancreatic cancer patients more than doubled the tumor response rates compared to the response rates for chemotherapy treatment alone. That data set not only garnered fast track designation from the FDA, but it also brought us to our collaboration with the Global Coalition For Adaptive Research or GCAR, where this combination will be evaluated in an adaptive registration enabling trial. As we near a critical inflection point in the company's growth trajectory, we are encouraged by the recent regulatory and clinical progress and look forward to building on this momentum. I would now like to turn the call over to Tom to provide a more detailed update. Speaker 300:06:20Tom? Speaker 400:06:22Thank you, Wayne. As a reminder, PELLA is an intravenously delivered immunotherapeutic agent that acts systemically, inducing anticancer immune responses and promoting an inflamed tumor phenotype that is turning cold tumors hot. This allows the anti tumor immune cells induced by Pella to attack the cancer. As Wayne mentioned, we are currently focused on advancing Pella toward registrational studies in breast and pancreatic cancer. We have exciting data and other indications like anal cancer that could eventually lead to additional registrational opportunities, but for today, we'll just focus on breast and pancreatic cancer. Speaker 400:07:01Starting with our breast cancer program, I'd like to touch on 2 topics. Our recent productive Type C meeting with the FDA and the anticipated BRACELET 1 study survival results. In June, we provided a recap of our Type C meeting with the FDA. We had a very productive and helpful discussion with the agency that provided valuable guidance on our proposed registration enabling study. 1 perhaps underappreciated takeaway was that the FDA endorsed progression free survival the primary endpoint of the study with overall survival as a secondary endpoint. Speaker 400:07:36Having progression free survival as the primary endpoint mirrors the path taken by Pfizer for the initial approval of Ibrance based on the PALOMA-one study and could save substantial development time by allowing us to reach the potential registrational endpoint sooner. The patient population for the registrational study is anticipated to include patients who have failed hormonal therapy and have received no more than one line of antibody drug conjugate therapy. Our derisk breast cancer program builds on compelling data and key learnings from 2 prior randomized studies, BRACLE1 and IND-two thirteen, which demonstrated clinically meaningful benefit in patients who were treated with pellet and paclitaxel compared to paclitaxel alone. I should also mention that we have translational data from the AWARE-one study that provided valuable insights into PELLA's immune mediated mechanism of action, including its ability to remodel the tumor microenvironment. Aligning with the FDA on key design elements and objectives of our planned registrational trial marks a critical step toward bringing this innovative treatment to patients. Speaker 400:08:43Next, I'd like to move on to the anticipated BRACELET-one survival data. As a reminder, BRACELET-one is a Phase 2 randomized study in patients with HR positive HER2 negative metastatic breast cancer. The study enrolled 48 patients into 3 cohorts. Patients in Cohort 1 received paclitaxel, which served as the control arm. Patients in Cohort 2 received paclitaxel plus pela and patients in Cohort 3 received paclitaxel, pela and the checkpoint inhibitor avelumab. Speaker 400:09:13We previously reported strong tumor response and progression free survival results from the BRACE-one study. These included a near tripling of the confirmed overall response rate, a greater than 50% improvement in median progression free survival and a hazard ratio of 0.29 for patients receiving Pella and paclitaxel compared to paclitaxel alone. Overall survival results have alone. Overall survival results have not yet been reported due to ongoing patient follow-up, but are anticipated later this year. As noted, the earlier IND-two thirteen study showed a statistically significant survival benefit in HR positive HER2 negative metastatic breast cancer patients who received the combination of Pella and paclitaxel compared to paclitaxel alone. Speaker 400:09:58A strong overall survival readout in the pelapaclitaxel arm in the BRACE-one study will serve to further validate these earlier findings and support continuing discussions with potential strategic partners and regulators. Now turning to our pancreatic cancer program, I'd like to start by highlighting our new goblet study cohort, which is supported by a $5,000,000 therapeutic accelerator award from the Pancreatic Cancer Action Network or PANCAM. PanCAM launched the therapeutic accelerator award to speed up pancreatic cancer drug development so new therapies could be made available to patients sooner. By way of background, the goblet study is a Phase onetwo signal finding study in advanced or metastatic gastrointestinal cancers. The study is being conducted across 17 centers in Germany and is being managed by AIO, a medical oncology working group within the German Cancer Society. Speaker 400:10:58To date, we have evaluated Pella in first line metastatic pancreatic ductal adenocarcinoma or PDAC, 3rd line metastatic colorectal cancer and second line or later anal cancer. In each of these indications, the Pella based combination therapy met the pre specified success criteria. Pancreatic cancer has one of the lowest survival rates among all cancers and is the 3rd leading cause of cancer mortality in the U. S. Despite its growing incidence, efforts to improve upon the standard of care have met with limited success over the past several years. Speaker 400:11:36In June, we announced the dosing of the first patient in our new goblet study cohort evaluating Pella combined with modified filferonox with or without atezolizumab in newly diagnosed metastatic PDAC patients. This study utilizes assignment 2 stage design and the co primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, 1 or both treatment arms may be expanded to Stage 2 in which 17 additional evaluable patients per arm would be enrolled. The chemotherapy regimens of modified filferonox and gemcitabineab paclitaxel are the 2 most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of Pella, gemcitabine, nab paclitaxel and atezolizumab yielded tumor response rates more than double the historical results. Speaker 400:12:34Should the combination of Pella and modified filferonox also produce a positive outcome, it would indicate that an even broader range of metastatic PDAC patients may benefit from pellet based therapy. Importantly, this treatment regimen could result in another registrational opportunity for pellet in this challenging indication. While we believe there's an exciting opportunity for pellet combined with modified filferonox, our immediate registrational strategy in PDAC continues to focus on Pella combined with atezolizumab, gemcitabine and nab paclitaxel based on the very positive results from the goblet study. We continue to collaborate with GCAR to design a study utilizing an adaptive approach to evaluate this combination therapy and we look forward to providing an update as our plans are finalized. Before I turn the call over to Christophe, who will discuss our GCAR collaboration in more detail, I would like to briefly mention our 2 presentations at this year's ASCO meeting. Speaker 400:13:36Details of the trial design for our new goblet study pancreatic cancer cohort in which pelas combined with modified filferonox were presented. Additionally, we presented an abstract detailing Pella's ability to induce the expansion of tumor infiltrating lymphocytes or TILs across multiple cancers including breast, pancreatic and colorectal cancer. TELA's ability to expand Till populations is important because Till expansion correlates with tumor response. These data further highlight Pela's immunotherapeutic mechanism of action and its promise as a backbone immunotherapy for multiple cancer indications. Taken together, we are extremely excited about the advancements across our pipeline and the growing body of clinical data showcasing Pella's broad therapeutic potential. Speaker 400:14:25With that, I will turn the call over to Christophe, who is joining us for the first time on a financial results call. He will be heading up our business development efforts going forward and is here to discuss our recent collaborations and partnership opportunities. Christophe? Speaker 500:14:41Thank you, Tom. I'm excited to join the team and see a real opportunity for Pela and Oncolytics to make an impact to treatment of cancer, so I'm thrilled to be here. In the Q2, we enter into a preliminary collaboration with GCA, which we believe underscores the strength of the growing pillar data set that continues to attract and peak the interest of the clinical oncology committee. GCA is a non profit corporation uniting physicians, clinical researchers, advocacy and philanthropic organizations, biotech pharma companies, health authorities and other key stakeholders in health care. Vika's objective is to expedite the discovery and development of treatment for patients with rare and deadly diseases. Speaker 500:15:28As a sponsor of innovative trials, including master protocols and adaptive platform trials, GKAR is dedicated to the advancement of science by modernizing clinical trials that support more efficient, less costly drug development. We are pleased to partner with GCAR and are honored that PETA has been selected as the 1st therapeutic for evaluation in their planned adaptive trial in pancreatic cancer patients. The selection process was thorough and involved meeting with and presenting our clinical data to multiple pancreatic cancer key opinion leaders. We are working together to finalize a Phase twothree master protocol design that will evaluate PELA and other investigational therapies for the treatment of pancreatic cancer. GCAR's anticipated trial design seeks to cut registrational study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner. Speaker 500:16:26This strategy, which includes leveraging GCAR extensive investigator network, offers a cost effective opportunity to enhance our ability to quickly and effectively advance the development of this PELA based combination therapy for metastatic pancreatic cancer, a disease with a very high unmet medical need and limited treatment options. Beyond GECAR, we intend to continue to seek strategic opportunities to collaborate and maximize the therapeutic and commercial potential of Pela. We have an ongoing dialogue with current and potential collaborators and believe additional data updates will continue to strengthen our value proposition. I will now turn the call over to Kirk to review the financial results for the Q2 of 2024. Kirk? Speaker 600:17:15Thanks, Christophe, and good afternoon, everyone. I'd like to briefly run through our financial results for the Q2 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 afternoon. We continue to be cognizant of our cash resources and make the necessary investments to progress Pella's development, while ensuring we have funds needed to reach critical milestones. As of June 30, 2024, the company reported $24,900,000 in cash and cash equivalents with the projected cash runway into 2025. Speaker 600:18:00Net cash used in operating activities for the 6 months ended June 30, 2024 was $14,300,000 compared to $16,300,000 for the 6 months ended June 30, 2023. The change reflected non cash working capital changes, partly offset by higher net operating activities in 2024. Now general and administrative expenses for the Q2 of 2024 were $3,400,000 consistent with $3,500,000 for the Q2 of 2023. Research and development expenses for the Q2 of 2024 were $4,600,000 compared to $3,700,000 for the Q2 of 2023. The increase was primarily due to higher clinical trial expenses, including Bracelet 1 data analysis and the GCAR collaboration and higher share based compensation expenses. Speaker 600:18:53The increase was partly offset by lower production run and process and analytical development activities The net loss for the Q2 of 2024 was $7,300,000 compared to a net loss of $7,400,000 for the Q2 of 2023. The basic and diluted loss per share was $0.10 per share in the Q2 of 2024 compared to a basic and diluted loss per share of $0.12 in the Q2 of 2023. Now this is an exciting time for the company. And as we conclude today's call, I would like to highlight a few critical events that we believe move us closer to our ultimate goal of regulatory approval for Pella. In the Q2 of 2024, we continue to propel Pella towards registration enabling studies in breast and pancreatic cancer. Speaker 600:19:42We established a strategic collaboration with GCAR and continue to have productive discussions with key opinion leaders, our clinical collaborators and regulators. In summary, we received productive feedback from the Type C meeting with the FDA for our planned registration enabling trial for pelleted HR positive HER2 negative metastatic breast cancer and expect to provide further guidance on the path forward in the second half of the year. We continued following patients from the BRACELET-one breast cancer study and remain on schedule to report overall survival data in the second half of this year. We entered into a collaboration with GCAR for inclusion of Pella in an adaptive registration enabling pancreatic cancer trial and expect to finalize the master protocol for Pella, gemcitabine, nab paclitaxel and atezolizumab in the second half of twenty twenty four. With our collaborators, we then plan to initiate the adaptive registration enabling trial in the first half of twenty twenty five. Speaker 600:20:41We dosed the 1st patient in the new goblet modified fulferonox pancreatic cancer cohort supported by funding from pan can, which could result in another registrational opportunity for Pella. We expect to report a safety run and update in the second half of the year. Taken together, we believe our robust positive clinical and translational data support Pella's MOA as an immunotherapeutic agent and potential to improve the lives of people with cancer. Before we conclude today's call, I would like once again to thank the entire Oncolytics team, our investors and the many people who are supporting us along the way, including our patients and their families. With that, we are happy to take questions. Speaker 600:21:23Operator? Operator00:21:28Thank you. Ladies and gentlemen, we will now begin the question and answer session. And we will now take our first question. This comes from the line of Louise Chen from Cantor. Please go ahead. Speaker 700:22:11Hi, good afternoon, everyone. This is Carly on for Louis from Cantor. Thanks for taking our questions. 1st, can you remind us of the size of the commercial opportunity for Pella and HR plus HER2- metastatic breast cancer? And second, what would your registration trial design look like? Speaker 700:22:30Thank you. Speaker 600:22:34Thanks for the questions, Kirby. First, I'll turn it over to Christophe to speak to the market. Speaker 500:22:42Yes. Hi. Yes, I mean, as you may know, I mean, this is a very changing environment with obviously some ADCs and to in particular making some obviously some changing a lot of this market and based on recent data. So we're currently in the process of updating the commercial opportunity. And I think in the next call, we'll be able to provide more detail. Speaker 500:23:09There's still a significant commercial opportunity. If you think about the way an O2 is going to be used in these patients. Obviously, they are going to they are not approved yet, but I think it's very likely that they would come right after the overall therapy. But unfortunately, as you know, this patient will still relapse and you'll need a subsequent line of treatment. And we believe there's a significant commercial opportunity in ERN2 failures. Speaker 500:23:41And also, we need to think consider the patient who will not be eligible to HER2 because of very low O2 levels or other condition that may prevent the use of an ADC with these patients. Speaker 600:23:57And I'll ask Tom to respond to the plan. Speaker 400:24:01Yes. So we expect to move forward with our next trial in the form of a registration enabling large Phase II study with a primary endpoint of progression free survival and in the population that Christophe actually described, which is patients who have either failed antibody drug conjugate therapy following progression on hormonal therapy or patients for whom antibody drug conjugate therapy is inappropriate or who cannot tolerate such agents. So we and this study would allow us with 2 opportunities to win if it meets a high level of significance for the investigational arm, it would put us in the position of applying for an accelerated approval. And at a very minimum, it would substantially de risk any subsequent trial that we would conduct to confirm the efficacy of the combination therapy. Speaker 700:25:09Great. Thank you so much. Operator00:25:13Thank you. And the next question comes from the line of John Newman from Canaccord. Please go ahead. Speaker 800:25:23Hi, there. Thanks for taking my question. Excuse me. I also had a question about the registration enabling study for pelareorep in breast cancer. I'm assuming that most of the patients, if not all the patients enrolling in the study will have previously been treated with an ADC. Speaker 800:25:48Is there any specificity as to which ADC? And then the second question that I had was just in terms of the geography of the study, would this be primarily a U. S.-based study or would you also include patients from Europe? Thanks. Speaker 400:26:02Yes. So John, I can Tom here. I can comment. So I think the as Christophe said, the treatment approach in patients as it relates to the antibody drug conjugates still evolving, right? So I don't think anyone can say with precision exactly what proportion of patients in our study would have failed antibody drug conjugate therapy. Speaker 400:26:26But I think it's very, very reasonable to assume that the majority of them would have received antibody drug conjugate therapy. There will be patients who are not appropriate for antibody drug conjugate therapy or who take it for a short period of time and cannot tolerate it. So there will be patients who have who come into the study through other pathways. But at present, the data that are available in the population we're looking at would suggest that the antibody drug conjugate therapy that would be most in play that is to say the pop the patient therapy that patients would have failed before coming into our study would be in HER2, right? That's the agent for which the data currently exists suggesting a solid benefit immediately following the failure of hormonal therapy. Speaker 400:27:25On the geography, yes, I'm sorry. Yes, this study, we would anticipate that this study would be a substantial enrollment in North America, of course, and we're currently evaluating possible other geographies for enrollment. It seems reasonable to expect that there would be sites in some of the major Western European countries, for example, and beyond that, we need to consider our option. Speaker 900:27:52Thank you. Operator00:27:56Thank you. And the next question comes from the line of Sumit Roy from Jones Research. Please go ahead. Speaker 1000:28:05Good afternoon, everyone. Possibly a question for Tom. The BRACELET-one trial, have you disclosed P value or was it too small of a cohort size? And second question is, for the Phase II, III race ratio trial in breast cancer, do you expect potentially is a portion of patients being treated with ADC as the only major variable difference between bracelet 1 and the Phase IIIII? Or do you see other changes could be there, differences between Bracelet and the Phase twothree? Speaker 400:28:43Yes. So we have the P value for the PFS comparison, okay. And the comparison the P value for the comparison between paclitaxel and the paclitaxel plus pelareoreb arm was 0.03. So it was less significant at less than the 0.05 level. And with regard to the differences in the bracelet population, yes, I mean, I think you're right. Speaker 400:29:13We would be enrolling patients in this study as discussed already, who have failed ADC therapy, which were not enrolled in bracelet because they simply did not exist at that time. But otherwise the patient population would be essentially identical to the bracelet patient population. Speaker 1000:29:30A quick follow-up, do you expect to do any sub analysis separating out those patients with prior ADC in Phase twothree or are you thinking of what was it? Speaker 400:29:42Well, we haven't so we haven't formalized our analysis plans to that level, but I'm sure that we would be looking at any distinctions between significant population groups within any randomized study. Speaker 900:29:57Thank you again and congrats on the progress. Thank you. Operator00:30:02Thank you. And the next question comes from the line of Michael Kumawyek from Maxim Group. Please go ahead. Speaker 900:30:12Hey, guys. Thank you for taking my questions today. I just want to see if you could help clarify the nature of the additional registrational opportunity that you're saying could emerge from Cohort 5 of the goblet study. Is there an expectation here that you could file for accelerated based on that data? Or are you referring to the ability to launch a second registrational study based on that data? Speaker 400:30:40Yes. So the data that we're generating in Cohort 5 of the goblet study, we view that as a kind of signal finding proof of concept data. We would not expect that those data would support in and of themselves an accelerated approval. However, as you know, we are planning to move forward with the other combination, the pellet plus gemcitabine, nab paclitaxel in through the collaboration with GCAR, right, which is a which is it would be in a registrational approach. And it is certainly possible if the cohort 5 results look good and turn out the way we hope and expect they will that combination could be evaluated, for example, in a platform study such as what we're doing with GCAR already or through some other mechanism. Speaker 900:31:39All right. Thank you. It's very helpful. And then one other for me and I'll hop back in the queue. I wanted to see if you had any expectations on the size of the potential pivotal study in breast cancer that you need based on the prior PFS data that you haven't passed for a PAILA in this setting? Speaker 400:31:56Yes. What we're looking at, I mean the model that we're following is very similar to the approach that was used by Pfizer, for example, for their initial licensure of Ibrance and then subsequently by Daiichi for the initial licensure of INHER2. So what we'd be looking at would be a study of sub-two hundred patients, 180, 200 patients somewhere in that order of magnitude. Speaker 900:32:22All right. Thank you very much and wishing for a speedy recovery for Matt. Speaker 400:32:27Yes. Thank you. Thank you. Operator00:32:30Thank you. And the next question comes from the line of Rahul Sarugaser from Raymond James. Please go ahead. Speaker 100:32:42Good afternoon, gents. Thanks so much for taking our questions. And also I'll just reiterate Jason's point about wishing Speaker 900:32:49a speedy recovery for Matt. Speaker 100:32:51But also following up from Jason's question, talking about the now that you're through the Type C meeting and you're looking at setting up the breast cancer trial, These patients are effectively going to be 2nd, 3rd line after your excellular hormone or potentially an ADC. So, perhaps you can let us know give us a sense of your confidence on patient recruitment, the number sites you'll need to be able to fill the study and how fast do you think you'll be able to recruit given that we think that this can be a relatively competitive patient group? Speaker 400:33:31Well, I mean, I think that in that keep in mind that we are not for the breast cancer, the next study in breast cancer, we are not planning to compete within HER2, right? We would be coming in and recruiting patients who can either not receive in HER2, for example, or who have failed in HER2, right? And for those groups, the only options really available are traditional chemotherapy for the large majority of those patients. And actually to the contrary, I suspect that there will be a pretty high demand for patients participation in a study that offers something with clear earlier data that improves upon standard of care chemo. If you see what I'm saying. Speaker 400:34:22In other words, I think there'll be plenty of patients who would be looking for a better options than what would otherwise be available. So I would anticipate that the enrollment into the study would be reasonably straightforward. Speaker 100:34:40That's helpful, really. Thank you very much. That's very helpful. And now just as a follow on pivoting to the Golub study in Tancan, Could you perhaps give us a sense for the destination at which point partners might be interested? Is there a set of outcomes or interim readouts that you think would engender that interest? Speaker 600:35:10Yes, Raul, thanks for the question. That's a challenging one. Our expectation is on the pancreatic cancer side of things is that we will as we see the GPAR study, the first part of the adaptive design study readout is that we'll be able to leverage that and go out specifically with that information to speak to potential partners. What we do find interesting on the Cohort 5 on the goblet side of things with the modified FOLFIRINOX combination is we think that that can be quite interesting because if it shows some more data as to cohort 1 with the GEMNAB paclitaxel combination, we think that we have an opportunity to capture a large percentage of the pancreatic cancer treatment market in this particular stage. So we will take advantage of that data and those results. Speaker 600:36:21So when they come out and then we'll start to obviously outreach towards partners at that time. That said though, prior to that data coming out, we will have and things are progressing as expected on the bracelet overall survival analysis. And so that's happening much quicker. And so we'll be looking to perform some meaningful outreach with that information in hand subject to the results earlier than what we see out of the pancreatic cancer Speaker 100:37:00cohorts. Terrific. You asked my other question. So thanks very much, Kirk. Really appreciate it. Speaker 1000:37:06We'll get back in the queue and best wishes to Matt. Speaker 600:37:09Thank you. Operator00:37:13Thank you. That concludes our conference I mean the Q and A session for today. And I will now hand back the call to Kirk Luth. Please go ahead, sir. Speaker 600:37:24Well, thank you everyone and for all that are participating in today's call and for your interest in Oncolytics development. We continue to be passionate about improving cancer treatment options for patients and we're taking the necessary steps to bring Pella to patients by working with our regulators, our clinical collaborators and the investigators running our studies. We really look forward to our next opportunity to provide another update on our progress and sharing our plans for the rest of the year and into 2025. I'll end our prepared remarks by wishing everyone a great evening. Thanks very much. Operator00:37:58Thank you. This concludes our conference for today. Thank you all for participating. You may now disconnect your lines.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallOncolytics Biotech Q2 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K) Oncolytics Biotech Earnings HeadlinesOncolytics Biotech® to Showcase New Pancreatic Cancer Data at ASCO Highlighting Pelareorep's Tumor-Fighting Mechanism of ActionApril 24, 2025 | prnewswire.comAs Cancer Rates Climb, Wall Street Turns Its Gaze Toward New Frontiers in Cancer TreatmentsApril 14, 2025 | baystreet.caWhat if America bought gold like it used to?History Says Gold Wins When This Signal Flashes — and It’s Flashing Now Every time the Buffett Indicator has hit extreme levels, stocks have crashed — and gold has dominated the decade that followed. Today, the Buffett Indicator is at its highest reading in history… and Buffett himself is sitting on an unprecedented $325 billion cash pile. Sources say he’s preparing to deploy it — not into stocks, but into gold. Garrett Goggin has uncovered which gold company could be his next big move.April 30, 2025 | Golden Portfolio (Ad)Oncolytics Biotech Secures $20 Million Funding for Pelareorep DevelopmentApril 10, 2025 | tipranks.comOncolytics Biotech® Funds Pelareorep's Ongoing Clinical Development with a Share Purchase Agreement in Partnership with Alumni CapitalApril 10, 2025 | prnewswire.comOncolytics Biotech® and Pelareorep Discussed During Recent H.C. Wainwright Key Opinion Leader Event on Oncolytic Immunotherapies in Breast and Pancreatic CancersApril 10, 2025 | prnewswire.comSee More Oncolytics Biotech Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Oncolytics Biotech? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Oncolytics Biotech and other key companies, straight to your email. Email Address About Oncolytics BiotechOncolytics Biotech (NASDAQ:ONCY), a clinical-stage biopharmaceutical company, focuses on the discovery and development of pharmaceutical products for the treatment of cancer. The company is developing pelareorep, an intravenously delivered immunotherapeutic agent, which is in phase 3 clinical trial for the treatment of hormone receptor-positive / human epidermal growth factor 2-negative metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma. It has a co-development agreement with Merck KGaA and Pfizer Inc. to co-develop pelareorep, as well as with Roche Holding AG. The company was incorporated in 1998 and is headquartered in Calgary, Canada.View Oncolytics Biotech ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Alphabet Rebounds After Strong Earnings and Buyback AnnouncementMarkets Think Robinhood Earnings Could Send the Stock UpIs the Floor in for Lam Research After Bullish Earnings?Texas Instruments: Earnings Beat, Upbeat Guidance Fuel RecoveryMarket Anticipation Builds: Joby Stock Climbs Ahead of EarningsIs Intuitive Surgical a Buy After Volatile Reaction to Earnings?Seismic Shift at Intel: Massive Layoffs Precede Crucial Earnings Upcoming Earnings Monster Beverage (5/1/2025)Airbnb (5/1/2025)Amazon.com (5/1/2025)Apple (5/1/2025)Atlassian (5/1/2025)Amgen (5/1/2025)Strategy (5/1/2025)Linde (5/1/2025)MercadoLibre (5/1/2025)ING Groep (5/1/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 11 speakers on the call. Operator00:00:01To Oncolytics Biotech's 2nd Quarter 2024 Conference Call. All participants are now in a listen only mode. There will be a question and answer session at the end of this call. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Jan Patton, Director of Investor Relations and Communications. Operator00:00:26Please go Speaker 100:00:29ahead. Speaker 200:00:31Thank you, operator. Earlier today, OnClinics issued a press release providing recent operational highlights and financial results for the Q2 of 2024. A replay of today's call will be available on the Events section of the Onclinix website. And after remarks from company management, we will open the call for Q and 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 pelarep, including statements regarding the company's mission, strategy and milestones the company's belief as to the potential and mechanism of action of pelivirip as a cancer therapeutic our belief that we are positioned to execute on our key priorities and reach multiple milestones throughout the second half of the year and into 2025 our potential registrational opportunities for palivirap anticipated timing of the release of additional data, our cash runway and other statements related to anticipated developments in the company's business. Speaker 200:01:27These 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 of 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 belief will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions to our regulatory agencies and those other factors detailed in the company's filings with SEDAR and the SEC. Oncluence does not undertake any obligation to update these forward looking statements except as required by applicable laws. Joining me to discuss the substantial progress we made during the Q2 are a few members of the management team, including Chair of Oncolytics Board of Directors and Interim CEO, Wayne Pisano Chief Medical Officer, Doctor. Speaker 200:02:35Tom Heinemann Chief Financial Officer, Kirk Look Vice President, Business Development, Christophe DeGlois. And with that, it's my pleasure to turn the call over to Wayne. Wayne? Speaker 300:02:47Thank you, John. Good afternoon. I appreciate everyone taking the time to join us today. While I know you are accustomed to our CEO, Matt Coffey leading these presentations, personally and on behalf of the Board, I'd like to wish Matt a swift recovery. In the interim, the Board and I are highly confident in our tenured executive team's ability to continue executing our mission, achieve our strategic priorities and deliver on our long term goals and ultimately bringing pelareorep to patients with cancer. Speaker 300:03:20Following my brief introduction, Tom will provide an update on the clinical advancements, Christoph will discuss recent collaborations and partnership opportunities, Kirk will review the financials. And finally, we will end by taking your questions. In the Q2 of 2024, we continue to make excellent progress in advancing our potentially leading immunotherapeutic agent pelareorep or pellet as we often refer to it. We believe we are well positioned to execute on our key priorities and reach multiple milestones for the second half of the year and into 2025. Now before Tom provides a comprehensive update on our progress and how recent activities continue our mission to improve the lives of people with cancer, I would like to highlight a few important advancements. Speaker 300:04:12Notably, we held an extremely productive Type C meeting with the FDA and we are able to communicate what we consider to be the optimal path for pellet and breast cancer going forward. With input from the agency, we were able to align our key elements for the next steps we plan to take and are bolstered by compelling data from 2 randomized breast cancer studies showing the benefit of Pella combined with paclitaxel compared with paclitaxel monotherapy. This gives us confidence in TELUS potential to demonstrate a clinically meaningful benefit in a future registration enabling study. Importantly, we remain on track to report overall survival results from the BRACELE-one trial in the second half of twenty twenty four. Looking at the opportunity in pancreatic cancer, we dosed the 1st patient in the modified polferonox cohort of the goblet study. Speaker 300:05:11This represents an exciting opportunity to evaluate the combination of PELLA with another first line pancreatic cancer chemotherapy regimen that could result in a second registration program in this indication. As you may recall, this opportunity came about as a result of positive data demonstrating that the combination of Pella, cislelizumab, gemcitabine and nab paclitaxel in pancreatic cancer patients more than doubled the tumor response rates compared to the response rates for chemotherapy treatment alone. That data set not only garnered fast track designation from the FDA, but it also brought us to our collaboration with the Global Coalition For Adaptive Research or GCAR, where this combination will be evaluated in an adaptive registration enabling trial. As we near a critical inflection point in the company's growth trajectory, we are encouraged by the recent regulatory and clinical progress and look forward to building on this momentum. I would now like to turn the call over to Tom to provide a more detailed update. Speaker 300:06:20Tom? Speaker 400:06:22Thank you, Wayne. As a reminder, PELLA is an intravenously delivered immunotherapeutic agent that acts systemically, inducing anticancer immune responses and promoting an inflamed tumor phenotype that is turning cold tumors hot. This allows the anti tumor immune cells induced by Pella to attack the cancer. As Wayne mentioned, we are currently focused on advancing Pella toward registrational studies in breast and pancreatic cancer. We have exciting data and other indications like anal cancer that could eventually lead to additional registrational opportunities, but for today, we'll just focus on breast and pancreatic cancer. Speaker 400:07:01Starting with our breast cancer program, I'd like to touch on 2 topics. Our recent productive Type C meeting with the FDA and the anticipated BRACELET 1 study survival results. In June, we provided a recap of our Type C meeting with the FDA. We had a very productive and helpful discussion with the agency that provided valuable guidance on our proposed registration enabling study. 1 perhaps underappreciated takeaway was that the FDA endorsed progression free survival the primary endpoint of the study with overall survival as a secondary endpoint. Speaker 400:07:36Having progression free survival as the primary endpoint mirrors the path taken by Pfizer for the initial approval of Ibrance based on the PALOMA-one study and could save substantial development time by allowing us to reach the potential registrational endpoint sooner. The patient population for the registrational study is anticipated to include patients who have failed hormonal therapy and have received no more than one line of antibody drug conjugate therapy. Our derisk breast cancer program builds on compelling data and key learnings from 2 prior randomized studies, BRACLE1 and IND-two thirteen, which demonstrated clinically meaningful benefit in patients who were treated with pellet and paclitaxel compared to paclitaxel alone. I should also mention that we have translational data from the AWARE-one study that provided valuable insights into PELLA's immune mediated mechanism of action, including its ability to remodel the tumor microenvironment. Aligning with the FDA on key design elements and objectives of our planned registrational trial marks a critical step toward bringing this innovative treatment to patients. Speaker 400:08:43Next, I'd like to move on to the anticipated BRACELET-one survival data. As a reminder, BRACELET-one is a Phase 2 randomized study in patients with HR positive HER2 negative metastatic breast cancer. The study enrolled 48 patients into 3 cohorts. Patients in Cohort 1 received paclitaxel, which served as the control arm. Patients in Cohort 2 received paclitaxel plus pela and patients in Cohort 3 received paclitaxel, pela and the checkpoint inhibitor avelumab. Speaker 400:09:13We previously reported strong tumor response and progression free survival results from the BRACE-one study. These included a near tripling of the confirmed overall response rate, a greater than 50% improvement in median progression free survival and a hazard ratio of 0.29 for patients receiving Pella and paclitaxel compared to paclitaxel alone. Overall survival results have alone. Overall survival results have not yet been reported due to ongoing patient follow-up, but are anticipated later this year. As noted, the earlier IND-two thirteen study showed a statistically significant survival benefit in HR positive HER2 negative metastatic breast cancer patients who received the combination of Pella and paclitaxel compared to paclitaxel alone. Speaker 400:09:58A strong overall survival readout in the pelapaclitaxel arm in the BRACE-one study will serve to further validate these earlier findings and support continuing discussions with potential strategic partners and regulators. Now turning to our pancreatic cancer program, I'd like to start by highlighting our new goblet study cohort, which is supported by a $5,000,000 therapeutic accelerator award from the Pancreatic Cancer Action Network or PANCAM. PanCAM launched the therapeutic accelerator award to speed up pancreatic cancer drug development so new therapies could be made available to patients sooner. By way of background, the goblet study is a Phase onetwo signal finding study in advanced or metastatic gastrointestinal cancers. The study is being conducted across 17 centers in Germany and is being managed by AIO, a medical oncology working group within the German Cancer Society. Speaker 400:10:58To date, we have evaluated Pella in first line metastatic pancreatic ductal adenocarcinoma or PDAC, 3rd line metastatic colorectal cancer and second line or later anal cancer. In each of these indications, the Pella based combination therapy met the pre specified success criteria. Pancreatic cancer has one of the lowest survival rates among all cancers and is the 3rd leading cause of cancer mortality in the U. S. Despite its growing incidence, efforts to improve upon the standard of care have met with limited success over the past several years. Speaker 400:11:36In June, we announced the dosing of the first patient in our new goblet study cohort evaluating Pella combined with modified filferonox with or without atezolizumab in newly diagnosed metastatic PDAC patients. This study utilizes assignment 2 stage design and the co primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, 1 or both treatment arms may be expanded to Stage 2 in which 17 additional evaluable patients per arm would be enrolled. The chemotherapy regimens of modified filferonox and gemcitabineab paclitaxel are the 2 most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of Pella, gemcitabine, nab paclitaxel and atezolizumab yielded tumor response rates more than double the historical results. Speaker 400:12:34Should the combination of Pella and modified filferonox also produce a positive outcome, it would indicate that an even broader range of metastatic PDAC patients may benefit from pellet based therapy. Importantly, this treatment regimen could result in another registrational opportunity for pellet in this challenging indication. While we believe there's an exciting opportunity for pellet combined with modified filferonox, our immediate registrational strategy in PDAC continues to focus on Pella combined with atezolizumab, gemcitabine and nab paclitaxel based on the very positive results from the goblet study. We continue to collaborate with GCAR to design a study utilizing an adaptive approach to evaluate this combination therapy and we look forward to providing an update as our plans are finalized. Before I turn the call over to Christophe, who will discuss our GCAR collaboration in more detail, I would like to briefly mention our 2 presentations at this year's ASCO meeting. Speaker 400:13:36Details of the trial design for our new goblet study pancreatic cancer cohort in which pelas combined with modified filferonox were presented. Additionally, we presented an abstract detailing Pella's ability to induce the expansion of tumor infiltrating lymphocytes or TILs across multiple cancers including breast, pancreatic and colorectal cancer. TELA's ability to expand Till populations is important because Till expansion correlates with tumor response. These data further highlight Pela's immunotherapeutic mechanism of action and its promise as a backbone immunotherapy for multiple cancer indications. Taken together, we are extremely excited about the advancements across our pipeline and the growing body of clinical data showcasing Pella's broad therapeutic potential. Speaker 400:14:25With that, I will turn the call over to Christophe, who is joining us for the first time on a financial results call. He will be heading up our business development efforts going forward and is here to discuss our recent collaborations and partnership opportunities. Christophe? Speaker 500:14:41Thank you, Tom. I'm excited to join the team and see a real opportunity for Pela and Oncolytics to make an impact to treatment of cancer, so I'm thrilled to be here. In the Q2, we enter into a preliminary collaboration with GCA, which we believe underscores the strength of the growing pillar data set that continues to attract and peak the interest of the clinical oncology committee. GCA is a non profit corporation uniting physicians, clinical researchers, advocacy and philanthropic organizations, biotech pharma companies, health authorities and other key stakeholders in health care. Vika's objective is to expedite the discovery and development of treatment for patients with rare and deadly diseases. Speaker 500:15:28As a sponsor of innovative trials, including master protocols and adaptive platform trials, GKAR is dedicated to the advancement of science by modernizing clinical trials that support more efficient, less costly drug development. We are pleased to partner with GCAR and are honored that PETA has been selected as the 1st therapeutic for evaluation in their planned adaptive trial in pancreatic cancer patients. The selection process was thorough and involved meeting with and presenting our clinical data to multiple pancreatic cancer key opinion leaders. We are working together to finalize a Phase twothree master protocol design that will evaluate PELA and other investigational therapies for the treatment of pancreatic cancer. GCAR's anticipated trial design seeks to cut registrational study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner. Speaker 500:16:26This strategy, which includes leveraging GCAR extensive investigator network, offers a cost effective opportunity to enhance our ability to quickly and effectively advance the development of this PELA based combination therapy for metastatic pancreatic cancer, a disease with a very high unmet medical need and limited treatment options. Beyond GECAR, we intend to continue to seek strategic opportunities to collaborate and maximize the therapeutic and commercial potential of Pela. We have an ongoing dialogue with current and potential collaborators and believe additional data updates will continue to strengthen our value proposition. I will now turn the call over to Kirk to review the financial results for the Q2 of 2024. Kirk? Speaker 600:17:15Thanks, Christophe, and good afternoon, everyone. I'd like to briefly run through our financial results for the Q2 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 afternoon. We continue to be cognizant of our cash resources and make the necessary investments to progress Pella's development, while ensuring we have funds needed to reach critical milestones. As of June 30, 2024, the company reported $24,900,000 in cash and cash equivalents with the projected cash runway into 2025. Speaker 600:18:00Net cash used in operating activities for the 6 months ended June 30, 2024 was $14,300,000 compared to $16,300,000 for the 6 months ended June 30, 2023. The change reflected non cash working capital changes, partly offset by higher net operating activities in 2024. Now general and administrative expenses for the Q2 of 2024 were $3,400,000 consistent with $3,500,000 for the Q2 of 2023. Research and development expenses for the Q2 of 2024 were $4,600,000 compared to $3,700,000 for the Q2 of 2023. The increase was primarily due to higher clinical trial expenses, including Bracelet 1 data analysis and the GCAR collaboration and higher share based compensation expenses. Speaker 600:18:53The increase was partly offset by lower production run and process and analytical development activities The net loss for the Q2 of 2024 was $7,300,000 compared to a net loss of $7,400,000 for the Q2 of 2023. The basic and diluted loss per share was $0.10 per share in the Q2 of 2024 compared to a basic and diluted loss per share of $0.12 in the Q2 of 2023. Now this is an exciting time for the company. And as we conclude today's call, I would like to highlight a few critical events that we believe move us closer to our ultimate goal of regulatory approval for Pella. In the Q2 of 2024, we continue to propel Pella towards registration enabling studies in breast and pancreatic cancer. Speaker 600:19:42We established a strategic collaboration with GCAR and continue to have productive discussions with key opinion leaders, our clinical collaborators and regulators. In summary, we received productive feedback from the Type C meeting with the FDA for our planned registration enabling trial for pelleted HR positive HER2 negative metastatic breast cancer and expect to provide further guidance on the path forward in the second half of the year. We continued following patients from the BRACELET-one breast cancer study and remain on schedule to report overall survival data in the second half of this year. We entered into a collaboration with GCAR for inclusion of Pella in an adaptive registration enabling pancreatic cancer trial and expect to finalize the master protocol for Pella, gemcitabine, nab paclitaxel and atezolizumab in the second half of twenty twenty four. With our collaborators, we then plan to initiate the adaptive registration enabling trial in the first half of twenty twenty five. Speaker 600:20:41We dosed the 1st patient in the new goblet modified fulferonox pancreatic cancer cohort supported by funding from pan can, which could result in another registrational opportunity for Pella. We expect to report a safety run and update in the second half of the year. Taken together, we believe our robust positive clinical and translational data support Pella's MOA as an immunotherapeutic agent and potential to improve the lives of people with cancer. Before we conclude today's call, I would like once again to thank the entire Oncolytics team, our investors and the many people who are supporting us along the way, including our patients and their families. With that, we are happy to take questions. Speaker 600:21:23Operator? Operator00:21:28Thank you. Ladies and gentlemen, we will now begin the question and answer session. And we will now take our first question. This comes from the line of Louise Chen from Cantor. Please go ahead. Speaker 700:22:11Hi, good afternoon, everyone. This is Carly on for Louis from Cantor. Thanks for taking our questions. 1st, can you remind us of the size of the commercial opportunity for Pella and HR plus HER2- metastatic breast cancer? And second, what would your registration trial design look like? Speaker 700:22:30Thank you. Speaker 600:22:34Thanks for the questions, Kirby. First, I'll turn it over to Christophe to speak to the market. Speaker 500:22:42Yes. Hi. Yes, I mean, as you may know, I mean, this is a very changing environment with obviously some ADCs and to in particular making some obviously some changing a lot of this market and based on recent data. So we're currently in the process of updating the commercial opportunity. And I think in the next call, we'll be able to provide more detail. Speaker 500:23:09There's still a significant commercial opportunity. If you think about the way an O2 is going to be used in these patients. Obviously, they are going to they are not approved yet, but I think it's very likely that they would come right after the overall therapy. But unfortunately, as you know, this patient will still relapse and you'll need a subsequent line of treatment. And we believe there's a significant commercial opportunity in ERN2 failures. Speaker 500:23:41And also, we need to think consider the patient who will not be eligible to HER2 because of very low O2 levels or other condition that may prevent the use of an ADC with these patients. Speaker 600:23:57And I'll ask Tom to respond to the plan. Speaker 400:24:01Yes. So we expect to move forward with our next trial in the form of a registration enabling large Phase II study with a primary endpoint of progression free survival and in the population that Christophe actually described, which is patients who have either failed antibody drug conjugate therapy following progression on hormonal therapy or patients for whom antibody drug conjugate therapy is inappropriate or who cannot tolerate such agents. So we and this study would allow us with 2 opportunities to win if it meets a high level of significance for the investigational arm, it would put us in the position of applying for an accelerated approval. And at a very minimum, it would substantially de risk any subsequent trial that we would conduct to confirm the efficacy of the combination therapy. Speaker 700:25:09Great. Thank you so much. Operator00:25:13Thank you. And the next question comes from the line of John Newman from Canaccord. Please go ahead. Speaker 800:25:23Hi, there. Thanks for taking my question. Excuse me. I also had a question about the registration enabling study for pelareorep in breast cancer. I'm assuming that most of the patients, if not all the patients enrolling in the study will have previously been treated with an ADC. Speaker 800:25:48Is there any specificity as to which ADC? And then the second question that I had was just in terms of the geography of the study, would this be primarily a U. S.-based study or would you also include patients from Europe? Thanks. Speaker 400:26:02Yes. So John, I can Tom here. I can comment. So I think the as Christophe said, the treatment approach in patients as it relates to the antibody drug conjugates still evolving, right? So I don't think anyone can say with precision exactly what proportion of patients in our study would have failed antibody drug conjugate therapy. Speaker 400:26:26But I think it's very, very reasonable to assume that the majority of them would have received antibody drug conjugate therapy. There will be patients who are not appropriate for antibody drug conjugate therapy or who take it for a short period of time and cannot tolerate it. So there will be patients who have who come into the study through other pathways. But at present, the data that are available in the population we're looking at would suggest that the antibody drug conjugate therapy that would be most in play that is to say the pop the patient therapy that patients would have failed before coming into our study would be in HER2, right? That's the agent for which the data currently exists suggesting a solid benefit immediately following the failure of hormonal therapy. Speaker 400:27:25On the geography, yes, I'm sorry. Yes, this study, we would anticipate that this study would be a substantial enrollment in North America, of course, and we're currently evaluating possible other geographies for enrollment. It seems reasonable to expect that there would be sites in some of the major Western European countries, for example, and beyond that, we need to consider our option. Speaker 900:27:52Thank you. Operator00:27:56Thank you. And the next question comes from the line of Sumit Roy from Jones Research. Please go ahead. Speaker 1000:28:05Good afternoon, everyone. Possibly a question for Tom. The BRACELET-one trial, have you disclosed P value or was it too small of a cohort size? And second question is, for the Phase II, III race ratio trial in breast cancer, do you expect potentially is a portion of patients being treated with ADC as the only major variable difference between bracelet 1 and the Phase IIIII? Or do you see other changes could be there, differences between Bracelet and the Phase twothree? Speaker 400:28:43Yes. So we have the P value for the PFS comparison, okay. And the comparison the P value for the comparison between paclitaxel and the paclitaxel plus pelareoreb arm was 0.03. So it was less significant at less than the 0.05 level. And with regard to the differences in the bracelet population, yes, I mean, I think you're right. Speaker 400:29:13We would be enrolling patients in this study as discussed already, who have failed ADC therapy, which were not enrolled in bracelet because they simply did not exist at that time. But otherwise the patient population would be essentially identical to the bracelet patient population. Speaker 1000:29:30A quick follow-up, do you expect to do any sub analysis separating out those patients with prior ADC in Phase twothree or are you thinking of what was it? Speaker 400:29:42Well, we haven't so we haven't formalized our analysis plans to that level, but I'm sure that we would be looking at any distinctions between significant population groups within any randomized study. Speaker 900:29:57Thank you again and congrats on the progress. Thank you. Operator00:30:02Thank you. And the next question comes from the line of Michael Kumawyek from Maxim Group. Please go ahead. Speaker 900:30:12Hey, guys. Thank you for taking my questions today. I just want to see if you could help clarify the nature of the additional registrational opportunity that you're saying could emerge from Cohort 5 of the goblet study. Is there an expectation here that you could file for accelerated based on that data? Or are you referring to the ability to launch a second registrational study based on that data? Speaker 400:30:40Yes. So the data that we're generating in Cohort 5 of the goblet study, we view that as a kind of signal finding proof of concept data. We would not expect that those data would support in and of themselves an accelerated approval. However, as you know, we are planning to move forward with the other combination, the pellet plus gemcitabine, nab paclitaxel in through the collaboration with GCAR, right, which is a which is it would be in a registrational approach. And it is certainly possible if the cohort 5 results look good and turn out the way we hope and expect they will that combination could be evaluated, for example, in a platform study such as what we're doing with GCAR already or through some other mechanism. Speaker 900:31:39All right. Thank you. It's very helpful. And then one other for me and I'll hop back in the queue. I wanted to see if you had any expectations on the size of the potential pivotal study in breast cancer that you need based on the prior PFS data that you haven't passed for a PAILA in this setting? Speaker 400:31:56Yes. What we're looking at, I mean the model that we're following is very similar to the approach that was used by Pfizer, for example, for their initial licensure of Ibrance and then subsequently by Daiichi for the initial licensure of INHER2. So what we'd be looking at would be a study of sub-two hundred patients, 180, 200 patients somewhere in that order of magnitude. Speaker 900:32:22All right. Thank you very much and wishing for a speedy recovery for Matt. Speaker 400:32:27Yes. Thank you. Thank you. Operator00:32:30Thank you. And the next question comes from the line of Rahul Sarugaser from Raymond James. Please go ahead. Speaker 100:32:42Good afternoon, gents. Thanks so much for taking our questions. And also I'll just reiterate Jason's point about wishing Speaker 900:32:49a speedy recovery for Matt. Speaker 100:32:51But also following up from Jason's question, talking about the now that you're through the Type C meeting and you're looking at setting up the breast cancer trial, These patients are effectively going to be 2nd, 3rd line after your excellular hormone or potentially an ADC. So, perhaps you can let us know give us a sense of your confidence on patient recruitment, the number sites you'll need to be able to fill the study and how fast do you think you'll be able to recruit given that we think that this can be a relatively competitive patient group? Speaker 400:33:31Well, I mean, I think that in that keep in mind that we are not for the breast cancer, the next study in breast cancer, we are not planning to compete within HER2, right? We would be coming in and recruiting patients who can either not receive in HER2, for example, or who have failed in HER2, right? And for those groups, the only options really available are traditional chemotherapy for the large majority of those patients. And actually to the contrary, I suspect that there will be a pretty high demand for patients participation in a study that offers something with clear earlier data that improves upon standard of care chemo. If you see what I'm saying. Speaker 400:34:22In other words, I think there'll be plenty of patients who would be looking for a better options than what would otherwise be available. So I would anticipate that the enrollment into the study would be reasonably straightforward. Speaker 100:34:40That's helpful, really. Thank you very much. That's very helpful. And now just as a follow on pivoting to the Golub study in Tancan, Could you perhaps give us a sense for the destination at which point partners might be interested? Is there a set of outcomes or interim readouts that you think would engender that interest? Speaker 600:35:10Yes, Raul, thanks for the question. That's a challenging one. Our expectation is on the pancreatic cancer side of things is that we will as we see the GPAR study, the first part of the adaptive design study readout is that we'll be able to leverage that and go out specifically with that information to speak to potential partners. What we do find interesting on the Cohort 5 on the goblet side of things with the modified FOLFIRINOX combination is we think that that can be quite interesting because if it shows some more data as to cohort 1 with the GEMNAB paclitaxel combination, we think that we have an opportunity to capture a large percentage of the pancreatic cancer treatment market in this particular stage. So we will take advantage of that data and those results. Speaker 600:36:21So when they come out and then we'll start to obviously outreach towards partners at that time. That said though, prior to that data coming out, we will have and things are progressing as expected on the bracelet overall survival analysis. And so that's happening much quicker. And so we'll be looking to perform some meaningful outreach with that information in hand subject to the results earlier than what we see out of the pancreatic cancer Speaker 100:37:00cohorts. Terrific. You asked my other question. So thanks very much, Kirk. Really appreciate it. Speaker 1000:37:06We'll get back in the queue and best wishes to Matt. Speaker 600:37:09Thank you. Operator00:37:13Thank you. That concludes our conference I mean the Q and A session for today. And I will now hand back the call to Kirk Luth. Please go ahead, sir. Speaker 600:37:24Well, thank you everyone and for all that are participating in today's call and for your interest in Oncolytics development. We continue to be passionate about improving cancer treatment options for patients and we're taking the necessary steps to bring Pella to patients by working with our regulators, our clinical collaborators and the investigators running our studies. We really look forward to our next opportunity to provide another update on our progress and sharing our plans for the rest of the year and into 2025. I'll end our prepared remarks by wishing everyone a great evening. Thanks very much. Operator00:37:58Thank you. This concludes our conference for today. Thank you all for participating. You may now disconnect your lines.Read morePowered by