NASDAQ:ONCY Oncolytics Biotech Q2 2023 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-$0.09Consensus EPS -$0.09Beat/MissMet ExpectationsOne Year Ago EPS-$0.07Oncolytics Biotech Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AOncolytics Biotech Announcement DetailsQuarterQ2 2023Date8/14/2023TimeBefore Market OpensConference Call DateMonday, August 14, 2023Conference Call Time8:30AM 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 2023 Earnings Call TranscriptProvided by QuartrAugust 14, 2023 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Good morning, and welcome to Oncolytics Biotech's Second Quarter 2023 Conference Call. All participants are now in a listen only mode. There will be a question and answer session at the end of this call. Please be advised that this call is being recorded at the company's request. And I would like to turn the call over to John Patten, Director of Investor Relations and Communications. Operator00:00:24Please go ahead. Speaker 100:00:26Thank you, operator, and good morning, everyone. Earlier this morning, Oncolex issued a press release providing recent operational highlights and Financial Results for the Q2 of 2023. A replay of today's call will be available on the Events and Presentations section of the Oncletics' website As a reminder, Peri's remarks made during this call contain certain forward looking statements relating to the company's business prospects and the development and commercialization of pelivirap, Including statements regarding the company's focus, strategy and objectives, the company's belief as to the potential and mode of action of palareorep as a cancer therapeutic, The company's plans regarding Precision Promise and the anticipated timing of entering into a definitive agreement in connection therewith, the These statements are based on management's current expectations and beliefs and are subject to a number of factors, which involve known and unknown risks, delays, uncertainties and other factors not under the company's control that may cause actual results, performance or achievements of the company to be materially different from the results, 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 expectation or belief will be achieved. Speaker 100:02:00These factors include results of current or pending clinical trials, risk associated with intellectual property protection, financial projections, actions by regulatory agencies, Those are the factors detailed in the company's filings with SEDAR and the SEC. Oncletics does not undertake any obligation to update these forward looking statements On our call today, you'll hear from Oncolytics' Chief Executive Officer, Doctor. Matt Coffey Chief Medical Officer, Doctor. Thomas Heinemann Global Head of Business Development, Andrew D. Gudadaro and Chief Financial Officer, Kirk Look. Speaker 100:02:32I'll now hand the call off to Matt to give a few highlights from this past quarter. Matt? Speaker 200:02:39Thank you, John, and welcome to all who have joined us this morning. We are excited by the continued progress of our CARP programs In June, at the ASCO Annual Meeting, we presented results from our HR positive HER2 negative metastatic breast cancer program. The data from the randomized BRACELET-one trial showed a 50% improvement in progression free survival and a nearly threefold increase in confirmed overall This impressive data readout validated earlier Phase 2 results Meaning this program is now Phase 3 ready. The company will now prioritize progressing swiftly to our registrational trial program in pancreatic cancer has generated compelling data and is clearly attracting attention amongst thought leaders in the community. This is evidenced by Pella being selected as a new investigational treatment in Precision Promise, an innovative adaptive Phase 3 clinical trial designed to The study, if successful, is expected to support approval of Pella in combination with the checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nav paclitaxel for the treatment of first line metastatic pancreatic ductal adenocarcinoma. Speaker 200:04:31KELA's inclusion in Precision Promise is supported by prior pancreatic cancer clinical data that suggests it synergizes with checkpoint inhibition and chemotherapy. As a reminder, our Phase III goblet study data has almost tripled the average historical objective response rate By combining Pella with nab paclitaxel, gemcitabine and atezolizumab in first line advanced pancreatic cancer. However, in total, we have data from over 120 pancreatic cancer patients we have treated across multiple studies with finalized agreements with the Precision Promise team by the Q4 of this year, and we expect to open the investigational treatment of Pella, A checkpoint inhibitor, gemcitabine and nab paclitaxel in early 2024. At the end of July, we announced a U. S. Speaker 200:05:25Dollars 15,000,000 equity offering, which closed last week and was led by a healthcare focused institutional investor. Our HR positive HER2 negative metastatic breast cancer and metastatic pancreatic cancer programs We plan to provide guidance on the registration enabling pathway for both of these programs later this year. Now I will turn the call over to Tom and Andrew for a more detailed We will start with you, Tom. Speaker 300:06:01Thanks, Matt. I'll begin my section by Summarizing and highlighting the key data from our 2 pillar programs. As Matt mentioned, we are thrilled with the readout From our randomized BRACELE-one trial of Pella combined with paclitaxel in HR positive HER2 negative metastatic breast cancer, These data show that pellet combination therapy led to a robust improvement in progression free survival with a hazard ratio of 0.29 And a nearly threefold increase in the confirmed overall response rate. Just to emphasize, a hazard ratio of 0.29 Means the combination of Pella and paclitaxel reduced the risk of disease progression by 71% compared to paclitaxel monotherapy. We hosted a key opinion leader webinar on June 5 to provide expert perspectives on these results And what they mean for our HR positive HER2 negative breast cancer programs next steps. Speaker 300:06:59If you missed the webinar and are interested in a more detailed discussion The Bracelet 1 results, we encourage you to watch the replay that is available in the Events and Presentations section of our company website. As a reminder, BRACELE-one is a randomized Phase 2 trial that enrolled a total of 48 HR positive HER2 negative metastatic breast cancer patients into 3 groups, the control group that received paclitaxel monotherapy, a group that received the combination of paclitaxel and pela And the 3rd group have received paclitaxel, pellet and the checkpoint inhibitor avelumab. The bracelet 1 primary endpoint Overall response rate of week 16 with additional endpoints of progression free survival, safety and tolerability and immune biomarker evaluation. The Bracelet 1 primary endpoint of overall response rate at week 16 increased from 20% in the paclitaxel monotherapy arm to 31% In the paclitaxelpella combination arm, the benefit of adding pela to paclitaxel became even more apparent as the data matured With a 37.5 percent confirmed overall response rate in the pelapaclitaxel combination arm Compared to only 13% for paclitaxel monotherapy, adding avelumab to paclitaxel and pellet did not improve anticancer activity, Which reinforces our decision to focus on the pelapaclitaxel doublet as we move forward to our registrational study. Speaker 300:08:33BRAZLA-one also includes an endpoint of progression free survival, which has been used to support approvals oncology drugs, including in breast cancer. We observed a robust increase in progression free survival in the pellet plus paclitaxel cohort compared to the control arm. Median progression free survival was 6.3 months in the paclitaxel monotherapy group and increased by more than 50% to 9.5 months In the pelapaclitaxel combination group for a hazard ratio of 0.29 as of March 2023 data cutoff. While the study was not designed for statistical comparisons, the progression free survival benefit in the pellet plus paclitaxel arm did In fact, reached statistical significance. The addition of avelumab to the pelopaclitaxel combination did not add clinical benefit. Speaker 300:09:25In fact, the avelumab combination behaves similarly to paclitaxel monotherapy suggesting that the addition of avelumab Actually nullified the beneficial effects of pelo. The question of why adding evelumab may have reversed the beneficial effects of The pelopaclitaxel combination therapy was discussed during our key opinion leader webinar on June 5th. Briefly, Avelumab is unique among licensed checkpoint inhibitors in its ability to bind Fc receptors, including those on immune cells. This may have led to the eradication of potentially protective pellet induced immune responses. Translational data from the BRACLE-one study support this hypothesis. Speaker 300:10:06It is important to note that overall survival results from BRACELET-one have not been reported yet as multiple patients continue to be followed for survival. Bracelin 1 is the 2nd randomized Phase 2 study in which Pella combined with paclitaxel provided clinical benefit in patients with metastatic breast cancer. Specifically, these data support the findings from the earlier IND-two thirteen study in which pellet These two trials taken together provide a strong foundation for a registrational study with dual primary endpoints Overall survival and progression free survival, incorporating progression free survival as an endpoint offers the potential to deliver A key data readout substantially earlier than would be possible with a single primary endpoint of overall survival. Based on the findings from IND-two thirteen And BRACE of 1, we can now confidently move to a registrational study in HR positive HER2 negative metastatic breast cancer. Next, I'd like to switch to a discussion of our pancreatic cancer program. Speaker 300:11:20Our Phase onetwo goblet trial in which patients are treated with Pella Plus Roche's checkpoint inhibitor atezolizumab is evaluating multiple gastrointestinal cancers and continues to make encouraging progress towards key milestones, Especially in the pancreatic cancer cohort, which forms our pipeline's 2nd core pillar. As Matt mentioned, we are very excited The appellate combination therapy has been selected by a panel of pancreatic cancer experts as a new investigational treatment arm in the pivotal Precision Promise Phase 3 platform trial. The Precision Promise trial is designed to The development of promising new therapies for metastatic pancreatic cancer. The trial was designed with guidance from the FDA And optimizes the number of participants needed to generate licensure enabling data. This along with operational efficiencies can accelerate late stage development by up to 2 years compared to traditional registrational trials. Speaker 300:12:21The inclusion of pellet based combination therapy in the PRECISION PROMISE trial It's based on data from our prior pancreatic cancer clinical studies that support Pella's ability to synergize with checkpoint inhibition m Chemotherapy to benefit patients with metastatic pancreatic cancer. Prior data include preliminary results From our Phase onetwo goblet study that showed a 69% objective response rate in first line advanced metastatic pancreatic cancer patients treated with Pella combined with atezolizumab and standard of care chemotherapy gemcitabine and nab paclitaxel. This compares to an average of about 25 percent objective response rate observed at historical trials in metastatic pancreatic cancer. While the goblet study is our most recent pancreatic cancer trial, we also have data from several prior studies in this disease And have treated over 120 pancreatic cancer patients with pellet based combination therapies. The previous studies laid the foundation for the goblet study As they suggested that pellet based combination therapies could provide favorable outcomes in pancreatic cancer patients. Speaker 300:13:33These included improved overall survival as well as potentially beneficial immunologic effects, including the stimulation of adaptive immune responses And an influx of CD8 positive T cells into the tumors. Looking forward, we anticipate providing updated data from the goblet pancreatic cancer cohort as well as updates from the advanced anal and metastatic colorectal cancer cohorts in the second half of the year. We will also provide additional guidance on the path towards registration in pancreatic cancer later this year. Rounding out our recent clinical news, At ASCO this year, we also presented additional preclinical analyses pertaining to Pella's ability to improve CAR T cell therapy in solid tumors. These studies were conducted at the Mayo Clinic in collaboration with Doctor. Speaker 300:14:24Richard Weil And followed a publication in Science Translational Medicine last year that reported Pella's ability to synergistically enhance CAR T cell efficacy in marine cancer models. Specifically, Pella has shown the potential to enable CAR T therapy To effectively treat solid tumors by addressing the most challenging roadblocks for this type of therapy, including reducing antigen escape, Improving T cell perseverance, overcoming the challenging solid tumor microenvironment and notably demonstrating that APELEA BOOST Can enhance efficacy, including cures in 80% of murine solid tumor cases. And with that, Andrew will now speak about our business development efforts. Andrew? Speaker 400:15:12Thank you, Tom, and good morning, everyone. From a BD perspective, the top line data readout from our BRACELET-one trial was the featured headline of the quarter. As the BRACELE-one data mature and we integrate data that we've already generated from IND-two thirteen and AWARE-one, we'll be able to better leverage the full suite Commercialization partnership. We have already established several relationships with leading biopharma companies like Pfizer, Roche, Merck Serrano and others. This initial interest came from our previously reported IND-two thirteen study, which demonstrated statistically significant near doubling of median overall survival An HR positive HER2 negative metastatic breast cancer patients, the same population that was treated in BRACELET-one. Speaker 400:16:08Having seen the BRACELET-one study data made public in June at ASCO, additional biopharma companies have come forward and we have just begun meaningful biopharma community. We plan to foster these relationships to generate competitive tension between potential partners To ensure we reach the optimal deal for the future of HELLA and our shareholders at the right time. On the pancreatic cancer front, We reported interim data from the goblet study in November of last year and we announced we received fast track designation from the FDA in December. The effect of these news events are still being felt in the Precision Promise announcement Tom discussed. What some people may not realize is the vetting process for pelareorep to be included in the precision promise platform trial was quite rigorous. Speaker 400:17:03We had meetings and presentations with multiple in pancreatic cancer top U. S. Key opinion leaders Over the course of several months where they reviewed the goblet data, but also multiple historical pancreatic cancer studies That in aggregate have included over 120 pilaria rep patients. We were very pleased to have been selected for this Phase 3 opportunity in a subset of cancer patients with hematological malignancies. The potential for Palatin to enable CAR T therapies in solid tumor indications Represents an opportunity for us to expand what is an already large market, since solid tumors are the vast majority of the cancers diagnosed each year. Speaker 400:17:59Our strategy is to engage potential partners with the goal of out licensing pellet development as an enabling technology for CAR T therapies, which would allow us to participate in the lucrative upside potential CAR T commercial opportunity with minimal risk and a continued focus on our Current core clinical programs in breast and pancreatic cancer. The impressive and growing safety database, Coppella, combined with numerous leading anticancer agents Without causing unacceptable toxicities has been exhibited across many combinations and indications. This supports the case for Continued development of Pella as an immunotherapy backbone that can enhance the efficacy of other agents and continues to be a strong selling point in our conversations with potential partners who are interested in harnessing its immunologic effects to maximize the commercial impact of their own drugs and therapeutic candidates. Next, I'll hand it to Kirk discuss our recent financial results. Kirk? Speaker 500:18:54Thank you, Andrew. I'm pleased to report that Onclytics continues to improve Financial position. As Matt mentioned at the start of our call, we successfully raised US15 $1,000,000 We're a public offering led by a healthcare focused institutional investor. These funds, along with our existing resources, allow us to move forward with the definitive agreements for the We can continue to move forward with the regulatory process seeking FDA advice and guidance on a registrational study in HR positive HER2 negative metastatic breast cancer. As of June 30, 2023, we had $24,400,000 in cash, cash equivalents and marketable securities compared to $32,100,000 as of December 31, 2022. Speaker 500:19:48After the close of our recently announced public offering, Our pro form a cash balance stands at $42,700,000 and our anticipated financial runway now extends towards the end of 2024. Our general and administrative expenses for the Q2 of 2023 were $3,500,000 compared to $2,800,000 for the same period last year. Now the increase is primarily due to higher Investor Relations activities and a rise in costs associated with our Annual General Meeting. Research and development expenses for the Q2 of 2023 were $3,700,000 compared to $3,200,000 for the same period last year. The increase coming from higher manufacturing and personnel related expenses, partly offset by lower Bracelet 1 study costs. Speaker 500:20:35Now the net loss for the Q2 of 2023 was $7,400,000 compared to $5,100,000 in the Q2 of 2022. This completes my financial review and brings us to Matt's closing remarks. Matt? Speaker 200:20:59Thanks, Kirk. Now before moving to the Q and A, I'll provide a brief recap of all the exciting milestones we expect to achieve by the end of the year. We plan to provide updates at ESMO in the second half of the year from goblet patients in our first line pancreatic cancer cohort and third line metastatic colorectal cancer cohort. We also anticipate providing additional guidance on the registrational pathway for both of our core programs in pancreatic cancer And HR positive HER2 negative metastatic breast cancer. The BRAFAL 1 overall survival data continues to mature, so we'll provide an As always, I would like to express my gratitude for all the contributions from our collaborators, Talendin employees, dedicated investigators, the patients participating in our studies and of course all of our investors. Speaker 200:21:48We'll now open the call up for questions. Operator? Operator00:21:52Thank And your first question will be from Patrick Trucchio at H. C. Wainwright. Please go ahead. Speaker 600:22:25Thanks. Good morning and congrats on all the progress. I guess just a couple of questions from me. The first is, can you talk a little bit about the Case of enrollment in the Precision Promise program and specifically how much influence will you have on the conduct of this program And how is it expected to accelerate the registrational pathway for pelareorep? And then Secondly, also regarding this program, what would you expect to be necessary to lead to an accelerated approval pathway in pancreatic? Speaker 600:22:59And When might you have that first data cut from the program? Speaker 200:23:04Thanks, Patrick. That's a great question. Tom and Andrew are probably Closest to this, I'll let Tom talk to the regulatory acceleration and the benefits of working in this. And I think Andrew might want to weigh in a little bit on what their presumed timelines are based on the enrollment assumptions that they've made public. Tom, do you want to kick us off a little bit? Speaker 300:23:27Sure. So the yes, so the benefits of working with Precision Promise, well, there are several benefits in addition to The cost considerations, One of the benefits is that the Precision Promise protocol is already a well established Study that has been vetted by and discussed at length with the FDA. And so we have already a very solid We know that we're entering a study with a very solid clinical program, very solid clinical pathway. The study is already working with well established and in fact many of the best Academic sites in the U. S. Speaker 300:24:21So that we have a whole access to A large number of pancreatic cancer experts and they're all very experienced Not only in pancreatic cancer, but in with this particular study. And so there is a very solid Group of partners with whom we will be working right away, which will not only enhance the enrollment, but also provide us With individuals with whom we can work, who can help us make sure that everything is going smoothly with the study and deal with any issues that might arise And from a regulatory perspective, as I said, this study was developed and discussed already with the FDA. And so If everything goes smoothly and we come out the other end with the anticipated positive results, Then there should be a clear path towards a BLA submission directly from the results of this study without having To do additional studies subsequently. So that's some of the benefits of working with them in addition to the operational benefits, Which working with sites, as I said, who are very experienced already, since this study is up and running, we do not we can save time because we will not have To do things like initiate sites and get everyone familiar with the protocol. Speaker 300:25:52So I think that there are obvious operational efficiencies in Addition to the regulatory benefits and the access to the strong experts in the field. Speaker 700:26:05Yes. Andrew, Speaker 400:26:09can you enroll Speaker 200:26:09as a number of sites and anticipated enrollment? I think we're targeting 18 months after the time of initiation for that first read? Speaker 400:26:17Yes, about that. We expect we'll sign the agreement In the next couple of months hopefully somewhere around there and then it's about 17 months to get to a gono go Analysis, so figure around the first half of twenty twenty five, we'd have that initial read, Patrick, Because of the fact that and this is much faster than if we had to start this organically as Tom was saying where you have to Start every site. In terms of number of sites, they're at 28 sites. What's unique about the sites is they're all brand name, Top sites with some of the most famous pancreatic KOLs in the industry. So you're talking about places like MD Anderson, Memorial Sloan Kettering So they can recruit fast because that's where patients are referred to for something as intractable as pancreatic. Speaker 400:27:15So, they've given us their projections. We're pretty positive that we can get to that go, no go decision around the first half of twenty twenty five, Assuming everything moves forward as planned with the execution of the definitive agreements and other paperwork that needs to be put in place and that's already ongoing as we speak. Speaker 600:27:35Right. Got it. That's really helpful. And I'm wondering if you can discuss further some of the preclinical research collaboration evaluating pellet plus CAR T combination and when you might have further details to present? Speaker 400:27:50That's a great question. So we do have companies we've been public about without naming whom, who are testing Largely, for instance, with PD-one L1s, we work pretty well with all of them with the exception of 1, that had the Fc portion, discrepancy. That's not the case with CAR Ts. CAR Ts, as you know, are very particular, both to the antigen, their construct, How they're made and what they target. And so we really have to go 1 by 1 with companies that are interested and have Arpella tested with their constructs. Speaker 400:28:32So far, the results have been promising. But I don't know yet When those will be presented because a lot of that is really in the hands, is dependent on the type of agreement and How willing the company may be to share those results publicly quickly, especially if it confers a Potential advantage in moving forward. But certainly, before anything moves into the clinic, they would have to sign a definitive licensing agreement with us to allow them Do that work. And so at that point, we would make something more public for sure. Speaker 600:29:09Great. Thank you very much. Operator00:29:12Thank you. Next question will be from Soumit Roy at Jones Research. Please go ahead. Speaker 700:29:19Good morning, everyone, and congratulations on all the progress. On the breast cancer front, trying to understand how stringent was the enrollment criteria for the HER2 negatives. Do you think there were some HER2 lows were considered Prior to reemergence of HER2, low to be actually effective against HER2 therapies. So trying to understand if How stringent was the enrollment criteria and what went right in fact with your 15, 16 patient on each arm trial That is giving you the confidence that in the registration trial, you're going to have that kind of enrollment criteria that would continue the success? Speaker 200:30:03Tom, do Speaker 400:30:05you want to jump in Speaker 200:30:06and talk about, sort of the evolving HER2 status and what that means potentially going forward and why we're so confident that this study is replicating what we're seeing with IND-two thirteen? Speaker 300:30:19Sure. So when this study was enrolled, of course, the concept of HER2 low As a marker for specific therapy was not in play yet, right? The antibody drug conjugates had not been approved. So patients so we do so we are I'm quite sure that in this study both we enrolled both HER2 negative and HER2 low patients As would have been expected in a study like this, but the reason that we're confident that the data from this study provide a basis for moving forward Is that in this population, these are patients who had failed standard of care hormonal therapy, including CDK4six So this is a population that is very typical of patients who with metastatic breast cancer who are now ready for chemotherapy. And in this population, we saw a very strong objective response rate and PFS benefit. Speaker 300:31:21And so going forward, these patients are still going to exist in the real world even with the advent of the antibody drug conjugates Because some patients as you know will not be eligible for antibody drug conjugates and they will need options, But even perhaps more importantly, there are going to be patients who receive antibody drug conjugates who then fail those because as good as they are, they are not Sure. So once patients are treated with antibody drug conjugates and then progress, they will also need treatment options. And Speaker 700:31:56we believe that Speaker 300:31:59the pellet based combination will be a very potentially beneficial Treatment for both patients who are antibody drug conjugate ineligible and those who ultimately fail antibody drug conjugate therapy. Speaker 700:32:15So for the registration trial, how would you set up the enrollment criteria? Would you make it strictly as HER2 negatives or You would be more amenable depending on the physician's charge if they are ready. Speaker 600:32:28Well, I think I mean, this Speaker 300:32:29is a matter for Ongoing discussion, including ultimately with the FDA, but I think we can pretty confidently say that there is a medical population with a Substantial medical need that we can define in the Phase 3 population, right. So whether the exact details Need to be worked out, but it's likely to include, for example, patients who have failed antibody drug conjugate therapy, Plus or minus perhaps those patients who are ineligible for antibody drug conjugate. So there are plenty of patients out there Who are going to need options and I don't think we'll have any trouble to finding a population in Phase 3 that can address that need. Speaker 200:33:12Understandable. Thank you for Speaker 700:33:13the color. And just one last question. When should we expect the update on the registration trial for breast cancer? Is it More like end of the year. And the second is or third is the pancreatic cancer trial, do we know the Primary endpoint is the CFS or the U. Speaker 700:33:31S? Speaker 300:33:33Yes. I mean for the pancreatic cancer trial, It will be overall survival, right, as is typical customary in pancreatic cancer studies. Perhaps I'll let Matt comment on the update of the breast cancer. Speaker 500:33:51Yes. Shobhit, Speaker 200:33:53We're letting the OS actually develop, just to make sure that we have the likelihood of a dual endpoint. We're still actually Tracing or tracking patients who are just receiving paclitaxel plus pellet. So we haven't even got the full PFS actually on that, which is fascinating because ARM-one, we didn't even get anyone out to like 12 months. We know we have patients out at cycle 22, 23 now. What we sort of suspect will happen is we're in discussion with a number of groups, as Tom alluded to. Speaker 200:34:25We think it's Probably easiest to capture this population in the post ADAC, so people would go from a CDK4six to a first line ADAC. That's we're just seeing people get on to first line ADX now. We do anticipate after San Antonio, there'll be more of these patients. So we're thinking about a sufficient pool of patients will be available mid next year. In terms of regulatory filings, we'll be reaching out to So we're hoping for the ability to provide some regulatory guidance late this year, early next as the OS matures. Speaker 200:35:00But some of this, of course, is just scheduling with the FDA. And of course, the parties we're talking to who have vested interested in the ADACs Would obviously like us to not cannibalize those sales, but rather be accretive to them by just tracking the same patients that are going to be able to receive the HR Lowes and presumably, Shamin, as I'm sure you know at ASCO, the true HR negative patients, There's literature now saying you can test a patient and have them be negative, test them again and they'll be slightly positive. So the whole concept around what is an HR negative patient, I think, is in flux. So I think by doing our regulatory filings this year, we'll have more color around what the true nature of the patient population is. But as Tom said, There's no shortage of these patients. Speaker 200:35:46So we're very confident we'll get to a definable patient population that stakeholders and the FDA can agree with. Speaker 700:35:55Thank you so much again for all the color and taking the questions. I look forward to the ESMO data. Speaker 200:36:02Thanks so Operator00:36:03much. Thank you. And your next question will be from John Newman at Canaccord. Please go ahead. Speaker 200:36:17Hey guys, good morning and thanks for taking my question. So Matt, Just had a kind of a follow-up question on the ADCs. How do you think about pelareorep, excuse me, being used long term With ADCs, do you kind of do you see a pathway here where perhaps you get your initial approval in combination with chemotherapy, but then You're able to perhaps investigate the combination with ADCs. And if so, is there a specific subset of patients That you think might be more attractive for that combination? Thanks. Speaker 200:36:56Yes. No, absolutely. To the first part of your question, what we would look To do is go after ADAC failures who are still taxic naive. So similar to the patient population that we treated on bracelets In terms that they would be taxane naive, we don't think that ADACs are especially immunosuppressive. They're actually deemed to be quite, I don't want to say mild, but mild in terms in comparison to chemotherapy. Speaker 200:37:23So we don't think this would be something that would diminish the immunological response. In terms of ultimately combining with ADEX, we are very interested in that possibility. What we know of our agent is anything that causes a cellular stress does lead to susceptibility, especially in the context of not being immunosuppressive, That has always been a concern of the company that we'd be using too high chemotherapy that you would blunt the immunological response to this. What we are seeing is the product does seem to work better in patients that have better immunological status or basically just saying it works better in patients It's heavily appreciated. So we do think that there is a role for combining this with ADAC. Speaker 200:38:06That would be part of our lifecycle management. And it is something that stakeholders have actively asked us to pursue. So it is obviously an area of interest for us. Great. Thank you. Operator00:38:20Thank you. And at this time, gentlemen, it appears that we have no other questions. Please proceed with any closing remarks. Speaker 200:38:29Well, thank you, operator, and thanks to all who joined our call today. Have a great day. Thanks very much. Operator00:38:34Thank you, sir. Ladies and gentlemen, this does indeed conclude your conference call for today. Once again, thank you for attending. And at this time, we do ask that you please disconnect your lines.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallOncolytics Biotech Q2 202300:00 / 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.caDOGE officially begins retirement transformationElon Musk's Department of Government Efficiency ("DOGE") just announced the first-ever "fully digital retirement" process . This fired the starting gun on the biggest economic transformation in American history.April 30, 2025 | Altimetry (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 8 speakers on the call. Operator00:00:00Good morning, and welcome to Oncolytics Biotech's Second Quarter 2023 Conference Call. All participants are now in a listen only mode. There will be a question and answer session at the end of this call. Please be advised that this call is being recorded at the company's request. And I would like to turn the call over to John Patten, Director of Investor Relations and Communications. Operator00:00:24Please go ahead. Speaker 100:00:26Thank you, operator, and good morning, everyone. Earlier this morning, Oncolex issued a press release providing recent operational highlights and Financial Results for the Q2 of 2023. A replay of today's call will be available on the Events and Presentations section of the Oncletics' website As a reminder, Peri's remarks made during this call contain certain forward looking statements relating to the company's business prospects and the development and commercialization of pelivirap, Including statements regarding the company's focus, strategy and objectives, the company's belief as to the potential and mode of action of palareorep as a cancer therapeutic, The company's plans regarding Precision Promise and the anticipated timing of entering into a definitive agreement in connection therewith, the These statements are based on management's current expectations and beliefs and are subject to a number of factors, which involve known and unknown risks, delays, uncertainties and other factors not under the company's control that may cause actual results, performance or achievements of the company to be materially different from the results, 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 expectation or belief will be achieved. Speaker 100:02:00These factors include results of current or pending clinical trials, risk associated with intellectual property protection, financial projections, actions by regulatory agencies, Those are the factors detailed in the company's filings with SEDAR and the SEC. Oncletics does not undertake any obligation to update these forward looking statements On our call today, you'll hear from Oncolytics' Chief Executive Officer, Doctor. Matt Coffey Chief Medical Officer, Doctor. Thomas Heinemann Global Head of Business Development, Andrew D. Gudadaro and Chief Financial Officer, Kirk Look. Speaker 100:02:32I'll now hand the call off to Matt to give a few highlights from this past quarter. Matt? Speaker 200:02:39Thank you, John, and welcome to all who have joined us this morning. We are excited by the continued progress of our CARP programs In June, at the ASCO Annual Meeting, we presented results from our HR positive HER2 negative metastatic breast cancer program. The data from the randomized BRACELET-one trial showed a 50% improvement in progression free survival and a nearly threefold increase in confirmed overall This impressive data readout validated earlier Phase 2 results Meaning this program is now Phase 3 ready. The company will now prioritize progressing swiftly to our registrational trial program in pancreatic cancer has generated compelling data and is clearly attracting attention amongst thought leaders in the community. This is evidenced by Pella being selected as a new investigational treatment in Precision Promise, an innovative adaptive Phase 3 clinical trial designed to The study, if successful, is expected to support approval of Pella in combination with the checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nav paclitaxel for the treatment of first line metastatic pancreatic ductal adenocarcinoma. Speaker 200:04:31KELA's inclusion in Precision Promise is supported by prior pancreatic cancer clinical data that suggests it synergizes with checkpoint inhibition and chemotherapy. As a reminder, our Phase III goblet study data has almost tripled the average historical objective response rate By combining Pella with nab paclitaxel, gemcitabine and atezolizumab in first line advanced pancreatic cancer. However, in total, we have data from over 120 pancreatic cancer patients we have treated across multiple studies with finalized agreements with the Precision Promise team by the Q4 of this year, and we expect to open the investigational treatment of Pella, A checkpoint inhibitor, gemcitabine and nab paclitaxel in early 2024. At the end of July, we announced a U. S. Speaker 200:05:25Dollars 15,000,000 equity offering, which closed last week and was led by a healthcare focused institutional investor. Our HR positive HER2 negative metastatic breast cancer and metastatic pancreatic cancer programs We plan to provide guidance on the registration enabling pathway for both of these programs later this year. Now I will turn the call over to Tom and Andrew for a more detailed We will start with you, Tom. Speaker 300:06:01Thanks, Matt. I'll begin my section by Summarizing and highlighting the key data from our 2 pillar programs. As Matt mentioned, we are thrilled with the readout From our randomized BRACELE-one trial of Pella combined with paclitaxel in HR positive HER2 negative metastatic breast cancer, These data show that pellet combination therapy led to a robust improvement in progression free survival with a hazard ratio of 0.29 And a nearly threefold increase in the confirmed overall response rate. Just to emphasize, a hazard ratio of 0.29 Means the combination of Pella and paclitaxel reduced the risk of disease progression by 71% compared to paclitaxel monotherapy. We hosted a key opinion leader webinar on June 5 to provide expert perspectives on these results And what they mean for our HR positive HER2 negative breast cancer programs next steps. Speaker 300:06:59If you missed the webinar and are interested in a more detailed discussion The Bracelet 1 results, we encourage you to watch the replay that is available in the Events and Presentations section of our company website. As a reminder, BRACELE-one is a randomized Phase 2 trial that enrolled a total of 48 HR positive HER2 negative metastatic breast cancer patients into 3 groups, the control group that received paclitaxel monotherapy, a group that received the combination of paclitaxel and pela And the 3rd group have received paclitaxel, pellet and the checkpoint inhibitor avelumab. The bracelet 1 primary endpoint Overall response rate of week 16 with additional endpoints of progression free survival, safety and tolerability and immune biomarker evaluation. The Bracelet 1 primary endpoint of overall response rate at week 16 increased from 20% in the paclitaxel monotherapy arm to 31% In the paclitaxelpella combination arm, the benefit of adding pela to paclitaxel became even more apparent as the data matured With a 37.5 percent confirmed overall response rate in the pelapaclitaxel combination arm Compared to only 13% for paclitaxel monotherapy, adding avelumab to paclitaxel and pellet did not improve anticancer activity, Which reinforces our decision to focus on the pelapaclitaxel doublet as we move forward to our registrational study. Speaker 300:08:33BRAZLA-one also includes an endpoint of progression free survival, which has been used to support approvals oncology drugs, including in breast cancer. We observed a robust increase in progression free survival in the pellet plus paclitaxel cohort compared to the control arm. Median progression free survival was 6.3 months in the paclitaxel monotherapy group and increased by more than 50% to 9.5 months In the pelapaclitaxel combination group for a hazard ratio of 0.29 as of March 2023 data cutoff. While the study was not designed for statistical comparisons, the progression free survival benefit in the pellet plus paclitaxel arm did In fact, reached statistical significance. The addition of avelumab to the pelopaclitaxel combination did not add clinical benefit. Speaker 300:09:25In fact, the avelumab combination behaves similarly to paclitaxel monotherapy suggesting that the addition of avelumab Actually nullified the beneficial effects of pelo. The question of why adding evelumab may have reversed the beneficial effects of The pelopaclitaxel combination therapy was discussed during our key opinion leader webinar on June 5th. Briefly, Avelumab is unique among licensed checkpoint inhibitors in its ability to bind Fc receptors, including those on immune cells. This may have led to the eradication of potentially protective pellet induced immune responses. Translational data from the BRACLE-one study support this hypothesis. Speaker 300:10:06It is important to note that overall survival results from BRACELET-one have not been reported yet as multiple patients continue to be followed for survival. Bracelin 1 is the 2nd randomized Phase 2 study in which Pella combined with paclitaxel provided clinical benefit in patients with metastatic breast cancer. Specifically, these data support the findings from the earlier IND-two thirteen study in which pellet These two trials taken together provide a strong foundation for a registrational study with dual primary endpoints Overall survival and progression free survival, incorporating progression free survival as an endpoint offers the potential to deliver A key data readout substantially earlier than would be possible with a single primary endpoint of overall survival. Based on the findings from IND-two thirteen And BRACE of 1, we can now confidently move to a registrational study in HR positive HER2 negative metastatic breast cancer. Next, I'd like to switch to a discussion of our pancreatic cancer program. Speaker 300:11:20Our Phase onetwo goblet trial in which patients are treated with Pella Plus Roche's checkpoint inhibitor atezolizumab is evaluating multiple gastrointestinal cancers and continues to make encouraging progress towards key milestones, Especially in the pancreatic cancer cohort, which forms our pipeline's 2nd core pillar. As Matt mentioned, we are very excited The appellate combination therapy has been selected by a panel of pancreatic cancer experts as a new investigational treatment arm in the pivotal Precision Promise Phase 3 platform trial. The Precision Promise trial is designed to The development of promising new therapies for metastatic pancreatic cancer. The trial was designed with guidance from the FDA And optimizes the number of participants needed to generate licensure enabling data. This along with operational efficiencies can accelerate late stage development by up to 2 years compared to traditional registrational trials. Speaker 300:12:21The inclusion of pellet based combination therapy in the PRECISION PROMISE trial It's based on data from our prior pancreatic cancer clinical studies that support Pella's ability to synergize with checkpoint inhibition m Chemotherapy to benefit patients with metastatic pancreatic cancer. Prior data include preliminary results From our Phase onetwo goblet study that showed a 69% objective response rate in first line advanced metastatic pancreatic cancer patients treated with Pella combined with atezolizumab and standard of care chemotherapy gemcitabine and nab paclitaxel. This compares to an average of about 25 percent objective response rate observed at historical trials in metastatic pancreatic cancer. While the goblet study is our most recent pancreatic cancer trial, we also have data from several prior studies in this disease And have treated over 120 pancreatic cancer patients with pellet based combination therapies. The previous studies laid the foundation for the goblet study As they suggested that pellet based combination therapies could provide favorable outcomes in pancreatic cancer patients. Speaker 300:13:33These included improved overall survival as well as potentially beneficial immunologic effects, including the stimulation of adaptive immune responses And an influx of CD8 positive T cells into the tumors. Looking forward, we anticipate providing updated data from the goblet pancreatic cancer cohort as well as updates from the advanced anal and metastatic colorectal cancer cohorts in the second half of the year. We will also provide additional guidance on the path towards registration in pancreatic cancer later this year. Rounding out our recent clinical news, At ASCO this year, we also presented additional preclinical analyses pertaining to Pella's ability to improve CAR T cell therapy in solid tumors. These studies were conducted at the Mayo Clinic in collaboration with Doctor. Speaker 300:14:24Richard Weil And followed a publication in Science Translational Medicine last year that reported Pella's ability to synergistically enhance CAR T cell efficacy in marine cancer models. Specifically, Pella has shown the potential to enable CAR T therapy To effectively treat solid tumors by addressing the most challenging roadblocks for this type of therapy, including reducing antigen escape, Improving T cell perseverance, overcoming the challenging solid tumor microenvironment and notably demonstrating that APELEA BOOST Can enhance efficacy, including cures in 80% of murine solid tumor cases. And with that, Andrew will now speak about our business development efforts. Andrew? Speaker 400:15:12Thank you, Tom, and good morning, everyone. From a BD perspective, the top line data readout from our BRACELET-one trial was the featured headline of the quarter. As the BRACELE-one data mature and we integrate data that we've already generated from IND-two thirteen and AWARE-one, we'll be able to better leverage the full suite Commercialization partnership. We have already established several relationships with leading biopharma companies like Pfizer, Roche, Merck Serrano and others. This initial interest came from our previously reported IND-two thirteen study, which demonstrated statistically significant near doubling of median overall survival An HR positive HER2 negative metastatic breast cancer patients, the same population that was treated in BRACELET-one. Speaker 400:16:08Having seen the BRACELET-one study data made public in June at ASCO, additional biopharma companies have come forward and we have just begun meaningful biopharma community. We plan to foster these relationships to generate competitive tension between potential partners To ensure we reach the optimal deal for the future of HELLA and our shareholders at the right time. On the pancreatic cancer front, We reported interim data from the goblet study in November of last year and we announced we received fast track designation from the FDA in December. The effect of these news events are still being felt in the Precision Promise announcement Tom discussed. What some people may not realize is the vetting process for pelareorep to be included in the precision promise platform trial was quite rigorous. Speaker 400:17:03We had meetings and presentations with multiple in pancreatic cancer top U. S. Key opinion leaders Over the course of several months where they reviewed the goblet data, but also multiple historical pancreatic cancer studies That in aggregate have included over 120 pilaria rep patients. We were very pleased to have been selected for this Phase 3 opportunity in a subset of cancer patients with hematological malignancies. The potential for Palatin to enable CAR T therapies in solid tumor indications Represents an opportunity for us to expand what is an already large market, since solid tumors are the vast majority of the cancers diagnosed each year. Speaker 400:17:59Our strategy is to engage potential partners with the goal of out licensing pellet development as an enabling technology for CAR T therapies, which would allow us to participate in the lucrative upside potential CAR T commercial opportunity with minimal risk and a continued focus on our Current core clinical programs in breast and pancreatic cancer. The impressive and growing safety database, Coppella, combined with numerous leading anticancer agents Without causing unacceptable toxicities has been exhibited across many combinations and indications. This supports the case for Continued development of Pella as an immunotherapy backbone that can enhance the efficacy of other agents and continues to be a strong selling point in our conversations with potential partners who are interested in harnessing its immunologic effects to maximize the commercial impact of their own drugs and therapeutic candidates. Next, I'll hand it to Kirk discuss our recent financial results. Kirk? Speaker 500:18:54Thank you, Andrew. I'm pleased to report that Onclytics continues to improve Financial position. As Matt mentioned at the start of our call, we successfully raised US15 $1,000,000 We're a public offering led by a healthcare focused institutional investor. These funds, along with our existing resources, allow us to move forward with the definitive agreements for the We can continue to move forward with the regulatory process seeking FDA advice and guidance on a registrational study in HR positive HER2 negative metastatic breast cancer. As of June 30, 2023, we had $24,400,000 in cash, cash equivalents and marketable securities compared to $32,100,000 as of December 31, 2022. Speaker 500:19:48After the close of our recently announced public offering, Our pro form a cash balance stands at $42,700,000 and our anticipated financial runway now extends towards the end of 2024. Our general and administrative expenses for the Q2 of 2023 were $3,500,000 compared to $2,800,000 for the same period last year. Now the increase is primarily due to higher Investor Relations activities and a rise in costs associated with our Annual General Meeting. Research and development expenses for the Q2 of 2023 were $3,700,000 compared to $3,200,000 for the same period last year. The increase coming from higher manufacturing and personnel related expenses, partly offset by lower Bracelet 1 study costs. Speaker 500:20:35Now the net loss for the Q2 of 2023 was $7,400,000 compared to $5,100,000 in the Q2 of 2022. This completes my financial review and brings us to Matt's closing remarks. Matt? Speaker 200:20:59Thanks, Kirk. Now before moving to the Q and A, I'll provide a brief recap of all the exciting milestones we expect to achieve by the end of the year. We plan to provide updates at ESMO in the second half of the year from goblet patients in our first line pancreatic cancer cohort and third line metastatic colorectal cancer cohort. We also anticipate providing additional guidance on the registrational pathway for both of our core programs in pancreatic cancer And HR positive HER2 negative metastatic breast cancer. The BRAFAL 1 overall survival data continues to mature, so we'll provide an As always, I would like to express my gratitude for all the contributions from our collaborators, Talendin employees, dedicated investigators, the patients participating in our studies and of course all of our investors. Speaker 200:21:48We'll now open the call up for questions. Operator? Operator00:21:52Thank And your first question will be from Patrick Trucchio at H. C. Wainwright. Please go ahead. Speaker 600:22:25Thanks. Good morning and congrats on all the progress. I guess just a couple of questions from me. The first is, can you talk a little bit about the Case of enrollment in the Precision Promise program and specifically how much influence will you have on the conduct of this program And how is it expected to accelerate the registrational pathway for pelareorep? And then Secondly, also regarding this program, what would you expect to be necessary to lead to an accelerated approval pathway in pancreatic? Speaker 600:22:59And When might you have that first data cut from the program? Speaker 200:23:04Thanks, Patrick. That's a great question. Tom and Andrew are probably Closest to this, I'll let Tom talk to the regulatory acceleration and the benefits of working in this. And I think Andrew might want to weigh in a little bit on what their presumed timelines are based on the enrollment assumptions that they've made public. Tom, do you want to kick us off a little bit? Speaker 300:23:27Sure. So the yes, so the benefits of working with Precision Promise, well, there are several benefits in addition to The cost considerations, One of the benefits is that the Precision Promise protocol is already a well established Study that has been vetted by and discussed at length with the FDA. And so we have already a very solid We know that we're entering a study with a very solid clinical program, very solid clinical pathway. The study is already working with well established and in fact many of the best Academic sites in the U. S. Speaker 300:24:21So that we have a whole access to A large number of pancreatic cancer experts and they're all very experienced Not only in pancreatic cancer, but in with this particular study. And so there is a very solid Group of partners with whom we will be working right away, which will not only enhance the enrollment, but also provide us With individuals with whom we can work, who can help us make sure that everything is going smoothly with the study and deal with any issues that might arise And from a regulatory perspective, as I said, this study was developed and discussed already with the FDA. And so If everything goes smoothly and we come out the other end with the anticipated positive results, Then there should be a clear path towards a BLA submission directly from the results of this study without having To do additional studies subsequently. So that's some of the benefits of working with them in addition to the operational benefits, Which working with sites, as I said, who are very experienced already, since this study is up and running, we do not we can save time because we will not have To do things like initiate sites and get everyone familiar with the protocol. Speaker 300:25:52So I think that there are obvious operational efficiencies in Addition to the regulatory benefits and the access to the strong experts in the field. Speaker 700:26:05Yes. Andrew, Speaker 400:26:09can you enroll Speaker 200:26:09as a number of sites and anticipated enrollment? I think we're targeting 18 months after the time of initiation for that first read? Speaker 400:26:17Yes, about that. We expect we'll sign the agreement In the next couple of months hopefully somewhere around there and then it's about 17 months to get to a gono go Analysis, so figure around the first half of twenty twenty five, we'd have that initial read, Patrick, Because of the fact that and this is much faster than if we had to start this organically as Tom was saying where you have to Start every site. In terms of number of sites, they're at 28 sites. What's unique about the sites is they're all brand name, Top sites with some of the most famous pancreatic KOLs in the industry. So you're talking about places like MD Anderson, Memorial Sloan Kettering So they can recruit fast because that's where patients are referred to for something as intractable as pancreatic. Speaker 400:27:15So, they've given us their projections. We're pretty positive that we can get to that go, no go decision around the first half of twenty twenty five, Assuming everything moves forward as planned with the execution of the definitive agreements and other paperwork that needs to be put in place and that's already ongoing as we speak. Speaker 600:27:35Right. Got it. That's really helpful. And I'm wondering if you can discuss further some of the preclinical research collaboration evaluating pellet plus CAR T combination and when you might have further details to present? Speaker 400:27:50That's a great question. So we do have companies we've been public about without naming whom, who are testing Largely, for instance, with PD-one L1s, we work pretty well with all of them with the exception of 1, that had the Fc portion, discrepancy. That's not the case with CAR Ts. CAR Ts, as you know, are very particular, both to the antigen, their construct, How they're made and what they target. And so we really have to go 1 by 1 with companies that are interested and have Arpella tested with their constructs. Speaker 400:28:32So far, the results have been promising. But I don't know yet When those will be presented because a lot of that is really in the hands, is dependent on the type of agreement and How willing the company may be to share those results publicly quickly, especially if it confers a Potential advantage in moving forward. But certainly, before anything moves into the clinic, they would have to sign a definitive licensing agreement with us to allow them Do that work. And so at that point, we would make something more public for sure. Speaker 600:29:09Great. Thank you very much. Operator00:29:12Thank you. Next question will be from Soumit Roy at Jones Research. Please go ahead. Speaker 700:29:19Good morning, everyone, and congratulations on all the progress. On the breast cancer front, trying to understand how stringent was the enrollment criteria for the HER2 negatives. Do you think there were some HER2 lows were considered Prior to reemergence of HER2, low to be actually effective against HER2 therapies. So trying to understand if How stringent was the enrollment criteria and what went right in fact with your 15, 16 patient on each arm trial That is giving you the confidence that in the registration trial, you're going to have that kind of enrollment criteria that would continue the success? Speaker 200:30:03Tom, do Speaker 400:30:05you want to jump in Speaker 200:30:06and talk about, sort of the evolving HER2 status and what that means potentially going forward and why we're so confident that this study is replicating what we're seeing with IND-two thirteen? Speaker 300:30:19Sure. So when this study was enrolled, of course, the concept of HER2 low As a marker for specific therapy was not in play yet, right? The antibody drug conjugates had not been approved. So patients so we do so we are I'm quite sure that in this study both we enrolled both HER2 negative and HER2 low patients As would have been expected in a study like this, but the reason that we're confident that the data from this study provide a basis for moving forward Is that in this population, these are patients who had failed standard of care hormonal therapy, including CDK4six So this is a population that is very typical of patients who with metastatic breast cancer who are now ready for chemotherapy. And in this population, we saw a very strong objective response rate and PFS benefit. Speaker 300:31:21And so going forward, these patients are still going to exist in the real world even with the advent of the antibody drug conjugates Because some patients as you know will not be eligible for antibody drug conjugates and they will need options, But even perhaps more importantly, there are going to be patients who receive antibody drug conjugates who then fail those because as good as they are, they are not Sure. So once patients are treated with antibody drug conjugates and then progress, they will also need treatment options. And Speaker 700:31:56we believe that Speaker 300:31:59the pellet based combination will be a very potentially beneficial Treatment for both patients who are antibody drug conjugate ineligible and those who ultimately fail antibody drug conjugate therapy. Speaker 700:32:15So for the registration trial, how would you set up the enrollment criteria? Would you make it strictly as HER2 negatives or You would be more amenable depending on the physician's charge if they are ready. Speaker 600:32:28Well, I think I mean, this Speaker 300:32:29is a matter for Ongoing discussion, including ultimately with the FDA, but I think we can pretty confidently say that there is a medical population with a Substantial medical need that we can define in the Phase 3 population, right. So whether the exact details Need to be worked out, but it's likely to include, for example, patients who have failed antibody drug conjugate therapy, Plus or minus perhaps those patients who are ineligible for antibody drug conjugate. So there are plenty of patients out there Who are going to need options and I don't think we'll have any trouble to finding a population in Phase 3 that can address that need. Speaker 200:33:12Understandable. Thank you for Speaker 700:33:13the color. And just one last question. When should we expect the update on the registration trial for breast cancer? Is it More like end of the year. And the second is or third is the pancreatic cancer trial, do we know the Primary endpoint is the CFS or the U. Speaker 700:33:31S? Speaker 300:33:33Yes. I mean for the pancreatic cancer trial, It will be overall survival, right, as is typical customary in pancreatic cancer studies. Perhaps I'll let Matt comment on the update of the breast cancer. Speaker 500:33:51Yes. Shobhit, Speaker 200:33:53We're letting the OS actually develop, just to make sure that we have the likelihood of a dual endpoint. We're still actually Tracing or tracking patients who are just receiving paclitaxel plus pellet. So we haven't even got the full PFS actually on that, which is fascinating because ARM-one, we didn't even get anyone out to like 12 months. We know we have patients out at cycle 22, 23 now. What we sort of suspect will happen is we're in discussion with a number of groups, as Tom alluded to. Speaker 200:34:25We think it's Probably easiest to capture this population in the post ADAC, so people would go from a CDK4six to a first line ADAC. That's we're just seeing people get on to first line ADX now. We do anticipate after San Antonio, there'll be more of these patients. So we're thinking about a sufficient pool of patients will be available mid next year. In terms of regulatory filings, we'll be reaching out to So we're hoping for the ability to provide some regulatory guidance late this year, early next as the OS matures. Speaker 200:35:00But some of this, of course, is just scheduling with the FDA. And of course, the parties we're talking to who have vested interested in the ADACs Would obviously like us to not cannibalize those sales, but rather be accretive to them by just tracking the same patients that are going to be able to receive the HR Lowes and presumably, Shamin, as I'm sure you know at ASCO, the true HR negative patients, There's literature now saying you can test a patient and have them be negative, test them again and they'll be slightly positive. So the whole concept around what is an HR negative patient, I think, is in flux. So I think by doing our regulatory filings this year, we'll have more color around what the true nature of the patient population is. But as Tom said, There's no shortage of these patients. Speaker 200:35:46So we're very confident we'll get to a definable patient population that stakeholders and the FDA can agree with. Speaker 700:35:55Thank you so much again for all the color and taking the questions. I look forward to the ESMO data. Speaker 200:36:02Thanks so Operator00:36:03much. Thank you. And your next question will be from John Newman at Canaccord. Please go ahead. Speaker 200:36:17Hey guys, good morning and thanks for taking my question. So Matt, Just had a kind of a follow-up question on the ADCs. How do you think about pelareorep, excuse me, being used long term With ADCs, do you kind of do you see a pathway here where perhaps you get your initial approval in combination with chemotherapy, but then You're able to perhaps investigate the combination with ADCs. And if so, is there a specific subset of patients That you think might be more attractive for that combination? Thanks. Speaker 200:36:56Yes. No, absolutely. To the first part of your question, what we would look To do is go after ADAC failures who are still taxic naive. So similar to the patient population that we treated on bracelets In terms that they would be taxane naive, we don't think that ADACs are especially immunosuppressive. They're actually deemed to be quite, I don't want to say mild, but mild in terms in comparison to chemotherapy. Speaker 200:37:23So we don't think this would be something that would diminish the immunological response. In terms of ultimately combining with ADEX, we are very interested in that possibility. What we know of our agent is anything that causes a cellular stress does lead to susceptibility, especially in the context of not being immunosuppressive, That has always been a concern of the company that we'd be using too high chemotherapy that you would blunt the immunological response to this. What we are seeing is the product does seem to work better in patients that have better immunological status or basically just saying it works better in patients It's heavily appreciated. So we do think that there is a role for combining this with ADAC. Speaker 200:38:06That would be part of our lifecycle management. And it is something that stakeholders have actively asked us to pursue. So it is obviously an area of interest for us. Great. Thank you. Operator00:38:20Thank you. And at this time, gentlemen, it appears that we have no other questions. Please proceed with any closing remarks. Speaker 200:38:29Well, thank you, operator, and thanks to all who joined our call today. Have a great day. Thanks very much. Operator00:38:34Thank you, sir. Ladies and gentlemen, this does indeed conclude your conference call for today. Once again, thank you for attending. And at this time, we do ask that you please disconnect your lines.Read morePowered by