This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk01: Good 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 Patton, Director of Investor Relations and Communications. Please go ahead.
spk02: Thank you, Operator, and good morning, everyone. Earlier this morning, Onclytics issued a press release providing recent operational highlights and financial results for the second quarter of 2023. A replay of today's call will be available on the events and presentation section of the Onclytics website approximately two hours after its completion. After remarks from company management, we will open the call for Q&A. As a reminder, various remarks made during this call contain certain forward-looking statements relating to the company's business prospects, and the development and commercialization of Pella ReRap, including statements regarding the company's focus, strategy and objectives, the company's belief as to the potential and mode of action of Pella ReRap 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 company's plans and expectations regarding potential registrational studies, the company's business development plans and strategies, and other statements related to anticipated developments in the company's business. These statements are based on management's current expectations and beliefs and are subject to a number of factors which involve known and unknown risks, delays, uncertainties, and other factors not under the company's control that may cause actual results, performance, or achievements of the company to be materially different from the results, performance, or expectations implied by these forward-looking statements. In any forward-looking statement in which Onclyx expresses an expectation or belief as to future results, such expectations or beliefs professing good faith, and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These factors include results of current or pending clinical trials, which is associated with intellectual property protection, financial projections, actions by regulatory agencies, and those other factors detailed in the company's filings with CDAR and the SEC. OnClinics does not undertake any obligation to update these forward-looking statements except as required by applicable laws. On our call today, we'll hear from Oncologics Chief Executive Officer, Dr. Matt Coffey, Chief Medical Officer, Dr. Thomas Heinemann, Global Head of Business Development, Andrew DiGutadaro, and Chief Financial Officer, Kirk Look. I'll now hand the call off to Matt to give a few highlights from this past quarter. Matt?
spk08: Thank you, John, and welcome to all who have joined us this morning. We are excited by the continued progress of our CARP programs for Pella Rear Rep, or Pella as we'll refer to it, in pancreatic and breast cancer that are accelerated towards registrational studies. In June, at the ASCO annual meeting, we presented results from our HR-positive, HER2-negative metastatic breast cancer program. Data from the randomized Bracelet-1 trial showed a 50% improvement in progression-free survival and a nearly threefold increase in confirmed overall response rate for Pella in combination with Paclitaxel versus Paclitaxel alone. This impressive data readout validated earlier Phase II results from IND213, which showed a statistically significant near-doubling of median overall survival in HR-positive HER2-negative metastatic breast cancer patients, meaning this program is now Phase III ready. The company will now prioritize progressing swiftly to a registrational trial of Pella Paclitaxel combination therapy in HR-positive HER2-negative metastatic breast cancer. Our second registration program in pancreatic cancer has generated compelling data and is clearly attracting attention among thought leaders in the community. This is evidenced by Pella being selected as a new investigational treatment in Precision Promise, an innovative, adaptive phase three clinical trial designed to accelerate registration pathways for pancreatic cancer therapies and expected to reduce phase three costs by about 50% compared to a traditional trial. The study, if successful, is expected to support approval of Pella in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nabpaclitaxel for the treatment of first-line metastatic pancreatic ductal adenocarcinoma. Pella'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 I-II goblet study data has almost tripled the average historical objective response rate by combining Pella with nabpaclitaxel, 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 and without chemotherapy and checkpoint inhibitors, which Tom will discuss a bit later. Our plan for this indication is to finalize agreements with the Precision Promise team by the fourth quarter of this year, and we expect to open the investigational treatment of Pella, a checkpoint inhibitor, gemcitabine, and nalpaclitaxel in early 2024. At the end of July, we announced the U.S. $15 million 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 both represent meaningful registration opportunities, and this additional funding further strengthens our position to advance Pella into registrational trials. 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 discussion of our clinical programs and business development efforts. We will start with you, Tom.
spk00: Thanks, Matt. I'll begin my section by summarizing and highlighting the key data from our two pillar programs. As Matt mentioned, we are thrilled with the readout from our randomized bracelet one trial of Pella combined with Paclitaxel in HR-positive HER2-negative metastatic breast cancer. These data showed that Pella combination therapy led to a robust improvement in progression-free survival with a hazard ratio of 0.29 and a nearly three-fold increase in the confirmed overall response rate. Just to emphasize, a hazard ratio of 0.29 means a 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 5th to provide expert perspectives on these results and what they mean for our HR-positive, HER2-negative breast cancer program's next steps. If you missed the webinar, and are interested in a more detailed discussion of 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, Bracelet-1 is a randomized Phase II trial that enrolled a total of 48 HR-positive HER2-negative metastatic breast cancer patients into three groups, a control group that received paclitaxel monotherapy, a group that received the combination of paclitaxel and Pella, and a third group that received paclitaxel, Pella, and the checkpoint inhibitor of Velumab. The bracelet one primary endpoint was overall response rate at week 16 with additional endpoints of progression-free survival, safety and tolerability, and immune biomarker evaluation. The bracelet one primary endpoint of overall response rate at week 16 increased from 20% in the paclitaxel monotherapy arm to 31% in the Paclitaxel-Pella combination arm. The benefit of adding Pella to Paclitaxel became even more apparent as the data matured with a 37.5% confirmed overall response rate in the Pella-Paclitaxel combination arm compared to only 13% for Paclitaxel monotherapy. Adding a Valumab to Paclitaxel and Pella did not improve anti-cancer activity, which reinforces our decision to focus on the Pella-Paclitaxel doublet as we move forward to our registrational study. Bracelet 1 also includes an endpoint of progression-free survival, which has been used to support approvals on oncology drugs, including in breast cancer. We observed a robust increase in progression-free survival in the Pella 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 Pella-paclitaxel combination group for a hazard ratio of 0.29 as of a March 2023 data cutoff. While the study was not designed for statistical comparisons, the progression-free survival benefit in the Pella plus paclitaxel arm did, in fact, reach statistical significance. The addition of avelumab to the Pella-paclitaxel combination did not add clinical benefit. In fact, the Avelumab combination behaves similarly to paclitaxel monotherapy, suggesting that the addition of Avelumab actually nullified the beneficial effects of Pella. The question of why adding Avelumab may have reversed the beneficial effects of the Pella-paclitaxel 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 Pella-induced immune responses. Translational data from the Bracelet 1 study support this hypothesis. It is important to note that overall survival results from Bracelet 1 have not been reported yet as multiple patients continue to be followed for survival. Bracelet 1 is the second 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 IND213 study in which Pella plus Paclitaxel demonstrated a statistically significant near doubling of median overall survival in HR-positive HER2-negative metastatic breast cancer patients. These two trials taken together provide a strong foundation for a registrational study with dual primary endpoints of 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 IND213 and BRACEL1, 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. Our Phase I-II 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 second core pillar. As Matt mentioned, we are very excited that Pella combination therapy has been selected by a panel of pancreatic cancer experts as a new investigational treatment arm in the pivotal Precision PROMIS Phase III Platform Trial. The Precision PROMIS trial is designed to accelerate 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 two years compared to traditional registrational trials. The inclusion of Pella-based combination therapy in the Precision Promise Trial is based on data from our prior pancreatic cancer clinical studies that support Pella's ability to synergize with checkpoint inhibition and chemotherapy to benefit patients with metastatic pancreatic cancer. Prior data include preliminary results from our Phase I-II Goblet Study that showed a 69% objective response rate in first-line advanced or metastatic pancreatic cancer patients treated with Pella combined with atezolizumab and standard-of-care chemotherapy, gemcitabine and nabpaclitaxel. This compares to an average of about 25% objective response rate observed in historical trials in metastatic pancreatic cancer. While the GOBLED 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 Pella-based combination therapies. The previous studies laid the foundation for the Goblet Study as they suggested that Pella-based combination therapies could provide favorable outcomes in pancreatic cancer patients. These 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 Dr. Richard Weil and followed a publication in Science Translational Medicine last year that reported Pella's ability to synergistically enhance CAR-T cell efficacy in murine 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 a PellaBoost 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?
spk07: Thank you, Tom, and good morning, everyone. From a BD perspective, the top-line data readout from our Bracelet 1 trial was the featured headline of the quarter. As the Bracelet 1 data mature and we integrate data that we've already generated from IND213 and the Wear 1, we'll be able to better leverage the full suite of immunotherapeutic effects of PEL and breast cancer. As we move towards registration, we plan to pursue the most advantageous global clinical and 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 IND213 study, which demonstrated a statistically significant near doubling of median overall survival in HR-positive HER2-negative metastatic breast cancer patients. the same population that was treated in bracelet one. Having seen the bracelet one study data made public in June at ASCO, additional biopharma companies have come forward and we have just begun meaningful discussions with certain potential new collaborators. While it is too soon to speculate on a potential deal at this juncture, it has been encouraging to have an uptick in interest from the 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 Pella 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 Pella ReRef to be included in the precision promise platform trial was quite rigorous. We had meetings and presentations with multiple 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 pilariorept patients. We were very pleased to have been selected for this phase three opportunity, and we look forward to a productive relationship to bring better treatment options to pancreatic cancer patients. We also continue to be excited by the preclinical CAR-T results presented at ASCO and in science translational medicine. CAR-T therapies generated more than a billion dollars in sales last year in a subset of cancer patients with hematological malignancies. The potential for Pella 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. Our strategy is to engage potential partners with the goal of outlicensing Pella's 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 for Pella, combined with numerous leading anti-cancer 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 to discuss our recent financial results. Kirk? Thank you, Andrew.
spk05: I'm pleased to report that Oncolytics continues to improve its financial position. As Matt mentioned at the start of our call, we successfully raised $15 million US through 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 Precision Promise Study and obtain the necessary regulatory approval to start enrollment. With the ASCO Bracelet 1 data in hand, 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 $24.4 million in cash equivalents and marketable securities compared to $32.1 million as of December 31, 2022. After the close of our recently announced public offering, our pro forma cash balance stands at $42.7 million and our anticipated financial runway now extends towards the end of 2024. Our general and administrative expenses for the second quarter of 2023 were $3.5 million compared to $2.8 million 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 second quarter of 2023 were 3.7 million compared to 3.2 million for the same period last year. The increase coming from higher manufacturing and personnel related expenses partly offset by lower bracelet one study costs. Now the net loss for the second quarter of 2023 was 7.4 million compared to $5.1 million in the second quarter of 2022. This equates to a net loss of 12 cents per share for the second quarter of 23 and 9 cents per share for the second quarter of 2022. This completes my financial review and brings us to Matt's closing remarks. Matt?
spk08: Thanks, Kirk. Now, before moving to the Q&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 BRACELET1 overall survival data continues to mature, so we'll provide an update on that timeline once we can provide a reasonable expectation. As always, I would like to express my gratitude for all the contributions from our collaborators, talented employees, dedicated investigators, the patients participating in our studies, and of course, all of our investors. We'll now open the call up for questions. Operator?
spk01: Thank you, sir. Ladies and gentlemen, if you would like to ask a question, please press star followed by one on your touchtone phone. You will then hear a three-tone prompt acknowledging your request. And if you would like to withdraw from the question queue, please press star followed by two. And if you're using a speakerphone, we do ask that you please lift the handset before pressing any keys. Please go ahead and press star 1 now if you do have any questions. And your first question will be from Patrick Turrico at HC Wainwright. Please go ahead.
spk04: Thanks. 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 pace 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 Pella-Rio rep? And then secondly, also regarding this program, you know, what would you expect to be necessary to lead to an accelerated approval pathway in pancreatic? And when might you have that first data cut from the program?
spk08: Thanks, Patrick. That's a great question. Tom and Andrew are probably closest to this, so I'll let Tom talked 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?
spk00: Sure. So the – yeah, 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, a 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. so that we have access to a large number of pancreatic cancer experts, and they're all very experienced, not only in pancreatic cancer, but with this particular study. And so there is a very solid group of partners with whom we'll 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 during the study. 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 of working with sites, as I said, who are very experienced already, since this study is up and running, we can save time because we will not have to do things like initiate sites and get everyone familiar with the protocol So I think that there are obvious operational efficiencies in addition to the regulatory benefits and the access to the strong experts in the field.
spk04: Yep.
spk08: Andrew, can you talk a little bit as to the number of sites and the anticipated enrollment? I think we're targeting, what, 18 months after the time of initiation for that first read?
spk07: Yeah, about that. We expect we'll sign the agreements in the next couple of months, hopefully, somewhere around there. And then it's about 17 months to get to a go-no-go analysis. So figure around the first half of 2025, 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, and the like. So, you know, they can recruit fast because that's where patients are referred to for something as intractable as pancreatic. So 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 2025, 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.
spk04: Right. Got it. That's really helpful. And I'm wondering if you can discuss further some of the preclinical research collaboration, evaluating Pella plus CAR-T combination, and when you might have further details to present.
spk07: That's a great question. So we do have companies we've been public about without naming whom, who are testing our Pella rear rep with their CAR-Ts because, you know, we believe that largely, for instance, with PD-1L ones, we work pretty well with all of them with the exception of one that had that FC portion discrepancy. That's not the case with CAR-Gs. CAR-Gs, as you know, are very particular, both to the antigen, their constructs, how they're made, and what they target. And so we really have to go one by one with companies that are interested and have are Pella tested with their constructs. So 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 to do that work. And so at that point, we would make something more public for sure.
spk04: Great. Thank you very much.
spk01: Thank you. Next question will be from Shomit Roy at Jones Research. Please go ahead.
spk03: Good 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 how stringent was the enrollment criteria and what went right, in fact, with your 15, 16 patients on each arm trial that is giving you the confidence that in the registration trial, you want to have that kind of enrollment criteria that would continue the success.
spk08: Great question. Tom, do you want to jump in and 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 IND213?
spk00: Sure. 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 are, I'm quite sure that in this study, 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 CDK4-6 patients. So this is a population that is very typical of patients 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. And 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 cures. So once patients are treated with antibody drug conjugates and then progress, they will also need treatment options. And we believe that the Pella-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.
spk03: So 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 choice, if they are ready?
spk00: Well, I think, I mean, this is 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 III 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 defining a population in phase three that can address that need.
spk03: Understandable. Thank you for the 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 it the TFS or the OS?
spk00: Yes. 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.
spk08: Shobit, we'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 Pella, so we haven't even got to the full PFS actually on that, which is fascinating because you know, arm one, you know, we didn't even get anyone out to like 12 months. And 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, we think it's probably easiest to capture this population in the post ADAC. So people would go from a CDK4-6 to a first line ADAC. That we're just seeing people get on to first line ADACs 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 the agency this year. So we're hoping for the ability to provide some regulatory guidance late this year, early next as the OS matures. But some of this, of course, is just scheduling with the FDA. And of course, the parties we're talking to, who are vested interested in the 8X would obviously like us to not cannibalize those sales, but rather be creative to them by just tracking the same patients that are going to be able to receive the HR lows. And presumably, Sherman, as I'm sure you know at ASCO, the true HR negative patients, you know, there's literature now saying you can test a patient, 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. So we're very confident we'll get to a definable patient population that the stakeholders and the FDA can agree with.
spk03: Thank you so much again for all the color and taking the questions. We look forward to the ESMO data. Thanks so much.
spk01: Thank you. As a reminder, ladies and gentlemen, if you would like to ask a question, please press star followed by one on your touch-tone phone. And your next question will be from John Newman at Canaccord. Please go ahead.
spk06: Hi, guys. Good morning, and thanks for taking my question. So, Matt, just kind of a follow-up question on the ADCs. How do you think about Pell ReRep 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 a combination with ADCs? And if so, is there a specific subset of patients that you think might be more attractive for that combination? Thanks.
spk08: Yeah, no, absolutely. To the first part of your question, what we would look to do is go after ADAC failures who are still toxic-naive. similar to the patient population that we treated on bracelet in terms that they would be taxing 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. So we don't think this would be something that would diminish the immunological response. In terms of Ultimately, combining with 8X, 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 it's 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 who aren't as heavily pre-treated. So we do think that there is a role for combining this with ADACs. That 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.
spk06: Great. Thank you.
spk01: Thank you. And at this time, gentlemen, it appears that we have no other questions. Please proceed with any closing remarks.
spk08: Well, thank you, Operator, and thanks to all who joined our call today. Have a great day. Thanks very much.
spk01: Thank 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.
Disclaimer