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spk01: Ladies and gentlemen, thank you for standing by, and welcome to the Infinity Pharmaceuticals conference call to discuss the company's operations and full year 2020 financial results. My name is Victor, and I'll be your operator for today's call. At this time, all participant lines are in listen-only mode. There will be a question and answer session to follow. Please be advised that this call is being recorded at Infinity's request. Now, I would like to introduce your host for today's call, Jane Kaufman. Please go ahead.
spk02: Thank you, Victor, and good afternoon, everyone. Welcome to today's call to discuss our recent business progress and review of our full 2020 financial results. On the call with me today are Adeline Perkins, Chief Executive Officer, Larry Block, President, and Brian Schwartz, Consulting Chief Physician. We'll open up the call for Q&A following our remarks. The press release issued this afternoon details our results and is available on our website at infi.com. Please note that during this call we may make forward-looking statements about our future expectations and plans, including clinical development objectives, the therapeutic potential of our product candidates, our strategic plans and strategies, and financial projections. Our actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the risk factors section of our quarterly report, on Form 10-Q for the third quarter of 2020, and in other filings we make with the SEC. These forward-looking statements represent our views only as of today, and we caution you that we may not update them in the future, whether as a result of new information, future events, or otherwise. Now, I would like to turn the call over to Adeline.
spk03: Thanks, Jane, and thank you to everyone for joining us today. The past four months have been transformative for big analysts at An Infinity, with two presentations of MERIO-1 data at the Society for Immunotherapy of Cancer meeting in November, two presentations at the San Antonio Breast Cancer Symposium in December of frontline triple negative breast cancer data from our MERIO-3 study, and second line and above, TNBC and ovarian cancer data from the ARC-II study conducted by our collaborator, Arcus Biosciences, and our most recent presentation last month of MERIO-275 data in second-line urothelial cancer at ASCO-GU, which together demonstrate the broad potential of aganalysib to improve upon diverse standard of care treatment regimens. We're thrilled that our foundational work in discovering and developing aganalysib a first-in-class macrophage reprogramming therapeutic candidate in solid tumors, has now translated through to clinical benefit across our program, driven by Aganalysed's unique and fundamental immune-modulating mechanism. On today's call, our Consultant Chief Physician, Dr. Brian Schwartz, will review the clinical and translational data from our recent Aganalysed presentations and discuss next steps for our program. But before that, I'd like to briefly summarize this encouraging data. First, data from MARIA-1, our Phase I 1B study in collaboration with Bristol-Myers Squibb, evaluating aganalysib in combination with Opivo in patients with advanced solid tumors, was presented at SISI. The data from this study reinforced the potential of aganalysib to overcome resistance to checkpoint inhibition in patients with melanoma and squamous cell cancer of the head and neck, who had progressed on a checkpoint inhibitor as their immediate prior therapy. Second, data from the TNBC cohort of Mario 3, our Phase II study in collaboration with Roche Genentech, and would clear evaluate in the combination of a Ganylisib with Ticentric and Abraxane as a frontline treatment in patients with TNBC, was presented at SABSI. The data showed an increase in the overall response rate and disease control rate versus the concentric anabraxane doublet therapy approved for the treatment of PD-L1 high frontline CNBC patients. Additionally, 100% of patients in this study achieved a reduction in tumor volume irrespective of PD-L1 status, and there was a 100% response rate in PD-L1 high patients. Third, data from our ARCIC collaboration, a phase 1b study evaluating aganalysib in a novel checkpoint inhibitor-free regimen that includes their dual-identifying receptor antagonist, endoxyl, in patients with relapsed refractory triple-negative breast cancer and ovarian cancer was also presented at SABSI. This data showed an increase in response rate with the addition of aganalysib to the novel doublet therapy in both indications. And finally, data from MARIO275, our randomized double-blind placebo-controlled stage 2 study in collaboration with BMS, in which we are evaluating aganalysib in combination with Opdivo in patients with advanced urothelial cancer, was presented at ASCO-GU last month. This data showed improvements in response rate, disease control rate, and progression-free survival, particularly in patients with low levels of PD-L1 expression who are known to not respond as well to checkpoint inhibitors. Across these studies, which include double and triple combinations in first, second, third, and beyond lines of therapy across multiple solid tumors, a clear signal is emerging that the addition of aganalysib improves upon standard of care regimens in diverse treatment settings and indications. These signs of efficacy are bolstered by our translational data, which show robust and highly consistent immune-modulating activity, providing clear mechanistic rationale for the ability of aganalysib to turn cold tumors hot and activate an immune response. This results in an upregulation of PD-L1, thus priming for checkpoint inhibition and improving responses in patients with some of the greatest unmet needs in oncology. The data has enabled us to begin mapping out a clear path forward with the analysis, including a potentially rapid path to approval in advanced urothelial cancer by focusing on the PD-L1 low population to address the significant unmet need for these patients. While the data we have generated suggests that aganalysib may provide benefit for both PD-L1 high and PD-L1 low patients, focusing on the PD-L1 low patient population in urothelial cancer provides a number of distinct advantages. First, there's a tremendous unmet need in PD-L1 low cancer patients with many checkpoint inhibitors not providing benefit for this population. evidenced by the fact that the approvals of Keytruda and Ticentric in frontline urothelial cancer are limited to PD-L1 high patients only. And even in cases where checkpoint inhibitors are approved for the entire intent-to-treat population, such as the Opdivo approval in second-line urothelial cancer, retrospective analyses have demonstrated that there's little to no benefit for the PD-L1 low patients. In Mario 275, we see that by adding aganalysib to Updivo, we increase the overall response rate in the PD-L1 low patients to a level that's equivalent to the response rate seen in the PD-L1 high patients with Updivo monotherapy in Checkmate 275. We had a similar success in bringing the disease control rate in PD-L1 low patients to a level above that what was achieved in PD-L1 high patients in Checkmate 275. enabling PD-L1 low patients to achieve the same level of benefit from immuno-oncology therapy as the PD-L1 high group. Furthermore, as a controlled trial, we were able to measure the difference in progression-free survival between the monotherapy and the ganylysin combination arm, which showed that PD-L1 low patients were 46% less likely to experience disease progression with the addition of a ganylysin. Importantly, Given the magnitude of the benefit seen with aganalysib in MARIO275 with a hazard ratio of 0.54, it should be possible to demonstrate its benefit in a registration-focused trial with a relatively few number of patients, such this trial can be smaller, faster, and less expensive to conduct. Our goal is to utilize aganalysib to extend the reach of immuno-oncology drugs to broader patient populations including those with low levels of PD-L1 expression who represent the largest patient population and have the greatest unmet need. From a strategic perspective, while we are initially focusing on the PD-L1 patients for the reasons I just highlighted, the data suggests aganalysib will also be of benefit more broadly beyond the PD-L1 low patients. This is because the immune-activating mechanism of aganalysib PD-L1 expression is increased regardless of whether patients are starting with low or high PD-L1 levels. So in the long term, the data suggests we'll ultimately provide broad benefit across patients and tumor types, but we're starting where we believe aganalysib can be approved most rapidly and cost-effectively in PD-L1 low patients. Before I turn the call over to Brian to provide a recap of the data and our next steps across our programs, I want to highlight that we're really thrilled with these data, which facilitated our recent $92 million public offering that leaves us very well positioned to continue the aggressive execution of our clinical development strategy. It's also important to note that aganalysib is the only macrophage-targeted therapeutic in clinical development focused on solid tumors. And given that we've retained full development and commercial rights for aganalysib, and have strong composition of matter patents through 2034, even prior to any patent term extension. Our unique, wholly-owned therapeutic candidate holds incredible promise for patients and value creation potential for shareholders. We are very grateful for the commitment and dedication of our employees, collaborators, partners, and especially our investigators and patients who have enabled this progress. And with that, I'll turn the call over to Brian.
spk00: Thank you, Adeline. I'd like to start with MARIO275, a randomized placebo-controlled Phase II study evaluating the efficacy and safety of eganilisib in combination with nivolumab or Optivo in second-line platinum refractory ionaive patients with advanced urothelial cancer. The study was designed to evaluate the benefit of adding eganilisib to standard of care nivolumab by leveraging Eganilisib's mechanism of action, the insights of Checkmate 275, the accelerated approval study for nivolumab in second-line IO-naive urothelial cancer patients. Our results presented at ASCO-GU were highly encouraging, with a combination of Eganilisib with nivolumab demonstrating improved overall response rate, disease control rate, and progression-free survival versus second-line standard of care nivolumab monotherapy. And, as Adeline described, it was rarely in the PD-L1 low patients where we saw the greatest benefits. Our Moria 275 ORR of 26% in the PD-L1 low patients is exactly the same as the overall response rate that BMS achieved in the PD-L1 high patients with nivolumab monotherapy in Checkmate 275. When looking at disease control rate, we reported 57% in the PD-L1 low, which is just above the DCR rate of 52%, which BMS achieved in the PD-L1 high patients with nivolumab monotherapy in that study. Together, these results strongly suggest that Diganalysip has the potential to raise the level of benefit for which the PD-L1 patients received to the same level of benefit from IO therapy as the PD-L1 high patients currently receive from standard of care. Moving on to PFS. In Moria 275, the hazard ratio for PFS was 0.54, such that patients receiving the combination treatment are 46% less likely to progress relative to patients on nivolumab plus placebo-alm, an indication of significant patient benefit. I'd like to emphasize how important the hazard ratios are in evaluating immuno-oncology treatments. First, I will remind you that the hazard ratios can only be measured in controlled trials, given that hazard ratios measure the differences in time to event endpoints of PFS or OS between the experimental arm and the control arm of the study, and therefore cannot be evaluated in a single-arm study Furthermore, hazard ratios qualify the difference between two arms of the control study over the entire study period. This is particularly relevant with immuno-oncology drugs, where there's been a consistent demonstration over the past decade that there are trends to be significant long-term benefit in a small number of patients, which is not reflected in the median PFS or OS statistics. The long-term benefit is referred to the tail of the curve on PFS or OS Kaplan-Meier plots. The goal of research with immuno-oncology drugs over the past decade has been to increase the percentage of patients who receive this longer-term benefit, thus raising the tail of the curve. We see this exact effect in MARIA-275, in which the tail of the curve is raised, precisely what one would hope to expect to see in enhancing the activity of a checkpoint inhibitor. this leading to a compelling .54 hazard ratio. In contrast, the difference in the median PFS which fails to capture the long-term tail effect between the two arms differs only by a few weeks. Based on these results, we are in the planning stages for a registration trial and are soliciting regular input and expect initial feedback by early April. This process may well entail additional rounds of regulatory feedback, but we expect that by the end of Q2 2021, we will be in a position to present our proposed trial design along with more information about the program. We will, of course, leverage all the strong findings coming out of Moria 275 and will focus on PD-L1 low patients, the 30 milligram dose, and the time to event customary for a regulatory approval. Also, since our last quarterly call, we presented data from MARIO3, the triple negative breast cancer cohort, at San Antonio Breast Cancer Symposium. Like MARIO275, MARIO3 study is adding iganalysib to an approved regimen, in this case, the ROSE Genetic Regimen of Ticentric and Abraxane, in frontline TNBC, which is approved for use only in PD-L1 positive patients. Triple negative breast cancer is another example of where the benefit of checkpoint inhibitors is limited to the PD-L1 high, such as approval for both Ticentric and Keytruda in the frontline TNBC setting. Given that again illicit mechanism action, which leads to an upregulation of PD-L1, and the early data from Morio3, the addition of Eganilisib to current standard of care regimens may enable the expansion to benefit the PD-L1 low patient population as well. To assess Eganilisib's contribution over to Centric and Abraxane, the Morio3 trial was designed with high fidelity to the Roche Genentech IMPASSION 130 approval study with respect to inclusion and exclusion criteria and endpoints to provide a clear benchmark for comparison. At the breast cancer conference, we presented efficacy data from the first 13 evaluable patients and had an additional seven patients enrolled at that time who were included in the safety data set but who had not received their first scans. We were extremely encouraged to report that of the 13 patients, 100% of patients had a reduction in their tumor volume and 69% had either a partial response or a complete response, with 100% of the PD-L1 high patients responding and 50% of the PD-L1 low patients responding. We are very pleased that the study is progressing well, and in the first half of this year, we will provide an update that will include approximately twice as many valuable patients from the efficacy perspective, in addition to a more mature data set including a first look at durability from the first 13 patients we presented at SEPC last year. So in terms of what next for TMBC, we see three potential wins and paths for approval. The most immediate opportunity is in the PD-L1 low group, where checkpoint inhibitors have not yet been approved, including Ticentric and Abraxane combination, which is not approved in this patient population. And given that this regimen is not approved in the PD-L1 low population, in an approval trial with Eganilisib, one would expect to be going up against a Braxane monotherapy, which is currently the standard of care, where an ORR in the range of 40 to 45% is expected. Importantly, these responses on a Braxane monotherapy have not been durable, so we are looking for both response rates and to improve the durability of the responses, three or four scans or six or eight months, which would be a clear win in this setting. MARIA-3 data also suggests that we have the opportunity to improve on the benefit obtained from Ticentric and Abraxane in the PD-L1 high patients as well. In that setting, we think an ORR of about 70% would be meaningful improvement above the 50%. 58.9% for the Impassion 130, paired with an improved PFS in the range of 9 to 10 months as compared to 7 months in the Impassion 130 study. This would be a big win in the PD-L1 high group. I think it is also important to remember that we see broad potential for Eganilisib to improve upon regimens in TMBC beyond the frontline setting and specific to Centric and Abraxane doublets. The ARC2 data presented by our collaborator, ARCIS, at the same conference, which compared the doublet of etrimidin plus doxil to the triplet of eganilisib plus etrimidin plus doxil, demonstrated that exact potential. ARC2 evaluated both ovarian and advanced triple negative breast cancer patients in both settings, The addition of Eganilisib to the doublet demonstrated a clear benefit. In ovarian cancer, dose escalation portion, patients in the doublet arm had a response rate of 14%, which went up to 75% with the addition of Eganilisib, with no CRs in the doublet and one CR in the triplet. In the triple negative breast cancer patients in second line and beyond, The response rate was 9% for the doublet and went up to 25% with the addition of Eganilisib. We were very pleased with this data that shows the promise of Eganilisib in improving outcomes in additional regimens, including a checkpoint-free regimen in the second line and above setting TNBC. This complements our data in the frontline setting with a checkpoint inhibitor. This data shows that Eganilisib has the potential to be backbone therapy in TNBC in the front line and to a triplet, which includes a checkpoint inhibitor and chemotherapy, and in the second line and later lines, in a triplet that includes chemotherapy but not a checkpoint inhibitor. And As mentioned earlier, our frontline data with a checkpoint inhibitor and chemo has a potential to be differentiated with better activity in PD-L1 low patients, pointing to a broad opportunity for agian illicit to improve upon emerging regimens in triple negative breast cancer in multiple combinations and lines of therapy. Moving to the renal cell cohort in MARIO3, As a reminder, in this cohort, we are combining Ticentric and Abraxane with Eganilisib in frontline renal cell carcinoma. We have completed enrollment with 30 patients in this cohort and expect to report data in the first half of 2022. In contrast to triple negative breast cancer cohort of Moria 3, where we are adding Eganilisib to an approved doublet, In renal cell cohort, we are adding Eganilisib to a doublet, which is not approved, and thus is more proof-of-concept study. To provide some context, there's a lot of excitement around the potential of combining checkpoint inhibitors and VEGF antibodies, so we are adding Eganilisib to this type of regimen to test a hypothesis of whether Eganilisib can improve outcomes above what we are seeing with Ticentric and Avastin. If we now move forward with the registration study, we'll be evaluating that data from MARIO3 proof of concept study along with data from recent frontline trials to determine the best approved checkpoint inhibitor and VEGF combination to combine with iganilisib moving forward. Finally, touching on MARIO1. At CITC, we presented data showing ORR of greater than 20% and a disease control equal to 40% in melanoma and squamous cell patients who had progressed on a checkpoint inhibitor as their immediate past therapy after having received two or less prior therapies. Moving forward, we see multiple opportunities to leverage this data. First, We're interested in further delineating the mechanism in head and neck cancer with a window of opportunity study with our investigator, Ezra Cohen, who presented the Morio1 head and neck cancer data as an oral presentation at SIPC. In this window of opportunity study, Eganilisib is administered prior to surgical resection of the tumor so that the changes in the tumor can subsequently be evaluated in the resector tissue followed treatment of the Eganilisib. Data from this study, combined with data presented at CIPSE, which showed responsive eganilisa plus nivolumab in patients who have progressed on immediately prior to checkpoint inhibitor therapy, will best inform us of the next steps for head and neck cancer. In terms of melanoma, we are in active discussions with a number of investigators to leverage our data from MARIO-1 in melanoma where a doublet of Eganilisib and PD-1 blockade in addition to the triplets including a PD-1 inhibitor, a CTLA-4 inhibitor from our Nature publication with Jed Wolchoff to understand the potential synergies of Eganilisib, PD-1, and CTLA-4. We are really excited to see if there's an opportunity to meaningfully increase the efficacy in the PD-1 or PD-1 refractory melanoma subset. In the past few months, we have revealed a compelling and consistent broad activity profile for aganalysib. We believe that we have an immediate opportunity for success in the PD-1 low metastatic urothelial cancer patients and are looking forward to planning a registration trial in this indication. And beyond urothelial cancer, Eganilisib activity is seen consistently across a diverse setting, indication, and regimens, demonstrating that the addition of Eganilisib broadly increases patients' benefit through its unique immune-modulating mechanism. We are focused on continued execution in MORIA3 for both the TMBC and RCC and on also evaluating what the data suggests is the ability of Eganilisib to extend beyond these indications with a focus on PD-L1 low patients as well as the potential for other solid tumors. The PD-L1 low opportunity is truly vast given the majority of patients, and the majority of patients with solid tumors have low levels of PD-L1 expression, making it one of the largest unmet needs in oncology. We therefore believe that the potential of Eganilisib is enormous in terms of addressing the unmet medical needs and as a commercial opportunity, and we're really focused on delivering on that promise. Before I turn over the call to Larry, I'd especially like to thank our patients, our investigators, collaborators at BMS, Roche Genetic, and Arcus, whose continued dedication has enabled our progress within Gamelisib. I now turn the call over to Larry. Thank you, Brian.
spk05: Before I turn to our financial results, I'd like to emphasize what Brian just said in regard to our appreciation for our patients and their clinicians who have been our inspiration and our collaborators who have been our true thought partners. In regard to the latter aspect, The true intellectual foundation for our MERIO studies, which stands for Macrophage Reprogramming in Immune Oncology, was laid out in collaboration with our preclinical collaborators, including Professor Jed Wolchuk from Morrison Kettering Cancer Center and Professor Judy Varner from UCSD, who are the lead authors on our two back-to-back nature articles, which were published in November 2016. and which delineated the fundamental methods of action of selective pharmacological inhibition of PSK gamma. And then at the 2017 American Association for Cancer Research Annual Meeting, Dr. Jeff Kutok, the chair of the Infinity Scientific Advisory Board, gave a seminal presentation entitled Reprogramming Tumor-Associated Microphages by Targeting PSK Gamma Through a Small Molecule Approach. And now we're truly gratified by the progress which we've made in the course of the last four years since Dr. Kutok's AACR presentation, as well as the increasing appreciation for the potential for macrophage targeting therapeutics more broadly. And we're therefore very pleased that Dr. G. Varner has been invited to give a talk at the upcoming AACR annual meeting next month. It will be a major symposium presentation entitled improving therapy through normalization of the tumor microenvironment. The presentation release date is Friday, April 9th, and there will also be a moderated 30-minute panel session for question and answers on Thursday, April 15th at 1.30 to 2 p.m. Eastern Time. Now turning to our full year 2020 financial results. December 31st, 2020, Infinity had total cash, cash equivalents, and available for sale securities of $34.1 million compared to $42.4 million at December 31, 2019. Importantly, this does not include the approximately $86 million in net proceeds from the public offering that we completed in February of 2021. Revenue during 2020 was $1.7 million, which relates to royalties on net sales of Pipitra from VeriSpem and Securibio, Revenue during 2019 was $3 million, which primarily relates to the achievement of a $2 million milestone from Telepharm for the initiation of the first Phase III study of pedigabed in Gorlin syndrome. Research development expense for 2020 was $26.8 million compared to $27.1 million in 2019. And general and administrative expense was $12.4 million for 2020 compared to $14.3 million for 2019. This decrease in G&A expense in 2020 compared to 2019 was primarily due to a decrease of $800,000 in compensation, primarily related to a reduction in stock compensation, as well as a decrease of half a million dollars in professional services. Net loss for 2020 was $40.5 million, or a basic and diluted loss per common share of $0.68, compared to a net loss of $47.1 million, or a basic and diluted loss per common share of $0.83 for 2019. Decrease in net loss was mostly driven by a decrease in royalty expense for 2020. In 2019, Takita consented to the sale of the Dublisipco Petro Royalties to healthcare royalty partners. or HCR, and agreed to promote its rights to an equal share of the royalties due from Securibio. In exchange, we paid Takeda $6.7 million, representing 25% of the net proceeds from this royalty monetization, which we then recognized as royalty expense in 2019. Infinity's 2021 financial guidance, following the closing of the $92 million in gross proceeds public offering on Infinity's common stock, early this quarter is as follows. Infinity expects net loss for 2021 to range from between $40 to $50 million. And in terms of cash investments, Infinity expects to end 2021 with the year-end cash, cash equivalents, and available for sale securities balance ranging from between $70 million and $80 million. So based on current operating plans, Infinity expects that its existing cash, cash equivalents, and available sales securities, including the $86 million net proceeds of the public offering to be closed in February 2021, will be adequate to satisfy the company's capital needs for at least the next 12 months from today. This guidance does not include the potential for additional funding for or business development activities, potential $5 million milestone payment from BVF for positive Phase III data from the Gorlin Syndrome Phase III, the Pelopharm, is conducting, or the sale of the company's equity interest in Pella Farm, or the potential value of Vendee's right to repurchase from DVF, its Pella Farm royalty interest, once Vendee's stock price has a VWAP of greater than or equal to $5 a share for at least 20 days between now until January 25, 2023, or earlier termination of the agreement. We appreciate your continued support as we move forward with development of again a list of At this time, we can also call for questions. Operator?
spk01: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. And to withdraw your question, press the pound key. Please sign by while we compile the Q&A roster. Our first question will come from the line of Nick Abbott from Wells Fargo. You may begin.
spk07: Hey, good afternoon. Thanks for taking my question, and congratulations. quite impressive set of data readouts there in the last few months. Just in terms of guidance that the cache is going to be sufficient for the next phase of the aganalysed, what does that entail? Is that a single registration trial or a registration trial plus some other exploratory trials?
spk05: Thanks, Nick. This is Larry. I'll take that question. So the guidance we have currently is based on our current operating plans, which are includes the initiation of the potential registration enabling study, but obviously that will be informed by, as Brian said, our upcoming interactions with the FDA. So there's some confidence interval around what the scale and scope of that trial might look like. It does not include additional initiations of studies that we might initiate based upon, for example, the ongoing Mario 3 TMBC data. We're providing updates for later, first half this year as well as in the second half this year. And we look forward to providing some updates on additional clinical investigations that we might initiate in the balance of this year or thereafter.
spk07: Great. Thank you.
spk01: Thanks, Dick. Our next question will come from a line of Anupam Rama from J.P. Morgan. You may begin.
spk04: Hey, good evening, guys. Thanks for taking our question. This is Matt for Onupom. So we know that the details on the design of the trial for Eganilisib in urothelial cancer are forthcoming, but we were wondering more on the financial and logistical side if the clinical collaboration with Bristol from earlier studies, including Mario 275, will carry over into the registration-focused trial. And actually, if you could remind us of the terms of the existing agreement, that would be super helpful. Thanks so much.
spk03: Sure. Matt, thanks for the question. So the existing relationship with BMS on the MERI 275 is what we refer to as an arm's length relationship. And so BMS has been extraordinarily supportive in providing Opdivo free of charge, which has been important because Opdivo is included on both arms of the study, given that we're adding, again, Elizabeth, two Opdivo on the combination arm and comparing it to the treatment arm, as well as sharing a lot of insights from their CheckNate 275 study and being actively involved in the design of our Mario 275 study. So it's been a terrific collaboration. We have not yet made decisions about partnerships with – who and when we'll make partnerships for the registration study. So that's to be determined at this point.
spk04: Okay. Thank you, and I look forward to AACR and future updates. Thanks, guys. Great. Thanks, Matt.
spk01: And once again, that's Star 1 for questions. Our next question will come from Ted Tentoff from Piper Sandler. You may begin.
spk06: Great. Thank you very much. Congrats on the update and all the progress. Just trying to get a sense, I'm appreciating that you provide more detail following additional conversations with the FDA, but how large do you think a phase three study might be in urothelial cancer? Thanks.
spk03: So I'll start that, and Brian, you might elaborate. It really does depend on some of the conversations that we'll have, but the reason that we've we're pursuing right now a focus on the PD-L1 low patients is because of that strong hazard ratio of 0.54, which as a result, when we look at ranges for the registration trial, we believe we can achieve an approvable hazard ratio with a relatively small number. You know, it's, again, a little premature prior to having those conversations with You might target in the, you know, and it depends on exactly what endpoints we use, something in the 200 patient range plus or minus 50 patients. So it really does depend on conversations, but that's the ballpark of what we're thinking about right now.
spk06: That's really helpful. Looking forward to hearing more details on this study.
spk03: Thanks, Chet.
spk01: Thank you. And I'm actually not showing any for the questions. I'd like to turn the call over to Adeline for any closing remarks.
spk03: Thank you, Victor. We're really excited to be advancing this tremendous opportunity for, again, illicit and PD-L1 locations in urothelial cancer, and we look forward to sharing additional data from Mario 3 and frontline TNBC, as well as our plans, more specific plans for the registration trial in the coming months. So thank you all for your continued support and for joining us on today's call, and have a nice evening.
spk01: Ladies and gentlemen, this concludes the conference call. Thank you for participating. Let me not disconnect.
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