Good morning, everyone, and thank you for standing by. Welcome to the CG Oncology's Bond 003 Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. At this time, I would like to turn the conference over to Sarah Connors, Vice President, Communications and Patient Advocacy at CG Oncology. Please go ahead. Thank you, and good morning to everyone on the call. Earlier this morning, we issued a press release summarizing the encouraging results from Cohort C of our registrational Bond 3 study of cretostimogene grenadenorep in high-risk, BCG-unresponsive, non-muscle-invasive bladder cancer. The press release and the slide deck accompanying today's webcast are available on the investor relations section of our website. With us on the call today are Arthur Kuan, Chairman and Chief Executive Officer, and Dr. Mark Tyson, Urologic Oncologist at Mayo Clinic, Phoenix, Arizona. Ambaw Bellette, President and Chief Operating Officer, and Dr. Vijay Kasturi, Chief Medical Officer, will also be available for the Q&A session following prepared remarks. Before we begin, I would like to remind everyone that during this call, we will be making forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements may involve significant risks and uncertainties, and therefore, actual results could differ materially from those expressed or implied on this call. Factors that may cause such difference include uncertainty associated with clinical development and the regulatory approval process, as well as difficulty in forecasting sales, revenues, and expenses. CG Oncology is not under any obligation to update statements regarding the future or to confirm these statements in relation to actual results unless required by law. With that, let me turn the call over to Arthur. Welcome to our investor conference call. Today, we are honored to have the lead PI on BOND-003, Dr. Mark Tyson, share the late-breaking top-line results of BOND-003 with you. Without further ado, I would like to hand over the mic to Dr. Tyson. Good morning. Thank you, Arthur. My name is Mark Tyson, and I'm a urologic oncologist. Delighted to be here with you today to provide a top-line result for BOND-003, a phase 3 registrational trial evaluating cretostimogene grenadenorep and Cretostimogene grenadenorepvec monotherapy for the treatment of BCG unresponsive, non-muscle-invasive bladder cancer. Just by way of brief review, Cretostimogene grenadenorepvec is a conditionally replicating oncolytic adenovirus that enters the cell through the CAR receptor, and it employs a dual mechanism of action. First, the E2F1 promoter restricts replication to Rb pathway deficient tumor cells, thereby causing direct tumor cell lysis and sparing normal tissue. And second, the GM-CSF transgene expression primes tumor-specific immunity after the release of viral and tumor-specific antigens. Together, this makes Cretostimogene grenadenorepvec a highly immunogenic and well-tolerated oncolytic immunotherapy. Moving on to the design of BOND-003, this is a registrational phase 3 study evaluating cretostimogene grenadenorep in the treatment of BCG unresponsive, non-muscle-invasive bladder cancer according to the strict FDA definition. The induction and maintenance treatment follows the classic BCG induction and maintenance paradigm, with repeat induction permitted for patients who have persistent disease at the initial disease assessment. Complete response rate at any time point is the primary endpoint, and the key secondary endpoints are listed there. Mandatory biopsies are done at 12 months with central path review, and I'm happy to report that enrollment is now complete and cretostimogene grenadenorep has been given fast track and breakthrough therapy designation from the Food and Drug Administration. In terms of baseline characteristics, the trial population was broadly representative, but predominantly white older men. Two-thirds of the patients came from the United States, and as expected, the cohort was heavily pretreated with BCG, intravesical chemotherapy, and systemic immunotherapy. The median number of BCG treatments was 12, which is pretty standard for these populations, and about 38% had received intravesical chemotherapy and 7% had received systemic immunotherapy, and I'll just note, somewhat parenthetically, that these are very, very difficult patients to treat. Next slide. Turning now to efficacy. As of September 30, 2024, the efficacy population demonstrated a complete response rate at any time point of 74.5%, with a 95% confidence interval indicating a range of plausible CRs between 65% and 82%. At 12 months, 46% of the cohort was in complete response, with 25% confirmed complete responses so far at 24 months. Progression to muscle-invasive disease was very rare in this cohort as well, with a 97.3% progression-free survival rate at 12 months and a 90% cystectomy-free survival rate at 12 months as well. Beyond complete response rates, cretostimogene grenadenorep demonstrates sustained efficacy with a median duration of response that exceeds 12 months, though it has not yet been reached. At a median follow-up of 14 and a half months for responders, 63.5% and 56.6% maintained their complete response at 12 and 24 months, respectively. The swimmers plot is shown here, and I would just note several responses have been observed beyond 30 months. We also note that 50% of reinduction patients went on to convert to a complete response, with two-thirds of them durable at the time of the data cutoff. This indicates that reinduction may bolster efficacy potentially through the establishment of immunologic memory. In terms of how this drug compares across the landscape of other approved agents and other agents in the pipeline, the median duration of response compares very favorably at 27 months. The next highest was pembrolizumab at 16 months, followed by nadofaragene firadenovec at 10 months. N-803's median duration of response is not on the label, and it has not yet been reported for TARGET100. In terms of how this drug compares across multiple patient subgroups, cretostimogene grenadenorep has done very, very well. You can see in this fourth plot, there's very little variation in complete response rates. This indicates that cretostimogene grenadenorep is effective across multiple patient-level demographic and clinical characteristics. I would just point your attention to a few high-risk phenotypes here too. The CIS and T1 population there, point estimate, is nearing 80%, which this is probably the highest-risk cohort and demonstrating very effective complete response rates. Beyond efficacy, cretostimogene grenadenorep is well tolerated with mostly grade 1 and grade 2 AEs. There were no grade 3 or higher treatment-related adverse events and no deaths. There were two grade 2 SAEs. In one case, the patient developed non-infective cystitis, and in another case, clot retention. These are two very common observations in any patient receiving intravesical chemotherapy. Importantly, and certainly a distinguishing feature of cretostimogene grenadenorep, is that 97.3% completed all protocol-defined treatments with no treatment-related discontinuations. And certainly, from my experience in the clinic and talking with patients, the tolerability of this agent is one of the things that really sets it apart. Next slide. This is not meant for comparative purposes, but more for just descriptive purposes. But you can see how the complete response rates, the durability of response, and the tolerability of each of these agents compare across the spectrum. The 75% complete response rate at any time point is every bit as good as anything else that's been published so far, and then the tolerability, obviously, is, again, I think, a distinguishing differentiator for cretostimogene grenadenorep. On behalf of all of my co-investigators, we would like to thank the patients and their families, as well as the study coordinators and their nurses, whose dedication made this study possible. Thank you. Thank you, Dr. Tyson, for your insightful presentation. Before we open the floor for questions, I'd like to share a few closing remarks. The data that you've just seen represent a decade of hard work of being a patient-centered organization that continues to fight for patients every single day in our existence. Over the past 10 years, we've witnessed tremendous progress in the field of NMIBC, and yet there remains a significant need for new and innovative treatment options for patients. CG Oncology's singular focus on attacking bladder cancer has led us to develop what we believe is a potentially best-in-class bladder-sparing therapy. The BOND-003 monotherapy data demonstrates cretostimogene grenadenorep's compelling efficacy and favorable safety profile, which allows patients to stay on therapy longer and keep their bladders longer. I will highlight a couple of key points here. This is the largest data set in BCG unresponsive high-risk NMIBC. We've shown one of the highest CR rates against approved therapies, even in patients with prior chemotherapy, which represented up to 37% of the BOND-003 trial. The landmark DOR at 12 months and 24 months, which were 64% and 57%, tell us that if you're a responder, there is a high probability of maintaining a CR even after two years. As of the data cutoff on September 30, the median DOR is greater than 27 months, and it is still ongoing. We look forward to continuing the follow-up in these patients. And as you've seen in our swimmer plot, we have a number of patients who still remain in response even beyond the 24-month mark, with one patient who has already reached month 39 and is still responding. We attribute these remarkable results to the fact that cretostimogene grenadenorep was designed and engineered as an oncolytic immunotherapy with a differentiated MOA. We believe this unique modality is a key driver for the favorable safety and adverse profile that we have seen. One of the most important things when it comes to adoption in this concentrated market is that cretostimogene grenadenorep integrates seamlessly in existing workflows at urology practices. Cretostimogene grenadenorep is delivered by a medical assistant without the need for retraining. Lastly, I'll just close with a special thank you to all of the patients who have participated in the clinical trial, as well as all the investigators and their staff who made it possible. I also want to thank all of our partners, investors who have entrusted us with their capital and trust and have supported us throughout the years. There is still a lot of work to be done, but we are encouraged by these results today. They strengthen our commitment to bring this product to patients as quickly as possible. Thank you. Now I'll turn it back to the operator for questions. Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We ask to please limit to one question. And one moment for the first question. And the first question will come from Jeff Hung with Morgan Stanley. Your line is now open. Congratulations on the data, and thanks for taking my question. Can you just talk more about the two additional responders that were confirmed after the data cutoff? Were these after a second induction, and how long after that until they experienced the CR? Thanks. Good morning, Jeff. This is Vijay Kasturi, Chief Medical Officer here at CG Oncology. Thank you for your question. So as of the September 30 data cutoff, we had reported results. There were two confirmed responders who were confirmed to be in CR after the data cutoff date, and therefore, in view of maintaining full transparency for all patient results for all patients, we are reporting them all. They were not reinduced patients. And the next question will come from Charlie Yang with Bank of America. Your line is open. Great. Thanks for taking the question, and congrats on the data and all the progress. Can you just talk about in terms of your following next steps and perhaps some of the commercial strategies that you're thinking, just given the competitive landscape? Thank you. Good morning, Charlie. Thank you very much for your question. This is Ambaw Bellette, President and Chief Operating Officer of the company. Our outlook is that, obviously, we're encouraged by the data that we're sharing today. In addition to that, as we've stated publicly before, we plan to submit our data package to the agency in the second half of 2025. In addition, obviously, looking at this data, it really is the best-in-class data that we've seen in the class for patients with BCG unresponsive non-muscle-invasive bladder cancer. So we're encouraged by that as we're planning our launch strategies for commercialization of cretostimogene grenadenorep. Our next question will come from Sam Slutsky with LifeSci Capital. Your line is open. Hey, good morning, everyone. Thanks for taking the questions and congrats on this update. Just wanted to dive into kind of baseline characteristics in terms of, if I remember correctly, about a third of patients back at AUA had received prior pembrolizumab or chemo. If I recall correctly, responses were kind of similar regardless of whether they had prior therapy or not. Can you just discuss how that data has matured? And then, just given that there are many treatments in development, how that helps you in the competitive landscape? Hi, Sam. Thank you for the question. What we have reported is that approximately 47% of patients in the study had any prior intravesical therapy in addition to BCG. Of these patients, about 38% had prior intravesical chemotherapy, and about 7% had intravesical systemic checkpoint inhibitor, primarily pembrolizumab. Sorry, intravenous pembrolizumab. My apology. I'm sorry, I did not get the second part of your question. The nuances on responses between those who had other treatments prior to your drug and not? Yes. So we have not seen any differences, as we showed in our fourth plot during Dr. Tyson's presentation. We have seen no differences in the complete response rate between those who received prior intervening therapy and those who did not. Awesome. Thank you. You're welcome. Our next question comes from Corinne Jenkins with Goldman Sachs. Your line is open. Thank you. What do you use, or what are most important as you consider which treatment option you give to patients? Thanks. I think we missed most of that question. You might have been cut off. Can you repeat the question? Yeah. Okay. Yeah. I think we might have missed the question. I don't know if you guys can hear me. Oh, yeah. We can hear you now. That's better. Go ahead. Okay. I just asked maybe for the physician if you could point us to the efficacy and other parameters that you think are most important as you evaluate which treatment options you give to patients, kind of looking across that comparative line. Yeah. And the question is, which efficacy parameters am I looking at in choosing which therapy? Is that the question? Did I hear it right? Okay. Yeah. Yeah. Thank you for your question. So as a physician, I am, first and foremost, concerned with durability of response. The complete response rates are very promising for Cretostimogene grenadenorepvec, but in my opinion, what's more promising is the durability. So the median duration of response at 27 months and then counting is a really important patient-oriented outcome because they don't frankly care if the complete response rate at three months is 75%. What they care about is whether they're going to keep the bladder for another couple of years and whether they're going to survive the disease. And so that flat curve that we see on the KM, that long tail, tells us that the people that this works in, it works really well, and it's durable. Half of these responders, two years later, have kept their bladder, and they've been disease-free. I'll just tell you anecdotally from my experience with cretostimogene, these are not easy patients. These are people that have come for second, third, and fourth opinions with disease that has not responded to immunotherapy, intravesical chemotherapy, and so forth. So the question about which parameter I'm looking at in terms of efficacy would be this, but I would also say that I think tolerability is really important. And patients don't want to trade good bladder function for a lifetime of urinary frequency and urgency and pain. Many of those patients would probably just rather have a cystectomy, but we don't see that with cretostimogene. We see it's pretty well tolerated. I mean, there's grade 1 and grade 2 urinary symptoms like everybody else, but it's not burning out their bladders. It's not causing major lifestyle changes. Just in my conversations with patients, many of them, several of them, have said to me, "Wow, this was a lot easier than BCG." So those are the two things that I look at as a physician, and I hope that answers your question. Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. The next question comes from Josh Schimmer with Cantor Fitzgerald. Your line is open. Great. Thanks for taking the questions. Two for me. One, what is the status of the patients who progressed to MIBC? And then second, maybe you can give us an update on manufacturing scale-up and how that's going ahead of expected launch. Thanks. Hi, Josh. Good morning, Vijay Kasturi. So as you know, 97.3% of patients are progression-free from MIBC. So the small minority of patients who progressed to MIBC have either gone to cystectomy or received systemic treatment. Arthur or Sam, I'm here for the second question. Yeah. So in terms of CMC, we're very encouraged that the stability of cretostimogene grenadenorep at 2-8 degrees Celsius continues to be very stable. So we now have up to four weeks of stability at that condition. So we believe this is a significant improvement and will greatly help with adoption. And in terms of the overall preparation for CMC, the beauty of cretostimogene grenadenorep is that it is manufactured in a very simple and robust process. So we've not had to change any processes between our phase two and phase three trials, as well as the commercial launch products. So very encouraged by the simple process and our ability to be fully ready at launch. Thank you. Our next question will come from David Dai with UBS. Your line is open. Great. Thank you for taking my questions. I just have two from my end. One is, just looking at the number of patients we enrolled, you're looking at 112 patients, but then when you presented here for the CR, there's basically 110 patients. So just wondering what happened to those two patients that were not included in the CR analysis. And the second question is just around maybe for the physician, help us understand the CR at 12 months, the actual CR rate of 46% versus the Kaplan-Meier estimate of 50%. How would you, if you were to look at those two numbers, what exactly is the right number to evaluate for looking at durability? Thank you for that question. So of the 112 patients, two patients did not complete the protocol-specified three-month efficacy assessment, and thus were removed from the efficacy analysis set, which is why there's 110 patients in the efficacy analysis set. As far as I will turn it over to Dr. Tyson to talk about the CR for NMIBC. Yeah. Thank you for your question. The number I look at here is the 46% CR rate, this simple mathematical way to tell you how many people in the cohort one year later are disease-free. The KM estimate at 12 months here is accounting for those two patients that Vijay just mentioned. It's an estimate of what their counterfactual outcome would have been. But I think given the maturity of this cohort, you don't really need to look at the KM estimate for 12 months. You should look at the complete response rate at 12 months. But the KM estimate is very helpful for the 24-month time point because we don't have mature follow-up for the cohort, for many of the cohort at 24 months. So that's where the Kaplan-Meier estimate is really helpful to tell you, projecting after censoring and dropouts and all of that, what is the complete response rate going to look like in all likelihood at 24 months? Got it. Thank you so much. And the next question will come from Gregory Renza with RBC Capital Markets. Your line is open. Greg, good morning, Arthur, CG team, and Dr. Tyson. Congrats on the data. Thanks for taking my questions. Arthur, maybe just two from me. Just given CREDO as an oncolytic virus, maybe you can just discuss a bit what you had talked about with respect to the ease of use and the seamlessness within a practice and the installation, what setup might be required for treatment centers to administer such a therapy, and any additional sort of post-install safety measures and protocols that are worth mentioning. And then secondly, now that we have this data and what you've seen in CORE-001, what's your level of interest in exploring the combo and prioritizing CREDO and Keytruda to potentially increase this therapeutic efficacy? Thanks so much, and congrats again. Thanks, Greg. So the beauty of CREDO is that it really just fits right into the existing workflow. And these urology practices are so familiar with giving standard of care BCG, which is also a BSL level 2 agent. So really, there are no meaningful changes that's required or retraining that's necessary. So we're very confident that this oncolytic immunotherapy will actually be seen as a great positive because it is more selective and specific relative to BCG, and there are major differences in side effect profiles as well as noted by some patients and physicians. In terms of your second question, the combination data definitely was very impressive. And however, as you've seen today, the monotherapy results have a median DOR greater than 27 months, and it is still ongoing. This compares very favorably relative to pembrolizumab mono, which was only 16 months of median DOR. So we're very encouraged by the mono, and we believe this on its own will be the backbone therapy of which that will build our business upon. Thank you. As a reminder to ask a question, please press star 11 on your telephone. I show no further questions at this time. Thank you so much for participating. This does conclude today's call. You may now disconnect.