Good morning, everyone, and thank you for standing by. Welcome to the CG Oncology Sponsored Therapeutic Health Conference Call. At this time, all participants on the list have been disclosed. Following management's prepared remarks, we will hold a Q&A session. As a courtesy to others, we would ask participants to limit themselves to one question and one follow-up question per person. As a reminder, this call is being recorded. Today is Monday, April 28, 2025. I would now like to turn the conference over to Sarah Connors, Vice President of Communication and Patient Advocacy at CG Oncology. Please go ahead.
Thank you, Operator. Joining us on the call today are Arthur Kuan, Chairman and Chief Executive Officer; Ambaw Bellette, President and Chief Operating Officer; Dr. Vijay Kasturi, Chief Medical Officer; and Corleen Roche, Chief Financial Officer. During this call, we will make forward-looking statements, including statements related to the efficacy and safety of our product candidate and our clinical development plans, which constitute forward-looking statements for the purposes of the Safe Harbor Provision under the Private Securities Litigation Reform Act of 1995. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties associated with our business, including those discussed in our filings with the SEC and the press release we issued on Saturday, April 26, 2025.
We undertake no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations. The data we'll be discussing on this call are subject to the press release we issued on Saturday, which can be found on the news section of CG Oncology's website. Today's call also will reference the slide deck that can be downloaded from the IR portion of CG Oncology's website at www.cgoncology.com. With that, I will turn the call over to Arthur Kuan, Chief Executive Officer of CG Oncology. Arthur?
Thank you, Sarah, and good morning, everyone. Thank you for joining our call. Now, let's please turn to slide three. Our mission at CG Oncology is to develop bladder-sparing therapeutics for patients afflicted with bladder cancer. To that end, we have multiple programs in this place that address more than 70% of the non-muscle-invasive bladder cancer market in the intermediate-risk and high-risk space. Now, let's please turn to slide four. These programs offer us multiple shots on goal, starting with the high-risk BCG unresponsive, both in CIS-containing and high-grade Ta T1-only disease, which we have reported on Saturday at AUA. In addition to that, I want to turn your attention to the intermediate-risk non-muscle-invasive bladder cancer program, PIVOT-006, which we have partnered with the SUO-CTC.
This is a phase 3 randomized controlled trial, and we're very happy to report that patient enrollment is well ahead of schedule, and it will complete likely in the second half of 2025. On the bottom corner here, we're also running CORE-008, further expanding the potential applicability of cretostimogene into both BCG naive and BCG exposed in the high-risk setting. Cohort A has now been fully enrolled, and we have just initiated Cohort CX. Please turn to slide five. This slide highlights key attributes on the labels of the three approved products in this space. In a number of metrics, cretostimogene could have advantages over these existing therapies, including CR rate, DOR, free from progression to muscle-invasive disease, cystectomy-free survival, as well as safety and tolerability. Now, let me hand the call over to Dr. Vijay Kasturi, our Chief Medical Officer, to go through our BOND-003 clinical update.
Thank you, Arthur. Good morning. Please turn to slide seven. This is the design of our study, BOND-003, which is the pivotal phase three registrational study which evaluated the safety and efficacy of cretostimogene grenadenorepvec in 112 patients with high-risk BCG-unresponsive non-muscle-invasive bladder cancer. All participants had previously received adequate BCG and were high-risk BCG-unresponsive non-muscle-invasive bladder cancer by the FDA guidance issued in 2018. The cretostimogene treatment consisted of six weekly doses during the induction phase, followed by three weekly maintenance cycles at months three, six, nine, twelve, and eighteen, similar to intravesical BCG. All participants were eligible for repeat induction therapy at month three if persistent high-grade carcinoma or CIS was noted at biopsy. Response assessments included serial cystoscopy, urine cytology, axial imaging, and mandatory mapping biopsy at month twelve, with centralized review of all pathology.
The primary outcome measure was complete response at any time. Other secondary and exploratory endpoints were also assessed and are listed here on the slide. The enrollment was completed two years ago, and cretostimogene received both FDA Fast Track and Breakthrough Therapy designations. Please turn to slide eight. In this slide on patient demographics, the majority of patients on BOND-003 were elderly, white, and male. This population is representative of the patients we may treat, as 63.4% of patients, or two-thirds of the population in this study, were enrolled in the United States. BOND-003 also enrolled a higher proportion of Asian and Black patients than other clinical trials in this space. The demographics reflect high risk and a very highly pre-treated population.
Prior intervening therapy consisted of intravesical BCG with a median of 12 prior doses and intravesical chemotherapy at a rate of 41.1%, with a high proportion of these patients receiving gemcitabine and docetaxel doublet chemotherapy, almost half, and immunotherapy, including systemic pembrolizumab. Please turn to slide nine. I'm pleased to report the latest results from BOND-003 reflect the largest data set enrolled in high-risk BCG-unresponsive non-muscle-invasive bladder cancer. Efficacy evaluable in this study was defined as patients meeting BCG-unresponsive FDA definition from the 2018 guidance, those who had received at least one dose of cretostimogene and had an assessment at the three-month time point. As of March 14, 2025, data cut off, and in the efficacy evaluable population, we report a consistent and compelling 75.5% complete response at any time, with possible complete responses between 66.3% and 83.2%.
Please note that this was maintained from results presented at SUO 2024 and the European Association of Urology meeting in March 2025. 46% of these patients demonstrate ongoing complete responses at 12 months. Importantly, cretostimogene demonstrates a class-leading 24-month complete response rate of 33.7%, with nine ongoing complete responders still pending their 24-month assessment. A KM estimate is appropriate here, as patients continue to pend assessments at these longer-term time points. Please note that Adstiladrin had a 25% and nadofaragene firadenovec 19% and pembrolizumab 9% complete response rate at 24 months, respectively. Additionally, in a majority of this population of patients with BCG unresponsive disease, these patients tend to be elderly, have many other comorbidities, and they are going to be either unable or unwilling to undergo radical cystectomy.
Thus, a few important endpoints, especially at 24 months, 97.3% of patients were free from progression to muscle-invasive bladder cancer, and 84% avoided radical cystectomy and successfully preserved their bladders.
Among those who did undergo radical cystectomy, 82.4% were either T0 or non-muscle-invasive bladder cancer. For context here, with pembrolizumab, 49% had a radical cystectomy; nadofaragene firadenovec, 30% had a radical cystectomy; and in the Adstiladrin group, 16% had a radical cystectomy. We therefore believe that cretostimogene is starting to show its benefit by reducing the progression rate for patients with high-risk non-muscle-invasive bladder cancer. All complete response rates are centrally confirmed, and the high local to central concordance supports strong site execution and trial processes, as well as overall trial integrity and validity. Please turn to slide ten. Beyond initial complete response rates, we have demonstrated best-in-class duration of response. The median duration of response is 27.9 months and ongoing.
91% of the patients in complete response at 12 months are projected to remain in complete response at 24 months. This is similar to our combination study CORE-001, which was published in 2024, suggesting a significant contribution from cretostimogene. As you can see here in the Kaplan-Meier curve, at a median follow-up of 22.3 months for the responders, 64.1% maintained their complete response at 12 months, and 58.3% maintained their complete response at 24 months. These data underscore the potential role for cretostimogene in driving innate to adaptive immune switching, which is reflected by this long tail on the Kaplan-Meier curve. Please turn to slide eleven. The swimming plot here shows patients having sustained responses observed over 45 months, with the one patient out so far up to 45 months and counting.
The swimming plot shows insights into the 83 patients with complete response, with a median follow-up of 22 months, and underlines the clinical implication of this data. There are 34 confirmed complete responses at 24 months and beyond, with the nine pending ongoing CRs, as I mentioned, that have yet to reach the 24-month time point. There are two additional complete response patients that discontinued treatment before their 24-month assessment that will be returning for long-term follow-up visits in the near future. Half of the reinduction patients converted to complete response, with 64.3% remaining in durable response. The best-case scenario for 24-month complete response rate is potentially 39-42%. Reinduction bolsters the high early efficacy that we see with cretostimogene's efficacy, paired with its durability of response.
Furthermore, patients remain in response even after completing treatment with cretostimogene, as shown on the swimming plot, the green diamonds on this plot. This further supports the immunological mechanism of action and the innate to adaptive switch and immunological memory. Please turn to slide twelve. Cretostimogene demonstrates the longest median duration of response in any data set of patients with BCG unresponsive high-risk non-muscle-invasive bladder cancer. This exceeds 28 months and is still ongoing. Please turn to slide thirteen. In this fourth part of subgroup analysis, the complete response rate is consistent across patient subgroups, regardless of prior baseline patient or disease characteristics, as shown by the overlapping confidence intervals. I'd like to draw your attention to the subgroups on the top.
Cretostimogene works in the post-chemotherapy setting, including those who received prior gemcitabine and docetaxel, and irrespective of BCG relapse or refractory status, thus showing that we can effectively overcome T cell exhaustion. Additionally, response is maintained in the higher-risk phenotype populations, including CIS alone and CIS plus high-grade T1. Please turn to slide fourteen. The safety profile of cretostimogene is highly tolerable. There were 0% grade three or greater treatment-related adverse events. Most adverse events were grade one and two, with a median time to treatment-related adverse event resolution of one day. Two patients had treatment-related serious adverse events, which were non-infective cystitis and clot retention, both grade two. In this study, there were no treatment-related discontinuations, and 97.3% of patients completed all protocol-defined treatments. These findings emphasize high patient adherence and compliance and tolerability with cretostimogene.
This is highly relevant for non-muscle-invasive bladder cancer patients, where BCG treatments can result in almost up to half of the patients having either dose holds, delays, or discontinuations. Please turn to slide fifteen. The competitive landscape shows that cretostimogene is very well-positioned as a backbone therapy in non-muscle-invasive bladder cancer, with best-in-class durability as well as safety. The complete response rate of 75.5% compares in this space, including the currently being developed TAR-200. The 24-month duration of response, with a KM of 58.3%, is also highly favorable compared to the other agents. The freedom from progression to muscle-invasive bladder cancer at 97.3% at 24 months is class-leading in this space, as well as the cystectomy-free survival at 91.6% at 24 months is also class-leading in this space. The safety profile, as in this indirect comparison, shows the high tolerability of cretostimogene. Please turn to slide sixteen.
Cretostimogene is administered intravesically into the bladder, and this is similar to standard BCG therapy. This is something that urology practices perform regularly. Cretostimogene can be prepared and administered by a medical assistant, a nurse practitioner, or a physician assistant. A urologist is not required to be present. The total procedure time is approximately one hour. Please turn to slide seventeen. Cretostimogene will be shipped via just-in-time delivery, with multi-day stability in the box, and at least four weeks in a regular refrigerator at two to eight degrees Celsius under administration. As I mentioned, it can be prepared and administered by a medical assistant, a nurse, or a nurse practitioner, or a physician assistant, and a urologist is not required to be present. There is no pre-administration of anticholinergics required.
Any site that administers BCG or intravesical chemotherapy can prepare and administer cretostimogene because cretostimogene is a BSL-2 agent, exactly like BCG or intravesical chemotherapy. There is no monitoring requirement expected for the commercial setting. Thirty minutes is being performed currently in the clinical trial setting. However, we have not seen any adverse events during this time. There are no close contact precautions needed post-treatment.
Please turn to slide eighteen. As you can see here, the data that we have presented today for cretostimogene compares quite favorably to the current benchmarks for patients with high-risk BCG unresponsive—sorry, this is for high-grade Ta and T1 patients. We also presented data at AUA on patients with high-grade Ta T1 patients with BCG unresponsive disease. These are the current benchmarks that have been published. Pembrolizumab with a three-month rate of 87.7% and 12 months of 43.5% firadenovec at 72.9% for three months and 43.8% for 12 months.
These two agents are in the NCCN guidelines. However, Adstiladrin is not in the NCCN guidelines, and the 12-month rate was 55.4%. Please turn to slide nineteen. These are the preliminary results in the first 24 patients treated with cretostimogene for high-risk BCG-unresponsive high-grade Ta T1 without CIS. This shows 90.5% high-grade recurrence-free survival at three, six, and nine months in this cohort thus far. We believe this compares quite favorably with the data that I've shown you on the previous slide regarding the benchmarks. This is a well-tolerated regimen in these patients, and the safety profile remains consistent with what we have seen in BOND-003 Cohort C. There have been no serious adverse events or discontinuations related to cretostimogene. Please turn to slide twenty.
PIVOT-006, as mentioned by Arthur, is our Phase 3 trial of cretostimogene for intermediate-risk non-muscle-invasive bladder cancer, and we expect, as Arthur has mentioned, to fully enroll this trial ahead of schedule in the second half of 2025. We believe enrollment on this trial will occur at the fastest rate of any trial thus far in non-muscle-invasive bladder cancer. The study design is reflected here on this slide. The primary endpoint is the recurrence-free survival rate. Please turn to slide twenty-one. Additional shots on goal show us moving or generating data in the BCG-naive space, as well as the BCG-exposed non-muscle-invasive high-risk space with our CORE-008 study. Cohort A has completed enrollment for arms one and two, and Cohort B will begin enrolling in the second half of this year. Please turn to slide twenty-two.
The combination potential of cretostimogene was shown in our proof of concept CORE-001 study, which was published in Nature Medicine in 2024. The combination of pembrolizumab and cretostimogene showed an overall complete response rate of 82.9%, with a 24-month complete response rate of 54.3%. Please turn to slide twenty-four. We believe there is potential synergy between cretostimogene and gemcitabine, with respect to the mechanism of action being both complementary and non-overlapping. The oncolytic immunotherapy potential of cretostimogene we believe can be cemented with the apoptotic effects of gemcitabine. Please turn to slide twenty-five. In CORE-008 Cohort CX, which has begun enrollment, we are evaluating the combination of cretostimogene and gemcitabine given either concurrently or sequentially, as is depicted on this slide. This is in patients with high-risk BCG-exposed non-muscle-invasive bladder cancer, with the primary endpoint being high-grade event-free survival and additional endpoints as shown on this slide.
We believe the class-leading monotherapy data presented in the latest phase three readout of BOND-003 in the high-risk BCG-unresponsive CIS setting, as well as the early promising data that we have shown in the high-risk BCG-unresponsive high-grade Ta T1 without CIS setting, position us very well for success in these additional studies. Now, let me hand the call back to Arthur.
Thank you, Vijay. We believe that with the data that we have shown thus far, cretostimogene has the best in disease durability and safety data, which really sets us up nicely for addressing this blockbuster opportunity in non-muscle-invasive bladder cancer. It really hinges upon our unique MOA, with Creto being an oncolytic immunotherapy that has a dual mechanism of action. This is very versatile as it allows us to combine with other agents with different MOAs.
We're very excited about our expansion potential into the frontline settings in both intermediate-risk and high-risk disease. As I mentioned here, Creto is very easily prepared and administered by any HCP without a urologist, and this fits right into the existing workflow without any retraining required. Lastly, I want to mention that we have a very strong balance sheet with a cash runway expected into the first half of 2028 that includes all of the programs that we have mentioned here. Now I would like to open up the call for questions. Operator.
Thank you. As a reminder to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, simply press star one one again. As a reminder, please limit yourself to one question and one follow-up.
Please stand by while we compile the candidate roster. Our first question coming from the line of David Allemann with UBS. Your line is now open.
Hi, thanks for taking my questions and congrats on this great data update at AUA, guys. A couple of questions from me. One, it's just on the BLA submission process for cretostimogene and what are some gating steps for the BLA submission?
Hey, David, this is Ambaw. Thank you very much for your question. I mean, I think really from an approach perspective, what we previously stated is that we plan to initiate our BLA submission in the second half of this year. We remain on that guidance path. Really just a reminder as well that we have Breakthrough Therapy Designation, which does allow us eligibility for rolling submission as well.
We plan to closely continue to work with the FDA to find the most efficient pathway for submission that will really afford us the broadest label for cretostimogene for patients ultimately.
Got it. That's helpful. Just to follow up on that, Ambaw, we know that Johnson & Johnson already submitted TAR-200 for RTOR . Now the expectation is that they'll probably launch first. What are some of the key commercial activities you're doing to potentially come on top and leapfrog Johnson & Johnson?
Yeah, again, thanks for that particular question. From a pre-launch activity perspective, we actually initiated our pre-launch activities in 2024 and really rolling into 2025. We've accelerated our activities. Our medical team is actually currently calling on a daily basis with our future commercial customer base, and they continue to do that.
What they're doing is scientific exchange around the clinical data for cretostimogene, such as now, for example, the AUA data will continue to be amplified within that customer segment out there. In addition to that, we have the ongoing clinical programs that Vijay alluded to as well, where we're engaging the top sites in the country, both in the community sites as well as in the academic facilities as well in an engaged fashion to actually engage them, really thereby earning and gaining clinical expertise on the use of cretostimogene in their patient population. Lastly, I don't want to forget our expanded access program, which we initiated as well.
It's focused all around really the key top 10 customers that we have for cretostimogene, that's out 10, nine, and eight, and our focus is really deploying that within that segment of the future commercial customer base that we'll have for cretostimogene.
Thank you. Our next question coming from the line of Sam Slutsky with LifeSci Capital.
Hey, good morning, everyone. Congrats on the update this weekend. Could you just talk a bit more about the background for choosing gemcitabine as the combo partner of choice for Credo and Cohort CX? What you're hoping to see there with the combo as kind of an internal benchmark and then what that path forward might look like?
Sam, thank you very much for that question. We are committed to developing intravesical therapies for patients with high-risk non-muscle-invasive bladder cancer.
Gemcitabine fits the profile of an intravesical therapy that we feel can be combined with cretostimogene and can potentiate the mechanism of action of cretostimogene and thus resulting in potentially higher efficacy as well as a good safety profile. We have generated some pre-clinical data as well for this combination, and that allows us to have confidence in moving forward with the combination of cretostimogene and gemcitabine in the BCG exposed setting in Cohort CX.
Okay. Just what you might do on the back of that in terms of a potential path forward as it relates to regulatory or registration studies, etc.?
I believe we need to look at the data that we will generate for Cohort CX before we can decide on further steps.
Thank you. Our next question coming from the line of Gregory Renza with RBC Capital Markets.
Hey, good morning, Arthur and team. Thanks for taking my question and congrats on the nice data this weekend. Arthur, maybe just a question around, as you've nicely laid out, Credo versus the competition, what do you believe will ultimately be the key to clinical adoption? With respect to the 24-month CR data, how significant is that just based on your market research and driving the adoption that you're anticipating? Just lastly, related, as you've mentioned, with the guidance continuing on the BLA submission for a potential rolling for second half 2025, I know you've also mentioned a potential commercial launch in 2026. Just want to see if you believe that timing still lines up with where you and the company are. Thank you very much.
Thank you, Greg. I'll answer the first part of your question first.
Really, let's think about what is the goal of therapy in this disease space, right? Patients do not want to get a radical cystectomy. Really, the number one thing they look at is what are the trade-offs, right? Can I actually have my bladder saved at one year, at two years, maybe three years, and beyond? Long-term durability and actual CR rate at those time points are extremely meaningful for patients. Hence, those are really key metrics that we'll be focusing on, starting with a two-year CR rate that we believe is already best in class. The next thing is, what is the risk of progressing into a more invasive disease? Free from muscle-invasive progression is actually a very important metric. We believe that it's really the high PFS rate that we have here to MIBC is really driven by the unique MOA of Credo.
There is some emerging preclinical as well as translational data that supports Credo's MOA in driving down these aneuploidies in these bladder cancer cells that really are looking as if they're going into a muscle-invasive disease, but Credo is able to stop that and even reverse that. The next thing is cystectomy-free survival. Ultimately, patients want to know, for these patients who went on this trial, what's the percentage of them actually not getting a radical cystectomy? That is an important secondary endpoint that we have included in Bond 3 as well. I'll point you to one more thing that Vijay has highlighted, which is the median time to AE resolution. Credo has the best median time to AE resolution that's been reported to date of one day, right?
To contextualize this, you really need to think about these elderly patients who are typically 75 years or so. They really don't want to deal with a lot of side effects in the bladder or urinary tract. And Credo really has that ideal profile so that patients will not have to be bothered with these potential side effects. I'll turn it to Ambaw for some of your commercial questions.
Yeah. I mean, I think in terms of commercial timing, as I've just previously indicated, I mentioned really the commercial sets of activities that we're already conducting in terms of physician-level engagement with our clinical trials along with our expanded access program. In addition, we're conducting disease state awareness programs as well with respect to that in the field.
I think just to piggyback on Arthur's comment, I think when you look at the physician-patient discussion, which is what Arthur was articulating in his comments back on the profile elements of it, I would say we're looking at efficacy, does it work for me, how long is it going to work for me. Also, I think an important key metric that Vijay alluded to is that if you're in CR on month 12, nine out of 10 patients will be in CR month 24. It's an important aspect of that discussion. What type of lifestyle changes do I need to incur from a safety perspective? I think that's another element of it. Those are the things that I would highlight and articulate in there on that question.
Great. Thanks, guys. Congratulations, guys.
Thank you. Thanks, Greg.
Our next question coming from the line of Tyler Van Buren, with TD Cowen.
Hey, guys. Congratulations on the tremendous data update and the overall win this weekend at AUA. TAR-200's CR rate is clearly declining at a faster rate than Credo based on the data update this weekend, which is encouraging as we think about how the mature 24-month CR rates will compare. What have physicians and KOLs at AUA been saying, and is there consensus on why the TAR-200 CR rate is declining quicker?
Yeah. I mean, Tyler, thank you very much for your question. At the end of the day, it's still chemotherapy. I think it's important to recognize—forgive me for my voice—it's important to recognize that chemotherapy may have an initial high CR rate, but in time, durability is a big question on chemotherapy. Ultimately, I think that's what we are seeing here as well.
Again, we haven't seen the full data set, but I would just look at MOA. From an MOA perspective, our oncolytic immunotherapy MOA for cretostimogene has shown really a durable response in patients. From a monotherapy basis as well, it's shown the highest CR that we've seen at month 24 in this set of patients as well.
Thank you. Our next question coming from the line of Sean Laaman with Morgan Stanley.
Thank you, Alberta. Good morning, Arthur and team. Hope everyone's well and congratulations on these data. Given the recent changes, which were quite significant at the FDA, Arthur, I'm wondering if you can provide us any commentary if you've seen any change in the interactions you've had with the agency or how that feeds in your expectations for the BLA filing. Thank you, Arthur.
Thank you, Sean, for the question. I'll take that question on.
This is something that we've really been keeping a very close eye in terms of our interactions with the agency. We continue to check with the agency on our review team and the status of our review team. I would say overall, the main review team is intact and is in place still at the agency. We continue to have interactions really at different levels of the organization on an ongoing basis. So far, we do have to say that they are in place, I guess, in role for now. The other thing I do want to highlight is that each of those roles, whether it's clinical review or pharmacology and other areas, they are three, four, five people deep. They are further backed by the number of individuals that are in role and in function as well.
I would say that so far, what we've seen is that it's stable. It's probably the best way that I would articulate it.
Thank you, sir. We'll speak after the call.
Thank you. Our next question coming from the line of Alec Stranahan with Bank of America.
Hey, guys. Thanks for taking our questions and want to offer our congrats on the strong update as well. Maybe first, just on the ease of delivery, curious if you run these handling requirements past any of your pre-market work and what the feedback has been versus other options and whether you might—this might limit you to larger centers initially or any, I guess, lower-hanging fruit in your view on the additional options.
Yeah. Thank you very much for that question.
Really, from a delivery perspective, first of all, delivering on a just-in-time basis is something that urologist practices are well familiar with. They currently are actually in that same path for another nadofaragene, for example. Really, the stability that we've shared, the commercial product being shipped on a just-in-time basis, the multi-day box, that it can stay within the box, can be taken out of the box and actually stored in a normal refrigerator for up to four weeks at two to eight degrees, really offers them a high degree of flexibility. We've continued to test this with our future commercial base of customers who are currently in clinical trials for cretostimogene. They're actually gaining that experience today on how the product is delivered and administered in their office, whether it's in the large urology practices, community practices, or academic setting.
Regardless of setting, we'll be able to deliver this in a way that it actually could be deployed effectively within the practice.
Okay. Great. Maybe just one on the papillary data you shared. I appreciate it's still early days here, but the RFS from the 24 patients you shared, those look encouraging. I guess, why focus on RFS versus, say, DFS in the way that you present the data? Is it just kind of the timing and the fact that it's early on? Anything from the emerging data that you think is notable either from your program or externally? Thank you.
Yeah. Thanks for the question. Our primary endpoint is actually high-grade event-free survival. So far, because these are preliminary data, we have assessed the recurrence-free survival on this initial group of 24 patients.
Therefore, we reported the high-grade recurrence-free survival in this data set. We're extremely pleased by the 90.5% rate that we're seeing at not just three months, but also at nine months. One of the three patients had recurred at the three-month time point. One of those patients was re-induced and did convert to CR at month six, and is continuing on therapy. Two additional patients who recurred at month three are currently in the process of re-induction as well. Overall, this regimen has been very well tolerated. We really have not seen any serious adverse events, no Grade 3 or greater AEs, no discontinuation. The safety profile looks essentially identical to what we're seeing in BOND-003 Cohort C with the CIS patients.
Thank you. Our next question coming from the line of Chris Maldonado with TBC.
Hi, everyone.
Thank you for taking the questions and congrats on the data. Given the emerging evidence that tertiary lymphoid structures and humoral immunity may contribute to cretostimogene's activity, how is the company planning to incorporate potentially B- cell-related biomarkers to correlate TLS presence with clinical outcomes in future clinical studies?
Yeah. Thank you for that question. You are referring to the data that was published in the Nature Med publication for CORE-002, which is our proof of concept study in muscle-invasive bladder cancer in 2024, where tertiary lymphoid structures were found to potentially correlate with response. We have an extensive translational program that we have put in place for all our studies, including BOND-003 Cohort C and BOND-003 Cohort B. We continue to evaluate the data arising from these translational programs. In fact, here at the AUA this week, Dr. Colin Dinney of the MD Anderson Cancer Center presented some preliminary results of our translational program as well. We are hopeful that future data arising from this translational analysis will enable us to look at the potential of other biomarkers, whether it be in the tissue or in the urine.
Great. Maybe one quick follow-up on the last question. How should we think, given the significant genetic heterogeneity and high-risk features seen between CIS versus papillary patients, how should investors be thinking about the differences of these responses for these two subgroups? Thank you very much.
Thank you. The CIS patient group is the highest risk group within the high-risk BCG unresponsive population. The other group with a very high potential of progression is the CIS plus high-grade T1 group.
What we have shown, as reflected in the first part I showed you, is that the response to cretostimogene essentially maintains a very high complete response in either of these two groups. In fact, in patients with high-grade CIS alone and in patients with CIS plus high-grade T1, we are seeing very high complete response rates. We feel, given the heavily pretreated patient population, the higher genetic heterogeneity, cretostimogene with its oncolytic immunotherapy mechanism of action is able to overcome these high-risk features in these patients. We are showing this with our translational data that was presented at this meeting as well.
Thank you. Our next question coming from the line of George Saravelos with Deutsche Bank.
Hi. Good morning. Sean for George. Can you hear me okay?
Yes, we can. Great.
Two from us.
In the clinical trial protocol, patients can receive a second induction third month, right? Could you clarify for us the criteria for determining who will receive that induction if these are not mandatory at month three point? That is the first question. I have a follow-up.
Thank you for that. You want to know the criteria for re-induction. The criteria for re-induction in BOND-003 and with other studies that we are conducting is patients who have persistent CIS or high-grade Ta at month three. If somebody has high-grade T1 at month three, they have to come off the study. Only patients with persistent CIS and high-grade Ta are eligible for re-induction. Does that help answer your question?
Yes. Thank you.
For the follow-up, I was wondering if you could share some color on the patients who achieve a CR after the first induction compared to those who achieve a CR after the first versus re-induction. What kind of differences in patient baseline properties have you found so far? If there's any meaningful difference in who eventually gets more durable CR over time, if that makes sense.
Thank you for that question. We are not seeing any differences based on clinical characteristics of the patients at the present time between the re-induced patients versus the patients who have CR at first induction, primary induction. We have not seen any of that. That's partly the reason we're also evaluating these patients within our translational program. We are hopeful we will have more data in the future that may help delineate differences between these patient populations.
Okay.
They're both kind of giving you roughly a similar type of durability response as well?
They are. We're seeing durable responses at 12 months from the re-induced patient population as well.
Okay. Great. Thanks very much.
Thank you. Our next question coming from the line of Sam Slutsky with LifeSci Capital. Your line is open.
Hey. Just a quick follow-up for me. On the just-in-time delivery, as you mentioned, currently, the stability is in a fridge for at least four weeks. Just remind us if any steps are being taken to potentially expand this in the future to even longer time points than four weeks. On the two versus five-step administration process, how much time does the two-step process save, and what's kind of the hope for what the label may look like between the two?
Thank you, Sam, for your question.
In reference to the stability, we continue to do work on stability along with shipping validation studies as well. That is part of our approach in terms of validating various elements and delivery mechanisms that we will be undertaking. We will update you all once we get additional data, but we continue to work on expanding that timely. With respect to two vs 5 that you were asked about, you are taking away three different saline washes out of this process in itself. That probably reduces somewhere about 15 minutes or so out of the process because you are just doing a DDM dwell followed by cretostimogene all in, as Vijay indicated, approximately an hour in.
Okay. Thanks.
Thank you. I am showing no further questions in the queue at this time. I would now like to turn the call back over to Arthur Kuan for his closing remarks.
Great.
Thank you, everyone, for dialing in. This is truly an exciting time, and we are on track to make cretostimogene the imaging backbone therapy for all lines in IR and HR and MIBC. Thank you. Ladies and gentlemen, this concludes today's conference call. You may now disconnect.