CG Oncology, Inc. (CGON)
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Investor Update

May 3, 2024

Operator

Welcome to the CG Oncology conference call to discuss updated results from the company's BOND-003, phase III clinical trial of cretostimogene for the treatment of high-risk BCG-unresponsive, non-muscle invasive bladder cancer. At this time, all participants are in a listen-only mode. 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, Friday, May 3rd, 2024. I would now like to turn the conference call over to Laurence Watts of New Street Investor Relations. Please go ahead.

Laurence Watts
CEO and Founder, New Street Investor Relations

Thank you, operator. Joining us on the call today from CG Oncology are Arthur Kuan, Chairman and Chief Executive Officer; Ambaw Bellete, President and Chief Operating Officer; Dr. Vijay Kasturi, Chief Medical Officer; and Colin Roche, Chief Financial Officer. During this call, management will make forward-looking statements, including statements related to the efficacy and safety of our product candidates and our clinical development plans, which constitute forward-looking statements for the purpose 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 earlier today.

CG Oncology undertakes 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 the subject of a press release we issued earlier today, which can be found on the news section of CG Oncology's website. Today's call also will reference a 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?

Arthur Kuan
Chairman and CEO, CG Oncology

Thank you, Laurence, and good afternoon, everyone. We are excited to present updated results of CG Oncology's BOND-003 single-arm, open label, phase III registrational study evaluating cretostimogene grenadenorepvec monotherapy for BCG-unresponsive non-muscle invasive bladder cancer. The data was presented earlier today by Dr. Mark Tyson in the paradigm-shifting plenary session at the American Urological Association meeting in San Antonio, Texas, and it is the largest data set presented in BCG-unresponsive disease thus far. As a reminder, we reported 75.7% CR at any time in 66 patients last December at SUO 2023, and it is encouraging that our CR rate at any time maintained at 75.2% out of 105 patients. Here are four main points we'd like everyone to take away about cretostimogene from today's call.

1, complete response rate at any time, which is our primary endpoint. 2, duration of complete response. 3, safety and tolerability. Last but not least, our novel mechanism of action, which supports the three points I mentioned. But for now, I would like to turn it over to Dr. Vijay Kasturi, our Chief Medical Officer.

Vijay Kasturi
Chief Medical Officer, CG Oncology

Thank you, Arthur. Please turn to slide 3. So what is cretostimogene grenadenorepvec? cretostimogene grenadenorepvec is an investigational oncolytic immunotherapy, serotype 5 adenovirus, which has dual mechanisms of action, and it has been designed to replicate in and kill cancer cells. The E2F1 promoter drives the expression of essential viral genes, which restricts replication to RB E2F pathway-deficient bladder tumor cells. It also encodes the complementary DNA for GM-CSF, which has been shown to be a potent cytokine inducer of antitumor immunity. The primary receptor for cretostimogene grenadenorepvec is the Coxsackie adenovirus receptor, which is expressed in all stages of bladder cancer. Please turn to slide 4. Once cretostimogene grenadenorepvec binds the CAR receptor, it enters the malignant cells, where viral replication leads to tumor cell lysis and release of viral and tumor-specific antigens. These antigens are picked up by the dendritic cells and presented to T cells, which initiate the local antitumor response.

Activated T cells then travel to the tumor tissue, where T cell-attracting chemokines recruit more immune cells, thereby potentiating this immunotherapeutic effect. Please turn to slide 5. This leads us to BOND-003, Cohort C, a single-arm, phase III registrational study evaluating cretostimogene grenadenorepvec in the treatment of BCG-unresponsive CIS according to the strict criteria laid out by the FDA in their 2018 guidance. Concomitant papillary or high-grade Ta, T1 disease was allowed, but this had to be completely resected prior to study enrollment. Importantly, patients underwent a mandatory biopsy at 12 months, which included five regions of the bladder as well as the prostatic urethra. Patients underwent six weekly sequential instillations of cretostimogene grenadenorepvec, followed by repeat induction for non-responders and maintenance for responders. The primary endpoint was complete response at any time. Key secondary endpoints include duration of response, recurrence-free, progression-free, and cystectomy-free survival.

Please turn to slide 6. In total, 112 patients enrolled in BOND-003, and the data presented here are for the first 105 evaluable patients up to a cutoff date of April 1, 2024. This is the largest data set presented in BCG unresponsive NMIBC. In terms of baseline characteristics, most patients were White, male, and of Medicare age. About 20% did have concomitant papillary disease, and as expected, the cohort was heavily pretreated with a median number of prior BCG instillations of 12, including several patients who had also received prior intravesical chemotherapy or systemic immunotherapy with pembrolizumab. Please turn to slide 7.

In terms of the efficacy analysis, the complete response at any time point for the 105 evaluable patients based upon central review was 75.2%, with a confidence interval indicating a range of possible CRs between 65% and 83%. Please turn to slide 8. Here, the swimmer plot shows the distribution of the CRs over the entire cohort, and a key observation worth noting here is that 54% of patients who did not respond to the initial induction course of cretostimogene responded to a second induction course of cretostimogene, including several patients whose response exceeded 12 months. This speaks to an oncolytic immunotherapy mechanism of action that the immune system switches from an innate to an adaptive immune response, as also seen with the second induction course of BCG.

We also observed that 29 of 35 patients, or 83%, maintained their complete response for greater than 12 months, with 22 complete responders still pending evaluation. Lastly, 92% of patients did not undergo a radical cystectomy at one year. Please turn to slide 9. In terms of tolerability, we observed no grade 3 or greater adverse events and no deaths. There were two grade 2 serious adverse events, which we previously reported at SUO, and no new serious adverse events have been observed since then. One patient discontinued treatment, but this was due to an unrelated AE. Notably, 94.5% of patients completed all protocol-mandated treatments. Please turn to slide 10. In terms of the instillation process, the cretostimogene administration is a familiar and convenient workflow.

It is instilled by a nurse or a medical assistant, and the favorable tolerability profile lends itself to enhancing patient compliance. This is supported by the observation that 100% of patients that completed their protocol-mandated treatments in the BOND-003 trial were able to tolerate the instillation and the dwell of cretostimogene. Efficiency and patient experience continue to be a priority for us, with even more streamlined workflows being carried forward into future studies and cohorts. Please turn to slide 11. Recognizing that comparison across studies is difficult due to differences in the underlying populations, among other factors, cretostimogene would at least appear to compare favorably to the current nonsurgical approved therapies.

The 75% complete response rate at any time point observed for cretostimogene monotherapy compares favorably to the 62% observed for combination therapy with N-803 and BCG, and to the 51% observed for nadofaragene, as well as the 41% observed for pembrolizumab. Similarly, the interim duration of complete response for cretostimogene monotherapy compares favorably, with 29 of 35 patients, or 83%, maintaining a durable CR for 12 months or more. Also, toxicity compares favorably as well, with no grade 3 or greater treatment-related adverse events and no treatment-related discontinuations observed in BOND-003. Please turn to slide 12. As a reminder, the FDA has granted CG Oncology Fast Track designation and Breakthrough Therapy designation for the development of cretostimogene in the treatment of BCG unresponsive non-muscle invasive bladder cancer. Please turn to slide 13.

Now I'd like to draw your attention to two important amendments that we have made to our trial. We have now implemented a treatment extension phase for complete responders in years two and three. In addition, there is now a high-grade papillary-only cohort, called Cohort P, where papillary-only or high-grade Ta/T1 BCG-unresponsive patients receive cretostimogene at a similar dosing schedule as Cohort C. Cohort P is currently enrolling. Please turn to slide 14. Today, we are pleased to announce our expanded access program for cretostimogene. The program has simplified exclusion and inclusion criteria for BCG-unresponsive CIS, with or without Ta/T1 patients, and it's specifically designed to enhance the geographic and ethnic diversity, collecting real-world data for safety, efficacy, and patient-related outcomes.

Please turn to slide 15. We would also like to take this opportunity to highlight two important collaborations between CG Oncology and the Society of Urologic Oncology Clinical Trials Committee. PIVOT-006 is a randomized phase III study led by Dr. Rob Svatek, comparing cretostimogene versus surveillance after TURBT in patients with intermediate-risk non-muscle invasive bladder cancer. I'm pleased to report that the first few patients have been dosed in this study, and we are currently enrolling patients at more than 90 sites in North America. We are also progressing CORE-008, which is a phase II multi-arm, multi-cohort study, evaluating cretostimogene for high-risk patients who are BCG naive as well as BCG exposed. Please turn to slide 16.

We would like to take this opportunity to thank the patients and their families, the study coordinators and nurses, as well as the key collaborators listed here, who were instrumental in the success of this trial. I would like now, like to turn it back to Arthur, for any additional remarks.

Arthur Kuan
Chairman and CEO, CG Oncology

Thank you, Vijay. Now I would like to return to the key takeaways that I mentioned at the beginning of this call. Going to point number one, the primary endpoints of CR at any time. cretostimogene achieved a 75% CR at any time in 79 out of 105 patients. This is the largest data set reported in this indication. 79 complete responders is the highest number of CRs reported, and the CR rate also maintained from the last data cut at SUO 2023 in just 66 patients. This level of efficacy positions cretostimogene as a leading potential backbone therapy for patients with NMIBC. Number two, duration of response. cretostimogene has shown durable responses over time, with 29 of 35 patients maintaining a complete response for 12 months or more. This level of durability is potentially differentiating for cretostimogene. The next point, safety and tolerability.

No grade three or higher AEs related to cretostimogene were observed. 94.5% of patients completed all protocol-mandated treatments. This is the first time we reported cystectomy-free survival, a key secondary endpoint. As you've seen, 92% CFS was observed at 12 months, and notably, zero patients with CR underwent a radical cystectomy. This level of potential class-leading safety and tolerability could be a differentiator for cretostimogene. Finally, our mechanism of action as an oncolytic immunotherapy. This is a unique mechanism of action that serves as the basis for the above three points that I just mentioned. Based on these results, we look forward to presenting top-line results from BOND-003 at the end of this year.

Today's results also give us the confidence in our recently launched PIVOT-006, phase III pivotal trial in intermediate risk NMIBC, and CORE-008 in BCG-exposed and BCG-naive high-risk NMIBC. With that, I'll now open the call up for questions. Operator?

Operator

Thank you. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment, please. Our first question comes from the line of Jeff Hung with Morgan Stanley.

Jeff Hung
Equity Research Analyst, Morgan Stanley

Congratulations on the data, and thanks for taking my questions. I know the data are still very fresh, but what kinds of feedback have you heard from clinicians on the durability of response, and how do physicians think about the importance of CR rate at any time compared to durability and safety? And then I would follow up.

Arthur Kuan
Chairman and CEO, CG Oncology

Thank you, Jeff. I'll turn it to Vijay to answer that question.

Vijay Kasturi
Chief Medical Officer, CG Oncology

Yeah. Jeff, the results have been received extremely well. We have had a high degree of urologists reaching out to us since the presentation this morning, meeting us at the booth here at AUA and asking to be enrolled into our trials, our ongoing trials, the Cohort B in BCG unresponsive disease, the expanded access program, asking us about CORE-008. They also want to join PIVOT-006. I think the degree of enthusiasm that we have seen for the results has been incredible for us. Frankly, some of the feedback that we have heard is that the simplified instillation process, something that they're really used to in the clinic, you know, matters a lot to them in this process of a new agent, a new therapeutic option for their patients. And the second part of your question, Arthur...

Oh, I'm sorry, could you repeat the second part of your question, Jeff?

Jeff Hung
Equity Research Analyst, Morgan Stanley

Yeah. I was just curious on how physicians think about the importance of the CR rate at any time, compared to durability and safety.

Vijay Kasturi
Chief Medical Officer, CG Oncology

Yeah, the feedback, at least, that we have gotten so far is they are receiving a CR rate at any time extremely well. They are very pleased about the durability as well, and they're especially concerned about the safety being so good. Doc, I shouldn't say concerned, but I would say they're happy that the safety looks so good. You remember, this population of patients is a older population. The median age is 73. These are Medicare patients, and tolerability is a major factor for these patients because they have multiple comorbid medical conditions. So it is very important for urologists that the patients be able to tolerate therapy, and durability is only enhanced the longer you're able to stay on therapy.

Jeff Hung
Equity Research Analyst, Morgan Stanley

... Sure. Great, thanks. If I can ask a follow-up question on, is there sufficient data yet on the patients who underwent repeat induction and converted to a CR, how their durability looks versus the other patients? And, you know, is there any difference in the patient characteristics of those who did versus did not subsequently convert to CR? Thank you.

Vijay Kasturi
Chief Medical Officer, CG Oncology

So we are still evaluating the data on the reinduction patients at the present time. What I can say is that we have seen, as we reported earlier today, that several of the patients who underwent reinduction have maintained complete responses in excess of 12 months.

Jeff Hung
Equity Research Analyst, Morgan Stanley

Thanks.

Operator

Thank you. One moment, please, for our next question. Our next question comes from the line of Corinne Jenkins with Goldman Sachs.

Corinne Jenkins
VP of Equity Research, Goldman Sachs

Good afternoon, guys. Two from us. One, and I'm sorry if this is a bit pedantic, but can you just walk us through that 83% duration of response at 12 months with a particular focus on how you have the denominator of 35 patients, and how the way you measured it compares kind of relative to how other people are measuring duration of response in the industry? I just think that was a point of confusion today. Then, I would also have a question on just, like, how you think about reinduction as part of the profile for cretostimogene, given a reasonable portion of patients had to be reinduced and then obviously went on to respond. But as, like, a physician, how would you think about the need for reinduction in some portion of patients? Thanks.

Vijay Kasturi
Chief Medical Officer, CG Oncology

So Corinne, thank you for that question. You know, out of the 35 evaluable patients who have reached a duration of response of at least 12 months, there are 29 confirmed complete responders who have had a DOR greater than four months. And there were six that did not maintain their DOR for greater than 12 months. There are still 22 responders that are pending assessment and evaluation at subsequent time points. So and if you look at all approved therapies in this indication, were approved by FDA based on CR at any point and duration of complete response. From a regulatory perspective, these two endpoints are the major efficacy outcomes that are critical for an approval. From a patient perspective, you know, they care about whether their bladder can be preserved one year or two years from now. And, second part of your question.

Sorry, my apologies, but could you repeat the second part of your question?

Corinne Jenkins
VP of Equity Research, Goldman Sachs

I want to clarify on that, that last question. I guess we understand there's 22 patients pending, but there was 79 initial responders. So people are trying to understand what happens to the other 22 patients and why they wouldn't be included in duration of response. I'd just like for you to walk through why that's not included in this analysis and how it compares across the industry in terms of practice. My second question was, like, how do doctors and patients think about the potential need for reinduction in order to achieve-

Vijay Kasturi
Chief Medical Officer, CG Oncology

Yeah.

Corinne Jenkins
VP of Equity Research, Goldman Sachs

-um, response?

Vijay Kasturi
Chief Medical Officer, CG Oncology

So the 22 responders just haven't reached the 12-month time point at the present time. So, once they reach that time point, we'll analyze those results, and we hope to present all the entire data set of patients, all the data at SUO 2024. In terms of patients with reinduction, reinduction is a common phenomenon with BCG. This has been done for 30 years because BCG is an immune therapy, and cretostimogene is an oncolytic immunotherapy. So agents such as cretostimogene, with our dual mechanism of action, the reinduction is a testament to the mechanism of action for cretostimogene. So we don't foresee any issues. In fact, for the 26 non-responders who underwent reinduction, we were very pleased to see that 54% converted to CR.

That rate is actually higher than what is seen with BCG reinduction.

Corinne Jenkins
VP of Equity Research, Goldman Sachs

Okay, thank you.

Ambaw Bellete
President and COO, CG Oncology

In addition, and Corinne, this is Ambaw. My apologies. In addition, as we've seen most recently, there was a recent approval that actually also cited reinduction that was part of their package insert and communication that was out also from the agency. So reinduction really is an accepted approach in terms of how this type of therapies, especially things like oncolytic immunotherapy, such as Cretostimogene.

Operator

Thank you. One moment, please, for our next question. Our next question comes from the line of Josh Schimmer with Cantor.

Josh Schimmer
Managing Director, Cantor

Thanks so much for hosting the call and taking the questions. Obviously getting a lot of questions on the comparison of cretostimogene to J&J's TAR-200, especially as we think about the landmark 12-month CR rates. Do you have any comments or cautions you might have about kind of comparing these trials at this point and drawing comparisons between the two? That'd be great.

Vijay Kasturi
Chief Medical Officer, CG Oncology

Yeah, Josh, there are different methodologies for numbers in this particular regard, but I think if you pay particular attention to the FDA guidance, what matters for the approval of agents is the CR anytime and the durability of complete response. We have seen that, as Ambaw mentioned, in the recent label for the most recently approved agent as well. There's no landmark there that are considered in that approval. So we feel, you know, that our reported CR anytime today of 75.2% and the durability of complete response with 83% of the responders going beyond 12 months thus far is favorable, you know, compared to at least the approved therapies in this space.

Josh Schimmer
Managing Director, Cantor

... so I'm also getting questions from investors on manufacturing scale-up and any issues there might be for supplying the market, as well on logistical challenges of cold storage handling for cretostimogene. So if you can address those as well, it'd be very helpful.

Arthur Kuan
Chairman and CEO, CG Oncology

Thank you, Josh. I'll take the first part of the question. So from a CMC perspective, I think the number 1 point that I want everyone to take away with is, we are not changing our process. Because of how robust it is, we're taking the same process that went into the phase III trial to the BLA and commercial launch. This significantly really improves the risk profile of our CMC program. Number 2, we have assembled one of the world-leading CMC advisory board, who are, you know, ex-FDA, ex-large pharma, into our advisory board, leading and guiding our team forward. Number 3, our CTO, Savnoor Marwaha, came from Seattle Genetics as well as other CDMO. He himself has handled very complex manufacturing products such as antibody drug conjugates, arguably, more complex than what oncolytic immunotherapy is.

For the second part of your question, I'll turn it over to Ambaw to address the shipping and cold storage question.

Ambaw Bellete
President and COO, CG Oncology

Thank you, Arthur. Thanks, Josh, for your question. And just to clarify on that point, we plan to ship cretostimogene in a just-in-time manner to our customers. So that will be delivered really upon the day or the day before the procedure is going to be for instilling cretostimogene into patients. This will be in a multi-day shipper box that will allow for it to be stored in that box for a period of days, while it's also at the account. We plan to ship at a negative 60-degree temperature as well. Thaw time, which is an important aspect of how these products are utilized, and I would tell you that the thaw time for cretostimogene, for getting it ready to be intravesically delivered, is 10 minutes.

Josh Schimmer
Managing Director, Cantor

Okay, got it. Great. I have some additional questions, but I'll, I'll get back into the queue to give others a chance to ask.

Ambaw Bellete
President and COO, CG Oncology

Thank you, Josh.

Operator

Thank you. One moment, please, for our next question. Our next question comes from the line of Sam Slutsky with LifeSci Capital.

Sam Slutsky
Senior Research Analyst, LifeSci Capital

Hey, thanks for the questions and update today. A couple for me, just on safety. Given that urologists are often the ones treating NMIBC patients, can you just talk about the importance of safety of treatments in the urology community in particular, versus how safety is typically viewed and managed by oncologists? That'd be good to know.

Vijay Kasturi
Chief Medical Officer, CG Oncology

Yeah. Thank you, Sam. As a medical oncologist who practiced in this space for over 25 years, it's an important question to ask. You know, medical oncologists are typically treating advanced metastatic bladder cancer patients, and the therapeutics used in that arena are very complex and certainly associated with a high degree of adverse events. The intravesical therapies delivered in non-muscle invasive bladder cancer can have local adverse events, many of which may not be tolerable for patients. Now, we were very pleased to see that 100% of the instillations of Cretostimogene occurred without any issues, no delays, no interruptions of therapy. This is an important factor in patients being able to tolerate the therapy. Not having any grade 3 or 4 adverse events also is a significant factor here.

As I mentioned previously, this is an elderly population, median age 73, Medicare population. These patients have multiple comorbid medical conditions such as heart disease, kidney disease, and COPD. So convenience and tolerability for these patients is absolutely paramount. If they are receiving a therapy such as cretostimogene, which is delivered in a manner which, to which they're accustomed to, which is through a simple catheter in the bladder, very similar to the BCGs that they received in the past, it becomes a familiar arena for them to receive the therapy. But safety is an absolute important point for this population of patients.

Sam Slutsky
Senior Research Analyst, LifeSci Capital

Got it. Then your slides mentioned that you had a heavily pretreated population, which included patients with prior intravesical chemo as well as anti-PD-1 therapy. Could you just discuss what proportion, approximately, this entailed within the population, and then whether that should have any impact on how to interpret your data set?

Vijay Kasturi
Chief Medical Officer, CG Oncology

Yeah, it's a good question. About one third of patients had prior intravesical chemotherapy or and/or pembrolizumab. We have so far seen no differences between the patients who had prior intravesical therapy, other intravesical therapy, versus those who only had prior BCG. We'll be reporting additional data on this at the SUO 2024 meeting.

Sam Slutsky
Senior Research Analyst, LifeSci Capital

Okay, excellent. And just real quick, last one. Just for the PD-1 combo, which we'll get more data from at ASCO, just how are you thinking on the implementation of that in practice versus the monotherapy?

Vijay Kasturi
Chief Medical Officer, CG Oncology

So we believe cretostimogene monotherapy to be the potential backbone therapy in non-muscle invasive bladder cancer. Our 75% CR rate that we have shown today actually compares favorably even to the 85% for the combination that we showed at AUA last year. Now, we're gonna update that combination data with 24-month data at ASCO this year... And different, you know, once we have that, and we see where cretostimogene monotherapy is at our final analysis or top-line data, then we'll make some decisions about which patients would benefit most from combination therapy.

Sam Slutsky
Senior Research Analyst, LifeSci Capital

Awesome. Thanks.

Operator

Thank you. One moment, please, for our next question. Our next question comes from the line of Andres Maldonado with H.C. Wainwright.

Andres Maldonado
Senior Biotechnology Analyst, H.C. Wainwright

Hi, everyone. Thanks for taking my questions, and congrats on the progress today. So first question, on the translatability, given the data today presented, as we start to think about, cretostimogene moving into the intermediate setting or maybe in the muscle-invasive setting, you know, what are the bellwethers of performance that we're seeing here that give you the conviction that, cretostimogene performance will be good in either of those settings? And how do those kind of benchmarks change based upon where the disease is?

Vijay Kasturi
Chief Medical Officer, CG Oncology

Well, the most important factor here for us is the high complete response rate. Okay? This is the highest complete response rate for the largest data set of patients in non-muscle, BCG unresponsive, non-muscle invasive bladder cancer thus far. You know, that gives us a great deal of confidence. That, along with the durability that we are seeing as a CR, gives us a great deal of confidence that this is going to be effective in intermediate risk, non-muscle invasive bladder cancer as well. I, you know, I'm not going to comment on the muscle-invasive factor at the present time. We are laser focused on developing cretostimogene as that backbone therapy in non-muscle invasive bladder cancer.

Andres Maldonado
Senior Biotechnology Analyst, H.C. Wainwright

Great. And then as a... Oh, go ahead.

Ambaw Bellete
President and COO, CG Oncology

No, I'll just add one more point. This is a heavily treated, pre-treated population. If we're able to achieve the results that have been achieved to date, the complete response rate of 75.2% that we shared earlier today, that's where Vijay is really speaking about. It's like, if it does work in that patient population, it really does give us continued confidence of how it would be in the intermediate-risk patient population and other populations that we're looking at.

Andres Maldonado
Senior Biotechnology Analyst, H.C. Wainwright

Great. And then, really quickly, on the combination with pembrolizumab, does it surprise you on Pembro's contribution to efficacy, in terms of... Obviously, the monotherapy is working well. I'm curious on, you know, mechanistically, where do you think, what do you think is going on, or how much Pembro is either contributing or maybe slowing down in the combination?

Vijay Kasturi
Chief Medical Officer, CG Oncology

Well, we certainly believe there are some potential immunotherapeutic benefits to the combination. While we're not necessarily seeing that in the CR any time rate, I would say, for the combination, since the monotherapy CR rate of 75% is so good, you know, I think you'll have to wait till ASCO to see the durability data for 24 months, at which time we can probably comment a little bit more on what the effect of pembro has been.

Andres Maldonado
Senior Biotechnology Analyst, H.C. Wainwright

Thank you very much.

Operator

Thank you. One moment, please, for our next question. Our next question comes from the line of Josh Schimmer with Cantor.

Josh Schimmer
Managing Director, Cantor

All right. Thanks so much. Just have a few more. So first, as we think about the unmet need in MIBC, what's your latest thinking about whether we should be considering the incidence of high-risk patients versus the prevalence for the model of potential uptake of cretostimogene?

Arthur Kuan
Chairman and CEO, CG Oncology

Thank you, Josh. I'll take that. So, you know, as in discussion with various KOLs in the space and based upon our own proprietary market research, we believe the prevalence space is at least twice as large as the incidence population, as a conservative measure to estimate the panel.

Josh Schimmer
Managing Director, Cantor

Got it. And so we should be thinking a little bit more along those lines than instances?

Ambaw Bellete
President and COO, CG Oncology

Correct.

Josh Schimmer
Managing Director, Cantor

Got it. Okay. As we're learning about the various emerging treatment modalities for MIBC, what do you think the median number of lines of therapy that patients are likely to receive after exposure to BCG?

Vijay Kasturi
Chief Medical Officer, CG Oncology

Well, so, you know, in non-muscle invasive bladder cancer, patients want to preserve their bladder. They do not want to undergo a radical cystectomy. It is the most complicated genitourinary surgery with a high degree of morbidity and mortality. So, for that respect, we expect patients to be able to take anywhere between two to four lines of therapy, you know, after BCG.

Josh Schimmer
Managing Director, Cantor

Got it. All right. Makes sense. So plenty of room for multiple different options there. And then last question, you know, just given the profile of cretostimogene in terms of the number of instillations that patients receive, any thoughts or plans to try to perhaps reduce that number to make it a little less intensive in terms of the office visits during either induction or I guess, less so during the maintenance phase?

Vijay Kasturi
Chief Medical Officer, CG Oncology

... So at the present time, the schedule of administration that we have for cretostimogene in high risk, and I will point out these are high risk patients, we feel is the most appropriate schedule. In the intermediate risk, PIVOT-006 trial, which is a slightly lower risk population, we have modified the schedule of administration to ensure it's appropriate with the risk level of those patients.

Josh Schimmer
Managing Director, Cantor

Got it. And last, last question for me. ImmunityBio recently announced their, their price point for Anktiva, I think, somewhat higher than what we had been considering for cretostimogene. Maybe you can share your latest thoughts on what, what the appropriate price point for the, for novel NMIBC therapeutics would be.

Dan Barrow
Pamela R. Rollins Professor and Chair, Emory

Josh, this is Dan Barrow. I'll take that question. Thank you for your question. You know, I would say that I, I think it's hard for us to comment on some other company's approach into the marketplace in terms of how they have priced, you know, their, their drug. It's certainly the highest that we've seen within the class, just based on face value of what the number looks like. The ICER report, you know, with respect to BCG unresponsive disease and the research that they've shown, showed a range of around $200,000-$250,000 being the range in terms of quality of life from a QoL, you know, a QALY perspective on a yearly basis. You know, that's the range that's published, you know, so that, that I can comment on.

So, I think that's probably the best way that I can, you know, give you a response is, you know, that's a reference point, I think that people will refer to.

Josh Schimmer
Managing Director, Cantor

Okay, thank you very much.

Operator

Thank you. I'm showing no further questions at this time. So with that, I'll hand the call back over to CEO, Arthur Kuan, for any closing remarks.

Arthur Kuan
Chairman and CEO, CG Oncology

Thank you all for tuning in today and supporting CG Oncology. We made a promise to develop bladder-sparing therapeutics for bladder cancer patients, and we are honored to have presented data on cretostimogene at AUA's inaugural P2 plenary session today. Moving forward, we do not intend to leave any patients behind in bladder cancer. Have a great day, everyone.

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