Relmada Therapeutics, Inc. (RLMD) Earnings Call Transcript & Summary

Good afternoon, and welcome to the Relmada Pharmaceuticals Virtual KOL event. [Operator Instructions]. As a reminder, this call is being recorded, and a replay will be made available on the Relmada website following the conclusion of the event. Before we begin, the company would like you to refer to Slide 2 for a cautionary statement regarding today's discussion. I'd now like to turn the call over to Sergio Traversa, Chief Executive Officer at Relmada Therapeutics. Please go ahead, Sergio.

Thank you, Tara, and good afternoon, everyone, and welcome to the Relmada NDV-01 KOL call. On today's call, Dr. Boris Chertin will review the top-line Phase II data of NDV-01 as presented earlier today at the American Urological Association. Professor Chertin is the Chairman of the Department of Urology and Pediatric Urology at the Shaare Zedek Medical Center. Professor Chertin is the primary investigator of the Phase II trial of NDV-01 in high-risk non-muscle invasive bladder cancer and presented the data today at the AUA. Following the NDV-01 data presentation, we will have a discussion and question-and-answer session with Dr. Lawton and Dr. Chertin. Now turn the call to Dr. Chertin to review the first top-line Phase II results for MDV01 presented today. You can move to the next slide. Before you do that, I would just like to give you a quick overview of what MDV01 is. And if you can move to the next slide. So NDV-01 is an intravesical therapy that is designed for an extended release of gemcitabine and docetaxel, through chemotherapy used in the treatment of cancer. And NDV-01 is an in-situ reservoir that stays inside the bladder and delivers simultaneously a fixed dose combination of gemcitabine 1,000 milligrams and docetaxel at 40 milligrams. NDV-01 releases the drug into the bladder continuously over 10 days of time. It is biodegradable and it gradually disintegrates and is safely excreted in the urine. NDV-01 has been demonstrated in the interim Phase II data to be safe, highly tolerable, and resulting in good patient compliance. It is supplied in a prefilled syringe that is easily installed in the office in the doctor's office in less than 10 minutes. You can go to the next slide. It is a graphical representation of how NDV-01 forms a matrix inside the bladder, and the chemotherapy is released over 10 days through different mechanisms of action. At this point, with no further delays, I would like Dr. Chertin to go through the data. Boris, you have the stage.

Thank you very much. May I have the next slide, please? Thank you very much for the very kind presentation. As Sergio told you, my name is Boris Chertin. I'm Chairman of the Urology Department at Shaare Zedek Medical Center [indiscernible]. I was a payer, will hopefully still be a payer in this study. So it's an ongoing study, open-label, single-arm, single-center. So we aim to evaluate the efficacy and durability of NDV-01 in high-risk non-muscle invasive bladder cancer patients. So, just in general speaking, this is a very difficult group of patients. The bladder cancer high-risk patients have, very nasty disease, very hard to treat. And the consequences of untreated patients are very, very, very devastating. So that's in order to avoid the further development of disease and avoid the disease will becoming to muscular invasive and metastatic disease, we have to do everything to avoid it and to try to delay when we are going with our patients for radical cystectomy or different treatments. So the inclusion criteria for this study were high-grade disease, patients with TA carcinoma in situ patients, patients with T1 with carcinoma in situ patients, or T1 patients. We decided to include patients with BCG naive, so patients that never got any BCG intravesical treatment, BCG unresponsive patients, or patients who weren't able to proceed with BCG intravesical therapy because of the side effects of BCG. So, as Sergio told us before, our main purpose was to evaluate with this pivotal study the potential of NDV-01 as a safe and effective treatment for these patients. The primary endpoint is safety and complete response at 12 months during the therapy. So the second point was disease efficacy. We wanted to see the overall survival of those patients. And of course, we would like to measure the concentration of gemcitabine and docetaxel, which are inside this formulation during the study period, to see if it wouldn't cause any systemic events. The study design is very simple. We wanted to enroll 70 patients with high-risk patients, non-muscle invasive bladder cancer. The study protocol is for a 2-week installation of the NDV. And if the patients are free of disease, we are going for the maintenance therapy every 6 weeks installation as a maintenance. The follow-up is very clear. It's like every patient with bladder cancer. We are taking in cytology. We do the cystoscopy examination every 3 months. We proceed with the upper track imaging, and we do TURBT or bladder biopsy if it's necessary, and also a confirmatory biopsy in the patient with carcinoma in situ. Just to be sure, as per the indication of the FDA, there is no recurrence. When we don't see any microscopic lesions, we would like to be sure that there is no recurrence of [indiscernible] nonbladder. Next slide, please. This is the patient demographic data. Actually, I think it reflects the general population of bladder cancer patients, the majority of male. The smoking status is divided by smokers and non-smokers, and the performance status of the majority of patients who were enrolled in this study was good. Next slide, please. The pathology was divided as shown in this slide: 11% of patients with carcinoma in cyto, TA high grade 61% of the patients and the remaining 27 patients with T1 high grade. Our status of our patients is also as we expected, we have half of the patients with BCG unresponsive disease, 11% of the patients who did not tolerate the BCG and required to switch to alternative therapies and 9 patients overall 34% of the patients with BCG naive but we never got any intravesical therapy. Next slide, please. So it's very important to emphasize the negligible ratio of the side effects in our patients. If you look at the data, our data, the 8 cases of very mild [indiscernible] which resolved during 2 days following the therapy, 5 cases of nonspecific flank, which we attributed probably to the musculoskeletal origin. It's very important that we ask our patients who had a history of BCG therapy to compare the quality of life following BCG therapy and NDV-01. And the quality of life improved dramatically in all patients who had a history of BCG therapy by 25.08 points. So the quality of life dramatically increased in patients who are able to compare the previous treatment with the current one. Next slide, please. This graph shows you the durability and the response of the patients who are currently in the study. So we currently enrolled 26 patients, out of whom 20 patients completed 3 months of follow-up. We have an 85% high rate of recurrence-free survival. It's a very nice result. It's very important that 3 patients who actually did show on the first cystosco examination recur all 3 patients received another course of the induction therapy, another 6 weekly installations. Out of those patients already completed this course and under a cystoscopy exam only last week and showed a complete response. There is no recurrency whatsoever in any part of the bladder. So the recurrence rate went up after this patient. Next slide, please. So this slide, you can see the clinical activity at the 3-month point. As I told you before, on the left part of this slide, you can see the pathology of those patients. And as I mentioned before, 85% showed no recurrence at 3 months of period. On the right side of the slide, you can see the response in naive BCG-naive and BCG-experienced patients. Next slide, please. Sorry, that shows the clinical activity of our patients at any time, and you can see if you look at the overall survival, it's 90% of our patients actually showed a high survival at this current stage of the study. So on the right side of the slide, you can see the pathology, the status of those patients, if you divide them according to BCG-naive and BCG-experienced patients. It's very important to show also it's a very small group of patients, but the complete response in cyto patients, which are a very difficult group of patients, is over 100%. So none of the cyto patients actually, all of them showed a complete response, which we proved by confirmatory biopsy. Next slide, please. So I think Sergio here, I can just forward the slides up to you.

Sure. So this is a summary of the benefits that NDV-01 can bring to doctors and to patients. It's very easy to administer, and can be administered in the doctor's office without any anesthesia in less than 10 minutes and then makes the workload much easier for the doctor, and for the patients is much less burden to take this form of delivering Gem/doce. With that said, I would like to open for questions. And Tara, you can coordinate the question and answer.

[Operator Instructions] Our first question comes from Uy Ear at Mizuho.

Congrats on the data, guys. It seems like an exciting technology. So maybe our first question we've been getting from investors was, I think people were kind of surprised by the small number of patients with cyst versus the larger number of patients with papillary. So maybe just help us to understand, was that just the nature of the site, the number of patients who went there? Or was this by design? And why did you choose to pursue this route instead of, I think, showing data that are sort of more related, as some of the other competitors have?

Thank you, Uy. Dr. Chertin, maybe this question can be answered by you.

If you look at the general population of patients with bladder cancer, I think that approximately 10% of those patients presented with Carcinoma in cyto. And as I told you before, it's our demographic data just shows and reflects what actually happened in this population. I suppose Dr. will turn an endorsement on this one. The first enrollment in this study was by the end of October last year. So we're just 6 months into the study. And I think now it's just the beginning of the study, and it's a very, very initial data that we are showing. And of course, the main purpose of enrolling more patients with carcinoma cyto this reason, we will open the study for multiple centers. But at this stage, I think the demographic data of this group of patients just reflects exactly what's happened in the general population.

And if I can follow up. How do you view the data relative to some of the competing therapies, like from J&J, TAR-200, as well as the Credo CGIs Credo data that was presented this weekend?

No, I understand. I think as a urologist body is not only sitting in the academic center. I think you have to have, in the end design, the device, the pharmacological formulation will be able to be applied in every place, very easily, and for the broad group of patients, not only for some selective patients. So you have to have some device. I'm talking about device pharmacological formulations, which you can apply in every place. You don't need to have any dedicated facility to prepare, any dedicated facility to supply any dedicated facility to keep it. In this term, you can't compare NDV-01 with any current formulation. It's very easy to prepare. It's coming out with the pre-filled, ready-to-use syringe. You can use it in every place. You don't need any facility to do it, it can be done in every clinic, in every general urology facility. To install it, it's like it takes less than 5 minutes to do it. You just put the cutter in, you put 2 syringes, you're done. So that's just easy for everyone. You don't need to train somebody else to do it in the proper place. You don't need any special office facilities. You don't need the device, and replace something else. So I think it's just for somebody who is doing everyday practice, that's the win-win situation.

And Dr. Lon, you have a lot of experience also with other products. So maybe you want to add to the question.

Yes. Thank you. So I think, first of all, a lot of people are trying to make a comparison between relatively small single-arm trials. Most of these trials have 80 to 100 patients, and they're not randomized. So I think it's not really fair to make comparisons, even though eventually, as physicians and we're going to have to make recommendations to patients based on CR rates. I think there was a question about the prevalence of CIS, which is about 10%. We do see concomitant CIS. So not unexpected to see 3 patients out of 26 that fall within the typical incidence for carcinoma in situ. I would say that intravesical gemcitabine and docetaxel are commonly used in academic centers in the U.S. based on mostly retrospective studies, and are off-label use. And even though the results for intravesical gem/doce are promising based on the retrospective data, we're always challenged with the fact that you need a cancer center pharmacy to mix it. We can't mix it without a hood. And that's one of the reasons that intravesical gemcitabine and docetaxel, and even intravesical chemotherapy at all, is not widely used in the community setting. So one of the main advantages here is that we have a combination of drugs that historically have worked quite well, both anywhere from chemoablation to adjuvant therapy for intermediate or high-risk disease, but were difficult to get access to in the U.S. market because of the lack of cancer center pharmacies. This is a formulation that would be readily available to community urologists as well as academic urologists. I can't mix it in my office either. I still have to wait for it from the cancer center pharmacy. So that's the promise of the medication. And the added bonus is that we think that prolonged exposure would be beneficial. So if you look, for example, at TAR-200, it's gemcitabine with prolonged exposure from a device. This would be a combination, which we think usually works better than a single agent, and also provides prolonged exposure rather than a 1-hour to 2-hour dose that sits there during installation. So obviously, not recommending any comparisons at this point, but the data is promising, and there are a lot of potential advantages in terms of administration.

Was the safety as you expected? Did you see anything that's out of the ordinary or anything to that effect, at least based on what you seem to present, it seems fine for us.

Yes, that's exactly the point. That's what we presented is our real data. And you can see just the main complaint of those patients, [indiscernible], very mild one, which completely disappeared after 2 days that you can see in every patient who underwent any procedure on the urethra, you put the catheter inside some of the patients have a [indiscernible] suppose that we put a pharmacological formulation but the was very mild. None of the patients so far required any additional treatment in order to get rid of it, and we didn't see any systemic effects in none of our patients, which is very good proof that the material is very safe.

And can I ask Dr. Lawton a follow-up question? Can you speak a bit about the community doctors and perhaps the need for efficiency, and how this could play into that? I think you mentioned some of that already. Just wanted to know relative to the other therapies that will come to market or that are already on the market.

Sure. I mean, I think that at least for most physicians, access is the most important thing. So if you look at trials like MoonRISe-1 and PIVOT-6, they're enrolling extremely fast, and that's because there are no competitors even commercially in the community, which are readily accessible. So, intravesical chemotherapy, which is recommended in the guidelines, is not readily accessible because community offices don't have ways of mixing the drugs. We can mix BCG, which comes in powder, in our clinics, but we cannot mix chemotherapy, which requires a hood. So it's very important for communitylogists to have access to a drug. And medical oncologists who do have access to chemotherapy don't give intravesical therapies. They're not familiar with placing catheters. And so for them, it's technically challenging and not familiar for them. And so we have a gap where we have drugs that we think we recommend in the guidelines, and yet no access to them. So the accessibility is probably going to be the most important aspect of this drug. It can be given in 2 syringes and instilled through a catheter placement. That's going to make it very easy. And probably the most important thing for community urologists is to be able to get their hands on and deliver the drugs.

So our next question comes from Mark Goodman at Leerink. And he's asking, could you please provide some color on the market opportunity, such as size, treatment landscape, and competition, please?

Dr. Lawton, maybe this one is for you.

Sure. I think that, by and large, there are various potential applications for this drug. Chemoablation is something that's sort of a newer paradigm that could be explored. There have been multiple studies published on chemoablation using intravesical chemotherapy. It's not really been heavily utilized, but there has been an increasing awareness of the risk of TURBT, both from a standpoint of going under anesthesia with elderly patients as well as an increased risk for dementia from repeated applications of anesthesia. So people are trying to avoid doing as many TURBTs. There's also a risk of bleeding and perforation that we want to avoid. So, especially in patients with low-risk or intermediate-risk low-grade cancers, chemoablation is something that could be a potential use. There aren't really other drugs currently approved in that setting. UroGen has obviously done a trial called ENVISION in that setting. It hasn't gone to the FDA yet. That's a single agent with mitomycin. So that could be a potential competitor. But on the other hand, a dual agent could potentially be more effective. In terms of adjuvant therapies, chemotherapy, as I talked about, is commonly used in academic centers, but difficult to access. That probably represents about 30% to 40% of all prevalent bladder cancers, so probably over 100,000 patients have recurrent low-grade tumors. Those patients don't typically die of their disease, they do continue to have recurrences throughout their lives. Agents that will reduce recurrence in that population that are accessible to community urologists are going to be quite important. And then finally, as you see the presentations about BCG-unresponsive disease, many people are using gemcitabine and docetaxel in that setting in large part because even the best presentations that came out for TAR-200 and Cretostimogene had about a 40% to 45% durability response at one year. So likely, there's going to be room for several lines of therapy, especially in patients with carcinoma in situ. So I think that on one hand, this is a new agent and offers some advantages in terms of delivery and in terms of having a much longer presence in the bladder up to 10 days rather than 1 to 2 hours. On the other hand, we've been using intravesical chemotherapies for years. They're safe. They do have good effectiveness in general. And so it's not like we're starting from scratch in terms of just a whole new formulation that we don't know will work.

Thank you, Dr. Lawton. Hope this answered the question.

So our next question comes from Andres Maldonado at H.C. Wainwright.

A few from us. Number one, over the years, we've spoken to a number of urologists and have detected a true bifurcation of the original results that I guess were founded by Dr. Michael O'Donnell, who really started the Gem/Doce angle to treat NMIBC. So the first question is, for those urologists who are a little bit more skeptical on the Gem/Doce regimens' place in NMIBC, what do you have to say to them to win them over? And what are they missing? And then I have a few follow-ups.

Yes. Dr. Lawton, maybe you should answer this one, too.

Yes. I mean, so it's interesting. I think when you go to academic meetings, I think the main concern about Gem/Doce is the lack of prospective data in a true clinical trial sense, that most of the data is retrospective. Part of the reason for that has been that no company has commercialized Gem/Doce and done prospective trials like the other agents. And I think there's appropriate skepticism when you look at retrospective data and try to compare it to historical controls. Similarly, there is some skepticism with nonrandomized trials in the BCG-unresponsive space as well, where you hear people saying, well, how do you know that this is better than another agent? I think that one of the important components of this drug is that there will be a need for or it will be necessary to have prospective data, and that, I think, will increase the level of confidence with it rather than relying on retrospective studies, which I think appropriately led to some concern. The second point that I'll make briefly is that many community urologists can't get their hands on the drug, and so they don't have any experience with treating patients with intravesical Gem/Doce. I would say that the vast majority of academic urologists use it quite frequently. In fact, despite the fact that I have clinical trials and available agents like [indiscernible] and Ankitva, I still use quite a bit more Gem/Doce than I do either of these agents. And so we have a lot more familiarity with these agents than with the newer ones. And so I think if you have access to it and you are able to use it, you feel much more comfortable.

And then the second question is, in a hypothetical treatment landscape where Cretostimogene and TAR-200 are approved, given that TAR-200 uses gemcitabine, what does that say for this product in terms of there is a chance for desensitization, given that it's a combination with docetaxel and with a secondary chemotherapy? Furthermore, CG Oncology announced that Cretostimogene will now be studied in combination with gemcitabine. Naturally, does this exclude these patient populations? And can you help us just fill in the gaps to where you see the best fit in this scenario?

First of all, I'm not sure that resensitization is the appropriate terminology here. I think the question is, why do half the patients become resistant or recur despite getting single-agent gemcitabine within the first year? And we don't really have sufficient data to understand any mechanisms of that, nor do we understand why the immune therapies don't work well long-term either. Clearly, we don't have a permanent tail on any of these drugs. You can even look at 5-year data now for Adstiladrin, and we were part of the Phase II and Phase III, and only about 9% of CIS patients are disease-free at 5 years. So we don't see extremely long-term cures. We did see recurrences. And I suppose I don't have enough data to explain one or the other. I think in the question of sequencing, which I think is what you're suggesting of, can you use Gem/Doce in a patient who had gemcitabine previously, we do that fairly routinely in patients with intermediate risk disease, at least in academic centers, we don't give everybody Gem/Doce right off the bat just because it's a little bit more intensive. We usually give single-agent gemcitabine. And if they don't respond, then we usually give Gem/Doce and still see a response. So my personal experience is that you can get a benefit with dual drugs when a single agent doesn't work. But there's certainly no data post TAR-200 for any agent, much less this combination. I think in the future, though, we will start seeing how well these drugs perform in the second and third line, but that's going to take some time. The only comment I would say is that I suspect that people have access to drugs, they'll have to decide later on how they want to sequence them best, and whether or not they think that a dual agent is going to be better to start off with a single agent.

And if I can ask another question. Help us contextualize where the pecking order of where this therapy ranks in terms of ease of administration. We've heard a lot of companies spinning on their drug, saying that this can be a plug-and-play into normal urology practices. I mean, given that this is really a disease that is majorly treated by community urologists, I mean, I understand that the technology is supposed to aid in helping of urologists being able to handle a chemotherapy agent. Can you talk a little bit about where this ranks in terms of ease of administration is the question?

Sure. And maybe we would love to hear the opinion of both Dr. Boris and Dr. Lawton, as Dr. Channing is using the drug in the clinical trial. And so it would be interesting to have both points of view.

Sure. Listen, we are obviously biased because we have used this and we have installed it for over the period of 6 months. So Dr. Lawton can take it forward for them. I just can tell you that in terms of the urology practice, the general urologist doesn't need to train somebody else, as I told you before, it's very easy to install it. It takes approximately 5 minutes to do it. And in my practice, the residents, the nurse practitioner, can do it very easily. So you don't need any dedicated facility to do it. So just it should be very easy for any urologists working in community center, community practice or academical practice will be the same.

Yes. I mean, I guess I can comment because I was part of SunRise-1, so I've instilled the TAR 200 on multiple occasions. On one hand, I would say if you're a urologist and you're facile with a cystoscope and [indiscernible], it's easy to remove and instill. On the other hand, you have to do it, or at least the trained PA has to do it; a nurse cannot do it. And so the convenience, for example, for TAR-200 is every 3 weeks, but somebody with experience has to be present to do it. You just can't have your nurse do it. [indiscernible] has the benefit of only every 3 months, but it has to be defrosted for over 3 hours. The community also has to buy a minus-80 freezer. They would have to deliver it. You can't refreeze it, so I don't defrost it until I see the patient and make sure he's okay, because if the patient doesn't show up, then it's a $60,000 dose you can't do anything with. So we will literally wait, ask the patient how they're doing, and make sure they don't have an infection or a lot of symptoms. It's also one dose. So we're very concerned that if they don't hold it for an hour, what are we going to do, because some of these patients with BCG treatments have bladders with a lot of frequency and urgency. So we actually premedicate with anticholinergics for several days so that they can actually hold that one dose because if they urinate it out after 15, 30 minutes, what are you going to do? You can't treat them for another 3 months. You don't know if you have the effectiveness. So the convenience is a single use every 3 months. The inconvenience is having the freezer and having to defrost it for over 3 to 4 hours. As far as other drugs, the credos imaging can be given by a nurse, but it's once weekly for 6 weeks. This is every other week. And so I don't know that there's a huge difference. I know that when you talk to CG Oncology and J&J, they're trying to compare each other because their efficacy is very similar. So there's a lot of discussion about how inconvenient it is to have a cystoscopy, and a procedure placed versus weekly treatments. I'm not sure if that's as critical, but certainly, this drug being able to be given by a nurse in 10 minutes, the main advantage over other chemotherapies, you don't need a hood, and it's safe to deliver and can be done very quickly.

So our next question comes from Leland Gershell at Oppenheimer.

Dr. Lawton, a question for you here. Maybe more of a mechanistic question, and may relate to sequencing down the road as these agents become available. But we're seeing in the high-risk NMIBC space, sort of the immunotherapeutic approaches and then the chemotherapeutic approaches. One could argue that the chemo approaches may be potentially harmful or working against the immunotherapeutic approaches, given that they may be destroying some of the components of the immune system that could be actively working to destroy the tumor. So just wondering if that could affect how urologists may think about sequencing these agents as NDV-01 comes forward, and then also, of course, the TAR-200 and so forth? And I have a follow-up.

Sure. I appreciate that. So I think there's a lot of basic science that we do not understand. One of the big questions I had when we started doing the FKD at Sullivan trials is we had studies with BCG plus interferon that were not better than BCG many years ago. We take a patient who has already gotten BCG, and we're giving them more interferon, which just happens to last for 7 to 10 days. How is that going to even work? So I would say that I've tried to learned and forgotten immunology about 3 different times in my career as new agents have come on. We have not been able to personalize medicine yet. If you have a patient who is BCG unresponsive, we don't understand the microenvironment to see is it -- do they have a fatigued immune system? Does it make sense to give any immune agent now, like an IL-15 agonist or interferon, or genes IL-12, who knows? We have not been able to say in that patient, if it's an immune-depleted cold tumor, maybe chemotherapy makes a lot more sense. We don't know if giving a virus plus chemotherapy makes sense at all. We don't know if giving a virus that stimulates the immune system and kills cells makes sense. So it's an important question to ask, but we don't have a perfect answer. We know that certain patients who are immunosuppressed and even patients over the age of 80 don't respond as well to BCG in the first place. And it will be interesting to see what the results of the BRIDGE trial, which is a cooperative group trial that's almost done enrolling comparing Gem/Doce to BCG in the BCG naive setting because maybe it's best to give the chemotherapy upfront before the immune system is impacted at all and then give the immune therapies later. But I think if anybody is really being honest, we just do not understand very well how to sequence, who should get what type of therapy. My personal belief is that you can't just give 2 or 3 or 4 lines of immune therapy and then hope that suddenly the immune system will kick in. So maybe we'll find that alternating chemotherapy and the immune system, just to give your immune system a chance to rest or revive itself, might be the best strategy. But it's way too early to figure that out. Hopefully, my career will be long enough so we know.

And yes, for the Relmada team, just curious, as this trial presumably continues to have further follow-up, do we expect to see another interim from this trial later this year? Could that be at SUO, or perhaps you have shared plans? Yes, just curious.

Yes. Thanks, Leland. I can answer that. Yes, we will provide data at the traditional points. I believe the next one will be the 6-month data that should be available for at least the 20 patients now in the June-July time frame. So we'll provide updates.

So our next question is, when is the next clinical update expected? And when will you file for a U.S. IND?

Well, thanks for the question. So the next update will be the 6-month data and as soon as they will be available. And we are planning now to have a pre-IND meeting with the FDA, and we'll propose and discuss what the potential clinical development plan is, and we will provide an update to the street as well on the conversation we have with the FDA. After that, we also provide guidance on when we will file the IND, which would be the next step. I hope I answered your question.

Thanks, Sergio. Our next question is, can you contrast the technology and effectiveness versus Urogen's reverse thermal gel?

Dr. Lawton, Dr. Chertin, any insight on this?

I think I can comment. I've been treated with JELMYTO for a while. But that is a temperature-based solution that dissolves over about 4 to 6 hours and then gets urinated out. This technology stays in place for about 10 days. One is mitomycin, and this obviously is gemcitabine, docetaxel. So I would say those are the main differences. Boris, do you want to comment, perhaps?

Thanks. I don't have any experience with the matter, so I'm not able to discuss and just compare only the historical data or just the data that we published. As I previously showed that the adverse effects are negligible in our study. And I think we are just starting to measure the PK. And if you don't see any -- it was a negligible concentration of the Gemsa and dossi in the blood in plasma of those patients. So, if you also just compare our previous experience in this hydrogel formulation, if you don't see any thicker values of the metabolites of Gem/Doce in the plasma, you don't expect any systemic reaction. And also -- and our data in terms of the adverse effects as a patient reported right now are pretty good. So that's what I can say. Again, I don't have any experience with different intermedical formulations. We used to have mitomycin as a part of the integral part of installation for RBT stopped doing that because of some very serious side effects as a result of the postoperative installation of mitomycin for RBT.

So our next question is, did any CIS patients require reduction?

We have 3 patients in this study. All 3 patients showed a complete response after 3 months. We did the cystoscopy examination 6 months on one of those patients, and we did take a confirmatory biopsy that happened last, which happened like 1 day before I just left for AUA. So hopefully, we'll get the results and I'll be back to [indiscernible]. But all 3 patients, all of them after 3 months, got a confirmatory biopsy with clean disease.

So this concludes today's Q&A session. I will now turn it back over to Sergio for closing remarks.

Well, thank you, Tara. Thank you all. Before we close the call, I would just like to leave the audience with a few key takeaways. This was an important step in the evolution of Relmada in this field. And we are preparing to enter the registration studies for NDV-01, and the non-muscle invasive bladder cancer is a very large opportunity. And in the U.S. only, there is a prevalence of around 600,000 patients. There are treatments available, but the options are still limited as there is a considerable amount of patients who don't respond to all the options that are available. And today, we presented the 3-month Phase II data for NDV-01 and which is a sustained release formulation of gemcitabine and docetaxel or Gem/Doce. The data presented showed that 90% of the patients treated with the NDV-01 achieved high-grade disease-free status at any time point following the treatment, including 88% high-grade recurrence-free survival in papillary patients and 100% complete response in patients with carcinoma in situ. So we believe that NDV-01 has the potential to become a class-leading therapy for NMIBC and across a very wide spectrum of patients and based on the compelling proof of concept that we have shown today. We are very excited about advancing this differentiated, ready-to-use Gem/Doce formulation and improving patients' outcomes and expanding the treatment option for NMIBC. With that said, thank you very much to all. And on behalf of the management team of Relmada, I want to thank you for joining today's call. I will turn the call back to Tara.

Thank you, Sergio. So at this time, the webinar has ended. You may now disconnect.