Relmada Therapeutics Inc Aktie

Thank you. One. Good afternoon and welcome to Realmada Therapeutics' second quarter earnings conference call. At this time, all participants are in a listen-only mode. After the prepared remarks, we will conduct a question and answer session. To ask a question, please press star 1. As a reminder, this conference call is being recorded and will be available for replay on the Realmada website. I would now like to turn the call over to Joyce Longigan. Please go ahead.

Thank you, Operator. Good day, everyone, and thank you for joining us today. afternoon, Ramada issued a press release providing the business update and outlining its financial results for the three and six months ended June 30, 2026. Please note that certain information discussed on the call today is covered under the safe harbor provision of the private securities litigation. act. Ramada's management team will be making forward-looking statements during this call. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in RealMata's press release issued today and the company's SEC filings, including the company's 10-Q filing for the quarter ended June 30, 2026, filed after the close today. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast on August 6, 2026. Ramada undertakes no obligation to revise or update any forelooking statements to reflect events or circumstances after the the date of this conference call.

With me on today's call are Ramada's Chief Executive Officer, Sergio Traversa, who will provide a business update. Vipin Dhamia, Ramada's Chief Business Officer, will offer his perspective on NDV-01 and the non-muscle invasive bladder cancer landscape. And Ramada's Chief Financial Officer, Megha Chanuta, will review the second quarter financial results. After that, we will open the line for a brief Q&A session. Now, I would like to hand the call over to Sergio Traversa.

Thank you, Joyce. Good afternoon, everyone, and welcome to the Real Mada Second Quarter 2026 Conference Call. Girl Mothers enter a critical execution phase. We have a strong balance sheet, an experienced and strengthened leadership team, and a clear plan to move NDVO-1 into registrational development. I would like to use this time today to tell you where we stand and why we are confident in the path ahead. Let me start with a brief recap. Ndivo1 is a novel sustained release intravesicle formulation of gensitabine and docetaxel or Gendosi. that builds on the well-established safety and efficacy profile of conventional gem dosing. We believe NDVO-1 has the potential to be a best-in-class therapy for patients with non-muscle-invasive bladder cancer, or NMIBC, a disease affecting more than 744,000 people in the United States alone.

Our clinical regulatory foundation is strong. The 12 months phase two data are compelling. 95% of patients achieve the complete response at any time. 76% had a durable complete response at 12 months, and safety has been favorable throughout. We have FDA alignment on the two planned registration pathways, and we continue to see strong interest from the uro-oncology community. Let me go directly to manufacturing because it is our immediate priority. NDVO-1 is a novel, sustained release therapy that combines two chemotherapies in a single delivery system. Manufacturing a product like this to a scalable and registration of standards is demanding work. It requires a specialized capability, coordination across several supply chain partners, and a scale up from a laboratory prototype to a full good manufacturing practice or GMP production.

We have done the work to understand what that requires. We also have planned the remaining activities needed to support the A&D, and we are executing against a clear plan to complete them. This is work driven through quality, and we are dedicated to getting it done right. Importantly, all the components around manufacturing are ready. They have FDA alignment, a robust data set, and clinical trial sites that are engaged and prepared to begin enrolling patients as soon as the IND is cleared and clinical material is available. Manufacturing is the final piece and we are confident in our plan and in our team. We plan to file the IND NDB01 by the end of 2026 and to initiate the Phase III Rescue Registration Program upon IND clearance.

The same discipline applies to Cepranolone. Our program in Prader-Willi Syndrome, or PWS, a rare and underserved condition, has estimated to affect 350,000 to 400,000 people worldwide. Here, the formulation development is complete, and the one remaining step is finalizing the pre-filled syringe delivery system. We expect to file the SEPRANALON IND by year end 2026 as well, and to initiate phase two proof of concept study upon an IND clearance. So on both programs, we have characterized what is required, we have a clear plan in place, and we are executing on it. Before we turn to our financial results, I would like to have the privilege to introduce Bipin Dahlia, our new Chief Business Officer. Bipin joined us this quarter and and brings nearly three decades of experience in uro-oncology, business development, and manufacturing of parasites, including leading the U.S. launch of the first FDA-approved intravesical gene therapy for NMIBC.

BIPIN also brings strong industry relationship and an outstanding track record of value creation. Pippin, it's all on you. Thank you, Sergio.

Good afternoon, everyone. As Sergio mentioned, I've spent nearly three decades in biopharmaceuticals, including many years focused on uro-oncology, and especially non-muscle invasive bladder cancer, or and MIBC. During my first two weeks with the company, I've spent considerable time reviewing NDV01's clinical, regulatory, and manufacturing plans. as well as our patent strategy. That work has only strengthened my belief that NDVO-1 represents one of the most compelling opportunities in NMIBC. Let me explain why. The NMIBC treatment landscape is evolving rapidly. particularly in BCD unresponsive disease where bladder preservation is increasingly the primary goal of treatment. And yet patients and physicians are still forced to make important tradeoffs. The newer therapies available today may deliver on one dimension. either efficacy or durability or convenience, but in each case at the expense of another important dimension. Our market research and KOL discussions suggest that what physicians and patients continue to need is an intravascular therapy that delivers meaningful efficacy and durable responses without complications. compromising safety, tolerability, convenience, or ease of use.

And these tradeoffs will become even more important as the market moves into the community setting where The majority of the patients are, and into earlier stages of NMI-BC, such as intermediate risk and BCG-naive settings. And that is where we believe NDVO1 has the potential to differentiate itself. What I find particularly compelling about NDV-01 is that we're building on a strong clinical foundation rather than starting from scratch. We're leveraging decades of published clinical experience with gemcitabine and docetaxel, combination that is deeply familiar to the urology community. Our innovation is not in changing those therapies, but in finding a better way to deliver them through a sustained release formulation that combines long bladder exposure without the use of a surgical device with a simple office-based procedure that can be completed in approximately five minutes. In summary, the combination of a well-established therapeutic foundation encouraging efficacy and durability results from our phase two study, favorable safety and tolerability, practical ease of use, and applicability across most NMIBC patient populations differentiates NDV01 from many current and emerging approaches in the field. combined with a clear FDA-agreed regulatory path and strong patent protection. Taken together, these attributes support our belief that NDVO-1, if approved, has the potential to become a foundational and best-in-class intravesical therapy across the NMIBC disease spectrum.

I joined Almada because I believe in that potential and in this team's ability to execute. While important work remains ahead, the path forward is well-defined. We have an experienced team and strong external partners focused on executing against a clear plan and well-defined near-term milestones. I'm excited to be part of RealMada at this important stage and look forward to helping advance NDV-01 for patients who need new treatment options. With that, I'll turn the call over to Magid. Magid?.

Thank you, Vipin, and good afternoon, everyone. I'll walk you through our second quarter 2026 financial results. A PRESS RELEASE AND TEN-Q FILINGS PROVIDE THE FULL DETAILS. REL MOTTO CLOSED THE SECOND QUARTER OF 2026 WITH CASH, CASH EQUIVALENCE, AND SHORT-TERM INVESTMENTS OF $217.7 MILLION, COMPARED TO $93 MILLION ON DECEMBER 31, 2025. Current cash resources are expected to fund company operations through 2029, including completion of the Phase 3 Rescue Program for NDVO-1. Moving briefly through our second quarter financial results, research and development expense for the three months ended June 30, 2026, totaled $8.4 million compared to $2.8 million for the three months ended June 30, 2025. The increase was primarily attributable to higher NDVL-1 and subgrant alone study costs. and increased manufacturing and drug storage costs, partially offset by lower employee compensation.

General and administrative expense for the same period totaled $6.6 million compared to $7.4 million for the same period last year. The decrease was primarily driven by lower stock-based compensation and lower employee compensation, partially offset by higher stock appreciation rights expense and consulting services. Net cash used in operating activities for the three months ended June 30, 2026, totaled $9.6 million compared to $6.4 million for the same period in 2025. The net loss for the quarter was $12.9 million, or 11 cents per basic and diluted chair, compared with a net loss of $9.9 million, or 30 cents per basic and diluted chair for the second quarter of 2025. Before we open the call for questions, I'll turn back to Sergio for some closing comments.

Thank you, Maggot. I believe we can open the call for questions, but before we do that, let me close on this. So Ramada is in a position of strength. We have a differentiated clinically validated acid in NDV01 with FDA alignment on our path to registration, a phase three program that is ready to enroll and the capital to see this work through. Our focus now is execution, completing the manufacturing work to the highest standard and fighting both the NDVO-1 and CEPRANOL INDs by year end. We know what is front of us, we have a clear plan, and we have the team and the resources to deliver. I am very confident in this program and optimistic about Renato's future. I look forward to keeping you close to our programs along the way. operator.

I would like now to open the call for questions. Thank you.

Thank you. As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. Our first question comes from the line of Wee Year of Mizuho. Please go ahead.

Hi, guys. Yes, thanks for holding this call. And I guess we have a couple of questions from reading your press release. Before I ask the questions, I also want to welcome Biven to Bermuda. I hope to work with you in the future. So maybe a general question for Bibin first. Maybe just help us understand what your role at Real Malda and how do you envision bringing NDV-01 essentially from this stage up to commercialization? And the second question is, Based on your press release, it seems that you indicated manufacturing as well as CMC activities. Maybe just help us get some more color on the... the gating factors for both of these items? Is it, You know, is there issues with the release of the chemo from the gel? Is it scaling? Is it just consistency, stability, maybe just help us get a flavor? Thank you.

Sure, thank you. I'm a bit beeping. You want to take the first one, then we can, all of us can take the second one.

Yes, Sergio. So thank you, Oye. I also look forward to working with you. So my role as Chief Business Officer and primarily responsible for the NDVO-1 program be corporate strategy, commercial planning, which includes new product planning, making sure our program maximize the the potential of NDVO-1, business development if and when that becomes relevant, But I also bring a lot of development in manufacturing experience in addition to commercial. So I will be very closely involved in.

in all aspects of MDV-01. Thanks, Vipin. Thank you. Yes, I hope this answer your first question. The second we can take, I mean, I can start, right? Look, manufacturing is always like, you can go as much in detail as we want to, but the top-down is that the formulation has been done locked the process has been locked so now is the question of getting into the I would say the schedule of the manufacturer, you know, our manufacturer is Pyramal, that is a pretty large company. And so to get on their schedule and make the product and then that would be made at the scalable quantity. So that's. that's where we are manufacturing. That's where we are. Bipin, you want to add something to...

The topic, the subject? Yes, no, absolutely. I think Sergio, we have the formulation, which is the same as the formulation we used in Phase 2. We of course have a new scalable process and that is locked now. So the remaining active, if we have analytics in place, so the analytical process program is complete. So now it's just a matter of blocking and tackling. and producing the GNP batches and putting them on stability are needed for R&D filing.

And that's where we are. It's just a matter of execution now. So you're kind of saying that it's primarily an engineering issue that you can resolve relatively quickly. Is that a way of summarizing it?.

Yes, take it. Go ahead.

Yes, so in manufacturing, you have to develop a formulation. You have to develop a process. That's the development activities. when you have the manufacturing activities. So there is, the development activities are complete. the manufacturing activities are our next focus. That takes some time because You have to get on the schedule of the GMP, kind of clean room and what we call working with an external partner for that. And then once you manufacture the GMP batch, you need some degree of stability data needed to file in the IND. So I wouldn't call it an engineering or a non-engineering platform.

The way to think about it is development is complete, and now manufacturing is what we do. we will do in the next, in the coming months. Thank you, Bibi. Super helpful, thanks.

Our next question comes from Farven Haak of Jefferies. Please go ahead.

Hi, thank you for taking my question. Just to follow up on the last one, do you need FDA input on the GMT once you have the manufacturing batch GMP ready prior to filing?.

Thank you, Francine. Bipin, do you want to take this? I don't believe so. I mean, we already had the minutes from the meetings we had with the FDA on the development. So, we'll just file the IND, but Bipin, you're more expert, so you can... No, I don't believe we need any FDA input.

before filing the IND. Got it. And then how many sites are being planned? And how much, basically, how quickly can you go from the IND clearance to the first patient dose?.

Thank you, President. That's a great question. It's also easy to answer. We have around, I believe, 80 sites enrolled, of which 60 are primary and 20 are like more backup and to speed up the enrollment. And I believe as soon as the IND is clear, there will be 30 days after we file it, technically we can start to enroll patient at any time. So everything else is pretty much good to go. We are waiting for the product to be delivered and the data on the product to be delivered to file the IND and 30 days later, hopefully, we'll be okay for clearing and then we can start to enroll pretty much, right?.

right after the IND is cleared. Got it, and then a quick follow up. Do you have any plans to disclose the 18 month cut from the phase two data later this year?.

Yes, we haven't looked. To be honest, we haven't focused on the phase two. The site in Israel is continuing to involve patients, but we have been totally focused on the phase three preparation. We'll probably, yes, we'll publish the 18 data at some point, but we don't have plan to do it. We have not seen the data after the 12 months. So at some point, we'll probably publish that. But the focus has been the registration more than anything else.

Thank you so much. Thank you, Farzin. Your next question comes from Kelsey Goodwin of Piper Sandler. Please go ahead.

Great. Hey, thanks for taking our questions. First, just to circle back on the NDV01-IND, I guess, what steps or tasks required took longer than you were expecting when you had initially guided to mid-26? And then secondly, I know you had initially guided to some clinical data later this year, that three-month CR look. Should we expect that in the first half now or are you maybe reevaluating what the initial disclosure is going to look like? That's it for me, thank you.

Hey Kelsey, good afternoon, great to hear you. These are actually two different questions, right, and require two different answers. One, what was unexpected? Well, you know, when we made the initial projection, it's like we kind of listened to the manufacturer and what's the best educated guess. to give a timeline, but I don't think, and BP and Magda, you have been involved too in the manufacturing. There was really nothing unexpected. It's just everything in manufacturing, until you have done and you are to the final, you never know. So it's a trial and error. And there was just a question, I would say probably the most, the biggest hurdle is always to get into the manufacturing schedule because not that you call and they put the product in manufacturing right away. Usually there is at least one or two or three months where they give you a slot.

To make the product, it takes technically two days. It's not very, it's not a lot of time, but you have to get in their schedule and they have other clients and so that was not unexpected but it's still something that we have to get done and so that's where we are so and And the second question was, remind me, was the...

Yes, the initial clinical data that was guided for the end of the year, the three-month CR data, Just, you know, will that be pushed into the first half of 27, or are you thinking about maybe just doing a different disclosure altogether?.

Yes, look, we haven't decided yet. We have been hearing different opinions from all the people that are helping us on doing this. The current tendency, yes, it would be, I would say, first half, but the current trend or what we think is that... we would like to have a certain number of patients, not to publish data on five patients, right? To have a certain number of patients and make it relevant. I don't know what the number is, but it's probably 15, 20 patients, so it's significant. You know, four or five patients don't really mean anything or not much. And the second one, you know, the treatment three months, they may not be that representative for, like the retreatment is allowed after three months, so the patient doesn't respond after three months can be retreated. So probably the six months is a lot more meaningful in terms of showing what the real results are.

But we haven't decided yet. really to file the IND to get the trial started. Then we can think about the data. It's an open label, one arm, so we can see the data.

hope I answer your question yes that's perfect thank you so much.

Thank you, Kelsey. As a reminder, if you would like to ask a question, please press star 1. All right. We have another question from Farven Honk of Jefferies. Please go ahead.

Thank you for taking the follow-up. Just to clarify in your last comment, the clinicaltrials.gov allows one reinduction after disease recurrence. So does the reinduction count towards the primary CR endpoint, or is it captured as a secondary?.

Thanks for the question. Give me a chance to clarify. The primary point is response at any time. So the six months is anytime by the high response during the trial. So the patients can have one re-induction if needed? Correct. Okay, got it. Thank you. So if they don't respond at three months, they can be re-induced, and they may respond at six months. So for the primary endpoints, the highest response rate is the one that matters.

Thanks for the question. It was important. All right. Looks like we have another question from Weir of Mizuho. Please go ahead.

Hey guys, yes thanks for taking the follow-up. I just wanted to ask, I don't know if you guys or Raj has watched the FDA adcom on the reprimand product and I just wanted to see if you think that there's any read through to your second line your second line development, you know, for MDV01 as And yes, just wanted to see if you think there's any read through considering that, you know, the, I guess the FDA was looking for a. large response rate and in their opinion it wasn't really the case but the ADCOM at it sort of differently and saw a signal and I think took into.

taking us again into consideration. Maybe I can step in here. You know, I think it's important for us to comment on, you know other companies adcoms and different disease areas as well so i i don't you know i don't I don't know that it would be again prudent for us to comment here, but thank you for the question,.

Yes, there are different indications and what we can share is that with the meeting with the FDA, there is no fixed number about what kind of response rate the FDA expects to approve NDVA-1. And I believe they stated that they want to see the overall data in terms of response rate and durability. So it's really different from any other comparison. Okay, thanks.

Thank you. This concludes our question and answer session and call for today. Thank you, everyone. You may now disconnect.

This live transcript is auto-generated without human intervention or review.

[Call has ended.]

Good afternoon, and welcome to Relmada Therapeutics First Quarter Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded and will be available for replay on the Relmada website.

I would now like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.

Thank you. Good day, everyone, and thank you for joining us today. This afternoon, Relmada issued a press release providing a business update and outlining its financial results for the 3 months ended March 31, 2026.

Please note that, certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during today's call, Relmada's management team will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Relmada's press release issued today and the company's SEC filings, including in the 10-Q filing for the quarter ended March 31, 2026, filed after the close today.

This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast on May 12, 2026. Relmada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

With me on today's call are Relmada's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights; Dr. Raj Pruthi, Relmada's CMO Urology, who will provide an NDV-01 program update; and Relmada's CFO, Maged Shenouda, who will provide an update on sepranolone and a review of the company's Q1 financial results. After that, we will open the line for a brief Q&A session.

Now, I would like to hand the call over to Sergio Traversa. Sergio?

Thank you, Brian. Good afternoon, and welcome, everyone, to the Relmada first quarter 2026 conference call. Relmada continues to make excellent progress this year, and we are excited about where we stand. The robust 12-months data for NDV-01 in non-muscle invasive bladder cancer or NMIBC and the successful completion of a $160 million private placement financing, meaningful milestones that reflect the strength of our progress. Importantly, we remain on track to initiate the Phase 3 RESCUE program in mid-2026, which we believe will be a transformational moment for Relmada.

Let me briefly describe what makes NDV-01 distinct. NDV-01 is a ready-to-use sustained-release intravesical formulation of gemcitabine and docetaxel or Gem/Doce. It's designed to build on a well-established safety and efficacy profile of conventional Gem/Doce and deliver a best-in-class therapy for patients living with NMIBC. We remain focused on maximizing its potential for success for patients, the urology community and our investors.

Let me walk you through 4 milestones that speak to the momentum we have built this year. Number one, we have continued to derisk the development of NDV-01 with the report of solid and durable 12-months efficacy data from the ongoing Phase 2 study of NDV-01.

We will be presenting these data and an overview of the Phase 3 RESCUE program at the American Urological Association 2026 Annual Meeting later this week. High response rates, a favorable safety profile and ease of use continue to strengthen our conviction that NDV-01 has the potential to provide what urologists and patients with NMIBC need, a simple, durably effective treatment that readily fits into real-world practice setting.

Number two, we achieved FDA alignment for our planned registrational Phase 3 RESCUE programs. Number three, in April, we filed a provisional patent application in the U.S. directed to formulations and methods of treatment for NDV-01. This application, if issued, could form the basis for worldwide patent filings and have a term into 2047.

Lastly, we have fortified our balance sheet. With the private financing that was completed in March, we have the resources to support completion of the Phase 3 RESCUE program.

Before I hand the call to Raj, I want to underscore the significance of the patent filing. The provisional application is directed to both the formulations and methods of treatment, reflecting the breadth and novelty of the NDV-01 platform.

If granted, it could form the basis for worldwide patent filings, significantly expanding our global IP protection. Most importantly, it would meaningfully extend the covered claims of NDV-01 into 2047, providing a 9-year extension of commercial exclusivity and strengthening our competitive positions as we advance toward registration.

Looking ahead, as we enter the second half of 2026, our focus is on execution. We remain on track to initiate the registrational Phase 3 RESCUE program for NDV-01 in mid-2026. We are also preparing to initiate a proof-of-concept study for sepranolone in Prader-Willi syndrome targeted for mid-2026. Maged will speak about it in more detail shortly.

Next, I will turn the call over to Dr. Raj Pruti, who will provide a review of the NDV program, including 12 months follow-up data from the ongoing Phase 2b study and the summary of our Phase 3 plans. Raj?

Thank you, Sergio, and good afternoon, everyone. I'm delighted to provide an update of NDV-01 and our upcoming presentations at the AUA meeting this coming weekend. The AUA is an important platform for us as we look forward to introducing NDV-01 to the broader urology community, building awareness of NDV-01 as a differentiated sustained release Gem/Doce and generating investigator interest in the Phase 3 RESCUE program.

Bladder cancer is one of the most common cancers we see and its impact on the patients is significant. Most are diagnosed in their mid-70s. The disease often comes with high recurrence rates and intensive treatments that can greatly affect quality of life during a stage of life when preserving it is especially important.

I want to touch on 3 topics during today's call. First, a recap of the NDV-01 12-month data; second, a summary of our planned Phase 3 program; and third, a discussion of how NDV-01 might fit in the real-world practice of a urologist.

As Sergio noted, NDV-01 is a novel sustained-release intravesical formulation of gemcitabine and docetaxel. It builds on physicians' established familiarity with conventional Gem/Doce. This is particularly meaningful for patients who are unresponsive to BCG, where bladder-sparing options that avoid radical cystectomy can be life-changing.

Turning to the 12-month data. NDV-01 has demonstrated high response rates and durable efficacy in our ongoing Phase 2 study. We believe these results compare favorably to other programs in this space and support NDV-01's potential as a best-in-class treatment for patients with bladder cancer, if approved.

The Phase 2 study is an open-label single-arm trial in patients with high-risk NMIBC. Patients receive 6 biweekly doses, that is every other week, followed by monthly maintenance for up to 1 year. Regular assessments include cystoscopy, cytology and biopsy if needed.

The study was designed to enroll up to 70 patients. Primary endpoints are safety and complete response rate at 12 months. The data demonstrated a 95% complete response rate at any time at a durable 76% CR at 12 months in the high-risk NMIBC patients and a 94% CR at any time and a durable 80% CR rate at 12 months in the difficult-to-treat BCG-unresponsive subpopulation, reinforcing its best-in-class potential in NMIBC.

No patients had progression to muscle invasive disease and no patients underwent a radical cystectomy. On the strength of these findings, we are advancing NDV-01 into a Phase 3 RESCUE registrational program. The program will evaluate NDV-01 in both second-line BCG-unresponsive disease and in intermediate risk bladder cancer as an adjuvant therapy following transurethral resection or TURBT.

We will be presenting the 12-months data set at the AUA Annual Meeting this Friday. We believe these data are compelling and look forward to the discussion they will generate in the urology community.

Given the burdensome nature of the existing bladder cancer therapies, safety remains a critical aspect of the therapy's overall profile. We continue to be encouraged by the favorable safety profile observed for NDV-01 in our clinical program.

In the 12-month data set, no patients experienced a grade 3 or higher treatment-related adverse event. There were no dose interruptions or discontinuations due to adverse events, and most treatment-related adverse events were Grade 1.

Now turning to the Phase 3 RESCUE program. We designed the program with 2 separate approval pathways to increase the likelihood of success while creating the most streamlined route to regulatory approval.

We expect to file the U.S. IND and initiate RESCUE program across an estimated 80 sites in North America in mid-2026. The RESCUE program will also be highlighted in the trials in progress session at the AUA Annual Meeting on Sunday, May 17, providing an important opportunity to engage the urology community.

Let me now walk you through each of the 2 studies that form the RESCUE program. Registrational pathway 1 focuses on patients in the second-line setting, patients who are BCG-unresponsive with carcinoma in situ or CIS and refractory to first-line therapies that are approved or in development.

We estimate approximately 5,000 patients per year in the U.S. fall into this setting. With few treatment -- few effective alternatives to radical cystectomy, this study is designed as a single-arm trial. The primary endpoint is complete response rate at any time. Secondary endpoints include duration of response, progression-free survival and recurrence-free survival. We expect to report the first 3-month response data around year-end. This pathway could offer a rapid route to approval.

Registrational pathway #2 evaluates NDV-01 as an adjuvant therapy following TURBT in patients with intermediate risk NMIBC. We estimate approximately 75,000 patients per year in the U.S. fall into this setting. Since no approved treatments exist in this setting, the study is designed as an open-label randomized controlled trial comparing NDV-01 versus observation.

The primary endpoint is disease-free survival. Secondary endpoints include high-grade recurrence-free survival, progression-free survival and quality of life endpoints. We see this as a very attractive opportunity to incorporate NDV-01 into patient care after TURBT and pave the way for broader adoption.

Let me share our thinking on how NDV-01 might work in the real-world practice of a urologist. NDV-01 is formulated to create a soft matrix in the bladder, enhancing local urothelial exposure while minimizing systemic toxicity. It can be delivered in the office by a nurse or LPN in under 5 minutes and does not require specialized pharmacy or hub. This streamlined administration model offers a level of convenience and time savings that differentiates NDV-01 from other agents.

As I hand the call over to our CFO, Maged Shenouda, I want to emphasize why we're so excited about NDV-01. Our Phase 2 data gives us high confidence in the RESCUE program. We believe NDV-01 addresses a clear unmet need with a unique sustained delivery platform and has the potential to redefine the standard of care in bladder cancer. Maged?

Sure. Thanks, Raj, and good afternoon, everyone. Today, I'll spend a few minutes on sepranolone and then provide you with an overview of our first quarter 2026 financial results.

Sepranolone is a novel neuro-steroid that modulates GABA, one of the most important neurotransmitters. Sepranolone is intended to act on the GABA neurotransmitter pathway to normalize the activity of GABAA -- of the GABAA receptor and alleviate the repetitive symptoms in compulsivity disorders. These disorders affect millions of people around the world and include obsessive-compulsive disorder, Tourette syndrome and Prader-Willi syndrome. We plan to initiate a proof-of-concept study in Prader-Willi syndrome in mid-2026. Our immediate preparations are focused on engaging with the FDA regarding our proposed trial design and putting a robust supply chain in place.

Moving now to our financial results. As noted earlier by Brian, this afternoon, Relmada issued a press release announcing our business and financial results for the first quarter ended March 31, 2026. During this call, I will provide a high-level review of our financial results and refer you to our press release and 10-Q filing issued this afternoon with more detailed information.

Starting with our cash balance. Relmada closed the first quarter of 2026 with a cash balance of $234 million compared to $94 million at December 31, 2025. Our first quarter cash balance includes net proceeds of approximately $150 million from a private financing announced on March 9, 2026. We expect our current cash resources to provide sufficient runway to fund company operations through 2029, including completion of the Phase 3 RESCUE program for NDV-01.

Moving briefly through our first quarter financial results. Research and development expense for the 3 months ended March 31, 2026, totaled $8.1 million compared to $12 million for the 3 months ended March 31, 2025, a decrease of $3.9 million. The decrease was primarily attributable to non-recurring costs associated with the acquisitions of -- with the acquisition of sepranolone and the license agreement of NDV-01 in 2025. This 2026 decrease was partially offset by increased costs related to the start-up of the Phase 3 NDV-01 trials and the Phase 2b sepranolone study and additional R&D personnel.

General and administrative expense for the 3 months ended March 31, 2026, was $11.4 million compared to $6.3 million for the 3 months ended March 31, 2025, an increase of approximately $5.1 million. The increase was primarily driven by an increase in compensation costs, partially offset by a decrease in stock-based compensation costs.

Net cash used in operating activities for the 3 months ended March 31, 2026, totaled $15.1 million compared to $18.1 million for the same period in 2025. The net loss for the 3 months ended March 31, 2026, was $19.1 million or $0.22 per basic and diluted share, compared with a net loss of $17.6 million or $0.58 per basic and diluted share for the first -- for the 3 months ended March 31, 2025.

Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?

Thank you, Maged. In closing, I'm very confident and optimistic about our clinical programs and the long-term prospects for Relmada. As we are getting ready to initiate the RESCUE registrational program for NDV-01 in mid-2026, we are focused on execution and look forward to updating you on our progress in the coming quarters.

Operator, I would like now to open the call for questions.

[Operator Instructions] We now have our first question, and this comes from Kelsey Goodwin from Piper Sandler.

Looking forward to seeing the data this weekend at AUA. I guess, a couple for me, if you don't mind. First, for AUA this weekend, it seems like there's some Gem/Doce presentations. I guess, how should we think about the growing literature on Gem/Doce and the degree of read-through to NDV-01? And then secondly, maybe just updated thoughts on how we should think about this first look at the BCG-unresponsive second-line data later in the year? Maybe how many patients we might see or how to benchmark that? And I'll leave it at that.

Thank you, Kelsey. Sergio here. Well, the -- maybe I can take a little point on the first question, I see that Gem/Doce, conventional Gem/Doce data always is a positive because it just consolidates how the urology community believes that this is a very effective and way to treat bladder cancer. And with that said, I'll let Raj to expand and answer you the second question. Raj?

Yes. Thanks for the question, Kelsey. I'm excited as a urologic oncologist to see the number of non-muscle invasive bladder cancers in general in the hundreds at the AUA this year. And you're right, there's a significant number of Gem/Doce papers being presented, more and more on the efficacy of Gem/Doce, especially in the high-risk patient population.

The other that I think is notable is that of time toxicity with Gem/Doce. There's 2 papers being presented on the burden of conventional sequential Gem/Doce time toxicity, the burden to the patient and to the provider. So I think that provides -- really tees us up to address that time toxicity with our sustained release formulation.

Regarding -- I think your second question was on our Cohort 2A for the second-line BCG-unresponsive. My hope in that is that by -- as we get the study going, that we'll have a handful of patients maybe by the end of this calendar year that we will be able to share 3-months data. This is an open-label study. So a 3-months response and safety rate data by the end of this year or early next year. And we anticipate at a cadence of every 3 months sharing that data into 2027. I think I got both your questions.

And the next question comes from Christopher Liu from Lucid Capital Markets.

Congrats on the progress you guys have been making so far. So for my question, I was just wondering what your updated thoughts are going into this AUA update in terms of what would be a positive readout for you guys at this 12-month mark in your opinion?

Thank you, Chris. Sergio here. I would let Raj, the expert to answer this one. Raj?

Yes. I think for -- I really kind of hone in on the BCG-unresponsive population. I think that's the most difficult to treat failing BCG. I think for the -- our BCG-unresponsive, we see numbers of 80% landmark and 84% KM at the 12-month standpoint, which I think is best-in-class. I think you see approved agents, the best-in-class approved agents for BCG-unresponsive with CIS are around 45%. And I think others have seen numbers up towards 70%. But I think the numbers of 80% and 85% that we have are really best-in-class at that point and along with a good safety profile. I think, Chris, I think that's the number that I would kind of look at is that 80% number.

And the next question comes from Uy Ear from Mizuho.

Congrats on all the progress you've made. Maybe just help us to understand a little bit more about your patent estate. So you filed the provisional patent. And I wasn't -- I'm not sure I quite understand the phrase if approved patents claiming priority to the provisional patent would have extended patent life, I guess, into 2047. Could you maybe just help clarify that, what that means exactly? And also, with the extended patent term, which is quite extensive. How are you perhaps thinking about doing additional clinical trials? Like does it give you a greater chance of -- or are you thinking about perhaps doing combination studies in addition after the RESCUE programs are done?

Sergio here. I'll take the first one on the IP, and then I'll let Raj to handle the one on the development. So we just filed a patent a few weeks ago. So allow me to be not too specific on what the claims are. But in general, these are new patents and reflect the work that has been done in the U.S. in the formulation and manufacturing. And it is a new patent that we filed in the U.S. and then we'll have the opportunity, we have sometime at least 1 year to file outside of the U.S. And so these are new patents, so they will provide coverage if granted, of course, until sometime in 2047. I hope I kind of answered your question.

When do you expect the prosecution to enter? When do you expect the patent to be issued?

Yes. It's always a guess. We just filed. So from my experience, I would not expect anything at least for the first 12 months, first year. It looks like the patent office is very, very busy with a lot of filing and applications. So I would not focus on any response before at least 1 year.

And Uy, I can jump in on your other question about now we have the opportunities to look at NDV-01 in where else in lower track or upper tract disease. I think there are a lot of opportunities, and we can just follow the path of where has Gem/Doce been effective. I think we started with BCG-unresponsive and discussed that with those results. I think the extension into intermediate risk disease is a significant opportunity and market opportunity for Relmada.

I think also another opportunity that we're considering is in the high-risk BCG-naive population, another large patient population. I think on the heels of the BRIDGE study, which completed enrollment, I believe, in August 2025 and will take a couple -- it's an event-driven study will take a couple of years to read out. I think that's also another place where we BRIDGE does read out as Gem/Doce is noninferior to BCG and becomes an alternative. I think NDV-01 can nicely step in there as an easier to use, less burdensome approach for Gem/Doce in the BCG-naive, high-risk population.

[Operator Instructions] The next question comes from Farzin Haque from Jefferies.

So following up on an earlier question, like you have a broad inclusion criteria for Phase 3, the BCG-unresponsive setting and you're allowing up to 2 prior lines, including a wide range TAR-200, INLEXZO, et cetera. So how are you modeling the potential for variability or dilution of efficacy? And could you add just to 1 prior line as the trial progresses?

Raj, I think would you mind to take this?

Yes. Yes, my pleasure. Thanks for the question, Farzin. It's a very thoughtful question. I think we've built in kind of guardrails to that study of up to 2 prior first-line therapies. With that, the idea that beyond that may -- there may be some resistance mechanisms. And we'll evaluate -- we'll break that down by 1 or 2 lines of prior therapy. So we're looking at that.

And within the therapy, too, another area we're looking at. And remember, these are open-label studies, so we can see how these patients are doing. We're also going to look at patients who've had prior intravesical chemotherapy as part of their BCG-unresponsive disease. Particularly INLEXZO, we are excluding prior Gem/Doce in those patients because we're giving a Gem/Doce treatment. But we'll look at INLEXZO and gemcitabine and we've heard and in my own practice, having Gem/Doce as a rescue for gemcitabine is appropriate.

So we'll be looking at both of those closely. And I think we want to see our efficacy is what is our approach is what is the appropriate second-line therapy, right? These therapies are going to be sequenced by urologists, 2, 3, 4, 5 times before cystectomy. Right now, there's a lot of agents approved and in development for the first line. There's none in second-line therapy. So that gives us an opportunity to have -- provide the highest levels of evidence and a label for the second-line approach. And then from there, once urologists use it there, as we do, they could use it before or after. But we are -- that you bring up a good point. We are looking at lines of therapy and also what that prior therapy was. Thanks for the question, Farzin.

And then on your Phase 3 primary endpoint, does FDA's acceptance of CR at any time imply any durable responses, for example, median duration of response greater than 6 months?

So there -- what their phrase was they want the primary endpoint to be CR any, and they also want to see duration of response. And the words that they use is they want to look at the "totality of the data." So I think they're getting at what you are is a strong CR any, which could be at 3 months is great, but they want to see some level of durability in that. They didn't give the number on that, but they want to see some durability.

So CR any together with durability in this framed as duration of response is what they want to see. And given the fact that there is no agents that have been approved in this space, I think they'll put all that together, as they said, in the totality of the data. But really, the other alternative for the patients at this point in their journey is radical cystectomy.

Right. And then a quick one is that what is your expectation for enrollment cadence across both your pivotals? Can the drug's in-office profile serve as a recruitment advantage potentially?

Yes, that's a great question, Farzin. I think -- and having been on a number of calls of our site qualification visits, the enthusiasm by investigators is significant. A lot of the sites participated to address Cohort 1, which is intermediate risk, have participated in PIVOT-006, and they're excited for the next intermediate risk study. We've modeled out up to 15 to 18 months, but with that enthusiasm and with -- given what CG has been able to do as far as recruitment and number of events, I feel confident that we'll be able to meet or exceed that timeline.

Regarding the second-line therapy, we are anticipating 12 months, but that's, again, Farzin, another area where there's incredible enthusiasm because urologists have nothing else at this point in their armamentarium to treat these patients. So a lot of these urologists, even the best-case scenarios are 45% 12-month CR. You see 19% to 45%, meaning 55% to 80% of patients are recurring within 1 year with the first-line therapy. So there's a large population of patients out there with BCG-unresponsive CIS who failed first-line therapy. We're not competing with any other study. I'm optimistic that we'll be able to reach that 12 months enrollment.

Thank you. And there are no further questions that came through. This concludes our question-and-answer session and the call for today. Thank you, everyone. You may now disconnect.

Undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With me on today's call are Relmada's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights; Dr. Raj Pruthi, Relmada's CMO Oncology, who will provide an NDB01 program update and Romana CFO,Maged Shenouda, who will provide an update on sepanolone and a review of the company's Q4 financial results. After that, we will open the line for a brief Q&A session. Now I would like to hand the call over to Sergio Traversa. Sergio?

Thank you, Brian. Good afternoon, and welcome, everyone, to the Ramada Fourth Quarter and Year-End 2020 Conference Call. 2025 has been a transformational year for Relmada, marked by significant progress for our lead program, NOI -- as a reminder, N1 is a sustained release formulation of gencitabine and docetaxel. We are developing this investigational product candidate for the treatment of non-muscle invasive bladder cancer or NMIBC. Most recently, we reported compelling responses and durable 12 months efficacy data for our ongoing Phase II study of MDI.

We achieved FDA alignment for our planned registration of Phase III rescue programs. We fortified our team, and we substantially strengthened our balance sheet. As we reflect on our recent accomplishments and planned next steps, I would like to highlight 4 key areas. First, None -- we believe that the strength of the recently reported 12 months follow-up data could position NVR1 as a potential best-in-class therapy for the treatment of NMIBC. Furthermore, the strength of the clinical data and the unique easy-to-administer sustained-release formulation gives us confidence that NDVI has the potential to provide what urologists and patients with NMIBC need a simple, durable effective treatment that readily fits into real-world practice setting.

We plan to initiate the Phase III rescue program in the middle of this year. Our Phase III regulatory strategy agreed upon BPSD includes 2 independent registrational pathways. AT1 is focused on adjuvant therapy following TURBT in patients with intermediate-risk bladder cancer, which affects about 75,000 patients in the United States.

Pathway 2 is focused on second-line treatment BCG unresponsive patients, which represent about 5,000 patients in the United States. Second, sepranolon. Setanon has previously demonstrated proof of concept in the red syndrome is a disorder characterized by composite behavior. We are getting ready to begin approval concept study in Prader-Willi syndrome in the middle of this year. And third, our team -- we substantially strengthened our development team with the appointment of Dr. Raj Pruthi, a highly regarded physician scientists and urologic oncologist as Chief Medical Officer, Oncology.

In addition, we established a scientific advisory board comprised of similarly distinct peers to further support the NB-01 program. Dr. Air Lotan from the University of Texas Southwestern Medical Center; and Dr. Mas Katz from John Hopkins University School of Medicine. Fourth and last, financial strength. We just completed a successful EUR 160 million private financing. Based on existing forecasts, these funds plus our existing cash balance provide Relmada with capital through 2029 and importantly, through the completion of the planned VS1 program.

Looking ahead, is poised to be another important year of value creation for Relmada, with the initiation of our Phase III rescue program for ND01 in bladder cancer, and the Phase II proof of concept trial for Ceprano in Prader-Willi syndrome. With that, I also would like to express my appreciation for the trust and support of our investors employees, collaborators and the patients who participate in our studies.

Next, I will turn the call over to Dr. Raj Protti, who will provide a review of the NDB-01 program, including 12 months follow-up data from the ongoing Phase II study and the summary of our Phase III plans. Raj?

Thank you, Sergio. Good afternoon, everyone. It's a privilege to share an update on the clinical progress we've made this year, headlined by the truly compelling and best-in-class results for NDV01 MIBC. Bladder cancer is a high-frequency cancer that has a major impact on the lives of patients. generally diagnosed in their early to mid 7s. -- high recurrence rates and burdensome treatment disrupt quality of life at a time when patients are eager to enjoy life.

I want to touch on 3 topics during today's call. One, an overview of the NDV-01 12-month data; two, a summary of our planned Phase III program and through a discussion of how NDV-01 might fit into the practice of a urologic hercology. Sergio noted that NDV-01 is a novel sustained release intravesical formulation of 2 chemotherapy agents, gemcitabine and docetaxel or Genos, as we say. Our program builds on physicians establish familiarity with the efficacy and safety profile of conventional gem dosing.

More specifically in patients who are unresponsive to BCG. This combination offers a salvage a bladder sparing option that may help avoid a radical cystectomy. Moving on to the 12-month data. We are pleased to report that MDR1 has demonstrated a high response rate and durable 12-month efficacy from the ongoing Phase II study. We believe these data stand out in comparison to the other benchmark programs. And I could position NDV-01 as a best-in-class treatment option for patients with bladder cancer, if approved.

The study is an open-label single-arm trial in patients with high-risk NMIBC. Patients receive biweekly doses every other week time 6 followed by monthly maintenance for up to 1 year. Patients undergo regular assessments with cystoscopy, typology and it needed biopsy. The study was designed to enroll up to 70 patients with high-risk NMIBC. The primary endpoints are safety and complete response rate at 12 months -- endpoints or duration of response and event-free survival. The data demonstrated a 12-month complete response rate of 76% with a favorable safety profile.

Notably, the study also showed a 12-month complete response rate of 80% in the BCG underspent population, one of the most difficult-to-treat segments of NMIBC. These findings support the advancement into the Phase III registrational program, which we are calling [ rescue. ] The program will evaluate NMI NDV-01 in both second-line BCG unresponsive diseases and in intermediate risk or cancer as an adjuvant therapy following TURBT.

When you look at the complete responses or CR at any time in the overall population, we see a CR any time of 95%, based on 38 patients. Among those with BCG and responsive disease, we see a CR rate at any time of 94%. Given the burden nature of recurrent bladder cancer treatment -- is a critical element of our product profile. We continue to be encouraged by the favorable safety profile observed for NDV-01 across our clinical program.

In the 12-month data set for NDV-01, no patients had progression to muscle-invasive disease. No patients underwent a radical cystectomy. No patients had agreed 3 or higher treatment-related adverse events. No interruptions or discontinuations or treatment due to adverse events occured. And most treatment-related adverse events were I think grade 1 level.

Moving on to the planned Phase III Rescue program. We believe our 12-month response and durability data compare points favorably to the current commercial and development stage platform. We have constructed our Phase III registrational pathways to maximize our probability of success and create the most efficient path to FDA approval. The rescue registration program was designed in alignment with the FDA to provide 2 separate approval pathways. We expect to secure a U.S. IND clearance and initiate the Phase III rescue program in the middle of this year.

Let's review the 2 studies that form the Rescue program. registrational pathway on focuses on the evaluation of NDV-01 in patients with intermediate-risk bladder cancer as an adjuvant therapy following TURBT surgeries. We estimate there are about 75,000 patients each year in the U.S. in esthetics. This study is planned to be an open-label, randomized controlled trial. As there are no approved treatments for adjuvant intermediate risk NMIBC. The study will evaluate NDV-01 versus observation. The primary endpoint is disease free survival or DFS.

Secondary endpoints included high-grade recurrence-free survival, progression-free survival and quality of life metrics. We feel that the opportunity to incorporate NDV-01 into patient care post RBT is very attractive, and it could pave the way for important clinical indication and broader adoption. Registration pathway #2 is focused on the valuation of NDV-01 in the second-line setting in patients who are BCG unresponsive with carcinoma institute or I for refractory to first-line therapies approved or in development. We estimate that there are about 5,000 patients per year in the U.S. in this set.

These patients have few if any effective treatment alternatives to radical suspect. The study is designed as a single arm open-label trial. The primary endpoint is CR at time. Secondary endpoints will include the duration of response, or DOR, progression-free survival and recurrence-free survival on my first bond. We expect to report the initial 3-month response data from this study by the end of 2026. We're excited about this pathway because it could offer a rapid route to approval.

Before I hand the call over to Megan, I'd like to make a note of how the NDV-01 in clinical practice. N1 is formulated to create a soft metrics in the bladder to enhance local bladder urothelial exposure and minimize systemic toxicity. It is delivered in the office in less than 5 minutes. This simple formulation and administration model has the potential to optimize the delivery experience for patients and providers offering a level of simplicity and time savings that stands up amongst amongst the others.

Before I hand the call over to our CFO,Maged Shenouda . Our Phase II data gives us high confidence in our registrational program. By addressing a clear unmet need with a unique sustained delivery profile, we believe DV01 is uniquely positioned to redefine the standard of care in bladder cancer. We look forward to initiating the rescue registrational program at an estimated 80 sites in North America in the middle of this year as we work to bring NDD01omboterate cancer patients as soon as possible. Maged?.

Thanks, Raj, and good afternoon, everyone. Today, I'll spend a few minutes on sepranolone and then provide you with an overview of our fourth quarter 2025 financial results. Because supranalone modulates GABA, 1 of the most important neurotransmitters, it is defined as a DAMSABA-modulating steroid antagonist to pranalone's novel action on the Gabon transmitter pathway gives it the potential to normalize the activity of the GABA A receptor and alleviate the repetitive symptoms of compulsivity disorders. These disorders affect millions of people around the world and include indications such as obsessive compulsive disorder, Tourette syndrome and Potter Willy syndrome.

We are preparing to initiate a proof-of-concept study in Pratt or Willy syndrome in mid-2026. Our immediate efforts are dedicated to completing study preparations, including engaging with the FDA on our proposed trial design and establishing a robust supply chain. Moving now to our financial results. As noted earlier by Brian, this afternoon, Romata issued a press release announcing our business and financial results for the fourth quarter and 12 months ended December 31, 2025.

During this call, I'll review our fourth quarter 2025 financial results and refer you to our press release and 10-K filing issued this afternoon for financial information for the last 12 weeks. Starting with our cash balance. Ramada closed 2025 with a cash balance of $93 million. This includes net proceeds of approximately $94 million from an underwritten stock offering announced on November 5, 2025. This compares to cash, cash equivalents and short-term investments of approximately $45 million at December 31, 2024. On March 9, 2025, the company announced a $160 million of private financing with net proceeds of approximately $150 million.

This financing, along with our cash balance as of December 31, 2025, is expected to provide sufficient resources to fund company operations through 2029, including completion of the Phase III rescue program for NDV-01. Moving through our fourth quarter financial results. Research and development expense for the 3 months ended December 31, 2025, and totaled $8.1 million compared to $11 million for the 3 months ended December 31, 2024, a decrease of $2.9 million.

The decrease was primarily driven by a decrease in study costs associated with the completion of 2 Phase III trials for NDV-01 partially offset by increased costs related to the startup of the Phase III NDV-01 trials in Phase IIb subranolone study and additional R&D personnel. General and administrative expense for the 3 months ended December 31, 2025, totaled $12.3 million PAUSE compared to $8.1 million for the 3 months ended December 31, 2024, an increase of approximately $4.2 million. The increase was primarily driven by an increase in compensation costs partially offset by a decrease in stock compensation costs. PAUSE

Net cash used in operating activities for the 3 months ended December 31, 2025, totaled $14.6 million compared to $8.8 million for the 3 months ended December 31, 2024. The net loss for the 3 months ended December 31, 2025, was $19.9 million or $0.27 per basic and diluted share compared to a net loss of $18.7 million or $0.62 per basic and diluted share for the 3 months ended December 31, 2024.

Before we open the call for questions, I'll turn it back to Sergio for some closing comments. Sergio?

Thank you, Maged. In closing of our prepared remarks, I would like to share that I'm very confident and optimistic about our clinical programs and the long-term prospects for Relmada. As we are getting ready to initiate the rescue registrational program for NDV-01, we are focused on execution and looking forward to updating you on our progress in the coming quarters. Operator, I would now like to open the call for questions.

[Operator Instructions] Our first question is from Uy Ear with Mizuho Securities. PAUSE.

Congrats on the great data and the pipe. It seems like you guys did a lot of work this quarter. So maybe there's been getting some questions on whether you will present additional data from your Phase II study. Should we kind of expect going forward maybe updates every 3 months. And will you also have data, I guess, at AUA by any chance? So that's the first question.

And the second question that we've been kind of getting is, there's been, I guess, some investors are a little bit concerned that the second-line patients may not be necessarily second line, but maybe by the time they get to your regimen, it could be their third line. Maybe just help us understand how -- what you're doing exactly to ensure that those patients are truly second-line patients.

And the third question is you indicated that you have 3 months data from your Phase III BCG unresponsive second line in response to patients. Will this be from the entire patient population? Or would this be sort of interim and is part portion of the number of patients that you expect to enroll.

Thank you all for the questions. I think Raj is -- you can answer these questions. I pass it to Raj.

Thank you, Serge. Good to hear for you. Regarding the data, we will be presenting an updated data this 12-month data at the AUA. It has been acceptance of that. We'll also be presenting a trial in progress as we get rescue going. Our plan is to focus on introducing data, and I think this is your last question, in the pet responsive second-line group starting at the end of the year. So as we start the trial in the midyear, we should have some 3-month data to be able to share externally by the end of the year as is a single-arm open label -- and our thought is to then actually at a cadence of about every 3 months share the data as we get 6, 9 and 12 months on that data set.

I think you provided an excellent question on second line, third line, fourth line. And we are indeed limiting the number of prior therapy lines to 2. So you can have 1 live therapy at silicon, for example, and while allowing the second of those still be followed by -- we're also at a maximum of 2. We're also going to look at 15 patients at 3 months of those who received 1 line therapy versus 2, just to make sure there -- it's an open-label study that there's nothing concerning that we want there, those should be excluded. And this is reflective of the conversations we've had with the FDA. But I think it's a good question. We mined a number of kind of third or fourth lines.

our next question is from Farzin Haque with Jefferies.

So I had 1 on the operational standpoint. In space is becoming congested with active trials and drugs approved too. So like what is your expectation for enrollment cadence across your 2 studies? And can the drug in office profile potentially serve as a recruitment advantage?

Thank you, Farzin. Raj, do you want to take that?

Yes, yes. Yes, good to hear from you. I think you're right. It's -- I think the high-risk BCG response has been a crowded space, but I think our is coming in as a second-line therapy provides a unique advantage and there's no drugs that have been approved in that setting and none that I'm aware of that are even being investigated as a pivotal study in that setting. So I think we have a competitive advantage and that we can go to sites that even in development drugs in development and follow them in this unique path. And same for Intermediate risk. I think right now, there's it's becoming a bigger expansive interest.

But what I've seen in, for example, CG Oncology has an intermediate risk trial that looks like it it's ahead of schedule and accrued very rapidly. I think there's a lot of interest in -- from investigators and looking at intermediate risk patients. I think what we -- I expect us to enrolled that pretty rapidly ahead of schedule like CT did. Thanks for the question, Farzin.

Got it. And then for the second-line, high-grade fittings, beyond the primary endpoint of CR rate at any time, has the FDA stipulated a minimum duration of follow-up required for all patients by dissubmitting the IDA

Another great question. They haven't required a minimum of follow-up. They said they want us to CRM, as you said, and durability of response or duration of response. I think the wording to use what I think is important is they've kind of seen the totality of the data. So they want to see do you have a response? And is there some level of durability, I mean they haven't specified what that number is.

Next question is from Christopher Liu.

Thanks for the question. I was just wondering, given the population differences between your Phase II and Phase III rescue, what are you expecting to see in terms of the CR rate at the 3-month mark as well as what we should be benchmarking against with the status?

Thank you, Chris. Raj, do you want to take this one as well?.

Yes, sure. Yes. Thanks, Chris. Thanks for the question. So in the intermediate risk, we are looking at we structured the trial to look at a -- the statistics around it, a 2-year RFS of 75%. And that actually is reflected in the literature with Jetsen. And I think with what we've seen in this population and with sustained release, we should exceed that, but that's our target number that drives the statistics. It's an event-driven study. So that's kind of the 128 events as a target. Regarding the BTG on responses to line, it is -- we have looked at that, what is the -- the -- it's interesting that in first line, the first drug approved was valrubisin in 1998 at 8% 12 months here, followed by KEYTRUDA and 19% at shown.

So I think -- I'm glad that there is not -- the FDA wasn't fixated on a certain number, but I think that number should be at those levels or lower than what we've seen in first-line beepyjust as a precedent if that makes sense.

[Operator Instructions] Our next question is from Kelsey Goodwin with Piper Sandler.

Congrats on the recent clinical update. Regarding, I guess, specifically to that update regarding the patient baseline characteristics and the CIS versus papillary split I guess how should we be comparing this data set to that of competitors with primarily CIS patients there? And I guess any data to support that Genosylooks similar in CIS in papillary patients.

Kelcy, I sell you here. Raj, it seems that this 1 also has for you.

Yes. Great question, Kelcy. Regarding -- so starting with the last part of your question first, there is, in fact, it's interesting as the clinicians. You often think, okay, the patient is B2Goresponse and this might be more virulent -- but we don't at think is CIS versus capillary some people show pure site beebetter, but T1 pap were. So it's a mixed bag. It's actually interesting for Gemo there's a hard hold by Steinberg in 2020 in the Journal of Urology that looked at heavily pretreated, basically B2Datients. And at 12 months, the RFS in those patients are CRs with 60% in the CIS population and 61% in pathways. So there isn't a market difference typically in between that.

But even if you go back and look at our data of what we've showed, ours at 12-month is 80%, 12-month came at 84%. And that does include 4 patients with at 12 months for patients with CIS. We had 4 out of 4 with complete response at any time 2 out of 2 or 12 months. Completely understood these are small numbers, but I think it still compares quite favorably. Even if you take PAUSE NDV-01 and the BCG unresponsive our entire population, including CS and compare it to the best-in-class papillary, which is in J&K and Leo I think their 12-month TAM was 74%.

So even taking our entire over, we have -- we're significantly higher. So I think it's still best in us. I hope I answered your question.

Yes. No, that's super helpful. And then maybe just 1 follow-up, if I can. With respect to the intermediate risk setting and in that kind of market overall, I guess, how much do you think that market might need to be built out by these early launches, just given we haven't had an approved agent until last year.

Been another great question, if you don't mind me jumping in Sergio.

No, no, no, go ahead.

Right now, I mean, we mentioned it's about 75,000 to 80,000 patients with intermediate risk disease. And if you look at the data analysis, only about 35% of those patients will receive adjuvant therapy. What's important in our studies and in CV study is that in our interest population, we do include small less than 3-centimeter TA high-grade patients. I think that's very important because 20% of the intermediate risk disease in these high-grade PA patients. And those are the ones that probably more than anybody needs adjuvant therapy to prevent recurrence. So we go back to what receive an adjuvant therapy. I think it's exactly what you're alluding to. Right now, there isn't an approved therapy. There isn't a lot of data. And there is a that are can be reimbursed to the urologists in build model, for example.

So I think that 35% number is going to only grow as you've seen data from from monitor from RES to our intermediate study as we get data and gives patients confidence that, hey, here is an agent that might reduce my risk of having another and give your alts confidence that I have an agent that I can deliver in my office that will use to BT risk for life patients -- it's only going to grow.

Thank you. This concludes our question-and-answer session. I would now like to hand the floor back over to Sergio Traversa for any closing remarks.

Well, closing remarks is a big thank you to everybody that is allowed to Renato to get where we are now. We create data with a drug that can really help patient with bladder cancer. So looking forward to update everybody on our progress. Thank you, and enjoy the rest of the day.

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you again for your participation.

Thank you.

Good afternoon, and welcome to Relmada Therapeutics Third Quarter 202 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded and will be available for replay on the Relmada website. I would now like to turn the call over to Brian Ritchie of LifeSci Advisors. Please go ahead.

Good day, everyone, and thank you for joining us today. This afternoon, Relmada issued a press release providing a business update and outlining its financial results for the 3 months ended September 30, 2025. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Relmada's management team will be making forward-looking statements.

Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Relmada's press release issued today and the company's SEC filings, including in the annual report on Form 10-Q for the quarter ended September 30, 2025, filed after the close today.

This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast on November 13, 2025. Relmada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

With me on today's call are Relmada's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights; Dr. Raj Pruthi, Relmada's CMO, who will provide an NDV-01 program update; and Relmada's CFO, Maged Shenouda, who will provide an update on sepranolone and a review of the company's Q3 financial results. After that, we will open the line for a brief Q&A session. Now I would like to hand the call over to Sergio. Sergio, please go ahead.

Thank you, Brian, as always, and good afternoon, and welcome, everyone, to the Relmada Third Quarter 2025 Conference Call. 2025 is shaping up to be a standout year for Relmada with excellent product development progress driven by the effort of our outstanding team and strengthened by our recent successful capital raise.

We are developing one late-stage and one mid-stage clinical program that we believe could be life-changing for patients. Each program has the potential to be the best-in-class treatment. Our lead program is NDV-01, a sustained release formulation of gemcitabine docetaxel or Gemdoce in development for non-muscle invasive bladder cancer, or NMIBC, which affects about 68,000 new patients each year in the U.S. and has a prevalence of approximately 744,000 patients in the U.S. only.

Our second program is sepranolone that is intended to normalize GABA-A receptor activity in compulsive disorder. Sepranolone is in development for Prader-Willi syndrome, which has a U.S. prevalence of approximately 20,000 patients.

Here are the 3 key messages that we will cover today. Number one, we reported 9 months follow-up data from the Phase II study of NDV-01 in patients with NMIBC. In brief, the study showed a 92% overall response rate at any time with favorable overall safety. We are very pleased by the encouraging and consistent data.

Number two, we are pleased to have secured FDA alignment on the key elements of the Phase III program for NDV-01. It is intended to enable 2 distinct and independent registrational tracks for NDV-01 in NMIBC. This is an important key derisking milestone for the program that opens the door to a broad market opportunity in NMIBC.

Number three, with the recently completed $100 million underwritten financing, we are well capitalized. The recent offering provides the resources to support our planned operations into 2028 and drive forward the planned registration studies for NDV-01 and the Phase II study of sepranolone pin PWS.

We are preparing to initiate these studies in 2026. For NDV-01, we expect to begin 2 separate registrational studies for NMIBC starting in the first half of 2026. For sepranolone, we anticipate starting a Phase II study in PWS also in the first half of 2026. We are well positioned to advance our pipeline, thanks to our expanding clinical team. Earlier this year, we appointed Dr. Raj Pruthi as Chief Medical Officer, Uro-oncology. Dr. Pruthi is a highly respected expert in bladder cancer and urologic oncology, who brings vast experience advancing novel therapies for NMIBC.

We have also established a Clinical Advisory Board to provide additional guidance for the pivotal program for NDV-01. The Board is comprised of prominent leaders in NMIBC and chaired by Dr. Yair Lotan, a renowned urologic oncologist. In October, we were pleased to welcome Dr. Max Kates to our Advisory Clinical Advisory Board. Dr. Kates bring a wealth of experience from chairing the landmark Phase III BRIDGE study and leading several other practice-changing studies.

I am very pleased with Relmada work this year to derisk our pipeline and advance 2 potentially life-changing therapies. We are looking ahead to 2026 with enthusiasm with several value inflection catalysts ahead.

Next, Raj is going to provide an update on the NDV-01 development program, including the 9-month follow-up data from the Phase II and a summary of the key highlights from the recent Type B pre-IND meeting with the FDA. Raj?

Thank you, Sergio, and good afternoon, everyone. I believe this is a very exciting time for our patients based on our excellent progress with the NDV-01 development program. I want to touch on 3 items today: An overview of the patient care journey in non-muscle invasive bladder cancer, or NMIBC, a review of the 9-month data and a summary of the FDA meeting highlights.

Let's start with the NMIBC and the patient journey. There are about 85,000 new cases of bladder cancer diagnosed each year in the United States and 744,000 people living with bladder cancer. About 80% of bladder cancer patients have NMIBC and recurrence rates over 5 years are about 60% to 80%.

Relmada is focused on high-risk NMIBC and on intermediate risk NMIBC, representing about 80% of NMIBC cases or 54,000 people per year. In brief, the patient care journey most commonly begins when a patient presents with blood in the urine or hematuria. Suspected bladder cancer cases are diagnosed using cystoscopy and cytology. Treatment begins with a surgical procedure called transurethral resection of the bladder tumor, or TURBT. This procedure allows surgeons to classify the patient's disease stage and risk category and define the treatment plan.

After surgery, patients with high-risk disease receive intravesical adjuvant therapy with standard of care immunotherapy known as Bacillus Calmette-Guérin or BCG. Patients are then monitored with regular cystoscopies and urine cytology every 3 months to assess for recurrence. Patients with recurrent disease are treated with repeat surgery, alternating with intravesical treatments.

NDV-01 is a novel sustained-release intravesical formulation of 2 chemotherapy agents, gemcitabine and docetaxel or Gemdoce, as we say. It was designed to build on data from numerous studies conducted over the past decade, showing that combination use of these 2 agents receives -- achieves response rates and recurrence-free survival that are comparable to or better than historical standard of care BCG.

And for those who are unresponsive to BCG, it can provide a second-line bladder sparing option to avoid radical cystectomy. The sustained release formulation of NDV-01 will be provided to study sites in a ready-to-use format that does not require a specialized pharmacy or biocontainment hood to formulate the Gemdoce combination. NDV-01 is intended to be instilled into the bladder through a regular catheter in the office in a less than 5-minute intravesical installation.

Upon administration, the formulation creates a soft matrix that is intended to enhance local exposure and minimize systemic toxicity.

Moving to the 9-month data. We're pleased to report that NDV-01's continued positive Phase II performance, strongly supporting its potential to transform the treatment of NMIBC. The study is a single-arm, single-center ex-U.S. trial in patients with high-risk NMIBC.

Patients are treated with NDV-01 in a 6 biweekly induction phase, followed by monthly maintenance for up to 1 year. Patients receive regular assessments with cystoscopy, cytology and if needed, biopsy. The study is designed to enroll up to 70 patients with localized high-risk NMIBC.

The primary endpoints are safety and complete response at 12 months. Secondary efficacy endpoints are duration of response and event-free survival. Efficacy assessments for the 9-month follow-up included analysis of data at 9 months and at any time point. These are the same safety and efficacy parameters that were applied to the 6-month data reviewed during our Q2 call in August and the 3-month data presented at the American Urological Association meeting in April.

Looking at the data, we observed a complete response rate of 92% at any time based on 25 patients. Amongst patients with BCG unresponsive disease, we see a 91% CR any time. At the 9-month assessment, we observed a complete response rate of 85%. No patients had progression to muscle invasive disease and no patients underwent a radical cystectomy. Patients who have been reinduced had a 60% complete response rate.

The study also includes certain defined subpopulations. For example, patients with BCG unresponsive disease, we saw a 91% CR anytime and a 9-month CR rate of 88%. [indiscernible] NDV-01 continues to demonstrate favorable safety consistent with our expectations and known efficacy and safety of Gemdoce. There were no reported new safety signals, no patients who had treatment-related adverse events that were Grade 3 or higher and no patients discontinued treatment due to adverse events. The most common treatment-related adverse events were transient dysuria and hematuria and asymptomatic positive urine cultures and incidental finding observed in 9% of patients with hematuria only seen at 7%.

All patients with dysuria were grade 1 and resolved within 24 hours. Our goal is to bring NDV-01 to patients as soon as possible. We intend to initiate the Phase III program for NDV-01 in the first half of 2026. The recent positive Type B FDA meeting is a key milestone that reinforces our confidence in the path forward for NDV-01.

I'd like to summarize the key outcomes from the FDA meeting, a very positive, constructive and pragmatic discussion with them. Relmada has secured FDA alignment on certain key elements of the planned Phase III pivotal program for NDV-01, incorporating 2 separate and distinct registrational paths. Number one, high-risk second-line BCG unresponsive NMIBC patients; and number two, intermediate risk NMIBC in the adjuvant setting.

In the setting of high-risk second-line BCG unresponsive disease, the FDA stated that a single-arm trial might be acceptable in a more refractory patient population. We're excited about this approach because it could offer a rapid route to approval. In the indication of intermediate risk in the adjuvant setting, the FDA agreed that a proposal to randomize patients post TURBT to adjuvant NDV-01 versus observation, evaluating a time-to-event endpoint is generally acceptable.

We feel that the opportunity to incorporate NDV-01 into patient care after TURBT is very attractive. It could pave the way for an additional indication and broader clinical adoption. Importantly, the FDA indicated that no further clinical -- nonclinical studies are required to support a 505(b)(2) NDA. This is very good news. We look forward to working with the FDA to complete the study design and initiate the registrational program in the first half of 2026.

Our efforts in the coming months will also focus on transferring production to contract manufacturers to complete scale-up and production of clinical batches. As I hand the call over to our CFO, Maged Shenouda, I am optimistic about the NDV-01 clinical development program based on the excellent 9-month results, positive outcomes with the FDA meeting and our ongoing Phase III preparation. Maged?

Thanks, Raj, and good afternoon, everyone. Today, I'll spend a few minutes on sepranolone and then provide you with an overview of our third quarter 2025 financials. Sepranolone is a member of a new subgroup of neurosteroids called GAMSAs or GABA-Modulating Steroid Antagonist. We believe sepranolone's novel action on the GABA neurotransmitter pathway gives a unique potential to normalize GABAA receptor activity and alleviate the repetitive symptoms in disorders where compulsive behaviors are a common feature. These disorders affect millions of people in the U.S. and around the world and include indications such as Prader-Willi syndrome and Tourette syndrome. We have selected Prader-Willi Syndrome, or PWS, as the first clinical indication that we will evaluate for sepranolone. It affects approximately 350,000 people worldwide, including approximately 20,000 people in the U.S. PWS is a complex genetic disorder, often defined by persistent hunger and overheating.

Current treatment is focused on improving the obsessive compulsive behaviors and other medical complications that characterize the disorder. Phase II data from a study in patients with Tourette syndrome established sepranolone's initial efficacy in a compulsivity disorder with good overall tolerability.

We intend to initiate a proof-of-concept study in PWS in the first half of 2026. Our immediate efforts are dedicated to completing study preparations, including engaging with the FDA and our proposed trial design -- on our proposed trial design and establishing a robust supply chain.

Moving now to our financial results. As noted earlier by Brian, this afternoon, Relmada issued a press release announcing our business and financial results for the third quarter and 9 months ended September 30, 2025.

As of September 30, 2025, Relmada had cash, cash equivalents and short-term investments of approximately $13.9 million compared to $44.9 million as of December 31, 2024. Notably, this excludes net proceeds of approximately $94 million from our $100 million underwritten offering of common stock and prefunded warrants, which the company closed on November 5, 2025.

Based on current plans, the company believes that its current cash balance, including net proceeds from the offering, is sufficient to support planned expenses into 2028. Cash used in operations in the third quarter ended September 30, 2025, was $6.7 million compared to $16.7 million for the same period in 2024.

During today's call, I'll review our third quarter 2025 financial results. Information regarding the 9 months results are included in our press release and 10-Q filings issued this afternoon. Research and development expense for the third quarter of 2025 totaled $4 million compared to $11.1 million for the third quarter of 2024, a decrease of $7.1 million. The lower spend was primarily driven by lower study costs with the wind down of clinical trials for REL-1017, partially offset by an increase in manufacturing and drug storage costs associated with the ramp-up of NDV-01 and sepranolone studies and an increase in R&D employees.

General and administrative expense for the third quarter of 2025 totaled $6.3 million compared to $11.9 million for the third quarter of 2024, a decrease of approximately $5.6 million. The decrease was primarily driven by a decrease in stock-based compensation expense as well as direct employee and administrative expense.

The net loss for the third quarter of 2025 was $10.1 million or $0.30 per basic and diluted share compared with a net loss of $21.7 million or $0.72 per basic and diluted share for the third quarter of 2024.

Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?

Thank you, Maged. Before we go to the Q&A session, I would like to share that I'm very pleased with Relmada work this year to advance and derisk our portfolio of potentially life-changing therapy for patients. With our progress comes our gratitude for your support and for taking time to join today's call. 2026 is shaping up to be another very important year for the company, and we look forward to updating you on our continued progress.

Operator, I would like now to open the call for questions.

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

Yes, congrats on all the progress that you've made over the last 9 months, yes. It takes a lot of doing. Maybe the first question we have is maybe just help us understand a little bit about the different potential market opportunity for the 2, I guess, indications that you are kind of going after?

And maybe also help us understand the sequence of it. Will you start the study at the same time? And when you think that one study will finish before the other? And if you can maybe provide some guidance on when each of the study could complete.

So maybe talk about the potential number of patients in the refractory second-line setting versus the potential number of patients in low-grade intermediate risk who would -- who could benefit from the adjuvant combination of NDV-01? First question.

Thank you, Uy, for the question. I believe Raj that runs the clinical program can answer your question appropriately. Raj, do you want to try?

Yes, of course. So as I mentioned, there's 2 proposed indications. One is in BCG unresponsive refractory to first-line therapy. And I'll talk -- let me talk a little bit about this population, then the intermediate risk, and then we'll talk about time lines.

So this is a relatively smaller population. There are about 8,000 patients per year. Now with current therapies, 55% to 80% of those patients will recur after first-line therapy. So there's a growing number of patients that are needed in the second-line indication. So from 8,000, you can take that down to 55% to 80% each year that will be BCG unresponsive that fail a primary therapy.

Now the intermediate risk population, and this is high-grade and low-grade intermediate risk is a much larger patient population, estimated about 80,000 incident and prevalent patients each year in the United States with intermediate-risk NMIBC. A significant number of them, probably over half will receive an adjuvant therapy. And so that's about 40,000. So that represents a significant market for us to address.

And I think if you look at surveys of urologists, chemotherapy and Gemdoce chemotherapy is the preferred choice. Now regarding your question on timing, our plan is to initiate both of these trials, although they are separate indications, both trials at about the same time in the second quarter of 2026. I think this will provide for operational efficiencies and contracting and addressing sites. And I think for the sites will be easier as they kind of know how to do a clinical trial one side or the other.

In the unresponsive patient population, the first patient in being Q2 '26, will likely have clinical data, 3-month data by Q4 '26 to provide internally and externally. And then the endpoint is going to be a 12-month CR. So that will be Q2 '27 with top line data in Q2 '28.

In the intermediate risk study also initiating in Q2 '26, that's an open-label but randomized study that will take probably about 15 months to complete enrollment. With that completed enrollment, we'll need probably about 18 to 24 months of follow-up. It's -- I think it's a little bit trickier. We plan to do an interim analysis at 70% events.

Regarding the ability to provide data before then, I think that's a conversation we'll have to have with the FDA, although it's an open-label study, we certainly wouldn't want to expand alpha along the way. So I hope that gives you an idea of the size of the populations and the time lines.

Yes, that was super helpful. So maybe just help us with the other element. So with J&J and Lexo, I think the price is $69,000 per dose or per one of those [ pretzel tubes ] and the induction phase is, I think it's you need 8 of those. So that sort of rounds up to about $550,000 a year. Does that sort of make sense in terms of -- I know it's probably too early to sort of speak about pricing. Just wanted to maybe get your view on what potential pricing could look like?

Yes. Let me actually take a quick answer to that, and then I'd like to ask our CEO, Sergio, to comment. So yes, I think you're right, if you actually add up the induction phase and maintenance phase in the first year for -- in Lexo, it approaches $700,000. So that certainly has now set the new benchmark above Antiva if you look at 1 year of therapy. The other end of the spectrum to me is Zosduri, which is in low-grade intermediate chemoablation, which the yearly cost there is about $120,000. So I think the numbers will fall somewhere between. But Sergio, do you mind if I ask you to comment on that?

Yes. No, sure. Thanks, Raj. And look, it's a bit early to talk about pricing because we have to -- will be data-driven. Depending on what the data will look like, we will price accordingly to the value added for patients. And -- but we do have a luxury to watch what the uptake and the penetration of J&J and the other chemotherapy UroGen with their pricing, and we'll base our decision based on also how their pricing is -- will be received by the urology community.

So I hope I answered your question the best way I can, but we don't really have any like a specific pricing orientation for now.

Yes. I know it's probably -- it's way too early. And you're right, you need to look at the data, but it's -- I guess it's kind of encouraging that the pricing is kind of interesting. So maybe our last question. Maybe just help us to kind of understand a little better with respect to the differentiation and from the conventional Gemdoce.

I think on the call, you mentioned that you need a special biochemical hood and you need a special pharmacists, I guess someone who maybe even licensed who needs to put the product into syringes to be used. Yes, just help us understand like because of this hurdle, where the product is currently used? Is it mostly in academic center? And if all of this goes away, like what -- how does it open up the market for you if it does?

Yes, that's a wonderful question. Yes, and I think has been the hurdle of Gemdoce, right? It's -- we know it works as urologists. We know it works well, like I mentioned for a decade. The obstacles for the community urologists where 70% to 80% of these patients are taken care of in the community is you need a specialized pharmacy. And if you look at the overall procedural time of sequential gemcitabine followed by docetaxel, it's upwards of 4 hours. So that's a very -- that's easy to do in an academic center, and I think that's where most of the uptake has, been very difficult in the community, lack of specialized pharmacy and room or chair time and the staff for that for 4 hours.

So I think by having prefilled syringes avoiding the specialized pharmacy and having a 5-minute or so instillation to a catheter, removing the catheter, watching the patient, allowing them to go home, I think opens the door. This is an opportunity for academic centers as well, but I think also to meet the patients where they're at and to meet the urologists where they're at as well. So I think this -- it opens up the market significantly.

Okay. Sorry, maybe just one additional question. So I know you're going after just the 2 indications, which is actually quite broad, particularly in the intermediate risk section. But there is an ongoing study in BCG-naive patients called, I guess, the BRIDGE study. If this study succeeds, like what does that do to the potential opportunity for this product to be used off label, even though you won't be promoting it because every doc will probably know about your product.

Yes, Raj, do you want to give your view?

Yes. Thank you, Sergio. So that's a very insightful question, you. And actually, Max Kates is head of the BRIDGE trial. So the BRIDGE trial is a randomized study of BCG versus Gemdoce in high-risk disease. And it's an 800-patient trial, cooperative group trial that is near end of enrollment and will read out in 2 years. So the timing is nice for us. It's meant to look if Gemdoce is noninferior to BCG. So we know that the obstacles with BCG now are supply issues, and that's been ongoing for 15 years in the U.S. globally.

And also, it does have toxicity to it. It's effective, but it does have toxicity. So if now you introduce the ability of Gemdoce to substitute in for BCG, I think that especially as you said, in an off-label use, an easier way to give it, I think that opens the market significantly. That's a tremendous opportunity for Relmada. Great question. Thank you.

Ladies and gentlemen, this concludes our question-and-answer session. I will now hand over to Sergio Traversa for closing remarks.

Thank you very much, and thank you, everyone. And just an extended thank you to investors, patients and employees, collaborators, consultants that has helped us to get where we are now, and they will continue to help us to get where we want to be, that is to bring NDV-01 and sepranolone available for doctors and patients.

Thank you very much, and I wish everyone a great evening for the rest of the day. Thank you.

Thank you, sir. Ladies and gentlemen, that concludes today's call. Thank you for joining us, and you may now disconnect.