Relmada Therapeutics, Inc.

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 Longergan. Please go ahead.

Thanks a lot, Krater. Good day everyone and thank you for joining us today. This 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 Reform 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 Mada'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 at 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 date of this conference call. With me on today's call are Ramada's Chief Executive Officer, Sergio Traversa, will provide a business update. Vipin Dalmia, Valmada's Chief Business Officer, will offer his perspective on NDV-01 and the non-muscle invasive bladder cancer landscape. And Valmada's Chief Financial Officer, Maged Shenouda, 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 RealMada Second Quarter 2026 Conference Call. RealMada has entered a critical execution phase. We have a strong balance sheet, an experienced and strengthened leadership team, and a clear plan to move any of your want 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. NDVO-1 is a novel, sustained-release, intravesical formulation of gencytabine-endocetaxel, or GENDOSY, that builds on the well-established safety and efficacy profile of conventional GENDOSY. 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 and regulatory foundation is strong. The 12-month Phase II data are compelling. 95% of patients achieved a 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 registrational pathways, and we continue to see strong interest from the uro-ontology community. Let me go directly to manufacturing because it is our immediate priority. Any of your one 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 IND, and we are executing against a clear plan to complete them. This is work driven to quality, and we are dedicated to getting it done right. Importantly, all the components around manufacturing are ready. We 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, NDDO1, by year end of 2026, and to initiate the Phase III Rescue Registration Program upon IND clearance. The same discipline applies to Sopranolone. Our program in Prader-Willi Syndrome, or PWS, a rare and underserved condition, estimated to affect 350,000 to 400,000 people worldwide. Here, the formulation development is complete, and the one remaining step is finalizing the Preference Service Delivery System. We expect to file the Sopranol on IMD by year end 2026 as well, and to initiate phase two proof of concept study upon an IMD 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 Daunia, our new Chief Business Officer. Bipin joined us this quarter and brings nearly three decades of experience in uro-oncology, business development, and manufacturing oversight, including leading the U.S. launch of the first FDA-approved intravesical gene therapy for NMIVC. Leaping also brings strong industry relationship and an outstanding track record of value creation. Leaping, call on you.

Thank you, Sergio, and good afternoon, everyone. As Sergio mentioned, I've spent nearly three decades in biopharmaceuticals, including many years focused on uro-oncology, especially non-muscle invasive liver cancer, During my first two weeks with the company, I've spent considerable time reviewing NDVO-1'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 BCG and responsive disease, where bladder preservation is increasingly the primary goal of treatment. And yet patients and physicians are still forced to make important trade-offs. 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 compromising safety, tolerability, convenience, or ease of use. and these trade-offs will become even more important as the market moves into the community setting where majority of the patients are and into earlier stages of NMIBC such as intermediate risk and BCG naive settings. And that is where we believe NDV-01 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, a 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 for long bladder exposure without the use of a physical device with a simple process-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 II study, favorable safety and tolerability, practical ease of use, and applicability across most NMIBC patient populations differentiates NDV-01 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 NDV-01, 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 Almada 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 Maged. Maged?

Thank you, Vipin, and good afternoon, everyone. I'll walk you through our second quarter 2026 financial results. Our press release and 10Q filings provide the full details. RealModa closed the second quarter of 2026 with cash, cash equivalents, and short-term investments of $217.7 million, compared to $93 million on December 31, 2025. Our current cash resources are expected to fund company operations through 2029, including completion of the Phase III Rescue Program for NDVO-1. Moving briefly through our second quarter financial results. Research and Development Expense for the three months into June 30, 2026 totaled $8.4 million compared to $2.8 million for the three months into June 30, 2025. The increase was primarily attributable to higher NDVO-1 and sucranolone 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 share compared with a net loss of $9.9 million or 30 cents per basic and diluted share for the second quarter of 2025. Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?

Thank you, Magid. 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 NDVO1 with FDA alignment on our path to registration, a phase 3 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 CEPRAN-1 INDs by event. We know what is in 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 Remada'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 Uyir of Mizuho. Please, go ahead.

Hi, guys. Yeah, 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 Bermalda. I hope to work with you in the future. So maybe a general question for Biven first. Maybe just help us understand what your role at Bermalda and How do you envision bringing NVV-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 gating factors for both of these items. 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, Oye. Maybe, Bipin, you want to take the first one? Then we can, all of us can take the second one.

Yeah, 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 MDVO1 program will be Corporate Strategy, Commercial Planning, which includes new product planning, making sure our program maximizes the potential of MDBO1. 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 all aspects of MDBO1.

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

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 – we have analytics in place, so the analytical program is complete. So now it's just a matter of locking and tackling. and producing the GMP batches and putting them on stability 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?

Yeah, take it. Go ahead.

Yeah, so in manufacturing, you have to develop a formulation, you have to develop a process, that's the development activities, and then you have the manufacturing activities. So there is, the development activities are complete. The manufacturing activities are our next focus, and that takes some time because You have to get on the schedule of the GMP, kind of clean room, and we're 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 IMD. 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 will do in the next, in the coming months. Thank you, Vipul.

Super helpful.

Thanks. Our next question comes from Farvan Haque 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 GNP once you have the manufacturing batch GNP ready prior to filing?

Thank you, Farzeem. Deepin, 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 Deepin, 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 INV is clear, that would be 30 days after we file it, technically we can start to enroll patients 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 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 2 data later this year? That's a great question.

Well, yes. To be honest, we haven't focused on The Phase 2, the site in Israel is continuing to involve patients, but we have been totally focused on the Phase 3 preparation. We'll probably, yes, we'll publish the 18 data at some point, but we don't have a specific plan to do it. We have not seen the data after the 12 months, so at some point we'll probably publish it, but the focus has been on the registration more than anything else.

Thank you so much.

Thank you, Francine.

Our next question comes from Kelsey Goodwin of Piper Sandler. Please go ahead.

Oh, great. Hey, thanks for taking our questions. First, just to circle back on the NDD-01-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.

AKLC, good afternoon. Great to hear from you. There 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, you know, what's the best educated guess to give a timeline. But I don't think, and DT and Magda, you have been equal too in the manufacturer. There was really nothing unexpected. It's just, you know, 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 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. And the second question was... Remind me what it is.

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

Yeah, look, we haven't decided yet. We've been hearing a different opinion 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 probably stay 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 or that it's significant. You know, four or five patients don't really mean anything or not much. And the second one, you know, the three months they may not be that representative for, like the re-treatment is allowed after three months, so the patient does the response after three months can be re-treated. 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. The focus really is to find the AMD 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. I hope I answered your question.

Yeah, 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 Farvin Hawk of Jefferies. Please go ahead.

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

Well, thanks for the question. So give me a chance to clarify. The primary endpoint is a response of HIV.

Thank you.

So if they don't respond in three months, they can be re-induced, and they may respond in 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 Wee Ear of Mizuho. Please go ahead.

Hey, guys. Yeah, 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 Repromune 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 NDVO1. And, yeah, 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, and in their opinion it wasn't really the case but the ATCOM looked at it sort of differently and saw a signal and I think took into taking us into consideration.

Maybe I can step in here. You know, I think it's imprudent for us to comment on, you know, other companies' outcomes and different disease areas as well. So I don't, you know, I don't know that it would be, again, prudent for us to comment here. But thank you for the question, Roy.

Yeah, there are different indications and what we can share is that With a meeting with the FDA, there is no fixed number about what kind of response rate the FDA expects to approve NDVO-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.