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

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.