RELMADA THERAPEUTICS, INC.(RLMD)Q2 2026 法說會逐字稿

Good afternoon, and welcome to Relmada Therapeutics Second Quarter Earnings Conference Call. 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 Joyce Lonergan. Please go ahead.

Thank you, operator. 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 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. Relmada'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 Relmada'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. 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 Chief Executive Officer, Sergio Traversa, who will provide a business update; Bipin Dalmia, Relmada's Chief Business Officer, will offer his perspective on NDV-01 and the non-muscle-invasive bladder cancer landscape; and Relmada's Chief Financial Officer, Maged Shenouda, who 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. Sergio?

Thank you, Joyce. Good afternoon, everyone, and welcome to the Relmada Second Quarter 2026 Conference Call. Relmada has entered a critical execution phase. We have a strong balance sheet, an experienced and strengthened leadership team, and a clear plan to move NDV-01 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. NDV-01 is a novel, sustained-release intravesical formulation of gemcitabine and docetaxel, or Gem/Doce, that builds on the well-established safety and efficacy profile of conventional Gem/Doce. We believe NDV-01 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-month Phase II data are compelling.

Ninety-five percent of patients achieved a complete response at any time. Seventy-six percent 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. NDV-01 is a novel, sustained-release therapy that combines two chemotherapies in a single delivery system. Manufacturing a product like this to a scalable and registrational standard 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 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 for NDV-01 by the end of 2026 and to initiate the Phase III RESCUE registrational program upon IND clearance. The same discipline applies to sepranolone. Our program in Prader-Willi Syndrome, or PWS, a rare and underserved condition, is 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 sepranolone IND by year-end 2026 as well, and to initiate a Phase II proof-of-concept study upon 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 Dalmia, our new Chief Business Officer. Bipin joined us this quarter and brings nearly three decades of experience in uro-oncology, business development, and manufacturing of plasmids, including leading the U.S. launch of the first FDA-approved intravesical gene therapy for NMIBC. Bipin also brings strong industry relationships and an outstanding track record of value creation. Bipin, 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 NMIBC. During my first two weeks with the company, I've spent considerable time reviewing NDV-01's clinical, regulatory, and manufacturing plans, as well as our patent strategy. That work has only strengthened my belief that NDV-01 represents one of the most compelling opportunities in NMIBC. Let me explain why. The NMIBC treatment landscape is evolving rapidly, particularly in BCG-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 intravesical therapy that delivers meaningful efficacy and durable responses without 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 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 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 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 Relmada 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 Relmada 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, Bipin, and good afternoon, everyone. I'll walk you through our second quarter 2026 financial results. Our press release and 10-Q filings provide the full details. Relmada 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. Current cash resources are expected to fund company operations through 2029, including completion of the Phase III RESCUE program for NDV-01. 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 NDV-01 and sepranolone 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 $0.11 per basic and diluted share, compared with a net loss of $9.9 million, or $0.30 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, Maged. I believe we can open the call for questions, but before we do that, let me close on this. Relmada is in a position of strength. We have a differentiated, clinically validated asset in NDV-01 with FDA alignment on our path to registration, a Phase III 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 filing both the NDV-01 and sepranolone INDs by year-end. 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 Relmada'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.

Our first question comes from the line of Uy Ear of Mizuho. Please go ahead.

I guess we have a couple of questions from reading your press release. Before I ask the questions, I also want to welcome Bipin to Relmada. I hope to work with you in the future. So maybe a general question for Bipin first. Maybe just help us understand what your role at Relmada is 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 gating factors for both of these items? Is it an issue with the release of the chemotherapy from the gel? Is it scaling? Is it just consistency, stability, maybe just help us get a flavor?

Sure, thank you. Bipin, you want to take the first one, then all of us can take the second one.

Yes, Sergio. So thank you, Uy. I also look forward to working with you. So my role as Chief Business Officer and being primarily responsible for the NDV-01 program will include corporate strategy, commercial planning, which includes new product planning, making sure our program maximizes the potential of NDV-01, and business development if and when that becomes relevant. But I also bring a lot of development and manufacturing experience in addition to commercial. So I will be very closely involved in all aspects of NDV-01.

Thanks, Bipin. Yes, I hope this answers your first question. The second we can take. I can start. Look, manufacturing is always detailed, but the top-down is that the formulation has been locked, the process has been locked, so now it is a question of getting into the manufacturer's schedule. Our manufacturer is Piramal, which is a sizable company. To get on their schedule and make the product at scalable quantity is where we are. That's our current status in manufacturing. Bipin, do you want to add something?

Yes, no, absolutely. I think Sergio summarized it well. We have the formulation, which is the same as used in Phase II. We, of course, have a new scalable process and that is locked now. The remaining activities include analytics; the analytical program is complete. So now it's just a matter of blocking and tackling: producing the GMP batches and putting them on stability, which are needed for IND filing. That's where we are. It's a matter of execution in the coming months.

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. Bipin, go ahead.

So in manufacturing, you have development and manufacturing activities. Development—formulation and process—are complete. Manufacturing activities are our next focus. That takes some time because you have to get on the schedule of the GMP clean room and work with an external partner. 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 purely an engineering or non-engineering problem. The correct way to think about it is development is complete, and now manufacturing is what we will do in the next months.

Thank you, Bipin.

Super helpful, thanks.

Our next question comes from Farzin Haque of Jefferies. Please go ahead.

Just to follow up on the last one, do you need FDA input on the GMP once you have the manufacturing batch GMP ready prior to filing?

Thank you, Farzin. Bipin, do you want to take this? I don't believe so. We already had minutes from the meetings we had with the FDA on the development. We'll just file the IND.

No, I don't believe we need any FDA input before filing the IND.

Got it. And then a quick follow-up. How many sites are being planned? And how quickly can you go from IND clearance to the first patient dosed?

Thank you, Farzin. That's a great question. We have around 80 sites engaged, of which approximately 60 are primary and 20 are backup sites to help speed enrollment. As soon as the IND is cleared, there is a 30-day period after we file it, and technically sites can start enrolling patients. Everything else is prepared. We are waiting for the product to be delivered and the associated data to be available to file the IND. Thirty days after filing, assuming the IND is not placed on hold, we expect to be able to start enrolling almost immediately once clinical material is available.

Got it. And then a quick follow-up: do you have any plans to disclose the 18-month cut from the Phase II data later this year?

We haven't focused on the Phase II dataset recently because the site in Israel is continuing to enroll patients and our core focus has been Phase III preparation. We'll probably publish the 18-month data at some point, but we don't have plans to do it immediately. We have not yet reviewed the data beyond 12 months. At some point we'll publish it, but our current priority is the registration path.

Thank you so much.

Thank you, Farzin.

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

First, just to circle back on the NDV-01 IND, what steps or tasks required took longer than you were expecting when you had initially guided to mid-2026? And then secondly, you had initially guided to some clinical data later this year, that three-month complete response look. Should we expect that in the first half now, or are you reevaluating what the initial disclosure is going to look like?

Hey Kelsey, good afternoon. These are two separate questions. Regarding what was unexpected: when we made the initial projection we relied on the manufacturer's best educated estimate for scheduling. There was nothing unexpected in terms of development; the biggest hurdle has been getting on the manufacturer's schedule. Manufacturing itself—making the product—takes only a short time, but scheduling with a large CDMO can add a month or two. That is essentially what delayed the timeline relative to our prior guidance. On the clinical data question: we haven't decided yet. We have heard different opinions from advisors. Our current thinking is that any meaningful disclosure would likely be in the first half of next year, but we want a reasonable number of patients—probably in the range of 15 to 20—to make the data meaningful. A three-month read can be informative, but six months is more meaningful given that reinduction is allowed after three months. For now our focus is filing the IND and getting the Phase III underway; data disclosure decisions will follow.

Yes, that's perfect. Thank you so much.

Thank you, Kelsey.

All right. We have another question from Farzin Haque of Jefferies. Please go ahead.

Just to clarify in your last comment, ClinicalTrials.gov allows one reinduction after disease recurrence?

Right.

So does the reinduction count towards the primary complete response endpoint, or is it captured as a secondary?

Thanks for the question. To clarify: the primary endpoint is response at any time. So the endpoint considers the highest response observed during the trial. Patients can have one reinduction if needed, and if a patient does not respond at three months they can be reinduced and could respond at six months. For the primary endpoint, the highest response rate is what matters.

Okay, got it. Thank you.

All right. Looks like we have another question from Uy Ear of Mizuho. Please go ahead.

I just wanted to ask, I don't know if you guys or Rodge has watched the FDA advisory committee on the referenced product, and I just wanted to see if you think there's any read-through to your second-line development for NDV-01 as well. I wanted to see if you think there's any read-through considering that the FDA was looking for a large response rate and in their opinion it wasn't really the case, but the advisory committee saw a signal and seemed to take that into consideration.

Maybe I can step in here. I think it's important for us to be cautious about commenting on other companies' advisory committee meetings or products in different disease areas. It would not be prudent for us to draw direct read-through conclusions here, but thank you for the question.

There are different indications and regulatory contexts. What we can share is that in our meetings with the FDA, there is no fixed numeric threshold for what response rate would support approval of NDV-01. The FDA has emphasized looking at overall data in terms of both response rate and durability. So any read-through from other products would not be straightforward.

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