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 3 and 6 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, who 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 and regulatory foundation is strong. The 12-month Phase 2 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-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 scalable and registrational standards is demanding work.

It requires specialized capability, coordination across several supply chain partners, and 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 NDV-01 by year-end 2026 and to initiate the Phase 3 Rescue registrational program upon IND clearance.

The same discipline applies to seprenolone, 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 prefilled syringe delivery system.

We expect to file the seprenolone IND by year-end 2026 as well, and to initiate Phase 2 proof-of-concept study upon an IND clearance. 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 oversight, including leading the US 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. Bipin, it's all 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, and specially non-muscle-invasive bladder cancer, or NMIBC.

During my first 2 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.

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 intravesical therapy that delivers meaningful efficacy and durable responses without compromising safety, tolerability, convenience, or ease of use. 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.

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 prolonged bladder exposure without the use of a physical device, with a simple office-based procedure that can be completed in approximately 5 minutes.

In summary, the combination of a well-established therapeutic foundation, encouraging efficacy and durability results from our Phase 2 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.

Our current cash resources are expected to fund company operations through 2029, including completion of the Phase 3 Rescue program for NDV-01. Moving briefly through our second quarter financial results.

Research and development expense for the 3 months ended June 30, 2026, totaled $8.4 million, compared to $2.8 million for the 3 months ended June 30, 2025. The increase was primarily attributable to higher NDV-01 and seprenolone 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 3 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, Maged. I believe we can open the call for questions.

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 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 filing both the NDV-01 and seprenolone 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'm very confident in this program and optimistic about Relmada's future. I look forward to keeping you close to our progress along the way.

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

Hi, guys. Thanks for holding this call.

I guess we just 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. Maybe a general question for Bipin first.

Maybe just help us understand what's your role at Relmada and how do you envision bringing NDV-01 essentially from this stage up to commercialization? 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, Uy.

Bipin, you want to take the first one? Then all of us can take the second one.

Sergio. Thank you, Uy.

I also look forward to working with you. My role as Chief Business Officer and primarily responsible for the NDV-01 program will be corporate strategy, commercial planning, which includes new product planning, making sure our program maximize the potential of NDV-01, business development if and when that becomes relevant, but I also bring a lot of development in manufacturing experience in addition to commercial.

I will be very closely involved in all aspects of NDV-01.

Thanks, Bipin. I hope, Uy, this answer your first question.

The second, I can start, right? Look, manufacturing is always you can go as much as in detail as if we want to.

The top-down is that the formulation has been locked, the process has been locked, now is a question of getting into the schedule of the manufacturer. Our manufacturer is Piramal, that is pretty large company, and so to get on their schedule and make the product and then that would be make at the scalable quantity.

That's where we are with manufacturing. That's where we are.

Bipin, you want to add something to the subject?

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. We have analytics in place, the analytical program is complete.

Now it's just a matter of blocking and tackling and producing the GMP batches and putting them on stability needed for IND filing. That's where we are.

It's just a matter of execution now.

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?

I wouldn't even call it—yeah, take it. Go ahead, Bipin.

Yeah. In manufacturing, you have to develop a formulation, you have to develop a process, so that's the development activities.

Then you have the manufacturing activities. 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. Then once you manufacture the GMP batch, you need some degree of stability data needed to file in the IND.

I wouldn't call it an engineering or a non-engineering problem. The way to think about it is development is complete, and now manufacturing is what we will do in the coming months.

Great.

Super helpful. Thanks.

Hi. Thank you for taking my question.

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

Thank you, Farzin. Bipin, you want to take this?

I don't believe so. We already had the minutes from the meetings we had with the FDA on the development, we'll just file the IND, but, Bipin, you are more expert.

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

Got it. Then how many sites are being planned, and basically how quickly can you go from the IND clearance to the first patient dosed?

Oh,

thank you, Farzin. 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 more backup and to speed up the enrollment. I believe as soon as the IND is cleared, it would be 30 days after we file it, technically we can start to enroll patient at any time.

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. 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 good question. Yes.

To be honest, we haven't focused on the Phase 2. The site in Israel has continued to enroll patients, but we have been totally focused on the Phase 3 preparation.

Yes, we'll publish the 18 data at some point, but we don't have specific plan to do it. We have not seen the data after the 12 months, at some point, we'll probably publish them.

The focus has been the registration more than anything else.

Thank you so much.

Thank you, Farzin.

All right. Hey, thanks for taking our questions.

First, just to circle back on the NDV-01 IND, I guess what steps or tasks required took longer than you were expecting when you had initially guided to mid-'26? Then secondly, I know you had initially guided to some clinical data later this year, that 3-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 from you. These are actually two different questions, right, and require two different answers.

One, what was unexpected? When we made the initial projection, we kind of listen to the manufacturer, and was the best educated guess to give a timeline.

Bipin and Maged, 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.

It's a trial and error. I would say probably the biggest hurdle is always to get into the manufacturing schedule, cuz not that you call and they put the product in manufacturing right away.

Usually there is at least 1 or 2 or 3 months where they give you a slot to make the product. It takes technically 2 days.

It's not a lot of time. 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.

That's where we are. The second question—remind me.

The initial clinical data that was guided for the end of the year, the 3-month CR data, just will that be pushed into the first half of '27, or are you thinking about maybe just doing a different disclosure altogether?

Look, we haven't decided yet. We have been hearing 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. 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 patient and make it relevant.

I don't know what the number is, but it's probably 15, 20 patients so that it's significant. 4, 5 patient no really mean anything or not much.

The second one, the 3 months, they may not be that representative for the retreatment is allowed after 3 months. If a patient doesn't respond after 3 months, can be retreated.

Probably the 6 months is a lot more meaningful in term of showing what the real results are. We haven't decided yet, the focus really to file the IND and to get the trial started, then we can think about the data.

It's an open label, one arm, we can see the data. Hope I answer your question.

That's perfect. Thank you so much.

Thank you, Kelsey.

Thank you for taking the follow-up. Just to clarify on your last comment, the ClinicalTrials.gov allows one reinduction after disease recurrence.

Does 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 endpoint is response at any time. The 6 months is anytime by this higher response during the trial.

The patients can have one reinduction if needed.

Correct.

Okay. Got it.

Thank you.

If they don't respond at 3 months, they can be re-induced, and they may respond at 6 months. For the primary endpoints, the highest response rate is the one that matters.

That question was important.

Hey, guys. Thanks for taking the follow-up.

I just wanted to ask, I don't know if you guys or Rajesh has watched the FDA AdCom on the Recorlev product, and I just wanted to see if you think that there's any read-through to your second-line development for NDV-01 plus and yeah, just wanted to see if you think there's any read-through considering that, I guess the FDA was looking for a large response rate, and in their opinion, it wasn't really the case, but the AdCom looked at it sort of differently and saw a signal, and I think took into consideration—

Maybe I can step in here. I think it's imprudent for us to comment on other company's AdComs and different disease areas as well.

I don't know that it would be, again, prudent for us to comment here. Thank you for the question, Uy.

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 NDV-01, and I believe they stated that they want to see the overall data in term of response rate and durability. It's really different from any other comparison.

Okay. Thanks.

Thank you.

Thank you. Thank you all.

Thanks.