RLMD

Good afternoon, and welcome to Relmada Therapeutics first quarter earnings conference call. 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 three months ended 31st March 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 31st March 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 12th May 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. 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-month 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 strengths of our progress. Importantly, we remain on track to initiation the phase III 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 four milestones that speak to the momentum we have built this year. Number one, we have continued to de-risk the development of NDV-01 with the report of solid and durable 12-month efficacy data from the ongoing phase II study of NDV-01. We will be presenting this data and an overview of the phase III 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 one, we achieved FDA alignment for our planned registration of phase III 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 III 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 method 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 coverage, covered claims of NDV-01 into 2047, providing a nine 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 registration of phase III RESCUE program for NDV-01 in mid-2026. We are also preparing to initiate approval concept study for sepranolone in Prader-Willi syndrome, targeted for mid-2026. Maged will speak about it in more detail shortly. Next, I'll turn the call over to Dr. Raj Pruthi, who will provide a review of the NDV 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. 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 III 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-seventies. 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 three topics during today's call. First, a recap of the NDV-01 12-month data. Second, a summary of our planned phase III program.

Third, a discussion of how NDV-01 might fit in the real-world practice of a urologist. As Sergio Traversa 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 II 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 II study is an open-label single-arm trial in patients with high-risk NMIBC. Patients receive six biweekly doses, that is every other week, followed by monthly maintenance for up to one 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 and 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 III 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-month 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 three 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 one. Now turning to the phase III RESCUE program. We designed the program with two 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 17th, providing an important opportunity to engage the urology community. Let me now walk you through each of the two studies that form the RESCUE program. Registrational Pathway one focuses on patients in the 2nd-line setting, patients who are BCG unresponsive with carcinoma in situ, or CIS, and refractory to 1st-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 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 three month response data around year-end. This pathway could offer a rapid route to approval. Registrational Pathway number 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 a 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 II data gives us high confidence in the RESCUE. 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 neurosteroid that modulates GABA, one of the most important neurotransmitters. Sepranolone is intended to act on the GABA neurotransmitter pathway to normalize the activity of the GABA A 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 1st quarter ended 31st March 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 1st quarter of 2026 with a cash balance of $234 million compared to $94 million at 31st December 2025. Our 1st quarter cash balance includes net proceeds of approximately $150 million from a private financing announced March 9, 2026. We expect our current cash resources to provide sufficient runway to fund company operations through 2029, including completion of the phase III RESCUE program for NDV-01.

Moving briefly through our first quarter financial results. Research and development expense for the three months ended 31st March 2026 totaled $8.1 million, compared to $12 million for the three months ended 31st March 2025, a decrease of $3.9 million. The decrease was primarily attributable to non-recurrent costs associated 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 startup of the phase III NDV-01 trials and phase II-B sepranolone study and additional R&D personnel.

General and administrative expense for the three months ended 31st March 2026, was $11.4 million compared to $6.3 million for the three months ended 31st March 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 three months ended 31st March 2026, totaled $15.1 million compared to $18.1 million for the same period in 2025.

The net loss for the three months ended 31st March 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 three months ended 31st March 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.

Yes, sir. Thank you. As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Please stand by while we compile the Q&A roster. Thank you for waiting. We now have our first question, and this comes from Kelsey Gold from Piper Sandler. Your line is now open. Please go ahead.

Hey. Thanks for taking my questions. Looking forward to seeing the data this weekend at AUA. I guess a couple from me, if you don't mind. First, for AUA this weekend, it seems like there's some gemcitabine presentations. I guess how should we think about the growing literature on gemcitabine and the degree of read-through to NDV-01? 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. I'll leave it at that. Thank you so much.

Thank you, Kelsey. Sergio here, good afternoon. Well, maybe I can take, like, a little point on the first question. I see the, you know, gemcitabine, conventional gemcitabine data always as a positive because it just consolidate how urology, the urology community, believes that this is a very effective and way to treat bladder cancer. With that said, I let Raj to expand and answer you the second question. Raj.

Yeah. Thanks for the question, Kelsey. You know, 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. You're right, there's a significant number of gemcitabine papers being presented more and more on the efficacy of gemcitabine, especially in the high-risk patient population. The other that I think is notable is that of time toxicity with gemcitabine. There's two papers being presented on the burden of conventional sequential gemcitabine time toxicity, the burden to the patient and to the provider. 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 two way for the second-line BCG unresponsive.

You know, my hope in that is that by, you know, as we get this study going, that we'll have a handful of patients maybe by the end of this calendar year that will be able to share three month data. You know, this is an open label study, so a three month response and safety rate data by the end of this year or early next year. We anticipate at a cadence of every three months sharing that data into 2027. I think I got both of your questions.

Perfect. Thank you so much.

Thank you, Kelsey.

Thank you. The next question comes from Christopher Lui from Lucid Capital Markets. Your line is now open. Please go ahead.

Thank you. Congrats on the progress you guys have been making so far. 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 AUA expert, to answer this one. Raj.

Yeah. I think, you know, I really kind of hone in on the BCG unresponsive population. I think that's the most difficult to treat at failing BCG. I think for 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%. I think others have seen numbers up towards 70%. 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 kinda look at is that 80% number.

Got it. I appreciate the color. Thank you.

You bet.

Thank you. The next question comes from Uy Ear from Mizuho. Your line is now open. Please go ahead.

Hey, guys. Yeah, thanks for taking our questions, and congrats on all the progress you've made. Maybe just help us to understand a little bit more about your patent estate. You filed the provisional patent, and 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? Also, with the extended patent term, you know, which is quite extensive, how are you perhaps thinking about doing additional clinical trials? Like, does it give you greater chance of, you know, or are you thinking about, you know, perhaps doing combination studies in addition after the RESCUE programs are done? Thanks.

Good afternoon, Uy Ear. Sergio here. I'll take the first one on the IP and then let Raj to handle the one on the development. Look, the we just filed a patent a few weeks ago, so allow me to be not too specific on what the claims are. In general, these are new patents and reflect the work that has been done in the U.S. in the formulation and manufacturing. These are new patent we filed in the U.S., and then we'll have the opportunity, we have some time, I believe it's one year, to file outside of the U.S. These are new patents, so they will provide coverage, if granted, of course, until sometime in 2047. I hope I kind of answer your question.

When do you expect the prosecution to end, or when do you expect the patent to be issued?

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

Okay.

Uy Ear, 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 track disease. I think there are a lot of opportunities, we can just follow the path of where has gemcitabine 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. It's an event-driven study, will take a couple years to read out.

I think that's also another place where we, you know, if BRIDGE does read out as gemcitabine is non-inferior to BCG and becomes an alternative, I think NDV-01 can nicely step in there as a, as an, yeah, easier-to-use, less burdensome approach for gemcitabine in the BCG naive high-risk population. Great question. Thank you.

Thanks.

Thank you, Uy Ear.

Thank you. Once again, for those who want to ask a question, please press star and one on your telephone keypad and wait for your name to be announced. Star and one if you wish to ask a question. The next question comes from Farzin Haque from Jefferies. Your line is now open. Please go ahead.

Good afternoon. Thank you for taking my question. Following up on an earlier question, like you have a broad inclusion criteria for phase III, the BCG unresponsive setting, and you're allowing up to two prior lines, including a wide range, TAR-200, Anktiva, etc. How are you modeling the potential for variability or dilution of efficacy, and could you adjust to one prior line as the trial progresses?

Thank you, Farzin.

Yeah.

Raj, I think, would you mind to take this?

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 two prior first-line therapies, with the idea that, you know, beyond that there may be some resistance mechanisms. We'll evaluate, we'll break that down by one or two lines of prior therapy. We're looking at that. 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 Anktiva, we are excluding prior gemcitabine in those patients because we're giving a gemcitabine treatment.

We'll look at Anktiva and gemcitabine, and we have heard, and in my own practice, having gemcitabine as a rescue for gemcitabine is appropriate. I think we wanna see, you know, our efficacy is what is the our approach is what is the appropriate second-line therapy, right? These therapies are gonna be sequenced by urologists 2, 3, 4, 5x 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, that gives us an opportunity to provide the highest levels of evidence and a label for the second-line approach. From there, once urologists use it there, as we do, they could use it before or after.

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.

Then on your phase III primary endpoint, does FDA's acceptance of CR at any time imply any durable responses, for example, median duration response greater than six months?

Their phrase was, they want the primary endpoint to be CR, and they also want to see duration of response. The words that they use is they want to look at the, quote, "totality of the data," close quote. I think they're getting at what you are, is a strong CR, which could be at three 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. CR, together with durability in this, framed as duration of response is what they'll want to see. 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.

Really the other alternative for the patients at this point in their journey is radical cystectomy.

Right. Makes sense. 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?

Yeah, that's a great question, Farzeen. 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 one, 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 15-18 months, but with that enthusiasm and 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, Farzeen, another area where there's incredible enthusiasm because urologists have nothing else at this point in their armamentarium to treat these patients.

A lot of these urologists, even the best in case scenarios, are 45% 12-month CR. You see 19%-45%, meaning 55%-80% of patients are recurring within one year with the first-line therapy. 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-month enrollment.

Great. Super helpful. Thank you, Rich.

Thanks, Farzin.

Thank you. 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.

Good afternoon, and welcome to the Relmada Therapeutics, Inc. Fourth Quarter and Full Year 2025 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. As a reminder, this conference call is being recorded and will be available for replay on the Relmada Therapeutics, Inc. website. I would now like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.

Good day, everyone, and thank you for joining us today. This afternoon, Relmada Therapeutics, Inc. issued a press release providing a business update and outlining its financial results for the three months and year ended December 31, 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 Therapeutics, Inc.'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 Therapeutics, Inc.'s press release issued today and the company's SEC filings, including in the Annual Report on Form 10-K for the year ended December 31, 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 March 19, 2026. Relmada Therapeutics, Inc. 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 Therapeutics, Inc.'s CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights; Dr. Raj S. Pruthi, Relmada Therapeutics, Inc.'s CMO, Oncology, who will provide an NDV-01 program update; and Relmada Therapeutics, Inc.'s CFO, Maged S. Shenouda, who will provide an update on cipranolone 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 Relmada Therapeutics, Inc. Fourth Quarter and Year-End 2025 Conference Call. 2025 has been a transformational year for Relmada Therapeutics, Inc., marked by significant progress for our lead program NDV-01. As a reminder, NDV-01 is a sustained-release formulation of gemcitabine 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-month efficacy data for our ongoing Phase II study of NDV-01. We achieved FDA alignment for our planned registrational 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 four key areas. First, NDV-01. We believe that the strength of the recently reported 12-month follow-up data could position NDV-01 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 give us confidence that NDV-01 has the potential to provide what urologists and patients with NMIBC need: a simple, durable, effective treatment that readily fits into real-world practice settings. We plan to initiate the Phase III RESCUE program in the middle of this year. Our Phase III regulatory strategy, agreed upon with the FDA, includes two independent registrational pathways. Pathway one 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 two is focused on second-line treatment in BCG-unresponsive patients, which represents about 5,000 patients in the United States. Second, cipranolone. Cipranolone has previously demonstrated proof of concept in Tourette syndrome. It is a disorder characterized by compulsive behavior. We are getting ready to begin a proof-of-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 S. Pruthi, a highly regarded physician-scientist and urologic oncologist, as Chief Medical Officer, Oncology. In addition, we established a scientific advisory board comprised of similarly distinguished peers to further support the NDV-01 program, including Dr. Yair Lotan from the University of Texas Southwestern Medical Center and Dr. Kates from Johns Hopkins University School of Medicine. Fourth and last, financial strength. We just completed a successful $160 million private financing. Based on existing forecasts, these funds plus our existing cash balance provide Relmada Therapeutics, Inc. with capital through 2029 and, importantly, through the completion of the planned NDV-01 program. Looking ahead, 2026 is poised to be another important year of value creation for Relmada Therapeutics, Inc., with the initiation of our Phase III RESCUE program for NDV-01 in bladder cancer and the Phase II proof-of-concept trial for cipranolone 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 S. Pruthi, who will provide a review of the NDV-01 program, including 12-month 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 is a privilege to share an update on the clinical progress we have made this year, headlined by the truly compelling and best-in-class results for NDV-01 in NMIBC. Bladder cancer is a high-frequency cancer that has a major impact on the lives of patients, generally diagnosed in their early to mid-70s. High recurrence rates and burdensome treatments disrupt quality of life at a time when patients are eager to enjoy life. I want to touch on three 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 three, a discussion of how NDV-01 might fit into the practice of urologic oncology. As Sergio noted, NDV-01 is a novel, sustained-release intravesical formulation of two chemotherapy agents, gemcitabine and docetaxel, or GemDosi, as we say. Our program builds on physicians' established familiarity with the efficacy and safety profile of conventional GemDosi. More specifically, in patients who are unresponsive to BCG, this combination offers a salvage, bladder-sparing option that may help avoid a radical cystectomy. Moving on to the 12-month data, we are pleased to report that NDV-01 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 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 six biweekly doses, every other week times six, followed by monthly maintenance for up to one year. Patients undergo regular assessments with cystoscopy, pathology, and, if 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. Secondary endpoints are 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-unresponsive 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 NDV-01 in both second-line BCG-unresponsive disease and in intermediate-risk disease 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 anytime of 95% based on 38 patients. Among those with BCG-unresponsive disease, we see a CR rate at any time of 94%. Given the burdensome nature of recurrent bladder cancer treatment, safety 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 a grade 3 or higher treatment-related adverse event, no interruptions or discontinuations of treatment due to adverse events occurred, and most treatment-related adverse events were at the grade 1 level. Moving on to the planned Phase III RESCUE program. We believe our 12-month response and durability data compare quite favorably to the current commercial and development-stage trials. We have constructed our Phase III registrational pathways to maximize our probability of success and create the most efficient path to FDA approval. The entire RESCUE registrational program was designed in alignment with the FDA to provide two separate approval pathways. We expect to secure U.S. IND clearance and initiate the Phase III RESCUE program in the middle of this year. Let us review the two studies that form the RESCUE program. Registrational pathway one focuses on the evaluation of NDV-01 in patients with intermediate-risk bladder cancer as an adjuvant therapy following TURBT surgery. We estimate there are about 70,000 to 75,000 patients each year in the U.S. in this setting. This study is planned to be an open-label, randomized, controlled trial. Since 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 include 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-TURBT is very attractive, and it could pave the way for an important clinical indication and broader adoption. Registrational pathway number two is focused on the evaluation of NDV-01 in the second-line setting in patients who are BCG-unresponsive with carcinoma in situ, or CIS, or 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 setting. Since these patients have few, if any, effective treatment alternatives to radical cystectomy, the study is designed as a single-arm, open-label trial. The primary endpoint is CR anytime. Secondary endpoints will include the duration of response, or DOR, progression-free survival, and recurrence-free survival among responders. We expect to report the initial three-month response data from this study by the end of 2026. We are excited about this pathway because it could offer a rapid route to approval. Before I hand the call over to Maged, I would like to make a note about how we feel NDV-01 might fit into clinical practice. NDV-01 is formulated to create a soft matrix in the bladder to enhance local bladder urothelial exposure and minimize systemic toxicity. It is delivered in the office in less than five 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 out amongst the others. Our Phase II data give us high confidence in our registrational program. By addressing a clear unmet need with a unique sustained-delivery profile, we believe NDV-01 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, and we will work to bring NDV-01 to bladder cancer patients as soon as possible. Maged?

Thanks, Raj, and good afternoon, everyone. Today, I will spend a few minutes on 2025 financial results. Because cipranolone modulates GABA, one of the most important neurotransmitters, it is defined as a GABA or GABA-modulating steroid antagonist. Cipranolone's novel action on the GABA neurotransmitter pathway gives it the potential to normalize the activity of the GABAA 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 Prader-Willi syndrome. We are preparing to initiate a proof-of-concept study in Prader-Willi 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, Relmada Therapeutics, Inc. issued a press release announcing our business and financial results for the fourth quarter and twelve months ended December 31, 2025. During this call, I will review our fourth quarter 2025 financial results and refer you to our press release and Form 10-K filing issued this afternoon for financial information for the last twelve months. Starting with our cash balance, Relmada Therapeutics, Inc. 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, 2026, the company announced a $160 million 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 three months ended December 31, 2025, totaled $8.1 million compared to $11.0 million for the three 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 two Phase III trials for REL-1017, partially offset by increased costs related to the start-up of the Phase III NDV-01 trials and Phase 2b cipranolone study, and additional R&D personnel. General and administrative expense for the three months ended December 31, 2025, totaled $12.3 million compared to $8.1 million for the three 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. Net cash used in operating activities for the three months ended December 31, 2025, totaled $14.6 million, compared to $8.8 million for the three months ended December 31, 2024. The net loss for the three months ended December 31, 2025, was $19.9 million, or 27¢ per basic and diluted share, compared to a net loss of $18.7 million, or $0.06 per basic and diluted share, for the three months ended December 31, 2024. Before we open the call for questions, I will turn back to Sergio for some closing comments. Sergio?

Thank you, Maged. In closing of our prepared remarks, I would like to share that I am very confident and optimistic about our clinical programs and the long-term prospects for Relmada Therapeutics, Inc. 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.

Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press 1 on your telephone keypad. One moment, please, while we poll for questions. Our first question is from Uy Sieng Ear with Mizuho Securities.

Hey, guys. Congrats on the great data and the financing. Yeah, it seems like you did a lot of work this quarter. Maybe we are getting some questions on whether you will present additional data from your Phase II study. Should we expect, going forward, updates every three months, and will you also have data at AUA by any chance? That is the first question. The second question that we have been getting is there is some concern 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. Please help us understand what you are doing to ensure that those patients are truly second-line patients. And the third question is, you indicated that you have three-month data from your Phase III BCG-unresponsive second-line patients. Will this be from the entire patient population, or would this be an interim from a portion of the number of patients that you expect to enroll. Thanks.

Thank you, Uy, for the questions. I think Raj can answer these questions. I will pass it to Raj.

Thank you, Sergio. Good to hear from you, Uy. Regarding the data, we will be presenting updated 12-month data at the AUA. It has been accepted to AUA. We will also be presenting a trial in progress as we get RESCUE going. Our plan is to focus on introducing data, and to your last question, in the BCG-unresponsive second-line group, starting at the end of the year. As we start the trial in midyear, we should have some three-month data to share externally by the end of the year, as it is a single-arm, open-label study. Our thought is then to have, at a cadence of about every three months, additional updates as we get six-, nine-, and twelve-month follow-up on that data set. You provided an excellent question on second line, third line, fourth line. We are indeed limiting the number of prior therapy lines to two. So you can have had one line of therapy and still have been BCG-unresponsive, for example, while allowing a second line to be an alternative intravesical. We are also going to look at 15 patients at three months for those who received one prior line of therapy versus two, just to make sure there is nothing concerning in this open-label study that would warrant exclusion. This is reflective of the conversations we have had with the FDA. But it is a good question, and we are limiting the number of third or fourth lines.

Thank you.

Our next question is from Farzin Hak with Jefferies. Congrats on the progress, and thank you for taking my questions.

I have one on the operational standpoint. The NMIBC space is becoming congested with active trials and drugs approved, too. What is your expectation for enrollment cadence across your two studies, and can the drug’s in-office profile potentially serve as a recruitment advantage?

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

Thank you. Yeah, Farzin, good to hear from you. I think you are right. The high-risk, BCG-unresponsive space has been crowded, but I think ours, coming in as a second-line therapy, provides a unique advantage. There are no drugs that have been approved in that setting and none that I am aware of that are even being investigated as a pivotal study in that setting. So I think we have a competitive advantage in that we can go to sites that, even with drugs in development, can follow them in this unique path. The same for intermediate risk. Right now, it is becoming an area of broader interest. CG Oncology, for example, has an intermediate-risk trial that looks like it is ahead of schedule and accrued very rapidly. I think there is a lot of interest from investigators in intermediate-risk patients. I expect us to enroll that study pretty rapidly and ahead of schedule like CG did. Thanks for the question, Farzin.

Got it. And then for the second-line high-grade settings, 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 submitting the NDA?

Another great question. They have not required a minimum follow-up. They said they want to see CR anytime, as you said, and durability of response or duration of response. I think the wording they used, which I think is important, is they want to see the totality of the data. They want to see that you have a response and there is some level of durability. They have not specified what that number is.

Got it. Thank you so much.

Thank you, Farzin. Your next question is from Christopher with Lucent.

Hey, guys. Thanks for the question. I was 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 three-month mark, as well as what we should be benchmarking against with the status of the field?

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

Yes. Thanks, Chris. Thanks for the question. In the intermediate-risk study, we structured the trial statistics around a two-year RFS of 75%. That is reflected in the literature with GemDosi. With what we have seen in this population and with sustained release, we should exceed that, but that is our target number and it drives the statistics. It is an event-driven study with a target of 128 events. Regarding the BCG-unresponsive second-line, if you look historically, in first line the first drug approved was valrubicin in 1998 at 8% 12-month CR, followed by Keytruda at 19% and then other programs in the 24% range. So I am glad the FDA was not fixated on a certain number, but I think that threshold should be at those levels or lower than what we have seen in first-line therapy, just as precedent.

Got it. Thanks for the question.

Our next question is from Kelsey Goodwin with Piper Sandler.

Hey, thanks so much for taking my question and congrats on the recent clinical update. Regarding that update, on the patient baseline characteristics and the CIS versus papillary split, how should we be comparing this data set to that of competitors with primarily CIS patients? And do you have any data to support that GemDosi looks similar in CIS and papillary patients?

Hi, Kelsey. It is Sergio here. Raj, it seems that this one also is for you.

Great question, Kelsey. Starting with the last part of your question, as a clinician you often think if the patient is BCG-unresponsive, this might be more virulent, but we do not often parse whether it is CIS versus papillary. Some people show pure CIS behaves better, but T1 actually is worse, so it is a mixed bag. For GemDosi, there is an article by Steinberg in 2020 in the Journal of Urology that looked at heavily pretreated patients, and at 12 months the RFS or CRs were 60% in the CIS population and 61% in papillary, so there is not a marked difference typically. If you go back and look at our data, our 12-month CR in BCG-unresponsive is 80%, and our 12-month CR in the overall population is 84%. That includes four patients with CIS; we had four out of four with complete response at any time and two out of two at 12 months. These are small numbers, but they still compare quite favorably. Even if you take NDV-01 and the BCG-unresponsive population, including CIS, and compare it to the best-in-class categories, I think their 12-month CR was 74%. Taking our entire cohort, we are significantly higher, so I think it is still best in class. I hope I answered your question.

That is super helpful. Thank you so much for that. And one follow-up: with respect to the intermediate-risk setting and that market overall, how much do you think that market might need to be built out by these early launches, given we have not had an approved agent until last year? Thanks so much.

You bet, Kelsey. Right now, we mentioned there are about 75,000 to 80,000 patients with intermediate-risk disease. If you look at the data now, only about 35% of those patients receive adjuvant therapy. What is important in our studies and in CG’s study is that in our intermediate-risk population, we include small, less than 3-centimeter Ta high-grade patients. That is very important because 20% of the intermediate-risk disease is these high-grade Ta patients, and those are the ones, probably more than anybody, who need adjuvant therapy to prevent recurrence. Going back, while about 35% receive adjuvant therapy, I think that number will grow as you see data from Moonlight or from PIVOT-006 or from our RESCUE intermediate study. As we get data, it gives patients confidence that there is an agent that might reduce the risk of another TURBT and gives urologists confidence that there is an agent they can deliver in the office that will reduce TURBT risk for patients. It is only going to grow.

That is great. Thank you so much.

Thank you, Kelsey. 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.

The closing remark is a big thank you to everybody that has allowed Relmada Therapeutics, Inc. to get where we are now. We created data with a drug that can really help patients with bladder cancer. We are looking forward to updating 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.