Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q1 2026 Earnings Call Transcript

Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q1 2026 Earnings Call Transcript May 12, 2026

Relmada Therapeutics, Inc. misses on earnings expectations. Reported EPS is $-0.22 EPS, expectations were $-0.18.

Operator: Good afternoon, and welcome to Relmada Therapeutics First Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. As a reminder, this conference call is being recorded. And will be available for replay on the Realmada website. I would now like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.

Brian 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 3 months ended March 31, 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 03/31/2026, 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 05/12/2026. 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 S. Pruthi, Relmada’s CMO Urology, who will provide an NDB-01 program update and Relmada’s CFO, Maged S. Shenouda, who will provide an update on ceproantolone and a review of the company’s Q1 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?

Sergio Traversa: Thank you, Brian. Good afternoon, and welcome, everyone, to the Realmada First Quarter 26 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 initiate the phase 3 rescue program in mid 26. 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 for gemcitabine and docetaxel or Gemdosi.

it is designed to build on a well established safety and profile of conventional Gemdosi. And deliver a best in class therapy for patients living with NMIBC. We remain focused on maximizing its potential for success for patients, their urology community, and our investors. Let me walk you through 4 miles on that speak to the momentum we have built this year. Number 1, we have continued to derisk the development of NDV-01 with the report of solid and durable 12 months efficacy data from the ongoing phase 2 study of NDV-01. We will be presenting this data and an overview of the phase 3 rescue program at the American Urological Association 26 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 2, we achieved FDA alignment for our plan registration of Phase III rescue programs. Number 3, in April, we filed a provisional patent application in The US 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 3 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 breath 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, would meaningfully extend the coverage covered claims of NDVIO 1 into 2047. Providing a 9-year extension of commercial exclusivity and strengthen our competitive positions as we advanced our registration. Looking ahead, as we enter 2026, our focus is on execution. We remain on track to initiate the registration of Phase 3 rescue program for NDV-01 in mid 26. We are also preparing to initiate a proof-of-concept study for Cipranolone in Prader Willi syndrome. Targeted for mid-26.

Maged will speak about it in more detail shortly. Next, I will turn the call over to Dr. Raj, who will provide a review of the NDV-01 program. Including 12-month follow-up data from the ongoing Phase 2 study, and the summary of our Phase 3 plans. Raj?

Raj S. Pruthi: Thank you, Sergio, and good afternoon, everyone. I am 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 Gemdosi and generating investigator interest in the phase 3 rescue program. Bladder cancer is 1 of the most common cancers we see. And its impact on the patients is significant. Most are diagnosed in their mid-70s 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 3 topics during today’s call. First, a recap of the NDV-01 12-month data. Second, a summary of our planned Phase III program. And third, a discussion of how NDV-01 might fit in the real world practice of a urologist. As Sergio noted, NDV-01 is a novel sustained release intravesical formulation of gemcitabine and docetaxel. It builds on physicians’ established familiarity with conventional Gemdosi. 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 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 2 study is an open label single arm trial in patients with high risk NMIBC. Patients received 6 biweekly doses that is every other week, followed by monthly maintenance for up to 1 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 anytime and a durable 80% CR rate at 12 months in the difficult-to-treat BCG-unresponsive sub population, re-enforcing 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 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 3 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 1. Now turning to the phase 3 rescue program. We designed the program with 2 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-26. The rescue program will also be highlighted in the trials and 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 2 studies that formed the rescue program. Registrational pathway 1, focuses on patients in the second line setting patients who are BCG unresponsive with carcinoma in situ or CIS and refractory to first line therapies that are approved or in development.

We estimate approximately 5 thousand 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 3-month response data around year end. This pathway could offer a rapid route to approval. Registrational pathway number 2 evaluates NDV-01 as an adjuvant therapy following TURBT in patients with intermediate risk NMIBC. We estimate approximately 75 thousand 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 control 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 does not require specialized pharmacy or hood. 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 S. Shenouda, I want to emphasize why we are so excited about NDV-01. Our Phase II data gives us high confidence in the rescue program. We believe NDVR1 addresses a clear unmet need with a unique sustained delivery platform and has the potential to redefine the standard of care in bladder cancer. Megan?

Maged S. Shenouda: Sure. Thanks, Raj, and good afternoon, everyone. Today, I will spend a few minutes on cipranolone and then provide you with an overview of our first quarter 26 financial results. Cipranolone is a novel neurosteroid that modulates GABA. Of the most important neurotransmitters. Cipranolone is intended to act on the GABA neurotransmitter path to normalize the activity of GABAA receptor and alleviate the repetitive symptoms and 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-26. 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 first quarter ended 03/31/2026. During this call, I will provide a high level review of our financial results refer you to our press release and 10 Q filing issued this afternoon with more detailed information Starting with our cash balance, Realmada closed the first quarter 26 with a cash balance of $234 million compared to $94 million at 12/31/2025. Our first quarter cash balance includes net proceeds of approximately $150 million from a private financing announced 03/09/2026. 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 3 months ended 03/31/2026, totaled $8.1 million compared to $12 million for the 3 months ended 03/31/2025. A decrease of $3.9 million The decrease was primarily attributable to nonrecurring costs associated with the acquisitions of the acquisition of Cipranoloneone and the license agreement of NDV-01 in 2025. This 2026 decrease was partially offset by increased costs related to the start up of the Phase 3 NDV-01 trials and phase 2b cipranolone study and additional R&D personnel. General and administrative expense for the 3 months ended 03/31/2026, was $11.4 million compared to $6.3 million for the 3 months ended 03/31/2025.

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 3 months ended 03/31/2026, totaled $15.1 million compared to $18.1 million the same period in 2025. The net loss for the 3 months ended 03/31/2026, was $19.1 million or 22 cents per basic and diluted share. Compared with a net loss of $17.6 million or 58 cents per basic and diluted share for the first for the 3 months ended 03/31/2025. Before we open the call for questions, I will turn back to Sergio for some closing remarks. Sergio?

Sergio Traversa: Thank you, Maged. In closing, I am 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-26, 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.

Q&A Session

Operator: Yes, sir. Thank you. As a reminder, if you would like to ask a question, please press 1 on your telephone keypad. Thank you for waiting. We now have our first question. And this comes from Kelsey Goodwin from Piper Sandler. Your line is now open. Please go ahead.

Analyst (Kelsey Goodwin): Oh, hey. Thanks for taking my questions, and looking forward to seeing the data this weekend at AUA. I guess a couple from me, if you do not mind. First, for AUA this weekend, it seems like there is some Gemdosi I guess, how should we think about the growing literature on gem and the degree of read through to NDV-01? And then 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. And I will leave it at that. Thank you so much.

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

Raj S. Pruthi: Yeah. Thanks for the question, Kelsey. You know, I am excited as a urologic oncologist to see the number of nonmuscle invasive bladder cancers in general in the hundreds at the AUA this year. And you are right. there is a significant number of Gemdosi papers being presented. More and more on the efficacy of Gemdosi, especially in the high risk patient population. The other thing that I think is notable is that of time-toxicity with Gemdosi. there is 2 papers being presented on the burden of conventional sequential Gemdosi time-toxicity, the burden to the patient and to the provider. So 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 2A for the second line BCG unresponsive.

You know, my hope in that is that by, you know, as we get the study going, that we will have a handful of patients maybe by the end of this calendar year that will be able to share 3-month data. You know, this is an open label study, so a 3-month response and safety rate data by the end of this year, early next year. And we anticipate at a cadence of every 3 months sharing that data into 2027. I think I got both of your questions.

Sergio Traversa: Perfect. Thank you so much. Thank you, Kelsey.

Operator: Thank you. And the next question comes from Christopher Lu from Lucid Capital Markets. Thank you.

Analyst: And congrats on the progress you guys have been making so far. So 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?

Sergio Traversa: Thank you, Chris. Sergio here. I will let Raj, the AUA expert, answer this 1. Raj?

Raj S. Pruthi: Yeah. I think, you know, I think for you know, I really kind of hone in on the BCG unresponsive population. I think that is the most difficult to treat. At failing BCG. I think for our BCG unresponsive, we see numbers of 80% landmark and 84% Kaplan-Meier estimates 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%. But I think the numbers of 80-85% that we have are really best in class at that point. Yeah. And along with a good safety profile. I think, Chris, I think that is the number that I would kind of look at is that 80% number.

Sergio Traversa: I appreciate the color. Thank you. You bet.

Operator: And the next question comes from Uy Sieng Ear from Mizuho.

Analyst (Uy Sieng Ear): Congrats on all the progress you have made. Maybe just help us to understand a little bit more about your patent estate. So you filed the provisional patent And I am not sure I quite understand the phrase if a 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? And, 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.

Sergio Traversa: Good afternoon, Uy. it is Sergio here. I will take the first 1 on the IP and then I will let Raj. to handle the 1 on the development. So we just filed a patent a few weeks ago, so allow me to be not too specific on what the claims are. But in general, these are new patents and reflect the work that has been done in the U.S. in the formulation and manufacturing. And it is a new patent that we filed in the U.S., and then we will have the opportunity. We have some time, I believe, 1 year to file, outside of the U.S. And so these are new patents, so they will provide coverage if granted, of course. Until sometime in 2047. I hope I kind of answered your question. When do you expect the prosecution to and when do you expect the to be issued?

Yeah. it is it is always it is always a guess. Oh, we just filed. So from my experience, I would not expect anything at least for the first 12 months, first year. It looks like the patent office is very, very busy. With a lot of filing and application, so I would not I would not focus on any response before at least 1 year. Okay.

Raj S. Pruthi: And, Uy, I can jump in on your other question about now we have the opportunities to look at NDV-01 in where else in lower-tract or upper-tract disease? I think there are a lot of opportunities, and we can just follow the path of where has Gemdosi 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 it also another opportunity that we are considering is in the high risk BCG naive population, is another large patient population. I think on the heels of the bridge study, which completed enrollment, I believe, in August 2025 and will take a And it is an event driven study.

Will take a couple of years to read out, I think that is also another place where, you know, Bridge does read out as Gemdosi is noninferior to BCG and becomes an alternative, I think NDV-01 can nicely step in there as an, yeah, easier to use less burdensome approach for Gemdosi in the BCG-naive high-risk population. Great question.

Sergio Traversa: Thank you. Thanks. Thank you, Uy.

Operator: Thank you. Once again, for those who want to ask a question. The next question comes from Farzin Hak from Jefferies. Your line is now open. Please go ahead.

Analyst (Farzin Haq): Good afternoon, and thank you for taking my question. Following up on an earlier question like you have a broad inclusion criteria for Phase 3, the BCG-unresponsive setting. And you are allowing up to 2 prior lines, including a wide range, TAR-200, Anktiva, etcetera. So how are you modeling the potential for variability or dilution of efficacy And could you adjust to 1 prior line as the trial progresses?

Sergio Traversa: Thank you for this. Raj, I think, would you mind to take this. Yeah.

Raj S. Pruthi: Yeah. My pleasure. Thanks for the question, Farzin. it is a very thoughtful question. I think we have built in kind of guardrails to that study of up to 2 prior first line therapies with that. The idea that, you know, beyond that there may be some resistance mechanisms, and we will evaluate and we will break that down by 1 or 2 prior lines of prior therapy. So we are looking at that. Within the therapy too, another area we are looking at and remember, these are open label studies. So we can see how these patients are doing. We are also gonna look at patients who have had prior intravesical chemotherapy as part of their BCG unresponsive disease. Particularly Anktiva. We are excluding prior Gemdosi in those patients because we are giving a Gemdosi treatment.

But we will look at Inlyta and gemcitabine and we have heard and in my own practice, having Gemdosi as a rescue for gemcitabine is appropriate. So we will be looking at both of those closely. And I think we wanna see you know, our efficacy is. Our approach is what is the appropriate second line therapy? Right? These therapies are going to be sequenced by urologists. 2, 3, 4, 5 times before cystectomy. Right now, there is a lot of agents approved and in development for the first line. there is none in second line therapy, so that gives us an opportunity to have provide the highest levels of evidence and a label for the second line approach. And then from there, once urologists use it there, as we do, they could use it before or after. But we are that you bring up a good point.

We are looking at lines of therapy and also what that prior therapy was.

Sergio Traversa: Thanks for the question, Farzin.

Analyst (Farzin Haq): And then on your phase 3 primary endpoint, does FDA’s acceptance of CR at anytime imply any durable responses? For example, median duration response greater than 6 months.

Raj S. Pruthi: So their phrase was, they want the primary endpoint to be CR at anytime. And they also wanna see duration of response. And the words that they use is they want to look at the, quote, totality of the data, close quote. So I think they are getting at what you are, is a strong CR at anytime, which could be a 3 months is great, but they wanna see some level of durability in that. They did not give the number on that, but they want to see some durability. So CR at anytime together with durability in this framed as duration of response is what they want to see. And given the fact that there is no agents that have been approved in this space, I think they will 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.

Analyst (Farzin Haq): And then a quick 1, is what is the expectation for enrollment cadence across both your pivotal Can the drugs in office profile serve as a recruitment advantage potentially?

Raj S. Pruthi: Yeah. that is a great question, Farzin. I think 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 1, which is intermediate risk, have participated in PIVOT-006, and they are excited for the next intermediate risk study. We have modeled out up to 15 to 18 months. But with that enthusiasm, and with given what SWOG has been able to do as far as recruitment and number of events, I feel confident that we will be able to meet or exceed that timeline. Regarding the second line therapy, we are anticipating 12 months, but that is again, for Zymfentra, another area where there is incredible enthusiasm because urologists have nothing else at this point.

in their armamentarium to treat these patients. So a lot of the these urologists, even the best-case scenarios are 45%, 12 month CR. from 19% to 45%, meaning 55% to 80% of patients are recurring within 1 year with the first line therapy. So there is a large population of patients out there with BCG unresponsive CIS who failed first line therapy. We are not competing with any other study. So I am optimistic that we will be able to reach that 12 month. Enrollment.

Sergio Traversa: Great. Super helpful. Thank you, Raj. Thanks, Farzin.

Operator: Thank you. And 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.