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LLM Evaluations

Transcript Summary

Relmada Therapeutics reported strong progress for Q1 2026, headlined by durable 12-month Phase 2 data for NDV-01 in bladder cancer. The lead candidate, a sustained-release Gem/Doce formulation, achieved an 80% 12-month complete response rate in BCG-unresponsive patients with a favorable safety profile (no Grade 3+ AEs). This performance underpins the upcoming mid-2026 launch of the Phase 3 RESCUE registrational program, which features two distinct approval pathways for NMIBC. Financially, Relmada is well-capitalized following a $160 million private placement, ending the quarter with $234 million in cash—sufficient to fund operations through 2029 and complete Phase 3 development. Additionally, the company filed a provisional patent that could extend NDV-01's market exclusivity to 2047. Relmada also plans to initiate a proof-of-concept study for sepranolone in Prader-Willi syndrome in mid-2026. Management emphasized that NDV-01’s in-office administration model provides a competitive edge by reducing 'time toxicity' for patients and providers. With FDA alignment on trial design and a robust balance sheet, the company is focused on execution as it moves toward registrational milestones later this year and into 2027.

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Relmada Therapeutics: A Serial Diluter Pivoting Through Terminated Pipelines

Full Earnings Call Transcript — Q1 • 2026-05-12

Operator: Good afternoon, and welcome to Relmada Therapeutics First Quarter Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded and will be available for replay on the Relmada website. I would now like to turn the call over to 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 March 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 May 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 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. 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 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-months 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 strength of our progress. Importantly, we remain on track to initiate the Phase 3 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 4 milestones that speak to the momentum we have built this year. Number one, 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 these data and an overview of the Phase 3 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 two, we achieved FDA alignment for our planned registrational Phase 3 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 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 methods 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 covered claims of NDV-01 into 2047, providing a 9-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 registrational Phase 3 RESCUE program for NDV-01 in mid-2026. We are also preparing to initiate a proof-of-concept study for sepranolone in Prader-Willi syndrome targeted for mid-2026. Maged will speak about it in more detail shortly. Next, I will turn the call over to Dr. Raj Pruti, who will provide a review of the NDV program, including 12 months follow-up data from the ongoing Phase 2b study and the summary of our Phase 3 plans. Raj?
Raj Pruthi: Thank you, Sergio, and 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 3 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-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 3 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 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 2 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 receive 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 at 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 3 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-months 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 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-2026. The RESCUE program will also be highlighted in the trials in progress session at the AUA Annual Meeting on Sunday, May 17, providing an important opportunity to engage the urology community. Let me now walk you through each of the 2 studies that form 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 5,000 patients per year in the U.S. fall into this setting. With few treatment -- 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 #2 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 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 2 data gives us high confidence in the RESCUE program. 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?
Maged Shenouda: 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 neuro-steroid that modulates GABA, one of the most important neurotransmitters. Sepranolone is intended to act on the GABA neurotransmitter pathway to normalize the activity of GABAA -- of the GABAA 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 first quarter ended March 31, 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 first quarter of 2026 with a cash balance of $234 million compared to $94 million at December 31, 2025. Our first quarter cash balance includes net proceeds of approximately $150 million from a private financing announced on March 9, 2026. We expect our current cash resources to provide sufficient runway to fund company operations through 2029, including completion of the Phase 3 RESCUE program for NDV-01. Moving briefly through our first quarter financial results. Research and development expense for the 3 months ended March 31, 2026, totaled $8.1 million compared to $12 million for the 3 months ended March 31, 2025, a decrease of $3.9 million. The decrease was primarily attributable to non-recurring costs associated with the acquisitions of -- 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 start-up of the Phase 3 NDV-01 trials and the Phase 2b sepranolone study and additional R&D personnel. General and administrative expense for the 3 months ended March 31, 2026, was $11.4 million compared to $6.3 million for the 3 months ended March 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 March 31, 2026, totaled $15.1 million compared to $18.1 million for the same period in 2025. The net loss for the 3 months ended March 31, 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 first -- for the 3 months ended March 31, 2025. Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?
Sergio Traversa: 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.
Operator: [Operator Instructions] We now have our first question, and this comes from Kelsey Goodwin from Piper Sandler.
Kelsey Goodwin: Looking forward to seeing the data this weekend at AUA. I guess, a couple for me, if you don't mind. First, for AUA this weekend, it seems like there's some Gem/Doce presentations. I guess, how should we think about the growing literature on Gem/Doce 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'll leave it at that.
Sergio Traversa: Thank you, Kelsey. Sergio here. Well, the -- maybe I can take a little point on the first question, I see that Gem/Doce, conventional Gem/Doce data always is a positive because it just consolidates how the urology community believes that this is a very effective and way to treat bladder cancer. And with that said, I'll let Raj to expand and answer you the second question. Raj?
Raj Pruthi: Yes. Thanks for the question, Kelsey. 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. And you're right, there's a significant number of Gem/Doce papers being presented, more and more on the efficacy of Gem/Doce, especially in the high-risk patient population. The other that I think is notable is that of time toxicity with Gem/Doce. There's 2 papers being presented on the burden of conventional sequential Gem/Doce 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. My hope in that is that by -- as we get the study going, that we'll have a handful of patients maybe by the end of this calendar year that we will be able to share 3-months data. This is an open-label study. So a 3-months response and safety rate data by the end of this year or early next year. And we anticipate at a cadence of every 3 months sharing that data into 2027. I think I got both your questions.
Operator: And the next question comes from Christopher Liu from Lucid Capital Markets.
Christopher Liu: 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 would let Raj, the expert to answer this one. Raj?
Raj Pruthi: Yes. I think for -- I really kind of hone in on the BCG-unresponsive population. I think that's the most difficult to treat failing BCG. I think for the -- 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%. And I think others have seen numbers up towards 70%. But 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 kind of look at is that 80% number.
Operator: And the next question comes from Uy Ear from Mizuho.
Uy Ear: Congrats on all the progress you've made. Maybe just help us to understand a little bit more about your patent estate. So you filed the provisional patent. And I wasn't -- 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? And also, with the extended patent term, which is quite extensive. How are you perhaps thinking about doing additional clinical trials? Like does it give you a greater chance of -- or are you thinking about perhaps doing combination studies in addition after the RESCUE programs are done?
Sergio Traversa: Sergio here. I'll take the first one on the IP, and then I'll let Raj to handle the one 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'll have the opportunity, we have sometime at least 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.
Uy Ear: When do you expect the prosecution to enter? When do you expect the patent to be issued?
Sergio Traversa: Yes. It's always a guess. 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 applications. So I would not focus on any response before at least 1 year.
Raj 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 track or upper tract disease. I think there are a lot of opportunities, and we can just follow the path of where has Gem/Doce 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 and will take a couple -- it's an event-driven study will take a couple of years to read out. I think that's also another place where we BRIDGE does read out as Gem/Doce is noninferior to BCG and becomes an alternative. I think NDV-01 can nicely step in there as an easier to use, less burdensome approach for Gem/Doce in the BCG-naive, high-risk population.
Operator: [Operator Instructions] The next question comes from Farzin Haque from Jefferies.
Farzin Haque: So following up on an earlier question, like you have a broad inclusion criteria for Phase 3, the BCG-unresponsive setting and you're allowing up to 2 prior lines, including a wide range TAR-200, INLEXZO, et cetera. So how are you modeling the potential for variability or dilution of efficacy? And could you add just to 1 prior line as the trial progresses?
Sergio Traversa: Raj, I think would you mind to take this?
Raj Pruthi: Yes. Yes, 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 2 prior first-line therapies. With that, the idea that beyond that may -- there may be some resistance mechanisms. And we'll evaluate -- we'll break that down by 1 or 2 lines of prior therapy. So we're looking at that. And 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 INLEXZO, we are excluding prior Gem/Doce in those patients because we're giving a Gem/Doce treatment. But we'll look at INLEXZO and gemcitabine and we've heard and in my own practice, having Gem/Doce as a rescue for gemcitabine is appropriate. So we'll be looking at both of those closely. And I think we want to see our efficacy is what 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's a lot of agents approved and in development for the first line. There's 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. Thanks for the question, Farzin.
Farzin Haque: And then on your Phase 3 primary endpoint, does FDA's acceptance of CR at any time imply any durable responses, for example, median duration of response greater than 6 months?
Raj Pruthi: So there -- what their phrase was they want the primary endpoint to be CR any, and they also want to see duration of response. And the words that they use is they want to look at the "totality of the data." So I think they're getting at what you are is a strong CR any, which could be at 3 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. So CR any 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'll put all that together, as they said, in the totality of the data. But really, the other alternative for the patients at this point in their journey is radical cystectomy.
Farzin Haque: Right. And 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?
Raj Pruthi: Yes, that's a great question, Farzin. 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 1, 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 to 18 months, but with that enthusiasm and with -- 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, Farzin, another area where there's incredible enthusiasm because urologists have nothing else at this point in their armamentarium to treat these patients. So a lot of these urologists, even the best-case scenarios are 45% 12-month CR. You see 19% to 45%, meaning 55% to 80% of patients are recurring within 1 year with the first-line therapy. So 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 months enrollment.
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.