Q1 2026 Relmada Therapeutics Inc Earnings Call
Speaker #2: To ask a question, please press *1. As a reminder, this conference call is being recorded. And we'll be available for replay on the RELMADA website.
Speaker #2: I would now like to turn the call over to Brian Ritchie from LifeSight Advisors. Please go ahead, Mr. Ritchie. Thank you. Good day, everyone, and thank you for joining us today.
Speaker #2: This afternoon, RELMADA issued a press release providing a business update and outlining its financial results for the three 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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 advise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.
Speaker #2: 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 NDB01 program update; and RELMADA's CFO, Maged Shenouda, who will provide an update on SEP-363856 and a review of the company's Q1 financial results.
Speaker #2: After that, we will open the line for a brief Q&A session. Now, I would like to end the call over to Sergio Traversa. Sergio?
Speaker #3: 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.
Speaker #3: The robust 12-month data for NDB01 in non-muscle invasive bladder cancer, or NMIBC, and the successful completion of $160 million private placement financing are meaningful milestones that reflect the strengths of our progress.
Speaker #3: Importantly, we remain on track to initiate the phase three rescue program in mid-2026, which we believe will be a transformational moment for RELMADA. Let me briefly describe what makes NDB01 distinct.
Speaker #3: NDB01 is a ready-to-use, sustained-release intravesical formulation for gemcitabine and docetaxel, or gemdose. It's designed to build on a well-established safety and efficacy profile of conventional gemdose, and deliver a best-in-class therapy for patients living with NMIBC.
Speaker #3: 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.
Speaker #3: Number one, we have continued to de-risk the development of NDB01 with the report of solid and durable 12-month efficacy data from the ongoing phase two study of NDB01.
Speaker #3: We will be presenting this data and an overview of the phase three rescue program at the American Urological Association 2026 annual meeting later this week.
Speaker #3: High response rates, a favorable safety profile, and ease of use continue to strengthen our conviction that NDB01 has the potential to provide what urologists and patients with NMIBC need.
Speaker #3: A simple, durably effective treatment that readily fits into real-world practice settings. Number two, we achieved FDA alignment for our planned registration of Phase 3 rescue programs.
Speaker #3: Number three, in April, we filed a provisional patent application in the US directed to formulations and methods of treatment for NDB01. This application efficient could form the basis for worldwide patent filings and have a term into 2047.
Speaker #3: 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.
Speaker #3: Before I end 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 NDB01 platform.
Speaker #3: 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 for NDB01 into 2047, providing a nine-year extension of commercial exclusivity and strengthening our competitive positions as we advance our registration.
Speaker #3: 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 three rescue program for NDB01 in mid-2026.
Speaker #3: We are also preparing to initiate approval council study for. Not only in Prader-Willi syndrome, targeted for mid-2026. Maged will speak about it in more detail shortly.
Speaker #3: Next, I'll turn I will turn the call over to Dr. Raj Pruthi, who will provide a review of the NDB program, including 12-month follow-up data from the ongoing phase two study and the summary of our phase three plans.
Speaker #3: Raj, thank you, Sergio, and good afternoon, everyone. I'm delighted to provide an update on NDB01 and our upcoming presentations at the AUA meeting this coming weekend.
Speaker #3: The AUA is an important platform for us as we look forward to introducing NDB01 to the broader urology community building awareness of NDB01 as a differentiated, sustained release gemdose and generating investigator interest in the phase three rescue program.
Speaker #3: 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.
Speaker #3: I want to touch on three topics during today's call. First, a recap of the NDB01 12-month data. Second, a summary of our planned Phase 3 program.
Speaker #3: And third, a discussion of how NDB01 might fit in the real-world practice of a urologist. As Sergio noted, NDB01 is a novel sustained release intravesical formulation of gemcitabine and docetaxel.
Speaker #3: It builds on physicians' established familiarity with conventional gemdose. This is particularly meaningful for patients who are unresponsive to BCG, where bladder-sparing options that avoid radical cystectomy can be life-changing.
Speaker #3: Turning to the 12-month data, NDB01 has demonstrated high response rates and durable efficacy in our ongoing phase two study. We believe these results compare favorably to other programs in this space and support NDB01's potential as a best-in-class treatment for patients with bladder cancer if approved.
Speaker #3: The phase two 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: No patients had progression to muscle-invasive disease, and no patients underwent a radical cystectomy. On the strength of these findings, we are advancing NDB01 into a Phase 3 rescue registration program.
Speaker #3: The program will evaluate NDB01 in both second-line BCG unresponsive disease and in intermediate-risk bladder cancer as an adjuvant therapy following transurethral resection or TURBT.
Speaker #3: We will be presenting the 12-month dataset 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.
Speaker #3: 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 NDB01 in our clinical program.
Speaker #3: In the 12-month dataset, no patients experienced a grade three or higher treatment-related adverse event. There were no dose interruptions or discontinuations due to adverse events.
Speaker #3: And most treatment-related adverse events were grade one. Now, turning to the Phase 3 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.
Speaker #3: We expect to file the US 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 and progress session at the AUA annual meeting on Sunday, May 17th.
Speaker #3: 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.
Speaker #3: Registrational pathway one, 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.
Speaker #3: We estimate approximately 5,000 patients per year in the US fall into this setting. With few treatment few effective alternatives to radical cystectomy, this study is designed as a single-arm trial.
Speaker #3: 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.
Speaker #3: This pathway could offer a rapid route to approval. Registrational pathway number two evaluates NDB01 as an adjuvant therapy following TURBT in patients with intermediate-risk NMIBC.
Speaker #3: We estimate approximately 75,000 patients per year in the US fall into this setting. Since no approved treatments exist in this setting, the study is designed as an open-label randomized control trial comparing NDB01 versus observation.
Speaker #3: The 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 NDB01 into patient care after TURBT and pave the way for broader adoption.
Speaker #3: Let me share our thinking on how NDB01 might work in the real-world practice of a urologist. NDB01 is formulated to create a soft matrix in the bladder, enhancing local urothelial exposure while minimizing systemic toxicity.
Speaker #3: It can be delivered in the office by a nurse or LPN in under five minutes and does not require specialized pharmacy or hub. This streamlined administration model offers a level of convenience and time savings that differentiates NDB01 from other agents.
Speaker #3: As I hand the call over to our CFO, Maged Shenouda, I want to emphasize why we're so excited about NDB01. Our Phase 2 data gives us high confidence in the rescue program.
Speaker #3: We believe NDB01 addresses a clear unmet need with a unique sustained delivery platform and has the potential to redefine the standard of care in bladder cancer.
Speaker #3: Maged, thanks. Raj, and good afternoon, everyone. Today, I'll spend a few minutes on sopranolone and then provide you with an overview of our first-quarter 2026 financial results.
Speaker #3: Sopranolone is a novel newer steroid that modulates GABA, one of the most important neurotransmitters. Sopranolone is intended to act on the GABA neurotransmitter pathway to normalize the activity of GABA-A of the GABA-A receptor and alleviate the repetitive symptoms and compulsivity disorders.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: 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, which contain more detailed information.
Speaker #3: Starting with our cash balance, RELMADA closed the first quarter 2026 with a cash balance of $234 million, compared to $94 million at December 31, 2025.
Speaker #3: Our first-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 three rescue program for NDB01.
Speaker #3: Moving briefly through our first-quarter financial results. Research and development expense for the three months ended March 31, 2026, totaled $8.1 million, compared to $12 million for the three months ended March 31, 2025.
Speaker #3: A decrease of $3.9 million; the decrease was primarily attributable to non-recurrent costs associated with the acquisitions of sopranolone and the license agreement of NDB01 in 2025.
Speaker #3: This 2026 decrease was partially offset by increased costs related to the startup of the phase three NDB01 trials and the phase two B sopranolone study and additional R&D personnel.
Speaker #3: General and administrative expense for the three months ended March 31, 2026, was $11.4 million, compared to $6.3 million for the three months ended March 31, 2025, an increase of approximately $5.1 million.
Speaker #3: 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 March 31, 2026, totaled $15.1 million, compared to $18.1 million for the same period in 2025.
Speaker #3: The net loss for the three months ended March 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 three months ended March 31, 2025.
Speaker #3: Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?
Speaker #2: 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 registration program for NDB01 in mid-2026, we are focused on execution and look forward to updating you on our progress in the coming quarters.
Speaker #2: Operator, I would like now to open the call for questions.
Speaker #3: 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.
Speaker #3: Thank you for waiting. We now have our first question. And this comes from Kelsey Goldwin from Piper Sandler, your line is now open. Please go ahead.
Speaker #4: Oh, hey. Thanks for taking my questions. And looking forward to seeing the data this weekend at AUA. I guess a couple for me, if you don't mind.
Speaker #4: First, for AUA this weekend, it seems like there's some gemdosy presentations I guess. How should we think about the growing literature on gemdosy and the degree of read-through to NDB01?
Speaker #4: 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.
Speaker #4: Maybe how many patients we might see or how to benchmark that. And I'll leave it at that. Thank you so much.
Speaker #2: Thank you, Kelsey, Sergio here, and good afternoon. Well, maybe I can take a little point on the first question. I see that gemdosy conventional gemdosy data always as a positive because it just consolidates how urology the urology community believes that this is a very effective way to treat bladder cancer.
Speaker #2: But with that said, I let Raj to expand and answer you the second question. Raj?
Speaker #5: Yeah. 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.
Speaker #5: And you're right, there's a significant number of gemdosy papers being presented. More and more on the efficacy of gemdosy, especially in the high-risk patient population.
Speaker #5: The other that I think is notable is that of time toxicity with gemdosy. There are two papers being presented on the burden of conventional sequential gemdosy time toxicity.
Speaker #5: 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.
Speaker #5: Regarding, I think, your second question was on our cohort two-way 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 will be able to share three-month data this is an open-label study, so a three-month response and safety rate data by the end of this year, early next year.
Speaker #5: And we anticipate at a cadence of every three months sharing that data into 2027. I think I got both of your questions.
Speaker #4: Perfect. Thank you so much.
Speaker #2: Thank you, Kelsey.
Speaker #3: Thank you. And the next question comes from Christopher Liu from Lucid Capital Markets, your line is now open. Please go ahead.
Speaker #5: Thank you. 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?
Speaker #2: Thank you, Chris, Sergio here. I would let Raj at the AUA expert to answer this one. Raj?
Speaker #6: Yeah. 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.
Speaker #6: 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.
Speaker #6: 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%.
Speaker #6: But I think the numbers of 80 and 85 percent that we have are really best in class at that point. And along with a good safety profile.
Speaker #6: I think, Chris, I think that that's the number that I would kind of look at—is that 80% number.
Speaker #5: Got it. I appreciate the color. Thank you.
Speaker #6: You bet.
Speaker #3: Thank you. And the next question comes from Uyir from Mizuho, your line is now open. Please go ahead.
Speaker #7: 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 so you file the provisional patent?
Speaker #7: 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.
Speaker #7: Could you maybe just help clarify that? What that means exactly? And also, with the extended patent term, which is quite an extensive how are you perhaps thinking about doing additional clinical trials?
Speaker #7: 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? Thanks.
Speaker #2: Good afternoon, Oy. And Sergio here. I'll take the first one on the IP and then I'll let Raj to handle the one on the development.
Speaker #2: 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.
Speaker #2: And reflect the work that has been done in the US in the formulation and manufacturing. And these are new patents. We filed in the US and then we left the opportunity we have some time, I believe, is one year to file outside of the US.
Speaker #2: And so the 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.
Speaker #7: When do you expect the prosecution to handle? When do you expect the patent to be issued?
Speaker #2: Yeah. 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.
Speaker #2: It looks like the patent office is very, very busy, with a lot of filings and applications. So, I would not focus on any response before at least one year.
Speaker #7: Okay.
Speaker #5: And Oy, I can jump in on your other question about now we have the opportunities to look at NDV01 in where else in lower track or upper track disease.
Speaker #5: I think there are a lot of opportunities, and we can just follow the path of where has gemdosy been effective. I think we started with BCG-unresponsive and discussed that with those results.
Speaker #5: I think the extension into intermediate-risk disease is a significant opportunity and market opportunity for Relmada, I think. And also, another opportunity that we're considering is in the high-risk BCG-naive population.
Speaker #5: Another large patient population, I think, on the heels of the BRIDG study, which completed enrollment, I believe, in August 2025. And we'll take a couple—it's an event-driven study.
Speaker #5: We'll take a couple of years to read out. I think that's also another place where BRIDG does read out, as gemdosy is non-inferior to BCG and becomes an alternative.
Speaker #5: I think NDV01 can nicely step in there as an easier to use less burdensome approach for gemdosy in the BCG naive high-risk population. Great question.
Speaker #5: Thank you.
Speaker #7: Thanks.
Speaker #2: Thank you, Oy.
Speaker #3: Thank you once again. For those who want to ask a question, please press star and 1 on your telephone keypad and wait for your name to be announced.
Speaker #3: Star and 1 if you wish to ask a question. The next question comes from Farzin Haque from Jefferies, your line is now open. Please go ahead.
Speaker #8: Good afternoon and thank you for taking my question. So following up on an earlier question, you have a broad inclusion criteria for phase three the BCG unresponsive setting.
Speaker #8: And you're allowing up to two prior lines including a wide range star 200 in Lexa, etc. So how are you modeling the potential for variability or dilution of efficacy?
Speaker #8: And could you add just to one prior line as the trial progresses?
Speaker #2: Thank you, Farzin.
Speaker #5: Yeah. Raj, I think would you mind to take this?
Speaker #4: Yeah. Yeah. 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.
Speaker #4: With that, the idea that beyond that may there may be some resistance mechanisms. And we'll evaluate we'll break that down by one or two lines of prior therapies.
Speaker #4: 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.
Speaker #4: We're also going to look at patients who've had prior intravesical chemotherapy as part of their BCG unresponsive disease. Particularly in Lexa, we are excluding prior gemdosy in those patients.
Speaker #4: Because we're giving a gemdosy treatment. But we'll look at in Lexa and gemcitabine and we've heard and in my own practice having gemdosy as a rescue for gemcitabine is appropriate.
Speaker #4: So we'll be looking at both of those closely. And I think we want to see our efficacy, is what is the approach, is what is the appropriate second-line therapy, right?
Speaker #4: These therapies are going to be sequenced by urologists two, three, four, five times before cystectomy. Right now, there's a lot of agents approved and in development for the first line.
Speaker #4: There's none in second-line therapy, so that gives us an opportunity to provide the highest levels of evidence and a label for the second-line approach.
Speaker #4: 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.
Speaker #4: We are looking at lines of therapy and also what that prior therapy was. Thanks for the question, Farzin.
Speaker #8: And then on your phase three primary endpoint, does FDA's acceptance of CR at any time imply any durable responses? For example, median duration response, greater than six months?
Speaker #5: So there what their phrase was, they want the primary endpoint to be CRNE. 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" close quote.
Speaker #5: So I think they're getting at what you are is a strong CRNE which could be a three months is great. But they want to see some level of durability in that.
Speaker #5: They didn't give the number on that. But they want to see some durability. So CRNE together with durability in the framed as duration of response is what they'll want to see.
Speaker #5: And given the fact that there are 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.
Speaker #5: Because really the other alternative for the patients at this point in their journey is radical cystectomy.
Speaker #8: Right. Makes sense. And then a quick one is that what is the expectation for enrollment cadence across both your pivotals? And can the drugs in-office profile serve as a recruitment advantage, potentially?
Speaker #5: Yeah. That's a great question, Farzin. I think in having been on a number of calls of our site qualification visits, the enthusiasm by investigators is significant.
Speaker #5: 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.
Speaker #5: 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.
Speaker #5: Regarding the second-line therapy, we're 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.
Speaker #5: 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 one year with the first-line therapies.
Speaker #5: 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, so I'm optimistic that we'll be able to reach that 12-month.
Speaker #5: Enrollment.
Speaker #8: Great. Super helpful. Thank you, Raj.
Speaker #5: Thanks, Farzin.
Speaker #8: 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.
