On Tuesday, Relmada Therapeutics (NASDAQ:RLMD) discussed first-quarter financial results during its earnings call. The full transcript is provided below.

This content is powered by Benzinga APIs. For comprehensive financial data and transcripts, visit https://www.benzinga.com/apis/.

The full earnings call is available at https://viavid.webcasts.com/starthere.jsp?ei=1760811&tp_key=4a374687cc

Summary

Relmada Therapeutics reported progress with NDV01, a sustained release formulation for bladder cancer, highlighting robust 12-month efficacy data and a favorable safety profile.

The company completed a $160 million private placement financing to support the Phase 3 Rescue Program, slated to begin mid-2026.

Relmada filed a provisional patent for NDV01, potentially extending patent protection into 2047, and remains focused on executing its strategic initiatives, including a study for Sopranolone in Prader Willi Syndrome.

Financially, the company ended Q1 2026 with a cash balance of $234 million, expecting this to fund operations through 2029, despite a slight increase in net loss compared to the previous year.

Management expressed confidence in the potential of NDV01 to address unmet needs in bladder cancer and emphasized the significance of upcoming presentations at the American Urological Association meeting.

Full Transcript

OPERATOR

Good afternoon and welcome to Relmada Therapeutics first Quarter Earnings Conference call. At this time all participants are in a listen only mode. After the prepared remarks, we'll conduct a question and answer session. To ask a question, please press star one. 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 Ricci from LifeSci Advisors. Please go ahead. Mr. Ricci.

Brian Ricci

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 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 10Q 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 CEO Dr. Sergio Traversa who will briefly provide a summary of Recent business highlights Dr. Raj Pruthi, Relmada CMO Urology, who will provide an NDB 01 program update and Relmada CFO Magn Cinauda who will provide an update on Supranolone and a review of the company's Q1 financial results. After that we will open the line for a brief Q and A session. Now I would like to hand the call over to Sergio Traversa.

Sergio Traversa (Chief Executive Officer)

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 NDB01 in non-muscle invasive bladder cancer or NMIBC and the successful completion of 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-2026, which we believe will be a transformational moment for Relmada. Let me briefly describe what makes NDV01 distinct. NDV01 is a ready to use sustained release intravesical formulation for gemcitabine and docetaxel or gemdosy. It's designed to build on a well established safety and efficacy profile of conventional gemdosing 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 four milestones that speak to the momentum we have built this year. Number one we have continued to derisk the development of NDV01 with the report of solid and durable 12 months efficacy data from the ongoing phase two study of NDV01. We will be presenting this data an 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 NDV01 has the potential to provide what urologists and patients with NMIBC need: a simple, durably effective treatment that readily fits into a real world practice setting. Number two we achieved FTA alignment for our plan Registration of Phase three Rescue programs Number three In April we filed a provisional patent application in the US directed to formulations and methods of treatment for NDV01. This application, efficient, could form the basis for worldwide patent filings and EBITERM 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 three rescue program. 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 NDV01 platform. If granted, it could form the basis for worldwide patent filings, significantly expanding our global IP protection. Most importantly would meaningfully extend the covered claims of NDB1 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 3 Rescue Program for NDVO1 in mid-2026. We are also preparing to initiate approval Counsel study for Supranolone in Prader Willi Syndrome targeted for mid-2026 Maget will speak about it in more detail shortly. Next we'll turn the call over to Dr. Raj Pruti who will provide a review of the MDV program including 12 months follow up data from the ongoing phase two study and the summary of our phase three plans. Raj

Dr. Raj Pruthi

thank you Sergio and good afternoon everyone. I'm delighted to provide an update of NDV01 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 NDV01 to the broader urology community, building awareness of NDV01 as a differentiated sustained release gemdosi and generating investigator interest in the Phase three 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 three topics during today's call. First, a recap of the NDV01 12 month data, second, a summary of our planned phase three program and third, a discussion of how NDV01 might fit in the real world practice of a urologist. As Sergio noted, NDV01 is a novel sustained release intravesical formulation of gemcitabine and docetaxel. It builds on physicians established familiarity with conventional GEM dosing. 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, NDV01 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 NDV01's potential as a best in class treatment for patients with bladder cancer if approved. The Phase two 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 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% Complete Response (CR) at 12 months in the high risk NMIBC patients and a 94% Complete Response (CR) at any time and a durable 80% Complete Response (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 NDV01 into a Phase 3 Rescue Registrational Program. The program will evaluate NDV01 in both second line BCG unresponsive disease and in intermediate risk bladder cancer as an adjuvant therapy following Transurethral Resection of Bladder Tumor (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 NDV01 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 one. Now turning to the Phase three 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 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 in Progress session at the 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 two 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 US 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 three month response data around year end. This pathway could offer a rapid route to approval. Registrational pathway number two evaluates NDV01 as an adjuvant therapy following TRBT in patients with intermediate risk NMIBC. 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 NDV01 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 NDV01 into patient care after pave the way for broader adoption. Let me share our thinking on how NDV01 might work in the real world practice of a urologist. ND V01 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 NDV01 from other agents. As I hand the call over to our CFO Maget Shenouda, I want to emphasize why we're so excited about NDV01. Our phase two data gives us high confidence in the rescue program. We believe NDV01 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

Maget Shenouda

thanks Raj and good afternoon everyone. Today I'll spend a few minutes on Supranolone and then provide you with an overview of our first quarter 2026 financial results. Supranolone is a novel neurosteroid that modulates GABA, one of the most important neurotransmitters. Supranolone is intended to act on the GABA neurotransmitter pathway to normalize the activity of gaba A 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 Ramada 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 10Q filing issued this afternoon with more detailed information 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. Our first quarter cash balance includes net proceeds of approximately $150 million 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 3 rescue program for NDV01. 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 31st, 2025, a decrease of $3.9 million. The decrease was primarily attributable to non recurring costs associated with the acquisitions of the acquisition of Supranolone and the license agreement of NDV01 in 2025. This 2026 decrease was partially offset by increased costs related to the startup of the phase 3 NDV01 trials and phase 2b Supranolone study and additional R and D personnel. 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 31st, 2025, an increase of approximately $5.1 million. The increase was primarily driven by an increase in compensation costs partially offset by 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. The net loss for the three months ended March 31st, 2026 was $19.1 million or $0.22 per basic and diluted chair, compared with a net loss of $17.6 million or $0.58 per basic and diluted share for the three 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 (Chief Executive Officer)

thank you Maget. In closing, I'm very confident and optimistic about our clinical programs and the long term prospect for Almada as we are getting ready to initiate the rescue registration 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

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 Goldwin from Piper Sandler. Your line is now open. Please go ahead.

Kelsey Goldwin (Equity Analyst)

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. I am from 1st for AUA this weekend. It seems like there's some gemdosi presentations I guess how should we think about the growing literature on gemdosi 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 Bacillus Calmette-Guérin (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. Thank you so much.

Sergio Traversa (Chief Executive Officer)

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

Raj Pruthi (Chief Medical Officer, Urology)

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. And you're right, there's 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 that I think is notable is that of time toxicity with Gemdosi. There's two 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. 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'll 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 and we anticipate at a cadence of every three months sharing that data into 2027. I think I got both of your questions

Kelsey Goldwin (Equity Analyst)

Perfect. Thank you so much.

Sergio Traversa (Chief Executive Officer)

Thank you Kelsey.

OPERATOR

Thank you. And the next question comes from Christopher Liu from Lucid Capital Markets. Your line is now open, please. Go ahead.

Christopher Liu (Equity Analyst)

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.

Sergio Traversa (Chief Executive Officer)

Thank you, Chris. Sergio here. I would let Raj, the AU expert to answer this one. Raj?

Raj Pruthi (Chief Medical Officer, Urology)

Yeah, I think, you know, I think for, 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 the RBCG 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 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.

Christopher Liu (Equity Analyst)

I appreciate the color. Thank you.

OPERATOR

Thank you. And the next question comes from UI Ear from Mizuho. Your line is now open. Please go ahead, guys.

Oi Ear

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 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? Does it give you greater chance of or are you thinking about perhaps doing combination studies in addition after the rescue programs are done? Thanks.

Sergio Traversa (Chief Executive Officer)

Good afternoon. Oi and Sergio here. I'll take the first one on the IT 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 US in the formulation and manufacturing and is a new patent we filed in the US and then we'll have the, the opportunity we have sometime, I believe is one year to file outside of The US and so 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.

Oi Ear

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

Sergio Traversa (Chief Executive Officer)

Yeah, it's always, 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 a patent office is very, very busy with a lot of filing and applications. So I would not, I would not focus on, on any response before at least one year.

Raj Pruthi (Chief Medical Officer, Urology)

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 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, is a significant opportunity and market opportunity for relmata, I think. And 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 years to read out. I think that's also another place where if BRIDG does read out as gemdosis non inferior to BCG and becomes an alternative, I think NDV01 can nicely step in there as an easier to use less burdensome approach for Gemdosi in the BCG naive high risk population.

Oi Ear

Great question. Thank you. Thank you.

OPERATOR

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 N1. If you wish to ask a question, the next question comes from Farzinhaq. From Jeffries. Your line is now open. Please go ahead.

Farzinhaq

Good afternoon and thank you for taking my question. So following up on an earlier question, like you have a broad inclusion Criteria for phase three, the BCG unresponsive setting and you're allowing up to two prior lines including a wide range star 200 in Lex, etc. So how are you modeling the potential for variability or dilution of efficacy and could you adjust to one prior line as the trial progresses?

Sergio Traversa (Chief Executive Officer)

Thank you for being. Yeah, Raj, I think. Would you mind to take this?

Raj Pruthi (Chief Medical Officer, Urology)

Yeah, yeah, my pleasure. Thanks for the question. Farzee and 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 that, the idea that, you know, 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 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 in Lexo. We are excluding prior gemdosi in those patients because we're giving a Gemdosi treatment. But we'll look at, in Lexo and Gemcitabine and we have heard, and in my own practice having Gemdosi as a rescue for gemcitabine is appropriate. So we'll be looking at both of those closely and I think we want to see, you know, our efficacy is what is the, 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, you bring up a good point. We are looking at lines of therapy and also what that prior therapy was. Thanks for the question, Farzine.

Farzinhaq

And then on your phase three primary endpoint, does FDA's acceptance of CP at any time imply any durable responses, for example, median duration, response greater than six months? So 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, quote, totality of the data, close quote. So I think they're getting at what you are as a strong crne, 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. So CRNE together with durability in this, framed as duration of response is what they'll 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. Really the other alternative for the patients at this point in their journey is radical cystectomy. Right, Makes sense. And then a quick one is that what is the expectation for enrollment cadence across both your pivotals? Can the drugs in office profile serve as a recruitment advantage? Potentially, yeah. That's a great question, Farzee. 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 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 for zine. 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 one year with the first line therapies. 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 enrollment. Great. Super helpful. Thank you, Raj.

Raj Pruthi (Chief Medical Officer, Urology)

Thanks, Farzee.

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.

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.