Q3 2025 Relmada Therapeutics Inc Earnings Call
Speaker #1: Good afternoon and welcome to Relmada Therapeutics' third quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the prepared remarks, we will conduct a question-and-answer session.
Speaker #1: To ask a question, please press star, and a reminder, this conference call is being recorded. And will be available for replay on the Relmada one. website.
Speaker #1: To ask a question, please press star, and a reminder, this conference call is being recorded. And will be available for replay on the Relmada one.
Speaker #2: everyone, and thank you for joining us afternoon, Relmada issued a press today. This
Speaker #2: September 30, 2025. Please note that certain releases providing business update information discussed on the call today are covered under the Safe Harbor Provision of the Reform Act, which cautions listeners that during this call, Relmada's management team will be making.
Speaker #2: forward-looking Private Securities Litigation As Lightside Advisors.
Speaker #2: statements. Actual results could Please 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 cautionary statements and forward-looking statements are qualified by the information contained in Relmada's press release and its annual report on Form 10-Q for the quarter ended September 30, 2025, filed after the close today.
Speaker #2: These cautionary statements and forward-looking statements are qualified by today and the company's information contained in Relmada's press release issued annual report on Form 10-Q for the quarter ended September 30, 2025, filed after the close of SEC filings, including in this conference call. Also, information that is accurate only as of the date of this live call in 2025.
Speaker #2: Relmada undertakes no obligation to revise or update any broadcast on November 13th, forward-looking statements to reflect contains time-sensitive after the date of this conference call are Relmada's Traversa, who will briefly provide a summary call.
Speaker #2: Relmada undertakes no obligation to revise or update any broadcast on November 13th, forward-looking statements to reflect contains time-sensitive after the date of this conference call are Relmada's Traversa, who will briefly provide a summary call. CEO, Dr. Sergio highlights, Dr. Raj Pruthi, Relmada's CMO, who will provide events or circumstances an NDVO1 program CFO, Maged Shenouda, who will provide an of recent business and a review of the company's Q3 results.
Speaker #2: With me on today's After that, we will open the line for
Speaker #3: everyone, to the Relmada update on Soprano Loan call over to third quarter 2025 conference call. 2025 is shaping up to be a standout year for Relmada, with excellent product development progress driven by the efforts of our outstanding
Speaker #3: recent successful capital raise. We are developing one late-stage and one mid-stage clinical program that we believe could patients. Each program is the potential to be the best-in-class be life-changing for treatment.
Speaker #3: Our new program is NDVO1, a sustained-release formulation of gemcitabine docetaxel or gemdosi, in development for non-muscle invasive bladder cancer or NMIBC. Which affects about 68,000 new patients each year in the US, and has a prevalence of approximately 744,000 patients in the US only.
Speaker #3: second program is Soprano Loan, Our that is intended to in compulsive normalize GABA A receptor activity for Prader-Willi syndrome, which has a US prevalence disorder.
Speaker #3: 20,000 of approximately messages that we will cover today. Number patients. Here are the three key one, we report that nine months follow-up data from the phase two study of NDVO1 in patients with NMIBC.
Speaker #3: showed a 92% overall response rate at any time, with favorable overall safety. We are very pleased by this encouraging and consistent data. Number two, we are pleased to have secured Soprano Loan is in development In brief, the study FDA alignment on the key elements of the phase three program for to enable two NDVO1.
Speaker #3: registrational tracks for NMIBC. This is an important key NDVO1 in de-risking milestone for the program that opens the door to a broad market opportunity It is intended in NMIBC.
Speaker #3: Number three, with the recently completed $100 million underwritten financing, we are well capitalized. The recent offering provides the resources to support our planned operations into 2028 and drive forward the planned registration studies for NDVO1 and the phase two study for Soprano Loan in PWS.
Speaker #3: We are preparing to initiate the studies in 2026. For NDVO1, we expect to begin two separate registrational studies for NMIBC, starting in the first half of 2026.
Speaker #3: For Soprano Loan, we anticipate starting a phase two study in PWS also in the first half of 2026. We are well positioned to advance our pipeline thanks to our expanded clinical team.
Speaker #3: Dr. Raj Pruthi, as Chief Medical Officer Euro Oncology. Dr. Pruthi is a highly respected expert in bladder Earlier this year, we appointed cancer and urologic oncology who brings vast experience advancing novel therapies for NMIBC.
Speaker #3: We have also established a clinical advisory board to provide additional guidance for the pivotal program of NDVO1. The board is comprised of prominent leaders in NMIBC and is chaired by Dr. Jair Lothan.
Speaker #3: A renowned urologic oncologist. In October, we were pleased to welcome Dr. Max Case to our advisory clinical advisory board. Dr. Case chairing the landmark phase three bridge study and leading several brings a wealth of experience from other practice changing studies.
Speaker #3: I am very pleased with Relmada's work this year to de-risk our pipeline and advance two potentially life-changing therapies. We are looking forward with enthusiasm, with several value inflection catalysts ahead.
Speaker #3: ahead to 2026 with Raj, thank you, everyone. I believe this is a very Raj is going to provide an update on with the NDVO1 development patients.
Speaker #3: Next, the NDVO1 development program, including a nine-month follow-up data from the phase two, and a summary of the key highlights from B pre-IND meeting with the FDA.
Speaker #3: program, I want to touch on three items today. An overview of the patient the recent type care journey in non-muscle Based on our excellent progress NMIBC.
Speaker #3: A review Sergio, and good afternoon, FDA meeting invasive bladder cancer, or highlights. Let's start with the NMIBC and the patient journey. There are about 85,000 data.
Speaker #3: And a summary of the Relmada is focused on high-risk NMIBC and on intermediate-risk NMIBC. Representing about 80% of NMIBC cases or 54,000 people per year.
Speaker #3: new cases of bladder cancer diagnosed each year in the United people living with bladder States, and 744,000 cancer. About 80% of bladder cancer patients had NMIBC, and recurrence rates over five years are about 60 to 80%.
Speaker #3: In brief, the patient care journey most commonly begins when a patient presents with blood in the urine or hematuria. Suspected bladder cancer cases are diagnosed using cystoscopy and cytology.
Speaker #3: Treatment begins with a surgical procedure called transurethral resection of the bladder tumor, or TURBT. This procedure allows surgeons to classify the patient's disease stage and risk category and define the treatment plan.
Speaker #3: After surgery, patients with high-risk disease receive intravesical adjuvant therapy with the standard of care immunotherapy known as Bacillus Calmette-Guérin, or BCG. Patients are then monitored with regular cystoscopies and urine cytology every three months to assess for recurrence.
Speaker #3: Patients with recurrent disease are treated with repeat surgery alternating with intravesical treatment. NDVO1 is a novel sustained-release intravesical formulation of two chemotherapy agents, gemcitabine and docetaxel, or gemdosi, as we say.
Speaker #3: numerous studies conducted over the It was designed to build on data from past decade showing that combination use of these two agents receives response rates and recurrence-free survival that are comparable to or better than historical standard of care BCG.
Speaker #3: And for those who are unresponsive to BCG, it can provide a second-line bladder-sparing option to avoid radical cystectomy. The sustained-release formulation of NDVO1 will be provided to study sites in a ready-to-use format that does not require a specialized pharmacy or biocontainment hood to formulate the gemdosi combination.
Speaker #3: NDVO1 is intended to be instilled into the bladder through a regular catheter in the office in a less than five-minute intravesical instillation. Upon administration, the formulation creates a soft matrix that is intended to enhance local exposure and minimize systemic toxicity.
Speaker #3: Moving to the nine-month data, we're pleased to report that NDVO1's continued positive phase two performance strongly supports its potential to transform the treatment of NMIBC.
Speaker #3: The study is a single-arm, single-center XUS trial in patients with high-risk NMIBC. Patients are treated with NDVO1 in a six biweekly induction phase followed by monthly maintenance for up to one year.
Speaker #3: Patients receive regular assessments with cystoscopy, cytology, and if needed, biopsy. The study is designed to enroll up to 70 patients with localized high-risk NMIBC.
Speaker #3: The primary endpoints are safety and complete response at 12 months. Secondary efficacy endpoints are duration of response and event-free survival. Efficacy assessments for the nine-month follow-up included analysis of data at nine months and at any time point.
Speaker #3: These are the same safety and efficacy parameters that were applied to the six-month data reviewed during our Q2 call in August and the three-month data presented at the American Urological Association meeting in April.
Speaker #3: Looking at the data, we observed a complete response rate of 92% at any time based on 25 patients. Amongst patients with BCG unresponsive disease, we see a 91% CR any time.
Speaker #3: At the nine-month assessment, we observed a complete response rate of 85%. No patients had progression to muscle invasive disease, and no patients underwent a radical cystectomy.
Speaker #3: Patients who had been re-induced had a 60% complete response rate. The study also includes certain defined subpopulations. For example, patients with BCG unresponsive disease we saw a 91% CR any time and a nine-month CR rate of 88%.
Speaker #3: NDVO1 continues to demonstrate favorable safety, consistent with our expectations and the known efficacy and safety of gemdosi. There were no reported new safety signals; no patients experienced treatment-related adverse events that were Grade 3 or higher; and no patients discontinued treatment due to adverse events.
Speaker #3: The most common treatment-related adverse events were transient dysuria and hematuria, and asymptomatic positive urine cultures, and incidental findings observed in 9% of patients with hematuria only seen in 7%.
Speaker #3: All patients with dysuria were grade one and resolved within 24 hours. Our goal is to bring NDVO1 to patients as soon as possible. We intend to initiate the phase three program for NDVO1 in the first half of 2026.
Speaker #3: The recent positive type B FDA meeting is a key milestone that reinforces our confidence in the path forward for NDVO1. I'd like to summarize the key outcomes from the FDA meeting, a very positive constructive and pragmatic discussion with them.
Speaker #3: Relmada secured FDA alignment on certain key elements of the planned Phase 3 pivotal program for NDVO1, incorporating two separate and distinct registration paths: number one, high-risk, second-line BCG-unresponsive NMIBC patients.
Speaker #3: And number two, intermediate-risk NMIBC in the adjuvant setting. In the setting of high-risk second-line BCG unresponsive disease, the FDA stated that a single-arm trial might be acceptable in a more refractory patient population.
Speaker #3: We're excited about this approach because it could offer a rapid route to approval. In the indication of intermediate-risk in the adjuvant setting, the FDA agreed that a proposal to randomize patients post-TORBT to adjuvant NDV1 versus observation evaluating a time-to-event endpoint is generally acceptable.
Speaker #3: We feel that the opportunity to incorporate NDVO1 into patient care after TORBT is very attractive. It could pave the way for an additional indication and broader clinical adoption.
Speaker #3: Importantly, the FDA indicated that no further clinical or nonclinical studies are required to support a 505(b)(2) NDA. This is very good news. We look forward to working with the FDA to complete the study designs and initiate the registration program in the first half of 2026.
Speaker #3: Our efforts in the coming months will also focus on transferring production to contract manufacturers to complete scale-up and production of clinical batches. As I hand the call over to our CFO, Maged Shenouda, I am optimistic about the NDVO1 clinical development program based on the excellent nine-month results: positive outcomes with the FDA meeting and our ongoing phase three preparation.
Speaker #3: Maged?
Speaker #2: Thanks, Raj. And good afternoon, everyone. Today, I'll spend a few minutes on sopranolone and then provide you with an overview of our third quarter 2025 financials.
Speaker #2: Sopranolone is a member of a new subgroup of newer steroids called GAMSAs, or GABA-modulating steroid antagonists. We believe sopranolone's novel action on the GABA neurotransmitter pathway gives it unique potential to normalize GABA A receptor activity and alleviate the repetitive symptoms and disorders where compulsive behaviors are a common feature.
Speaker #2: These disorders affect millions of people in the US and around the world and include indications such as Prader-Willi syndrome and Tourette syndrome. We have selected Prader-Willi syndrome, or PWS, as the first clinical indication that we will evaluate for sopranolone.
Speaker #2: It affects approximately 350,000 people worldwide including approximately 20,000 people in the US. PWS is a complex genetic disorder, often defined by persistent hunger and overeating.
Speaker #2: Current treatment is focused on improving the obsessive-compulsive behaviors and other medical complications that characterize the disorder. Phase two data from a study in patients with Tourette syndrome established sopranolone's initial efficacy in a compulsivity disorder with good overall tolerability.
Speaker #2: We intend to initiate a proof-of-concept study in PWS in the first half of 2026. Our immediate efforts are dedicated to completing study preparations, including engaging with the FDA and our proposed trial design on our proposed trial design and establishing a robust supply chain.
Speaker #2: Moving now to our financial results. As noted earlier by Brian, this afternoon in Relmada issued a press release announcing our business and financial results for the third quarter and nine months ended September 30, 2025.
Speaker #2: As of September 30, 2025, Relmada had cash, cash equivalents, and short-term investments of approximately $13.9 million compared to $44.9 million as of December 31, 2024.
Speaker #2: Notably, this excludes net proceeds of approximately $94 million from our $100 million underwritten offering of common stock and pre-funded warrants, which the company closed on November 5, 2025.
Speaker #2: Based on current plans, the company believes that its current cash balance, including net proceeds from the offering, is sufficient to support planned expenses into 2028.
Speaker #2: Cash used in operations in the third quarter ended September 30, 2025, was $6.7 million. Compared to $16.7 million, for the same period in 2024.
Speaker #2: During today's call, I'll review our third quarter 2025 financial results. Information regarding the nine-month results is included in our press release and 10Q filing issued this afternoon.
Speaker #2: Research and development expense for the third quarter 2025 totaled $4 million compared to $11.1 million for the third quarter of 2024. A decrease of 7.1 million dollars.
Speaker #2: The lower spend was primarily driven by lower study costs with a wind-down of clinical trials for rel1017, partially offset by an increase in manufacturing drug storage costs associated with the ramp-up of NDVO1 and sopranolone studies and an increase in R&D employees.
Speaker #2: General and administrative expense for the third quarter 2025 totaled $6.3 million. Compared to $11.9 million for the third quarter of 2024. A decrease of approximately 5.6 million dollars.
Speaker #2: The decrease was primarily driven by a decrease in stock-based compensation expense as well as direct employee and administrative expense. The net loss for the third quarter of 2025 was $10.1 million, or 30 cents per basic and diluted share, compared with a net loss of $21.7 million or 72 cents per basic and diluted share for the third quarter of 2024.
Speaker #2: Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?
Speaker #3: Thank you, Maged. Before we go to the Q&A session, I would like to share that I'm very pleased with Relmada's work this year to advance the risk of a portfolio of potentially less change in therapy for patients.
Speaker #3: With our progress comes our gratitude for your support and for taking time to join today's call. 2026 is shaping up to be another very important year for the company, and we look forward to updating you on our continued progress.
Speaker #3: Operators, I would like now to open the call for questions.
Speaker #4: Thank you. Ladies and gentlemen, as a reminder, if you have asked questions, please press star and then one, on your telephone keypad. Our first question comes from Yuer of Museo Securities.
Speaker #4: Please go ahead.
Speaker #5: Hey, guys. Yeah, congrats on all the progress that you've made over the last nine months. Yeah. It takes a lot of doing maybe the first question we have is maybe just help us understand a little bit about the different potential market opportunity for the two, I guess, indications that you are kind of going after and maybe also help us understand the sequence of it.
Speaker #5: Will you start the study at the same time and when you think that one study will finish before the other and if you can maybe provide some guidance on when each of the studies could complete?
Speaker #5: So maybe talk about the potential number of patients in the refractory second-line setting versus the potential number of patients in low-grade intermediate risk who could benefit from the adjuvant.
Speaker #5: Combination of NDVO1. First question. Thanks.
Speaker #3: Thank you all for the question. I believe Raj that runs the clinical program can answer your question appropriately. Raj, you want to try?
Speaker #6: Yeah. Yeah, of course. So as I mentioned, there's two proposed indications. One is in BCG unresponsive, refractory to first-line therapy. And I'll talk—let me talk a little bit about this population, then the intermediate risk, and then we'll talk about timelines.
Speaker #6: So this is a relatively smaller population; there are about 8,000 patients per year. Now, with current therapies, 55% to 80% of those patients will recur after first-line therapy.
Speaker #6: So there's a growing number of patients that are needed in this second-line indication. So from 8,000, you can take that down to 55 to 80 percent.
Speaker #6: That'll—each year, that'll be BCG unresponsive that fail a primary therapy. Now, the intermediate risk population—and this is high-grade and low-grade intermediate risk—is a much larger patient population, estimated about 80,000 incident and prevalent patients each year in the United States, with intermediate risk and MIBC.
Speaker #6: Significant number of them probably over half will receive an adjuvant therapy. And so that's about 40,000. So that represents a significant market for us to address.
Speaker #6: And I think if you look at surveys of urologists, chemotherapy and gem-dosing chemotherapy is the preferred choice. Regarding your question on timings, our plan is to initiate both of these trials—although they're separate indications—both trials at about the same time in the second quarter of 2026.
Speaker #6: I think this will provide for operational efficiencies and contracting and addressing sites and, I think, for the sites will be easier as they kind of know how to do a clinical trial one side or the other.
Speaker #6: And the unresponsive patient population, the first patient in being Q2 '26, will likely have clinical data three-month data by Q4 '26 to provide internally and externally and then the endpoint is going to be a 12-month CR.
Speaker #6: So that'll be Q2 '27. With top-line data in Q2 '28. And the intermediate risk study also initiating in Q2 '26, that's an open-label but randomized study.
Speaker #6: That'll take probably about 15 months to complete enrollment. With that completed enrollment, we'll need probably about 18 to 24 months of follow-up. It's, I think it's a little bit tricky.
Speaker #6: We plan to do an interim analysis at 70% event. Regarding the ability to provide data before then, I think that's a conversation we'll have to have with the FDA.
Speaker #6: Although it's an open-label study, we certainly wouldn't want to expend alpha along the way. So I hope that gives you an idea of the size of the population and the
Speaker #6: timelines. Yeah, that was super
Speaker #5: helpful. So maybe just help us with the other element. So with J&J and LEXO, I think the price is 69,000 dollars per dose or per one of those Pretzel tubes.
Speaker #5: And the induction phase is, I think it's, what, you need eight of those. So that's sort of rounds up to about 550,000 dollars a year?
Speaker #5: Does that sort of make sense in terms of—I know it's probably too early to sort of speak about pricing. I just wanted to maybe get your view on what potential pricing could look like.
Speaker #6: Yeah, let me actually take a quick answer to that, and then I'd like to ask our CEO, Sergio, to comment. So yeah, I think if you actually add up the induction phase and maintenance phase in the first year for LEXO, it approaches 700,000 dollars.
Speaker #6: So that's certainly is now sent set the new benchmark above Antiva. For one, if you look at one year of therapy, the other end of the spectrum to me is Zusduri, which is in low-grade intermediate chemoablation.
Speaker #6: Which the yearly cost there is about 120,000 dollars. So I think the numbers will fall somewhere between. But Sergio, do you mind if I ask you to comment on that?
Speaker #3: Yeah, no, sure. Thanks, Raj. And look, it's a bit early to talk about pricing because we have to—we'll be data-driven depending on the data we look like.
Speaker #3: We will price accordingly to the value added for patients. But we do have a luxury to watch what the uptake and the penetration of J&J and the other chemotherapy origin with their pricing.
Speaker #3: And we'll base our decision based on also how their pricing is will be received by the urology community. So I hope I answered your question the best way I can.
Speaker #3: But we don't really have any specific pricing orientation for now.
Speaker #5: Yeah, thanks for that. I know it's probably—it's way too early. And you're right. You need to look at the data, but it's—I guess it's kind of encouraging that the pricing is kind of interesting.
Speaker #5: So maybe I'll ask question—maybe just help us to kind of understand a little better with respect to the differentiation and from the conventional gem-dosing—I think on the call you mentioned that you need a special biochemical hood and you need a special pharmacist, as I guess someone who maybe even licensed, who needs to put the product into syringes to be used.
Speaker #5: Yeah, just help us understand because of this hurdle, where the product is currently used? Is it mostly in academic center? And if all of this goes away, what how does it open up the market for you if it does?
Speaker #5: Thanks.
Speaker #6: Yeah, that's a wonderful question.
Speaker #6: And yeah, and I think has been the hurdle of gem-dosing, right? We know it works in urologists. We know it works well. Like I mentioned, for a decade.
Speaker #6: for the community The obstacles patients are taken care of in the urologists where 70 to 80 percent of these community is you need a specialized pharmacy.
Speaker #6: And if you look at the overall sequential gemcitabine followed by procedural time of docetaxel, it's upwards of four hours. So that's a very different—that's easy to do in an academic center.
Speaker #6: And I think that's where most of the uptake has, but very specialized pharmacy. And room difficult in the community lack of or chair time and the staff for that for four hours.
Speaker #6: So I think by having pre-filled syringes, avoiding the specialized pharmacy, and having a five-minute or so installation to a catheter, removing the catheter, and watching the patient, allowing them to go home, I think opened the door up.
Speaker #6: This is an opportunity for academic centers as well, patients where they're at and to meet the urologists but I think also to meet the where they're at as well.
Speaker #6: So I think it opens up the market significantly.
Speaker #3: Okay. Sorry, maybe just one additional the two indications which is question. So I know you're going after just actually quite broad. Particularly in the intermediate risk section.
Speaker #3: But there are BCG-naive patients called the, I guess, the Bridge ongoing study. If the study succeeds, there is the potential to be used off-label, even though you won't be promoting it.
Speaker #3: Because every doctor will probably have an opportunity for this product to
Speaker #3: product. Yeah,
Speaker #6: Yeah, thank you,
Speaker #6: Sergio. So that's a very
Speaker #6: Max Kates or one of his head of the bridge file. So the bridge trial is a randomized view? study of BCG versus gem-dosing it's an 800-patient trial enrollment and will read out in two cooperative group trial that is near end of years.
Speaker #6: So the timing is nice for us.
Speaker #6: It's And I wish everyone a great
Speaker #6: a tremendous opportunity for Relmada. Great question. Thank study. you.
Speaker #2: And they will continue to help us to If this get where we want to be. That is to bring available for doctors and patients.
Speaker #2: Thank you very NDVO1 and Sipranolon day. Thank evening. For the rest of the
Speaker #2: you. Thank you,
Speaker #1: sir. Ladies and gentlemen, that concludes today's call. Thank you for joining us. Anyone not disconnect?