RLMD - NASDAQ

Good afternoon, and welcome to Relmada Therapeutics, Inc. 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. As a reminder, this conference call is being recorded and will be available for replay on the Relmada Therapeutics, Inc. website. I would now like to turn the call over to Brian Ritchie of LifeSci Advisors. Please go ahead.

Thank you for joining us today. This afternoon, Relmada Therapeutics, Inc. issued a press release providing a business update and outlining its financial results for the three months ended September 30, 2025. 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 this 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 annual report on Form 10-Q for the quarter ended September 30, 2025, 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 November 13, 2025. Relmada Therapeutics, Inc. undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With me on today's call are Relmada's CEO Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights, Dr. Raj S. Pruthi, Relmada's CMO, who will provide an NDV-01 program update, and Relmada's CFO Maged S. Shenouda, who will provide an update on our 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. Sergio, please go ahead.

Thank you, Brian, as always. And good afternoon, and welcome everyone to the Relmada Therapeutics, Inc. Third Quarter 2025 Conference Call. 2025 is shaping up to be a standout year for Relmada Therapeutics, Inc. with excellent product development progress, driven by the effort of our outstanding team and strengthened by our recent successful capital raise. We are developing one late-stage and one mid-stage clinical program that we believe could be life-changing for patients. Each program has the potential to be the best-in-class treatment. Our lead program is NDV-01, 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. Our second program is Sepranolone. It is intended to normalize GABA A receptor activity in compulsive disorder. The plan is in development for Prader-Willi syndrome, which has a US prevalence of approximately 20,000 patients. Here are the three key messages that we will cover today. Number one, we report the nine months data from the phase two study of NDV-01 in patients with NMIBC. In brief, the study showed a 92% overall response rate at any time, with favorable overall safety. We are very pleased by these encouraging and consistent data. Number two, we are pleased to have secured FDA alignment on the key elements of the phase three program for NDV-01. It is intended to enable two distinct and independent registrational tracks for NDV-01 in NMIBC. This is an important key de-risking milestone for the program that opens the door to a broad market opportunity in NMIBC. Number three, with the recently completed $100 million underwritten finance, we are well capitalized. The recent offering provides the resources to support our planned operation into 2028 and drive forward the plan of registration studies for NDV-01 and the phase two study for Sepranolone in PWS. We are preparing to initiate these studies in 2026. For NDV-01, we expect to begin two separate registrational studies for NMIBC, starting in 2026. For Sepranolone, we anticipate starting a phase two study in PWS also in 2026. We are well positioned to advance our pipeline thanks to our expanding clinical team. Earlier this year, we appointed Dr. Raj S. Pruthi as Chief Medical Officer, Uro-Oncology. Dr. Pruthi is a highly respected expert in bladder cancer urologic oncologist who brings vast experience advancing novel therapies for NMIBC. We have also established a clinical advisory board to provide additional guidance for the pivotal program for NDV-01. The board is comprised of prominent leaders in NMIBC and chaired by Dr. Yair Lotan, a renowned urologist oncologist. In October, we were pleased to welcome Dr. Max Cates to our advisory clinical advisory board. Dr. Cates brings a wealth of experience from chairing the landmark phase three BRIDGE study and leading several other practice-changing studies. I am very pleased with Relmada Therapeutics, Inc.'s work this year to de-risk our pipeline and advance two potentially life-changing therapies. We are looking ahead to 2026 with enthusiasm, with several value inflection catalysts ahead. Next, Raj is going to provide an update on the NDV-01 development program, including a nine months follow-up data from the phase two and a summary of the key highlights from the recent Type B, pre-IND meeting with the FDA. Raj?

Thank you, Sergio, and good afternoon, everyone. I believe this is a very exciting time for our patients based on our excellent progress with the NDV-01 development program. I want to touch on three items today. An overview of the patient care journey in non-muscle invasive bladder cancer or NMIBC, a review of the nine-month data, and a summary of the FDA meeting highlights. Let's start with the NMIBC and the patient journey. There are about 85,000 new cases of bladder diagnosed each year in the United States and 744,000 people living with bladder cancer. About 80% of bladder cancer patients have NMIBC, and recurrence rates over five years are about 60 to 80%. Relmada Therapeutics, Inc. is focused on high-risk NMIBC and on intermediate-risk NMIBC, representing about 80% of NMIBC cases or 54,000 people per year. 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. 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. After surgery, patients with high-risk disease receive intravesical adjuvant therapy with standard of care immunotherapy known as bacillus Calmette-Guerin or BCG. Patients are then monitored with regular and urine cytology every three months to assess for recurrence. Patients with recurrent disease are treated with repeat surgery alternating with intravesical treatments. NDV-01 is a novel sustained release intravesical formulation of two chemotherapy agents, gemcitabine and docetaxel, or Gemdosi, as we say. It was designed to build on data from numerous studies conducted over the past decade showing that combination use of these two agents achieves response rates and recurrence-free survival that are comparable to or better than historical standard of care BCG. 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 NDV-01 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. NDV-01 is intended to be instilled into the bladder through a regular catheter in a less than five-minute intravesical installation. Upon administration, the formulation creates a soft matrix that is intended to enhance local exposure and minimize systemic toxicity. Moving to the nine-month data, we're pleased to report that NDV-01's continued positive phase two performance strongly supports its potential to transform the treatment of NMIBC. The study is a single-arm, single-center ex-US trial in patients with high-risk NMIBC. Patients are treated with NDV-01 in a six biweekly induction phase followed by monthly maintenance for up to one year. 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. The primary endpoints are safety and complete response at twelve 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. 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. 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 anytime. At the nine-month assessment, we observed a complete response rate of 85%. No patient had progression to muscle-invasive disease and no patients underwent a radical cystectomy. Patients who had been reinduced had a 60% complete response rate. The study also includes certain defined subpopulations. For example, patients with BCG unresponsive disease, we saw 91% CR anytime and a nine-month CR rate of 88%. NDV-01 continues to demonstrate favorable safety consistent with our expectations and known efficacy and safety of Gemdosi. There were no reported new safety signals, no patients who had treatment-related adverse events that were grade three or higher, and no patients discontinued treatment due to adverse events. The most common treatment-related adverse events were transient dysuria and hematuria and asymptomatic positive urine cultures, an incidental finding observed in 9% of patients with hematuria only seen in 7%. All patients with dysuria were grade one and resolved within 24 hours. Our goal is to bring NDV-01 to patients as soon as possible. We intend to initiate the phase three program for NDV-01 in 2026. The recent positive type B FDA meeting is a key milestone that reinforces our confidence in the path forward for NDV-01. I'd like to summarize the key outcomes from the FDA meeting, a very positive, constructive, and prior dialogue discussion with them. Relmada Therapeutics, Inc. secured FDA alignment on certain key elements of the planned Phase III pivotal program for NDV-01, incorporating two separate and distinct registrational paths. Number one, high-risk second-line BCG unresponsive NMIBC patients. 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. 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-TURBT to adjuvant NDV-01 versus observation evaluating a time-to-event endpoint is generally acceptable. We feel that the opportunity to incorporate NDV-01 into patient care after TURBT is very attractive. It could pave the way for an additional indication and broader clinical adoption. Importantly, the FDA indicated that no further clinical 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 design and initiate the registrational program in 2026. 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 S. Shenouda, I am optimistic about the NDV-01 clinical development program based on the excellent nine-month results, positive outcomes with the FDA meeting, and our ongoing phase three preparation. Maged?

Thanks, Raj, and good afternoon, everyone. Today, I'll spend a few minutes on Sepranolone, and then provide you with an overview of our third quarter 2025 financials. Sepranolone is a member of a new subgroup of neurosteroids called GAMSAs or GABA modulating steroid antagonists. We believe Sepranolone'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. These disorders affect millions of people in the US and around the world and include indications such as Prader-Willi syndrome and Tourette's syndrome. We have selected Prader-Willi syndrome, or PWS, as the first clinical indication that we will evaluate for Sepranolone. 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. Current treatment is focused on improving the obsessive-compulsive behaviors. Phase II data from a study in patients with Tourette's syndrome established Sepranolone's initial efficacy in a compulsivity disorder with good overall tolerability. We intend to initiate a proof of concept study in PWS in 2026. Our immediate efforts are dedicated to completing study preparations, including engaging with the FDA on our proposed trial design and in establishing a robust supply chain. Moving now to our financial results. As noted earlier by Brian, this afternoon, Relmada Therapeutics, Inc. issued a press release announcing our business and financial results for the third quarter and nine months ended September 30, 2025. As of September 30, 2025, Relmada Therapeutics, Inc. had cash, cash equivalents, and short-term investments of approximately $13.9 million compared to $44.9 million as of December 31, 2024. Notably, this excludes net proceeds of approximately $94 million from our $100 million underwritten offering of common stock prefunded warrants, which the company closed on November 5, 2025. 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. 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. During today's call, I'll review our third quarter 2025 financial results. Information regarding the nine months results are included in our press release and 10-Q filings issued this afternoon. Research and development expense for the third quarter 2025 totaled $4 million compared to $11.1 million for 2024, a decrease of $7.1 million. The lower spend was primarily driven by lower study costs with a wind-down of clinical trials for Rel-1017 partially offset by an increase in manufacturing drug storage costs associated with the ramp-up of NDV-01 and Sepranolone study and an increase in R&D employees. General and administrative expense for the third quarter 2025 totaled $6.3 million compared to $11.9 million for 2024, a decrease of approximately $5.6 million. 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 2025 was $10.1 million or 30¢ per basic and diluted share, compared with a net loss of $21.7 million or 72¢ per basic and diluted share for 2024. Sergio? Before we open the call for questions, I'll turn back to Sergio for some closing comments.

Thank you, Maged. Before we go to the Q&A session, I would like to share that I'm very pleased with Relmada Therapeutics, Inc.'s work this year to advance and de-risk a portfolio of potentially life-changing therapies for patients. 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. Operator, I would like now to open the call for questions.

Thank you. Ladies and gentlemen, as a reminder, if you have a question, please press one on your telephone keypad. Our first question comes from Uy Sieng Ear of Mizuho Securities. Please go ahead.

Hey, guys. Congrats on all the progress that you've made over the last nine months. It takes a lot of doing. Maybe, you know, the first question we have is maybe just help us understand a little bit about, you know, the different potential market opportunity for the two, I guess, indications that you are kind of going after, and maybe also, you know, help us understand the sequence of it. Will you start the study at the same time? And when do 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. So maybe, you know, 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 combination of NDV-01. First question. Thanks.

Thank you, Uy, for the question. I believe Raj, who runs the clinical program, can answer your question appropriately. Raj, do you want to try?

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. So this is a relatively smaller, about 8,000 patients per year. Now with current therapies, 55 to 80% of those patients will recur after first-line therapy. 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% that will each year be BCG unresponsive that fail primary therapy. High-grade and low-grade intermediate risk. Now the intermediate risk population, and this is a much larger patient population estimated about 80,000 incident and prevalent patients each year in the United States with intermediate risk NMIBC. A 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. And I think if you look at surveys of urologists, chemotherapy and Gemdosi chemotherapy is the preferred choice. Regarding your question on timing, our plan is to initiate both of these trials, although they're separate indications, both trials at about the same time in 2026. I think this will provide for operational efficiencies and cost checks, contracting, and addressing sites. And I think for the sites, it will be easier as they kind of know how to do a clinical trial one side or the other. And the unresponsive patient population, with the first patient in being Q2 2026, will likely have clinical data, three-month data by Q4 2026 to provide internally and externally. And then the endpoint is going to be a twelve-month CR. So that'll be Q2 2027, with top-line data in Q2 2028. And the intermediate risk study also initiating in Q2 2026. That's an open-label but randomized study. That'll take probably about fifteen months to complete enrollment. Within that completed enrollment, we'll need probably about 24 months of follow-up. It's, I think it's a little bit trickier. We plan to do an interim analysis that's 70% events. Regarding the ability to provide data before then, I think that's a conversation we'll have to have with the FDA. 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 populations and the timelines.

Yeah. That was super helpful. So maybe just help us with the other element. So, you know, with J&J and Lexo, I think the price is $69,000 per dose or per one of those pretzel tubes. And the induction phase is, I think it's what you need eight of those. So that sort of rounds up to about $550,000 a year. Does that sort of make sense in terms of, I know it's probably too early to sort of speak about pricing. Just wanted to maybe get your view on what potential pricing could look like.

Yeah. Let me actually take a quick answer to that, and then I would 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 Inlexo, it approaches $700,000. So that certainly is now 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

Yeah. No. Sure. Thanks, Raj. I know it look. It's a bit early to talk about pricing. Because, like, we have to, we'll be data-driven depending on what the data looks like. We will, you know, price accordingly to the value added for patients. But we do have the luxury to watch what the uptake and the penetration of J&J and the other chemotherapy origin with their pricing, and we'll base our decision based on also how their pricing will be received by the urology community. So I hope I answered your question the best way I can. But we don't really have any specific pricing orientation for now.

Mhmm. Yeah. Thanks for that. I know it's probably way too early. And you're right. You know, you need to look at the data, but it's, I guess it's kind of encouraging that the pricing is kind of interesting. So maybe our last question, you know, maybe just help us to kind of a little better with respect to the differentiation from, you know, the conventional Gemdosi. I think on the call, you mentioned that, you know, 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. Yeah. Just help us understand, like, because of this hurdle where the product is currently used? Is it mostly in academic centers? And if all of this goes away, like, how does it open up the market for you if it does? Thanks.

Yeah. That's a wonderful question. And I think that has been the hurdle of Gemdosi. Right? We know it works as urologists. We know it works well, like I mentioned, for a decade. The obstacles for the community urologist, where 70 to 80% of these patients are taken care of in the community, is you need a specialized pharmacy. And if you look at the overall procedural time of sequential gemcitabine followed by docetaxel, it's upwards of four hours. So that's very easy to do in an academic center, and I think that's where most of the uptake has been. Very difficult in the community, lack of specialized pharmacy, and room or chair time and the staff for that for four hours. So I think by having prefilled syringes, avoiding the specialized pharmacy, and having a five-minute or so installation to a catheter, removing the catheter, watching the patient, allowing them to go home, I think opens the door. This is an opportunity for academic centers as well, but I think also to meet the patients where they're at and to meet the urologists where they're at as well. So I think this opens up the market significantly.

Okay. Sorry. Maybe just one additional question. I know you're going after just the two indications, which is actually quite broad, particularly in the intermediate risk section. But you know, there's an ongoing study in BCG naive patients called the, I guess, the BRIDGE study. If this study succeeds, like, what does that do to the potential opportunity for this product to be used off-label even though you, you know, you won't be promoting it because every doc will probably know about your product.

Yeah. Raj, you want to give your view?

Yeah. Thank you, Sergio. So that's a very insightful question, Uy. And, actually, Max Cates is one of the heads in the BRIDGE trial. So the BRIDGE trial is a randomized study of BCG versus Gemdosi in high-risk disease. And it's an 800 patient trial, cooperative group trial that is near end of enrollment and will read out in two years. So timing is nice for us. It's meant to look if Gemdosi is noninferior to BCG. So we know that the obstacle with BCG now are supply issues, and that's been ongoing for fifteen years in the US globally. And, also, it does have toxicity to it. It's effective, but it does have toxicity. So if now you introduce the ability of Gemdosi to substitute in for BCG, you know, Uy, I think that especially as you said in an off-label use, an easier way to give it, I think that opens the market significantly. That's a tremendous opportunity for Relmada Therapeutics, Inc. Great question. Thank you.

Okay. Thank you.

Ladies and gentlemen, this concludes the question and answer session. I will now hand over to Sergio Traversa for closing remarks.

Thank you very much, and thank everyone. And just an extended thank you to investors, patients, employees, collaborators, and consultants that have helped us to get where we are now, and they will continue to help us to get where we want to be. That is to bring NDV-01 and Sepranolone available for doctors and patients. Thank you very much, and I wish everyone a great evening for the rest of the day.

Thank you.