RLMD - NASDAQ

Good afternoon, and welcome to the Relmada Therapeutics Second Quarter 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded and will be available for replay on the Relmada website. I would now like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.

Thank you. Good day, everyone, and thank you for joining us today. This afternoon, Relmada issued a press release providing a business update and outlining its financial results for the 3 months ended June 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-K -- in the quarterly report on Form 10-Q for the quarter ended June 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 August 7, 2025. Relmada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With me on today's call are Relmada's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights; Dr. Raj Pruthi, Relmada's CMO, who will provide an overview of NDV-01; and Relmada's CFO, Maged Shenouda, who will provide an update on sepranolone and a review of the company's Q2 financial results. After that, we will open the call for a brief Q&A session. Now I would like to turn the call over to Sergio Traversa. Sergio?

Thank you, Brian. Good afternoon, and welcome, everyone, to the Relmada Second Quarter 2025 Conference Call. During today's call, I will provide an overview of our recent progress and upcoming milestones. After that, Raj Pruthi will review the updated 6- month Phase II data for NDV-01 that we announced today. Maged will provide an update on sepranolone and review our financial results, then make a few closing remarks, and we'll take your questions. Relmada is making good progress this year. To get started, I would like to highlight 4 points. First, we are excited about the 2 product candidates that we added to the company. NDV-01 for non-muscle invasive bladder cancer or NMIBC and sepranolone for compulsivity disorders, starting with Prader-Willi syndrome, or PWS. NDV-01 and sepranolone are well aligned with our product acquisition criteria. They have demonstrated proof-of-concept data and good overall safety in the initial studies, and they have the potential to be first-in-class programs. In addition, they each address significant and underserved markets with potential to expand beyond the first indication. Second, we are pleased to report that the 6 months follow-up from the Phase II study or NDV-01 produced impressive response rates with 91% of patients achieving high- grade disease-free status at any time point following NDV-01 treatment. As a reminder, NDV-01 is a sustained release formulation of gemcitabine and docetaxel or Gem/Doce. Third, we have expanded our team with the addition of 2 highly respected expert in bladder cancer and urologic oncology. Dr. Raj Pruthi as Chief Medical Officer, Oncology and Dr. Yair Lotan as Chair of our Clinical Advisory Board. We believe the contribution will be instrumental to our success. And fourth, we have made significant progress toward our objective of bringing each program to patients as soon as possible with preparation underway to begin the next set of studies for NDV-01 and sepranolone in 2026. With 2 promising product candidates and expanded management team and Clinical Advisory Board, a $20.6 million cash balance and a clean balance sheet, I believe Relmada is well positioned to take the next value-creating steps for each program. Next, I would like to ask Dr. Pruthi to update you on NDV-01 and the new 6-month follow-up data. Raj is an accomplished urology expert with best clinical experience in the development of novel therapy for non-muscle invasive bladder cancer. Raj, on you.

Thank you, Sergio, and good afternoon, everyone. I'm excited to be part of the Relmada team. This afternoon, I'm pleased to provide a brief overview of NDV-01 and share the positive 6-month follow-up data from our Phase II open-label study in patients with high- grade non-muscle invasive bladder cancer. There are about 85,000 new cases of bladder cancer diagnosed each year in the United States, and 600,000 people in the U.S. living with bladder cancer. About 50% of new cases of bladder cancer have high-grade disease, that is a high risk of recurrence and potentially progression. I joined Relmada because I believe that NDV-01 has the unique potential to become a class-leading bladder-sparing therapy for NMIBC. This is an exciting time for our patients. NDV-01 is a novel sustained-release intravascular formulation of 2 chemotherapy agents, gemcitabine and docetaxel or Gem/Doce, as we say. It was designed to build on data from over the past decade from academic centers showing that combination use of these 2 agents achieved response rates and recurrence-free survival that were comparable to or better than the historical standard of care, BCG. And for those who are unresponsive to BCG, it can provide an effective second- line option to avoid cystectomy. The sustained release formulation of NDV-01 is intended to accomplish 4 objectives. First, prolonged bladder exposure to Gem/ Doce. Second, to minimize systemic toxicity. Third, to overcome cumbersome handling in preparation. And fourth, to simplify administration, decreasing the burden to patients and providers. NDV-01 is provided to study sites in a ready-to-use dose that can be administered in the office in less than 10 minutes without the need for a specialized pharmacy, biocontainment hood or newer dedicated equipment. Moving to the Phase II study. NDV-01 is being evaluated in a single-arm, single-center ex-U.S. clinical trial in patients with high- risk NMIBC. Patients are treated with NDV-01 in a 5 weekly induction phase followed by a monthly maintenance for up to 1 year with regular assessments done with cystoscopy, cytology and if needed, biopsy. The Phase II study was designed to enroll up to 70 subjects with localized non-metastatic high-risk NMIBC. The primary endpoints are safety and complete response or CRR at 12 months. Secondary efficacy endpoints are duration of response and event free survival. Efficacy assessments for the 6-month follow- up included analysis of the data at 6 months and at any time point. These are the same safety and efficacy parameters that were applied to the 3-month data that were presented at the American Urologic Association meeting in April. For the 6-month efficacy assessment, we observed a complete response rate of 90% based on 21 patients at 6 months. Looking at the data at any time point, we observed a complete response rate of 91% or 23 patients at any time. Of patients with BCG unresponsive disease, we see an 88% CR any time. And in carcinoma in situ or CIS patients, we see a 100% CR any time. The assessment of disease-free status at 6 months showed that, again, 90% of the 21 evaluable patients achieved disease-free status at the 6-month assessment. This is based on the 29 patients enrolled, which include 7 with concomitant CIS, 22 with papillary disease, that is TA or T1. In the study, 5 of these patients have been reinduced 4 at 3 months and 1 at 6 months. NDV-01 continues to demonstrate favorable safety. At the 6-month follow-up, there were no treatment-related adverse events greater than grade 3. The most common treatment- related adverse events were urinary dysuria and hematuria, with hematuria only seen in 4% of the patients. The majority of the patients with dysuria were grade 1 and resolved within 24 hours. No patients had treatment discontinuations related to adverse events. These durable 6-month follow-up data are consistent with our expectations and with the known efficacy of Gem/Doce. The results reported today raise our confidence in the potential for NDV-01 as a promising, effective, safe and durable treatment for non-muscle invasive bladder cancer. Our goal is to bring NDV-01 to patients as soon as possible. We intend to initiate a Phase III study for NDV-01 in the first half of 2026. Our efforts in the coming months will be focused on completing study preparations, including plans to interact with their Food and Drug Administration on our proposed trial design and transfer production to a contract manufacturer to complete scale-up and production of clinical batches. Now I'd like to turn the call over to our Chief Financial Officer, Maged Shenouda, to talk more about sepranolone in our financial results. Maged?

Thank you, Raj. I'll spend a few minutes on sepranolone and then provide you with an overview of our second quarter financial results. Separation is a member of a new subgroup of neurosteroids called GAMSA or GABA-A modulating steroid antagonists. We believe sepranolone's novel action on the GABA neurotransmitter pathway gives a unique potential to alleviate the repetitive symptoms in disorders where compulsive behaviors are common feature. These disorders affect millions of people in the U.S. 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 with sepranolone. It affects approximately 350,000 people worldwide, including approximately 20,000 people in the U.S. PWS is a complex genetic disorder, often defined by persistent hunger and overeating. Current treatment is focused on improving the excessive compulsive behaviors and other medical complications that characterize this disorder. Phase II data from a study in patients with Tourette's syndrome provided proof of concept for sepranolone's mechanism of action and compulsivity disorders and demonstrated that the compound has good overall tolerability. We intend to initiate proof of concept, a proof-of-concept study in PWS in the first half of 2026. Our efforts in the coming months will be focused on completing study preparations, including plans to interact with the FDA on our proposed trial design and setting up our product supply chain, including contract manufacturers. Moving now to our financials. We believe our disciplined development strategy and 2 promising innovative product candidates have significantly enhanced Relmada's pipeline and long-term value proposition. We think we are poised to make excellent progress in our upcoming milestones through the end of this year and beyond. As noted by Brian, this afternoon, we issued a press release announcing our business and financial results for the second quarter ended June 30, 2025. As of June 30, 2025, Relmada had cash, cash equivalents and short-term investments of approximately $20.6 million compared to $44.9 million as of December 31, 2024. Cash used in operations in the second quarter ended June 30, 2025, was $6.4 million compared to $13.3 million for the same period in 2024. Looking ahead, we are prioritizing the advancement of NDV-01. As we advance our clinical and regulatory strategy for each program, we expect to have a line of sight to our cash requirements and runway. During today's call, I will review the second quarter 2025 financial results. Information regarding the 6-month results are included in our press release and 10-Q issued this afternoon. Research and development expense for the second quarter 2025 totaled $2.8 million compared to $10.7 million for the second quarter of 2024, a decrease of $7.9 million. The lower spend was primarily driven by lower study costs, with the wind down of clinical trials for REL-1017, partially offset by an increase in costs associated with the ramp-up of NDV-01 and sepranolone activities and an increase in R&D employee compensation. General and administrative expense for the second quarter 2025 totaled $7.4 million compared to $8.1 million for the second quarter of 2024, a decrease of approximately $696,000. The decrease was primarily driven by a decrease in stock-based compensation expense, partially offset by an increase in employee and consulting service costs. The net loss for the second quarter of 2025 was $9.9 million or $0.30 per basic and diluted share compared with a net loss of $17.8 million or $0.59 for basic and diluted share for the second quarter of 2024. Before we open the call for questions, I will turn back to Sergio for some closing comments. Sergio?

Thank you, Maged. I'd like to leave you with these key messages from today's call. 2025 is off to a strong start for Relmada. First, we are excited about our innovative new programs, NDV-01 for non-muscle invasive bladder cancer or NMIBC and sepranolone for compulsivity disorder. They are well aligned with our strategic objectives. And second, we are pleased to report that the 6 months follow-up from the Phase II study of NDV-01 produced impressive response rate with 91% of high-risk patients achieving disease-free status at any time point following NDV-01 treatment. Third, we have expanded our team with the addition of 2 highly respected expert in bladder cancer and urological oncology. Dr. Raj Pruthi as Chief Medical Officer, Oncology; and Dr. Yair Lotan as Chair of Clinical Advisory Board. We believe that their contribution will be instrumental to our success. And fourth, we are preparing to begin a Phase III study for NDV-01 in the first half of 2026. In addition, we expect to initiate the Phase II study with sepranolone in Prader-Willi syndrome also in 2026. With 2 promising product candidates and expanded management team and clinical advisory board, $20.6 million in cash balance and a clean balance sheet, we believe Relmada is well positioned to take the next value-creating steps for each program. With our progress comes our gratitude for your support and for taking time to join the call today. We look forward to updating you on our continued progress throughout the year. Operator, I would now like to open the call for questions.

[Operator Instructions] Our first question is coming from the line of Uy Ear with Mizuho Securities.

Yes, congrats on the 6 months data. It looks very, very encouraging. So maybe just help us understand with the data at hand and also the recent approval that UroGen got for their product. Just help us -- how do these factors -- these events factor into your thinking with respect to NDV-01 going forward? Are you more focus on high grade or you're moving sort of away from that to maybe a larger market and less competitive market in non-grade, noninvasive bladder cancer. So that's the first question. And the second question is, I guess, when you're meeting with the FDA, like what -- maybe they're related. What are you hoping to accomplish there? And what sort of data will you present as well? Just stay with these 2 questions for now.

Sergio here, thank you all for the questions. I believe Raj is the right person to answer your questions. Raj?

Yes. Thank you. And I think your first question is what is the best approach? Is it high risk, which I shared with you the very exciting data? Or is it a UroGen type of approach with low-grade intermediate risk, I think was the question. And I'll address that first. I think the second was regarding the FDA. I think you bring up a great question as far as the go-forward strategy. I think you outlined it perfectly that there's a great opportunity and low-grade intermediate risk. The incident and prevalent population is very large. These are patients who don't just develop new tumors each year, but they recur, they recur at about a rate of 50%. So the prevalent population increases and the burden of TURBT or transurethral resection of bladder tumor is what the patient bears. I think UroGen with their approval earlier this year set an excellent precedent of a single-arm open-label study in this space getting approval. And this will lead into a conversation with FDA. So I think that is an excellent opportunity for any chemoablative of agent. And I think we're seeing chemoablation become a much more replacing TURBT, which there are about 100,000 performed each year become a much more attractive alternatives for clinicians and desired by patients. So I think that is an excellent opportunity. However, with the data we shared with you, the efficacy in high-grade disease is also significant and one that will continue to generate clinical evidence for urologists to have in hand and perhaps for guidelines inclusion. The FDA pathway for that is also clear that is what TAR-200 or Edstellron with Behring, or ANTivA, KEYTRUDA, others have -- are pursuing BCG or have achieved. It's a tougher group of patients. It's a smaller group of patients, and it's a little bit tougher to enroll because these are often BCG unresponsive with CIS. So again, much smaller patient population. But I think we have the clinical data to show that we're effective in high-risk disease. So I think there's 2 opportunities that you outlined, both which fit very well with NDV-01. Your second question is what will we ask the FDA? I think one of the main questions will be a conversation of is the UroGen path that there's precedent for, which they did earlier this year, a viable path for us forward for a single-arm, open-label study in chemoablation. That will be our main question with them. I hope I addressed your questions.

Yes. So maybe I can ask a follow-up, if it's possible. So if you have to sort of look between the data that you have in hand which is in high grade and what you would like to move in or potentially a better opportunity, which is below the intermediate grade, where do you sort of see more risks? Maybe just help us understand like what would give you confidence to move into the low to intermediate grade?

Great question. I think that, that conversation with the FDA will be very important to do that. I think another attractive -- why that's another attractive option is, I think we think that the -- that is a faster opportunity to FDA approval. I think you accrue to those trials much more rapidly in the low-grade intermediate patients, there's much more of them. So I think that's a faster path to FDA approval and to get this into urologist hands. The risk comes in. We have one study before, and that's with UroGen. The positive of that is it was approved than it was this year. But I think the FDA will help us make that decision.

Okay. Another question, if I may. How should we kind of sort of think about R&D going forward? The R&D has dropped meaningfully. I understand why, I guess, you're trying to conserve cash to prioritize NDV-01.

Yes, maybe a -- it's Sergio. Maybe I should answer that. Well, the R&D expense went down because we are not enrolling patients. The big cost of R&D is evolving patients. And we're planning to do that as soon as we start both the Phase II in sepranolone and the Phase III NDV-01 in the first half of next year. So until then, the cost is reduced because it's manufacturing, getting ready, dialogue with the FDA that these are not expensive activities. So don't think that because the cost of R&D went down, the activity also slowed down. We have well enough resources, financial to do what is needed to do now. And the expense will go up when we start to enroll patients.