Relmada Therapeutics - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 delivered materially lower OpEx and a narrower loss as RLMD pivots to two in-licensed assets; R&D fell 74% YoY to $2.8M and G&A declined 9% YoY to $7.4M, driving EPS improvement to $(0.30) from $(0.59) YoY.
• Clinical catalyst: 6‑month follow-up from the Phase 2 NDV-01 NMIBC study reported 90% CR at 6 months (19/21) and 91% CR at any time (21/23), with no Grade ≥3 TRAEs—strengthening the case for a 2026 registration-track study start.
• Guidance updates: NDV‑01 Phase 3 timing clarified to 1H 2026 (was late Q4 2025–early 2026); Sepranolone Phase 2 in PWS also targeted for 1H 2026 (previously late Q4 2025–early 2026).
• Liquidity: Cash, equivalents and ST investments were $20.6M at 6/30/25; management is prioritizing NDV‑01 and expects spend to ramp with 2026 trial initiations, implying a catalysts-driven financing window ahead.

What Went Well and What Went Wrong

What Went Well

• NDV‑01 durability and safety: 6‑month data showed 90% CR at 6 months and 91% CR at any time; no Grade ≥3 TRAEs, no treatment discontinuations due to AEs, no progression to muscle-invasive disease or cystectomies.
  • “...six-month follow-up... produced impressive results, with a 91% CR rate at any time... The data... raise our confidence in NDV‑01 as a potential durable treatment...” — Raj S. Pruthi, CMO.
• Strategic clarity and execution: Team expansion with CMO Oncology and Clinical Advisory Board Chair; program plans, FDA interactions and CMO/CMC scale-up defined into 2H25/1H26.
• Financial discipline: R&D down to $2.8M and G&A to $7.4M y/y; net loss narrowed to $9.9M vs $17.8M y/y; cash Op CF improved vs prior-year quarter ($6.4M vs $13.3M).

What Went Wrong

• Cash draw and runway: Cash and ST investments fell to $20.6M at quarter end from $44.9M at year-end 2024, reflecting operating cash use; larger studies in 2026 likely require additional capital.
• Development push/clarification: Both NDV‑01 Phase 3 and sepranolone Phase 2 start shifted/clarified to 1H 2026 vs prior “late Q4 2025–early 2026,” modestly extending the path to value inflections.
• Estimate visibility: No SPGI consensus available for Q2 revenue/EPS; absence of coverage complicates “beat/miss” framing for near-term trading [GetEstimates]*.

Transcript

Speaker 1

Afternoon and welcome to the Relmada Therapeutics second 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. 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 Ritchie from Lifeside Advisors. Please go ahead, Mr. Ritchie.

Speaker 2

Thank you. Good day, everyone, and thank you for joining us today. This afternoon, Relmada Therapeutics issued a press release providing a business update and outlining its financial results for the three 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 Therapeutics' 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 Therapeutics' press release issued today and the company's SEC filings, including in the annual report on Form 10-K, excuse me, 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 Therapeutics 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 Therapeutics' CEO, Dr.

Sergio Traversa, who will briefly provide a summary of recent business highlights, Dr. Raj Pruthi, Relmada Therapeutics' Chief Medical Officer, who will provide an overview of NDB01, and Relmada Therapeutics' CFO, Maged Shenouda, who will provide an update on separate loaning 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.

Speaker 3

Thank you, Brian. Good afternoon and welcome everyone to the Relmada Therapeutics 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 six-month phase 2 data for NDB01 that we announced today. Maged will provide an update on Safranolone and review our financial results. We will make a few closing remarks and take your questions. Relmada Therapeutics is making good progress this year. To get started, I would like to highlight four points. First, we are excited about the two product candidates that we added to the company: NDB01 for non-muscle invasive bladder cancer, or NMIBC, and Safranolone for compulsivity disorders, starting with Prader-Willi syndrome, or PWS. NDB01 and Safranolone are well aligned with our product acquisition criteria.

They have demonstrated proof-of-concept data and good overall safety in their 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 six-month follow-up from the phase 2 study of NDB01 produced impressive response rates, with 91% of patients achieving high-grade disease-free status at any time point following NDB01 treatment. As a reminder, NDB01 is a sustained-release formulation of gemcitabine and docetaxel, or Gemdosi. Third, we have expanded our team with the addition of two highly respected experts in bladder cancer and urologic oncology, Dr. Raj Pruthi, as Chief Medical Officer Oncology, and Dr. Jay Lothan, as Chair of our Clinical Advisory Board. We believe their contribution will be instrumental to our success.

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 NDB01 and Safranolone in 2026. With two promising product candidates, an expanded management team, a Clinical Advisory Board, a $20.6 million cash balance, and a clean balance sheet, I believe Relmada Therapeutics 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 NDB01 and the new six-month follow-up data. Raj is an accomplished urology expert with vast clinical experience in the development of novel therapies for non-muscle invasive bladder cancer. Raj, on you.

Speaker 2

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 NDB01 and share the positive six-month follow-up data from our phase 2 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 U.S., 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 NDB01 has the unique potential to become a class-leading bladder-sparing therapy for NMIBC. This is an exciting time for our patients. NDB01 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 over the past decade from academic centers showing that combination use of these two agents achieved response rates and recurrence-free survival that were comparable to or better than the historical standard of care, BCG. For those who are unresponsive to BCG, it can provide an effective second-line option to avoid cystectomy. The sustained-release formulation of NDB01 is intended to accomplish four objectives: first, prolonged bladder exposure to Gemdosi; second, to minimize systemic toxicity; third, to overcome cumbersome handling and preparation; and fourth, to simplify administration, decreasing the burden to patients and providers. NDB01 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 2 study, NDB01 is being evaluated in a single-arm, single-center ex-U.S.

clinical trial in patients with high-risk NMIBC. Patients are treated with NDB01 in a biweekly induction phase, followed by a monthly maintenance for up to one year, with regular assessments done with cystoscopy, cytology, and, if needed, biopsy. The phase 2 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 six-month follow-up included analysis of the data at six months and at any time point. These are the same safety and efficacy parameters that were applied to the three-month data that were presented at the American Urologic Association meeting in April. At the six-month efficacy assessment, we observed a complete response rate of 90% based on 21 patients at six months.

Looking at the data at any time point, we observed a complete response rate of 91% for 23 patients at any time. Of patients with BCG unresponsive disease, we see an 88% CR at any time. In carcinoma in situ, or CIS patients, we see 100% CR at any time. The assessment of disease-free status at six months showed that, again, 90% of the 21 evaluable patients achieved disease-free status at the six-month assessment. This is based on the 29 patients enrolled, which include seven with concomitant CIS, 22 with papillary disease, that is, TA or T1. In the study, five of these patients have been reinduced, four at three months and one at six months. NDB01 continues to demonstrate favorable safety. At the six-month follow-up, there were no treatment-related adverse events greater than grade three.

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 one and resolved within 24 hours. No patients had treatment discontinuations related to adverse events. These durable six-month follow-up data are consistent with our expectations and with the known efficacy of Gemdosi. The results reported today raise our confidence in the potential for NDB01 as a promising, effective, safe, and durable treatment for non-muscle invasive bladder cancer. Our goal is to bring NDB01 to patients as soon as possible. We intend to initiate a phase 3 study for NDB01 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 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 Safranolone and our financial results. Maged? Thank you, Raj. I'll spend a few minutes on Safranolone and then provide you with an overview of our second quarter financial results. Safranolone is a member of a new subgroup of neurosteroids called GAMSAs, or GABA-modulating steroid antagonists. We believe Safranolone's novel action on the GABA neurotransmitter pathway gives it unique potential to alleviate the repetitive symptoms and disorders where compulsive behaviors are a 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 Safranolone. 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 obsessive-compulsive behaviors and other medical complications that characterize this disorder. Phase 2 data from a study in patients with Tourette syndrome provided proof of concept for Safranolone's mechanism of action in compulsivity disorders and demonstrated that the compound has good overall tolerability. We intend to initiate 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 discipline, development strategy, and two promising innovative product candidates have significantly enhanced Relmada Therapeutics' 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 Therapeutics 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 NDB01. 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 six-month results are included in our press release and 10Q 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 a wind-down of clinical trials for REL-1017 partially offset by an increase in costs associated with the ramp-up of NDB01 and Safranolone 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 per 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?

Speaker 3

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, NDB01 for non-muscle invasive bladder cancer, or NMIBC, and Safranolone for compulsivity disorder. They are well aligned with our strategic objectives. Second, we are pleased to report that the six-month follow-up from the phase 2 study of NDB01 produced impressive response rates, with 91% of high-risk patients achieving disease-free status at any time point following NDB01 treatment. Third, we have expanded our team with the addition of two highly respected experts in bladder cancer and urologic oncology, Dr. Raj Pruthi as Chief Medical Officer Oncology and Dr. Jay Lotan as Chair of the Clinical Advisory Board. We believe that their contribution will be instrumental to our success.

Fourth, we are preparing to begin a phase 3 study for NDB01 in the first half of 2026. In addition, we expect to initiate a phase 2 study with Safranolone in Prader-Willi syndrome also in 2026. With two promising product candidates, an 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 discussion, for questions.

Speaker 1

Thank you. Ladies and gentlemen, as a reminder, if you would like to ask a question, please press star one on your telephone keypad at this time. Our first question is coming from the line of Uy Ear with Mizuho Securities. Please proceed with your question.

Speaker 0

Hey, guys. Congrats on the six-month data. It looks very, very encouraging. Maybe just help us understand, with the data at hand and also the recent approval that Eurogen got for their product, how do these factors or these events factor into your thinking with respect to NDB01 going forward? Are you more focused on high-grade or are you moving sort of away from that to maybe a larger market and less competitive market in non-high-grade, non-muscle invasive bladder cancer? That's the first question. The second question is, when you are meeting with the FDA, maybe they're related, what are you hoping to accomplish there and what sort of data will you present as well? I'll just stay with these two questions for now. Thanks.

Speaker 3

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

Speaker 2

Thank you. 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 Eurogen type of approach with low-grade intermediate risk? I think it was the question. I'll address that first. I think the second was regarding the FDA. You bring up a great question as far as the go-forward strategy. You outlined it perfectly that there's a great opportunity in 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%. The prevalent population increases and the burden of TURBT, or transurethral resection of bladder tumor, is what the patient bears.

Eurogen, with their approval earlier this year, set an excellent precedent of a single-arm, open-label study in this space getting approval. This will lead into a conversation with the FDA. That is an excellent opportunity for any chemoablative agent. We're seeing chemoablation become much more replacing TURBT, which there are about 100,000 performed each year, become a much more attractive alternative for clinicians and desired by patients. 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 TAR200 or Adstiladrin, with Beringer or Antiva, Keytruda, others are pursuing or NCG 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 carcinoma in situ. Much smaller patient population. We have the clinical data to show that we're effective in high-risk disease. There are two opportunities that you outlined, both which fit very well with NDB01. Your second question is, what will we ask the FDA? One of the main questions will be a conversation of, you know, is the Eurogen 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'll be our main question with them. I hope I addressed your question.

Speaker 0

Yes. Maybe I can ask a follow-up if it's possible. 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 the low to intermediate grade, where do you sort of see more risks? Maybe just help us understand what would give you confidence to move into the low to intermediate grade?

Speaker 2

Great question. I think that conversation with the FDA will be very important to do that. I think another attractive reason why that's another attractive option is I think we think that there 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. I think that's a faster path to FDA approval and to get this into urologists' hands. The risk comes in. We have one study before, and that's with Eurogen. The positive of that is it was approved, and it was this year. I think the FDA will help us make that decision.

Speaker 0

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. Understandably, I guess you're trying to conserve cash to prioritize NDB01.

Speaker 3

Maybe Oi at Sergio. Maybe I should answer that. The R&D expense went down because we are not enrolling patients. The big cost of R&D is enrolling patients. We're planning to do that as soon as we start both the phase 2 in Safranolone and the phase 3 in NDB01 in the first half of next year. Until then, the cost is reduced because it's manufacturing, getting ready, dialogue with the FDA. These are not expensive activities. 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. The expense will go up when we start to enroll patients.

Speaker 0

Okay, thank you.

Speaker 3

Thank you, Uy.

Speaker 1

Thank you. Ladies and gentlemen, this does conclude our question and answer session and our call for today. We thank you for your participation, and you may disconnect your lines at this time.