Relmada Therapeutics Q2 2025 Earnings Report

Relmada Therapeutics EPS Results

• Actual EPS: -$0.30
• Consensus EPS: -$0.25
• Beat/Miss: Missed by -$0.05
• One Year Ago EPS: N/A

Relmada Therapeutics Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Relmada Therapeutics Announcement Details

• Quarter: Q2 2025
• Date: 8/7/2025
• Time: After Market Closes
• Conference Call Date: Thursday, August 7, 2025
• Conference Call Time: 4:30PM ET

Relmada Therapeutics (NASDAQ:RLMD), a clinical-stage biotechnology company, focuses on developing various products for the treatment of central nervous system diseases (CNS) and other disorders in the United States. Its lead product candidate is Esmethadone (d-methadone, dextromethadone, and REL-1017), a N-methyl-D-aspartate receptor antagonist which is in phase 3 clinical trial for the adjunctive or monotherapy treatment of major depressive disorder. The company is headquartered in Coral Gables, Florida.

Relmada Therapeutics Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: We added two new product candidates, NDV-one for non-muscle invasive bladder cancer and sopranolone for compulsivity disorders, aligning with our acquisition strategy and targeting underserved markets.
• Positive Sentiment: Six-month Phase II data for NDV-one showed a 91% complete response rate at any time point and a 90% response at six months, with 100% response in carcinoma in situ patients.
• Positive Sentiment: We plan to initiate a Phase III trial of NDV-one and a Phase II proof-of-concept study of sopranolone in Prader-Willi syndrome in 2026.
• Positive Sentiment: We expanded our leadership team with the appointment of Dr. Raj Pruthi as Chief Medical Officer Oncology and Dr. Yair Lothan as Chair of our Clinical Advisory Board to drive program success.
• Negative Sentiment: Cash, equivalents and short-term investments declined to $20.6 million as of June 30, 2025, with Q2 net loss of $9.9 million, down from $44.9 million and a $17.8 million loss in the prior year period.

Presentation

[Operator]

Afternoon, and welcome to the Ramada Therapeutics Second Quarter twenty twenty five 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 Romada website. I would now like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.

[Brian Ritchie, Managing Director at LifeSci Advisors, LLC]

Thank you. Good day, everyone, and thank you for joining us today. This afternoon, Ramada issued a press release providing a business update and outlining its financial results for the three months ended 06/30/2025. 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, Ramada's management team will be making forward looking statements.

[Brian Ritchie, Managing Director at LifeSci Advisors, LLC]

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 Realmada's press release issued today and the company's SEC filings, including in the annual report on Form 10 ks excuse me, in the quarterly report on Form 10 Q for the quarter ended 06/30/2025 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 08/07/2025. Realmada 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 Realmada's CEO, Doctor.

[Brian Ritchie, Managing Director at LifeSci Advisors, LLC]

Sergio Traversa, who will briefly provide a summary of recent business highlights Doctor. Raj Pruthi, Ramada's CMO, who will provide an overview of NDV-one and Ramada's CFO, Magen Cinnouda, who will provide an update on cephalonin and a review of the company's Q2 financial results. After that, we will open the call for a brief Q and A session. Now I would like to turn the call over to Sergio Traversa. Sergio?

[Sergio Traversa, CEO & Director at Relmada Therapeutics]

Thank you, Brian. Good afternoon, and welcome, everyone, to the Realmada second quarter twenty twenty five conference call. During today's call, I will provide an overview of our recent progress and upcoming milestones. After that, Rajputti will review the updated six months Phase II data for NDV-one that we announced today. Naget will provide an update on Cefranilone and review our financial results.

[Sergio Traversa, CEO & Director at Relmada Therapeutics]

Then make a few closing remarks and we'll take your questions. Raman 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, NDVO-one for non muscle invasive bladder cancer or NMI BC and sepranolone for compulsivity disorders, starting with Prader Willi syndrome or PWS. NDV-one and sepranolone are well aligned with our product acquisition criteria.

[Sergio Traversa, CEO & Director at Relmada Therapeutics]

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 months follow-up from the phase two study or NDV01 produced impressive response rates, with ninety one percent of patients achieving high grade disease free status at any time point following NDVO-one treatment. As a reminder, NDVO-one is a sustained release formulation of gemcitabine and Doxitaxo or gemdosing. Third, we have expanded our team with the addition of two highly respected in bladder cancer and urologist urologic oncology.

[Sergio Traversa, CEO & Director at Relmada Therapeutics]

Doctor. Raj Prutti, as chief medical officer oncology, and Doctor. Jay Lothan, as chair of our clinical advisory board. We believe their contribution will be instrumental to our success. And fourth, we have made significant progress toward our objective of bringing each program to patient as soon as possible with preparation underway to begin the next set of studies for NDVO1 and Cefranilone in 2026.

[Sergio Traversa, CEO & Director at Relmada Therapeutics]

We threw promising product candidates and expanded management team and clinical advisory board, a 20,600,000.0 cash balance and a clean balance sheet. I believe Ramad is well positioned to take the next value creating steps for each program. Next, I would like to ask Doctor. Pruti to update you on NDV-one and the new six months 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, how are you?

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

Thank you, Sergio, and good afternoon, everyone. I'm excited to be part of the Ramada team. This afternoon, I'm pleased to provide a brief overview of NDV-one and share the positive six month follow-up data from our phase two open label study in patients with high grade non muscle invasive bladder cancer. There are about eighty five thousand new cases of bladder cancer diagnosed each year in The United States, and six hundred thousand people in The US living with bladder cancer. About fifty percent of new cases of bladder cancer have high grade disease.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

That is a high risk of recurrence and potentially progression. I joined Ramada because I believe that NDV-one has the unique potential to become a class leading bladder sparing therapy for NMIDC. This is an exciting time for our patients. NDV-one 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.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

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-one is intended to accomplish four objectives. First, prolonged bladder exposure to gem dosing. Second, to minimize systemic toxicity. Third, to overcome cumbersome handling and preparation.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

And fourth, to simplify administration, decreasing the burden to patients and providers. NDV-one is provided to study sites in a ready to use dose that can be administered in the office in less than ten minutes without the need for a specialized pharmacy, biocontainment hood or newer dedicated equipment. Moving to the phase two study, NDB-one is being evaluated in a single arm, single center ex US clinical trial in patients with high risk NMIBC. Patients are treated with NDV01 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 two study was designed to enroll up to 70 subjects with localized non metastatic high risk NMIBC.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

The primary endpoints are safety and complete response or CRR at twelve 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. For the six month efficacy assessment, we observed a complete response rate of ninety percent based on twenty one patients at six months.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

Looking at the data at any time point, we observed a complete response rate of ninety one percent or twenty three patients at any time. Of patients with BCG unresponsive disease, we see an eighty eight percent CR anytime. And in carcinoma in situ or CIS patients, we see a one hundred percent CR anytime. The assessment of disease free status at six months showed that again, ninety percent of the twenty one evaluable patients achieved disease free status at the six month assessment. This is based on the twenty nine patients enrolled, which include seven with concomitant CIS, twenty two with papillary disease that is TA or T1.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

In the study, five of these patients have been re induced, four at three months and one at six months. NBV-one 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 four percent of the patients. The majority of the patients with dysuria were grade one and resolved within twenty four hours.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

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 gem doses. The results reported today raise our confidence in the potential for NDV-one as a promising, effective, safe and durable treatment for non muscle invasive bladder cancer. Our goal is to bring NDV-one to patients as soon as possible. We intend to initiate a Phase three study for NDV-one in the 2026.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

Our efforts in the coming months will be focused on completing study preparations, including plans to interact with the 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, Magid Shanuda to talk more about sopranolone and our financial results. Magid?

[Maged Shenouda, Chief Financial Officer at Relmada Therapeutics]

Thank you, Raj. I'll spend a few minutes on sopranolone and then provide you with an overview of our second quarter financial results. Sopranolone is a member of a new subgroup of neurosteroids called GAMSAS or GABA modulating steroid antagonist. We believe sopranolone'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.

[Maged Shenouda, Chief Financial Officer at Relmada Therapeutics]

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 sopranolone. It affects approximately three hundred and fifty thousand people worldwide, including approximately twenty thousand people in The US. PWS is a complex genetic disorder often defined by persistent hunger and overeating.

[Maged Shenouda, Chief Financial Officer at Relmada Therapeutics]

Current treatment is focused on improving the obsessive compulsive behaviors and other medical complications that characterize this disorder. Phase two data from a study in patients with Tourette syndrome provided proof of concept for sopranolone's mechanism of action in 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 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.

[Maged Shenouda, Chief Financial Officer at Relmada Therapeutics]

We believe our disciplined development strategy and two promising innovative product candidates have significantly enhanced our modest 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 06/30/2025. As of 06/30/2025, RELMATA had cash, cash equivalents and short term investments of approximately $20,600,000 compared to $44,900,000 as of 12/31/2024. Cash used in operations in the second quarter ended 06/30/2025 was $6,400,000 compared to $13,300,000 for the same period in 2024.

[Maged Shenouda, Chief Financial Officer at Relmada Therapeutics]

Looking ahead, we are prioritizing the advancement of NDV-one. 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 twenty twenty five financial results. Information regarding the six month results are included in our press release and 10 Q issued this afternoon. Research and development expense for the second quarter twenty twenty five totaled $2,800,000 compared to $10,700,000 for the 2024, a decrease of $7,900,000 The lower spend was primarily driven by lower study costs with a wind down of clinical trials for REL-ten seventeen, partially offset by an increase in costs associated with the ramp up of NDV-one and sopranolone activities and an increase in R and D employee compensation.

[Maged Shenouda, Chief Financial Officer at Relmada Therapeutics]

General and administrative expense for the second quarter twenty twenty five totaled $7,400,000 compared to $8,100,000 for the 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 2025 was $9,900,000 or $0.30 per basic and diluted share compared with a net loss of $17,800,000 or $0.59 per basic and diluted share for the 2024. Before we open the call for questions, I will turn back to Sergio for some closing comments. Sergio?

[Sergio Traversa, CEO & Director at Relmada Therapeutics]

Thank you, Meggitt. I'd like to leave you with these key messages from today's call. 2025 is off to a strong start for Renmada. First, we are excited about our innovative new programs, NDV-one for non muscle invasive bladder cancer or NMA IBC, and sopranolone for compulsivity disorder. They are well aligned with our strategic objectives.

[Sergio Traversa, CEO & Director at Relmada Therapeutics]

And second, we are pleased to report that the six months follow-up from the phase two study of NDV-one produced impressive response rate, with ninety one percent of high risk patients achieving disease free status at any time point following NDV-one treatment. Third, we have expanded our team with the addition of two highly respected expert in bladder cancer and urologic oncology. Doctor. Rajputti, as Chief Medical Officer Oncology, and Doctor. Yair Lhotan as Chair of Clinical Advisory Board.

[Sergio Traversa, CEO & Director at Relmada Therapeutics]

We believe that their contribution will be instrumental to our success. And fourth, we are preparing to begin a phase three study for NDV-one in the 2026. In addition, we expect to initiate the phase two study with soprano in Prader Willi syndrome also in 2026. With two promising product candidates, an expanded management team and clinical advisory board, 20,600,000.0 in cash balance and a clean balance sheet, we believe Ramad 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.

[Sergio Traversa, CEO & Director at Relmada Therapeutics]

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.

[Operator]

Thank you. Our first question is coming from the line of Oi Eer with Mizuho Securities. Please proceed with your question.

[Uy Ear, Vice President at Mizuho Financial Group]

Hey, guys. Yeah, congrats on the six 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 NDV01 going forward?

[Uy Ear, Vice President at Mizuho Financial Group]

Are you more focused on high grade or you're moving sort of away from that to maybe a larger market and less competitive market in non high grade, non invasive bladder cancer? So, that's the first question. And the second question is, I guess, when you are meeting with the FDA, like, maybe they're related. What are you hoping to accomplish there? And what sort of data will you present as well?

[Uy Ear, Vice President at Mizuho Financial Group]

Yeah, I'll just stay with these two questions for now. Thanks.

[Sergio Traversa, CEO & Director at Relmada Therapeutics]

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

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

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.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

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 in low grade intermediate risk. The incident at 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 fifty percent.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

So prevalent population increases and the burden of TURB3 or transurethral resection of bladder tumor that is when 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 agent. And I think we're seeing chemoablation become a much more, replacing TURBT, there are about 100,000 performed each year, become a much more attractive alternative for clinicians and desired by patients.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

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 TAR200 or Estelidrin with Ferring or ANKTIVA, Keytruda, others are pursuing or in CG 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.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

But I think we have the clinical data to show that we're effective in high risk disease. So I think there's opportunities that you outlined, both which fit very well with NDV-one. 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'll be our main question with them. I hope I addressed your questions.

[Uy Ear, Vice President at Mizuho Financial Group]

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, and which is in high grade and what you would like to move in or, you know, potentially a better opportunity, which is the low to 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?

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

Great question. I 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 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.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

So I think that's a faster path to FDA approval and to get this into urologist hands. Risk comes in, we have one study before, and that's with UroGen. The positive of that is that it was approved and it was this year. But I think the FDA will help us make that decision.

[Uy Ear, Vice President at Mizuho Financial Group]

Okay. Another question, if I may. How should we kind of sort of think about R and D going forward? The R and D has dropped meaningfully. I understand why I guess you were trying to conserve cash to prioritize NDV one. Yeah.

[Sergio Traversa, CEO & Director at Relmada Therapeutics]

Maybe maybe, Oya, it's Sergey. Maybe I should answer that. Well, the the the the R and D expense went down because we are not enrolling patients. The big cost of R and D is enrolling patients. And, we're planning to do that as soon as we start both the Phase II in zepranulone and the Phase III in NDVO-one in the first half of next year.

[Sergio Traversa, CEO & Director at Relmada Therapeutics]

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 and 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.

[Uy Ear, Vice President at Mizuho Financial Group]

Okay. Thank you.

[Raj Pruthi, Chief Medical Officer at Relmada Therapeutics]

Thank you, Oi.

[Operator]

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.

Participants

Executives

• Sergio Traversa, CEO & Director
• Raj Pruthi, Chief Medical Officer
• Maged Shenouda, Chief Financial Officer

Analysts

• Brian Ritchie, Managing Director at LifeSci Advisors, LLC
• Uy Ear, Vice President at Mizuho Financial Group