Q4 2025 Relmada Therapeutics Inc Earnings Call

March 19, 2026

Operator 2: Good afternoon, and welcome to the Relmada Therapeutics Q4 and full year 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 LifeSci Advisors. Please go ahead, Mr. Ritchie.

Operator: Good afternoon, and welcome to the Relmada Therapeutics Q4 and full year 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 LifeSci Advisors. Please go ahead, Mr. Ritchie.

Speaker #1: After the prepared remarks, we will conduct a question-and-answer session. To ask a question, please press *1. As a reminder, this conference call is being recorded and will be available for replay on the Relmada website.

Speaker #1: I would now like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.

Speaker #2: 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 three months and year ended December 31, 2025.

Brian Ritchie: 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 three months and year ended December 31, 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 for the year ended December 31, 2025, filed after the close today.

Speaker #2: 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.

Speaker #2: Actual results could differ materially from those stated or implied by these forward-looking statements, due to risks and uncertainties associated with a 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 for the year ended December 31, 2025.

Speaker #2: 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 March 19, 2026.

Brian Ritchie: This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast on 19 March 2026. 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 Oncology, who will provide an NDV-01 program update, and Relmada's CFO, Maged Shenouda, who will provide an update on Sepranolone and a review of the company's Q4 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 Traversa. Sergio.

Speaker #2: 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, Oncology, who will provide an NDB-01 program update; and RELMADA's CFO, Maged Shenouda, who will provide an update on Sopranolone and a review of the company's Q4 financial results.

Speaker #2: After that, we will open the line for a brief Q&A session. Now, I would like to hand the call over to Sergio Traversa. Sergio?

Speaker #3: Thank you, Brian. Good afternoon, and welcome, everyone, to the RELMADA fourth quarter and year-end 2025 conference call. 2025 has been a transformational year for RELMADA, marked by significant progress for our lead program, NDB-01.

Sergio Traversa: Thank you, Brian. Good afternoon and welcome everyone to the Relmada Q4 and Year-End 2025 Conference Call. 2025 has been a transformational year for Relmada, marked by significant progress for our lead program, NDV-01. As a reminder, NDV-01 is a sustained-release formulation of gemcitabine and docetaxel. We are developing this investigational product candidate for the treatment of non-muscle invasive bladder cancer, or NMIBC. Most recently, we reported compelling responses and durable 12-month efficacy data for our ongoing Phase 2 study of NDV-01. We achieved FDA alignment for our planned registrational Phase 3 RESCUE program. We fortified our team, and we substantially strengthened our balance sheet. As we reflect on our recent accomplishments and planned next steps, I would like to highlight four key areas. First, NDV-01.

Speaker #3: As a reminder, NDB-01 is a sustained-release formulation of gemcitabine and docetaxel. We are developing this investigational product candidate for the treatment of non-muscle invasive bladder cancer, or NMIBC.

Speaker #3: Most recently, we reported compelling responses and durable 12-month efficacy data for our ongoing Phase 2 study of NDB-01. We achieved FDA alignment for our planned registration of Phase 3 rescue programs.

Speaker #3: We fortified our team, and we substantially strengthened our balance sheet. As we reflect on our recent accomplishments and planned next steps, I would like to highlight four key areas.

Speaker #3: First, NDB-01. We believe that the strength of the recently reported 12-month follow-up data could position NDB-01 as a potential best-in-class therapy for the treatment of NMIBC.

Sergio Traversa: We believe that the strength of the recent, recently reported 12 months follow-up data could position NDV-01 as a potential best-in-class therapy for the treatment of NMIBC. Furthermore, the strength of the clinical data and the unique, easy to administer sustained release formulation gives us confidence that NDV-01 has the potential to provide what urologists and patients with NMIBC need. A simple, durable, effective treatment that readily fits into real-world practice setting. We plan to initiate the Phase 3 RESCUE program in the middle of this year. Our Phase 3 regulatory strategy, agreed upon with the FDA, includes two independent registrational pathways. Pathway one is focused on adjuvant therapy following TURBT in patients with intermediate-risk bladder cancer, which affect about 75,000 patients in the United States. Pathway two is focused on second-line treatment BCG unresponsive patients, which represent about 5,000 patients in the United States. Second, Sepranolone.

Speaker #3: Furthermore, the strength of the clinical data and the unique, easy-to-administer sustained-release formulation give us confidence that NDB-01 has the potential to provide what urologists and patients with NMIBC need: a simple, durable, effective treatment that readily fits into real-world practice settings.

Speaker #3: We plan to initiate the Phase 3 rescue program in the middle of this year. Our Phase 3 regulatory strategy, agreed upon with the FDA, includes two independent registration pathways.

Speaker #3: Pathway 1 is focused on adjuvant therapy following TURBT in patients with intermediate-risk bladder cancer, which affects about 75,000 patients in the United States.

Speaker #3: Pathway 2 is focused on second-line treatment for BCG-unresponsive patients, which represent about 5,000 patients in the United States. Second, Sopranolone. Sopranolone has previously demonstrated proof of concept in Tourette syndrome.

Sergio Traversa: Sepranolone has previously demonstrated proof of concept in Tourette's syndrome, a disorder characterized by compulsive behavior. We are getting ready to begin a proof of concept study in Prader-Willi syndrome in the middle of this year. Third, our team. We substantially strengthened our development team with the appointment of Dr. Raj Pruthi, a highly regarded physician, scientist, and urologic oncologist as Chief Medical Officer, Oncology. In addition, we established a scientific advisory board comprised of similarly distinguished peers to further support the NDV-01 program. Dr. Yair Lotan from the University of Texas Southwestern Medical Center and Dr. Max Kates from Johns Hopkins University School of Medicine. Fourth and last, financial strength. We just completed a successful $160 million private financing.

Speaker #3: This is a disorder characterized by compulsive behavior. We are getting ready to begin a proof-of-concept study in Prader-Willi syndrome in the middle of this year.

Speaker #3: And third, our team. We substantially strengthened our development team with the appointment of Dr. Raj Pruthi, a highly regarded physician, scientist, and urology oncologist, as Chief Medical Officer, Oncology.

Speaker #3: In addition, we established a scientific advisory board comprised of similarly distinguished peers to further support the NDB-01 program. Dr. Yair Lawton from the University of Texas Southwestern Medical Center and Dr. Maskates from Johns Hopkins University School of Medicine.

Speaker #3: Fourth and last, financial strength. We just completed a successful $160 million private financing. Based on existing forecasts, these funds, plus our existing cash balance, provide RELMADA with capital through 2029 and, importantly, through the completion of the planned NDB-01 program.

Sergio Traversa: Based on existing forecasts, these funds, plus our existing cash balance, provide Relmada with capital through 2029 and importantly, through the completion of the planned NDV-01 program. Looking ahead, 2026 is poised to be another important year of value creation for Relmada with the initiation of our phase 3 RESCUE program for NDV-01 in bladder cancer and the phase 2 proof of concept trial for Sepranolone in Prader-Willi syndrome. With that, I also would like to express my appreciation for the trust and support of our investors, employees, collaborators, and the patients who participate in our studies. Next, I will turn the call over to Dr. Raj Pruthi, who will provide a review of the NDV-01 program, including 12 months follow-up data from the ongoing phase 2 study and a summary of our phase 3 plans. Raj.

Speaker #3: Looking ahead, 2026 is poised to be another important year of value creation for Relmada. With the initiation of our Phase 3 RESCUE program for NDB-01 in bladder cancer, and the Phase 2 proof-of-concept trial for Sopranolone in Prader-Willi syndrome.

Speaker #3: With that, I also would like to express my appreciation for the trust and support of our investors, employees, collaborators, and the patients who participate in our studies.

Speaker #3: Next, I will turn the call over to Dr. Raj Pruthi, who will provide a review of the NDB-01 program, including 12-month follow-up data from the ongoing Phase 2 study, and a summary of our Phase 3 plans.

Speaker #3: Raj?

Speaker #2: Thank you, Sergio. Good afternoon, everyone. It's a privilege to share an update on the clinical progress we've made this year, headlined by the truly compelling and best-in-class results for NDB-01 in NMIBC.

Raj S. Pruthi: Thank you, Sergio. Good afternoon, everyone. It's a privilege to share an update on the clinical progress we've made this year, headlined by the truly compelling and best-in-class results for NDV-01 in NMIBC. Bladder cancer is a high-frequency cancer that has a major impact on the lives of patients generally diagnosed in their early to mid-seventies. High recurrence rates and burdensome treatments disrupt quality of life at a time when patients are eager to enjoy life. I want to touch on three topics during today's call. One, an overview of the NDV-01 12-month data. Two, a summary of our planned phase 3 program. And three, a discussion of how NDV-01 might fit into the practice of a urologic oncologist. Sergio noted that NDV-01 is a novel sustained-release intravesical formulation of two chemotherapy agents, gemcitabine and docetaxel, or Gem/Doce, as we say.

Speaker #2: Bladder cancer is a high-frequency cancer that has a major impact on the lives of patients, generally diagnosed in their early to mid-70s. High recurrence rates and burdensome treatments disrupt quality of life at a time when patients are eager to enjoy life.

Speaker #2: I want to touch on three topics during today's call. One, an overview of the NDB-01 12-month data. Two, a summary of our planned Phase 3 program.

Speaker #2: And three, a discussion of how NDB-01 might fit into the practice of a urologic oncologist. Sergio noted that NDB-01 is a novel sustained-release intravesical formulation of two chemotherapy agents, gemcitabine and docetaxel—or 'gemdosi,' as we say.

Speaker #2: Our program builds on physicians' established familiarity with the efficacy and safety profile of conventional gemdosi. More specifically, in patients who are unresponsive to BCG, this combination offers a salvage of bladder-sparing options that may help avoid a radical cystectomy.

Raj S. Pruthi: Our program builds on physicians' established familiarity with the efficacy and safety profile of conventional Gem/Doce, more specifically in patients who are unresponsive to BCG. This combination offers a salvage, a bladder-sparing option that may help avoid a radical cystectomy. Moving on to the 12-month data, we are pleased to report that NDV-01 has demonstrated a high response rate and durable 12-month efficacy from the ongoing phase 2 study. We believe these data stand out in comparison to the other benchmark programs and could position NDV-01 as a best-in-class treatment option for patients with bladder cancer if approved. The study is an open-label, single-arm trial in patients with high-risk NMIBC. Patients receive six biweekly doses every other week times six, followed by monthly maintenance for up to 1 year. Patients undergo regular assessments with cystoscopy, cytology, and, if needed, biopsy.

Speaker #2: Moving on to the 12-month data, we are pleased to report that NDB-01 has demonstrated a high response rate and durable 12-month efficacy from the ongoing Phase 2 study.

Speaker #2: We believe these data stand out in comparison to the other benchmark programs, and could position NDB-01 as a best-in-class treatment option for patients with bladder cancer, if approved.

Speaker #2: The study is an open-label, single-arm trial in patients with high-risk NMIBC. Patients received six biweekly doses (every other week x6), followed by monthly maintenance for up to one year.

Speaker #2: Patients undergo regular assessments with cystoscopy, cytology, and, if needed, biopsy. The study was designed to enroll up to 70 patients with high-risk NMIBC. The primary endpoints are safety and complete response rate at 12 months.

Raj S. Pruthi: The study was designed to enroll up to 70 patients with high-risk NMIBC. The primary endpoints are safety and complete response rate at 12 months. Secondary endpoints are duration of response and event-free survival. The data demonstrated a 12-month complete response rate of 76% with a favorable safety profile. Notably, the study also showed a 12-month complete response rate of 80% in the BCG-unresponsive population, one of the most difficult to treat segments of NMIBC. These findings support the advancement into the Phase 3 registrational program, which we are calling RESCUE. The program will evaluate NDV-01 in both second-line BCG-unresponsive disease and in intermediate-risk bladder cancer as an adjuvant therapy following TURBT. When we look at the complete responses or CR at any time, in the overall population we see a CR anytime of 95% based on 38 patients.

Speaker #2: Secondary endpoints are duration of response and event-free survival. The data demonstrated a 12-month complete response rate of 76%, with a favorable safety profile. Notably, the study also showed a 12-month complete response rate of 80% in the BCG-unresponsive population.

Speaker #2: One of the most difficult-to-treat segments of NMIBC. These findings support the advancement into the Phase 3 registrational program, which we are calling RESCUE. The program will evaluate NMB-01 in both second-line BCG unresponsive disease and in intermediate-risk bladder cancer as an adjuvant therapy following TURBT.

Speaker #2: When we look at the complete responses, or CR, at any time, and the overall population, we see a CR at any time of 95%, based on 38 patients.

Speaker #2: Among those with BCG unresponsive disease, we see a CR rate at any time of 94%. Given the burdensome nature of recurrent bladder cancer treatment, safety is a critical element of a product profile.

Raj S. Pruthi: Among those with BCG unresponsive disease, we see a CR rate at any time of 94%. Given the burdensome nature of recurrent bladder cancer treatment, safety is a critical element of a product profile. We continue to be encouraged by the favorable safety profile observed for NDV-01 across our clinical program. In the 12-month data set for NDV-01, no patients had progression to muscle-invasive disease. No patients underwent a radical cystectomy. No patients had a grade 3 or higher treatment-related adverse events. No interruptions or discontinuations of treatment due to adverse events occurred, and most treatment-related adverse events were at the grade 1 level. Moving on to the planned Phase 3 RESCUE program, we believe our 12-month response and durability data compare quite favorably to the current commercial and development stage platforms.

Speaker #2: We continue to be encouraged by the favorable safety profile observed for NDB-01 across our clinical program. In the 12-month dataset for NDB-01, no patients had progression to muscle-invasive disease.

Speaker #2: No patients underwent a radical cystectomy. No patients had a grade 3 or higher treatment-related adverse event. No interruptions or discontinuations of treatment due to adverse events occurred.

Speaker #2: And most treatment-related adverse events were at the grade 1 level. Moving on to the planned Phase 3 rescue program, we believe our 12-month response and durability data compare quite favorably to the current commercial and development-stage benchmarks.

Speaker #2: We have constructed our Phase 3 registrational pathways to maximize our probability of success and create the most efficient path to FDA approval. The RESCUE registration program was designed in alignment with the FDA to provide two separate approval pathways.

Raj S. Pruthi: We have constructed our Phase 3 registrational pathways to maximize our probability of success and create the most efficient path to FDA approval. The RESCUE registration program was designed in alignment with the FDA to provide two separate approval pathways. We expect to secure a US IND clearance and initiate the Phase 3 RESCUE program in the middle of this year. Let's review the two studies that form the RESCUE program. Registrational pathway one focuses on the evaluation of NDV-01 in patients with intermediate-risk bladder cancer as an adjuvant therapy following TURBT surgery. We estimate there are about 70,000–75,000 patients each year in the US in this setting. This study is planned to be an open-label randomized controlled trial. Since there are no approved treatments for adjuvant intermediate-risk NMIBC, the study will evaluate NDV-01 versus observation.

Speaker #2: We expect to secure US IND clearance and initiate the Phase 3 RESCUE program in the middle of this year. Let's review the two studies that formed the RESCUE program.

Speaker #2: Registrational pathway one focuses on the evaluation of NDB-01 in patients with intermediate-risk bladder cancer as an adjuvant therapy following TURBT surgery. We estimate there are about 75,000 patients each year in the U.S. in this setting.

Speaker #2: This study is planned to be an open-label, randomized controlled trial. Since there are no approved treatments for adjuvant intermediate-risk NMIBC, the study will evaluate NDB-01 versus observation.

Speaker #2: The primary endpoint is disease-free survival, or DFS. Secondary endpoints include high-grade recurrence-free survival, progression-free survival, and quality of life metrics. We feel that the opportunity to incorporate NDB-01 into patient care post-TURBT is very attractive.

Raj S. Pruthi: The primary endpoint is disease-free survival or DFS. Secondary endpoints include high-grade recurrence-free survival, progression-free survival, and quality of life metrics. We feel that the opportunity to incorporate NDV-01 into patient care post TURBT is very attractive, and it could pave the way for important clinical indication and broader adoption. Registration pathway number two is focused on the evaluation of NDV-01 in the second-line setting in patients who are BCG unresponsive with carcinoma in situ or CIS who are refractory to first-line therapies approved or in development. We estimate that there are about 5,000 patients per year in the US in this setting. Since these patients have few, if any, effective treatment alternatives to radical cystectomy, the study is designed as a single-arm open label trial. The primary endpoint is CR anytime.

Speaker #2: And it could pave the way for important clinical indication and broader adoption. Registration pathway number two is focused on evaluation of NDB-01 in the second-line setting in patients who are BCG-unresponsive with carcinoma in situ, or CIS, or refractory to first-line therapies approved or in development.

Speaker #2: We estimate that there are about 5,000 patients per year in the US in this setting. Since these patients have few, if any, effective treatment alternatives to radical cystectomy, the study is designed as a single-arm, open-label trial.

Speaker #2: The primary endpoint is CR any time; secondary endpoints will include the duration of response, or DOR, progression-free survival, and recurrence-free survival. Among respondents, we expect to report the initial three-month response data from this study by the end of 2026.

Raj S. Pruthi: Secondary endpoints will include the duration of response or DOR, progression-free survival, and recurrence-free survival among responders. We expect to report the initial three-month response data from this study by the end of 2020. We're excited about this pathway because it could offer a rapid route to approval. Before I hand the call over to Maged, I'd like to make a note about how we feel NDV-01 might fit into clinical practice. NDV-01 is formulated to create a soft matrix in the bladder to enhance local bladder urothelial exposure and minimize systemic toxicity. It is delivered in the office in less than five minutes. This simple formulation and administration model has the potential to optimize the delivery experience for patients and providers, offering a level of simplicity and time saving that stands out among the others.

Speaker #2: We're excited about this pathway because it could offer a rapid route to approval. Before I hand the call over to Maged, I'd like to make a note about how we feel NDB-01 might fit into clinical practice.

Speaker #2: NDB-01 is formulated to create a soft matrix in the bladder to enhance local bladder urothelial exposure and minimize systemic toxicity. It is delivered in the office in less than five minutes.

Speaker #2: This simple formulation and administration model has the potential to optimize the delivery experience for patients and providers, offering a level of simplicity and time savings that stands out among the others.

Raj S. Pruthi: As I hand the call over to our CFO, Maged Shenouda, our phase 2 data gives us high confidence in our registrational program. By addressing a clear unmet need with a unique sustained delivery profile, we believe NDV-01 is uniquely positioned to redefine the standard of care in bladder cancer. We look forward to initiating the RESCUE registrational program at an estimated 80 sites in North America in the middle of this year as we work to bring NDV-01 to bladder cancer patients as soon as possible. Maggie?

Speaker #2: The hand the call over to our CFO, Maged Shenuda. Our Phase 2 data gives us high confidence in our registrational program. By addressing a clear, unmet need with a unique sustained delivery profile, we believe NDB-01 is uniquely positioned to redefine the standard of care in bladder cancer.

Speaker #2: We look forward to initiating the RESCUE registrational program at an estimated 80 sites in North America in the middle of this year as we work to bring NDB-01 to bladder cancer patients as soon as possible.

Speaker #2: Maged, thanks. Raj, good afternoon, everyone. Today, I'll spend a few minutes on sopranolone and then provide you with an overview of our fourth-quarter 2025 financial results.

Maged Shenouda: Thanks, Raj, and good afternoon, everyone. Today, I'll spend a few minutes on Sepranolone and then provide you with an overview of our Q4 2025 financial results. Because Sepranolone modulates GABA, one of the most important neurotransmitters, it is defined as a GAMSA or GABA modulating steroid antagonist. Sepranolone's novel action on the GABA neurotransmitter pathway gives it the potential to normalize the activity of the GABA-A receptor and alleviate the repetitive symptoms of compulsive disorders. These disorders affect millions of people around the world and include indications such as obsessive-compulsive disorder, Tourette's syndrome, and Prader-Willi syndrome. We are preparing to initiate a proof-of-concept study in Prader-Willi syndrome in mid-2026. Our immediate efforts are dedicated to completing study preparations, including engaging with the FDA on our proposed trial design and establishing a robust supply chain. Moving now to our financial results.

Speaker #2: Because sopranolone modulates GABA, one of the most important neurotransmitters, it is defined as a GAMPSA, or GABA-modulating steroid antagonist. Sopranolone's novel action on the GABA neurotransmitter pathway gives it the potential to normalize the activity of the GABA-A receptor and alleviate the repetitive symptoms of compulsivity disorders.

Speaker #2: These disorders affect millions of people around the world and include indications such as obsessive-compulsive disorder, Tourette syndrome, and Prader-Willi syndrome. We are preparing to initiate a proof-of-concept study in Prader-Willi syndrome in mid-2026.

Speaker #2: Our immediate efforts are dedicated to completing study preparations, including engaging with the FDA on our proposed trial design and establishing a robust supply chain.

Speaker #2: Moving now to our financial results. As noted earlier by Brian, this afternoon, RELMADA issued a press release announcing our business and financial results for the fourth quarter and 12 months ended December 31, 2025.

Maged Shenouda: As noted earlier by Brian, this afternoon, Relmada issued a press release announcing our business and financial results for Q4 and 12 months ended December 31, 2025. During this call, I'll review our Q4 2025 financial results and refer you to our press release and 10-K filing issued this afternoon for financial information for the last 12 months. Starting with our cash balance. Relmada closed 2025 with a cash balance of $93 million. This includes net proceeds of approximately $94 million from an underwritten stock offering announced on November 5, 2025. This compares to cash equivalents, and short-term investments of approximately $45 million at December 31, 2024. On March 9, 2025, the company announced a $160 million private financing with net proceeds of approximately $160 million.

Speaker #2: During this call, I'll review our fourth-quarter 2025 financial results, and refer you to our press release and 10-K filing issued this afternoon for financial information for the last 12 months.

Speaker #2: Starting with our cash balance, Relmada closed 2025 with a cash balance of $93 million. This includes net proceeds of approximately $94 million from an underwritten stock offering announced on November 5, 2025.

Speaker #2: This compares to cash, cash equivalents, and short-term investments of approximately $45 million at December 31, 2024. On March 9, 2025, the company announced a $160 million private financing with net proceeds of approximately $150 million.

Speaker #2: This financing, along with our cash balance as of December 31, 2025, is expected to provide sufficient resources to fund company operations through 2029, including completion of the Phase 3 RESCUE program for NDB-01.

Maged Shenouda: This financing, along with our cash balance as of December 31, 2025, is expected to provide sufficient resources to fund company operations through 2029, including completion of the phase 3 RESCUE program for NDV-01. Moving through our Q4 financial results. Research and development expense for the three months ended December 31, 2025 totaled $8.1 million compared to $11 million for the three months ended December 31, 2024, a decrease of $2.9 million. The decrease was primarily driven by a decrease in study costs associated with the completion of two phase 3 trials for REL-1017, partially offset by increased costs related to the start of the phase 3 NDV-01 trials and Phase 2b Sepranolone study and additional R&D personnel.

Speaker #2: Moving through our fourth-quarter financial results, research and development expense for the three months ended December 31, 2025, totaled $8.1 million, compared to $11 million for the three months ended December 31, 2024, a decrease of $2.9 million.

Speaker #2: The decrease is primarily driven by a decrease in study costs associated with the completion of two Phase 3 trials for L1017, partially offset by increased costs related to the startup of the Phase 3 NDB-01 trials and Phase 2b sopranolone study, and additional R&D personnel.

Speaker #2: General and administrative expense for the three months ended December 31, 2025, totaled $12.3 million, compared to $8.1 million for the three months ended December 31, 2024, an increase of approximately $4.2 million.

Maged Shenouda: General and administrative expense for the three months ended December 31, 2025 totaled $12.3 million compared to $8.1 million for the three months ended December 31, 2024, an increase of approximately $4.2 million. The increase was primarily driven by an increase in compensation costs, partially offset by a decrease in stock compensation costs. Net cash used in operating activities for the three months ended December 31, 2025 totaled $14.6 million compared to $8.8 million for the three months ended December 31, 2024.

Speaker #2: The increase was primarily driven by an increase in compensation costs, partially offset by a decrease in stock compensation costs. Net cash used in operating activities for the three months ended December 31, 2025, totaled $14.6 million.

Speaker #2: Compared to $8.8 million, for the three months ended December 31, 2024, the net loss for the three months ended December 31, 2025, was $19.9 million, or $27 per basic and diluted share.

Maged Shenouda: The net loss for the three months ended December 31, 2025 was $19.9 million or $0.27 per basic and diluted share, compared to a net loss of $18.7 million or $0.62 per basic and diluted share for the three months ended December 31, 2024. Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?

Speaker #2: Compared to a net loss of $18.7 million, or $62 per basic and diluted share, for the three months ended December 31, 2024. Before we open the call for questions, I'll turn back to Sergio for some closing comments.

Speaker #2: Sergio?

Speaker #1: Thank you, Maged. In closing of our prepared remarks, I would like to share that I'm very confident and optimistic about our clinical programs and the long-term prospects for Relmada.

Sergio Traversa: Thank you, Maggie. In closing of our prepared remarks, I would like to share that I'm very confident and optimistic about our clinical programs and the long-term prospects for Relmada. As we are getting ready to initiate the RESCUE registrational program for NDV-01, we are focused on execution and looking forward to updating you on our progress in the coming quarters. Operator, I would now like to open the call for questions.

Speaker #1: As we are getting ready to initiate the RESCUE registrational program for NDB-01, we are focused on execution and looking forward to updating you on our progress in the coming quarters.

Speaker #1: Operator, I would now like to open the call for questions.

Speaker #2: Thank you. We'll now be conducting a question-and-answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Operator 2: Thank you. We'll now be conducting a question and answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. Our first question is from Wei Yue with Mizuho Securities.

Operator: Thank you. We'll now be conducting a question and answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. Our first question is from Wei Yue with Mizuho Securities.

Speaker #2: You may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker #2: One moment, please, while we pull for questions. Thank you. Our first question is from Wee Ear with Mizuho Securities.

Speaker #3: Hey, guys. Congrats on the great data and the pipe. Yeah, seems like you guys did a lot of work this quarter. So maybe we've been getting some questions on whether you will present additional data from your Phase 2 study should we kind of expect going forward maybe updates every three months and will you also have data I guess at AUA by any chance?

Wei Yue: Hey, guys, congrats on the great data and the pipeline. Yeah, seems like you guys did a lot of work this quarter. Maybe you know we're getting some questions on whether you will present additional data from your phase 2 study.

Wei Yue: Should we kind of expect going forward maybe updates every 3 months? Will you also have data, I guess, at AUA by any chance? That's a first question. The second question that we've been kind of getting is, I guess some investors are a little bit concerned that the second-line patients may not be necessarily second-line, but maybe by the time they get to your regimen it could be their third-line. Maybe just help us understand how what you're doing exactly to ensure that those patients are truly second-line patients. The third question is, you indicated that you have 3 months data from your phase 3 BCG-unresponsive second-line unresponsive patients.

Speaker #3: So that's a first question and the second question that we've been kind of getting is there's been I guess some investors are a little bit concerned that the second-line patients may not second-line but maybe by the time they get to your regimen, it could be their third lines.

Speaker #3: Maybe just help us understand what you're doing exactly to ensure that those patients are truly second-line patients. And the third question is, you indicated that you have three months' data from your Phase 3 BCG-unresponsive, second-line, unresponsive patients.

Speaker #3: Will this be from the entire patient population, or would this be sort of interim and as a partial or portion of the number of patients that you expect to enroll?

Wei Yue: Will this be from the entire patient population, or would this be sort of interim and is partial or portion of the number of patients that you expect to enroll? Thanks.

Speaker #3: Thanks.

Speaker #1: Thank you, Oi, for the questions. I think Raj is the he can answer these questions. I pass it to Raj.

Sergio Traversa: Thank you, Wei, for the questions. I think Raj is the. He can answer these questions. I pass it to Raj.

Raj S. Pruthi: Yeah. Thank you, Sergio. Good to hear from you, Wei. Regarding the data, we will be presenting an updated data, this 12-month data at the AUA. It has been accepted to that. We'll also be presenting a trial in progress, as we get RESCUE going. Our plan is to focus on introducing data, and I think this is your last question, in the BCG unresponsive second-line group starting at the end of the year. As we start the trial in mid-year, we should have some 3-month data to be able to share externally by the end of the year, as it's a single-arm, open-label. Our thought is to then actually at a cadence of about every 3 months, share the data as we get 6, 9, and 12-month follow-up on that data set.

Speaker #4: Yeah, thank you, Sergio. Good to hear from you, Oi. Regarding the data, we will be presenting updated data—this 12-month data—at the AUA.

Speaker #4: It has been accepted for that. We'll also be presenting a trial in progress as we get RESCUE going. Our plan is to focus on introducing data, and I think this is your last question in the BCG-unresponsive second-line group starting at the end of the year.

Speaker #4: So, as we start the trial in the middle of the year, we should have some three-month data to be able to share externally by the end of the year, as it's a single-arm, open-label.

Speaker #4: And our thought is to then actually, at a cadence of about every three months, share the data as we get six-, nine-, and twelve-month follow-up on that data set.

Speaker #4: I think you provide an excellent question on second-line, third-line, fourth-line and we are indeed limiting the number of prior therapy lines to two. So you can have had one line of therapy, it's still going to, for example, and we're allowing a second of those say it's still going to be followed by Antiva.

Raj S. Pruthi: I think you provide an excellent question on second line, third line, fourth line. We are indeed limiting the number of prior therapy lines to two. You could have had one line therapy, Adcetris, for example. While allowing a second of those, say Adcetris followed by Anktiva, we're also allow a maximum of two. We're also gonna look at 15 patients at 3 months of those who received one first line therapy versus two, just to make sure they're, you know, it's an open label study that there's nothing concerning that we want there, that those should be excluded. This is reflective of the conversations we've had with the FDA, but I think it's a good question, limiting the number of kind of third or fourth lines. Thank you.

Speaker #4: We're also a maximum of two, but we're also going to look at 15 patients at three months of those who receive one first-line therapy versus two, just to make sure—it's an open-label study—that there's nothing concerning that we want there, that those should be excluded.

Speaker #4: And this is reflective of the conversations we've had with the FDA. But I think it's a good question. Limiting the number of kind of third or fourth lines.

Speaker #4: Thank you.

Speaker #2: All right.

Speaker #3: Thank you.

Wei Yue: Thank you.

Speaker #2: Our next question is from Farzan Haque with Jefferies.

Operator 3: Our next question is from Farzin Khan with Jefferies.

Operator: Our next question is from Farzin Haque with Jefferies.

Farzin Khan: Hi. Congrats on the progress, and thank you for taking my questions. I have one on the operational standpoint. The NMIBC space is becoming congested with active trials and drugs approved, too. Like, what is your expectation for enrollment cadence across your two studies? Can the drug's efficacy profile potentially serve as a recruitment advantage?

Farzin Haque: Hi. Congrats on the progress, and thank you for taking my questions. I have one on the operational standpoint. The NMIBC space is becoming congested with active trials and drugs approved, too. Like, what is your expectation for enrollment cadence across your two studies? Can the drug's efficacy profile potentially serve as a recruitment advantage?

Speaker #5: Hi. Congrats on the progress, and thank you for taking my questions. So, I had one on the operational standpoint. The NMIBC space is becoming congested, with active trials and drugs approved too.

Speaker #5: So, what is your expectation for enrollment cadence across your two studies? And can the drug's in-office profile potentially serve as a recruitment advantage?

Speaker #1: Thank you, Farzan. Raj, do you want to take that?

Sergio Traversa: Thank you, Farzin. Raj, you wanna take that?

Speaker #4: Yeah, yeah. Thank you. Yeah, Farzan, good to hear from you. I think you're right. I think the high-risk BCG-unresponsive has been a crowded space, but I think ours coming in as a second-line therapy provides a unique advantage, and there's no drugs that have been approved in that setting and none that I'm aware of that are even being investigated as a pivotal study in that setting.

Raj S. Pruthi: Yeah, yeah. Thank you. Yeah, Farzin, good to hear from you. I think you're right. It's the high-risk BCG unresponsive has been a crowded space, but I think ours coming in as a second line therapy provides a unique advantage. There's no drugs that have been approved in that setting and none that I'm aware of that are even being investigated, you know, as a pivotal study in that setting. I think we have a competitive advantage in that we can go to sites that even in development, you know, drugs and development, can follow them in this unique path. Same for intermediate risk. I think right now it's becoming a bigger expansive interest.

Speaker #4: So, I think we have a competitive advantage in that we can go to sites, even those in development, drugs in development, and follow them in this unique path.

Speaker #4: And same for intermediate risk. I think right now there's--it's becoming a bigger, expansive interest. But what I've seen in, for example, CG Oncology has an intermediate risk trial that looks like it's ahead of schedule and accrued very rapidly.

Raj S. Pruthi: What I've seen in, for example, CG Oncology has an intermediate risk trial that looks like it's ahead of schedule and accrued very rapidly. I think there's a lot of interest from investigators in looking at intermediate risk patients. I expect us to enroll that pretty rapidly ahead of schedule like CG did. Thanks for your question, Farzin.

Speaker #4: I think there's a lot of interest in from investigators and looking at intermediate risk patients. So I think we I expect us to enroll that pretty rapidly ahead of schedule like CG did.

Speaker #4: Thanks for your question, Farzan.

Speaker #5: Got it. And then, for the second-line high-grade settings, beyond the primary endpoint of CR rate at any time, has the FDA stipulated a minimum duration of follow-up required for all patients prior to submitting the NDA?

Farzin Khan: Got it. For the second line high grade settings, beyond the primary endpoint of CR rate at any time, has the FDA stipulated a minimum duration of follow-up required for all patients prior to submitting the NDA?

Farzin Haque: Got it. For the second line high grade settings, beyond the primary endpoint of CR rate at any time, has the FDA stipulated a minimum duration of follow-up required for all patients prior to submitting the NDA?

Speaker #4: Another great question. They haven't required a minimum of follow-up. They said they wanted to see CR, any as you said, and durability of response or duration of response.

Raj S. Pruthi: Another great question. They haven't required a minimum of follow-up. They said they wanted to see CR, any, as you said, and durability of response or duration of response. I think the wording they use, which I think is important, is they wanna see the totality of the data. They wanna see do you have a response and is there some level of durability? I mean, they haven't specified what that number is.

Speaker #4: I think the wording they used, which I think is important, is they want to see the totality of the data. So they want to see, do you have a response, and is there some level of durability?

Speaker #4: But for me, they haven't specified what that number is.

Speaker #5: Got it. Thank you so much.

Farzin Khan: Got it. Thank you so much.

Farzin Haque: Got it. Thank you so much.

Speaker #4: Thank you.

Raj S. Pruthi: Thank you.

Speaker #1: Thank you, Farzan.

Sergio Traversa: Thank you, Farzin.

Speaker #2: Perfect question. It's from Christopher Liu with Lucid.

Operator 3: Our next question is from Christopher Liu with Lucid.

Operator: Our next question is from Christopher Liu with Lucid.

Speaker #6: Hey, guys. Thanks for the question. I was just wondering given the population differences between your Phase 2 and Phase 3 RESCUE, what are you expecting to see in terms of the CR rate at the three-month mark as well as what we should be benchmarking against with the data set?

Christopher Liu: Hey guys. Thanks for the question. I was just wondering, given the population differences between, you know, your phase 2 and phase 3 RESCUE, what are you expecting to see in terms of the CR rate at the 3-month mark as well as, you know, what we should be benchmarking against with the status quo?

Speaker #1: Okay. Thank you, Grace. Raj, do you want to take this one as well?

Sergio Traversa: Thank you, Chris. Raj, you want to take this one as well?

Speaker #4: Yes, sure. Yeah. Thanks, Chris. Thanks for the question. So in the intermediate risk, we are looking at what we've structured the trial to look at—the statistics around it—a two-year RFS of 75%.

Raj S. Pruthi: Yes, sure. Yeah. Thanks, Chris. Thanks for the question. In the intermediate risk, we are looking at what we've structured the trial to look at the statistics around it, a 2-year RFS of 75%. That actually is reflected in the literature with Gem/Doce. I think with what we've seen in this population and with sustained release, we should exceed that, but that's our target number that drives the statistics. It's an event-driven study, but that's kind of the draw. With 128 events is the target. Regarding the BCG unresponsive second-line, yeah, it is. We have looked at that, of what is the...

Speaker #4: And that actually is reflected in the literature with GEM dosing. I think with what we've seen in this population and with sustained release, we should exceed that, but that's our target number.

Speaker #4: That drives the statistics. It's an event-driven study, but that's kind of the draw and with 128 events, it's a target. Regarding the BCG unresponsive second line, it is we have looked at that of what is the it's interesting that in first line, the first drug approved was valrubicin in 1998 at 8% 12-month CR.

Raj S. Pruthi: You know, it's interesting that in first-line, the first drug approved was Valrubicin in 1998 at 8% 12-month CR, followed by Keytruda at 19%, Adstiladrin 24%. I think, you know, I'm glad that the FDA wasn't fixated on a certain number, but I think that number should be at those levels or lower than what we've seen in a first-line therapy, just as a precedent, if that makes sense.

Speaker #4: Followed by Keytruda at 19% at children 24%. So I think I'm glad that there's not the FDA wasn't fixated on a certain number, but I think that number should be at those levels or lower than what we've seen in first-line therapy just as a precedent if that makes sense.

Speaker #6: Got it. Thanks for the question.

Christopher Liu: Got it. Thanks for the question.

Speaker #2: As a reminder, if you'd like to ask a question, please press *1 on your telephone keypad. Our next question is from Kelsey Goodwin with Piper Sandler.

Operator 2: As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. Our next question is from Kelsey Goodwin with Piper Sandler.

Operator: As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. Our next question is from Kelsey Goodwin with Piper Sandler.

Speaker #7: Oh, hey. Thanks so much for taking my question and congrats on the recent clinical update. Regarding I guess specifically to that update, regarding the patient baseline characteristics and the CIS versus papillary split, I guess how should we be comparing this data set to that of competitors with primarily CIS patients there?

Kelsey Goodwin: Thanks so much for taking my question, and congrats on the recent clinical update. I guess specifically to that update, regarding the patient baseline characteristics and the CIS versus papillary split, I guess how should we be comparing this data set to that of competitors, you know, with primarily CIS patients there? And I guess any data to support that Gem/Doce looks similar in CIS and papillary patients?

Speaker #7: And I guess, is there any data to support that gem dosing looks similar in CIS and papillary patients?

Speaker #1: Hi, Kelsey. And so you're here. Raj, it seems that this one also is for you.

Sergio Traversa: Hi, Kelsey. It's Sergio here. Raj, it seems that this one also is for you.

Speaker #4: Yeah. Great question, Kelsey. Regarding so start at the last part of your question first. There is, in fact, it's interesting as a clinician. You often think, "Okay.

Raj S. Pruthi: Yeah. Great question, Kelsey. Starting the last part of your question first. There is. In fact, it's interesting as a clinician. You know, you often think, okay, if the patient is BCG unresponsive, this might be more virulent. We don't often like think is it CIS versus papillary. Some people show pure CIS behaves better, but T1 papillary worse. It's a mixed bag. It's actually interesting for Gem/Doce. There's an article by Steinberg in 2020 in The Journal of Urology that looked at heavily pretreated, basically BCG-refractory patients. At 12 months, the RFS in those patients are CRs, with 60% in the CIS population and 61% in papillary. There isn't a marked difference typically between that.

Speaker #4: If the patient is BCG-unresponsive, this might be more virulent. But we don't often think of CIS versus papillary, because some people show pure CIS, which behaves better, but T1 papillary is worse.

Speaker #4: So it's a mixed bag. It's actually interesting for gemdosing there's an article by Steinberg in 2020 in the Journal of Urology that looked at heavily pretreated, basically BCG responsive patients.

Speaker #4: And at 12 months, the RFS in those patients are CRs, with 60% in the CIS population and 61% in papillary. So there isn’t a marked difference, typically, between that.

Speaker #4: But even if you go back and look at our data of what we showed, Rs at the 12 months is 80%, 12-month KM 84%.

Raj S. Pruthi: Even if you go back and look at our data of what we showed, ours at 12 months is 80%, 12-month CR of 84%. That does include 4 patients with CIS at 12 months. We had 4 out of 4 with complete response at any time, 2 out of 2 at 12 months. I completely understand these are small numbers, but I think it still compares quite favorably. Even if you take ADVO-01 and the BCG-unresponsive papillary-only on all our entire population, including CIS, and compare it to the best-in-class papillary, which is in J&J's Lexo, I think their 12-month CR was 74%. Even taking our entire cohort, we're significantly higher. I think still best-in-class. I hope I answered your question.

Speaker #4: Now, that does include four patients with CIS; at 12 months, four patients with CIS. We had four out of four with complete response at any time, and two out of two at 12 months.

Speaker #4: Completely understood these are small numbers, but I think it still compares quite favorably. And even if you take in DBO1 and the BCG unresponsive papillary, our entire population including CS and compare it to the best-in-class papillary, which is in J&J's in Lexo, I think their 12-month KM was 74%.

Speaker #4: So even taking our entire cohort, we have—we're significantly higher. So I think still best-in-class. I hope I answered your question.

Speaker #7: Yeah, no, that's super helpful. Thank you so much for that. And then maybe just one follow-up, if I can. With respect to the intermediate risk setting and that kind of market overall, I guess how much do you think that market might need to be built out by these early launches?

Kelsey Goodwin: Yeah. No, that's super helpful. Thank you so much for that. Maybe just one follow-up, if I can. With respect to the intermediate risk setting and that kind of market overall, I guess how much do you think that market might need to be built out by these early launches, just given we haven't had an approved agent until last year? Thanks so much.

Speaker #7: Just given we haven't had an approved agent until last year. Thanks so much.

Speaker #4: Oh, you bet, Kelsey. And another great question. If you don't mind me jumping in, Sergio.

Raj S. Pruthi: Oh, you bet, Kelsey. Another great question, if you don't mind me jumping in, Sergio.

Speaker #1: No, no. Go ahead.

Sergio Traversa: No, no. Go ahead.

Speaker #4: Right now, I mean, we mentioned it's about 75,000 to 80,000 patients with intermediate risk disease, and if you look at the data now, only about 35% of those patients will receive adjuvant therapy.

Raj S. Pruthi: Right now, I mean, we mentioned it's about 75 to 80,000 patients with intermediate risk disease. If you look at the data now, only about 35% of those patients will receive adjuvant therapy. What's important in our studies and in CV's study is that in our intermediate risk population, we do include small, less than 3 cm Ta high-grade patients. I think that's very important because 20% of the intermediate risk disease is these high-grade Ta patients, and those are the ones that probably more than anybody needs adjuvant therapy to prevent recurrence. To go back to what all those 5% receive adjuvant therapy, I think it's exactly what you're alluding to.

Speaker #4: What's important in our studies, and in CG's study, is that in our intermediate-risk population, we do include small, less than 3-centimeter TA high-grade patients.

Speaker #4: I think that's very important, because 20% of intermediate-risk disease is these high-grade TA patients. And those are the ones that probably more than anybody need adjuvant therapy to prevent recurrence.

Speaker #4: So, to go back to what I said, that 35% receive an adjuvant therapy—I think it's exactly what you're alluding to. Right now, there isn't an approved therapy.

Raj S. Pruthi: Right now, there isn't an approved therapy, there isn't a lot of data, there isn't a lot of agents that can be reimbursed to the urologist in a buy-and-bill model, for example. I think that 35% number is gonna only grow as you see data from MoonRISe-1, from PIVOT-006, or from RESCUE, our intermediate study. As we get data, it gives patients confidence that, hey, here's an agent that might reduce my risk of having another TURBT and give urologists confidence that I have an agent that I can deliver in my office, that'll reduce TURBT risk for my patients. It's only gonna grow.

Speaker #4: There isn't a lot of data, and there aren't a lot of agents that can be reimbursed to the urologist in a buy-and-bill model, for example.

Speaker #4: So I think that 35% number is only going to grow as you see data from Moonrise, or from Pivot006, or from Rescue, our intermediate study, as we get data that gives patients confidence that, 'Hey, here's an agent that might reduce my risk of having another TRVP,' and give urologists confidence that I have an agent that I can deliver in my office.

Speaker #4: That'll reduce TRVP risk for my patients. It's only going to grow, I think.

Speaker #7: That's great. Thank you so much.

Kelsey Goodwin: That's great. Thank you so much.

Speaker #1: Thank you, Kelsey.

Sergio Traversa: Thank you, Kelsey.

Speaker #2: Thank you. This concludes our question-and-answer session. I would now like to hand the floor back over to Sergio Traversa for any closing remarks.

Operator 2: Thank you. This concludes our question and answer session. I would now like to hand the floor back over to Sergio Traversa for any closing remarks.

Operator: Thank you. This concludes our question and answer session. I would now like to hand the floor back over to Sergio Traversa for any closing remarks.

Speaker #1: Well, my closing remark is a big thank you to everybody that has allowed Relmada to get where we are now, with great data and with a drug that can really help.

Sergio Traversa: Well, closing remark is a big thank you to everybody that has allowed Relmada to get where we are now with great data, with a drug that can really help patient with bladder cancer. We are looking forward to update everybody on our progresses. Thank you, and enjoy the rest of the day.

Speaker #1: Patient with bladder cancer. So we're looking forward to update everybody on our progresses. Thank you. And enjoy the rest of the day.

Speaker #4: Thank you.

Raj S. Pruthi: Thank you.

Operator 2: This concludes today's conference. You may disconnect your lines at this time. Thank you again for your participation.

Operator: This concludes today's conference. You may disconnect your lines at this time. Thank you again for your participation.

Q4 2025 Relmada Therapeutics Inc Earnings Call

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