Relmada Therapeutics Inc.'s 2025 Q4 Call: 12-Month Data Timing, Phase 3 Enrollment, and R&D Cost Signals Don’t Match

Date of Call: Mar 19, 2026

Financials Results

• EPS: $0.27 per basic and diluted share, compared to a net loss of $0.62 per basic and diluted share for the three months ended December 31, 2024

Guidance:

• Plan to initiate the phase 3 RESCUE program for NDV-01 in the middle of 2026.
• Expect to report initial 3-month response data from the BCG unresponsive study by the end of 2026.
• Plan to begin a proof of concept study for sepranolone in Prader-Willi syndrome in mid-2026.
• The company's cash balance and recent financing are expected to fund operations through 2029.

Business Commentary:

NDV-01 Program Progress:

• Relmada Therapeutics reported a 12-month complete response rate of 76% and a favorable safety profile for NDV-01 in the ongoing phase 2 study for non-muscle invasive bladder cancer (NMIBC).
• The strong response rate and durability position NDV-01 as a potential best-in-class therapy, with plans to initiate the phase 3 RESCUE program in mid-2026.

Financial Strength and Strategic Positioning:

• The company closed 2025 with a cash balance of $93 million, including net proceeds from an underwritten stock offering and a recent $160 million private financing.
• This financial strength provides sufficient resources to fund operations through 2029, supporting the advancement of NDV-01 and sepranolone programs.

Sepranolone Development:

• Sepranolone, which has demonstrated proof of concept in Tourette syndrome, is preparing to initiate a proof of concept study in Prader-Willi syndrome in mid-2026.
• The novel action on the GABA neurotransmitter pathway presents potential for alleviating compulsive disorders, with efforts focused on trial preparation and supply chain establishment.

Team and Expertise Enhancement:

• Relmada strengthened its development team with the appointment of Dr. Raj S. Pruthi as Chief Medical Officer - Oncology/Urology and established a scientific advisory board.
• These moves support the advancement of the NDV-01 program with expert guidance, enhancing the company's credibility and capability in oncology.

Sentiment Analysis:

Overall Tone: Positive

• Management described 2025 as 'a transformational year' and 'compelling responses and durable 12-month efficacy data.' They expressed confidence in NDV-01 being 'best-in-class' and 'uniquely positioned to redefine the standard of care.' The CEO stated, 'I’m very confident and optimistic about our clinical programs and the long-term prospects for Relmada.'

Q&A:

• Question from Uy Ear (Mizuho Securities): Should we expect updates every three months from the phase two study? Will there be data at AUA? How do you ensure second-line patients are not actually third-line? Is the 3-month data from the entire phase 3 population?
  Response: Will present updated 12-month data at AUA and plan to share 3-, 6-, 9-, and 12-month follow-up data every three months. The phase 3 BCG unresponsive study will limit patients to a maximum of two prior therapies. The initial 3-month data will be from the entire planned patient population.

• Question from Farzin Haque (Jefferies): What is the expectation for enrollment cadence across the two phase 3 studies? Does the in-office profile provide a recruitment advantage? Has the FDA stipulated a minimum duration of follow-up for the NDA in the second-line setting?
  Response: Believe the unique second-line BCG unresponsive pathway and in-office administration provide a competitive advantage, expecting rapid enrollment. The FDA has not required a specific minimum follow-up duration, but wants to see the totality of data showing complete response and durability.

• Question from Christopher Liu (Lucid): Given population differences between phase 2 and phase 3, what are expectations for the CR rate at the three-month mark and what should we benchmark against?
  Response: For the intermediate-risk study, the target is a two-year disease-free survival of 75%, driven by statistics. For the BCG unresponsive study, the CR rate should be at or above the levels seen in first-line therapies (e.g., Valrubicin at 8%, Keytruda at 19%, Adstiladrin at 24%).

• Question from Kelsey Goodwin (Piper Sandler): How should we compare the phase 2 data set's CIS versus papillary split to competitors, and is there data showing Gem-Doci is similar in CIS and papillary patients? How much does the intermediate-risk market need to be built out?
  Response: Cited literature showing no marked difference in CR rates between CIS and papillary patients in BCG unresponsive populations; NDV-01's 12-month CR rate compares favorably. The intermediate-risk market currently has only 35% of patients receiving adjuvant therapy, which is expected to grow with new data and potential approval.

Contradiction Point 1

Timeline for Presenting 12-Month Data

Direct contradiction on when critical 12-month data from the BCG-unresponsive trial will be available, impacting data availability timeline.

Uy Ear (Wei), Analyst, Mizuho Securities - Uy Ear (Wei), Analyst, Mizuho Securities

2025Q4: 12-month data will be presented at AUA. - Dr. Raj Pruthi(Chief Medical Officer - Oncology/Urology)

Will there be additional data presentations from the phase 2 study at AUA? - Uy Ear (Mizuho Securities)

20251114-2025 Q3: top-line 12-month complete response (CR) data expected in Q2 2028. - Raj Pruthi(Chief Medical Officer)

Contradiction Point 2

Enrollment Cadence Expectation for Phase 3 Studies

Contradiction on the speed of enrollment for Phase 3 trials, which directly impacts trial timelines and resource planning.

Farzin Haque, Analyst, Jefferies - Farzin Haque, Analyst, Jefferies

2025Q4: Enrollment is expected to be rapid, potentially ahead of schedule. - Dr. Raj Pruthi(Chief Medical Officer - Oncology/Urology)

What is the expected enrollment cadence for the two phase 3 studies, and how might the in-office administration profile impact recruitment? - Uy Ear (Mizuho Securities)

20251114-2025 Q3: Both trials ... to start in the second quarter of 2026. - Raj Pruthi(Chief Medical Officer) and Sergio Traversa(CEO)

Contradiction Point 3

Regulatory Pathway for Low/Intermediate-Grade Disease

Contradictory statements on the speed and risk profile of the low/intermediate-grade versus high-grade pathways, affecting strategic prioritization.

Kelsey Goodwin (Piper Sandler) - Kelsey Goodwin (Piper Sandler)

2025Q4: The intermediate-risk market currently has only 35% uptake of adjuvant therapy. This is expected to grow significantly as data from trials like RESCUE and PIVOT-006 become available... - Dr. Raj Pruthi(CMO)

What infrastructure is needed for early intermediate-risk market launches given ~35% adjuvant therapy uptake? - Uy Sieng Ear (Mizuho Securities USA LLC)

2025Q2: The low/intermediate-grade pathway is seen as a faster route to FDA approval due to easier and quicker patient accrual. - Raj S. Pruthi(CMO)

Contradiction Point 4

Status of Patient Enrollment and R&D Cost Drivers

Contradiction on whether patient enrollment is active or paused, directly impacting R&D expense outlook and financial forecasting.

Farzin Haque (Jefferies) - Farzin Haque (Jefferies)

2025Q4: Enrollment is expected to be rapid, potentially ahead of schedule... The in-office administration is a unique advantage... - Dr. Raj Pruthi(CMO)

Okay, let's tackle this. The user wants me to rewrite the input into one concise earnings-call question. The input is already a question, so I need to make sure it's clear and fits the rules.First, the original question is about the expected enrollment cadence for two phase 3 studies and whether the in-office administration profile is a recruitment advantage. The user wants it to be a single, concise question. I should check if combining the two parts into one question makes sense. The original has two parts connected by "and could," which might be okay, but maybe it's better to structure it as a single question without the conjunction. However, the original uses "and" to link both parts, which is acceptable as long as it's a single question.Also, need to ensure the output ends with a question mark. The original ends with a question mark, so that's good. The output must be exactly one line and only the final question text. No explanations or prefaces. I don't see any issues with the original question in terms of vagueness or missing info. It's specific about enrollment cadence and a potential advantage. So, the answer should be the original input as is, but maybe slightly rephrased if needed. Wait, the user says if it's already a clear question, output as-is. But the input has two parts. Let me check the rules again. The instruction says if the input is not a question, too vague, or lacks info, output as-is. Otherwise, rewrite into one question. But the input is already a question. However, the user wants it rewritten into one concise question. The original is two parts. Maybe combining them into a single question without the "and could" part. Let me see. For example: "What is the expected enrollment cadence for the two phase 3 studies, and could the in-office administration profile be a recruitment advantage?" That's the original. But maybe the user wants it more concise. However, the original is already concise. The rules say to output exactly as-is if it's a clear question. Wait, the user says "if the input is NOT a question, is too vague, or lacks enough information to form a clear earnings-call question, output the input EXACTLY as-is, with no modification." Since the input is a clear question, we need to rewrite it into one concise question. Wait, but the input is already a question. So perhaps the user wants to combine the two parts into a single, more concise question. Let me think. The original has two parts: enrollment cadence and recruitment advantage. Maybe rephrase it as a single question that encompasses both. For example: "What is the expected enrollment cadence for the two phase 3 studies, and how might the in-office administration profile impact recruitment?" That's slightly rephrased but more concise. But the original uses "could...be a recruitment advantage," which is a yes/no question. However, the user might prefer a more concise version. Alternatively, maybe it's acceptable as is. Since the original is already a valid question, maybe the answer is to output it as is. But the user says to rewrite into one concise question. Hmm. The instruction says "rewrite the input into ONE concise earnings-call question." So even if the input is a question, we need to make it more concise. Let me check the example. The input is a question with two parts. The output should be a single question. So perhaps combining the two parts into one. For example, "What is the expected enrollment cadence for the two phase 3 studies, and could the in-office administration profile serve as a recruitment advantage?" That's the same as the original. So maybe the original is already acceptable. Therefore, the answer is the original input as is. Wait, but the user says "if the input is NOT a question, is too vague, or lacks enough information to form a clear earnings-call question, output the input EXACTLY as-is, with no modification." Since the input is a clear question, we need to rewrite it. But how? The original is already a question. So perhaps the answer is to output the original input as is. Because it's already a valid question. But the user wants it rewritten into one concise question. Maybe the original is already concise. So the answer is the original input. Therefore, the output is the input as is. But the user says "rewrite the input into ONE concise earnings-call question." So maybe they want it rephrased. But the original is already a question. Maybe the answer is the original input. Let me check the rules again. The user says "If the input is NOT a question, is too vague, or lacks enough information to form a clear earnings-call question, output the input EXACTLY as-is, with no modification." Since the input is a valid question, we need to rewrite it. But how? The original is already a question. - Uy Sieng Ear (Mizuho Securities USA LLC)

2025Q2: The decrease in R&D expense is because patient enrollment has paused for the ongoing studies. The primary cost driver—patient enrollment—will resume when the Phase III study for NDV-01... begin in the first half of 2026. - Sergio Traversa(CFO)

Contradiction Point 5

Timing and Content of Future Data Presentations

Inconsistent statements about when and what data will be shared from the RESCUE program, affecting transparency and data availability expectations.

Uy Ear (Wei), Mizuho Securities - Uy Ear (Wei), Mizuho Securities

2025Q4: Data from the ongoing RESCUE program will be shared starting at the end of 2026, with updates every three months (6-, 9-, 12-month follow-ups). - Dr. Raj Pruthi(CMO)

Will there be additional data presentations from the phase 2 study and updates at AUA? - Matt Barcus (Jefferies, for Andrew Tsai)

2025Q1: Six-month complete response data for the 20 patients will be available around end of June or July 2025. Subsequent updates at 9 and 12 months will follow. - Sergio Traversa(CEO) and Yair Lotan(Chief, Urology and Oncology)