8-K: Relmada Reports Q3 2025, Advances Bladder Cancer Drug NDV-01

Relmada Therapeutics announced its third-quarter 2025 financial results, highlighted by positive 9-month data for its NDV-01 bladder cancer therapy and FDA alignment on Phase 3 trial designs, alongside a $100 million capital raise.

Summary

• Reported preliminary and unaudited financial results for the third fiscal quarter ended September 30, 2025, with a net loss of $10.1 million or $0.30 per share.
• Positive 9-month follow-up data for NDV-01 in non-muscle invasive bladder cancer (NMIBC) showed a 92% overall complete response rate at any time, with favorable overall safety.
• Secured FDA alignment on key elements of the Phase 3 program for NDV-01, establishing two independent paths for approval in high-risk 2nd line BCG-unresponsive and intermediate-risk NMIBC patients in the adjuvant setting.
• Phase 3 studies for NDV-01 are expected to begin in the first half of 2026.
• Completed a $100 million underwritten offering of common stock and pre-funded warrants on November 5, 2025, providing approximately $94.0 million in net proceeds.
• The recent financing is expected to support planned operations into 2028.
• Initiation of a Phase 2, proof of concept clinical trial for sepranolone in Prader-Willi Syndrome (PWS) is expected in the first half of 2026.

Sentiment

Score: 9

Explanation: The filing presents highly positive developments, including strong clinical data for NDV-01, clear FDA alignment for two distinct Phase 3 registrational paths, and a successful capital raise that significantly extends the company's financial runway. These factors substantially de-risk the lead program and provide a strong foundation for future growth, despite ongoing net losses.

Positives

• NDV-01 demonstrated a 92% complete response rate (CRR) at any time point in NMIBC patients, with 85% CRR at 9 months (for 20 patients) and 91% anytime CRR in the BCG-unresponsive subpopulation.
• NDV-01 showed a favorable overall safety profile with no progression to muscle-invasive disease, no radical cystectomy, no new safety signals, no Grade 3 treatment-related adverse events (TRAE), and no patient discontinuations due to AEs.
• FDA alignment on two distinct Phase 3 registrational paths for NDV-01, including the potential for a single-arm trial in high-risk, refractory BCG-unresponsive patients, which could offer a rapid route to approval.
• No further non-clinical studies are required by the FDA to support a 505(b)(2) New Drug Application (NDA) for NDV-01.
• Successfully completed a $100 million underwritten offering, significantly extending the company's cash runway into 2028.
• Reported a reduced net loss of $10.1 million for Q3 2025 compared to $21.7 million for Q3 2024, and $37.5 million for the nine months ended September 30, 2025, compared to $61.3 million for the same period in 2024.
• Research and Development (R&D) expenses decreased to $4.0 million in Q3 2025 from $11.1 million in Q3 2024, and General and Administrative (G&A) expenses decreased to $6.3 million from $11.9 million over the same periods.

Negatives

• The company continues to incur net losses, reporting $10.1 million for Q3 2025 and $37.5 million for the nine months ended September 30, 2025.
• Cash and cash equivalents, along with short-term investments, decreased from $44.9 million at December 31, 2024, to $13.9 million as of September 30, 2025, prior to the recent capital raise.
• 61% of enrolled patients receiving NDV-01 experienced a treatment-related adverse event (AE), although 62% of these were transient Grade 1 uncomfortable urination (dysuria).

Risks

• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, including the potential for product candidates to progress.
• Clinical trials may fail to deliver statistically and/or clinically significant evidence of efficacy and/or safety.
• Top-line results may not accurately reflect the complete results of the trial.
• Planned or ongoing preclinical and clinical studies may fail to demonstrate expected results.
• The company may fail to continue to secure FDA agreement on the regulatory path for NDV-01 and/or sepranolone.
• Future NDV-01 and/or sepranolone clinical results may not be acceptable to the FDA.
• There is a risk of failure to secure adequate NDV-01 and/or sepranolone drug supply.
• Uncertainties are inherent in estimating the company's cash runway, future expenses, and its ability to fund future operations, including clinical trials.

Future Outlook

The company expects to initiate Phase 3 trials for NDV-01 in two distinct NMIBC indications (high-risk 2nd line BCG-unresponsive and intermediate-risk adjuvant setting) in the first half of 2026, following FDA alignment on key program elements. Additionally, it anticipates releasing 12-month data from the ongoing Phase 2 NMIBC study for NDV-01 in Q1 2026 and initiating a Phase 2 proof-of-concept clinical trial for sepranolone in Prader-Willi Syndrome in H1 2026. With the recent $100 million capital raise, the company projects its cash balance to be sufficient to support planned expenses into 2028.

Management Comments

• Sergio Traversa, CEO: "Relmada's outstanding progress this year has significantly de-risked our lead program, NDV-01 for NMIBC, and established a strong foundation for future success. Positive 9-month data showing a 92% complete response (CR) rate at any time point and the positive outcome of our Type B meeting with the FDA further reinforce our confidence in NDV-01's potential to become a best-in-class treatment for NMIBC."
• Sergio Traversa, CEO: "The recent $100M underwritten financing provides the resources to drive forward the planned registrational studies for NDV-01, advance development of sepranolone for Prader-Willi Syndrome (PWS) and support the future growth of Relmada."
• Raj S. Pruthi, CMO-Oncology: "Positive 9-mo data and alignment with the FDA on the Phase 3 pivotal program are key milestones for the NDV-01 program. We are pleased that ongoing Phase 2 follow-up data continue to support the opportunity for NDV-01 to transform the treatment of NMIBC, by providing patients and physicians with a potential bladder-sparing, in-office, ready-to-use, safe, effective and durable, best-in-class therapy."
• Raj S. Pruthi, CMO-Oncology: "Securing FDA alignment for two distinct registrational paths provides a clear path to advance NDV-01 for patients with NMIBC who currently have limited options. We believe a single-arm registrational study in high-risk, refractory BCG-unresponsive patients offers a rapid route to potential approval, while alignment on a separate, second pivotal study in intermediate-risk NMIBC could enable an additional indication and broader clinical adoption. We look forward to working with the FDA to establish the final study design and initiate the registrational program in the first half of 2026."

Industry Context

Non-muscle invasive bladder cancer (NMIBC) represents a significant market opportunity, accounting for 75-80% of all bladder cancer cases with high recurrence rates (50-80% over 5 years) and over 744,000 prevalent cases in the U.S. Current treatment options are limited, making NDV-01's potential as a bladder-sparing, in-office, ready-to-use, safe, effective, and durable therapy highly relevant. It could serve as a frontline or salvage therapy across multiple NMIBC subtypes, addressing a substantial unmet medical need. Similarly, Prader-Willi Syndrome (PWS) is a rare genetic disorder affecting 350,000-400,000 patients globally, where existing treatments only manage symptoms, highlighting the need for therapies like sepranolone that target the underlying neurobehavioral pathology.

Comparison to Industry Standards

• The appointment of Dr. Max Kates, who chaired the landmark Phase 3 BRIDGE trial, to the Clinical Advisory Board suggests the company is aligning with leading experts and benchmarks in urologic oncology.
• NDV-01's 92% complete response rate (anytime) and favorable safety profile in NMIBC, particularly in BCG-unresponsive patients, appears highly competitive given the limited efficacy and significant side effects of current therapies, which often include radical cystectomy.
• The FDA's agreement to consider a single-arm trial for high-risk, 2nd line BCG-unresponsive NMIBC indicates a high unmet medical need and potentially strong preliminary data for NDV-01, as such trial designs are typically reserved for conditions with few or no effective treatment alternatives.

Management Changes

Stakeholder Impact

• Shareholders: Positive impact due to strong clinical data, clear regulatory path, and extended cash runway, potentially leading to increased share value. There is also dilution from the recent capital raise.
• Patients (NMIBC): Potential for a new, effective, bladder-sparing, in-office treatment option for a condition with limited therapies, especially for BCG-unresponsive patients.
• Patients (PWS): Potential for a new therapy targeting underlying neurobehavioral pathology, addressing a significant unmet medical need.
• Investment Professionals: Provides clear milestones and financial stability, offering a more attractive investment profile.
• Employees: Continued employment and potential growth opportunities as clinical programs advance and the company expands.

Next Steps

• Conduct a conference call and audio webcast on November 13, 2025, at 4:30 PM EST / 1:30 PM PST to discuss the corporate update and financial results.
• File the complete unaudited financial statements and notes in its Quarterly Report on Form 10-Q with the Securities and Exchange Commission.
• Release 12-month data from the ongoing Phase 2 NMIBC Study for NDV-01 in Q1 2026.
• Secure United States IND clearance for NDV-01 in the first half of 2026.
• Initiate the NDV-01 High-risk, 2nd line BCG-unresponsive NMIBC Phase 3 Trial in the first half of 2026.
• Initiate the NDV-01 Intermediate Risk in the Adjuvant Setting Phase 3 Trial in the first half of 2026.
• Initiate a Phase 2, proof of concept clinical trial for sepranolone in Prader-Willi Syndrome (PWS) in the first half of 2026.
• Work with the FDA to establish the final study design for the NDV-01 registrational program.

Key Dates

Recommendation

The filing demonstrates significant de-risking of the company's lead asset, NDV-01, through compelling 9-month Phase 2 clinical data and crucial FDA alignment on two distinct Phase 3 registrational pathways, including a potentially accelerated single-arm trial. The successful $100 million capital raise provides substantial financial runway into 2028, mitigating near-term funding concerns. While the company remains in a net loss position, the reduction in losses and clear path to market for a therapy addressing a high unmet need in NMIBC, coupled with progress on sepranolone, positions Relmada for strong future growth. These factors collectively present a highly attractive investment opportunity for seasoned investors.

Keywords

NDV-01, NMIBC, Non-Muscle Invasive Bladder Cancer, Bladder Cancer, Oncology, Sepranolone, Prader-Willi Syndrome, PWS, Clinical Trials, FDA Alignment, Phase 3, Biotechnology, Clinical-Stage, Financial Results, Capital Raise, RLMD