Relmada Therapeutics (RLMD): Is the 91% Response Rate in Bladder Cancer a Catalyst for a Phase 3-Driven Bull Run?

Relmada Therapeutics (NASDAQ: RLMD) has emerged as a focal point in the bladder cancer space, driven by its Phase 2 trial results for NDV-01, a sustained-release formulation of gemcitabine and docetaxel. The drug demonstrated a 91% overall response rate at 6 months in non-muscle invasive bladder cancer (NMIBC) patients, with 90% maintaining a response at that time point and no progression to muscle-invasive disease or radical cystectomy [1]. These results, coupled with a favorable safety profile (no Grade 3+ adverse events), position NDV-01 as a potential game-changer in a market where BCG-unresponsive patients face limited options [2].

Clinical Progress: A Strong Foundation for Phase 3

The Phase 2 trial (NCT06663137) enrolled 26 patients, including 45% BCG-unresponsive individuals, a population with unmet medical needs [3]. The 91% response rate outperforms existing therapies, such as Johnson & Johnson’s TAR-200 monotherapy (82.4% complete response rate) and the PADCEV™/KEYTRUDA™ combination for muscle-invasive disease [4]. Relmada’s data also suggest durability, with one patient maintaining a response at 9 months [3]. These findings, if replicated in Phase 3, could establish NDV-01 as a bladder-sparing alternative to surgery, a major differentiator in the NMIBC market.

However, the absence of statistical significance metrics (e.g., p-values, confidence intervals) in the Phase 2 data raises questions about the robustness of the results [5]. While the company plans to initiate a Phase 3 trial in H1 2026, regulatory alignment with the FDA on trial design will be critical to ensure the study addresses these gaps [1].

Capital Efficiency: A Tenuous Runway

Relmada’s financials paint a mixed picture. As of June 30, 2025, the company held $20.6 million in cash, down sharply from $44.9 million at year-end 2024 [1]. A quarterly burn rate of approximately $18 million—driven by R&D ($2.8 million in Q2 2025) and G&A expenses—leaves a runway extending only to mid-2026 [6]. This timeline aligns with the planned Phase 3 initiation but creates a high risk of dilution unless the company secures non-dilutive funding or partnerships.

Industry benchmarks highlight the urgency. EY’s 2025 Biotech Beyond Borders report notes that 39% of biotechs face less than a year of cash, up from 31% in 2022 [7]. Relmada’s reduced R&D expenses (down from $10.7 million in Q2 2024) reflect cost-cutting efforts, but the Phase 3 trial—a large-scale, costly endeavor—will likely strain resources. Without disclosed funding guarantees, the company may need to pivot to licensing deals or co-development partnerships, which could dilute equity or limit upside potential.

Strategic Considerations for Investors

The key question for investors is whether Relmada can execute a Phase 3 trial without dilution. While the company has pursued non-dilutive strategies (e.g., licensing deals with potential milestone payments), these have not yet materialized into concrete funding [8]. A successful Phase 3 trial could attract partners or investors, but the path is fraught with risk.

For context, industry averages for Phase 3 trials in oncology range from $50–150 million, depending on trial size and complexity [9]. If Relmada’s Phase 3 trial for NDV-01 falls within this range, its current cash reserves will be insufficient. This underscores the importance of regulatory alignment and data validation by late 2025 to bolster investor confidence and attract capital.

Conclusion: A High-Risk, High-Reward Play

Relmada’s 91% response rate in NMIBC is a compelling catalyst, but the company’s financial constraints and lack of Phase 3 cost estimates introduce significant uncertainty. Investors must weigh the clinical promise of NDV-01 against the capital efficiency challenges. A successful Phase 3 trial could drive a bull run, but the path to commercialization hinges on securing funding, demonstrating statistical significance, and navigating regulatory hurdles. For now, RLMD remains a speculative bet with high upside but limited margin for error.

Source:
[1] Relmada Therapeutics Reports Second Quarter 2025 Financial Results and Announces NDV-01 6-Month Follow-up Safety and Efficacy Data in NMIBC [https://www.relmada.com/for-investors/news/detail/322/relmada-therapeutics-reports-second-quarter-2025-financial]
[2] Bladder Cancer Drug Shows 91% Response Rate in [https://www.stocktitan.net/news/RLMD/relmada-therapeutics-reports-second-quarter-2025-financial-results-ax1dgqhy2zs2.html]
[3] Relmada Therapeutics Presents Positive Initial Phase 2 [https://www.relmada.com/for-investors/news/detail/316/relmada-therapeutics-presents-positive-initial-phase-2]
[4] Johnson & Johnson's TAR-200 monotherapy demonstrates highest complete response rate reported to date with sustained clinical benefits in patients with certain types of bladder cancer [https://innovativemedicine.jnj.com/emea/newsroom/johnson-johnsons-tar-200-monotherapy-demonstrates-highest-complete-response-rate-reported-to-date-with-sustained-clinical-benefits-in-patients-with-certain-types-of-bladder-cancer]
[5] Relmada Therapeutics: A High-Potential Biotech Play with [https://www.ainvest.com/news/relmada-therapeutics-high-potential-biotech-play-dual-pipeline-catalysts-2026-2508/]
[6] Relmada Therapeutics Reports Second Quarter 2025 Financial Results and Announces NDV-01 6-Month Follow-up Safety and Efficacy Data in NMIBC [https://www.globenewswire.com/news-release/2025/08/07/3129672/0/en/Relmada-Therapeutics-Reports-Second-Quarter-2025-Financial-Results-and-Announces-NDV-01-6-Month-Follow-up-Safety-and-Efficacy-Data-in-NMIBC.html]
[7] More Than One-Third of Biotechs Have Under a Year of Cash Left, EY Finds [https://www.biospace.com/business/more-than-one-third-of-biotechs-have-under-a-year-of-cash-left-ey-finds]
[8] Relmada Therapeutics (RLMD): Evaluating Pipeline Progress, Financial Health, and Pre-IPO Investment Opportunity [https://www.ainvest.com/news/relmada-therapeutics-rlmd-evaluating-pipeline-progress-financial-health-pre-ipo-investment-opportunity-2508/]
[9] Global Trends in R&D 2025: Signs of Higher Efficiency and Productivity [https://www.iqvia.com/blogs/2025/06/global-trends-in-r-and-d-2025-signs-of-higher-efficiency-and-productivity]