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CORAL GABLES, Fla. - Relmada Therapeutics, Inc. (NASDAQ:RLMD), a clinical-stage biotech with a strong balance sheet showing more cash than debt and a current market capitalization of $21 million, announced Tuesday the appointment of Dr. Yair Lotan as Chair of its Clinical Advisory Board as the company prepares for Phase 3 trials of its bladder cancer treatment candidate NDV-01.
Dr. Lotan, a urologic oncologist with over two decades of experience in bladder cancer care and clinical research, will help guide the development strategy for NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel designed for non-muscle invasive bladder cancer (NMIBC) treatment.
The appointment comes as Relmada plans to initiate Phase 3 trials for NDV-01 in the first half of 2026, following positive Phase 2 data presented at the American Urology Association 2025 Annual Meeting in April. According to InvestingPro data, the company’s stock has shown strong momentum with a 58% gain over the past six months, despite experiencing significant volatility.
"In my view, impressive initial Phase 2 data presented at AUA 2025 solidly support NDV-01’s unique potential to become a class-leading, bladder-sparing therapy for the treatment of NMIBC," Dr. Lotan said in the press release.
NDV-01 is designed to enable 10-day drug retention in the bladder with gradual release, creating a matrix that enhances local exposure while minimizing systemic toxicity. The company states the treatment can be administered in-office in less than 10 minutes without requiring anesthesia or specialized equipment.
NMIBC represents approximately 75% of all bladder cancer cases and has a high recurrence rate of 50-75% over seven years. With over 600,000 prevalent cases in the U.S., Relmada sees significant market potential for NDV-01 as either a frontline or salvage therapy. While InvestingPro analysis indicates the company is currently undervalued, analysts note that profitability remains a key challenge, with a Financial Health Score of 1.92 (FAIR). For deeper insights into Relmada’s financial outlook and detailed analysis, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
Dr. Lotan is recognized for his research on urine markers and molecular markers and has published over 650 peer-reviewed papers. He has participated in establishing practice guidelines for bladder cancer management and conducted health economics research. The company maintains a healthy liquidity position with a current ratio of 5.29, indicating strong ability to meet short-term obligations.
In other recent news, Relmada Therapeutics Inc. reported its first-quarter earnings for 2025, revealing a larger-than-expected loss. The company’s earnings per share were reported at -$0.58, missing analysts’ forecast of -$0.37. Relmada’s cash balance decreased significantly from $44.9 million in the previous quarter to $27.1 million. Despite the financial challenges, the company highlighted promising developments in its pipeline, particularly in treatments for bladder cancer and Prader-Willi syndrome. The bladder cancer treatment, NDV-one, showed an 85% response rate in recent trials, which the company plans to advance through FDA interactions and expanded manufacturing capabilities. The focus remains on securing U.S. IND clearance for NDV-one in the second half of 2025. Analyst feedback from Mizuho Securities and Jefferies during the earnings call highlighted the competitive landscape and the potential for NDV-one’s differentiation in the market. Relmada’s strategic approach includes expanding its manufacturing capacity to meet future demands.
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