Shares of Relmada Therapeutics, Inc. (NASDAQ:RLMD) climbed 25% on Monday after the company released 12-month interim results from its Phase 2 study of NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).
The trial reported a 12-month complete response (CR) rate of 76%, while 95% of patients achieved a complete response at some point during the study. Among patients whose disease was unresponsive to BCG therapy, the 12-month CR rate reached 80%, with 94% achieving CR at any time.
According to the company, none of the treated patients experienced progression to muscle-invasive disease or required radical cystectomy. The treatment also showed a favorable safety profile, with no treatment-related adverse events of Grade 3 or higher and no patients discontinuing therapy because of side effects.
Of the 48 patients who received at least one dose of NDV-01, 30 (63%) experienced a treatment-related adverse event. The most frequently reported event was dysuria, occurring in 54% of patients. Additionally, 8% experienced asymptomatic positive urine cultures and another 8% reported hematuria.
Relmada said it intends to move NDV-01 into its Phase 3 RESCUE registrational program by mid-2026, focusing on two potential indications: second-line treatment for BCG-unresponsive NMIBC and adjuvant therapy for intermediate-risk NMIBC. The company estimates that the intermediate-risk NMIBC market includes about 75,000 patients annually in the United States, while roughly 5,000 patients each year are diagnosed with BCG-unresponsive NMIBC with carcinoma in situ.
Relmada also announced plans for a private investment in public equity (PIPE) financing expected to raise approximately $160.0 million in gross proceeds. The company is offering 29,474,569 shares of common stock at $4.75 per share, along with pre-funded warrants to purchase 4,210,527 shares priced at $4.749 per warrant. The financing is expected to close on or around March 11, 2026.
Jefferies, Leerink Partners, Piper Sandler and Mizuho are serving as placement agents for the transaction.