Relmada Therapeutics (RLMD) Status Update summary

NDV-01 phase 2 trial overview

• NDV-01 is an intravesical, sustained-release combination of gemcitabine and docetaxel for high-risk non-muscle invasive bladder cancer (NMIBC), forming a soft matrix in the bladder for gradual drug release over 10 days.

• The phase 2 trial is open-label, single-arm, and single-center, targeting high-risk NMIBC patients, including BCG-naive, BCG-unresponsive, and BCG-intolerant individuals.

• Primary endpoints are safety and complete response at 12 months; secondary endpoints include disease efficacy, duration of response, event-free survival, and drug concentration monitoring.

• NDV-01 is administered biweekly, with maintenance every six weeks for disease-free patients, and follow-up includes urine cytology and cystoscopy every three months.

• 26 patients enrolled as of cutoff; 20 reached 3-month assessment, 7 reached 6-month assessment, and enrollment is ongoing.

Efficacy and clinical results

• Interim data show 85% high-grade recurrence-free survival at three months and 90% at any time point.

• All carcinoma in situ (CIS) patients (11% of cohort) achieved 100% complete response confirmed by biopsy.

• At 6 months, all evaluable patients (n=7) remained disease-free, including both CIS and papillary subtypes.

• NDV-01 demonstrated robust activity across BCG-naïve and BCG-unresponsive patients, regardless of disease pathology.

Safety and tolerability

• NDV-01 was well tolerated, with no treatment-related adverse events above Grade 1.

• Most common side effects were mild and transient (urinary urgency, dysuria, flank pain), resolving within 24-28 hours.

• No patients discontinued treatment due to adverse events.

• Quality of life improved significantly for patients previously treated with BCG.