Relmada Renames Phase 3 Program SPECTRUM

The Tip Desk · November 13, 2026 · 3 min read

Cash, cash equivalents and short-term investments stood at $202.1 million as of September 30, 2026, which the company said is expected to fund operations through 2029.

Relmada Therapeutics (RLMD), a clinical-stage biotechnology company developing therapies for oncology and central nervous system disorders, reported a net loss of $13.9 million, or $0.12 a share, for the three months ended September 30, 2026, compared with a net loss of $10.1 million, or $0.30 a share, a year earlier.

The company said it remains on track to submit an Investigational New Drug application for NDV-01 by year-end 2026 and to start the registrational Phase 3 program upon IND clearance. It renamed that program SPECTRUM from RESCUE, saying the change reflects the potential breadth of NDV-01 across the non-muscle invasive bladder cancer spectrum. The two independent registrational pathways in NMIBC were described as unchanged.

NDV-01 is a sustained-release intravesical co-formulation of gemcitabine and docetaxel. Chief Executive Officer Sergio Traversa said the company has established a manufacturing plan to provide uninterrupted clinical supply through completion of the Phase 3 SPECTRUM program.

Initial 18-month results from the ongoing Phase 2 TRGC-011 study in high-risk NMIBC showed that 86% of evaluable patients who reached 18 months remained in complete response. In the BCG-unresponsive subgroup, 88% of evaluable patients who reached 18 months remained in complete response. Two BCG-naïve patients progressed to muscle-invasive disease at the Month 15 assessment. Through 12 months, the company said there were no Grade 3 or higher treatment-related adverse events, no treatment-related serious adverse events, and no treatment-related discontinuations.

Updated 12-month efficacy results among 51 evaluable patients showed an anytime complete response rate of 94% and a 12-month complete response rate of 77%. In the BCG-unresponsive subgroup, the anytime complete response rate was 96% and the 12-month rate was 73%. Progression-free and cystectomy-free survival through 12 months was 100%.

The Phase 3 SPECTRUM design includes a single-arm study in second-line high-risk BCG-unresponsive carcinoma in situ with or without Ta/T1 disease, together with a separate exploratory single-arm cohort in BCG-unresponsive Ta/T1 disease without CIS, and a randomized adjuvant study versus observation in low-grade intermediate-risk NMIBC. Clinical trial sites are engaged and preparing to initiate enrollment upon IND clearance.

Sepranolone, a synthetic isoallopregnanolone, is being developed for Prader-Willi syndrome. The company said it is finalizing stability testing of a pre-filled syringe delivery system and that the sepranolone IND is on track for year-end 2026, with a Phase 2b trial expected to start upon IND clearance.

Research and development expense for the three months ended September 30, 2026, totaled $9.2 million, compared with $4.0 million a year earlier. The company said the increase was primarily attributable to higher NDV-01 and sepranolone study preparation costs, increased manufacturing and drug storage costs and higher employee compensation, partially offset by lower stock-based compensation. General and administrative expense was $3.9 million, compared with $6.3 million a year earlier, which the company attributed primarily to lower stock-based compensation and lower stock appreciation rights expense, partially offset by higher employee compensation and consulting services. Net cash used in operating activities was $12.6 million.

Cash, cash equivalents and short-term investments were $202.1 million as of September 30, 2026, compared with about $93.0 million at December 31, 2025. The company said those resources are expected to fund operations through 2029, including completion of the two registrational cohorts of the NDV-01 Phase 3 SPECTRUM program. Shares outstanding were 106,694,846 as of November 10, 2026.