Key Highlights

  • Third quarter 2026 net loss was $13.9 million, or $0.12 per share, compared with $10.1 million a year earlier.
  • Cash, cash equivalents and short-term investments totaled about $202.1 million at September 30, 2026.
  • The company expects to submit the NDV-01 IND by year-end 2026.
  • The registrational Phase 3 program has been renamed SPECTRUM.

Relmada Therapeutics (NASDAQ:RLMD) reported financial results for the third quarter ended September 30, 2026, and provided a Business update on November 12, 2026. The Coral Gables, Florida clinical-stage biotechnology company is advancing therapies for oncology and central nervous system disorders. The update included 18-month results from a Phase 2 study of NDV-01 in non-muscle invasive bladder cancer, a renamed Phase 3 program and timelines for regulatory filings for NDV-01 and sepranolone by year-end.

NDV-01 Clinical and Regulatory Timeline

Relmada said initial 18-month results from its ongoing Phase 2 TRGC-011 study of NDV-01 in high-risk non-muscle invasive bladder cancer show extended durability of complete responses and a continued favorable tolerability profile. The company's management has described these results as early findings from an ongoing study.

The company said its NDV-01 chemistry, Manufacturing and controls program is on track for an investigational new drug submission by year-end 2026. Relmada also said it has established a manufacturing plan intended to provide uninterrupted clinical Supply through completion of the Phase 3 program. The company expects to begin the SPECTRUM registrational program once the IND is cleared.

SPECTRUM Program and Sepranolone

The Phase 3 program was renamed SPECTRUM, although the company said its two independent registrational pathways in NMIBC are unchanged. Chief Business Officer Bipin Dalmia said the new name reflects the potential breadth of NDV-01 across the NMIBC disease spectrum.

For sepranolone, Relmada said it is finalizing stability testing of a pre-filled syringe delivery system to support an IND submission, which is also targeted for year-end 2026. The company expects to start a Phase 2b trial in Prader-Willi syndrome after IND clearance. The release does not give enrollment targets for either program.

Financial Results

The net loss for the three months ended September 30, 2026, was $13.9 million, or $0.12 per basic and diluted share, compared with $10.1 million, or $0.30 per share, a year earlier. The per-share figures reflect a change in the number of shares outstanding over the period. For the nine months ended September 30, 2026, the net loss was $45.8 million, or $0.44 per share, compared with $37.5 million, or $1.16 per share in the prior-year period.

Relmada reported cash, cash equivalents and short-term investments of about $202.1 million as of September 30, 2026. Based on its current plan, the company expects that balance to fund operations through 2029. Chief Executive Sergio Traversa, in the release, described the company's manufacturing and regulatory progress as on track.

Final Word

The third quarter shows Relmada advancing its NDV-01 manufacturing work toward a year-end IND, while the net loss increased from the prior year and the company's cash balance is expected to fund operations through 2029. The timing of the SPECTRUM start depends on IND clearance, and the sepranolone filing and Prader-Willi trial remain subject to the same year-end timeline. The company's next updates will indicate whether those filings proceed on schedule.