Key Highlights

  • Third-quarter 2026 net loss was USD 13.9 million, or USD 0.12 per share.
  • Cash, equivalents and short-term investments were USD 202.1 million at September 30, 2026.
  • Research and development expense was USD 9.2 million, against USD 4.0 million.
  • Management said cash funds operations through 2029, including Phase 3 SPECTRUM studies.

Relmada Therapeutics (NASDAQ:RLMD) reported a third-quarter 2026 net loss of USD 13.9 million, or USD 0.12 per share, against an estimate of a loss of USD 0.14 per share. The Nasdaq Capital Market-listed company reported no revenue. Its lead program is NDV-01, a sustained-release product being studied in non-muscle invasive bladder cancer, or NMIBC.

Management also reported updated Phase 2 results for NDV-01, including initial 18-month data from a long-term extension, and said it renamed its registrational Phase 3 program SPECTRUM.

Financial Results

Research and development expense was USD 9.2 million, against USD 4.0 million, which management attributed primarily to higher NDV-01 and sepranolone study preparation costs, increased Manufacturing drug storage costs and higher employee compensation, partially offset by lower stock-based compensation. General and administrative expense was USD 3.9 million, against USD 6.3 million, driven by lower stock-based compensation and lower stock appreciation rights expense, partially offset by higher employee compensation and consulting services.

Net loss was USD 13.9 million, or USD 0.12 per basic and diluted share, against USD 10.1 million, or USD 0.30. The 10-Q lists an unrealized loss on short-term investments of approximately USD 2,605,200 for the quarter, against an unrealized gain of USD 70,300. Net cash used in Operating Activities was USD 12.6 million, against USD 6.7 million.

For the nine months, net loss was approximately USD 45,828,300, against USD 37,517,400.

Cash and Financing

The company closed the quarter with cash, cash equivalents and short-term investments of USD 202.1 million, against USD 93 million at December 31, 2025. Net cash provided by financing activities for the nine months was USD 150,171,112, including proceeds of USD 159,999,996 from the issuance of common stock, offset by USD 9,817,890 of issuance fees and USD 131,924 of at-the-market expenses.

Chief Financial Officer Maged Shenouda said the company's current cash position is projected to fund operations through 2029, including completion of the registrational Phase 3 NDV-01 SPECTRUM studies.

NDV-01 Clinical Update

Management said 23 high-risk NMIBC patients in complete response, or CR, at 12 months continued into a long-term extension study. Of 14 evaluable patients at 18 months, 12, or 86%, remained in CR, including 7 of 8, or 88%, in the BCG-unresponsive subgroup. Two patients progressed to muscle-invasive disease at month 15, and no patients in the study have undergone a radical cystectomy to date.

Updated 12-month results now include 51 high-risk NMIBC patients, with an anytime CR rate of 94% and a 12-month CR rate of 77%. In the BCG-unresponsive subgroup, the anytime CR rate was 96% and the 12-month CR rate was 73%. Management said the Phase 2 study to date has recorded no Grade 3 or higher treatment-related adverse events, no treatment-related serious adverse events and no treatment-related discontinuations.

The SPECTRUM Phase 3 program has two FDA-aligned registration pathways: a single-arm study in second-line, high-risk BCG-unresponsive NMIBC patients with carcinoma in situ, with or without papillary disease, plus an exploratory papillary-only cohort, and a randomized study of NDV-01 as adjuvant therapy after TURBT versus observation in low-grade intermediate-risk NMIBC. Management said it continues to project submitting the IND for NDV-01 by year-end 2026 and initiating Phase 3 upon IND clearance, and that it also plans to file the IND for sepranolone by year-end.