On November 12, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported financial results for the third quarter ended September 30, 2026, and provided a business update, including 18-month results from the NDV-01 Phase 2 study, the registrational Phase 3 SPECTRUM program, and continued progress toward the planned year-end 2026 Investigational New Drug (IND) submission for NDV-01 and sepranolone.
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"Relmada has made significant progress in advancing the NDV-01 CMC program and remains on track to submit the NDV-01 IND by year-end 2026. Furthermore, we have established a manufacturing plan to provide uninterrupted clinical supply through the completion of the Phase 3 SPECTRUM program," said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics.
"Initial 18-month results from the ongoing NDV-01 Phase 2 study demonstrate extended durability of complete response and continued favorable tolerability," added Bipin Dalmia, Chief Business Officer of Relmada Therapeutics. "Our Phase 3 program remains unchanged, with two independent registrational pathways in NMIBC, and we have renamed it SPECTRUM to reflect the potential breadth of NDV-01 across the NMIBC disease spectrum. We expect to begin the SPECTRUM program upon IND clearance."
CMC and Manufacturing Update
NDV-01: NDV-01 CMC program is on track for IND submission by year-end 2026, with initiation of the registrational Phase 3 SPECTRUM program upon IND clearance. Furthermore, we have established a manufacturing plan to provide uninterrupted clinical supply through completion of the Phase 3 SPECTRUM program.
Sepranolone: The Company is finalizing the stability testing of the pre-filled syringe (PFS) delivery system to enable sepranolone IND submission, which is on track for year-end 2026. We expect to start the Phase 2b trial in Prader-Willi Syndrome upon IND clearance.
NDV-01 Clinical Update
Phase 2 Study: Initial 18-month results from the ongoing Phase 2 TRGC-011 study of NDV-01 in high-risk NMIBC continue to support extended durability of NDV-01 complete responses and continued favorable tolerability profile.
Initial 18-month durability results: 23 patients in complete response (CR) at 12 months continued into the long-term extension (LTE). 86% (12/14) of evaluable patients who reached 18 months remained in CR. In the BCG-unresponsive subgroup, 11 patients continued into the LTE, and 88% (7/8) of evaluable patients who reached 18 months remained in CR. Two BCG-naïve patients (T1 at study entry) progressed to muscle-invasive disease (T2a) at the Month 15 assessment.
Updated 12-month efficacy results: Among 51 evaluable patients, the anytime CR rate was 94% (48/51) and the 12-month CR rate was 77% (24/31). In the BCG-unresponsive subgroup, the anytime CR rate was 96% (22/23) and 12-month CR rate was 73% (11/15). Through 12-months, both progression-free and cystectomy-free survival was 100%.
Safety and tolerability: To date, there were no Grade ≥3 treatment-related adverse events (TRAEs), no treatment-related serious adverse events, and no treatment-related discontinuations.
Phase 3 SPECTRUM Program: The NDV-01 Phase 3 program remains unchanged and is designed to pursue two independent registrational pathways in NMIBC:
A single-arm study in second-line (2L) high-risk BCG-unresponsive carcinoma in situ (CIS) ± Ta/T1 (Cohort 2UC), together with a separate single-arm 2L high-risk BCG-unresponsive Ta/T1 w/o CIS exploratory cohort (Cohort 2UP).
A randomized study evaluating NDV-01 as adjuvant therapy following transurethral resection of bladder tumor (TURBT) versus observation in low-grade intermediate-risk NMIBC (Cohort IRA).
The Company has changed the name of its Phase 3 program from RESCUE to SPECTRUM to better reflect the potential breadth of NDV-01 across the entire NMIBC disease spectrum. Clinical trial sites are engaged and preparing to initiate patient enrollment upon IND clearance.
Anticipated Upcoming Milestones
NDV-01:
NDV-01 United States IND submission – By year-end 2026
NDV-01 Phase 3 SPECTRUM program initiation – Upon IND clearance
Sepranolone:
Sepranolone United States IND submission – By year-end 2026
Sepranolone Phase 2b initiation in Prader-Willi Syndrome – Upon IND clearance
Financial Results
Third Quarter 2026 Financial Results
Research and development expense for the three months ended September 30, 2026, totaled $9.2 million, compared to $4.0 million for the three months ended September 30, 2025, an increase of $5.2 million. 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 for the three months ended September 30, 2026, totaled $3.9 million compared to $6.3 million for the three months ended September 30, 2025, a decrease of approximately $2.4 million. The decrease was primarily driven by 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 for the three months ended September 30, 2026, totaled $12.6 million compared to $6.7 million for the three months ended September 30, 2025.
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 a net loss of $10.1 million, or $0.30 per basic and diluted share, for the three months ended September 30, 2025.
As of September 30, 2026, the Company’s cash, cash equivalents, and short-term investments totaled $202.1 million, compared to cash, cash equivalents, and short-term investments of approximately $93.0 million at December 31, 2025.
The Company’s current cash, cash equivalents, and short-term investments as of September 30, 2026, are expected to provide sufficient resources to fund Company operations through 2029, including completion of the two registrational cohorts of the NDV-01 Phase 3 SPECTRUM program.
The Company had 106,694,846 shares outstanding, as of November 10, 2026.
Nine Months Ended September 30, 2026 Financial Results
Research and development expense for the nine months ended September 30, 2026, totaled $25.7 million, compared to $18.8 million for the nine months ended September 30, 2025, an increase of $6.9 million. The increase was primarily attributable to increased manufacturing and drug storage costs, higher employee compensation and higher stock appreciation rights expense, partially offset by lower study costs and lower stock-based compensation.
General and administrative expense for the nine months ended September 30, 2026, totaled $21.9 million compared to $20.0 million for the nine months ended September 30, 2025, an increase of approximately $1.9 million. The increase was primarily driven by higher employee compensation, stock appreciation rights expense and consulting services, partially offset by lower stock-based compensation.
Net cash used in operating activities for the nine months ended September 30, 2026, totaled $37.3 million compared to $31.2 million for the nine months ended September 30, 2025.
The net loss for the nine months ended September 30, 2026, was $45.8 million, or $0.44 per basic and diluted share, compared with a net loss of $37.5 million, or $1.16 per basic and diluted share, for the nine months ended September 30, 2025.
Conference Call and Webcast Information
Relmada will host a conference call and webcast today at 4:30 PM ET to discuss recent business progress and financial results.
Date: Thursday, November 12, 2026 at 4:30 PM ET
Participant Dial-in (US): 1-800-717-1738
Participant Dial-in (International): 1-646-307-1865
Webcast Access: Click Here
A replay of the webcast will be available in the Investors section of the Relmada website at View Source
About NDV-01
NDV-01 is a novel, sustained-release, intravesical co-formulation of gemcitabine and docetaxel (Gem/Doce) being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). The formulation is engineered to provide prolonged bladder retention and sustained drug release for up to 10 days. By forming a soft intravesical matrix, NDV-01 is designed to increase local drug exposure while limiting systemic toxicity. The treatment can be administered conveniently in an office setting in under 5 minutes without the need for anesthesia or specialized equipment. NDV-01 is encompassed by multiple patent applications that if issued, could provide protection until 2047.
About the NDV-01 Phase 3 SPECTRUM Registrational Pathways:
Relmada has received written FDA feedback confirming alignment on two registrational pathways for NDV-01, including study design, patient populations, and primary endpoints. The Company expects to submit an IND by year-end 2026 and initiate the Phase 3 SPECTRUM program upon IND clearance.
About NMIBC
NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence rates (50–80% over 5 years) and disease progression in a subset of these patients. With 63,000 incident NMIBC cases per year in the U.S. and limited treatment options, the market opportunity is significant. High-risk BCG-unresponsive disease represents the biggest unmet need in NMIBC, with limited and suboptimal bladder-sparing treatment options. While four therapies are FDA-approved for first line BCG-unresponsive disease, there are no approved therapies in the second line or later. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies and patients with recurrence must undergo repeated surgical resections. NDV-01 has the potential to serve as a foundational intravesical therapy across the NMIBC disease spectrum.
About Sepranolone and GABA Modulation
Sepranolone, a synthetic isoallopregnanolone, selectively modulates GABAA receptors by antagonizing allopregnanolone (ALLO), without disrupting GABA signaling. It targets disorders linked to excess GABAergic activity such as Prader-Willi syndrome (PWS), Tourette syndrome, and obsessive-compulsive disorder (OCD). More than 335 patients have been treated with sepranolone in clinical trials to date, with a favorable safety profile. The Company is on track to submit the sepranolone IND by year-end 2026 and expects to initiate the Phase 2 study in Prader-Willi syndrome upon IND clearance.
About Prader-Willi Syndrome (PWS)
PWS is a rare genetic disorder caused by chromosomal deletions on chromosome 15, leading to neurodevelopmental and behavioral complications. Global prevalence is estimated to be 350,000-400,000 patients. Current treatments address symptoms but do not modify the underlying neurobehavioral pathology.
(Press release, Relmada Therapeutics, NOV 12, 2026, View Source [SID1234674719])