-- Positive 12-month Phase 2 data for NDV-01 in non-muscle invasive bladder
cancer (NMIBC) demonstrated a 95% complete response $(CR)$ rate at any time
and a durable 76% CR rate at 12 months, with favorable safety profile
-- Completed an oversubscribed $160 million PIPE financing led by leading
healthcare investors in March 2026, strengthens balance sheet to support
NDV-01 Phase 3 development
-- On track to initiate Phase 3 RESCUE registrational program in second line
(2L) BCG-unresponsive and adjuvant intermediate-risk NMIBC in mid-2026
-- Cash balance of $93.0 million as of December 31, 2025, plus gross
proceeds of $160 million from March 2026 PIPE expected to fund operations
through 2029, including completion of the NDV-01 RESCUE program
-- Management to host a conference call and webcast today at 4:30 PM ET
CORAL GABLES, Fla., March 19, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today reported audited financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update highlighting significant progress across its pipeline.
"This has truly been a transformational year for Relmada, marked by significant progress with our lead program NDV-01," said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. "Our recently reported 12-month data for NDV-01 demonstrated durable complete responses with a favorable safety profile, reinforcing the program's potential to become a best-in-class therapy for patients with non-muscle invasive bladder cancer. With a successful $160 million PIPE financing and regulatory alignment with the FDA on two registrational pathways, we believe that we are well positioned to advance NDV-01 into the Phase 3 RESCUE program in mid-2026. Our team is now focused on executing this plan and initiating the RESCUE registrational program as we work to bring NDV-01 to patients as efficiently as possible."
"NDV-01's compelling efficacy, durability, and favorable safety profile, combined with operational ease-of-use are the cornerstone of its differentiated product profile and best-in-class potential," said Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics. "We continue to be encouraged by the high response rates and durable clinical benefit observed through 12 months, including in the BCG-unresponsive population, alongside a favorable safety profile with no >= Grade 3 treatment-related adverse events and no treatment-related discontinuations. Our clinical program builds on the urologic oncology community's comfort with conventional Gem/Doce's efficacy and safety profile with a sustained release product that could provide physicians and patients with a streamlined, less than 5-minute in-office procedure. These results reinforce our confidence as we advance NDV-01 into the Phase 3 RESCUE registrational program in mid-2026."
Highlights of the 12-month follow-up data from the ongoing Phase 2 study of NDV-01:
In the 12-month follow-up of the Phase 2a study (March 9, 2026 Company press release) treatment with NDV-01 produced:
-- Durable 76% complete response $(CR)$ rate at 12 months with 95% CR rate at any time in high-risk NMIBC -- BCG-unresponsive patients achieved an 80% CR rate at 12 months and 94% CR rate at any time -- No patient had progression to muscle-invasive disease, and no patient underwent a radical cystectomy -- Favorable overall tolerability -- no >= Grade 3 treatment-related adverse events and no treatment-related discontinuations or dose interruptions.
Phase 3 RESCUE Registrational Pathways:
As previously disclosed in the Company's January 12, 2026 regulatory update, Relmada has received written feedback from the U.S. Food and Drug Administration (FDA) confirming alignment on two registrational development pathways for NDV-01, including study design, patient populations and primary endpoints.
Registrational Pathway 1 -- An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (NDV-01 vs. observation). There are no approved treatments for adjuvant intermediate risk NMIBC, which we estimate affect 75,000 patients/year in the U.S. The primary endpoint of the study is disease free survival $(DFS)$.
Registration Pathway 2 -- A single-arm trial in second line (2L) BCG-unresponsive NMIBC with carcinoma in situ (CIS) patients who are currently refractory to approved or developmental therapies. Patients with BCG-unresponsive NMIBC with CIS who fail first line (1L) therapies, which we estimate to affect 5,000 patients/year in the U.S., have few, if any, effective treatment alternatives to radical cystectomy. The primary endpoint of the study is complete response (CR) rate at any time.
Expected Upcoming Relmada Milestones:
-- NDV-01 United States IND clearance -- Mid-2026
-- NDV-01 Phase 3 RESCUE Program initiation -- Mid-2026
-- Sepranolone Phase 2 initiation in Prader-Willi syndrome -- Mid-2026
-- Initial 3-month NDV-01 data from Phase 3 2L BCG-unresponsive study
expected by YE 2026
Financial Results
Fourth Quarter 2025 Financial Results
-- Research and development expense for the three months ended December 31,
2025, totaled $8.1 million, compared to $11.0 million for the three
months ended December 31, 2024, a decrease of $2.9 million. The decrease
was primarily driven by a decrease in study costs associated with the
completion of two Phase 3 trials for REL-1017, partially offset by
increased costs related to the start-up the Phase 3 NDV-01 trials and
Phase 2b sepranolone study and additional R&D personnel.
-- General and administrative expense for the three months ended December
31, 2025, totaled $12.3 million compared to $8.1 million for the three
months ended December 31, 2024, an increase of approximately $4.2
million. The increase was primarily driven by an increase in compensation
costs partially offset by a decrease in stock based compensation costs.
-- Net cash used in operating activities for the three months ended December
31, 2025, totaled $14.6 million compared to $8.8 million for the three
months ended December 31, 2024.
-- The net loss for the three months ended December 31, 2025, was $19.9
million, or $0.27 per basic and diluted share, compared with a net loss
of $18.6 million, or $0.62 per basic and diluted share, for the three
months ended December 31, 2024.
Twelve Month Ended December 31, 2025 Financial Results
-- Research and development (R&D) expense for the 12 months ended December
31, 2025, totaled $26.9 million, compared to $46.2 million for the 12
months ended December 31, 2024, a decrease of $19.3 million. The decrease
was primarily driven by a decrease in study costs associated with
completion and conclusion of two Phase 3 trials for REL-1017, partially
offset by increased costs related to the acquisition of NDV-01 and
sepranolone, as well as the start-up of the Phase 3 NDV-01 trials and
Phase 2b sepranolone study.
-- General and administrative (G&A) expense for the 12 months ended December
31, 2025, totaled $32.2 million compared to $37.7 million for the 12
months ended December 31, 2024, a decrease of approximately $5.5 million.
The decrease was primarily driven by a decrease in stock-based
compensation expense and lower professional fees, partially offset by an
increase in personnel-related costs.
-- Net cash used in operating activities for the 12 months ended December
31, 2025, totaled $45.8 million compared to $51.8 million for the 12
months ended December 31, 2024.
-- The net loss for the 12 months ended December 31, 2025, was $57.4 million,
or $1.45 per basic and diluted share, compared with a net loss of $80.0
million, or $2.65 per basic and diluted share, for the 12 months ended
December 31, 2024.
-- The Company's cash balance of $93.0 million in cash, cash equivalents,
and short-term investments, includes net proceeds of approximately $94
million from an underwritten stock offering announced November 5, 2025.
This compares to cash, cash equivalents, and short-term investments of
approximately $44.9 million at December 31, 2024.
-- On March 9, 2026, the Company announced a private financing with gross
proceeds of $160 million. This financing, along with the cash, cash
equivalents, and short-term investments as of December 31, 2025, is
expected to provide sufficient resources to fund Company operations
through 2029, including completion of the Phase 3 NDV-01 RESCUE program.
-- The Company had 104,890,223 shares outstanding, as of March 16, 2026
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.
Conference Call and Webcast Information:
-- Date: Thursday, March 19, 2026 at 4:30 PM ET -- Participant Dial-in (US): 1-877-407-0792 -- Participant Dial-in (International): 1-201-689-8263 -- Webcast Access: Click Here
A replay of the webcast will be available in the Investors section of the Relmada website at https://www.relmada.com/investors/ir-calendar.
About NDV-01
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