RELMADA THERAPEUTICS (RLMD) Company Report

Relmada Therapeutics reported a net loss of $10.1 million or $0.30 per share for the third quarter ended September 30, 2025, compared to a net loss of $21.7 million or $0.72 per share in Q3 2024.
The company completed a $100 million underwritten offering of common stock and pre-funded warrants on November 5, 2025, which is expected to support planned operations into 2028.
Relmada secured FDA alignment on key elements of its Phase 3 program for NDV-01 in non-muscle invasive bladder cancer (NMIBC), with studies anticipated to commence in the first half of 2026.
Positive 9-month follow-up data for NDV-01 showed a 92% overall response rate at any time in NMIBC, with favorable overall safety.

Nov 13, 2025, 9:58 PM

Relmada Therapeutics Reports Q3 2025 Financials and Advances Pipeline Programs

RLMD

Earnings

Guidance Update

New Projects/Investments

Relmada Therapeutics reported a net loss of $10.1 million, or $0.30 per basic and diluted share, for Q3 2025, compared to a net loss of $21.7 million, or $0.72 per share, for Q3 2024.
As of September 30, 2025, cash, cash equivalents, and short-term investments totaled $13.9 million, which excludes net proceeds of approximately $94 million from a $100 million underwritten offering that closed on November 5, 2025. This capital raise is projected to support planned expenses into 2028.
The company announced positive nine-month follow-up data from its Phase 2 study of NDV-01 in non-muscle-invasive bladder cancer (NMIBC), demonstrating a 92% overall response rate at any time.
Relmada secured FDA alignment for the Phase 3 program of NDV-01, which will pursue two distinct registrational tracks and is slated to initiate in the first half of 2026. A Phase 2 study for Sopranalone in Prader-Willi syndrome is also anticipated to begin in the first half of 2026.

Nov 13, 2025, 9:30 PM

Relmada Announces Positive FDA Feedback for NDV-01 Registrational Studies and 9-Month Phase 2 Data

RLMD

New Projects/Investments

Guidance Update

Relmada Therapeutics, Inc. (RLMD) announced positive feedback from the U.S. Food and Drug Administration (FDA) supporting two separate registrational study paths for NDV-01 in non-muscle invasive bladder cancer (NMIBC).
The FDA feedback confirms that a single-arm trial might be acceptable for 2nd line refractory BCG-unresponsive NMIBC and a randomized controlled trial is generally acceptable for intermediate-risk NMIBC.
The company plans to initiate the Phase 3 pivotal program for NDV-01 in H1 2026.
Nine-month follow-up data from the Phase 2 study of NDV-01 in NMIBC showed a 92% overall response rate at any time and an 85% Complete Response rate at 9 months, with no new safety signals observed.

Nov 4, 2025, 12:00 PM

Relmada Therapeutics Provides Update on NDB-01 Phase 2 Results and Strategic Direction

RLMD

New Projects/Investments

Guidance Update

Relmada Therapeutics has shifted its strategy to acquire lower-risk programs, with a primary focus on NDB-01 for non-muscle invasive bladder cancer (NMIBC).
The Phase 2 study for NDB-01 showed 90% of patients were cancer-free at six months, which the company believes is the highest number ever seen for preventing bladder cancer recurrence.
NDB-01 is an extended-release gel combining gemcitabine and docetaxel, designed for easy administration in a doctor's office, addressing current treatment limitations.
Competitor products from UroGen and Johnson & Johnson are priced between $120,000 and $690,000 annually, indicating significant revenue potential for NDB-01.
As of the end of the second quarter, the company held $20.6 million in cash and cash equivalents and had 33.2 million shares outstanding, with plans to start NDB-01's registration study in Q2 2026.

Sep 18, 2025, 2:00 PM

RELMADA THERAPEUTICS, INC. Updates Corporate Presentation Highlighting Pipeline Progress and Financials

RLMD

New Projects/Investments

Guidance Update

RELMADA THERAPEUTICS, INC. filed a Form 8-K on September 17, 2025, furnishing an updated corporate presentation.
The company's NDV-01 program, a sustained-release intravesical formulation for Non-muscle invasive bladder cancer (NMIBC), demonstrated strong efficacy in its ongoing Phase 2 TRCG-011 study, reporting an anytime Complete Response Rate of 91% and a 6-month Complete Response Rate of 90%. Relmada plans to initiate a Phase 3 study for NDV-01 in H1 2026.
Sepranolone, a candidate for Prader-Willi Syndrome (PWS), has positive Phase 2 data , and the company expects to initiate a pilot Phase 2 study in PWS in H1 2026.
As of June 30, 2025, Relmada Therapeutics reported $20.6 million in cash, cash equivalents, and short-term investments, with no outstanding debt.