On August 6, 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 second quarter ended June 30, 2026, and provided a business update.

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"Relmada has entered a critical execution phase as we prepare NDV-01 for registrational development. With FDA alignment, a robust clinical dataset, an experienced leadership team, and capital expected to fund operations through completion of the Phase 3 RESCUE program, we believe the Company is well positioned to create significant long-term value," said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. "Our immediate priority is manufacturing execution for NDV-01. Bringing a novel, sustained-release therapy of this kind into registrational development requires careful execution, and we are focused on completing the remaining activities needed to support the IND filing."

Manufacturing and CMC Update

The Company is advancing manufacturing and chemistry, manufacturing, and controls (CMC) activities to support planned IND filings for both NDV-01 and sepranolone by year-end 2026. Each program is progressing along its own development path.

NDV-01: Manufacturing and CMC activities supporting the planned NDV-01 IND submission are ongoing. The Company expects to submit the NDV-01 IND by year-end 2026 and initiate the Phase 3 RESCUE registrational program upon IND clearance. Clinical trial sites are engaged and prepared to begin enrollment following IND clearance.

Sepranolone: Formulation development for sepranolone is complete, and the Company is finalizing the pre-filled syringe delivery system. This is the remaining step ahead of the sepranolone IND submission, which is expected by year-end 2026. The company expects to initiate the Phase 2 proof-of-concept study in Prader-Willi Syndrome following IND clearance.

Corporate Update

During the quarter, Relmada strengthened its leadership team with the appointment of Bipin Dalmia, PhD, MBA, as Chief Business Officer. He brings nearly three decades of biopharmaceutical leadership experience spanning business development, portfolio strategy, commercial planning, and uro-oncology, including leadership of the U.S. launch, indication expansion, global commercialization, and long-term manufacturing strategy for the first FDA-approved intravesical gene therapy for NMIBC.

"Since joining Relmada, I have become increasingly convinced that NDV-01 represents one of the most compelling opportunities in NMIBC," said Bipin Dalmia, Chief Business Officer of Relmada Therapeutics. "As the NMIBC treatment landscape continues to evolve, patients and physicians are seeking therapies that deliver meaningful efficacy and durability without compromising convenience, tolerability, or ease of use. As we advance toward registrational development, NDV-01’s highly differentiated profile and potential applicability across multiple patient populations position it to become a foundational and best-in-class intravesical therapy across the NMIBC disease spectrum."

Expected Upcoming Relmada Milestones:

NDV-01:

NDV-01 United States IND filing – By YE26
NDV-01 Phase 3 RESCUE program initiation – Upon IND Clearance
Sepranolone:

Sepranolone United States IND filing – By YE26
Sepranolone Phase 2 initiation in Prader-Willi Syndrome – Upon IND Clearance
Financial Results

Second Quarter 2026 Financial Results

Research and development expense for the three months ended June 30, 2026, totaled $8.4 million, compared to $2.8 million for the three months ended June 30, 2025, an increase of $5.6 million. The increase was primarily attributable to higher NDV-01 and sepranolone study costs and increased manufacturing and drug storage costs, partially offset by lower employee compensation.
General and administrative expense for the three months ended June 30, 2026, totaled $6.6 million compared to $7.4 million for the three months ended June 30, 2025, a decrease of approximately $0.8 million. The decrease was primarily driven by lower stock-based compensation and lower employee compensation, partially offset by higher stock appreciation rights expense and consulting services.
Net cash used in operating activities for the three months ended June 30, 2026, totaled $9.6 million compared to $6.4 million for the three months ended June 30, 2025.
The net loss for the three months ended June 30, 2026, was $12.9 million, or $0.11 per basic and diluted share, compared with a net loss of $9.9 million, or $0.30 per basic and diluted share, for the three months ended June 30, 2025.
As of June 30, 2026, the Company’s cash, cash equivalents, and short-term investments balance were $217.7 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 June 30, 2026, are expected to provide sufficient resources to fund Company operations through 2029, including completion of the Phase 3 NDV-01 RESCUE program.
The Company had 106,669,846 shares outstanding, as of August 4, 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.

(Press release, Relmada Therapeutics, AUG 6, 2026, View Source [SID1234669840])