Business Context and Reporting Period
Company: Relmada Therapeutics, Inc. (RLMD)
Filing Type: Form 8-K (Current Report)
Date of Report: March 9, 2026
Principal Executive Offices: Coral Gables, FL
Reporting Period: This filing reports specific events occurring on March 9, 2026, including the entry into a material definitive agreement for a private placement and the announcement of clinical trial data.
Key Financial Metrics and Capital Structure
Private Placement Details:
- Total Aggregate Purchase Price: Approximately $160.0 million.
- Common Stock Issued: 29,474,569 shares at $4.75 per share.
- Pre-Funded Warrants Issued: 4,210,527 warrants at $4.749 per warrant (exercise price $0.001).
- Expected Closing Date: March 11, 2026.
- Use of Proceeds: Working capital, general corporate purposes, and advancement of research and development for product candidates.
Financial Statements: This Form 8-K does not contain audited financial statements, revenue, profit, cash flow, or debt metrics. The filing focuses on the capital raise and clinical updates.
Material Changes and Clinical Developments
Clinical Data Announcement (NDV-01):
The Company announced 12-month interim data from its Phase 2 trial for NDV-01 in high-risk non-muscle invasive bladder cancer (NMIBC).
- Overall Population (N=48): 12-month Complete Response (CR) rate of 76% (19/25). Kaplan-Meier (KM) analysis showed 83%.
- BCG-Unresponsive Subpopulation (N=20): 12-month CR rate of 80% (8/10). KM analysis showed 84%.
- Safety Profile: No patients progressed to muscle-invasive disease; no radical cystectomies performed; no Grade 3 or higher treatment-related adverse events (TRAEs); no discontinuations due to adverse events.
Strategic Implications: The data supports the advancement of NDV-01 into the Phase 3 RESCUE registrational program targeting both second-line BCG-unresponsive and adjuvant intermediate-risk NMIBC.
Outlook, Guidance, and Risks
Upcoming Milestones:
- US IND Clearance: Expected Mid-2026.
- Phase 3 RESCUE Program Initiation: Expected Mid-2026.
- Initial Phase 3 Results: 3-month results from the 2L BCG-unresponsive study expected by year-end 2026.
Registration Rights and Penalties:
- The Company must file a registration statement for resale of shares by the later of 45 days post-closing or one business day after filing its 2025 10-K.
- Liquidated Damages: If the registration statement is not filed or declared effective by the deadlines, the Company must pay 1.0% of the aggregate purchase price per 30-day period (subject to caps).
Risks and Uncertainties:
- Completion of the Private Placement is subject to customary closing conditions.
- Forward-looking statements regarding clinical timelines and regulatory approvals involve significant risks and uncertainties.
- Placement fees and expenses will be paid to agents (Jefferies, Leerink, Piper Sandler, Mizuho).
Investor Verification Checklist
- Closing Confirmation: Verify the actual closing of the $160 million private placement on or around March 11, 2026.
- Dilution Impact: Assess the impact of issuing ~33.7 million new shares (common + pre-funded warrants) on existing shareholder ownership.
- Registration Timeline: Monitor the filing of the registration statement to avoid the 1.0% per 30-day liquidated damages penalty.
- Phase 3 Initiation: Confirm the receipt of US IND clearance and the start of the Phase 3 RESCUE trials in mid-2026.
- Exhibit Review: Review the full text of the Purchase Agreement (Exhibit 10.1) and Pre-Funded Warrant (Exhibit 4.1) for specific covenants and restrictions.