Relmada Therapeutics, Inc. (RLMD) - Q1 2026 Filing Summary
Business Context and Reporting Period
This Form 10-Q covers the quarterly period ended March 31, 2026. Relmada Therapeutics, Inc. is a clinical-stage biotechnology company that recently pivoted its strategy to focus on two primary product candidates: NDV-01 (a controlled-release intravesical formulation for non-muscle invasive bladder cancer) and sepranolone (a neurosteroid for Prader-Willi Syndrome and Tourette Syndrome). The company terminated its esmethadone and psilocybin programs in 2025.
Key Financial Metrics
| Metric | Q1 2026 | Q1 2025 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(19,051,956) | $(17,559,465) |
| Loss Per Share (Basic/Diluted) | $(0.22) | $(0.58) |
| Operating Cash Flow | $(15,067,488) | $(18,067,033) |
| Cash & Cash Equivalents | $9,776,400 | $1,149,706 |
| Short-Term Investments | $224,186,743 | $89,509,710 |
| Total Liquidity | $233,963,143 | $90,659,416 |
| Total Liabilities | $16,630,217 | $7,491,458 |
Material Changes vs. Prior Period
- Capital Raise: The company significantly strengthened its balance sheet through a private placement in March 2026, raising approximately $150 million (net of fees) by issuing 29.5 million shares and pre-funded warrants. This followed a $94 million underwritten offering in November 2025.
- Expense Shifts:
- R&D Expenses: Decreased by $3.9 million to $8.1 million, driven by the winding down of terminated programs (REL-1017) and reduced study costs, partially offset by increased manufacturing costs for new programs.
- G&A Expenses: Increased by $5.1 million to $11.4 million, primarily due to higher compensation costs and consulting fees.
- Investment Activity: Net cash used in investing activities was $135.2 million, reflecting the deployment of raised capital into short-term investments (purchases of $149.5 million vs. sales of $14.3 million).
- Share Count: Weighted average shares outstanding increased significantly from 30.4 million in Q1 2025 to 86.6 million in Q1 2026 due to equity issuances.
Outlook, Guidance, and Risks
- Clinical Milestones: Management expects to initiate Phase 3 trials for NDV-01 (both high-risk and intermediate-risk indications) and a Phase 2b study for sepranolone in Prader-Willi Syndrome by mid-2026.
- Liquidity: Management believes current cash and short-term investments are sufficient to fund operations for at least 12 months from the filing date.
- Risks: The company remains in a pre-revenue stage with an accumulated deficit of $717.3 million. Success depends on clinical trial outcomes, regulatory approvals, and the ability to raise additional capital for future phases. There are no material legal proceedings currently pending.
- Unusual Items: The filing includes significant non-cash compensation expenses related to Stock Appreciation Rights (SARs) totaling $2.7 million for the quarter.
Investor Verification Checklist
- Cash Runway: Verify the burn rate against the $234 million liquidity position to confirm the 12-month operational runway.
- NDV-01 Phase 3 Timeline: Monitor the mid-2026 initiation of Phase 3 trials and the FDA Type B pre-IND feedback status.
- Dilution Impact: Assess the impact of the recent 29.5 million share issuance and outstanding warrants (8 million) on future earnings per share.
- License Obligations: Review the $200 million potential milestone payments and 3% royalty obligations associated with the NDV-01 license from Trigone.
- Investment Portfolio: Confirm the composition and unrealized gains/losses of the $224 million short-term investment portfolio.