RLMD

Business Context and Reporting Period

Company: Relmada Therapeutics, Inc. (RLMD)
Filing Type: Form 10-Q (Unaudited)
Period Ended: September 30, 2025
Business Overview: Relmada is a clinical-stage biotechnology company that recently pivoted its strategy. It terminated its Esmethadone (REL-1017) and Psilocybin (REL-P11) programs in 2025. The company now focuses on two primary assets: NDV-01 (a novel intravesical formulation for non-muscle invasive bladder cancer, in Phase 2) and Sepranolone (a neurosteroid for Prader-Willi Syndrome and Tourette Syndrome, Phase 2b-ready). The company regained compliance with Nasdaq listing rules in September 2025.

Key Financial Metrics

Cash Flow (Nine Months Ended Sep 30, 2025):
- Net cash used in operating activities: $(31,190,765)
- Net cash provided by investing activities: $28,791,244 (primarily from sales of short-term investments)
- Net cash used in financing activities: $(73,021)

Material Changes vs. Prior Period

• Expense Reduction: Total operating expenses decreased by approximately $12.7 million in Q3 2025 compared to Q3 2024, and by $26.0 million on a year-to-date basis. This reduction is primarily due to the wind-down of the REL-1017 clinical studies and a significant decrease in stock-based compensation expenses.
• Strategic Acquisitions: In Q1 2025, the company incurred costs related to the acquisition of Sepranolone (paid $2.76 million) and the licensing of NDV-01 (paid $3.5 million upfront plus issuance of 3.02 million shares of common stock).
• Investment Portfolio: Short-term investments decreased from $41.1 million at year-end 2024 to $12.5 million at September 30, 2025, reflecting the sale of assets to fund operations.
• Stock-Based Compensation: Stock-based compensation expense dropped significantly year-over-year, from $23.5 million (YTD 2024) to $11.5 million (YTD 2025).

Guidance, Outlook, and Risks

Outlook and Milestones:
- NDV-01: The company expects to initiate Phase III trials for high-risk BCG-unresponsive NMIBC and intermediate-risk adjuvant settings in the first half of 2026. FDA alignment was secured in a Type B pre-IND meeting.
- Sepranolone: A Phase IIb study in Prader-Willi Syndrome is expected to initiate in the first half of 2026.
- Liquidity: As of September 30, 2025, the company projected insufficient liquidity to sustain operations for one year. However, on November 5, 2025 (subsequent event), the company closed an underwritten offering raising approximately $94 million in net proceeds. Management now believes it has sufficient funds for at least 12 months from the issuance of the report.

Risks and Contingencies:
- Going Concern: The financial statements were prepared with a going concern assumption, but substantial doubt existed as of the balance sheet date until the November 2025 financing.
- Development Risk: No products are currently approved; success depends on clinical trial outcomes and regulatory approvals.
- Market Risk: The company is subject to volatility in the biotechnology sector and dependence on capital markets for funding.

Investor Verification Checklist

• Financing Closure: Verify the final net proceeds and share count impact from the November 5, 2025, underwritten offering (approx. $94 million).
• Cash Burn Rate: Monitor the monthly cash burn rate post-financing to confirm the 12-month runway projection.
• NDV-01 Phase 2 Data: Review the upcoming 12-month data release from the Phase 2 NMIBC study (expected early 2026) for efficacy and safety signals.
• Stock-Based Compensation: Assess the impact of the 3.02 million shares issued for the NDV-01 license on future dilution and expense recognition.
• Regulatory Path: Confirm the timeline for the FDA Type B meetings regarding the Phase 3 trial designs for NDV-01.