Business Context and Reporting Period
Company: Relmada Therapeutics, Inc. (RLMD)
Filing Type: Form 8-K (Current Report)
Date of Report: February 3, 2025 (Event Date); February 6, 2025 (Signature Date)
Principal Event: Entry into a Material Definitive Agreement to acquire Sepranolone, a phase 2b ready neurosteroid for Tourette Syndrome and compulsive disorders, from Asarina Pharma AB.
Key Financial Metrics
This filing does not contain standard financial statements (revenue, profit, cash flow, or margins) as it reports a specific corporate transaction rather than periodic financial results.
| Metric | Value |
|---|---|
| Total Purchase Price | €3,000,000 |
| Upfront Payment Due | €2,756,000 (within 10 business days) |
| Applied Credit | $250,000 (from prior exclusivity agreement) |
| Liabilities Assumed | Only those arising after the effective date |
Material Changes
The primary material change is the expansion of the Company's asset portfolio through the acquisition of Sepranolone (isoallopregnanolone). The Company has agreed to purchase all rights, title, and interest in the asset from Asarina Pharma AB. The transaction involves a significant cash outflow of approximately €2.76 million net of credits, payable shortly after the agreement's effective date.
Outlook, Management Commentary, and Clinical Data
Asset Profile: Sepranolone is a GABAA Modulating Steroid Antagonist (GAMSA) designed to counteract Allopregnanolone effects in Tourette Syndrome.
Clinical Data (Phase 2a):
- Study Design: Open-label, randomized, 12-week, dual-center study with 26 subjects.
- Primary Endpoint: 28% reduction in tic severity (YGTSS) compared to standard of care (p=0.051).
- Secondary Endpoints:
- 69% greater increase in Quality of Life (GTS-QOL).
- 50% greater reduction in impairment (YGTSS).
- 44% greater reduction of premonitory urge to tic (PUTS).
- Safety: No off-target CNS effects or systemic side effects observed.
Future Status: The asset is described as "phase 2b ready."
Investor Verification Checklist
- Verify the exact effective date of the Purchase Agreement to determine the 10-business-day payment deadline.
- Confirm the exchange rate used to convert the €3,000,000 purchase price to USD for financial impact assessment.
- Review the full text of the Asset Purchase Agreement (Exhibit 10.1) for specific conditions precedent to closing.
- Assess the Company's current cash position to ensure liquidity for the €2,756,000 payment.
- Monitor upcoming regulatory filings for the initiation of the Phase 2b clinical trial.