Profusa, Inc. (PFSA) - Q1 2026 10-Q Summary
Business Context and Reporting Period
This report covers the quarterly period ended March 31, 2026. Profusa, Inc. is a clinical-stage digital health company developing biointegrated sensors, specifically the Lumee Oxygen platform for tissue oxygen monitoring and the Lumee Glucose platform for continuous glucose monitoring (CGM). The company operates as a single segment and is currently focused on R&D, regulatory approvals (CE Mark renewal in Europe, FDA clearance in the U.S.), and securing liquidity to fund commercialization.
Key Financial Metrics
| Metric | Q1 2026 | Q1 2025 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(3.5) million | $(2.7) million |
| Operating Expenses | $4.0 million | $1.4 million |
| Cash and Cash Equivalents | $0.4 million | $1.8 million (Dec 31, 2025) |
| Working Capital Deficit | $(28.4) million | N/A |
| Total Liabilities | $29.1 million | $30.4 million (Dec 31, 2025) |
| Stockholders' Deficit | $(28.2) million | $(26.7) million (Dec 31, 2025) |
Note: The company reported no revenue for the period. Operating expenses increased significantly due to higher R&D and G&A costs.
Material Changes vs. Prior Period
- Operating Expenses: Increased 181% to $4.0 million, driven by a 164% rise in R&D (due to CRO and regulatory costs) and a 189% rise in G&A (due to legal, accounting, and insurance fees).
- Net Loss: Increased 27% to $3.5 million. While operating losses widened, the net loss was partially offset by a $1.4 million gain on the extinguishment of a PPP loan and a $0.3 million gain on the change in fair value of warrant liabilities.
- Debt and Fair Value Adjustments: The company recorded a $0.8 million loss on the change in fair value of convertible notes. Interest expense decreased 98% to $18,000 following the conversion of junior convertible debt and senior notes during the prior year's business combination.
- Digital Assets: The company terminated its Bitcoin treasury strategy, selling 16.51 Bitcoins for $1.2 million, resulting in a $0.3 million realized loss.
- Liquidity: Cash decreased by $1.4 million during the quarter. The company utilized $2.6 million in operating cash flows.
Guidance, Outlook, Risks, and Unusual Items
- Going Concern: Management has raised substantial doubt about the company's ability to continue as a going concern within one year due to recurring losses, a working capital deficit of $28.4 million, and the need for additional financing.
- Nasdaq Compliance: The company failed to meet Nasdaq listing requirements for minimum bid price and market value. On May 6, 2026, the Nasdaq Hearings Panel granted an exception for continued listing, subject to conditions including a reverse stock split and transfer to the Nasdaq Capital Market by May 15, 2026.
- Financing Activities: The company has access to an Equity Line of Credit (ELOC) with $88.9 million remaining capacity and a PIPE Subscription Agreement with $10.5 million available for drawdown. Subsequent to quarter-end, the company issued additional PIPE notes and converted related-party debt to equity.
- Strategic Transactions:
- Mayo Clinic License: Entered a know-how license agreement for continuous oxygen measurement.
- Asset Acquisition: Signed an agreement to acquire Bio Insights LLC's PanOmics Assay for $30 million in convertible preferred stock (subject to shareholder approval).
- Internal Controls: The company disclosed material weaknesses in internal controls over financial reporting, specifically regarding segregation of duties and valuation of complex financial instruments.
Investor Verification Checklist
- Liquidity Runway: Verify the sufficiency of the $0.4 million cash balance against the $12.5 million in debt due within 12 months and the $15.9 million estimated capital requirement through 2027.
- Nasdaq Status: Confirm the successful transfer to the Nasdaq Capital Market and the timeline for the required reverse stock split to maintain listing.
- Debt Conversion Terms: Review the terms of the recent PIPE note issuances and related-party debt conversions to assess potential dilution and interest obligations.
- Regulatory Milestones: Monitor progress on the renewal of the CE Mark for Lumee Oxygen and FDA clearance for Lumee Glucose, as commercialization depends entirely on these approvals.
- Asset Acquisition Closing: Track the status of the $30 million Bio Insights acquisition, specifically the requirement for shareholder approval and the issuance of convertible preferred stock.