Phio Pharmaceuticals Corp. (PHIO) - Q1 2026 10-Q Summary
Business Context and Reporting Period
This report covers the quarterly period ended March 31, 2026. Phio Pharmaceuticals Corp. is a clinical-stage biopharmaceutical company developing immuno-oncology therapeutics based on its proprietary INTASYL® self-delivering siRNA technology. The company operates as a single segment with no product revenues to date. As of May 5, 2026, there were 11,617,250 shares of common stock outstanding.
Key Financial Metrics
| Metric | Q1 2026 | Q1 2025 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(4,003) thousand | $(1,769) thousand |
| Net Loss Per Share (Basic/Diluted) | $(0.34) | $(0.41) |
| Operating Expenses | $4,167 thousand | $1,872 thousand |
| Cash and Cash Equivalents (End of Period) | $17,031 thousand | $13,278 thousand |
| Net Cash Used in Operating Activities | $(4,003) thousand | $(1,275) thousand |
| Total Liabilities | $950 thousand | $1,340 thousand |
Note: Amounts in thousands except per share data.
Material Changes vs. Prior Period
- Increased Operating Expenses: Total operating expenses rose by $2.3 million (123%) to $4.2 million. This was driven by a $1.9 million increase in Research and Development (R&D) and a $0.4 million increase in General and Administrative (G&A) expenses.
- R&D Spend: R&D expenses increased 215% to $2.8 million, primarily due to a $1.6 million increase in nonclinical and clinical trial costs and CMC costs for the lead candidate PH-762, alongside higher personnel costs.
- Cash Position: Cash and cash equivalents decreased by $4.0 million during the quarter due to operating losses, resulting in a balance of $17.0 million. This is a significant increase compared to the $13.3 million balance in Q1 2025, reflecting capital raised in late 2025.
- Financing Activity: Unlike Q1 2025, which saw $9.2 million in financing proceeds from stock and warrant issuances, Q1 2026 had no financing cash flows.
Outlook, Management Commentary, and Risks
- PH-762 Progress: The Phase 1b clinical trial for PH-762 (targeting PD-1) is fully enrolled with 22 patients. Preliminary data indicates a 65% overall response rate in cutaneous squamous cell carcinoma (cSCC) patients, with 9 complete responses. The company plans to submit an FDA interaction request in Q2 2026 to discuss Phase 2b/3 trial design.
- PH-894 Status: Development of PH-894 (targeting BRD4) has been deferred to prioritize PH-762, though IND-enabling studies are complete.
- Liquidity: Management believes current cash resources ($17.0 million) are sufficient to fund operations for at least 12 months. This outlook relies on proceeds from financings completed in January, July, and November 2025.
- Subsequent Event: On April 8, 2026, the company entered into an "At the Market" (ATM) sales agreement with H.C. Wainwright & Co., LLC, allowing for the sale of up to $6.36 million of common stock to fund PH-762 development and working capital. No shares have been sold under this agreement as of the filing date.
- Risks: Key risks include the unproven nature of the INTASYL technology, potential delays in clinical trials, dependence on third-party manufacturers, and the need for substantial additional funding. The company has a history of recurring losses and no assurance exists that future financing will be available on acceptable terms.
Investor Verification Checklist
- Cash Runway: Verify the sufficiency of the $17.0 million cash balance against the projected burn rate for the upcoming Phase 2b/3 trial of PH-762.
- ATM Utilization: Monitor the execution of the new $6.36 million ATM program and its potential dilutive impact on existing shareholders.
- Clinical Data: Await the formal analysis and release of final Phase 1b data for PH-762, specifically the durability of the 65% response rate and safety profile.
- Regulatory Path: Track the outcome of the planned Q2 2026 FDA meeting regarding the design of the pivotal Phase 2b/3 trial.
- Warrant Overhang: Note the significant number of outstanding warrants (13.4 million shares) which could impact future share price and dilution if exercised.