Phio Pharmaceuticals Corp. — Q1 2024 Form 10-Q
Reporting period: Three months ended March 31, 2024. Phio is a clinical-stage biotechnology company developing cancer therapeutics using its INTASYL gene-silencing technology. It reported no product revenue and continues to fund operations primarily through securities sales.
Financial performance and position
| Metric | Q1 2024 | Q1 2023 / prior date |
|---|---|---|
| Revenue | No product revenue reported | No product revenue reported |
| Research and development expense | $1.148 million | $2.134 million |
| General and administrative expense | $1.061 million | $1.468 million |
| Total operating expenses / operating loss | $2.209 million | $3.602 million |
| Net loss | $2.154 million | $3.602 million |
| Net loss per share, basic and diluted | $0.47 | $3.15 |
| Net cash used in operating activities | $2.011 million | $2.708 million |
| Cash and cash equivalents | $6.475 million at March 31, 2024 | $8.490 million at December 31, 2023 |
| Total assets / stockholders’ equity | $6.853 million / $5.604 million | $9.364 million / $7.730 million at December 31, 2023 |
| Current liabilities | $1.249 million | $1.634 million at December 31, 2023 |
Operating expenses fell 39% year over year; R&D declined 46% and G&A declined 28%. Management attributed the reductions to cost rationalization, lower preclinical and clinical consulting costs, reduced personnel and facility costs, and lower manufacturing expenses. Net loss improved by $1.448 million, including $55,000 of other income in Q1 2024. Margins are not meaningful given the absence of reported product revenue. No debt balance is presented in the filing.
Cash declined $2.015 million during the quarter. The company reported recurring losses and negative operating cash flow and stated that its cash resources may not fund operations for at least the next 12 months from issuance of the financial statements. Management said continued operations depend on raising capital through equity, debt, or strategic opportunities; there is no assurance funding will be available on acceptable terms or at all. The filing identifies substantial doubt about the company’s ability to continue as a going concern.
Developments, outlook, and risks
- Clinical program: PH-762 is being studied in a U.S. Phase 1b dose-escalation trial for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. The first two patients in the first cohort completed treatment with no reported adverse events. Enrollment is expected to continue, with completion targeted for Q2 2025.
- AgonOx collaboration: On May 8, 2024, after the quarter-end, Phio terminated its clinical co-development agreement, citing enrollment delays. AgonOx had treated three patients in the Phase 1 trial; the first two received DP TIL alone and the third received DP TIL plus PH-762. Phio expects to pay approximately $388,000 for accrued obligations, previously treated patients, and other costs. Termination ends further development funding obligations and Phio’s eligibility for specified milestones and royalties; the parties plan to discuss an orderly trial wind-down.
- Cost and facility changes: Phio reduced headcount by approximately 36% and redirected savings toward the PH-762 Phase 1b trial. Its headquarters and primary research facility lease expired March 31, 2024; operations are now primarily remote, with a short-term Worcester laboratory lease.
- Nasdaq listing: Phio received a January 24, 2024 notice for noncompliance with Nasdaq’s $1.00 minimum bid-price requirement. It had until July 22, 2024 to regain compliance and was evaluating options, including a reverse stock split. Stockholders’ equity was $5.6 million at quarter-end versus Nasdaq’s stated $2.5 million minimum; future compliance is not assured.
- Other items: Management reported effective disclosure controls at the reasonable-assurance level and no material changes in internal control over financial reporting. No material legal proceedings were reported. The filing does not provide a clear forward revenue or earnings forecast.
Investor facts to verify
- Whether Phio secured financing sufficient to address the stated going-concern uncertainty and fund operations.
- Subsequent cash burn, actual runway, and the expected timing and cost of the PH-762 Phase 1b program.
- Nasdaq bid-price compliance status and any reverse-stock-split or other listing actions.
- Final payments and trial wind-down arrangements with AgonOx, including whether the approximately $388,000 estimate changed.
- Share-count and dilution effects: common shares outstanding rose from 3,747,329 at December 31, 2023 to 4,591,700 at March 31, 2024, including release of 826,370 warrant-related abeyance shares; 5,504,918 warrants remained outstanding at quarter-end.