Cardiff Oncology, Inc. — Q3 2023 Form 10-Q
Reporting period: Quarter and nine months ended September 30, 2023. Cardiff Oncology is a clinical-stage biotechnology company developing onvansertib, a PLK1 inhibitor, in combination with standard-of-care therapies. Reported royalty revenue is from other licensed intellectual property, not onvansertib product sales.
Financial performance
| Metric | Q3 2023 | Q3 2022 | Nine months 2023 | Nine months 2022 |
|---|---|---|---|---|
| Royalty revenue | $0.141 million | $0.093 million | $0.332 million | $0.258 million |
| Research and development | $8.022 million | $6.009 million | $25.094 million | $20.665 million |
| Selling, general and administrative | $2.939 million | $3.077 million | $10.318 million | $10.103 million |
| Operating loss | $10.820 million | $8.993 million | $35.080 million | $30.510 million |
| Net loss | $9.731 million | $8.571 million | $32.104 million | $30.007 million |
| Net loss per common share | $0.22 | $0.20 | $0.72 | $0.69 |
| Interest income, net | $1.068 million | $0.458 million | $3.061 million | $0.841 million |
Revenue remains immaterial relative to operating costs; the filing provides no meaningful gross-margin measure. R&D growth reflected clinical-program and outside-service costs, as well as increased staffing. Higher interest income partially offset operating losses, primarily due to higher rates on investments.
Cash, liquidity and capital resources
- At September 30, 2023, cash and cash equivalents were $15.233 million and short-term investments were $66.130 million, totaling $81.363 million. Working capital was $74.9 million, versus $103.5 million at December 31, 2022.
- Nine-month operating cash use was $23.748 million, compared with $24.430 million in the prior-year period. Investing activities provided $22.634 million, mainly from investment maturities and sales exceeding purchases; financing activities provided no cash.
- Total liabilities were $10.625 million, including $2.295 million of operating lease liabilities. The filing reports no borrowings or other financial debt.
- Management said resources were sufficient for at least 12 months from issuance of the statements and, based on current projections, expected to fund operations into 2025. The company expects continued losses and operating cash outflows and may need additional capital; equity financing could dilute shareholders.
Material changes and business developments
- Nine-month net loss increased to $32.104 million from $30.007 million. Operating expenses rose to $35.412 million from $30.768 million, led by a $4.429 million increase in R&D. Cash and short-term investments fell from $105.267 million at year-end 2022 to $81.363 million.
- Management discontinued enrollment in the ONSEMBLE (CRDF-003) trial and shifted the colorectal cancer program toward CRDF-004, informed by TROV-054 subgroup results, preclinical data and FDA feedback. CRDF-004 was expected to begin enrollment in Q4 2023, with interim data anticipated in mid-2024; a Phase 3 trial is contingent on results.
- TROV-054 data presented in August showed an overall 29% objective response rate and median progression-free survival of 9.3 months among evaluable patients. The bevacizumab-naive subgroup (15 patients) had a reported 73% response rate and 15-month median progression-free survival; these are clinical-trial results, not established comparative outcomes.
- CRDF-001 pancreatic cancer enrollment closed in October 2023. Preliminary data reported in September from 21 evaluable patients included a 19% response rate and 5.0-month median progression-free survival; some responses awaited confirmation.
- Preliminary small-cell lung cancer data in seven patients showed one confirmed partial response and three cases of stable disease. The TNBC investigator-initiated trial remained open for enrollment.
Outlook, risks and other items
The company remains pre-commercial and depends on clinical development and external capital. Management highlighted uncertainty around trial duration and results, regulatory review, costs, financing availability and competition. No material risk-factor changes were reported from the 2022 Form 10-K. The company reported no legal proceedings and stated it had no litigation matters expected to have a material adverse effect. Investment unrealized losses were attributed substantially to higher interest rates; no credit-loss allowance was recorded. A departing employee’s option modification resulted in $0.6 million of incremental stock-based compensation in the first nine months.
Important facts for investors to verify
- Whether CRDF-004 enrollment began on schedule and whether interim data arrive as anticipated.
- Updated, confirmed CRDF-001 results and subsequent data from TROV-054 and the investigator-initiated trials, including patient counts and follow-up.
- Actual cash burn, investment balances and runway compared with management’s projection into 2025, including any financing or dilution.
- The basis and limitations of trial comparisons with historical controls, particularly the small bevacizumab-naive subgroup.
- Future R&D spending, trial commitments and potential milestone or royalty obligations under licensing agreements.