Cardiff Oncology, Inc. — Q1 2024 Form 10-Q
Period: Three months ended March 31, 2024; unaudited. Cardiff is a clinical-stage biotechnology company developing onvansertib, a PLK1 inhibitor, in combination with standard-of-care therapies. The company reported limited royalty revenue from licenses unrelated to onvansertib.
Financial performance and position
Amounts in millions, except per-share data.
| Metric | Q1 2024 | Q1 2023 / comparison |
|---|---|---|
| Royalty revenue | $0.205 | $0.083 |
| Research and development expense | $8.008 | $9.052 |
| Selling, general and administrative expense | $3.130 | $3.083 |
| Operating loss | $(10.933) | $(12.052) |
| Interest income, net | $0.926 | $0.940 |
| Net loss | $(10.011) | $(11.223) |
| Net loss per common share | $(0.22) | $(0.25) |
| Net cash used in operating activities | $(7.740) | $(8.659) |
- Cash and cash equivalents were $18.658 million and short-term investments were $48.529 million at quarter-end, totaling $67.187 million. Working capital was $58.1 million.
- Total assets were $74.038 million; total liabilities were $13.144 million. The filing reports no borrowings; liabilities include operating lease obligations of approximately $2.0 million.
- Revenue is immaterial relative to clinical development costs; the filing does not present a meaningful operating margin. The company remains loss-making and expects continued operating cash outflows.
- Common shares outstanding were 44.710 million at March 31; 44.725 million were outstanding as of April 25. Potentially dilutive securities excluded from diluted EPS totaled 11.1 million, including options and warrants.
Changes versus the prior comparable period
- Revenue increased by $0.122 million, while net loss narrowed by $1.212 million and operating cash use declined by $0.919 million.
- R&D expense decreased by $1.044 million, primarily due to lower chemistry, manufacturing and control costs; salary and staff costs rose with increased R&D headcount. SG&A increased by $0.047 million.
- Cash and cash equivalents declined by $2.997 million during the quarter. Short-term investments also declined from year-end as maturities exceeded purchases.
- Accumulated deficit increased to $348.759 million. Available-for-sale investments recorded a $0.065 million unrealized loss in Q1 2024, compared with a $0.319 million unrealized gain in Q1 2023.
Outlook, programs and risks
- Management believes the $67.2 million of cash, cash equivalents and short-term investments will fund requirements for at least 12 months after issuance of the statements; based on current projections, it expects funding to last into the third quarter of 2025. The company anticipates further losses and may need additional capital; financing may be unavailable or cause shareholder dilution.
- CRDF-004, a Phase 2 first-line RAS-mutated metastatic colorectal cancer trial, began dosing its first patient in February 2024. Initial data are anticipated in the second half of 2024. A Phase 3 trial is contingent on CRDF-004 results.
- Management discontinued enrollment in the ONSEMBLE second-line colorectal cancer trial as it shifted the program toward first-line treatment. Reported ONSEMBLE responses were in bevacizumab-naïve patients in the onvansertib combination arms; no responses were reported in bevacizumab-exposed patients or the control arm.
- Other disclosed programs include pancreatic cancer, relapsed small cell lung cancer and triple-negative breast cancer trials. The filing reports preliminary trial data, which are not established evidence of future outcomes.
- Key risks include clinical and regulatory uncertainty, trial duration and results, competition, funding needs and potential equity dilution. Management reported no material change to the risk factors in the 2023 Form 10-K, no material litigation, and effective disclosure controls as of March 31, 2024.
- ASU 2020-06 was adopted using the modified-retrospective method on January 1, 2024, reversing $0.793 million of historical preferred-stock dividend accretion between additional paid-in capital and accumulated deficit, with no net change to total equity.
Important facts for investors to verify
- Whether the projected cash runway into Q3 2025 remains achievable as trial enrollment, development costs and operating needs evolve.
- CRDF-004 enrollment, timing and results, including whether findings support the proposed registrational Phase 3 path.
- Clinical-trial evidence and its limitations, including subgroup sizes and the difference between preliminary results and confirmed outcomes.
- Future financing requirements and the potential dilution from equity issuance, options and warrants.
- The nature and timing of royalty revenue, which is unrelated to onvansertib and depends on licensee sales activity.