Cardiff Oncology, Inc. — Q1 2021 Form 10-Q
Reporting period: Three months ended March 31, 2021. Cardiff Oncology is a clinical-stage biotechnology company developing onvansertib, including for KRAS-mutated metastatic colorectal cancer (mCRC), metastatic castration-resistant prostate cancer (mCRPC), and metastatic pancreatic cancer. Revenue is minimal and comes from royalties on other intellectual-property licenses, not onvansertib sales.
Financial results and position
| Metric | Q1 2021 | Q1 2020 / comparison |
|---|---|---|
| Revenue | $72,000 | $68,000 |
| Research and development expense | $3.279 million | $2.706 million |
| Selling, general and administrative expense | $2.235 million | $1.486 million |
| Operating loss | $5.442 million | $4.124 million |
| Net loss | $5.179 million | $4.089 million |
| Net loss attributable to common stockholders | $5.185 million | $4.095 million |
| Basic and diluted loss per share | $0.14 | $0.41 |
| Net cash used in operating activities | $5.884 million | $3.374 million |
Dollar figures above are converted from the filing’s stated thousands, except per-share data. Gross margin is not presented; the filing reports royalty revenue and operating expenses, with no product-sales business.
- At March 31, 2021, cash and cash equivalents were $14.662 million and short-term investments were $110.922 million, totaling $125.584 million. The company reported working capital of $124.1 million.
- Total assets were $129.573 million; total liabilities were $4.756 million. The filing reports no debt balance. Liabilities included operating lease obligations and $78,000 of warrant derivative liabilities.
- Cash and cash equivalents fell from $130.981 million at year-end 2020, primarily because $111.698 million of net cash was used to purchase short-term investments. Operating cash use was $5.884 million; financing provided $1.263 million, mainly from warrant exercises.
Changes versus the prior comparable period
- Net loss increased by $1.090 million, primarily due to higher operating expenses. R&D rose $573,000, mainly from clinical-program and outside-service costs for three onvansertib trials. SG&A rose $749,000, mainly from outside services and professional fees, including patent-related legal and recruiting costs, and higher stock compensation.
- Loss per share improved to $0.14 from $0.41, while weighted-average shares increased to 37.164 million from 9.910 million. The company attributed the per-share change chiefly to the increase in shares outstanding, including approximately 26.5 million shares issued from April 2020 through March 2021.
- Operating cash use increased by $2.510 million. Short-term investments were $110.922 million at quarter-end, compared with none reported at December 31, 2020.
Outlook, clinical updates, and risks
- Management said the $125.6 million of cash, cash equivalents, and short-term investments was expected to fund operations for at least 12 months after issuance of the financial statements. The company expects continuing losses and operating cash outflows for several years, and may need further capital; availability and terms are uncertain, and equity fundraising could dilute shareholders.
- Onvansertib trials: TROV-054 is a Phase 1b/2 study in KRAS-mutated mCRC with FOLFIRI and bevacizumab; TROV-053 is a Phase 2 mCRPC study with abiraterone and prednisone; CRDF-001 is a Phase 2 pancreatic cancer study, with first enrollment anticipated in the first half of 2021.
- Management reported April 2021 mCRC trial data for 18 efficacy-evaluable patients: 7 had partial responses (4 confirmed), and median progression-free survival was reported as 9.4 months. These are interim clinical findings, not established efficacy conclusions. The filing reported that 11% of adverse events associated with the combination were Grade 3 or 4; neutropenia was managed with dose delays, growth-factor therapy, and/or removal of the 5-FU bolus. The company reported no major or unexpected toxicities attributed to onvansertib to date.
- For the mCRPC study, management reported 12-week primary-endpoint responses of 29%, 25%, and 63% in Arms A, B, and C, respectively; Arm C had eight patients and the reported result was to date. The filing described the combination as safe across the three schedules.
- COVID-19 had not materially affected Q1 2021 financial statements, but a prolonged outbreak could disrupt trials, operations, or access to capital. Clinical development, regulatory review, competition, and financing are significant uncertainties. Management said there were no material changes to previously disclosed risk factors and no material litigation claims identified.
- Subsequent event: On May 5, 2021, Cardiff agreed to sell 2.0 million common shares for $20.0 million gross proceeds under its sales agreement with Jefferies LLC.
Important facts for investors to verify
- Whether the interim mCRC and mCRPC results are confirmed in larger studies, and how trial enrollment, follow-up, safety, and endpoints evolve.
- The company’s cash runway and future funding needs, including the impact of the May 2021 share sale and any additional financing or dilution.
- Whether clinical-trial timelines or operations are affected by COVID-19, enrollment challenges, or other development risks.
- How the $110.922 million investment portfolio, including its fair-value movements, performs and remains available to fund operations.