Cardiff Oncology(CRDF) - 2025 Q1 - Quarterly Report

PART I FINANCIAL INFORMATION Item 1. Financial Statements (unaudited) The unaudited condensed financial statements for Q1 2025 reflect decreased total assets, an increased net loss, and higher cash utilization in operating activities Condensed Balance Sheets Total assets decreased to $84.8 million as of March 31, 2025, primarily due to a reduction in cash and cash equivalents, leading to a decline in stockholders' equity Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $24,095 | $51,470 | | Short-term investments | $55,792 | $40,276 | | Total current assets | $82,711 | $95,054 | | Total Assets | $84,807 | $97,190 | | Liabilities & Equity | | | | Total current liabilities | $13,291 | $13,428 | | Total Liabilities | $13,931 | $14,241 | | Total stockholders' equity | $70,876 | $82,949 | Condensed Statements of Operations The company reported an increased net loss of $13.4 million for Q1 2025, primarily driven by higher operating expenses, particularly research and development costs Quarterly Operating Results (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Royalty revenues | $109 | $205 | | Research and development | $10,477 | $8,008 | | Selling, general and administrative | $4,014 | $3,130 | | Loss from operations | ($14,382) | ($10,933) | | Net loss | ($13,434) | ($10,011) | | Net loss per common share | ($0.20) | ($0.22) | Condensed Statements of Cash Flows Net cash used in operating activities significantly increased to $12.8 million in Q1 2025, alongside substantial cash used in investing activities, resulting in a $27.4 million decrease in cash and cash equivalents Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,794) | $(7,740) | | Net cash provided by (used in) investing activities | $(14,584) | $4,636 | | Net cash provided by financing activities | $3 | $107 | | Net change in cash and cash equivalents | $(27,375) | $(2,997) | Notes to Condensed Financial Statements The notes describe the company's clinical-stage biotechnology focus, confirm sufficient liquidity for 12 months, and detail commitments and stock-based compensation - Cardiff Oncology is a clinical-stage biotechnology company developing its lead asset, onvansertib (a PLK1 inhibitor), for various cancers including mCRC, mPDAC, SCLC, and TNBC[26] - As of March 31, 2025, the company had $79.9 million in cash, cash equivalents, and short-term investments, which is believed to be sufficient to fund requirements for at least the next 12 months[28] - The company has a license agreement with Nerviano for onvansertib, which includes potential future development and commercial milestone payments, as well as royalties on sales. No such payments were made in Q1 2025 or Q1 2024[52] Stock-Based Compensation Expense (in thousands) | Expense Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $515 | $389 | | Selling, general and administrative | $850 | $735 | | Total | $1,365 | $1,124 | Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the development of onvansertib, including positive CRDF-004 trial data, and attributes the increased net loss to higher R&D expenses, while confirming capital sufficiency into Q1 2027 Overview and Clinical Programs The company is advancing onvansertib, a PLK1 inhibitor, with completed enrollment and promising initial ORR data from the CRDF-004 Phase 2 trial in mCRC, alongside other ongoing investigator-initiated trials - The company's lead candidate is onvansertib, an oral, highly selective PLK1 inhibitor with a 24-hour half-life, being developed in combination with standard-of-care therapeutics[59][60] - Enrollment for the CRDF-004 Phase 2 randomized trial in first-line RAS-mutated mCRC was completed in April 2025 with approximately 90 evaluable patients[64] Initial Objective Response Rate (ORR) from CRDF-004 Trial | Arm | ORR | Patients (Responders/Total) | | :--- | :--- | :--- | | Control Arm (SoC alone) | 33% | 3 of 9 | | 20mg onvansertib + SoC | 50% | 5 of 10 | | 30mg onvansertib + SoC | 64% | 7 of 11 | | All onvansertib patients | 57% | 12 of 21 | - The company is supporting an investigator-initiated Phase 1b/2 trial of onvansertib in combination with NALIRIFOX for first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)[71] Results of Operations Q1 2025 saw decreased royalty revenues, while research and development expenses increased by $2.5 million due to clinical trials, and selling, general and administrative expenses rose by $0.9 million from professional fees Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Increase | | :--- | :--- | :--- | :--- | | Research and Development | $10,477 | $8,008 | $2,469 | | Selling, General and Administrative | $4,014 | $3,130 | $884 | - The increase in R&D expenses was primarily due to costs associated with the CRDF-004 clinical trial and other clinical programs for onvansertib[79] - The increase in SG&A expenses was mainly from professional fees related to strategic advisory services[80] Liquidity and Capital Resources As of March 31, 2025, the company held $79.9 million in cash and investments, projected to fund operations into Q1 2027, despite a history of net losses and negative operating cash flows - The company had $79.9 million in cash, cash equivalents, and short-term investments as of March 31, 2025[83] - Based on current projections, the company expects its capital resources are sufficient to fund operations into the first quarter of 2027[83] Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,794) | $(7,740) | | Net cash provided by (used in) investing activities | $(14,584) | $4,636 | | Net cash provided by financing activities | $3 | $107 | Item 3. Quantitative and Qualitative Disclosures About Market Risk This section is not applicable for the current reporting period - The company has indicated that quantitative and qualitative disclosures about market risk are not applicable[91] Item 4. Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[92] - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[94] PART II OTHER INFORMATION Item 1. Legal Proceedings The company reported no legal proceedings during the period - There are no legal proceedings to report[97] Item 1A. Risk Factors No material changes occurred to the risk factors previously disclosed in the company's Form 10-K for the year ended December 31, 2024 - No material changes from the risk factors disclosed in the Form 10-K for the year ended December 31, 2024[98] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities or use of proceeds during the period - There were no unregistered sales of equity securities or use of proceeds to report[99] Item 5. Other Information No directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q1 2025 - No directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter[102] Item 6. Exhibits This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL documents - Exhibits filed include CEO and CFO certifications (Rule 13a-14(a)/15d-14(a) and Section 906 of Sarbanes-Oxley) and XBRL data files[103]