Cardiff Oncology(CRDF) - 2025 Q2 - Quarterly Report

PART I - FINANCIAL INFORMATION Financial Statements (unaudited) The unaudited financial statements for Q2 2025 show decreased assets and increased net loss due to higher R&D, while maintaining near-term liquidity Condensed Balance Sheets As of June 30, 2025, total assets decreased to $75.7 million from $97.2 million, driven by reduced cash, while liabilities and equity shifted accordingly | Account | June 30, 2025 ($ in thousands) | December 31, 2024 ($ in thousands) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | 10,784 | 51,470 | | Short-term investments | 60,173 | 40,276 | | Total current assets | 73,696 | 95,054 | | Total Assets | 75,739 | 97,190 | | Liabilities & Equity | | | | Total current liabilities | 16,669 | 13,428 | | Total Liabilities | 17,133 | 14,241 | | Total stockholders' equity | 58,606 | 82,949 | | Total liabilities and stockholders' equity | 75,739 | 97,190 | Condensed Statements of Operations Net loss widened to $13.9 million for Q2 2025 and $27.4 million for the six months, primarily due to increased research and development expenses | Metric | Three Months Ended June 30, 2025 ($ in thousands) | Three Months Ended June 30, 2024 ($ in thousands) | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | | :--- | :--- | :--- | :--- | :--- | | Royalty revenues | 121 | 163 | 230 | 368 | | Research and development | 11,580 | 9,493 | 22,057 | 17,501 | | Selling, general and administrative | 3,318 | 3,215 | 7,332 | 6,345 | | Loss from operations | (14,777) | (12,545) | (29,159) | (23,478) | | Net loss | (13,943) | (11,778) | (27,377) | (21,789) | | Net loss per common share | (0.21) | (0.26) | (0.41) | (0.49) | Condensed Statements of Comprehensive Loss Total comprehensive loss increased to $14.0 million for Q2 2025 and $27.4 million for the six-month period compared to prior year | Metric | Three Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2025 ($ in thousands) | | :--- | :--- | :--- | | Net loss | (13,943) | (27,377) | | Unrealized gain (loss) on securities | (10) | (17) | | Total comprehensive loss | (13,953) | (27,394) | Condensed Statements of Stockholders' Equity Stockholders' equity decreased from $82.9 million to $58.6 million by June 30, 2025, mainly due to the $27.4 million net loss - Total stockholders' equity decreased from $82.9 million on December 31, 2024, to $58.6 million on June 30, 2025[18] - The decrease was mainly driven by a net loss of $27.4 million for the six-month period[12][18] Condensed Statements of Cash Flows Net cash used in operations increased to $21.1 million, while investing activities shifted to a $19.6 million use, leading to a $40.7 million cash decrease | Cash Flow Activity | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (21,122) | (16,970) | | Net cash (used in) provided by investing activities | (19,567) | 18,651 | | Net cash provided by financing activities | 3 | 2,165 | | Net change in cash and cash equivalents | (40,686) | 3,846 | | Cash and cash equivalents—End of period | 10,784 | 25,501 | Notes to Condensed Financial Statements The notes detail the company's clinical-stage focus on onvansertib, its $71.0 million liquidity, and the breakdown of R&D and SG&A expenses - Cardiff Oncology is a clinical-stage biotechnology company developing its lead asset, onvansertib (a PLK1 inhibitor), for various cancers including mCRC, mPDAC, SCLC, and mTNBC[27] - As of June 30, 2025, the company had $71.0 million in cash, cash equivalents, and short-term investments and believes it has sufficient cash for at least the next 12 months[29] - The company has a license agreement with Nerviano for onvansertib that includes potential development and commercial milestone payments, though no such payments were made in the first half of 2025 or 2024[54] Expense Breakdown (Six Months Ended June 30, 2025) | Expense Breakdown | Amount ($ in thousands) | | :--- | :--- | | Research and Development | | | Clinical trials, outside services, and lab supplies | 15,803 | | Salaries and staff costs | 4,103 | | Stock-based compensation | 1,187 | | Total R&D | 22,057 | | Selling, General and Administrative | | | Outside services and professional fees | 2,860 | | Stock-based compensation | 1,861 | | Salaries and staff costs | 1,775 | | Total SG&A | 7,332 | Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses onvansertib's clinical progress, increased R&D expenses, and capital sufficiency into Q1 2027, while anticipating future funding needs Overview and Clinical Programs The company focuses on onvansertib development, with the CRDF-004 Phase 2 trial for mCRC completing enrollment and showing promising initial ORR data - The company's lead drug candidate is onvansertib, an oral, highly selective PLK1 inhibitor with a 24-hour half-life, allowing for flexible dosing[62][63] - The CRDF-004 Phase 2 trial in first-line RAS-mutated mCRC completed enrollment of approximately 90 patients in April 2025[67] CRDF-004 Initial ORR Data (as of Nov 26, 2024) | CRDF-004 Initial ORR Data (as of Nov 26, 2024) | Objective Response Rate (ORR) | | :--- | :--- | | 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) | - An investigator-initiated Phase 1b/2 trial of onvansertib with NALIRIFOX for first-line mPDAC is open for enrollment[74] Results of Operations Royalty revenues decreased, while R&D expenses significantly increased by $2.1 million for the quarter and $4.6 million for six months due to clinical trials Expense Comparison (Three Months) | Expense Comparison | Three Months Ended June 30, 2025 ($ in thousands) | Three Months Ended June 30, 2024 ($ in thousands) | Change ($ in thousands) | | :--- | :--- | :--- | :--- | | Research and development | 11,580 | 9,493 | 2,087 | | Selling, general and administrative | 3,318 | 3,215 | 103 | Expense Comparison (Six Months) | Expense Comparison | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | Change ($ in thousands) | | :--- | :--- | :--- | :--- | | Research and development | 22,057 | 17,501 | 4,556 | | Selling, general and administrative | 7,332 | 6,345 | 987 | Liquidity and Capital Resources As of June 30, 2025, the company had $71.0 million in liquidity, sufficient to fund operations into Q1 2027, but anticipates future capital needs - As of June 30, 2025, the company had $71.0 million in cash, cash equivalents, and short-term investments[95] - Current capital resources are expected to be sufficient to fund operations into the first quarter of 2027[95] Cash Flow Summary | Cash Flow Summary | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (21,122) | (16,970) | | Net cash (used in) provided by investing activities | (19,567) | 18,651 | | Net cash provided by financing activities | 3 | 2,165 | Quantitative and Qualitative Disclosures About Market Risk This section is not applicable for the company as a smaller reporting company - Not applicable[103] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - Management concluded that disclosure controls and procedures were effective as of June 30, 2025[104] - 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[106] PART II - OTHER INFORMATION Legal Proceedings The company reported no legal proceedings during the period - None[108] Risk Factors There have been no material changes to the risk factors previously disclosed in the company's Form 10-K - There have been no material changes from the risk factors disclosed in the Form 10-K for the year ended December 31, 2024[109] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities - None[110] Defaults Upon Senior Securities The company reported no defaults upon senior securities - None[111] Mine Safety Disclosures This section is not applicable to the company - Not applicable[112] Other Information No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q2 2025 - No directors or officers adopted or terminated any "Rule 10b5-1 trading arrangements" or "non-Rule 10b5-1 trading arrangements" during the three months ended June 30, 2025[113] Exhibits This section lists the exhibits filed with the Form 10-Q, including required certifications and Inline XBRL documents - The report includes required certifications from the CEO and CFO (Exhibits 31.1, 31.2, 32.1, 32.2) and Inline XBRL data files[114]