Cardiff Oncology(CRDF) - 2024 Q2 - Quarterly Results

Business Update and Highlights Cardiff Oncology reported progress in its CRDF-004 trial, updated its mPDAC clinical plan, published preclinical data, and presented AACR abstracts - The initial data readout from the first-line RAS-mutated mCRC randomized CRDF-004 trial is a key upcoming milestone, expected in the second half of 2024[1][2] - The company is advancing its clinical development for metastatic pancreatic ductal adenocarcinoma (mPDAC) with a new investigator-initiated trial evaluating onvansertib in combination with NALIRIFOX, replacing a previously planned trial[2] - Preclinical data published in a peer-reviewed journal demonstrated that the combination of onvansertib and olaparib inhibited tumor growth and prolonged survival in olaparib-resistant high-grade serous ovarian carcinoma models, suggesting onvansertib can overcome PARP inhibitor resistance[1][2] - Five abstracts were presented at the American Association for Cancer Research (AACR) meeting, providing a strong scientific basis for the clinical development of onvansertib across multiple tumor types and in various combinations[1][2][3] Second Quarter 2024 Financial Results Cardiff Oncology reported $60.3 million in cash, a $9.2 million net cash burn from operations, and $12.7 million in operating expenses for Q2 2024 Liquidity, Cash Burn, and Cash Runway The company held $60.3 million in cash as of June 30, 2024, with a Q2 2024 net cash burn of $9.2 million, projecting a cash runway through Q3 2025 - The company projects its cash runway is sufficient to fund operations through the end of Q3 2025[1][4] Cash Position and Burn Rate (Q2 2024) | Metric | Q2 2024 | Q2 2023 | | :--- | :--- | :--- | | Cash, Cash Equivalents, & Short-term Investments | $60.3 million | N/A | | Net Cash Used in Operating Activities | $9.2 million | $7.1 million | Operating Results Total operating expenses for Q2 2024 increased to $12.7 million, primarily driven by clinical development costs for onvansertib Operating Expenses Comparison (Q2) | Period | Total Operating Expenses | | :--- | :--- | | Q2 2024 | $12.7 million | | Q2 2023 | $12.3 million | - The increase in operating expenses was mainly due to clinical program and outside service costs related to the development of onvansertib[5] Financial Statements Unaudited financial statements for Q2 2024 show a net loss of $11.8 million, total assets of $66.1 million, and $17.0 million net cash used in operations for the first six months Condensed Statements of Operations Cardiff Oncology reported a net loss of $11.8 million for Q2 2024, or ($0.26) per share, primarily due to increased research and development expenses Condensed Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Royalty revenues | $163 | $108 | $368 | $191 | | Research and development | $9,493 | $8,020 | $17,501 | $17,072 | | Selling, general and administrative | $3,215 | $4,296 | $6,345 | $7,379 | | Total operating expenses | $12,708 | $12,316 | $23,846 | $24,451 | | Loss from operations | $(12,545) | $(12,208) | $(23,478) | $(24,260) | | Net loss | $(11,778) | $(11,150) | $(21,789) | $(22,373) | | Net loss per common share | $(0.26) | $(0.25) | $(0.49) | $(0.50) | Condensed Balance Sheets As of June 30, 2024, total assets were $66.1 million, total liabilities $13.7 million, and stockholders' equity $52.4 million Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $25,501 | $21,655 | | Short-term investments | $34,818 | $53,168 | | Total Assets | $66,051 | $81,637 | | Total current liabilities | $12,522 | $10,440 | | Total Liabilities | $13,663 | $11,898 | | Stockholders' equity | $52,388 | $69,739 | Condensed Statements of Cash Flows For the six months ended June 30, 2024, net cash used in operations was $17.0 million, with $18.7 million from investing and $2.2 million from financing activities Condensed Statements of Cash Flows Highlights (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(16,970) | $(15,791) | | Net cash provided by investing activities | $18,651 | $18,813 | | Net cash provided by financing activities | $2,165 | $0 | | Net change in cash and cash equivalents | $3,846 | $3,022 | | Cash and cash equivalents—End of period | $25,501 | $19,369 | About Cardiff Oncology & Forward-Looking Statements Cardiff Oncology is a clinical-stage biotech developing onvansertib for cancer, with forward-looking statements subject to clinical, financial, and regulatory risks - Cardiff Oncology's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care therapeutics for indications like RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC)[7] - The company's development strategy aims to target tumor vulnerabilities to overcome treatment resistance and provide superior clinical benefits compared to the standard of care alone[7] - The report contains forward-looking statements concerning the company's expectations and plans, which are subject to material risks including uncertain clinical trial outcomes, potential trial suspensions, unfavorable results, and the need for additional financing[8][9]