Cardiff Oncology(CRDF) - 2024 Q1 - Quarterly Results

Business Update and Highlights Cardiff Oncology provided updates on its clinical programs, highlighting positive data for onvansertib in mCRC and other indications, with key trial readouts anticipated in 2H 2024 CEO's Remarks and Strategic Overview The CEO emphasized new data supporting onvansertib's potential in RAS-mutated mCRC and other indications, anticipating a key value inflection point from upcoming trial results - Data from the ONSEMBLE trial replicated, in a second independent and randomized dataset, the positive signal for bev-naïve patients previously seen in the Phase 1b/2 KRAS-mutated mCRC trial[16] - Presentations at the AACR conference suggest potential new indications for onvansertib in RAS wild-type mCRC, small cell lung cancer (SCLC), and ovarian cancer[16] - The upcoming data readout from the first-line trial in RAS-mutated mCRC is viewed as a key potential value inflection point for the company[16] Clinical Program Updates Clinical updates include the CRDF-004 trial readout expected in 2H 2024, a 50% ORR in ONSEMBLE's bev-naïve cohort, and broad preclinical activity for onvansertib - The expected timing for the initial readout from the first-line RAS-mutated mCRC randomized trial (CRDF-004) has been updated to the second half of 2024[2] - In the second-line ONSEMBLE trial, bev-naïve patients receiving onvansertib plus standard of care (SoC) showed a 50% objective response rate (ORR), whereas no responses were seen in patients on SoC alone or those previously exposed to bevacizumab (bev)[3] - Preclinical data presented at AACR 2024 showed onvansertib, as a single agent, induced tumor stasis or regression in 70% of RAS wild-type mCRC patient-derived xenograft (PDX) models. The combination with cetuximab was effective in 90% of models[3] - Further preclinical data at AACR highlighted that onvansertib in combination with paclitaxel showed superior efficacy in SCLC models, and in combination with gemcitabine or carboplatin showed anti-tumor activity in platinum-resistant ovarian cancer models[3] Upcoming Milestones Key upcoming milestones include interim topline results from the CRDF-004 trial in 2H 2024, potentially leading to a registrational Phase 3 trial - Interim topline results from the CRDF-004 trial for first-line RAS-mutated mCRC are expected in the second half of 2024[3] - Contingent on positive results from CRDF-004, the company plans to initiate a Phase 3 randomized trial, CRDF-005, with the intent for registration[3] Financial Results Cardiff Oncology reported a reduced net loss in Q1 2024, driven by lower operating expenses and increased royalty revenues, while maintaining sufficient liquidity Financial Performance Summary Q1 2024 saw a net loss of $10.0 million, an improvement from Q1 2023, driven by a $1.0 million decrease in operating expenses and higher royalty revenues Q1 2024 vs Q1 2023 Statement of Operations (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Royalty Revenues | $205 | $83 | | Research and Development | $8,008 | $9,052 | | Selling, General & Administrative | $3,130 | $3,083 | | Total Operating Expenses | $11,138 | $12,135 | | Loss from Operations | $(10,933) | $(12,052) | | Net Loss | $(10,011) | $(11,223) | | Net Loss Per Common Share | $(0.22) | $(0.25) | - Total operating expenses decreased by $1.0 million in Q1 2024 compared to Q1 2023, mainly due to a reduction in chemistry, manufacturing, and controls costs[18] Liquidity and Cash Position As of March 31, 2024, the company held $67.2 million in cash, projecting sufficient liquidity to fund operations into Q3 2025, with reduced cash burn - The company held approximately $67.2 million in cash, cash equivalents, and short-term investments as of March 31, 2024[4] - Current cash resources are projected to be sufficient to fund operations into Q3 2025[9] - Net cash used in operating activities was approximately $7.7 million for Q1 2024, down from $8.7 million in Q1 2023[17] Condensed Financial Statements (Unaudited) The unaudited condensed financial statements provide detailed figures for the company's operations, balance sheet, and cash flows for the first quarter of 2024 Condensed Statements of Operations The condensed statements of operations show a net loss of $10.0 million for Q1 2024, an improvement from $11.2 million in Q1 2023, with increased royalty revenues Condensed Statements of Operations (in thousands, except per share amounts) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | 2024 | 2023 | | Royalty revenues | $205 | $83 | | Research and development | $8,008 | $9,052 | | Selling, general and administrative | $3,130 | $3,083 | | Total operating expenses | $11,138 | $12,135 | | Loss from operations | $(10,933) | $(12,052) | | Interest income, net | $926 | $940 | | Net loss | $(10,011) | $(11,223) | | Net loss per common share — basic and diluted | $(0.22) | $(0.25) | Condensed Balance Sheets The balance sheet shows total assets of $74.0 million and total liabilities of $13.1 million as of March 31, 2024, reflecting a decrease in cash and investments Condensed Balance Sheets (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $18,658 | $21,655 | | Short-term investments | $48,529 | $53,168 | | Total current assets | $69,990 | $77,412 | | Total Assets | $74,038 | $81,637 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $11,843 | $10,440 | | Total Liabilities | $13,144 | $11,898 | | Stockholders' equity | $60,894 | $69,739 | | Total liabilities and stockholders' equity | $74,038 | $81,637 | Condensed Statements of Cash Flows Net cash used in operating activities was $7.7 million in Q1 2024, with investing activities providing $4.6 million, resulting in a $3.0 million net decrease in cash Condensed Statements of Cash Flows (in thousands) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | 2024 | 2023 | | Net cash used in operating activities | $(7,740) | $(8,659) | | Net cash provided by investing activities | $4,636 | $7,329 | | Net cash provided by financing activities | $107 | $— | | Net change in cash and cash equivalents | $(2,997) | $(1,330) | | Cash and cash equivalents—Beginning of period | $21,655 | $16,347 | About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel cancer therapies by inhibiting PLK1, with onvansertib as its lead asset Company Description Cardiff Oncology is a clinical-stage biotech company developing novel cancer therapies through PLK1 inhibition, with onvansertib as its lead asset in multiple clinical programs - Cardiff Oncology is a clinical-stage biotechnology company developing novel therapies by inhibiting PLK1, a validated oncology drug target[10] - The company's lead asset is onvansertib, which is being evaluated in combination with standard-of-care (SoC) therapies to overcome treatment resistance[10] - Key indications for onvansertib clinical programs include RAS-mutated metastatic colorectal cancer (mCRC), metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple negative breast cancer (TNBC)[10] Forward-Looking Statements This section outlines the inherent risks and uncertainties associated with forward-looking statements, emphasizing that actual results may differ materially from projections Risk Disclosure Forward-looking statements are subject to significant risks, including uncertain clinical trial outcomes, financing needs, and regulatory challenges, with no guarantee of commercial success - The press release contains forward-looking statements based on current expectations, but actual results could differ materially[20] - Significant risks include the uncertain outcomes of clinical trials, potential for trial suspension due to safety risks, the need for additional financing, and regulatory approval challenges[20][11] - Investors are advised to read the risk factors detailed in the company's Form 10-K and other SEC filings for a complete understanding of potential risks[11]