Cardiff Oncology(US:CRDF)2024-11-07 21:07Business and Operational Highlights Cardiff Oncology reported significant clinical progress, highlighted by positive Phase 2 trial results for onvansertib and promising preclinical data - Published positive Phase 2 trial results of onvansertib in combination with FOLFIRI and bevacizumab (bev) for second-line KRAS mutant mCRC in the peer-reviewed Journal of Clinical Oncology13 - A post hoc analysis revealed significantly greater clinical benefit in bev naïve patients, who showed an Objective Response Rate (ORR) of 77% and median Progression-Free Survival (mPFS) of 14.9 months, compared to an ORR of 10% and mPFS of 6.6 months in patients previously exposed to bev23 - The company expects to provide an initial data readout from its first-line RAS-mutated mCRC randomized trial (CRDF-004) by the end of 202413 - Published promising preclinical data showing the combination of onvansertib and alpelisib synergistically inhibited cell viability and demonstrated superior anti-tumor activity in PIK3CA-mutated HR-positive breast cancer models45 Third Quarter 2024 Financial Results Cardiff Oncology reported increased Q3 2024 operating expenses due to clinical advancements, with cash runway into Q1 2026 Liquidity, Cash Burn, and Cash Runway The company's cash position and burn rate indicate a projected cash runway extending into Q1 2026 Cash Position and Runway | Metric | Value | | :------------------------------------------------------------------------ | :-------------- | | Cash, cash equivalents, and short-term investments (as of Sep 30, 2024) | $57.7 million | | Net cash used in operating activities (Q3 2024) | $10.5 million | | Projected cash runway | Into Q1 2026 | - Net cash used in operating activities increased by $2.5 million in Q3 2024 compared to the same period in 2023 ($10.5 million vs $8.0 million)7 Operating Results Total operating expenses increased in Q3 2024, primarily driven by higher costs for clinical program advancements Operating Expenses Comparison (Q3) | Period | Total Operating Expenses | | :------ | :----------------------- | | Q3 2024 | $12.8 million | | Q3 2023 | $11.0 million | - The increase in operating expenses was primarily driven by costs related to clinical programs and outside services for the development of the lead drug candidate, onvansertib8 Financial Statements This section presents the unaudited condensed financial statements, including Statements of Operations, Balance Sheets, and Cash Flows Condensed Statements of Operations The Condensed Statements of Operations detail the company's financial performance, showing an increased net loss for Q3 2024 Q3 2024 vs Q3 2023 Statement of Operations (in thousands, except per share data) | Metric | Q3 2024 | Q3 2023 | | :------------------------------------------ | :---------- | :---------- | | Research and development | $9,640 | $8,022 | | Total operating expenses | $12,766 | $10,961 | | Loss from operations | $(12,601) | $(10,820) | | Net loss | $(11,855) | $(9,731) | | Net loss per common share — basic and diluted | $(0.25) | $(0.22) | Condensed Balance Sheets The Condensed Balance Sheets provide a snapshot of the company's financial position, detailing changes in assets, liabilities, and equity Balance Sheet Summary (in thousands) | Metric | Sep 30, 2024 | Dec 31, 2023 | | :----------------------------------- | :----------- | :----------- | | Cash and cash equivalents | $13,038 | $21,655 | | Short-term investments | $44,629 | $53,168 | | Total current assets | $59,332 | $77,412 | | Total Assets | $62,896 | $81,637 | | Total Liabilities | $13,504 | $11,898 | | Total Stockholders' equity | $49,392 | $69,739 | Condensed Statements of Cash Flows The Condensed Statements of Cash Flows summarize cash inflows and outflows from operating, investing, and financing activities Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Activity | 2024 | 2023 | | :---------------------------------------- | :---------- | :---------- | | Net cash used in operating activities | $(27,426) | $(23,748) | | Net cash provided by investing activities | $9,217 | $22,634 | | Net cash provided by financing activities | $9,592 | $0 | | Net change in cash and cash equivalents | $(8,617) | $(1,114) |