[Business and Operational Highlights](index=1&type=section&id=Business%20and%20Operational%20Highlights) 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 Oncology[1](index=1&type=chunk)[3](index=3&type=chunk) - 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 bev[2](index=2&type=chunk)[3](index=3&type=chunk) - The company expects to provide an initial data readout from its first-line RAS-mutated mCRC randomized trial (CRDF-004) by the end of 2024[1](index=1&type=chunk)[3](index=3&type=chunk) - 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 models[4](index=4&type=chunk)[5](index=5&type=chunk) [Third Quarter 2024 Financial Results](index=2&type=section&id=Third%20Quarter%202024%20Financial%20Results) Cardiff Oncology reported increased Q3 2024 operating expenses due to clinical advancements, with cash runway into Q1 2026 [Liquidity, Cash Burn, and Cash Runway](index=2&type=section&id=Liquidity%2C%20Cash%20Burn%2C%20and%20Cash%20Runway) 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](index=7&type=chunk) [Operating Results](index=2&type=section&id=Operating%20results) 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, onvansertib[8](index=8&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) This section presents the unaudited condensed financial statements, including Statements of Operations, Balance Sheets, and Cash Flows [Condensed Statements of Operations](index=3&type=section&id=Condensed%20Statements%20of%20Operations) 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](index=6&type=section&id=Condensed%20Balance%20Sheets) 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](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) 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) |

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-35558 CARDIFF ONCOLOGY, INC. (Exact Name of registrant as specified in its charter) Delaware 27-2004382 (State or other j ...

- Findings underscore that the combination of onvansertib with FOLFIRI and bevacizumab demonstrates clinical activity and is well tolerated in second-line KRAS-mutant mCRC - - Post hoc analysis resulted in a 7.7-fold higher clinical benefit in bev-naïve patients with an ORR of 77% compared to 10% in bev-exposed patients - - Results from this trial, along with translational studies, supported the transition of clinical development of onvansertib to first-line RAS-mutant mCRC - - Initial readout from first-l ...

howtogoto/iStock via Getty Images Cardiff Oncology, Inc. (NASDAQ:CRDF) is gearing up to report results from its phase 2 randomized CRDF-004 study, which is using its drug onvansertib + chemotherapy [Folfiri] + bevacizumab [Avastin] for the treatment of RAS-mutated metastatic colorectal cancer [mCRC] patients. This combination therapy of onvansertib is being compared to the current 1st-line standard of care [SOC] therapy chemotherapy + bevacizumab. The company is currently conducting this phase 2 randomized ...

Cardiff Oncology, Inc. (NASDAQ:CRDF) Q2 2024 Results Conference Call August 8, 2024 4:30 PM ET Company Participants Kiki Patel - Investor Relations, Gilmartin Group Mark Erlander - Chief Executive Officer Jamie Levine - Chief Financial Officer Conference Call Participants Andy Hsieh - William Blair Marc Frahm - TD Cowen Operator Welcome to the Cardiff Oncology Second Quarter 2024 Financial Results and Business Update Conference Call. [Operator Instructions] Please be advised that today's conference is being ...

Cardiff Oncology (CRDF) came out with a quarterly loss of $0.26 per share versus the Zacks Consensus Estimate of a loss of $0.25. This compares to loss of $0.25 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -4%. A quarter ago, it was expected that this molecular diagnostic company would post a loss of $0.25 per share when it actually produced a loss of $0.22, delivering a surprise of 12%. Over the last four quarters, the co ...

[Business Update and Highlights](index=1&type=section&id=Business%20Update%20and%20Highlights) 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](index=1&type=chunk)[2](index=2&type=chunk) - 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](index=2&type=chunk) - 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](index=1&type=chunk)[2](index=2&type=chunk) - 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](index=1&type=chunk)[2](index=2&type=chunk)[3](index=3&type=chunk) [Second Quarter 2024 Financial Results](index=3&type=section&id=Second%20Quarter%202024%20Financial%20Results) 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](index=3&type=section&id=Liquidity%2C%20cash%20burn%2C%20and%20cash%20runway) 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](index=1&type=chunk)[4](index=4&type=chunk) 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](index=3&type=section&id=Operating%20results) 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](index=5&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) 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](index=7&type=section&id=Condensed%20Statements%20of%20Operations) 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](index=8&type=section&id=Condensed%20Balance%20Sheets) 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](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) 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](index=3&type=section&id=About%20Cardiff%20Oncology%20%26%20Forward-Looking%20Statements) 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](index=7&type=chunk) - 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](index=7&type=chunk) - 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](index=8&type=chunk)[9](index=9&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-35558 CARDIFF ONCOLOGY, INC. (Exact Name of registrant as specified in its charter) Delaware 27-2004382 (State or other jurisd ...

SAN DIEGO, May 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical- stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that company management will participate in a company presentation and 1x1 investor meetings at the Jefferies Healthcare Conference, which is taking place at the Marriott Marquis in New York from June 5-6, 2024. Details of the presentations can be found below. Presenters: Mark Erlander, CEO ...

Xesai Cardiff Oncology, Inc. (NASDAQ:CRDF) is a San Diego-based clinical-stage biotech focusing on developing innovative cancer treatments. CRDF's leading drug candidate, Onvansertib, is a first-in-class oral Polo-like Kinase 1 [PLK1] inhibitor that interferes with cancer cell division and may hinder cancer growth. Onvansertib is an ongoing trial as a monotherapy in combination with SoC treatments for mCRC, mPDAC, SCLC, and TNBC. Early data suggests it's efficient in overcoming resistance to other treatment ...