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)

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section presents Cardiff Oncology, Inc.'s unaudited condensed financial statements for Q2 2024, covering balance sheets, operations, comprehensive loss, equity, cash flows, and detailed notes [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents Cardiff Oncology's unaudited condensed financial statements for Q2 2024, including balance sheets, operations, comprehensive loss, equity, cash flows, and detailed notes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Summarizes the company's financial position at June 30, 2024, and December 31, 2023, detailing assets, liabilities, and stockholders' equity | Metric (in thousands) | June 30, 2024 | December 31, 2023 | | :-------------------- | :------------ | :---------------- | | Total Assets | $66,051 | $81,637 | | Total Liabilities | $13,663 | $11,898 | | Total Stockholders' Equity | $52,388 | $69,739 | - Total Assets decreased by **$15.6 million** from December 31, 2023, to June 30, 2024[5](index=5&type=chunk) - Total Liabilities increased by **$1.8 million**, while Total Stockholders' Equity decreased by **$17.4 million**[5](index=5&type=chunk) [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2024, and 2023 | Metric (in thousands) | 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 | | R&D Expenses | $9,493 | $8,020 | $17,501 | $17,072 | | SG&A Expenses | $3,215 | $4,296 | $6,345 | $7,379 | | 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 (Basic & Diluted) | $(0.26) | $(0.25) | $(0.49) | $(0.50) | - For the three months ended June 30, 2024, royalty revenues increased by **50.9% YoY**, while net loss increased by **5.6% YoY**[8](index=8&type=chunk) - For the six months ended June 30, 2024, royalty revenues increased by **92.7% YoY**, and net loss decreased by **2.6% YoY**[8](index=8&type=chunk) [Condensed Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Statements%20of%20Comprehensive%20Loss) Outlines the company's total comprehensive loss, including net loss and other comprehensive income/loss, for the reported periods | Metric (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net Loss | $(11,778) | $(11,150) | $(21,789) | $(22,373) | | Unrealized gain (loss) on securities available-for-sale | $35 | $(355) | $(30) | $(36) | | Total Comprehensive Loss | $(11,743) | $(11,505) | $(21,819) | $(22,409) | - The company reported a total comprehensive loss of **$(11.7) million** for the three months ended June 30, 2024, compared to **$(11.5) million** in the prior year, primarily due to net loss and a shift from unrealized loss to gain on available-for-sale securities[10](index=10&type=chunk) [Condensed Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) Presents changes in stockholders' equity, including common stock, additional paid-in capital, and accumulated deficit, for the six months ended June 30, 2024 | Metric (in thousands) | December 31, 2023 | June 30, 2024 | | :-------------------- | :---------------- | :------------ | | Common Stock Shares Outstanding | 44,677 | 45,602 | | Additional Paid-In Capital | $409,343 | $413,017 | | Accumulated Deficit | $(339,541) | $(360,537) | | Total Stockholders' Equity | $69,739 | $52,388 | - Total stockholders' equity decreased from **$69.7 million** at December 31, 2023, to **$52.4 million** at June 30, 2024, primarily due to net losses, partially offset by stock-based compensation and issuance of common stock[12](index=12&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Summarizes cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2024, and 2023 | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 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 | - Net cash used in operating activities increased by **$1.2 million** for the six months ended June 30, 2024, compared to the same period in 2023[16](index=16&type=chunk) - Net cash provided by financing activities significantly increased to **$2.2 million** in 2024 due to common stock sales and option exercises, compared to zero in 2023[16](index=16&type=chunk) [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Provides detailed explanations and disclosures supporting the condensed financial statements, including accounting policies, fair value measurements, and subsequent events [1. Organization and Basis of Presentation](index=9&type=section&id=1.%20Organization%20and%20Basis%20of%20Presentation) Describes Cardiff Oncology, Inc.'s business, its focus on cancer therapies, and the basis for preparing the financial statements - Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing novel cancer therapies using PLK1 inhibition, with its lead asset onvansertib being evaluated in various clinical programs for RAS-mutated metastatic colorectal cancer (mCRC), metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple negative breast cancer (TNBC)[18](index=18&type=chunk) - The company has incurred net losses and negative operating cash flows since inception, but as of June 30, 2024, it had **$60.3 million** in cash, cash equivalents, and short-term investments, which is believed to be sufficient for at least the next 12 months[20](index=20&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Outlines the key accounting principles and methods used in preparing the condensed financial statements - No changes to significant accounting policies occurred during the six months ended June 30, 2024, as described in the Annual Report on Form 10-K for 2023[21](index=21&type=chunk) - The company adopted ASU No. 2020-06 on January 1, 2024, using the modified-retrospective method, which resulted in reversing **$793,000** of preferred stock dividends related to Series A Convertible Preferred Stock[23](index=23&type=chunk) [3. Fair Value Measurements](index=10&type=section&id=3.%20Fair%20Value%20Measurements) Details the fair value hierarchy and measurements for financial assets and liabilities on a recurring basis | Asset Category (in thousands) | Fair Value June 30, 2024 | Fair Value December 31, 2023 | | :---------------------------- | :----------------------- | :--------------------------- | | Money market fund | $24,349 | $21,606 | | Available for sale investments: | | | | Certificate of deposit | $5,946 | $8,333 | | Corporate debt securities | $13,849 | $19,373 | | Commercial paper | $2,399 | $6,202 | | U.S. treasury securities | $12,624 | $18

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 ...

Cardiff Oncology Contact: SAN DIEGO, May 13, 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 present at two upcoming investor conferences in May 2024. Details of the presentations can be found below. H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ Location: The Nasdaq Headquarters, New York City Presenter: Mar ...

Cardiff Oncology, Inc. (NASDAQ:CRDF) Q1 2024 Results Earnings Conference Call May 2, 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 Mark Frahm - TD Cowen Joseph Catanzaro - Piper Sandler Andy Hsieh - William Blair Operator Welcome to the Cardiff Oncology First Quarter 2024 Financial Results and Business Update Conference Call. At this time, all participants are i ...

[Business Update and Highlights](index=1&type=section&id=Cardiff%20Oncology%20Reports%20First%20Quarter%202024%20Results%20and%20Provides%20Business%20Update) 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](index=1&type=section&id=CEO's%20Remarks%20and%20Strategic%20Overview) 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](index=16&type=chunk) - 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](index=16&type=chunk) - 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](index=16&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) 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](index=2&type=chunk) - 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](index=3&type=chunk) - 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](index=3&type=chunk) - 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](index=3&type=chunk) [Upcoming Milestones](index=1&type=section&id=Upcoming%20expected%20milestones) 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](index=3&type=chunk) - 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](index=3&type=chunk) [Financial Results](index=4&type=section&id=First%20Quarter%202024%20Financial%20Results) 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](index=4&type=section&id=Financial%20Performance%20Summary) 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](index=18&type=chunk) [Liquidity and Cash Position](index=4&type=section&id=Liquidity%2C%20cash%20burn%2C%20and%20cash%20runway) 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](index=4&type=chunk) - Current cash resources are projected to be sufficient to fund operations into Q3 2025[9](index=9&type=chunk) - Net cash used in operating activities was approximately **$7.7 million** for Q1 2024, down from **$8.7 million** in Q1 2023[17](index=17&type=chunk) [Condensed Financial Statements (Unaudited)](index=7&type=section&id=Condensed%20Financial%20Statements%20(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](index=7&type=section&id=Condensed%20Statements%20of%20Operations) 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](index=8&type=section&id=Condensed%20Balance%20Sheets) 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](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) 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.](index=4&type=section&id=About%20Cardiff%20Oncology%2C%20Inc.) 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](index=4&type=section&id=Company%20Description) 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](index=10&type=chunk) - The company's lead asset is onvansertib, which is being evaluated in combination with standard-of-care (SoC) therapies to overcome treatment resistance[10](index=10&type=chunk) - 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](index=10&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines the inherent risks and uncertainties associated with forward-looking statements, emphasizing that actual results may differ materially from projections [Risk Disclosure](index=4&type=section&id=Risk%20Disclosure) 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](index=20&type=chunk) - 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](index=20&type=chunk)[11](index=11&type=chunk) - 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](index=11&type=chunk)

Clinical Trials and Efficacy - Onvansertib, a highly selective PLK1 inhibitor, has shown a 29% objective response rate (ORR) in the ongoing TROV-054 trial for KRAS-mutated metastatic colorectal cancer (mCRC) with a median duration of response of 12.0 months[67]. - The CRDF-004 trial for first-line treatment in RAS-mutated mCRC is expected to enroll approximately 90 evaluable patients, with initial data anticipated in the second half of 2024[63]. - In the ONSEMBLE trial, patients who were bevacizumab naïve had an ORR of 73% and a median progression-free survival of 15 months, significantly higher than historical controls[71]. - The Phase 2 trial in first-line mPDAC will assess the combination of onvansertib with Gemzar and Abraxane, with the primary endpoint being ORR[75]. - The objective response rate (ORR) in the Phase 2 trial for mPDAC was 19%, significantly higher than the historical control of 7.7%[79]. - Median progression-free survival (mPFS) in the same trial was 5.0 months, compared to 3.1 months with standard care[79]. - The disease control rate (DCR) in the Phase 2 trial for SCLC was 57%, with 4 out of 7 patients showing either confirmed partial response or stable disease[82]. Safety and Tolerability - Onvansertib has demonstrated favorable safety and tolerability, with no Grade 4 treatment-emergent adverse events (TEAEs) observed in the combination arms of the trials[71]. - Onvansertib has shown synergistic effects in combination with various cytotoxic agents, enhancing its potential efficacy across multiple cancer therapies[60]. Financial Performance - Total revenues for Q1 2024 were $205,000, up from $83,000 in Q1 2023, reflecting a significant increase in sales-based royalties[86]. - Research and development expenses decreased by $1.0 million to $8.0 million in Q1 2024 compared to $9.1 million in Q1 2023, primarily due to reduced clinical trial costs[88]. - As of March 31, 2024, the company had working capital of $58.1 million, down from $67.0 million at the end of 2023[91]. - Net cash used in operating activities for Q1 2024 was $7.7 million, a slight improvement from $8.7 million in Q1 2023[96]. - The company reported a net loss of $10.0 million for Q1 2024, compared to a net loss of $11.2 million in Q1 2023[97]. - Cash and cash equivalents totaled $67.2 million as of March 31, 2024, sufficient to meet funding requirements for at least the next 12 months[92]. - Net cash provided by investing activities for Q1 2024 was $4.6 million, down from $7.3 million in Q1 2023[99]. Future Plans and Regulatory Aspects - The company plans to initiate CRDF-005, a Phase 3 trial with registrational intent, contingent upon the results of CRDF-004, focusing on objective response rate as an interim endpoint[64]. - The ongoing clinical programs include five trials targeting various cancers, including mCRC and metastatic pancreatic ductal adenocarcinoma (mPDAC)[61]. - The FDA has agreed that a seamless trial design with ORR as an interim endpoint is acceptable for pursuing accelerated approval for onvansertib[64]. - The company emphasizes the importance of tumor genomics and biomarker assays in refining patient response assessments in its clinical development programs[57].

- Management will hold a conference call on Thursday, May 2 at 4:30 p.m. ET/1:30 p.m. PT - SAN DIEGO, April 25, 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 it plans to release financial results for the first quarter ended March 31, 2024 on Thursday, May 2 after the close of trading. Conference Call and Webcast Cardiff Oncology will host a conference ...