- 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 ...

Financial Data and Key Metrics Changes - As of June 30, 2024, cash and short-term investments totaled $60.3 million, with cash used in operating activities amounting to $9.2 million in Q2 2024 [13] - The company updated its cash runway guidance, now expecting to have sufficient resources through the end of Q3 2025, an extension from previous expectations [13] Business Line Data and Key Metrics Changes - The CRDF-004 trial is currently active in 33 sites, with plans to enroll 90 patients randomized to receive either a 20-milligram or a 30-milligram dose of onvansertib plus standard of care [6] - The pancreatic cancer program is shifting focus to an investigator-initiated trial combining onvansertib with NALIRIFOX, following the approval of NALIRIFOX for first-line metastatic PDAC [9] Market Data and Key Metrics Changes - The company is targeting a large patient population of nearly 50,000 new patients annually in the U.S. for RAS-mutated metastatic colorectal cancer [4] - There are currently no new therapies approved for RAS-mutated mCRC patients in the past 20 years, and no competing clinical trials exist for this patient population [4] Company Strategy and Development Direction - The company is focused on clinical execution of the CRDF-004 trial and is optimistic about the potential of onvansertib to change the treatment paradigm for RAS-mutated mCRC [14] - There is ongoing exploration of onvansertib's efficacy in other cancer indications, including ovarian cancer, where it has shown potential to overcome resistance to PARP inhibitors [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical development strategy for RAS-mutated mCRC and enthusiasm for the upcoming data readout of CRDF-004 later this year [14] - The company is encouraged by preclinical data demonstrating onvansertib's activity in various cancer indications with unmet clinical needs [10] Other Important Information - The company is leveraging Pfizer's resources to enhance patient enrollment in clinical trials [6] - Preclinical studies have shown onvansertib's potential in RAS wild-type mCRC, ER-positive breast cancer, triple-negative breast cancer, and platinum-resistant ovarian cancer [10] Q&A Session Summary Question: Enrollment trends in the CRDF-004 trial - Management confirmed that enrollment is tracking well and is on schedule for an initial data look later this year, aided by the partnership with Pfizer Ignite [15] Question: Adoption of NALIRIFOX in pancreatic cancer - Management explained that the combination of onvansertib with NALIRIFOX is based on previous positive data and good tolerability, making it a suitable choice for the first-line regimen [16][17] Question: Scientific validation of the change in pancreatic cancer trial - Management highlighted the synergy of onvansertib with irinotecan as a key reason for the new trial direction and noted the enthusiasm of the investigator involved [20] Question: Potential entry into ovarian cancer with ADCs - Management indicated that preclinical work is ongoing to explore combinations of onvansertib with ADCs across various cancer types, not limited to ovarian cancer [20]

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 ...