PART I - FINANCIAL INFORMATION [Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) The unaudited financial statements for Q2 2025 show decreased assets and increased net loss due to higher R&D, while maintaining near-term liquidity [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $75.7 million from $97.2 million, driven by reduced cash, while liabilities and equity shifted accordingly | Account | June 30, 2025 ($ in thousands) | December 31, 2024 ($ in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 10,784 | 51,470 | | Short-term investments | 60,173 | 40,276 | | Total current assets | 73,696 | 95,054 | | Total Assets | 75,739 | 97,190 | | **Liabilities & Equity** | | | | Total current liabilities | 16,669 | 13,428 | | Total Liabilities | 17,133 | 14,241 | | Total stockholders' equity | 58,606 | 82,949 | | Total liabilities and stockholders' equity | 75,739 | 97,190 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Net loss widened to $13.9 million for Q2 2025 and $27.4 million for the six months, primarily due to increased research and development expenses | Metric | Three Months Ended June 30, 2025 ($ in thousands) | Three Months Ended June 30, 2024 ($ in thousands) | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | | :--- | :--- | :--- | :--- | :--- | | Royalty revenues | 121 | 163 | 230 | 368 | | Research and development | 11,580 | 9,493 | 22,057 | 17,501 | | Selling, general and administrative | 3,318 | 3,215 | 7,332 | 6,345 | | Loss from operations | (14,777) | (12,545) | (29,159) | (23,478) | | Net loss | (13,943) | (11,778) | (27,377) | (21,789) | | Net loss per common share | (0.21) | (0.26) | (0.41) | (0.49) | [Condensed Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Statements%20of%20Comprehensive%20Loss) Total comprehensive loss increased to $14.0 million for Q2 2025 and $27.4 million for the six-month period compared to prior year | Metric | Three Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2025 ($ in thousands) | | :--- | :--- | :--- | | Net loss | (13,943) | (27,377) | | Unrealized gain (loss) on securities | (10) | (17) | | Total comprehensive loss | (13,953) | (27,394) | [Condensed Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased from $82.9 million to $58.6 million by June 30, 2025, mainly due to the $27.4 million net loss - Total stockholders' equity decreased from **$82.9 million** on December 31, 2024, to **$58.6 million** on June 30, 2025[18](index=18&type=chunk) - The decrease was mainly driven by a net loss of **$27.4 million** for the six-month period[12](index=12&type=chunk)[18](index=18&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to $21.1 million, while investing activities shifted to a $19.6 million use, leading to a $40.7 million cash decrease | Cash Flow Activity | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (21,122) | (16,970) | | Net cash (used in) provided by investing activities | (19,567) | 18,651 | | Net cash provided by financing activities | 3 | 2,165 | | Net change in cash and cash equivalents | (40,686) | 3,846 | | Cash and cash equivalents—End of period | 10,784 | 25,501 | [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail the company's clinical-stage focus on onvansertib, its $71.0 million liquidity, and the breakdown of R&D and SG&A expenses - Cardiff Oncology is a clinical-stage biotechnology company developing its lead asset, **onvansertib** (a PLK1 inhibitor), for various cancers including mCRC, mPDAC, SCLC, and mTNBC[27](index=27&type=chunk) - As of June 30, 2025, the company had **$71.0 million** in cash, cash equivalents, and short-term investments and believes it has sufficient cash for at least the next 12 months[29](index=29&type=chunk) - The company has a license agreement with Nerviano for **onvansertib** that includes potential development and commercial milestone payments, though no such payments were made in the first half of 2025 or 2024[54](index=54&type=chunk) Expense Breakdown (Six Months Ended June 30, 2025) | Expense Breakdown | Amount ($ in thousands) | | :--- | :--- | | **Research and Development** | | | Clinical trials, outside services, and lab supplies | 15,803 | | Salaries and staff costs | 4,103 | | Stock-based compensation | 1,187 | | **Total R&D** | **22,057** | | **Selling, General and Administrative** | | | Outside services and professional fees | 2,860 | | Stock-based compensation | 1,861 | | Salaries and staff costs | 1,775 | | **Total SG&A** | **7,332** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses onvansertib's clinical progress, increased R&D expenses, and capital sufficiency into Q1 2027, while anticipating future funding needs [Overview and Clinical Programs](index=20&type=section&id=Overview%20and%20Clinical%20Programs) The company focuses on onvansertib development, with the CRDF-004 Phase 2 trial for mCRC completing enrollment and showing promising initial ORR data - The company's lead drug candidate is **onvansertib**, an oral, highly selective PLK1 inhibitor with a 24-hour half-life, allowing for flexible dosing[62](index=62&type=chunk)[63](index=63&type=chunk) - The CRDF-004 Phase 2 trial in first-line RAS-mutated mCRC completed enrollment of approximately **90 patients** in April 2025[67](index=67&type=chunk) CRDF-004 Initial ORR Data (as of Nov 26, 2024) | CRDF-004 Initial ORR Data (as of Nov 26, 2024) | Objective Response Rate (ORR) | | :--- | :--- | | Control Arm (SoC alone) | 33% (3 of 9) | | 20mg onvansertib + SoC | 50% (5 of 10) | | 30mg onvansertib + SoC | 64% (7 of 11) | | **All onvansertib patients** | **57% (12 of 21)** | - An investigator-initiated Phase 1b/2 trial of **onvansertib** with NALIRIFOX for first-line mPDAC is open for enrollment[74](index=74&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Royalty revenues decreased, while R&D expenses significantly increased by $2.1 million for the quarter and $4.6 million for six months due to clinical trials Expense Comparison (Three Months) | Expense Comparison | Three Months Ended June 30, 2025 ($ in thousands) | Three Months Ended June 30, 2024 ($ in thousands) | Change ($ in thousands) | | :--- | :--- | :--- | :--- | | Research and development | 11,580 | 9,493 | 2,087 | | Selling, general and administrative | 3,318 | 3,215 | 103 | Expense Comparison (Six Months) | Expense Comparison | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | Change ($ in thousands) | | :--- | :--- | :--- | :--- | | Research and development | 22,057 | 17,501 | 4,556 | | Selling, general and administrative | 7,332 | 6,345 | 987 | [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had $71.0 million in liquidity, sufficient to fund operations into Q1 2027, but anticipates future capital needs - As of June 30, 2025, the company had **$71.0 million** in cash, cash equivalents, and short-term investments[95](index=95&type=chunk) - Current capital resources are expected to be sufficient to fund operations into the **first quarter of 2027**[95](index=95&type=chunk) Cash Flow Summary | Cash Flow Summary | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (21,122) | (16,970) | | Net cash (used in) provided by investing activities | (19,567) | 18,651 | | Net cash provided by financing activities | 3 | 2,165 | [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable for the company as a smaller reporting company - Not applicable[103](index=103&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - Management concluded that disclosure controls and procedures were **effective** as of June 30, 2025[104](index=104&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[106](index=106&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - None[108](index=108&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Form 10-K - There have been no material changes from the risk factors disclosed in the Form 10-K for the year ended December 31, 2024[109](index=109&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities - None[110](index=110&type=chunk) [Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[111](index=111&type=chunk) [Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable[112](index=112&type=chunk) [Other Information](index=30&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q2 2025 - No directors or officers adopted or terminated any "Rule 10b5-1 trading arrangements" or "non-Rule 10b5-1 trading arrangements" during the three months ended June 30, 2025[113](index=113&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including required certifications and Inline XBRL documents - The report includes required certifications from the CEO and CFO (Exhibits 31.1, 31.2, 32.1, 32.2) and Inline XBRL data files[114](index=114&type=chunk)

Core Points - Cardiff Oncology, Inc. has appointed Dr. Roger Sidhu as Chief Medical Officer, succeeding Dr. Fairooz Kabbinavar, who will remain in an advisory role [1][2] - The company plans to share additional clinical data from its lead program in RAS-mutated metastatic colorectal cancer (mCRC) on July 29, 2025 [1][2][5] - Dr. Sidhu brings over 20 years of experience in oncology research and development, having previously held significant roles at Treadwell Therapeutics and Amgen [2][3][4] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies through PLK1 inhibition for various cancers, with its lead asset being onvansertib [1][8] - The company is targeting RAS-mutated mCRC and has ongoing and planned trials for other indications, including metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple-negative breast cancer [8] Leadership Transition - Dr. Sidhu's appointment is seen as a strategic move to advance the clinical program for onvansertib through late-stage development [2][6] - The company expressed gratitude to Dr. Kabbinavar for his leadership in progressing onvansertib's clinical development across multiple tumor types [2] Upcoming Events - Cardiff Oncology will host a conference call and live webcast on July 29, 2025, to present additional clinical data from the CRDF-004 trial [5][6] - The conference call will be accessible via the company's website, with a replay available afterward [5] Stock Option Grant - In connection with Dr. Sidhu's appointment, the Board of Directors approved a grant of non-qualified stock options to purchase 600,000 shares of common stock, with an exercise price of $3.86 per share [6][7] - The stock options will vest over four years, with 25% vesting after 12 months and the remainder vesting monthly over the following 36 months [7]

Core Insights - Cardiff Oncology, Inc. announced positive results from a Phase 1b clinical trial evaluating onvansertib in combination with paclitaxel for metastatic triple-negative breast cancer (mTNBC), showing a 40% objective response rate [1][2][5] - The trial demonstrated that the combination was well-tolerated with a manageable toxicity profile, primarily myelosuppression being the most common adverse event [5] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies leveraging PLK1 inhibition across various cancers, with onvansertib as its lead asset [4] - The company is also exploring onvansertib in combination with standard of care treatments for other indications, including RAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, and small cell lung cancer [4] Clinical Trial Details - The Phase 1b trial was led by Antonio Giordano, MD, PhD, at Dana-Farber Cancer Institute, focusing on the safety, pharmacokinetics, and pharmacodynamics of the drug combination [5] - The study's primary endpoint was to assess safety and determine the recommended Phase 2 dose (RP2D), with secondary endpoints including pharmacokinetics and pharmacodynamics [5] - Patients in the trial had a median of 3 prior lines of chemotherapy, and the highest dose of onvansertib (18 mg/m²) resulted in a 40% objective response rate [5]

Core Viewpoint - Cardiff Oncology (CRDF) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of earnings estimate revisions, which are strongly correlated with near-term stock price movements [4][6]. - Rising earnings estimates for Cardiff Oncology suggest an improvement in the company's underlying business, potentially leading to higher stock prices [5]. Recent Earnings Estimate Revisions - For the fiscal year ending December 2025, Cardiff Oncology is expected to earn -$0.82 per share, reflecting a 13.7% change from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for Cardiff Oncology has increased by 13.1%, indicating a positive trend in earnings expectations [8]. Zacks Rank System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - The upgrade of Cardiff Oncology to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

Core Insights - The article discusses the process of identifying potential investment opportunities in the healthcare sector, particularly focusing on biotech and life-saving therapies [2]. Group 1: Investment Strategy - The investment strategy involves creating a high-priority watch list of ten companies within the healthcare sector, emphasizing innovative firms that are developing breakthrough therapies and pharmaceuticals [2]. - The author highlights a target-rich environment for finding candidate tickers to add to investment portfolios, indicating a robust market for healthcare investments [2]. Group 2: Analyst's Position - The analyst has disclosed a beneficial long position in the shares of IBRX and PFE, indicating confidence in these companies' future performance [3]. - There is an intention to potentially enter a long position in CRDF within the next 72 hours, suggesting ongoing evaluation of investment opportunities [3].

Group 1 - Cardiff Oncology reported a quarterly loss of $0.20 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.19, but an improvement from a loss of $0.22 per share a year ago, indicating a -5.26% earnings surprise [1] - The company posted revenues of $0.11 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 33.94%, and down from $0.21 million in the same quarter last year [2] - Cardiff Oncology shares have declined approximately 42.6% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] Group 2 - The earnings outlook for Cardiff Oncology is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The trend for estimate revisions for Cardiff Oncology is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, suggesting it is expected to outperform the market in the near future [6] - The current consensus EPS estimate for the upcoming quarter is -$0.19 on revenues of $0.17 million, and for the current fiscal year, it is -$0.78 on revenues of $0.65 million [7] Group 3 - The Medical - Biomedical and Genetics industry, to which Cardiff Oncology belongs, is currently ranked in the top 33% of over 250 Zacks industries, indicating a favorable outlook for stocks in this sector [8] - Another company in the same industry, Immatics, is expected to report a quarterly loss of $0.39 per share, reflecting a significant year-over-year decline of -875%, with revenues projected to be $14.9 million, down 54.7% from the previous year [9]

Cardiff Oncology First Quarter 2025 Financial Results and Business Update [Business Update and Highlights](index=1&type=section&id=Business%20Update%20and%20Highlights) Cardiff Oncology reported significant progress in its lead program for onvansertib, successfully completing enrollment for its Phase 2 CRDF-004 trial in first-line RAS-mutated metastatic colorectal cancer (mCRC) - Successfully completed enrollment in the randomized Phase 2 CRDF-004 trial, which evaluates onvansertib plus standard of care for first-line RAS-mutated mCRC[3](index=3&type=chunk)[4](index=4&type=chunk)[5](index=5&type=chunk) - Expanded its intellectual property with a second U.S. patent (**No. 12,263,173**) for onvansertib, covering its use with bevacizumab in all mCRC patients (both RAS-mutated and wild-type) across any line of therapy, with an expiration date of no earlier than **2043**[3](index=3&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - The company expects to report additional clinical data from the ongoing CRDF-004 trial in the first half of 2025[4](index=4&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) For the first quarter of 2025, Cardiff Oncology reported cash, cash equivalents, and short-term investments of $79.9 million, with a projected cash runway into Q1 2027 Liquidity and Cash Flow (Q1 2025) | Metric | Value | Note | | :--- | :--- | :--- | | Cash, Equivalents & Investments | $79.9 million | As of March 31, 2025 | | Projected Cash Runway | Into Q1 2027 | Based on current projections | | Net Cash Used in Operations | $12.8 million | Increase of $5.1M from $7.7M in Q1 2024 | Operating Expenses (Q1 2025 vs Q1 2024) | Period | Total Operating Expenses | Change (YoY) | | :--- | :--- | :--- | | Q1 2025 | $14.5 million | +$3.4 million | | Q1 2024 | $11.1 million | - | - The increase in operating expenses was primarily driven by costs associated with the CRDF-004 clinical trial, other clinical programs, and professional fees for strategic advisory services[9](index=9&type=chunk) [Company Overview and Forward-Looking Statements](index=2&type=section&id=Company%20Overview%20and%20Forward-Looking%20Statements) Cardiff Oncology is a clinical-stage biotechnology company focused on developing cancer therapies by inhibiting PLK1, with its lead asset being onvansertib - Cardiff Oncology is a clinical-stage biotech company leveraging PLK1 inhibition to develop novel therapies for a range of cancers[10](index=10&type=chunk) - The lead asset, onvansertib, is being evaluated in clinical programs for RAS-mutated mCRC, mPDAC, SCLC, and TNBC[10](index=10&type=chunk) - The press release contains forward-looking statements subject to risks and uncertainties, including those related to clinical trials, financing, and regulatory approvals, as detailed in the company's SEC filings[11](index=11&type=chunk)[12](index=12&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section presents the company's financial position and performance, detailing the condensed statements of operations and balance sheets for the first quarter of 2025 [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) For the first quarter ended March 31, 2025, Cardiff Oncology reported a net loss of $13.4 million, or ($0.20) per share, compared to a net loss of $10.0 million, or ($0.22) per share, for the same period in 2024 Q1 2025 vs. Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Royalty revenues | $109 | $205 | | Research and development | $10,477 | $8,008 | | Selling, general and administrative | $4,014 | $3,130 | | **Total operating expenses** | **$14,491** | **$11,138** | | **Loss from operations** | **($14,382)** | **($10,933)** | | **Net loss** | **($13,434)** | **($10,011)** | | **Net loss per common share** | **($0.20)** | **($0.22)** | [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, the company's total assets were $84.8 million, down from $97.2 million at year-end 2024, primarily due to a decrease in cash and cash equivalents Balance Sheet Highlights (in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $24,095 | $51,470 | | Short-term investments | $55,792 | $40,276 | | **Total Assets** | **$84,807** | **$97,190** | | **Total Liabilities** | **$13,931** | **$14,241** | | **Total Stockholders' Equity** | **$70,876** | **$82,949** |

Core Insights - Cardiff Oncology, Inc. reported financial results for Q1 2025, highlighting progress in clinical trials and intellectual property expansion [1][4][6] Financial Performance - As of March 31, 2025, the company had approximately $79.9 million in cash, cash equivalents, and short-term investments [6][9] - Net cash used in operating activities for Q1 2025 was approximately $12.8 million, an increase of about $5.1 million from $7.7 million in Q1 2024 [6][11] - Total operating expenses for the three months ended March 31, 2025, were approximately $14.5 million, up from $11.1 million in the same period in 2024 [11][16] - The net loss attributable to common stockholders for Q1 2025 was $13.4 million, compared to a net loss of $10.0 million in Q1 2024 [16] Clinical Development - The company completed enrollment in the Phase 2 CRDF-004 trial for onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC) [2][10] - The trial involved 41 clinical sites in the U.S. and evaluated onvansertib in combination with standard of care therapies [10] - Additional clinical data from the ongoing CRDF-004 trial is expected in the first half of 2025 [3] Intellectual Property - Cardiff Oncology expanded its intellectual property portfolio with the issuance of a second patent covering the treatment of mCRC for bev-naïve patients [5][9] - The new U.S. patent No. 12,263,173 is set to expire no earlier than 2043 and covers the use of onvansertib in combination with bevacizumab across all lines of therapy for mCRC patients [5][9] Future Outlook - The company believes its current cash resources are sufficient to fund operations into Q1 2027 [7][9]

[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) The unaudited condensed financial statements for Q1 2025 reflect decreased total assets, an increased net loss, and higher cash utilization in operating activities [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to $84.8 million as of March 31, 2025, primarily due to a reduction in cash and cash equivalents, leading to a decline in stockholders' equity Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $24,095 | $51,470 | | Short-term investments | $55,792 | $40,276 | | Total current assets | $82,711 | $95,054 | | Total Assets | $84,807 | $97,190 | | **Liabilities & Equity** | | | | Total current liabilities | $13,291 | $13,428 | | Total Liabilities | $13,931 | $14,241 | | Total stockholders' equity | $70,876 | $82,949 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) The company reported an increased net loss of $13.4 million for Q1 2025, primarily driven by higher operating expenses, particularly research and development costs Quarterly Operating Results (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Royalty revenues | $109 | $205 | | Research and development | $10,477 | $8,008 | | Selling, general and administrative | $4,014 | $3,130 | | Loss from operations | ($14,382) | ($10,933) | | Net loss | ($13,434) | ($10,011) | | Net loss per common share | ($0.20) | ($0.22) | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $12.8 million in Q1 2025, alongside substantial cash used in investing activities, resulting in a $27.4 million decrease in cash and cash equivalents Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,794) | $(7,740) | | Net cash provided by (used in) investing activities | $(14,584) | $4,636 | | Net cash provided by financing activities | $3 | $107 | | **Net change in cash and cash equivalents** | **$(27,375)** | **$(2,997)** | [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes describe the company's clinical-stage biotechnology focus, confirm sufficient liquidity for 12 months, and detail commitments and stock-based compensation - Cardiff Oncology is a clinical-stage biotechnology company developing its lead asset, onvansertib (a PLK1 inhibitor), for various cancers including mCRC, mPDAC, SCLC, and TNBC[26](index=26&type=chunk) - As of March 31, 2025, the company had **$79.9 million** in cash, cash equivalents, and short-term investments, which is believed to be sufficient to fund requirements for at least the next 12 months[28](index=28&type=chunk) - The company has a license agreement with Nerviano for onvansertib, which includes potential future development and commercial milestone payments, as well as royalties on sales. No such payments were made in Q1 2025 or Q1 2024[52](index=52&type=chunk) Stock-Based Compensation Expense (in thousands) | Expense Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $515 | $389 | | Selling, general and administrative | $850 | $735 | | **Total** | **$1,365** | **$1,124** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the development of onvansertib, including positive CRDF-004 trial data, and attributes the increased net loss to higher R&D expenses, while confirming capital sufficiency into Q1 2027 [Overview and Clinical Programs](index=18&type=section&id=Overview%20and%20Clinical%20Programs) The company is advancing onvansertib, a PLK1 inhibitor, with completed enrollment and promising initial ORR data from the CRDF-004 Phase 2 trial in mCRC, alongside other ongoing investigator-initiated trials - The company's lead candidate is onvansertib, an oral, highly selective PLK1 inhibitor with a 24-hour half-life, being developed in combination with standard-of-care therapeutics[59](index=59&type=chunk)[60](index=60&type=chunk) - Enrollment for the CRDF-004 Phase 2 randomized trial in first-line RAS-mutated mCRC was completed in April 2025 with approximately **90** evaluable patients[64](index=64&type=chunk) Initial Objective Response Rate (ORR) from CRDF-004 Trial | Arm | ORR | Patients (Responders/Total) | | :--- | :--- | :--- | | Control Arm (SoC alone) | 33% | 3 of 9 | | 20mg onvansertib + SoC | 50% | 5 of 10 | | 30mg onvansertib + SoC | 64% | 7 of 11 | | **All onvansertib patients** | **57%** | **12 of 21** | - The company is supporting an investigator-initiated Phase 1b/2 trial of onvansertib in combination with NALIRIFOX for first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)[71](index=71&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q1 2025 saw decreased royalty revenues, while research and development expenses increased by $2.5 million due to clinical trials, and selling, general and administrative expenses rose by $0.9 million from professional fees Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Increase | | :--- | :--- | :--- | :--- | | Research and Development | $10,477 | $8,008 | $2,469 | | Selling, General and Administrative | $4,014 | $3,130 | $884 | - The increase in R&D expenses was primarily due to costs associated with the CRDF-004 clinical trial and other clinical programs for onvansertib[79](index=79&type=chunk) - The increase in SG&A expenses was mainly from professional fees related to strategic advisory services[80](index=80&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$79.9 million** in cash and investments, projected to fund operations into Q1 2027, despite a history of net losses and negative operating cash flows - The company had **$79.9 million** in cash, cash equivalents, and short-term investments as of March 31, 2025[83](index=83&type=chunk) - Based on current projections, the company expects its capital resources are sufficient to fund operations into the first quarter of 2027[83](index=83&type=chunk) Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,794) | $(7,740) | | Net cash provided by (used in) investing activities | $(14,584) | $4,636 | | Net cash provided by financing activities | $3 | $107 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable for the current reporting period - The company has indicated that quantitative and qualitative disclosures about market risk are not applicable[91](index=91&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[92](index=92&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[94](index=94&type=chunk) [PART II OTHER INFORMATION](index=29&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - There are no legal proceedings to report[97](index=97&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) No material changes occurred to the risk factors previously disclosed in the company's Form 10-K for the year ended December 31, 2024 - No material changes from the risk factors disclosed in the Form 10-K for the year ended December 31, 2024[98](index=98&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period - There were no unregistered sales of equity securities or use of proceeds to report[99](index=99&type=chunk) [Item 5. Other Information](index=29&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q1 2025 - No directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter[102](index=102&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL documents - Exhibits filed include CEO and CFO certifications (Rule 13a-14(a)/15d-14(a) and Section 906 of Sarbanes-Oxley) and XBRL data files[103](index=103&type=chunk)

Group 1 - Cardiff Oncology (NASDAQ: CRDF) is emerging as a notable player in the colorectal cancer (CRC) biotech sector, with promising results from their randomized phase 2 trial [1] - The company has demonstrated significant potential in addressing CRC, which is a critical area in oncology [1] Group 2 - The article emphasizes the importance of understanding the science behind biotech investments to make informed decisions [1]