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]

Core Viewpoint - Cardiff Oncology is expected to report a year-over-year increase in earnings despite lower revenues, with the actual results being crucial for stock price movement [1][2]. Earnings Expectations - The consensus estimate indicates a quarterly loss of $0.19 per share, reflecting a year-over-year change of +13.6% [3]. - Revenues are projected to be $0.17 million, down 19.1% from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has been revised 9.52% higher in the last 30 days, indicating a positive reassessment by analysts [4]. - The Most Accurate Estimate for Cardiff Oncology is higher than the Zacks Consensus Estimate, leading to an Earnings ESP of +24.32% [10][11]. Earnings Surprise Prediction - A positive Earnings ESP is a strong predictor of an earnings beat, especially when combined with a Zacks Rank of 1 (Strong Buy), 2 (Buy), or 3 (Hold) [8]. - Cardiff Oncology currently holds a Zacks Rank of 2, suggesting a high likelihood of beating the consensus EPS estimate [11]. Historical Performance - In the last reported quarter, Cardiff Oncology was expected to post a loss of $0.25 per share but delivered a loss of $0.21, resulting in a surprise of +16% [12]. - Over the past four quarters, the company has beaten consensus EPS estimates three times [13]. Conclusion - Cardiff Oncology is positioned as a compelling earnings-beat candidate, but investors should consider other factors influencing stock performance beyond earnings results [16].

Core Viewpoint - Cardiff Oncology has received a patent for the use of onvansertib in combination with bevacizumab for treating all bev-naïve metastatic colorectal cancer (mCRC) patients, which is expected to enhance its market opportunities and growth potential [1][2]. Group 1: Patent and Treatment Scope - The newly issued patent covers the combination treatment of onvansertib and bevacizumab for all bev-naïve mCRC patients, including those with RAS mutations and RAS wild type, across all lines of therapy until at least 2043 [1]. - This patent expands the applicability of onvansertib beyond the current focus on first-line RAS-mutated patient populations, potentially redefining the standard of care for mCRC [2]. Group 2: Clinical Development - Onvansertib is currently being evaluated in a Phase 2 clinical trial (CRDF-004) in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab for RAS-mutated mCRC patients [2]. - Initial data from the ongoing CRDF-004 trial was announced in December 2024, with additional clinical data expected in the first half of 2025 [2]. Group 3: Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing therapies leveraging PLK1 inhibition for various cancers, with onvansertib as its lead asset [3]. - The company is targeting treatment-resistant tumors and aims to deliver superior clinical benefits compared to standard of care in indications such as mCRC, metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple-negative breast cancer [3].

Company Overview - Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing novel therapies through PLK1 inhibition for various cancers [3] - The company's lead asset, onvansertib, is being evaluated in combination with standard of care (SoC) therapeutics for indications such as RAS-mutated metastatic colorectal cancer (mCRC), metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple negative breast cancer (TNBC) [3] Stock Option Grant - On April 14, 2025, Cardiff Oncology granted non-qualified stock option awards to purchase a total of 35,040 shares of common stock to a new employee [1] - The exercise price for these options is set at $2.79 per share, which matches the closing price of the company's common stock on the grant date [2] - The options will vest over a 4-year period, with 25% vesting on the 1-year anniversary and the remaining shares vesting monthly over the subsequent 36 months, contingent on the employee's continued employment [2]

Core Insights - Cardiff Oncology has completed patient enrollment in the Phase 2 CRDF-004 trial for onvansertib in RAS-mutated metastatic colorectal cancer (mCRC) [1][2] - The trial aims to evaluate the efficacy of onvansertib in combination with standard of care treatments [2] - Additional clinical data from the trial is expected to be reported in the first half of 2025 [3] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing therapies leveraging PLK1 inhibition for various cancers [4] - The lead asset, onvansertib, is being tested in combination with standard treatments for RAS-mutated mCRC and other cancers [4] - The company aims to address treatment resistance and improve clinical outcomes compared to standard therapies [4]

Core Viewpoint - Cardiff Oncology (CRDF) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in a company's earnings picture, which is a powerful determinant of near-term stock price movements [2][4]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling actions that affect stock prices [4]. Company Performance and Outlook - The upgrade for Cardiff Oncology reflects an improvement in its underlying business, suggesting that investors may push the stock price higher due to this positive trend [5]. - Cardiff Oncology is expected to earn -$0.84 per share for the fiscal year ending December 2025, representing an 11.6% year-over-year change [8]. - Over the past three months, the Zacks Consensus Estimate for Cardiff Oncology has increased by 14.8%, indicating a positive revision trend [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks which have generated an average annual return of +25% since 1988 [7]. - The upgrade to Zacks Rank 2 places Cardiff Oncology in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Financial Data and Key Metrics Changes - As of December 31, 2024, cash and short-term investments totaled $91.7 million, which includes net proceeds from a $40 million capital raise completed in December [22] - Cash used in operating activities was $10.3 million in Q4 2024, consistent with typical quarterly cash burn [22] - Current cash resources are projected to provide a runway into the first quarter of 2027 based on forecasted cash spend for ongoing clinical programs [22] Business Line Data and Key Metrics Changes - The CRDF-004 trial in first-line RAS-Mutated Metastatic Colorectal Cancer (mCRC) showed a 64% overall response rate (ORR) for the 30 mg dose of onvansertib compared to a 33% ORR in the control arm [9] - The 30 mg arm demonstrated deeper tumor responses, with the five deepest tumor regressions occurring in patients receiving this dose [10] - Over 380 patients have been dosed with onvansertib across multiple clinical trials, indicating a favorable safety profile [11] Market Data and Key Metrics Changes - The FDA approval of Pfizer's encorafenib in Q4 2024 validates the registrational strategy for onvansertib in mCRC, as both drugs target different patient populations [13][14] - The regulatory pathway used by Pfizer for encorafenib's accelerated approval is similar to the plans agreed with the FDA for onvansertib [14] Company Strategy and Development Direction - The company aims to complete enrollment of 90 evaluable patients in the CRDF-004 trial in early 2025, with the trial now closed to new patients [12] - The intellectual property strategy was strengthened with a new patent covering the use of onvansertib in combination with bevacizumab for KRAS-mutated mCRC patients [15] - The company is exploring new opportunities to convert discoveries related to PLK1 inhibition into new intellectual property [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the efficacy results from the CRDF-004 trial and plans to share additional updates in the first half of 2025 [24] - The company believes onvansertib has the potential to change the treatment paradigm for RAS-Mutated mCRC patients [25] Other Important Information - The company filed a shelf registration statement on Form S-3, maintaining an active registration statement for future capital needs [23] Q&A Session Summary Question: Timing of data update and number of evaluable patients - Management aims to provide a more mature update in the first half of the year, but PFS data may not be available until later [28] Question: Dose selection decision and FDA interactions - The goal is to meet with the FDA soon to discuss dose selection and trial design for the registrational trial [32][34] Question: Response rate comparison with BREAKWATER trial - The response rate observed in the BREAKWATER trial aligns with the results seen in the CRDF-004 study [36] Question: Tumor size reduction and endpoints - Previous data indicates that earlier and deeper responses correlate with greater PFS and OS, which may inform approvable endpoints [43] Question: Patient numbers for accelerated approval - The company is considering the patient numbers used in the BREAKWATER trial for their discussions with the FDA regarding accelerated approval [44] Question: KRAS G12C inhibitors and their impact - The G12C inhibitors are not expected to impact the company's first-line strategy as they target a small subset of patients [50] Question: Enrollment completion and patient inclusion in updates - Management confirmed that enrollment is expected to complete soon, and they aim for a substantive update in the first half of the year [57]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company's cash and short-term investments totaled $91.7 million, which includes net proceeds from a $40 million capital raise completed in December [15] - The cash used in operating activities for Q4 2024 was $10.3 million, consistent with typical quarterly cash burn [15] - Current cash resources are projected to provide a runway into Q1 2027 based on the forecasted cash spend for ongoing clinical programs [15] Business Line Data and Key Metrics Changes - The CARTF004 trial in first-line RAS mutated metastatic colorectal cancer (MCRC) showed a 64% overall response rate (ORR) for the 30 mg dose of onvansertib compared to a 33% ORR in the control arm [8] - The 30 mg arm demonstrated deeper tumor responses, with the five deepest tumor regressions occurring in patients receiving this dose [8] - Over 380 patients have been dosed with onvansertib across multiple clinical trials, indicating a favorable safety profile [9] Market Data and Key Metrics Changes - The FDA approval of another company's drug in Q4 2024 validates the registrational strategy for onvansertib in MCRC, reinforcing the company's approach [10] - The regulatory pathway used by Pfizer for accelerated approval is similar to the plans agreed with the FDA for onvansertib [11] Company Strategy and Development Direction - The company aims to finalize the trial design for the registrational trial and engage with the FDA regarding dose selection [25] - The intellectual property strategy was strengthened with the issuance of a new patent covering the use of onvansertib in combination with bevacizumab for KRAS mutated MCRC patients [12] - The company is exploring new opportunities to convert discoveries related to PLK1 inhibition into new intellectual property [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the efficacy results from the CARTF004 trial and plans to share additional updates in the first half of 2025 [17] - The company believes onvansertib has the potential to change the treatment paradigm for RAS mutated MCRC patients [17] Other Important Information - The company filed a shelf registration statement on Form S3, maintaining an active shelf registration practice [16] - The company presented two preclinical posters at the San Antonio Breast Cancer Symposium, highlighting the potential of onvansertib in breast cancer treatment [13][14] Q&A Session Summary Question: When will the data update be available and how many new patients will be evaluable for ORR? - The company aims to provide a more mature update in the first half of the year, but PFS data may not be available until later [20] Question: When will the dose selection decision be made? - The company plans to discuss dose selection and trial design with the FDA as soon as possible, which may involve fewer than 90 patients [25][26] Question: How does the response rate in the breakwater trial compare to the company's findings? - The response rate observed in the breakwater trial is consistent with the company's findings [28] Question: What is the company's view on KRAS G12C inhibitors? - The company believes that G12C inhibitors do not significantly impact their first-line strategy, as they are primarily used in second-line treatments [37] Question: Will all 90 patients be included in the first half update? - The company is close to completing enrollment and aims to provide a substantive update based on the 90 patients [42]