Core Insights - The pharmaceutical industry is focusing on developing more effective therapies for metastatic colorectal cancer, with Cardiff Oncology's onvansertib showing promising results in a Phase 2 clinical trial [1][7]. Clinical Trial Results - The CRDF-004 Phase 2 trial involved patients randomized into six arms, with the high-dose (30mg) onvansertib plus standard-of-care (SoC) showing an overall objective response rate (ORR) of 59%, while the 20mg dose had a 50% ORR, compared to 43% in the control arm [2]. - Confirmed ORRs at 6 months were 49% for the high-dose, 42% for the low-dose, and 30% for the control arm [2]. - A comparison with December 2024 data indicated an ORR of 57% for all onvansertib patients, with 64% in the 30mg dose plus SoC arm, and 33% in the SoC alone arm [3]. Efficacy and Safety - Spider plots demonstrated deeper tumor size reductions in patients receiving the 30mg dose of onvansertib combined with SoC compared to the control and 20mg dose arms [4]. - Both the 20mg and 30mg onvansertib arms showed early separation of progression-free survival (PFS) curves compared to the control arm, although median PFS has not yet been reached [5]. - The safety analysis of 104 patients indicated that onvansertib combined with chemotherapy and bevacizumab was well-tolerated, with no major unexpected toxicities [6]. Future Outlook - The update on the first-line mCRC program is expected by the first quarter of 2026, and William Blair believes the current data justifies further investment, including a Phase 3 trial [7]. - Analyst Andy Hsieh noted that the data weakens bearish arguments against the stock, raising the question of whether ORR improvements will lead to significant PFS gains, which are crucial for approval [8]. Market Sentiment - Historical data suggests that even modest improvements in response rates can lead to successful trial outcomes, as seen in other studies [9]. - William Blair holds a bullish view on onvansertib's potential to disrupt the RAS-mutated frontline mCRC treatment paradigm, reiterating an Outperform rating despite a 19.94% drop in Cardiff Oncology shares to $2.65 at the time of publication [10].

Core Insights - Cardiff Oncology (NASDAQ: CRDF) is a company that has been under observation for a significant period, with an upcoming data readout presentation anticipated [1] Group 1: Company Overview - Cardiff Oncology specializes in the biotech sector, focusing on clinical trials and the development of cancer therapies [1] Group 2: Analyst Background - The analysis is conducted by an individual with a PhD in biochemistry and extensive experience in analyzing clinical trials and biotech companies, emphasizing the importance of understanding the science behind investments [1]

Summary of Cardiff Oncology Clinical Update Conference Call Company and Industry - **Company**: Cardiff Oncology - **Industry**: Oncology, specifically focusing on metastatic colorectal cancer (mCRC) treatment Core Points and Arguments 1. **Clinical Trial Update**: Cardiff Oncology provided an update on the CARDUP004 trial, emphasizing the significance of the data shared, which reinforces previous findings and supports the potential of ondansertib in first-line RAS mutated mCRC treatment [4][32] 2. **Drug Candidate**: Ondansertib is a serine kinase inhibitor targeting PLK1, with a favorable pharmacological profile that minimizes toxicities seen in earlier PLK inhibitors [5][4] 3. **Trial Objectives**: The CARDUP004 trial aims to assess the efficacy and safety of ondansertib in combination with standard chemotherapy regimens, with a focus on establishing a registrational path with the FDA [6][31] 4. **Patient Demographics**: The trial included patients with documented KRAS or NRAS mutations and unresectable metastatic disease, with a total of 110 patients randomized [13][24] 5. **Efficacy Results**: The trial reported a 49% objective response rate (ORR) in the 30 mg ondansertib arm compared to 30% in the control arm, indicating a significant improvement [16][32] 6. **Progression-Free Survival (PFS)**: Early PFS data shows promising trends, with a dose-dependent effect favoring the 30 mg dose, although median PFS has not yet been reached [26][27] 7. **Safety Profile**: Ondansertib was well tolerated, with adverse event rates comparable to control arms, indicating a positive risk-benefit profile [25][45] 8. **Regulatory Path Forward**: Cardiff Oncology plans to engage with the FDA regarding the registrational program based on the data presented, aiming for discussions before the end of the year [31][36] Additional Important Content 1. **Historical Context**: Colorectal cancer remains a significant health issue, with a low five-year survival rate of 15% and a median PFS of less than one year for first-line treatments [11] 2. **Need for New Therapies**: There is an urgent need for new therapies in mCRC, particularly for patients with RAS mutations, as the last new drug approval in this area was over 20 years ago [12] 3. **Comparative Analysis**: The trial's results were compared to historical data, highlighting the need for careful interpretation of response rates and the importance of focusing on RAS mutated populations [69][70] 4. **Future Updates**: Cardiff Oncology anticipates providing further updates on the RAS mutated mCRC program by Q1 2026 [34] This summary encapsulates the key points discussed during the conference call, focusing on the advancements in Cardiff Oncology's clinical trials and the implications for the treatment of metastatic colorectal cancer.

Core Insights - Cardiff Oncology, Inc. announced positive results from the CRDF-004 Phase 2 clinical trial of onvansertib in combination with standard-of-care for first-line RAS-mutated metastatic colorectal cancer (mCRC), showing a 49% confirmed objective response rate (ORR) in the 30mg dose arm compared to 30% in the control arm [1][2][4] Trial Design - The CRDF-004 trial enrolled patients with documented KRAS or NRAS mutations and evaluated onvansertib added to standard-of-care regimens [3] - Patients were randomized into six arms, including different doses of onvansertib combined with standard-of-care or standard-of-care alone, with primary and secondary endpoints focused on ORR and progression-free survival (PFS) [3] Efficacy Data - The confirmed ORR was 30% for the control arm, 42% for the 20mg onvansertib plus SoC arm, and 49% for the 30mg onvansertib plus SoC arm [4] - At the 6-month mark, the ORR was 22% for the control arm, 33% for the 20mg dose, and 46% for the 30mg dose [4] - Early PFS data indicated a trend favoring the 30mg onvansertib dose compared to the control arm [9] Safety and Tolerability - Onvansertib was well-tolerated among the 104 patients dosed, with no major or unexpected toxicities reported [10] - Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event [10] Future Outlook - The company plans to engage in discussions with the FDA and advance towards the registrational CRDF-005 trial, with an update on the first-line mCRC program expected by Q1 2026 [11][12]

Core Insights - Cardiff Oncology, Inc. has made significant progress in its clinical trials, particularly with the completion of enrollment in the Phase 2 CRDF-004 trial for first-line RAS-mutated metastatic colorectal cancer (mCRC) [2][8] - The company appointed Dr. Roger Sidhu as Chief Medical Officer to guide the development of onvansertib through the registrational phase [2][6] - Positive clinical data was announced from an investigator-initiated trial of onvansertib in combination with paclitaxel for metastatic triple negative breast cancer (mTNBC), showing a 40% objective response rate [4] Financial Overview - As of June 30, 2025, Cardiff Oncology reported cash and investments totaling approximately $71.0 million, with a projected runway into Q1 2027 [9][10] - The net cash used in operating activities for Q2 2025 was approximately $8.3 million, a decrease from $9.2 million in the same period of 2024 [9] - Total operating expenses for the quarter were approximately $14.9 million, an increase of $2.2 million from $12.7 million in Q2 2024, primarily due to costs associated with clinical trials and key hires [11] Clinical Development Highlights - The CRDF-004 trial reached its targeted enrollment across 41 clinical sites in the U.S. [8] - The Phase 1b study of onvansertib in combination with paclitaxel demonstrated a safe and manageable toxicity profile, with myelosuppression being the most common adverse event [4] - A second patent was issued for the treatment of mCRC in bevacizumab-naïve patients, with an expiration date no earlier than 2043 [5][7]

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].