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]

Clinical Trial Results - Cardiff Oncology reported a 64% objective response rate (ORR) for patients on the 30mg onvansertib dose arm in the CRDF-004 trial, compared to a 33% ORR in the control arm[2] - Cardiff Oncology's clinical trial data indicated that the 30mg dose of onvansertib demonstrated deeper tumor regression compared to the 20mg dose[6] - Onvansertib showed promising results in combination with paclitaxel for HR+ breast cancer, with ongoing clinical trials evaluating its efficacy[12] - The company published clinical data demonstrating that onvansertib combined with FOLFIRI and bev exhibited clinical activity in second-line KRAS mutant mCRC[12] Financial Performance - The company raised $40 million in an oversubscribed underwritten registered direct offering, strengthening its balance sheet[7] - As of December 31, 2024, Cardiff Oncology had approximately $91.7 million in cash and equivalents, projected to fund operations into Q1 2027[10][11] - Total operating expenses for the full year 2024 were approximately $49.3 million, an increase of $3.4 million from $45.9 million in 2023[13] - The net loss for the year ended December 31, 2024, was $45.4 million, compared to a net loss of $41.4 million in 2023[19] Intellectual Property - The company issued a new patent for the use of onvansertib in treating KRAS-mutated mCRC, with an expected expiration date of no earlier than 2043[5][8] Future Plans - The company plans to share additional clinical updates from the CRDF-004 trial in the first half of 2025[3]

Core Insights - Cardiff Oncology reported robust initial efficacy signals for onvansertib in combination with chemotherapy and bevacizumab for first-line RAS-mut metastatic colorectal cancer (mCRC) [1][2] - The company successfully raised $40 million through an oversubscribed underwritten registered direct offering, attracting both new and existing healthcare-focused investors [1][4] - A new patent was issued for onvansertib, specifically for its use in treating KRAS-mutated mCRC, with an expected expiration date no earlier than 2043 [1][4] - As of December 31, 2024, the company had cash and equivalents of $91.7 million, providing a projected runway into Q1 2027 [1][7] Clinical Trial Updates - The ongoing CRDF-004 trial showed that patients receiving the 30mg dose of onvansertib had a 64% objective response rate (ORR), compared to 33% in the control arm [2][4] - A dose-response relationship was observed, with the 30mg dose demonstrating deeper tumor regression compared to the 20mg dose, while both doses exhibited similar safety profiles [2][4] - The Phase 2 trial is currently enrolling patients with documented KRAS or NRAS mutations, randomizing them to receive either 20mg or 30mg of onvansertib alongside standard-of-care treatments [4] Financial Performance - For the full year 2024, the company reported total operating expenses of approximately $49.3 million, an increase from $45.9 million in 2023, primarily due to clinical program costs and increased staffing [8][16] - The net loss for 2024 was approximately $45.4 million, compared to a net loss of $41.4 million in 2023 [16][21] - Cash burn for operating activities was approximately $37.7 million for 2024, up from $30.9 million in 2023 [6][21] Upcoming Milestones - Additional clinical data from the CRDF-004 trial is expected in the first half of 2025 [3]