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]

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]

- Robust initial efficacy signal with onvansertib + chemo/bev in ongoing first-line RAS-mut metastatic colorectal cancer (“mCRC”) clinical trial (CRDF-004) - - Priced oversubscribed $40 million underwritten registered direct offering with participation from new and existing healthcare dedicated investors - - Issuance of new patent with claims for the use of onvansertib for treating KRAS-mut mCRC - - Cash and equivalents of $91.7 million as of December 31, 2024, projected runway into Q1 2027 - - Company wi ...

Clinical Trials and Drug Development - Onvansertib, a highly selective PLK1 inhibitor, demonstrated an overall response rate (ORR) of 64% in the 30mg dose group combined with standard-of-care (SoC) in the CRDF-004 trial for RAS-mutated metastatic colorectal cancer (mCRC) [23] - The CRDF-004 trial is expected to enroll approximately 90 evaluable patients, with primary endpoints focusing on ORR and secondary endpoints including progression-free survival and duration of response [20] - In the ONSEMBLE trial, the overall response rate across all evaluable patients was 29%, with a median duration of response of 12.0 months and median progression-free survival of 9.3 months [29] - The FDA approved NALIRIFOX as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC), leading to a new investigator-initiated trial of onvansertib in combination with NALIRIFOX [30] - A biomarker discovery trial showed one patient with mPDAC had an 86% decrease in Ki67 and a 28% decrease in CA 19-9, indicating potential anti-tumor activity of onvansertib [36] - The Phase 2 trial of onvansertib in combination with nanoliposomal irinotecan for second-line mPDAC completed enrollment in October 2023 [32] - The CRDF-005 trial, a Phase 3 randomized trial with registrational intent, is planned contingent upon the results of CRDF-004 [21] - Onvansertib has shown a favorable safety profile with no major or unexpected toxicities reported in combination with SoC therapies [24] - The ongoing Phase 2 trial for small cell lung cancer (SCLC) aims to enroll 15 patients in Stage 1, with a disease control rate of 57% observed in preliminary data [38] - The company is utilizing correlative biomarker analyses to optimize drug development and identify patient populations more likely to respond to onvansertib therapy [41] - The company is conducting a clinical trial for CRDF-004 in RAS-mutated metastatic colorectal cancer (mCRC), assessing changes in RAS mutational burden using ctDNA blood tests [42] - In the TROV-054 trial, decreases in KRAS Mutant Allelic Frequency (MAF) after the first treatment cycle were highly predictive of tumor shrinkage [42] Financial Condition and Capital Needs - As of December 31, 2024, the company has an accumulated total deficit of approximately $384.2 million, with net losses attributable to common stockholders of approximately $45.5 million and $41.5 million for the fiscal years ended December 31, 2024 and 2023, respectively [108] - The company's cash, cash equivalents, and short-term investments balance was approximately $91.7 million, with working capital of approximately $81.6 million as of December 31, 2024 [111] - The company is a clinical stage entity and has not yet generated significant revenue from operations, expecting to incur substantial net losses for the foreseeable future [109] - The company may need to raise substantial additional capital to continue the development and commercialization of onvansertib, which could be challenging under current market conditions [111] - The company has historically relied on private and public sales of equity and debt financings to fund operations, which may not be available on favorable terms in the future [111] Regulatory Environment - The FDA review process for marketing applications typically takes ten months, with potential extensions for additional information [72] - The FDA requires compliance with CGMPs for drug product manufacturing before approving NDAs or BLAs [73] - An approval letter from the FDA allows for commercial marketing but may impose post-approval testing and surveillance requirements [75] - The FDA may issue complete response letters outlining deficiencies that require additional testing before reconsideration of applications [74] - Manufacturers must continue to comply with CGMPs post-approval, or risk withdrawal of product approvals [79] - The regulatory approval process for the company's product candidate is lengthy and unpredictable, potentially taking many years and requiring substantial resources [132] - The company must provide extensive preclinical and clinical data to demonstrate the safety and efficacy of its product candidate before it can be approved for marketing [122] - The company plans to seek regulatory approval and commercialize its product candidate worldwide, including in the U.S. and the European Union, but must comply with varying regulatory requirements in different countries [137] Market and Competitive Landscape - The company faces significant competition from established pharmaceutical and biotechnology companies, which may have greater financial resources and expertise [147] - If the product candidate is approved, it will compete with existing prescription therapies in the targeted therapeutic area, potentially limiting demand [148] - The ability to manufacture the product candidate in commercial quantities is uncertain, which could hinder its market launch [157] - Market acceptance of the product candidate will depend on its demonstrated safety and efficacy, as well as pricing and reimbursement factors [161] - Recommendations from government agencies and professional organizations could impact the usage of the product, potentially leading to decreased demand [162] Intellectual Property and Legal Risks - The company faces risks related to intellectual property protection, as challenges to patents could impair competitive advantage and lead to costly litigation [192] - The U.S. patent system changes may increase uncertainties and costs surrounding patent applications and enforcement, impacting the company's ability to protect its technology [194] - The company may incur substantial costs from litigation related to intellectual property rights, which could divert management attention and resources [198] - The company may face significant costs related to patent litigation, which could adversely affect its financial condition [200] Operational Challenges - The company relies on third-party manufacturers and distributors for the supply and distribution of onvansertib used in clinical studies [58] - The company relies on third-party manufacturers for production, and any failure to meet regulatory compliance could delay product development and commercialization [151] - The company must ensure compliance with Good Manufacturing Practices (GMP) requirements, and any failure could result in significant penalties and delays [156] - The company relies on third-party contract manufacturers for product candidate formulation and manufacturing, exposing it to risks that could delay clinical trials or increase costs [163] - The company has limited resources for conducting preclinical studies and clinical trials, relying on third-party vendors, which may lead to delays or additional expenses if these vendors fail to perform satisfactorily [119] - The company faces challenges in recruiting and managing clinical trials, which could impair the timing of obtaining FDA approval and materially harm the business [120] Employee and Management Considerations - The company has a total of 33 employees, with 32 being full-time, and considers its relations with employees to be good [105] - The company is highly dependent on its management team and key personnel for the successful development of its product candidate, and losing key staff could delay clinical trials [126] - The company has identified material weaknesses in internal controls, which could harm financial reporting reliability and investor confidence [215] Economic and Market Conditions - General economic conditions, including healthcare reform and geopolitical issues, may negatively impact the company's business and financial condition [180] - The failures of Silicon Valley Bank, Signature Bank, and First Republic Bank in the first half of 2023 caused significant disruptions in the financial services industry, potentially affecting cash access [188] - Geopolitical risks from Russia's invasion of Ukraine have led to increased market volatility, which could adversely impact the company's financial condition and results of operations [189] Stock and Financial Reporting - The closing price of the company's common stock ranged from a low of $1.46 to a high of $5.91 during the year ended December 31, 2024 [205] - The company has never paid cash dividends on its common stock and does not expect to do so in the foreseeable future [207] - The market price of the company's common stock may be volatile due to various factors, including technological innovations and clinical trial results [206] - The company may face stockholder litigation, which could divert resources and adversely affect profitability [213] - The company is at risk of delisting from Nasdaq if it fails to meet continued listing requirements, which could reduce liquidity and investor confidence [214]

SAN DIEGO, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that company management will present at two upcoming investor conferences. Details of the presentations can be found below. B. Riley Securities Precision Oncology & Radiopharma ConferencePresenter: Mark Erlander, CEOFormat: Panel discussion on “What It Takes to Move the Needle in Improving R ...

- Management will hold a conference call on Thursday, February 27 at 4:30 p.m. ET/1:30 p.m. PT -SAN DIEGO, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that it will hold a conference call on Thursday, February 27 after the close of trading to review financial results for the fourth quarter ended December 31, 2024. Conference Call and Webcast Card ...

Cardiff Oncology (NASDAQ: CRDF ) has been a biotech of growing interest over the past few years, racing up and down as the fortunes of their PLK1 inhibitor onvansertib have risen and fallen. In particular, thereI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of in ...

Cardiff Oncology (CRDF) announced robust efficacy data from an ongoing mid-stage study evaluating two doses of its lead investigational candidate, onvansertib (20 mg and 30 mg), in combination with standard-of-care (SOC) chemotherapy to treat first-line RAS-mutated metastatic colorectal cancer (mCRC) patients. The stock rallied 54.9% on Tuesday following the encouraging news. The primary endpoint of the study was objective response rate (ORR), and the secondary endpoints included progression-free survival ( ...