Core Insights - Cardiff Oncology, Inc. is hosting a KOL webinar to discuss the treatment landscape for first-line RAS-mutated metastatic colorectal cancer (mCRC) on March 25, 2026 [1] - The webinar will feature key opinion leaders Scott Kopetz, M.D., Ph.D., FACP and Heinz-Josef Lenz, M.D., alongside interim CEO Mani Mohindru, focusing on the clinical data of onvansertib and its potential in mCRC management [2] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing innovative cancer treatments through PLK1 inhibition, with its lead asset onvansertib currently in a Phase 2 trial for first-line treatment of RAS-mutated mCRC [6] - Onvansertib targets a significant patient population with high unmet needs and is also being investigated in other PLK1-driven cancers, demonstrating robust clinical activity in challenging tumors [6] Key Opinion Leaders - Scott Kopetz, M.D., Ph.D., FACP, is a recognized leader in colorectal cancer research, focusing on new treatment approaches for molecularly defined colorectal cancers and has led numerous clinical studies [3] - Heinz-Josef Lenz, M.D., is a professor with a focus on molecular mechanisms of cancer and biomarker-driven treatment approaches, holding leadership roles in national oncology research initiatives [4] Webinar Details - Interested parties can register for the live webcast on Cardiff Oncology's website, with a replay available post-discussion [5]

Core Insights - Cardiff Oncology, Inc. announced new preclinical data showing that its oral PLK1 inhibitor, onvansertib, enhances the antitumor activity of trastuzumab deruxtecan (T-DXd) and reverses resistance in therapy-resistant HER2-low breast cancer models [1][2] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing innovative cancer treatments through PLK1 inhibition, which is a validated oncology target with significant potential [5] - The lead asset, onvansertib, is currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer and is also being evaluated in various other cancers through investigator-initiated studies [4][5] Upcoming Presentation - The findings will be presented at the American Association for Cancer Research Annual Meeting 2026, scheduled for April 17-22, 2026, in San Diego, California [1][7] - The poster presentation will be available on the company's Scientific Publications page following the event [3]

Core Insights - Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing novel cancer therapies through PLK1 inhibition [3] Group 1: Upcoming Conferences - Company management will participate in three investor conferences in March 2026, including the TD Cowen 46th Annual Health Care Conference on March 4, Barclays 28th Annual Global Healthcare Conference on March 10, and Leerink Partners Global Healthcare Conference on March 11 [2] Group 2: Company Overview - Cardiff Oncology's lead asset, onvansertib, is a specific oral PLK1 inhibitor currently in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), targeting a large, underserved patient population [3] - Onvansertib is also being investigated in other PLK1-driven cancers through ongoing investigator-initiated trials and has demonstrated robust clinical activity in difficult-to-treat tumors [3] - The company's goal is to target tumor vulnerabilities to overcome treatment resistance and improve clinical outcomes for patients [3]

Core Insights - Cardiff Oncology reported positive results from the Phase 2 CRDF-004 trial for first-line RAS-mutated metastatic colorectal cancer (mCRC), showing a robust objective response rate (ORR) of 72.2% with the 30 mg onvansertib + FOLFIRI/bev combination, compared to 43.2% with standard of care (SoC) [1][5] - The trial also demonstrated a significant improvement in progression-free survival (PFS) with a hazard ratio (HR) of 0.37, indicating a strong potential for onvansertib to enhance patient outcomes [1][5] - The company plans to advance the 30 mg dose of onvansertib into a registrational program, with detailed data and plans expected in the first half of 2026 [1][2] Clinical Development - The CRDF-004 trial results indicate a consistent, dose-dependent treatment benefit, with nearly a 30% improvement in response rate over the control arm and encouraging durability trends in PFS [2][5] - The company has not observed significant added toxicity with the 30 mg onvansertib dose in combination with FOLFIRI/bev, supporting its advancement into registrational development [5] Financial Performance - For the year ended December 31, 2025, Cardiff Oncology reported total operating expenses of approximately $49.6 million, a slight increase from $49.3 million in 2024, primarily due to higher selling, general, and administrative expenses [8][14] - The company reported a net loss of $45.876 million for 2025, compared to a net loss of $45.455 million in 2024, with a net loss per common share of $0.69 [14] - As of December 31, 2025, Cardiff had approximately $58.3 million in cash and cash equivalents, sufficient to fund operations into the first quarter of 2027 [7] Leadership Changes - In January 2026, Cardiff announced executive leadership changes to support its transition into late-stage clinical development, appointing Mani Mohindru as interim Chief Executive Officer [4] - The company is actively searching for a permanent Chief Executive Officer and Chief Financial Officer to strengthen its leadership team [4]

Core Insights - Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing novel cancer therapies through PLK1 inhibition [3] - The company will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, 2026, with a live webcast available for interested parties [1][2] Company Overview - Cardiff Oncology is advancing innovative cancer treatments, particularly targeting PLK1 inhibition, which is recognized as a validated oncology target with significant potential to change clinical practice [3] - The lead asset, onvansertib, is an oral PLK1 inhibitor currently in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large patient population with high unmet needs [3] - Onvansertib is also being investigated in other PLK1-driven cancers through ongoing investigator-initiated trials and has demonstrated robust clinical activity as a single agent in challenging tumors [3]

Core Insights - Cardiff Oncology, Inc. announced positive results from the CRDF-004 Phase 2 clinical trial, demonstrating that onvansertib combined with FOLFIRI/bevacizumab (bev) shows dose-dependent improvements in overall response rates and progression-free survival (PFS) in patients with RAS-mutated metastatic colorectal cancer (mCRC) [1][3][4] Group 1: Clinical Trial Results - The trial showed that the 30 mg dose of onvansertib with FOLFIRI/bev is selected for further registrational trials based on its efficacy [2][3] - In the intent-to-treat analysis, onvansertib with FOLFIRI/bev outperformed both standard of care (SoC) regimens, with a confirmed objective response rate (ORR) of 44.4% for the 30 mg dose [1][3] - Median PFS for the 30 mg onvansertib group was not reached, indicating a potential benefit over SoC [3][4] Group 2: Safety and Tolerability - Onvansertib was reported to be safe and well-tolerated, with no significant additive toxicity observed in the trial [1][3] - Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event [5] Group 3: Future Plans - Cardiff Oncology plans to initiate a registrational program later this year, pending finalization of trial design in consultation with the FDA [2][3] - The company expects to provide final data and registrational plans in the first half of 2026 [1][3] Group 4: Industry Context - There is a significant unmet need for improved first-line treatment options for patients with RAS-mutated mCRC, as current treatments have not significantly advanced in over two decades [5] - Onvansertib's novel mechanism of action and promising preliminary results support the need for further investigation in a large Phase 3 trial [5]

Core Insights - Cardiff Oncology, Inc. is undergoing a leadership transition to support its growth and advancement towards late-stage development and key clinical milestones [1][4] - Mani Mohindru, PhD, has been appointed as interim Chief Executive Officer, following the departure of Mark Erlander, PhD, and James Levine [2] - The company is actively searching for a permanent Chief Executive Officer and Chief Financial Officer [3] Leadership Changes - Mani Mohindru has been a member of Cardiff Oncology's Board of Directors since 2021 and has extensive experience in the biotech sector [2][6] - Brigitte Lindsay has been promoted to Chief Accounting Officer, ensuring continuity in the finance function [3] - The leadership transition is aimed at aligning executive and financial leadership with the company's evolving needs [5] Product Development - Cardiff Oncology's lead product candidate, onvansertib, is a specific oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer (mCRC) [4][7] - Onvansertib is also being evaluated in various other cancers, including pancreatic ductal adenocarcinoma, small cell lung cancer, triple-negative breast cancer, and chronic myelomonocytic leukemia [4] - The company aims to leverage onvansertib's activity to extend its benefits to other solid tumors and hematologic malignancies [5] Strategic Focus - The leadership transition reflects the company's commitment to execution and clinical advancement as its programs mature [4] - Dr. Mohindru emphasizes the importance of sharpening strategic priorities and advancing clinical programs while maintaining a disciplined approach to capital and execution [5]

Core Insights - Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing therapies leveraging PLK1 inhibition for various cancers [4] - Clinical data from a Phase 1 trial of onvansertib in chronic myelomonocytic leukemia (CMML) will be presented at the 67th American Society of Hematology Annual Meeting [1][3] Clinical Trial Results - In a Phase 1 dose escalation trial involving 9 patients, onvansertib as a monotherapy was well-tolerated and showed preliminary efficacy in approximately 40% of patients, with one patient achieving an optimal marrow response at the 9 mg/m dose [2] - The results support onvansertib's activity as a single agent in both hematologic and solid tumors, although the company does not plan to develop onvansertib specifically for CMML [2] Presentation Details - The poster presentation titled "Phase 1 clinical trial assessing the safety and efficacy of onvansertib, a novel, oral, PLK1 inhibitor in Relapsed/Refractory myeloproliferative chronic myelomonocytic leukemia (CMML)" will be delivered by Mrinal Patnaik, MD, MBBS, from Mayo Clinic [3] - The presentation is scheduled for December 8, 2025, from 6:00-8:00 PM EST as part of the Myelodysplastic Syndromes session [3] Company Overview - Cardiff Oncology's lead asset, onvansertib, is being evaluated in combination with standard of care therapies for indications such as RAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple negative breast cancer [4] - The company's development strategy aims to target tumor vulnerabilities to overcome treatment resistance and provide superior clinical benefits compared to standard therapies [4]

Group 1 - Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing novel therapies through PLK1 inhibition for various cancers [2] - The company's lead asset, onvansertib, is being evaluated in combination with standard of care therapeutics for indications such as RAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple negative breast cancer [2] - Cardiff Oncology will present at Sidoti's Year-End Virtual Investor Conference on December 11, 2025, with CEO Mark Erlander as the presenter [1] Group 2 - The company's development strategy aims to target tumor vulnerabilities to overcome treatment resistance and provide superior clinical benefits compared to standard of care alone [2] - Interested parties can register for the live webcast of the conference through the Cardiff Oncology website [1]

Core Insights - Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing novel therapies through PLK1 inhibition for various cancers [3] - The company will participate in the Piper Sandler 37th Annual Healthcare Conference from December 2-4, 2025, with a presentation by CEO Mark Erlander [1][2] Company Overview - Cardiff Oncology is leveraging PLK1 inhibition, a validated oncology drug target, to create therapies for cancers such as RAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple negative breast cancer [3] - The lead asset, onvansertib, is being evaluated in combination with standard of care therapeutics to address treatment resistance and enhance clinical benefits [3]