Reported positive update from Phase 2 CRDF-004 trial in first-line RAS-mutated mCRC, with the 30 mg onvansertib + FOLFIRI/bev arm demonstrating:• Robust ORR of 72.2% (vs 43.2% with combined SoC of FOLFOX/bev and FOLFIRI/bev)• Significant improvement in PFS over combined SoC (HR: 0.37, p<0.05) Data support selection of 30 mg onvansertib dose in combination with FOLFIRI/bev for planned registrational program; detailed data and registrational plans expected in the first half of 2026 SAN DIEGO, Feb. 24, 2026 (G ...

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]

Summary of Cardiff Oncology FY Conference Call Company Overview - **Company**: Cardiff Oncology (NasdaqCM:CRDF) - **Focus**: Development of onvansertib, a specific inhibitor of PLK1, targeting RAS mutated metastatic colorectal cancer [5][6] Key Points Clinical Development and Pipeline - **Current Trial**: CARD004 trial focusing on first-line RAS mutated metastatic colorectal cancer [6] - **Upcoming Data**: Expected data release in Q1 2026, focusing on durability, progression-free survival (PFS), and duration of response [6][29] - **Mechanism of Action**: Onvansertib shows synthetic lethality in RAS mutant backgrounds, synergy with topoisomerase one inhibitors, and with Bevacizumab [9][10][12] Unmet Need in Colorectal Cancer - **Prevalence**: Colorectal cancer is the third most common malignancy globally, with increasing incidence, especially in younger patients [14][15] - **Current Treatment Landscape**: Limited options with only Bevacizumab approved in the last 20 years for advanced colorectal cancer [15] - **Target Population**: Focus on first-line treatment for previously untreated metastatic colorectal cancer, addressing a significant unmet need [16] Clinical Trial Insights - **Response Rates**: High response rates observed in patients naive to Bevacizumab, with some achieving complete responses [11][25] - **Safety Profile**: Onvansertib demonstrated a favorable safety profile with no significant increase in adverse events compared to standard care [26][27] Regulatory and Market Strategy - **Regulatory Pathway**: Plans for a pivotal study with a seamless design for accelerated approval based on response rates and full approval based on PFS [31] - **Market Opportunity**: The first-line metastatic colorectal cancer market is described as a multi-billion dollar opportunity [35] - **Competitive Landscape**: Cardiff Oncology is uniquely positioned as the only company targeting the RAS mutated population in this setting [36] Financial Position - **Cash Reserves**: As of Q3, the company reported over $60 million in cash, providing a runway into 2027 [38] Future Development Opportunities - **Potential Expansion**: Interest in exploring onvansertib's application in other tumor types, including triple-negative breast cancer and EGFR rechallenge in colorectal cancer [40][42] Additional Insights - **Intellectual Property**: Issuance of new patents for patient selection in colorectal cancer, extending IP protection to 2043 [12] - **Clinical Trial Design**: Emphasis on randomized trial structure to ensure data integrity and reduce bias [19] This summary encapsulates the critical aspects of Cardiff Oncology's conference call, highlighting the company's strategic focus, clinical advancements, and market potential in the oncology space.

Core Insights - Cardiff Oncology announced positive data from the ongoing Phase 2 CRDF-004 trial evaluating onvansertib in combination with standard of care for first-line RAS-mutated metastatic colorectal cancer (mCRC) [1][2] - The company expects to report an update from the Phase 2 CRDF-004 trial in Q1 2026 [1] - As of September 30, 2025, the company had cash and investments totaling $60.6 million, projected to fund operations into Q1 2027 [1][5] Clinical Trial Results - The CRDF-004 trial demonstrated a 19% improvement in confirmed objective response rate (ORR) for the 30mg onvansertib cohort compared to the control arm as of the July 8, 2025 data cutoff [2][6] - Early progression-free survival (PFS) data show a trend favoring the 30mg onvansertib arm versus control, although median PFS has not yet been reached [6] - Onvansertib continues to be well-tolerated, with no major or unexpected toxicities observed [6] Financial Performance - For the third quarter of 2025, net cash used in operating activities was approximately $10.8 million, an increase from $10.5 million in the same period in 2024 [4] - Total operating expenses for the quarter were approximately $12.1 million, a decrease from $12.8 million for the same period in 2024, primarily due to reduced clinical trial expenses [6][7] - The company reported a net loss of $11.3 million for the third quarter of 2025, compared to a net loss of $11.9 million in the same period in 2024 [12] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies leveraging PLK1 inhibition for various cancers, with onvansertib as its lead asset [8] - The company is targeting significant medical needs in oncology, particularly for RAS-mutated mCRC, with approximately 150,000 new cases diagnosed annually in the U.S. [2][8]

Summary of Cardiff Oncology Conference Call - October 09, 2025 Company Overview - **Company**: Cardiff Oncology (NasdaqCM:CRDF) - **Lead Asset**: Onvansertib, a small molecule targeting PLK1, a known cancer therapy target Industry Context - **Disease Focus**: Colorectal cancer, the third most common cancer globally, with increasing incidence, particularly in individuals under 50 in the U.S. - **Market Need**: High unmet need in RAS-mutated metastatic colorectal cancer (MCRC), with limited innovation in the last 20 years Key Points and Arguments 1. **Onvansertib's Mechanism**: - First-in-class PLK1 inhibitor that is well tolerated and can be combined with chemotherapy for colorectal cancer treatment [2][3] - Demonstrates 5,000-fold greater specificity for PLK1 compared to other PLKs, contributing to its tolerability [3] 2. **Clinical Trial Insights**: - The CARDIFF-004 trial is a Phase II study focusing on first-line RAS-mutated MCRC, combining onvansertib with standard chemotherapy [7] - Confirmed objective response rate of 49%, a nearly 20% improvement over control [8] - Early signs of progression-free survival (PFS) separation observed, particularly in the 30 mg dose group [11][12] 3. **Patient Response**: - Significant depth of response noted, with some patients previously considered unresectable being referred for curative surgery [11] - High patient compliance due to the oral administration and low toxicity profile [13] 4. **Safety Profile**: - Minimal additive toxicity observed when combined with standard chemotherapy, with no significant increase in grade III or higher adverse events [13] 5. **Strategic Partnerships**: - Pfizer invested $15 million in Cardiff Oncology in 2021 and has a member on the Scientific Advisory Board, indicating strategic interest in onvansertib [19] - Pfizer is acting as a contract research organization for the ongoing trial, while Cardiff retains full ownership of onvansertib [20] 6. **Financial Position**: - As of June 30, 2025, Cardiff had $71 million in cash, funding operations into early 2027 [21] - Anticipated updates from the CARDIFF-004 trial in Q1 2026, expected to provide more data on durability and PFS [27] 7. **Commercial Opportunity**: - Analysts estimate peak sales for onvansertib between $2 billion and $3 billion annually, with a favorable competitive landscape in first-line RAS-mutated MCRC [31] - Rapid adoption expected if efficacy is demonstrated without additional toxicity [32] 8. **Market Positioning**: - Onvansertib targets RAS-mutated MCRC, which constitutes about 50% of the patient population, while competitors like Meris focus on RAS wild type patients, thus not seen as direct competition [35] Additional Important Content - **Future Directions**: Cardiff is exploring other indications for onvansertib, including triple-negative breast cancer and small cell lung cancer, while maintaining focus on colorectal cancer [24] - **Research Findings**: Novel findings regarding the synergy between onvansertib and bevacizumab published in top journals, with patents extending the commercial runway for onvansertib [18] This summary encapsulates the critical insights from the conference call, highlighting Cardiff Oncology's strategic positioning, clinical advancements, and market potential for onvansertib in treating colorectal cancer.