SAN DIEGO, Nov. 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 participate in a fireside chat and 1x1 investor meetings at the Piper Sandler 37th Annual Healthcare Conference, which is taking place from December 2-4, 2025. Details of the presentation can be found below. Presenters: Mark Erlander, PhD (CEO) Date: 12/02/2025Ti ...

Summary of Cardiff Oncology Conference Call Company Overview - **Company**: Cardiff Oncology (NasdaqCM:CRDF) - **Focus**: Development of onvansertib, a first-in-class PLK1 inhibitor targeting RAS mutated metastatic colorectal cancer [4][5] Industry Context - **Industry**: Biotechnology, specifically cancer therapeutics - **Market Need**: Colorectal cancer has a significant unmet need, with a 15% five-year survival rate and less than 12 months progression-free survival for metastatic cases [6] Key Points and Arguments 1. **Onvansertib Mechanism**: - Onvansertib is a selective PLK1 inhibitor, targeting a critical pathway in tumorigenesis and angiogenesis [4][5] - It is designed to be well-tolerated, addressing past toxicity issues associated with PLK1 inhibitors [5][19] 2. **Clinical Trials**: - The ongoing CARDIF-004 trial involves 110 patients with first-line RAS mutated unresectable colorectal cancer, comparing standard care with two doses of onvansertib [9][10] - Preliminary results show confirmed objective response rates (ORR) of 30% for control, 42% for 20 mg, and 49% for 30 mg doses of onvansertib [10][11] 3. **Response Rates**: - The trial indicates faster responses in the experimental arm, with 46% of patients in the 30 mg group achieving a confirmed response at six months compared to 22% in the control group [11] - Waterfall and spider plots demonstrate significant tumor shrinkage in patients receiving onvansertib [12][13] 4. **Safety Profile**: - Safety data shows no significant increase in grade three or higher adverse events compared to control, reassuring investigators about the drug's tolerability [19][20] 5. **Regulatory Pathway**: - Cardiff Oncology has engaged with the FDA to outline a seamless trial design for accelerated and full approval based on response rates and progression-free survival (PFS) [20][21] 6. **Intellectual Property**: - The company has secured patents extending into 2043, enhancing its competitive position in the colorectal cancer market [25] 7. **Financial Position**: - As of the last quarter, Cardiff Oncology reported $60-61 million in cash, providing a runway for ongoing trials and operations [27] 8. **Partnerships**: - Pfizer has invested $15 million in Cardiff Oncology and is involved in the trial's execution, indicating a strong collaborative relationship [26] Additional Insights - **Market Competition**: The competitive landscape is evolving, with new entrants in the KRAS inhibitor space and other innovative therapies targeting colorectal cancer [34][35] - **Patient Outcomes**: Patients achieving complete responses are being considered for curative surgeries, highlighting the potential effectiveness of onvansertib [15][36] - **Future Data Releases**: The company plans to provide more detailed data in Q1 2026, with expectations of median follow-up times around 12 months [28][29] This summary encapsulates the critical aspects of Cardiff Oncology's conference call, focusing on the company's innovative approach to treating colorectal cancer and its strategic positioning within the biotechnology industry.

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]

Core Insights - Cardiff Oncology's flagship drug, onvansertib, is highlighted as a significant potential player in the small-cap oncology sector, suggesting it could be a major story in recent times [1]. Company Overview - The article discusses the investment group's focus on innovative companies that are developing breakthrough therapies and pharmaceuticals, indicating a strategic interest in companies like Cardiff Oncology [1]. Investment Strategy - The investment group offers several features including model healthcare portfolios, a weekly newsletter, a daily watchlist, and a chat for dialogue and questions, which may provide valuable insights for investors [1].

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.

Core Insights - Cardiff Oncology, Inc. is participating in two investor conferences in October 2025, showcasing its focus on PLK1 inhibition for cancer therapies [1][2][3] Group 1: Upcoming Events - Cardiff Oncology will present at the Piper Sandler Virtual Oncology Symposium on October 9, 2025, at 1:00 PM ET, featuring CEO Mark Erlander, CFO James Levine, and CMO Roger Sidhu [2] - The company will also present at the Noble Capital Markets' Emerging Growth Virtual Equity Conference on the same day at 2:00 PM ET, with CEO Mark Erlander as the presenter [3] - Registration for the Noble Capital Markets conference is free, and a webcast replay will be available within 48 hours post-presentation on the company's website [3] Group 2: Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies through PLK1 inhibition, targeting various cancers [4] - The lead asset, onvansertib, is being evaluated in combination with standard of care treatments for RAS-mutated metastatic colorectal cancer and other cancers, including metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple negative breast cancer [4] - The company's development strategy aims to exploit tumor vulnerabilities to overcome treatment resistance and provide superior clinical benefits compared to standard therapies [4]

Core Insights - Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing novel therapies through PLK1 inhibition for various cancers [3] Group 1: Upcoming Investor Conferences - Cardiff Oncology management will participate in three investor conferences in September 2025 [1] - The conferences include the Wells Fargo 20 Annual Healthcare Conference on September 5, 2025, the Morgan Stanley 23 Annual Global Healthcare Conference on September 8, 2025, and the H.C. Wainwright 27 Annual Global Investment Conference on September 9, 2025 [2] Group 2: Company Overview - The lead asset of Cardiff Oncology is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care therapies for RAS-mutated metastatic colorectal cancer and other cancers [3] - The company's development strategy aims to target tumor vulnerabilities to overcome treatment resistance and provide superior clinical benefits compared to standard therapies [3]

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, 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]