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.

Financial Performance - The company had approximately $60.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025, with a projected runway into Q1 2027[4][5]. - Total operating expenses for Q3 2025 were approximately $12.1 million, a decrease of $0.7 million from $12.8 million in Q3 2024, primarily due to reduced clinical trial expenses[6]. - Net cash used in operating activities for Q3 2025 was approximately $10.8 million, an increase of $0.3 million from $10.5 million in the same period in 2024[4]. - The net loss attributable to common stockholders for Q3 2025 was $11.3 million, compared to a net loss of $11.9 million in Q3 2024[12]. - The company reported royalty revenues of $120,000 for Q3 2025, down from $165,000 in Q3 2024[12]. - Total assets as of September 30, 2025, were $63.8 million, down from $97.2 million as of December 31, 2024[14]. Clinical Trial Updates - Cardiff Oncology reported a 19% improvement in confirmed objective response rate (ORR) for the 30mg onvansertib cohort compared to the control arm in the ongoing Phase 2 CRDF-004 trial for first-line RAS-mutated metastatic colorectal cancer (mCRC) as of July 8, 2025[2]. - The median progression-free survival (PFS) has not yet been reached, but early PFS data show a trend favoring the 30mg onvansertib arm versus control[3]. - The company expects to provide an update from the ongoing Phase 2 CRDF-004 trial in Q1 2026[3]. Market Opportunity - Onvansertib is positioned to address a significant medical need, with approximately 150,000 new colorectal cancer patients diagnosed annually in the U.S.[2].

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]

Financial Performance - Total revenues for Q3 2025 were $0.1 million, down from $0.2 million in Q3 2024, primarily from sales-based royalties unrelated to onvansertib[80]. - Net cash used in operating activities was $32.0 million for the nine months ended September 30, 2025, compared to $27.4 million in 2024[94]. - The company reported net losses of $38.6 million for the nine months ended September 30, 2025, compared to $33.6 million in 2024[95]. - Interest income remained stable at $2.5 million for the nine months ended September 30, 2025, consistent with the same period in 2024[89]. - Net cash provided by financing activities was $28,000 for the nine months ended September 30, 2025, down from $9.6 million in 2024[98]. Research and Development - Research and development expenses decreased by $1.4 million to $8.2 million in Q3 2025, mainly due to reduced clinical trial expenses[82]. - Research and development expenses increased by $3.1 million to $30.3 million for the nine months ended September 30, 2025, compared to $27.1 million in 2024[87]. - The company is focusing on leveraging PLK1 inhibition to develop therapies for cancers with significant unmet medical needs, including mCRC, mPDAC, SCLC, and mTNBC[63]. Clinical Trials - Onvansertib demonstrated a 49% confirmed objective response rate (ORR) in combination with standard-of-care treatments for RAS-mutated metastatic colorectal cancer (mCRC) in the ongoing CRDF-004 trial[71]. - The CRDF-004 trial enrolled 110 patients and is assessing the efficacy of onvansertib in combination with FOLFIRI or FOLFOX and bevacizumab[68]. - The FDA agreed to a seamless Phase 3 trial (CRDF-005) for onvansertib with an interim endpoint of ORR, aiming for accelerated approval[69]. - In the Phase 1b/2 trial for metastatic pancreatic ductal adenocarcinoma (mPDAC), onvansertib is being evaluated in combination with the newly approved NALIRIFOX[73]. - The Phase 2 trial for small cell lung cancer (SCLC) is designed to enroll 15 patients, with preliminary data showing a disease control rate of 57%[76]. - Onvansertib in combination with paclitaxel showed a 40% objective response rate in a Phase 1b trial for metastatic triple-negative breast cancer (mTNBC)[81]. Expenses and Cash Position - Selling, general and administrative expenses increased by $0.8 million to $3.9 million in Q3 2025, primarily due to an employee severance agreement[83]. - Selling, general and administrative expenses rose by $1.8 million to $11.2 million for the nine months ended September 30, 2025, compared to $9.5 million in 2024[88]. - As of September 30, 2025, the company had working capital of $47.1 million, down from $81.6 million as of December 31, 2024[90]. - The company had $60.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025, sufficient to meet funding requirements for at least the next 12 months[91]. - Net cash used in investing activities was $9.4 million for the nine months ended September 30, 2025, compared to a net cash provided of $9.2 million in 2024[97]. - The company expects to continue incurring losses and will require additional capital to advance clinical trial programs[93].

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].

Core Insights - Cardiff Oncology, Inc. (NASDAQ: CRDF) has experienced significant stock declines this year, with mid-double-digit losses, but has recently seen some recovery with late single-digit gains as it approaches its Q3 2025 earnings call [1] Company Summary - Cardiff Oncology's stock performance has been challenging, marked by substantial losses throughout the year [1] - The company is preparing for its upcoming Q3 2025 earnings call, which may provide insights into its financial health and future prospects [1] Analyst Background - Gamu Dave Innocent Pasi is a financial professional with extensive experience in investment research and analysis, known for providing actionable trading ideas and investment recommendations [1] - He holds a Postgraduate Executive Certificate in Investments and Portfolio Management and a Bachelor of Business Studies Honors degree in Banking and Finance [1] - Pasi is recognized for his strong analytical skills and commitment to promoting Responsible Investment and ESG principles [1]

Core Insights - Cardiff Oncology, Inc. (NASDAQ: CRDF) has experienced significant stock declines this year, with mid-double-digit losses, but has recently seen some recovery with late single-digit gains as it approaches its Q3 2025 earnings call [1] Company Performance - The stock of Cardiff Oncology has faced a challenging year, marked by substantial losses, yet it has shown signs of recovery in the past month [1] Analyst Background - Gamu Dave Innocent Pasi, a financial professional with extensive experience in investment research and analysis, emphasizes the importance of financial inclusion, sustainability, and ESG principles in investment decision-making [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.