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 [2][35] Key Points and Arguments Product and Mechanism - **Onvansertib**: A highly selective PLK1 inhibitor designed for first-line treatment of RAS-mutated metastatic colorectal cancer [2][4] - **Mechanism**: PLK1 is an enzyme that drives tumor cell division and survival; onvansertib inhibits this enzyme, leading to reduced tumor growth and metastasis [3][4] Clinical Trials and Efficacy - **Clinical Trials**: Initial trials showed strong efficacy signals in RAS-mutated metastatic colorectal cancer, particularly in BEV-naive patients [3][11] - **Response Rates**: In a second-line trial, onvansertib combined with standard care showed a 73% response rate in BEV-naive patients compared to 16% in BEV-exposed patients [11] - **Progression-Free Survival (PFS)**: Nearly doubled in BEV-naive patients compared to historical controls [11] Market Opportunity - **Unmet Need**: Colorectal cancer has a low five-year survival rate of only 15%, with no new therapies introduced in over 20 years for RAS-mutated patients [5][6] - **Target Population**: Approximately 50% of newly diagnosed colorectal cancer patients have RAS mutations, indicating a significant market opportunity [6][35] Regulatory and Development Path - **FDA Alignment**: Received clear guidance from the FDA to pivot from second-line to first-line clinical development, addressing a larger patient population [4][18] - **Ongoing Trials**: The ongoing first-line trial is designed to assess the efficacy of onvansertib in combination with standard chemotherapy [19][20] Safety and Tolerability - **Safety Profile**: Onvansertib is well tolerated, with no significant increase in neutropenia compared to control groups [30][31] - **Combination Therapy**: The drug can be combined with existing chemotherapies without compromising safety, allowing for longer treatment durations [40][41] Financial and Strategic Partnerships - **Partnership with Pfizer**: Pfizer holds a 3% equity stake in Cardiff Oncology and is involved in trial execution through its Pfizer Ignite program, providing high-quality data without strings attached [33][34] Future Outlook - **Next Steps**: Plans to update on trial progress in Q1 of the following year, with a focus on durability data and potential registrational trials [36] - **Investment Opportunity**: The company is positioned to make a significant impact in the treatment of colorectal cancer, presenting a compelling investment opportunity [42][43] Additional Important Information - **Patents**: Two new patents were issued, extending the intellectual property protection for onvansertib until at least 2043 [17] - **Clinical Data Publication**: Findings have been published in the Journal of Clinical Oncology, highlighting the significance of the research [16] This summary encapsulates the critical insights from the conference call, emphasizing Cardiff Oncology's innovative approach to treating colorectal cancer and the potential for significant market impact.

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]

Summary of Cardiff Oncology FY Conference Call Company Overview - **Company**: Cardiff Oncology (NasdaqCM:CRDF) - **Focus**: Development of onvansertib, a first-in-class PLK1 inhibitor for treating RAS mutated metastatic colorectal cancer Key Points Industry and Product Insights - **PLK1 Biology**: PLK1 is a serine-threonine kinase essential for cell division and is overexpressed in tumor cells, driving metastasis and dependency on PLK1 [3][4] - **Onvansertib Characteristics**: - First-in-class oral drug with a 5,000-fold selectivity for PLK1 compared to other PLKs [4][5] - Short half-life of approximately 24 hours, allowing for better tolerability and combination with chemotherapies [5] Clinical Trial Data - **CRDF-004 Study**: - Aimed to evaluate the efficacy and safety of onvansertib combined with standard chemotherapy (FOLFOX and FOLFIRI with Avastin) in RAS mutant metastatic colorectal cancer [6][7] - Results showed a 19% improvement in confirmed objective response rate with the 30 mg dose compared to standard care [8] - Early signs of progression-free survival (PFS) benefit were observed without significant increases in toxicity [9][10] Future Plans - **Phase Three Trial**: - Plans to align with the FDA on the design of a registrational trial, aiming for accelerated approval based on response endpoints and full approval based on PFS [12] - Interest in exploring additional indications for onvansertib, including triple-negative breast cancer and small cell lung cancer [13][14] Financial Position - **Cash Reserves**: Company ended the third quarter with over $60 million in cash, sufficient to fund operations for one year while awaiting data updates in Q1 2027 [16] Additional Mechanisms and Synergies - **Combination Therapies**: - Potential synergies with other treatments, such as paclitaxel in breast cancer and Enhertu in HER2-positive breast cancer [17][18] - Ongoing exploration of single-agent activity in small cell lung cancer [18] Operational Considerations - **Funding Needs**: Additional funds will be necessary to support the phase three trial operations [19] Conclusion - Cardiff Oncology is positioned to advance onvansertib through clinical trials, with promising early data and a clear strategy for regulatory alignment and potential partnerships. The company is focused on expanding its therapeutic applications while maintaining a solid financial foundation.

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 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].