Cardiff Oncology, Inc.
For the period ended Sep 30, 2025. Filed Nov 6, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 6, 2025
CRDF$0.80+5.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-07-29.
0000950170-25-099610
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001193125-25-269424
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 97 previous paragraphs and 80 current paragraphs.
55 unchanged; 23 reworded; 1 added; 18 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (1)
Current report
Selling, general and administrative expenses increased by $0.8 million for the three months ended September 30, 2025, compared to the same period in 2024. The overall increase in expenses was primarily from an employee severance agreement recorded to salaries and staff costs within the current period.
Removed paragraphs (18)
Previous report
Phase 1b/2 Clinical Trial in Second-Line KRAS-mutated mCRC
Previous report
TROV-054, a Phase 1b/2 open-label multi-center clinical trial of onvansertib in combination with SoC FOLFIRI and bevacizumab for the second-line treatment of patients with KRAS-mutated mCRC, completed enrollment in October 2022.
Previous report
The primary objectives of this trial were to evaluate the Dose-Limiting Toxicities ("DLTs"), maximum tolerated dose ("MTD") and recommended Phase 2 dose ("RP2D") of onvansertib in combination with FOLFIRI and bevacizumab (Phase 1b) and to continue to assess the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab patients with KRAS-mutated mCRC (Phase 2). For more information, please visit NCT03829410 atwww.clinicialtrials.gov.
Previous report
On August 7, 2023, we presented data from the TROV-054 Phase 1b/2 single arm clinical trial in KRAS-mutated metastatic colorectal cancer:
Previous report
ORR across all evaluable patients was 29%, with 19 of 66 evaluable patients achieving an objective response. Responses have been observed across multiple KRAS variants;
Previous report
Median duration of response ("mDoR") across all evaluable patients was 12.0 months (95% confidence interval ("CI"): 8.9 – not reached);
Previous report
Median progression free survival ("mPFS") across all evaluable patients was 9.3 months (95% CI: 7.8 – 14). Historical control trials of different drug combinations, including the SoC of FOLFIRI with bevacizumab, in similar patient populations have shown ORR and mPFS of 5 – 13% and ~4.5 – 6.7 months, respectively;
Previous report
A subgroup analysis of patients who were bevacizumab naïve when they entered second-line therapy vs. patients who had received prior bevacizumab in first-line therapy showed that patients who were bevacizumab naïve (n=15) had an ORR of 73% and mPFS of 15 months, which is well above historical controls. In contrast, patients previously treated with bevacizumab (n=51) had an ORR of 16% and mPFS of 7.8 months;
Previous report
Data on Treatment Emergent Adverse Events ("TEAEs") on the trial showed that onvansertib is well-tolerated when used in combination with FOLFIRI and bevacizumab. The more severe, grade 4 TEAEs are either neutropenia or leukopenia, which are common events in patients treated with FOLFIRI and bevacizumab. None of the patients with grade 4 TEAEs discontinued treatment due to their condition and all resolved without issue. There were no major or unexpected toxicities seen in the trial;
Previous report
Data from the Phase 1b portion of this trial was published in the peer-reviewed journal Clinical Cancer Research, February 6, 2024 edition;
Previous report
Data from the Phase 2 portion of this trial was published online in the peer-reviewed journal of Clinical Oncology on October 30, 2024.
Previous report
mPDAC Program:
Previous report
Recent Updates
Previous report
Appointment of Chief Medical Officer
Previous report
On June 17, 2025, we announced the appointment of Roger Sidhu, M.D., as our Chief Medical Officer.
Previous report
Intellectual Property Update
Previous report
On April 23, 2025, we announced a second patent issuance from the United States Patent and Trademark Office (USPTO) for the treatment of mCRC for bev-naïve patients. U.S. patent No. 12,263,173 has an expected expiration date of no earlier than 2043. The claims of the patent cover the method of using onvansertib in combination with bevacizumab (bev) in any line of therapy for the treatment of metastatic colorectal cancer (mCRC) patients who have not previously been treated with bev.
Previous report
Selling, general and administrative expenses increased by $0.1 million for the three months ended June 30, 2025, compared to the same period in 2024. The overall increase in expenses which was primarily within stock based compensation was due to new stock option grants in the current period. The decrease in outside services and professional fees was primarily due to litigation settled in the comparative period.
Reworded paragraphs (23)
Previous wording
Onvansertib is highly potent and highly selective against the PLK1 enzyme (IC 50 = 2nM; IC 50 is the concentration for 50% inhibition), compared to prior PLK1 inhibitors that were pan-inhibitors of several PLK targets. Low or no activity of onvansertib was observed on a panel of 63 kinases (IC50>500 nM), including the PLK members PLK2 and PLK3 (IC 50>10,000 nM);
Current wording
Onvansertib is highly potent and highly selective against the PLK1 enzyme (IC 50 = 2nM; IC 50 is the concentration for 50% inhibition), compared to prior PLK1 inhibitors that were pan-inhibitors of several PLK targets. Low or no activity of onvansertib was observed on a panel of 63 kinases (IC 50>500 nM), including the PLK members PLK2 and PLK3 (IC 50>10,000 nM);
Previous wording
CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial of onvansertib in combination with SoC FOLFIRI and bevacizumab or SoC FOLFOX and bevacizumab for the first-line treatment of patients with RAS-mutated mCRC. The primary objectives of the CRDF-004 trial are to evaluate onvansertib’s safety and efficacy in combination with the SoC, as well as to evaluate two doses of onvansertib, 20mg and 30mg, given in combination with SoC, against SoC alone. The primary endpoint of the trial is objective response rate ("ORR"). Progression-free survival and duration of response will be secondary endpoints. This trial is conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies. Enrollment of approximately 90 evaluable patients was completed in April 2025. For more information, please visit NCT06106308 atwww.clinicialtrials.gov.
Current wording
CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial to assess the efficacy of two doses of onvansertib (20mg and 30mg) in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab, compared with FOLFIRI or FOLFOX and bevacizumab (SOC) alone, for the treatment of confirmed metastatic and unresectable colorectal cancer (mCRC) in patients with a KRAS or NRAS mutation in the first-line setting. Trial endpoints include objective response rate ("ORR"), progression-free survival ("PFS") and duration of response ("DoR") together with pharmacokinetics, and pharmacodynamics and safety assessments. Selection of the recommended phase 3 onvansertib dose will be based on a benefit-risk assessment of the totality of the evidence, including numerical differences between the onvansertib and SoC arms. The trial enrolled 110 patients in the intent-to-treat ("ITT") population and is conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies. For more information, please visit NCT06106308 atwww.clinicialtrials.gov.
Previous wording
Contingent upon the results of CRDF-004, we plan to initiate CRDF-005, a Phase 3, randomized trial with registrational intent. The FDA has agreed that a seamless trial with an interim endpoint of ORR, with duration of response, is acceptable to pursue accelerated approval, with progression-free survival and lack of detriment on overall survival being the endpoints for full approval.
Current wording
Contingent upon the results of CRDF-004, we plan to initiate CRDF-005, a Phase 3, randomized trial with registrational intent. The FDA agreed at a Type C meeting in June 2023 that a seamless trial with an interim endpoint of ORR, with DoR, is acceptable to pursue accelerated approval, with PFS and lack of detriment on overall survival being the endpoints for full approval.
Previous wording
Data presented on December 10, 2024 provided initial results from the ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated metastatic colorectal cancer. ORR, as of the data cut-off date of November 26, 2024, are shown below.
Current wording
Data presented on July 29, 2025 provided results from the ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC. ORR, as of the data cut-off date of July 8, 2025, are shown below.
Previous wording
Note: Radiographic response determined per RECIST 1.1 by blinded independent central review from an ongoing trial and unlocked database.
Current wording
Radiographic response determined per RECIST 1.1 by blinded independent central review from an ongoing trial and unlocked database.1 Confirmed Objective Response Rate (ORR) per RECIST v1.1 includes those patients who had a complete response (CR) or partial response (PR) confirmed by repeat imaging ≥4 weeks after response criteria first met.2 ORR per RECIST v1.1 includes confirmed CRs/PRs and unconfirmed PRs who were still on treatment and may yet be confirmed.
Previous wording
The primary objective in this study is to determine anti-tumor activity by measuring Overall Response Rate (ORR). The secondary objectives are to determine treatment safety based on toxicities in participants who have received at least one dose of onvansertib, to determine anti-tumor activity by Progression Free Survival (PFS), to determine anti-tumor activity by Disease Control Rate (DCR), to determine Overall Survival (OS).
Current wording
The primary objective in this study is to determine anti-tumor activity by measuring ORR. The secondary objectives are to determine treatment safety based on toxicities in participants who have received at least one dose of onvansertib, to determine anti-tumor activity by Progression Free Survival ("PFS"), to determine anti-tumor activity by Disease Control Rate ("DCR"), to determine Overall Survival ("OS").
Previous wording
A single-arm, two-stage, Phase 2 trial of onvansertib monotherapy in patients with relapsed SCLC is open for enrollment at the University of Maryland, Baltimore. The trial is designed to enroll 15 patients in Stage 1, with the study proceeding to Stage 2 if 2 or more Stage 1 patients achieve an objective response. Stage 2 is designed to enroll an additional 20 patients. The primary endpoint of the trial is ORR, while key secondary endpoints include PFS and overall survival. For more information, please visit NCT05450965 atwww.clinicialtrials.gov.
Current wording
A single-arm, two-stage, Phase 2 trial of onvansertib monotherapy in patients with relapsed SCLC is open for enrollment at the University of Maryland, Baltimore. The trial is designed to enroll 15 patients in Stage 1, with the study proceeding to Stage 2 if 2 or more Stage 1 patients achieve an objective response. Stage 2 is designed to enroll an additional 20 patients. The primary endpoint of the trial is ORR, while key secondary endpoints include PFS and OS. For more information, please visit NCT05450965 atwww.clinicialtrials.gov.
Previous wording
An examination of the safety data from the first six patients by the institutional review board confirmed the trial can continue to enroll as planned. Preliminary efficacy data for seven patients presented on September 26, 2023, showed one confirmed partial response (“PR”), three stable disease (“SD”) and three progressive disease (“PD”). The disease control rate (“DCR”), including PR and SD, is 57% (4 of 7 patients).
Current wording
An examination of the safety data from the first six patients by the institutional review board confirmed the trial can continue to enroll as planned. Preliminary efficacy data for seven patients presented on September 26, 2023, showed one confirmed partial response (“PR”), three stable disease (“SD”) and three progressive disease (“PD”). The DCR, including PR and SD, is 57% (4 of 7 patients).
Previous wording
Onvansertib in combination with paclitaxel demonstrated 40% objective response rate by RECIST 1.1 at RP2D of 18mg/m2 (n=10), with two confirmed partial responses and two unconfirmed partial responses.
Current wording
Onvansertib in combination with paclitaxel demonstrated 40% objective response rate by RECIST 1.1 at RP2D of 18mg/m 2 (n=10), with two confirmed partial responses and two unconfirmed partial responses.
Previous wording
Research and development expenses increased by $4.6 million for the six months ended June 30, 2025, compared to the same period in 2024. The overall increase in expenses was primarily due to costs associated with our CRDF-004 clinical trial, clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib. Salaries and staff costs increased generally from key hires in research and development and clinical operations.
Current wording
Research and development expenses decreased by $1.4 million for the three months ended September 30, 2025, compared to the same period in 2024. The overall decrease in expenses was primarily due to a reduction in clinical trial expenses and a decrease in preclinical activities. Salaries and staff costs increased generally from key hires in research and development and clinical operations.
Previous wording
Interest income, net was $0.8 million for the three months ended June 30, 2025 as compared to $0.8 million for the same period of 2024. Our interest income is primarily from our short-term investment portfolios and money market accounts. The amount of interest income earned varies each period based on the balance of our accounts and interest rates.
Current wording
Interest income, net was $0.7 million for the three months ended September 30, 2025 as compared to $0.7 million for the same period of 2024. Our interest income is primarily from our short-term investment portfolios and money market accounts. The amount of interest income earned varies each period based on the balance of our accounts and interest rates.
Previous wording
Total revenues were $0.2 million for the six months ended June 30, 2025, as compared to $0.4 million for the same period in 2024. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib. Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees.
Current wording
Total revenues were $0.4 million for the nine months ended September 30, 2025, as compared to $0.5 million for the same period in 2024. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib. Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees.
Previous wording
Research and development expenses increased by $2.1 million for the three months ended June 30, 2025, compared to the same period in 2024. The overall increase in expenses was primarily due to costs associated with our CRDF-004 clinical trial, clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib. Salaries and staff costs increased generally from key hires in research and development and clinical operations.
Current wording
Research and development expenses increased by $3.1 million for the nine months ended September 30, 2025, compared to the same period in 2024. The overall increase in expenses was primarily due to costs associated with our CRDF-004 clinical trial, clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib. Salaries and staff costs increased generally from key hires in research and development and clinical operations. The increase in stock based compensation was due to new stock option grants during the current period.
Previous wording
Selling, general and administrative expenses increased by $1.0 million for the six months ended June 30, 2025, compared to the same period in 2024. The overall increase in expenses was primarily from professional fees related to strategic advisory services utilized during the current period and an increase in patent fees. The increase in stock based compensation was due to new stock option grants during the current period.
Current wording
Selling, general and administrative expenses increased by $1.8 million for the nine months ended September 30, 2025, compared to the same period in 2024. The overall increase in expenses was primarily from an employee severance agreement recorded to salaries and staff costs within the current period. The increase in professional fees was primarily from strategic advisory services utilized during the current period and an increase in patent fees. The increase in stock based compensation was due to new stock option grants during the current period.
Previous wording
Interest income, net was $1.8 million for the six months ended June 30, 2025 as compared to $1.7 million for the same period of 2024. Our interest income is primarily from our short-term investment portfolios and money market accounts. The amount of interest income earned varies each period based on the balance of our accounts and interest rates.
Current wording
Interest income, net was $2.5 million for the nine months ended September 30, 2025 as compared to $2.5 million for the same period of 2024. Our interest income is primarily from our short-term investment portfolios and money market accounts. The amount of interest income earned varies each period based on the balance of our accounts and interest rates.
Previous wording
As of June 30, 2025, and December 31, 2024, we had working capital of $57.0 million and $81.6 million, respectively.
Current wording
As of September 30, 2025, and December 31, 2024, we had working capital of $47.1 million and $81.6 million, respectively.
Previous wording
We have incurred net losses since our inception and have negative operating cash flows. As of June 30, 2025, we had $71.0 million in cash, cash equivalents and short-term investments and we believe we have sufficient cash to meet our funding requirements for at least the next 12 months following the issuance date of this Quarterly Report on Form 10-Q. Based on our current projections, we expect that our capital resources are sufficient to fund our operations into the first quarter of 2027.
Current wording
We have incurred net losses since our inception and have negative operating cash flows. As of September 30, 2025, we had $60.6 million in cash, cash equivalents and short-term investments and we believe we have sufficient cash to meet our funding requirements for at least the next 12 months following the issuance date of this Quarterly Report on Form 10-Q. Based on our current projections, we expect that our capital resources are sufficient to fund our operations into the first quarter of 2027.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2024, was $17.0 million. Our primary use of cash was from our net loss of $21.8 million, adjusted for non-cash items of $2.5 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $2.3 million.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2025, was $32.0 million. Our primary use of cash was from our net loss of $38.6 million, adjusted for non-cash items of $4.4 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $2.3 million.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2025, was $21.1 million. Our primary use of cash was from our net loss of $27.4 million, adjusted for non-cash items of $3.1 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $3.2 million.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2024, was $27.4 million. Our primary use of cash was from our net loss of $33.6 million, adjusted for non-cash items of $3.8 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $2.4 million.
Previous wording
Net cash used in investing activities for the six months ended June 30, 2025 was $19.6 million, primarily related to purchases in excess of maturities and sales of marketable securities.
Current wording
Net cash used in investing activities for the nine months ended September 30, 2025 was $9.4 million, primarily related to purchases in excess of maturities and sales of marketable securities.
Previous wording
Net cash provided by investing activities for the six months ended June 30, 2024 was $18.7 million, primarily related to maturities and sales in excess of purchases of marketable securities.
Current wording
Net cash provided by investing activities for the nine months ended September 30, 2024 was $9.2 million, primarily related to maturities and sales in excess of purchases of marketable securities.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2025 was $3,000, from employee stock options exercises.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2025 was $28,000, from employee stock options exercises.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2024 was $2.2 million, from the sale of common stock and employee stock options exercises.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was $9.6 million, from the sale of common stock and employee stock options exercises.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Nine Months Ended September 30, 2025 and 2024
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Six Months Ended June 30, 2025 and 2024