Cardiff Oncology, Inc.
For the period ended Jun 30, 2025. Filed Jul 29, 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.
Jun 30, 2025 · Filed Jul 29, 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 2025-03-31; filed 2025-05-08.
0000950170-25-066886
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 75 previous paragraphs and 97 current paragraphs.
60 unchanged; 15 reworded; 15 added; 0 removed; 0 previous and 7 current paragraphs rearranged.
Tables are not compared: 4 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 (15)
Current report
In June 2025, the investigator presented positive data from this trial at ASCO:
Current report
Patients enrolled in the trial received a median of 3 prior lines of chemotherapy.
Current report
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 report
The combination of onvansertib and paclitaxel was well-tolerated and demonstrated a safe and manageable toxicity profile with myelosuppression being the most common adverse event.
Current report
Collectively, this clinical data further supports the potential exploration of the combination of onvansertib plus paclitaxel for the treatment of mTNBC.
Current report
Recent Updates
Current report
Appointment of Chief Medical Officer
Current report
On June 17, 2025, we announced the appointment of Roger Sidhu, M.D., as our Chief Medical Officer.
Current report
Intellectual Property Update
Current 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.
Current 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.
Current report
Revenues
Current report
Research and Development Expenses
Current report
Selling, General and Administrative Expenses
Current report
Interest Income, Net
Reworded paragraphs (15)
Previous wording
We are a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers with the greatest unmet medical need. Our goal is to target tumor vulnerabilities with treatment combinations of onvansertib, our oral and highly selective PLK1 inhibitor, and standard-of-care ("SoC") therapeutics. We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), and triple negative breast cancer ("TNBC"). Our clinical development programs incorporate tumor genomics and biomarker assays to refine assessment of patient response to treatment.
Current wording
We are a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers with the greatest unmet medical need. Our goal is to target tumor vulnerabilities with treatment combinations of onvansertib, our oral and highly selective PLK1 inhibitor, and standard-of-care ("SoC") therapeutics. We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), and metastatic triple negative breast cancer ("mTNBC"). Our clinical development programs incorporate tumor genomics and biomarker assays to refine assessment of patient response to treatment.
Previous wording
Phase 1b Investigator-Initiated Clinical Trial in TNBC
Current wording
Phase 1b Investigator-Initiated Clinical Trial in mTNBC
Previous wording
A single-arm, Phase 1b trial of onvansertib in combination with paclitaxel in patients with unresectable locally advanced or metastatic TNBC at Dana Farber Cancer Institute ("DFCI") has completed enrollment. The trial was designed to treat approximately 14-16 patients with different doses of onvansertib in combination with a fixed dose of paclitaxel to determine the maximum tolerated dose and the safety and efficacy of onvansertib in combination with paclitaxel. For more information, please visit NCT05383196 atwww.clinicialtrials.gov.
Current wording
A single-arm, Phase 1b trial of onvansertib in combination with paclitaxel in patients with unresectable locally advanced or metastatic TNBC at Dana Farber Cancer Institute ("DFCI") has completed enrollment. The trial was designed to treat approximately 14-16 patients with different doses of onvansertib in combination with a fixed dose of paclitaxel to determine the maximum tolerated dose and the safety and efficacy of onvansertib in combination with paclitaxel.
Previous wording
Research and development expenses increased by $2.5 million for the three months ended March 31, 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.
Current 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.
Previous wording
Interest income, net was $0.9 million for the three months ended March 31, 2025 as compared to $0.9 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 $0.8 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.
Previous wording
Total revenues were $0.1 million for the three months ended March 31, 2025, as compared to $0.2 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 $0.2 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.
Previous wording
Selling, general and administrative expenses increased by $0.9 million for the three months ended March 31, 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.
Current 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.
Previous wording
As of March 31, 2025, and December 31, 2024, we had working capital of $69.4 million and $81.6 million, respectively.
Current wording
As of June 30, 2025, and December 31, 2024, we had working capital of $57.0 million and $81.6 million, respectively.
Previous wording
We have incurred net losses since our inception and have negative operating cash flows. As of March 31, 2025, we had $79.9 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 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.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2024, was $7.7 million. Our primary use of cash was from our net loss of $10.0 million, adjusted for non-cash items of $1.2 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $1.1 million.
Current 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.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2025, was $12.8 million. Our primary use of cash was from our net loss of $13.4 million, adjusted for non-cash items of $1.5 million primarily related to stock-based compensation. The net change in our operating assets and liabilities increased cash used in operations by $0.8 million.
Current 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.
Previous wording
Net cash used in investing activities for the three months ended March 31, 2025 was $14.6 million, primarily related to purchases in excess of maturities of marketable securities.
Current 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.
Previous wording
Net cash provided by investing activities for the three months ended March 31, 2024 was $4.6 million, primarily related to maturities in excess of purchases of marketable securities.
Current 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.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2025 was $3,000, from employee stock options exercises.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2025 was $3,000, from employee stock options exercises.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2024 was $0.1 million, from the sale of common stock and employee stock options exercises.
Current 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.
Rearranged current paragraphs (7)
Current report — wording carried from elsewhere
For more information, please visit NCT05383196 atwww.clinicialtrials.gov.
Current report — wording carried from elsewhere
Total revenues were $0.1 million for the three months ended June 30, 2025, as compared to $0.2 million for the prior period. 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 report — wording carried from elsewhere
Six Months Ended June 30, 2025 and 2024
Current report — wording carried from elsewhere
Research and development expenses consisted of the following:
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
Selling, general and administrative expenses consisted of the following:
Current report — wording carried from elsewhere
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.