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Cardiff Oncology, Inc.

For the period ended Jun 30, 2026. Filed Aug 11, 2026.

View on SEC.gov

About 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, 2026 · Filed Aug 11, 2026

CRDF$0.80+5.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-14.

0001213037-26-000011

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-11.

0001193125-26-344545

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 85 previous paragraphs and 95 current paragraphs.

50 unchanged; 23 reworded; 17 added; 12 removed; 0 previous and 5 current paragraphs rearranged.

Tables are not compared: 4 previous and 5 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 (17)

Current report

Data highlights from the ongoing Phase 2 trial were presented at the ASCO Meeting on June 2, 2026, using a data cut of March 18, 2026. Overall, results showed that the onvansertib 30 mg + FOLFIRI/bev dose regimen, demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in ORR and PFS compared to SoC alone, with no additive adverse events. In the ITT population, the dose selected for the registrational program, 30 mg onvansertib arm in combination with FOLFIRI/ bev achieved:

Current report

Primary endpoint of confirmed objective response rate of 72.2% (13/18), compared with 42.1% (8/19) for FOLFIRI/bev alone, a 30% improvement over SoC. The responses were deeper and more durable in the onvansertib arm.

Current report

Secondary endpoint of PFS hazard ratio ("HR") of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) vs. FOLFIRI/bev by Blinded Independent Central Review ("BICR") and investigator assessment ("IA"), respectively.

Current report

Median PFS not reached in 30 mg onvansertib + FOLFIRI/bev arm, but has been reached in both SoC arms. Four patients remain on onvansertib treatment beyond 15 months, including 2 beyond 20 months.

Current report

No meaningful differences in efficacy were observed between the onvansertib + FOLFOX/bev arms and FOLFOX/bev alone.

Current report

Onvansertib in combination with both chemotherapy (FOLFIRI or FOLFOX)/bev regimens was well-tolerated. There were no major or unexpected toxicities observed, and no additive adverse events reported. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and SoC arms.

Current report

The Phase 2 trial is still ongoing and as of a June 23, 2026 data cut-off, 12 patients remain on trial, with 8 patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC.

Current report

In April 2026 we completed our End-of-Phase 2 Type B meeting with the U.S. Food and Drug Administration ("FDA"). Incorporating FDA feedback, we have designed the registrational Phase 3 trial (CRDF-005) as a global randomized, controlled trial that will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus SoC FOLFIRI/bev in patients with RAS mutated mCRC. We expect to enroll approximately 640 patients across sites in the US, Europe and other regions. Additional details of the trial will be disclosed at the time of initiation of the trial.

Current report

Additionally, we have initiated the process of soliciting scientific advice from the European Medicines Agency ("EMA") on our Phase 3 plans. We remain on track with the manufacturing of clinical material and also with companion diagnostic related regulatory activities as we prepare for the registrational trial.

Current report

Selling, general and administrative expenses increased by $0.5 million for the three months ended June 30, 2026, compared to the same period in 2025. The overall increase in expenses, primarily from outside services and professional fees, is primarily related to attorney costs for our intellectual property dispute with NMS. The decrease in stock-based compensation was a result of the departure of our former CEO and CFO during the first quarter of 2026, resulting in lower ongoing equity award expense.

Current report

Research and development expenses decreased by $9.4 million for the six months ended June 30, 2026, compared to the same period in 2025. The overall decrease of research and development expenses was related to the completion of clinical trials, as well as fewer patients still on treatment in our Phase 2 mCRC trial, and a reduction in pre-clinical activities as we focus on our upcoming Phase 3 mCRC trial.

Current report

Subsequent to quarter end, on July 14, 2026, we completed a registered direct offering that generated gross proceeds of approximately $10.1 million. See Note 7, Subsequent Events, for additional information.
Removed paragraphs (12)

Previous report

Data provided in the press release dated January 27, 2026 included updated data from the ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC. The 30 mg onvansertib + FOLFIRI/bev arm achieved a confirmed objective response rate (“ORR”) if 72.2% compared to 43.2% across the combined SoC arms. The 30 mg onvansertib dose in combination with FOLFIRI/bev also demonstrated marked improvement in progression-free survival (“PFS”) versus FOLFIRI/bev (HR: 0.38) and combined SoC of FOLFOX/bev and FOLFIRI/bev (HR: 0.37, p<0.05), with no significant added toxicity observed. The results as of the data cut-off date of January 22, 2026, are shown below.

Previous report

Bev=bevacizumab; BICR=Blinded Independent Central Review; CI=confidence interval; HR=hazard ratio; NR=not reached; Onv=onvansertib; ORR=objective response rate; PFS=progression-free survival; SoC=standard of care.

Previous report

b Progressive disease events were based on combined BICR and Investigator assessments due to very small number of events in BICR assessment. The earliest reported date was used for a conservative estimate.

Previous report

c SoC is the combination of the FOLFIRI/bev and FOLFOX/bev arms

Previous report

d PFS HR is the comparison of the onvansertib arm to FOLFIRI/bev

Previous report

We will report detailed updated data from our randomized Phase 2 CRDF-004 trial evaluating onvansertib in combination with FOLFIRI/bev or FOLFOX/bev in patients with first-line RAS-mutated mCRC in a rapid oral presentation at the ASCO Annual Meeting, taking place May 29–June 2 in Chicago.

Previous report

Completed End-of-Phase 2 Meeting with the FDA and Aligned on the Design of the Phase 3 Registrational Trial in Patients with First-line RAS-mutated mCRC

Previous report

In consultation with the U.S. Food and Drug Administration (FDA), Cardiff selected the 30 mg dose of onvansertib for evaluation with FOLFIRI/bev chemotherapy regimen for the Phase 3 trial in patients with first-line RAS-mutated mCRC. Additional details of the clinical trial will be shared by mid-2026.
Reworded paragraphs (23)

Previous wording

We are a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology drug target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer ("mCRC"), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through investigator-initiated trials such as metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), and metastatic triple negative breast cancer ("mTNBC"). Additionally, onvansertib has also shown robust single agent activity in an investigator-initiated trial in chronic myelomonocytic leukemia ("CMML"). These programs and our broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver improved clinical outcomes in patients. Our clinical development programs incorporate tumor genomics and biomarker assays to refine patient selection and assessment of patient response to treatment.

Current wording

We are a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology drug target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer ("mCRC"), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through investigator-initiated trials such as metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), and metastatic triple negative breast cancer ("mTNBC"). Additionally, onvansertib has also shown promising single agent activity in an ongoing investigator-initiated trial in chronic myelomonocytic leukemia ("CMML"). These programs and our broader development strategy are designed to target tumor vulnerabilities and deliver improved clinical outcomes in patients with cancer. Our clinical development programs incorporate tumor genomics and biomarker assays to refine patient selection and assessment of patient response to treatment.

Previous wording

In addition, in vivo combination studies have confirmed the positive results obtainedin vitro and additive or synergistic effects on efficacy have been observed in xenograft models of onvansertib in combination with irinotecan, 5-fluorouracil ("5-FU"), abiraterone, PARP inhibitors, venetoclax, paclitaxel, or bevacizumab. Combining onvansertib with standard of care ("SoC") cancer agents may provide opportunities for synergy with many cancer therapies.

Current wording

In addition, in vivo combination studies have confirmed the positive results obtainedin vitro and additive or synergistic effects on efficacy have been observed in xenograft models of onvansertib in combination with irinotecan, 5-fluorouracil ("5-FU"), abiraterone, PARP inhibitors, venetoclax, paclitaxel, and bevacizumab ("bev"). Combining onvansertib with standard of care ("SoC") cancer agents may provide opportunities for synergy with many cancer therapies.

Previous wording

There are several ongoing clinical trials of onvansertib in multiple indications: one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, and investigator-initiated trials in first-line mPDAC, first-line CMML as monotherapy, second-line relapsed SCLC as monotherapy, and second-line unresectable locally advanced or metastatic TNBC.

Current wording

There are ongoing clinical trials of onvansertib in select cancer indications: one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, and investigator-initiated trials in first-line mPDAC, relapsed / refractory or advanced CMML as monotherapy, second-line relapsed SCLC as monotherapy, and second-line unresectable locally advanced or metastatic TNBC.

Previous wording

CRDF-004 is a Phase 2, randomized, open label multi-center clinical trial to assess the efficacy of two different 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 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, 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.

Current wording

CRDF-004 is a Phase 2, randomized, open label multi-center clinical trial to assess the efficacy of two different doses of onvansertib (20 mg and 30 mg) in combination with FOLFIRI/bev or FOLFOX/bev, compared with FOLFIRI/bev or FOLFOX/bev SoC alone, for the treatment of 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, pharmacodynamics and safety assessments. The primary goal of the clinical trial is to select the safe and efficacious dose of onvansertib plus appropriate standard of care regimen for the Phase 3 trial based on a benefit-risk assessment of the totality of the evidence, including numerical differences between the onvansertib and SoC arms. The trial has enrolled 110 patients in the intent-to-treat ("ITT") population and is being 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

We support certain investigator-initiated trials by supplying onvansertib to academic clinicians who conduct clinical trials independently. These studies allow us to tap into the expertise of independent clinicians and academic investigators to explore new therapeutic indications or new dosage regimens at a low cost to us. By facilitating independent research, we have the opportunity to gain valuable evidence and safety data that can inform future regulatory decisions or improve our understanding of onvansertib’s efficacy. Furthermore, supporting investigator-initiated trials acts as a collaborative effort that strengthens relationships with KOLs.

Current wording

We support certain investigator-initiated trials by supplying onvansertib to academic clinicians who conduct clinical trials independently. These studies allow us to tap into the expertise of independent clinicians and academic investigators to explore new therapeutic indications or new dosage regimens at a low cost to us. By facilitating independent research, we have the opportunity to gain valuable evidence and safety data that can inform future regulatory decisions or improve our understanding of onvansertib’s efficacy. Furthermore, supporting investigator-initiated trials act as a collaborative effort that strengthens relationships with KOLs.

Previous wording

In February 2024, the FDA approved NALIRIFOX as a first-line treatment option for mPDAC. As a result, we are currently supporting an investigator-initiated mPDAC Phase 1b/2 trial of onvansertib in combination with first-line SoC NALIRIFOX, which is open for enrollment at the University of Kansas Medical Center. For more information, please visit NCT06736717 at www.clinicaltrials.gov.

Current wording

In February 2024, the FDA approved NALIRIFOX as a first-line treatment option for mPDAC. As a result, we are currently supporting an investigator-initiated mPDAC Phase 1b/2 trial of onvansertib in combination with first-line SoC NALIRIFOX, at the University of Kansas Medical Center. The trail has completed enrollment, and data will be disclosed by the investigator after completion of the trial. For more information, please visit NCT06736717 at www.clinicaltrials.gov.

Previous 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 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 PFS, Disease Control Rate ("DCR"), as well as 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 OS. 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 at the University of Maryland, Baltimore completed enrollment of 15 patients in Stage 1, with the study proceeding to Stage 2 if two 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

Collectively, this clinical data further supports the potential exploration of the combination of onvansertib plus paclitaxel for the treatment of mTNBC.

Current wording

These clinical data further support the potential exploration of the combination of onvansertib plus paclitaxel for the treatment of mTNBC.

Previous wording

This phase 1 trial is designed to evaluate the safety, effectiveness, and best dose of onvansertib as a monotherapy for the treatment of patients with CMML and Myelodysplastic syndrome/myeloproliferative neoplasm ("MDS/MPN") overlap neoplasms that has come back (recurrent) or that does not respond to treatment (refractory). For more information, please visit NCT05549661 atwww.clinicialtrials.gov.

Current wording

This Phase 1 trial is designed to evaluate the safety, effectiveness, and best dose of onvansertib as a monotherapy for the treatment of patients with CMML and Myelodysplastic syndrome/myeloproliferative neoplasm ("MDS/MPN") overlap neoplasms that have come back (recurrent) or that do not respond to treatment (refractory). For more information, please visit NCT05549661 atwww.clinicialtrials.gov.

Previous wording

On April 9, 2026, we announced the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO. She will continue as a member of the Board of Directors. We also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect Cardiff's commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential.

Current wording

On April 9, 2026, we announced the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO. She will continue as a member of the Board of Directors. We also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect our commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential.

Previous wording

Research and development expenses decreased by $3.7 million for the three months ended March 31, 2026, compared to the same period in 2025. The overall decrease in expenses was primarily due to a reduction in clinical trial expenses and a decrease in preclinical activities.

Current wording

Research and development expenses decreased by $5.7 million for the three months ended June 30, 2026, compared to the same period in 2025. The overall decrease of research and development expenses was related to the completion of clinical trials, as well as fewer patients still on treatment in our Phase 2 mCRC trial, and a reduction in pre-clinical activities as we focus on our upcoming Phase 3 mCRC trial.

Previous wording

Interest income, net was $0.5 million for the three months ended March 31, 2026 as compared to $0.9 million for the same period of 2025. 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 $0.4 million for the three months ended June 30, 2026 as compared to $0.8 million for the same period of 2025. 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 $41,000 for the three months ended March 31, 2026, as compared to $109,000 for the same period in 2025. 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 $0.1 million for the six months ended June 30, 2026, as compared to $0.2 million for the same period in 2025. 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 $2.1 million for the three months ended March 31, 2026, compared to the same period in 2025. The overall increase in expenses was primarily from employee severance agreements recorded to salaries and staff costs within the current period. The increase in stock based compensation was due the modification of stock options from employee severance agreements.

Current wording

Selling, general and administrative expenses increased by $2.6 million for the six months ended June 30, 2026, compared to the same period in 2025. The overall increase in expenses was primarily from employee severance agreements recorded to salaries and staff costs within the current period. The increase in outside services and professional fees is primarily related to attorney costs for our intellectual property dispute with NMS.

Previous wording

As of March 31, 2026, and December 31, 2025, we had working capital of $32.9 million and $43.7 million, respectively.

Current wording

As of June 30, 2026, and December 31, 2025, we had working capital of $24.8 million and $43.7 million, respectively.

Previous wording

We have incurred net losses since our inception and have negative operating cash flows. As of March 31, 2026, we had $46.1 million in cash, cash equivalents and short-term investments. Based on our current projections, we expect that our capital resources are sufficient to fund our operations into the first quarter of 2027, which is not sufficient to meet our funding requirements for at least the next 12 months following the issuance of our financial statements. Management has performed an analysis and concluded that there exists a substantial doubt about our ability to continue as a going concern, see Note 1 Business Organization and Overview - Going Concern Uncertainty to the financial statements for additional details.

Current wording

We have incurred net losses since our inception and have negative operating cash flows. As of June 30, 2026, we had $34.5 million in cash, cash equivalents and short-term investments. Based on our current projections, we expect that our capital resources are sufficient to fund our operations into the third quarter of 2027, which is not sufficient to meet our funding requirements for at least the next 12 months following the issuance of our financial statements. Management has performed an analysis and concluded that there exists a substantial doubt about our ability to continue as a going concern, see Note 1 Business Organization and Overview - Going Concern Uncertainty to the financial statements for additional details.

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 decreased cash used in operations by $0.8 million.

Current wording

Net cash used in operating activities for the six months ended June 30, 2026, was $24.1 million. Our primary use of cash was from our net loss of $21.6 million, adjusted for non-cash items of $2.9 million primarily related to stock-based compensation. The net change in our operating assets and liabilities increased cash used in operations by $5.3 million.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2026, was $12.3 million. Our primary use of cash was from our net loss of $12.3 million, adjusted for non-cash items of $1.8 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $1.7 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 provided by investing activities for the three months ended March 31, 2026 was $3.3 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, 2026 was $15.5 million, primarily related to maturities in excess of purchases of marketable securities.

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 and sales 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 financing activities for the three months ended March 31, 2026 was $105,000, from employee stock options exercises.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $254,000, from sales of common stock, warrants and employee stock options exercises.

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.
Rearranged current paragraphs (5)

Current report — wording carried from elsewhere

Total revenues were $0.1 million for the three months ended June 30, 2026, as compared to $0.1 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, 2026 and 2025

Current report — wording carried from elsewhere

Research and development expenses consisted of the following:

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 $0.9 million for the six months ended June 30, 2026 as compared to $1.8 million for the same period of 2025. 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.