Cardiff Oncology, Inc.

Cardiff Oncology, Inc. is 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. The company focuses its clinical program in indications such as RAS-mutated metastatic colorectal cancer (mCRC), as well as investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), metastatic triple negative breast cancer (mTNBC) and Chronic Myelomonocytic Leukemia (CMML). The American Cancer Society's estimates for the number of CRC diagnoses expected in the US in 2026 are 108,860 new cases of colon cancer and 49,990 new cases of rectal cancer, with an estimated 55,230 deaths predicted during 2026. RAS mutations in the CRC population are common, with greater than 50% of tumors from CRC patients harboring a RAS mutation (43% KRAS, 9% NRAS).

Onvansertib is not the first PLK inhibitor that has entered clinical development; however, the company believes it currently is the only oral PLK1 inhibitor in active clinical development that delivers highly selective PLK1 inhibition. The PLK inhibitor that reached the latest stage of clinical development (Phase 3) is volasertib, a pan-PLK inhibitor developed by Boehringer Ingelheim, which did not meet the primary endpoint of ORR. One additional PLK1 inhibitor in early-stage clinical development is plogosertib, which is being developed by Cyclacel. The competitive landscape in mCRC includes approved and investigational therapies, including BMS's KRAZATI (adagrasib), which has received accelerated FDA approval for previously treated KRAS G12C-mutated locally advanced or mCRC, as well as ongoing clinical trials sponsored by Amgen, Pfizer, BMS, and Summit Therapeutics evaluating targeted and immuno-oncology approaches focusing on KRAS G12C inhibitors, ID-1/VEGF and PD-L1/VEGF.

The company generates revenue from 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. The company operates in one business segment, using one measurement of profitability to manage its business, and does not assess the performance of geographic regions on measures of revenue or comprehensive income (loss) or expense.

Onvansertib is an oral, small molecule drug candidate that is highly specific for PLK1 inhibition with a 24-hour half-life. Onvansertib is highly potent and highly selective against the PLK1 enzyme (IC50 = 2nM), compared to prior PLK1 inhibitors that were pan-inhibitors of several PLK targets, with low or no activity observed on a panel of 63 kinases (IC50 >500 nM), including the PLK members PLK2 and PLK3 (IC50 >10,000 nM). In vitro studies have shown synergistic effects when onvansertib was administered in combination with different cytotoxic agents including microtubule-targeting agents, topoisomerase 1 inhibitors, antimetabolites, alkylating agents, proteasome inhibitors, kinase inhibitors, PARP inhibitors, BCL-2 inhibitors, and androgen biosynthesis inhibitors. The CRDF-004 trial 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. The trial enrolled 110 patients in the intent-to-treat (ITT) population and is conducted in partnership with Pfizer Ignite. 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, with results as of the data cut-off date of January 22, 2026 showing for the Onv 30 mg +FOLFIRI/bev arm a Confirmed ORR of 72.2% ¹ (p-value = 0.051 ² vs SoC), a PFS HR of 0.37 ³ (0.13-1.02) ⁴ vs SoC (p-value = 0.048 ⁵ vs SoC), and a PFS Rate at 6 months of 94.1% ⁶ (83.6-100) ⁷. In the investigator-initiated Phase 1b trial in mTNBC at Dana Farber Cancer Institute, onvansertib in combination with paclitaxel demonstrated 40% ⁸ objective response rate by RECIST 1.1 at RP2D of 18mg/m2 ⁹ (n=10) ¹⁰, with two confirmed partial responses and two unconfirmed partial responses. Data presented at the American Society of Hematology (ASH) meeting on December 8, 2025, from the ongoing Phase 1 dose-escalation trial in CMML (N=9) ¹¹ showed that onvansertib monotherapy was generally well tolerated and demonstrated preliminary efficacy in approximately 40% ¹² of patients.

As of December 31, 2025, the company's owned and licensed intellectual property included 51 ¹³ issued patents and 65 ¹⁴ pending patent applications in the U.S. and abroad. The owned intellectual property includes twenty-five patent families relating to onvansertib. One of the patent families includes U.S. Patent Nos. 12,144,813 and 12,263,173 with an expected expiration date of no earlier than 2043 ¹⁵. Additional families are directed to treating cancer using PLK1 inhibitors and determining efficacy of the treatment, treating benign prostatic hyperplasia using onvansertib, treating prostate cancer using PLK1 inhibitors, determining or predicting efficacies or responsiveness of PLK1 inhibitor treatments based on biomarkers, and treating cancers with combination therapies of PLK1 inhibitors. Any patents issued in these families will expire between 2039 ¹⁶ and 2045 ¹⁷. The intellectual property includes two patent families licensed from MIT, with one family relating to the combination of a PLK inhibitor and an anti-androgen or androgen antagonist including U.S. Patent Nos. 9,566,280, 10,155,006, 10,772,898, and 12,115,171 which will expire in 2035 ¹⁸. The intellectual property includes three patent families licensed from Nerviano Medical Sciences (NMS), with patents of this licensed portfolio expiring between 2027 ¹⁹ and 2030 ²⁰, and U.S. patents expiring in 2030 ²¹ with patent term extension up to 2035 ²². On February 18, 2026, Nerviano sent the company a written notice alleging material breach of the license agreement with respect to (i) alleged joint ownership of certain of the company's U.S. patents nos. 12.144.813 and 12.263.173 (the Cardiff Patents) and (ii) the filing of a joint invention continuation patent application.

In November 2021, the company entered into a Securities Purchase Agreement with Pfizer Inc., as part of the Pfizer Breakthrough Growth Initiative, pursuant to which Pfizer purchased 2.4 million ²³ shares of the company's common stock at a purchase price per share of $6.22 ²⁴ for gross proceeds of approximately $15.0 million ²⁵. In August 2023, the company announced that Pfizer Ignite will be responsible for the clinical activities of the new CRDF-004 trial in first-line RAS-mutated mCRC. On January 27, 2026, the company announced that Mani Mohindru, PhD, a member of the Board of Directors since 2021, has been appointed interim Chief Executive Officer, effective immediately, and that Mark Erlander, PhD, Chief Executive Officer, and James Levine, Chief Financial Officer, have stepped down from their respective roles, with Brigitte Lindsay promoted to the role of Chief Accounting Officer.

Total revenues were $0.6 million ²⁶ for the year ended December 31, 2025, as compared to $0.7 million ²⁷ for the same period in 2024. Research and development expenses decreased by $1.5 million ²⁸ for the year ended December 31, 2025, compared to the same period in 2024, totaling $35.329 million ²⁹ versus $36.852 million ³⁰. Selling, general and administrative expenses increased by $1.7 million ³¹ for the year ended December 31, 2025, compared to the same period in 2024, totaling $14.224 million ³² versus $12.482 million ³³. Interest income was $3.1 million ³⁴ for the year ended December 31, 2025 as compared to $3.3 million ³⁵ for the same period of 2024. Net loss was $45.851 million ³⁶ for the year ended December 31, 2025, compared to $45.431 million ³⁷ for the year ended December 31, 2024. Net loss attributable to common stockholders was $45.876 million ³⁸ for the year ended December 31, 2025, compared to $45.455 million ³⁹ for the year ended December 31, 2024. Net loss per common share — basic and diluted was $(0.69) ⁴⁰ for the year ended December 31, 2025, compared to $(0.95) ⁴¹ for the year ended December 31, 2024.

The company's primary growth vector is the advancement of onvansertib through clinical development, particularly the CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC. Contingent upon the results of CRDF-004, the company plans 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. The complete Phase 3 trial design will be finalized after discussion with the FDA upon sharing the full CRDF-004 trial results. The company is also supporting investigator-initiated trials in first-line mPDAC (Phase 1b/2), relapsed SCLC (Phase 2), mTNBC (Phase 1b), and CMML (Phase 1), which represent additional growth vectors for exploring the treatment opportunity for onvansertib across multiple cancer indications.

The company is focusing on identifying biomarkers that predict patient benefit, with correlative biomarker analyses being used to help inform decisions in the evaluation of dose-response and optimal regimen for desired pharmacologic effect and safety. In the ongoing CRDF-004 clinical trial in RAS-mutated mCRC, the company is quantitatively assessing changes in the RAS mutational burden with a blood test based on ctDNA. In TROV-054, the phase 1b/2 single-arm clinical trial in KRAS-mutated metastatic colorectal cancer, decreases in KRAS Mutant Allelic Frequency (MAF) in ctDNA after the first cycle of treatment were highly predictive of subsequent radiographic response observed as tumor shrinkage.The company currently relies on third-party manufacturers and distributors to supply and distribute onvansertib used in its clinical studies and nonclinical development programs. The company continues to pursue API and drug product supply agreements with other manufacturers. As of February 19, 2026, the company had a total of 31 ⁴² employees, 30 ⁴³ of whom were full-time. The company expects to incur substantial net losses for the foreseeable future as it seeks to further develop and commercialize onvansertib.

Research and development expenses were $35.329 million ⁴⁴ for the year ended December 31, 2025. Selling, general and administrative expenses were $14.224 million ⁴⁵ for the year ended December 31, 2025. Net cash used in operating activities for the year ended December 31, 2025 was $37.923 million ⁴⁶. Net cash provided by investing activities for the year ended December 31, 2025 was $1.342 million ⁴⁷. Net cash provided by financing activities for the year ended December 31, 2025 was $2.581 million ⁴⁸. The company has not paid any dividends to the holders of shares of its common stock and does not expect to pay any such dividends in the foreseeable future. Pursuant to the terms of the outstanding shares of Series A Convertible Preferred Stock, dividends cannot be paid to the holders of shares of common stock so long as any dividends due on the Series A Convertible Preferred Stock remain unpaid.

The company faces significant headwinds as a clinical stage company that has incurred losses since its formation, with an accumulated total deficit of approximately $430.0 million ⁴⁹ as of December 31, 2025. Management has performed an analysis and concluded that there exists a substantial doubt about the company's ability to continue as a going concern. As of December 31, 2025, the company's cash, cash equivalents and short-term investments balance was approximately $58.3 million ⁵⁰ and its working capital was approximately $43.7 million ⁵¹, which is not sufficient to meet its funding requirements for at least the next 12 months following the issuance of the financial statements. The company will be required to raise additional capital to complete the development and commercialization of its current product candidate, and its ability to obtain additional financing will be subject to a number of factors, including market conditions, operating performance and investor sentiment.

The company faces execution risks related to its reliance on third-party vendors to conduct preclinical studies or clinical trials, as the company has limited resources dedicated to designing, conducting and managing these activities. The company also faces risks related to the lengthy and expensive regulatory approval processes of the FDA and comparable foreign authorities, which are inherently unpredictable. The company's product candidate, onvansertib, is in the early-mid stages of clinical development and its commercial viability remains subject to current and future preclinical studies, clinical trials, regulatory approvals and the risks generally inherent in the development of a pharmaceutical product candidate.

The company is a clinical stage company and has incurred losses since its formation, with an accumulated total deficit of approximately $430.0 million ⁵² as of December 31, 2025, and may never earn a profit. Management has concluded that there exists a substantial doubt about the company's ability to continue as a going concern, as its cash, cash equivalents and short-term investments balance of approximately $58.3 million ⁵³ and working capital of approximately $43.7 million ⁵⁴ as of December 31, 2025 are not sufficient to meet funding requirements for at least the next 12 months. The company's product candidate, onvansertib, is in the early-mid stages of clinical development and its commercial viability remains subject to current and future preclinical studies, clinical trials, regulatory approvals and the risks generally inherent in the development of a pharmaceutical product candidate. On February 18, 2026, Nerviano sent the company a written notice alleging material breach of the license agreement with respect to (i) alleged joint ownership of certain of the company's U.S. patents nos. 12.144.813 and 12.263.173 and (ii) the filing of a joint invention continuation patent application; if the company is unable to cure or successfully dispute the alleged breach, Nerviano may have the right to terminate the license agreement, which would have a material adverse effect on the company's business, financial condition, and results of operations. The company faces competition from established pharmaceutical and biotechnology companies with significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products.

Management's message emphasizes the company's focus on leveraging PLK1 inhibition to develop novel therapies across a range of cancers with the greatest unmet medical need, targeting tumor vulnerabilities with treatment combinations of onvansertib and standard-of-care therapeutics. The company is focusing its clinical program in indications such as RAS-mutated mCRC, as well as investigator-initiated trials in mPDAC, SCLC, mTNBC and CMML. The strategic priorities emphasized for the period ahead include advancing the CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC, with the plan to initiate CRDF-005, a Phase 3, randomized trial with registrational intent contingent upon the results of CRDF-004. The company also continues to support investigator-initiated trials across multiple indications and is focusing on identifying biomarkers that predict patient benefit through correlative biomarker analyses.