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What changed in Cardiff Oncology, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Cardiff Oncology, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+189 added−171 removedSource: 10-K (2026-02-24) vs 10-K (2025-02-27)

Top changes in Cardiff Oncology, Inc.'s 2025 10-K

189 paragraphs added · 171 removed · 128 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

47 edited+20 added−25 removed99 unchanged
Biggest changeFailure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending New Drug Applications (“NDAs”) or Biologics License Applications (“BLAs”) warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, and criminal prosecution. 11 Pharmaceutical product development in the United States typically involves preclinical laboratory and animal tests, the submission to the FDA of an Investigational New Drug Application ("IND"), which must become effective before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug or biologic for each indication for which FDA approval is sought.
Biggest changeFailure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending New Drug Applications (“NDAs”) or Biologics License Applications (“BLAs”) warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, and criminal prosecution.
The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) which, among other things, imposes criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal 14 laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements or representations, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of, or payment for, benefits, items or services.
The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) which, among other things, imposes criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements or representations, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of, or payment for, benefits, items or services.
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); • Onvansertib is orally bioavailable, allowing for relative ease and flexibility of dosing; • Onvansertib has a relatively short drug half-life of 24 hours, allowing for flexible dosing and scheduling that has demonstrated a favorable safety profile across multiple clinical trials.
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); • Onvansertib is orally bioavailable, allowing for relative ease and flexibility of dosing; • Onvansertib has a relatively short drug half-life of 24 hours, allowing for flexible dosing and scheduling that has demonstrated a favorable safety profile across multiple clinical trials.
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount 16 program with a new discounting program (beginning in 2025).
Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Ensuring that business arrangements with third parties comply with applicable healthcare laws and regulations is costly and time consuming.
Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. 15 Ensuring that business arrangements with third parties comply with applicable healthcare laws and regulations is costly and time consuming.
In addition, until May 17, 2024 we agreed to provide Pfizer with rights of first access to any pre-clinical or final clinical data and results generated as part of the onvansertib development program at least two business days prior to us providing such data to a third party.
In addition, until May 17, 2024 we agreed to 9 provide Pfizer with rights of first access to any pre-clinical or final clinical data and results generated as part of the onvansertib development program at least two business days prior to us providing such data to a third party.
The FDA has 12 agreed to certain performance goals in the review of marketing applications. Most such applications for non-priority drug products are reviewed within ten months. The review process may be extended by the FDA for three additional months to consider new information submitted during the review or clarification regarding information already provided in the submission.
The FDA has agreed to certain performance goals in the review of marketing applications. Most such applications for non-priority drug products are reviewed within ten months. The review process may be extended by the FDA for three additional months to consider new information submitted during the review or clarification regarding information already provided in the submission.
Therefore, improving the treatment options and effectiveness of treatment is critical to changing the outcomes for the RAS-mutated patient population. Additional Cancer Indications We and certain investigators are currently conducting signal-finding clinical trials to explore the treatment opportunity for onvansertib in mPDAC, SCLC and TNBC. Collaborative Relationship Pfizer, Inc.
Therefore, improving the treatment options and effectiveness of treatment is critical to changing the outcomes for the RAS-mutated patient population. Additional Cancer Indications We and certain investigators are currently conducting signal-finding clinical trials to explore the treatment opportunity for onvansertib in mPDAC, SCLC, TNBC and CMML. Collaborative Relationship Pfizer, Inc.
In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine which drugs 16 and suppliers will be included in their healthcare programs. Furthermore, there has been increased interest by third party payors and governmental authorities in reference pricing systems and publication of discounts and list prices.
In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine which drugs and suppliers will be included in their healthcare programs. Furthermore, there has been increased interest by third party payors and governmental authorities in reference pricing systems and publication of discounts and list prices.
We do not assess the performance of geographic regions on measures of revenue or comprehensive income or expense. In addition, all of our principal operations, assets and decision-making functions are located in the U.S. We do not produce reports for, or measure the performance of, geographic regions on any asset-based metrics.
We do not assess the performance of geographic regions on measures of revenue or comprehensive income (loss) or expense. In addition, all of our principal operations, assets and decision-making functions are located in the U.S. We do not produce reports for, or measure the performance of, geographic regions on any asset-based metrics.
The FDC Act and other federal and state statutes and regulations govern the testing, manufacturing, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our products. As a result of these laws and regulations, product development and product approval processes are very expensive and time-consuming.
The FDC Act and other federal and state statutes and regulations govern the testing, manufacturing, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our products. As a result of 11 these laws and regulations, product development and product approval processes are very expensive and time-consuming.
The PLK inhibitor that reached the latest stage of clinical development (Phase 3), is volasertib, a pan-PLK inhibitor developed by Boehringer Ingelheim. Boehringer Ingelheim was developing volasertib plus LDAC for the 17 treatment of AML which did not meet the primary endpoint of ORR (EHA 2016).
The PLK inhibitor that reached the latest stage of clinical development (Phase 3), is volasertib, a pan-PLK inhibitor developed by Boehringer Ingelheim. Boehringer Ingelheim was developing volasertib plus LDAC for the treatment of AML which did not meet the primary endpoint of ORR (EHA 2016).
Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new BLA or BLA supplement, before the change can be implemented.
Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new BLA 13 or BLA supplement, before the change can be implemented.
Manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA during which the agency inspects manufacturing facilities 13 to assess compliance with CGMPs.
Manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA during which the agency inspects manufacturing facilities to assess compliance with CGMPs.
As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government.
As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” 14 for money or property presented to the U.S. government.
Competition Onvansertib is not the first PLK inhibitor that has entered clinical development; however, we believe it currently is the only oral PLK1 inhibitor in active clinical development that delivers highly selective PLK1 inhibition.
Competition 17 Onvansertib is not the first PLK inhibitor that has entered clinical development; however, we believe it currently is the only oral PLK1 inhibitor in active clinical development that delivers highly selective PLK1 inhibition.
Currently Nicholas Choong, 9 MD, Vice President of Clinical Development and Therapeutic Area Head of GI cancers, Gynecologic cancers and Melanoma is Pfizer's designee to our Scientific Advisory Board.
Currently Nicholas Choong, MD, Vice President of Clinical Development and Therapeutic Area Head of GI cancers, Gynecologic cancers and Melanoma is Pfizer's designee to our Scientific Advisory Board.
Onvansertib is also synergistic in combination with numerous chemotherapies and targeted therapeutics and may enhance and/or extend response to treatment across a number of solid tumor cancers. Over 380 patients have been dosed with onvansertib across multiple clinical programs and onvansertib was shown to be well-tolerated when dosed as a single agent or in combination with other therapies.
Onvansertib is also synergistic in combination with numerous chemotherapies and targeted therapeutics and may enhance and/or extend response to treatment across a number of solid tumor cancers. Over 400 patients have been dosed with onvansertib across multiple clinical programs and onvansertib was shown to be well-tolerated when dosed as a single agent or in combination with other therapies.
There are several ongoing and planned 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, relapsed SCLC and unresectable locally advanced or metastatic TNBC.
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, relapsed SCLC, unresectable locally advanced or metastatic TNBC and CMML.
We licensed onvansertib from Nerviano Medical Sciences ("NMS" or "Nerviano") pursuant to a license agreement with NMS dated March 13, 2017 which grants us exclusive, worldwide rights under a portfolio of three patent families of U.S. and foreign patents covering three broad areas: (1) onvansertib (composition of matter), related compounds and processes for making compounds; pharmaceutical compositions and methods of treating diseases characterized by dysregulated protein kinase activity; (2) salts and pharmaceutical compositions of onvansertib; methods of treating mammals in need of PLK inhibition; and (3) synergistic combinations of onvansertib and one or more of a broad range of antineoplastic agents, and pharmaceutical compositions of those combinations.
We licensed onvansertib from NMS pursuant to a license agreement dated March 13, 2017 which grants us exclusive, worldwide rights under a portfolio of three patent families of U.S. and foreign patents covering three broad areas: (1) onvansertib (composition of matter), related compounds and processes for making compounds; pharmaceutical compositions and methods of treating diseases characterized by dysregulated protein kinase activity; (2) salts and pharmaceutical compositions of onvansertib; methods of treating mammals in need of PLK inhibition; and (3) synergistic combinations of onvansertib and one or more of a broad range of antineoplastic agents, and pharmaceutical compositions of those combinations.
As a result, we are currently supporting a new investigator-initiated mPDAC Phase 1b/2 trial of onvansertib in combination with first-line SoC NALIRIFOX, which is now open for enrollment at the University of Kansas Medical Center. The trial replaced a previously planned two-cohort, non-randomized Phase 2 trial of onvansertib in combination with first-line SoC Gemzar ® and Abraxane ® .
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 now open for enrollment at the University of Kansas Medical Center. The trial 7 replaced a previously planned two-cohort, non-randomized Phase 2 trial of onvansertib in combination with first-line SoC Gemzar ® and Abraxane ® .
For more information, please visit NCT06736717 at www.clinicaltrials.gov. The primary objective in this study is to determine anti-tumor activity by measuring Overall Response Rate (ORR).
For more information, please visit NCT06736717 at www.clinicaltrials.gov. The primary objective in this study is to determine anti-tumor activity by measuring ORR.
Patent No. 9,566,280 encompasses using abiraterone in combination with onvansertib to treat cancer. U.S. Patent Nos. 10,155,006, 10,772,898 and 12,115,171 broaden earlier issued U.S.
Patent Nos. 9,566,280, 10,155,006, 10,772,898, and 12,115,171 which will expire in 2035. U.S. Patent No. 9,566,280 encompasses using abiraterone in combination with onvansertib to treat cancer. U.S. Patent Nos. 10,155,006, 10,772,898 and 12,115,171 broaden earlier issued U.S.
We believe our management team has the experience necessary to effectively implement our growth strategy and continue to drive shareholder value. We provide competitive compensation and benefits to attract and retain key personnel, while also providing a safe, inclusive and respectful workplace. As of February 20, 2025, we had a total of 33 employees, 32 of whom were full-time.
We believe our management team has the experience necessary to effectively implement our growth strategy and continue to drive shareholder value. We provide competitive compensation and benefits to attract and retain key personnel, while also providing a safe, inclusive and respectful workplace. As of February 19, 2026, we had a total of 31 employees, 30 of whom were full-time.
On September 19, 2018, we entered into an Exclusive Patent License Agreement with MIT to a patent family directed to combination therapies including an antiandrogen or androgen antagonist and a polo-like kinase inhibitor (such as onvansertib) for the treatment of cancer.
On September 19, 2018, we entered into an Exclusive Patent License Agreement with MIT to a patent family directed to combination therapies including an antiandrogen or androgen antagonist and a polo-like kinase inhibitor (such as onvansertib) for the treatment of cancer. The license agreement as amended covers the rights to develop combination therapies, expanding potential indications for onvansertib.
These families include patent applications 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 (including combination therapies of PLK1 inhibitors with B-cell lymphoma 2 inhibitors, poly ADP ribose polymerase inhibitors, fibroblast growth factor receptor 10 inhibitors, lysine-specific demethylase 1 inhibitors, irinotecan, MTDP inhibitors, or anti-agiogenics).
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 (including combination therapies of PLK1 inhibitors with B-cell lymphoma 2 inhibitors, poly ADP ribose polymerase inhibitors, fibroblast growth factor receptor inhibitors, lysine-specific demethylase 1 inhibitors, irinotecan, MTDP inhibitors, anti-angiogenics, cell cycle inhibitors, phosphoinositide 3-kinase inhibitors, Akt (protein kinase B) inhibitors).
Plogosertib has primary selectivity for PLK1 and secondary selectivity for PLK2 and PLK3. Human Capital The human capital objectives we focus on in managing our business include attracting, developing, and retaining key personnel. Our employees are critical to the success of our organization and we are committed to supporting our employees’ professional development.
Human Capital The human capital objectives we focus on in managing our business include attracting, developing, and retaining key personnel. Our employees are critical to the success of our organization and we are committed to supporting our employees’ professional development.
This trial is conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies, and it is expected to enroll approximately 90 evaluable patients. For more information, please visit NCT06106308 at www.clinicialtrials.gov . 5 Contingent upon the results of CRDF-004, we plan to initiate CRDF-005, a Phase 3, randomized trial with registrational intent.
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 at www.clinicialtrials.gov . Contingent upon the results of CRDF-004, we plan to initiate CRDF-005, a Phase 3, randomized trial with registrational intent.
If business operations are found to be in violation of any of the laws described above or any other applicable governmental regulations a pharmaceutical manufacturer may be subject to penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from governmental funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, diminished profits and future earnings, additional reporting obligations and oversight if subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and curtailment or restructuring of operations, any of which could adversely affect a pharmaceutical manufacturer’s ability to operate its business and the results of its operations. 15 Healthcare Reform in the United States Among policy makers and payors in the United States, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access.
If business operations are found to be in violation of any of the laws described above or any other applicable governmental regulations a pharmaceutical manufacturer may be subject to penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from governmental funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, diminished profits and future earnings, additional reporting obligations and oversight if subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and curtailment or restructuring of operations, any of which could adversely affect a pharmaceutical manufacturer’s ability to operate its business and the results of its operations.
Patent No. 9,566,280, by expanding the use of onvansertib to encompass combination therapies with any anti-androgen and androgen antagonist drug, such as Zytiga ® , Xtandi ® and Erleada ® for the treatment of cancer, including metastatic and non-metastatic castrate-resistant prostate cancer. Our owned intellectual property includes twenty-eight patent families related to onvansertib.
Patent No. 9,566,280, by expanding the use of onvansertib to encompass combination therapies with any anti-androgen and androgen antagonist drug, such as Zytiga®, Xtandi® and Erleada® for the treatment of cancer, including metastatic and non-metastatic castrate-resistant prostate cancer. 10 Our intellectual property includes three patent families licensed from Nerviano Medical Sciences ("NMS" or "Nerviano").
The American Cancer Society's estimates for the number of CRC diagnoses expected in the US in 2025 are 107,320 new cases of colon cancer and 46,950 new cases of rectal cancer, with an estimated 52,900 deaths predicted during 2025. Cancer‑specific mortality of CRC is predominantly due to metastatic disease.
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. Cancer‑specific mortality of CRC is predominantly due to metastatic disease.
If an investigational drug demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 clinical trials are undertaken to obtain additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the investigational drug and to provide adequate information for its labeling.
In the case of product candidates for severe or life-threatening diseases such as cancer, the initial human testing is often conducted in patients rather than in healthy volunteers. 12 If an investigational drug demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 clinical trials are undertaken to obtain additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the investigational drug and to provide adequate information for its labeling.
Identifying Biomarkers that Predict Patient Benefit Our laboratory in San Diego, California, enables us to optimize drug development and patient care. In the clinical development of our lead drug candidate, onvansertib, correlative biomarker analyses are being used to help inform decisions in the evaluation of dose-response and optimal regimen for desired pharmacologic effect and safety.
In the clinical development of our lead drug candidate, onvansertib, correlative biomarker analyses are being used to help inform decisions in the evaluation of dose-response and optimal regimen for desired pharmacologic effect and safety.
RAS-mutated mCRC Program: CRDF-004 Randomized Clinical Trial in First-Line RAS-mutated mCRC 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.
RAS-mutated mCRC Program: CRDF-004 Randomized Clinical Trial in First-Line RAS-mutated mCRC 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.
Other Clinical Programs: Phase 2 Investigator-Initiated Clinical Trial in SCLC 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.
Phase 2 Investigator-Initiated Clinical Trial in SCLC 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.
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 trend in overall survival being the endpoints for full approval.
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 disease control rate (“DCR”), including PR and SD, is 57% (4 of 7 patients). Phase 1b Investigator-Initiated Clinical Trial in TNBC 8 A single-arm, Phase 1b trial of onvansertib in combination with paclitaxel in patients with unresectable locally advanced or metastatic TNBC is open for enrollment at Dana Farber Cancer Institute ("DFCI").
Phase 1b Investigator-Initiated Clinical Trial in mTNBC 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 claims of the patent cover the method of using onvansertib in combination with bevacizumab (bev) for the treatment of KRAS mutated metastatic colorectal cancer (mCRC) patients who have not previously been treated with bev. Another one of the patent families includes a patent application directed to selecting and treating cancers with combination therapies of PLK1 inhibitors.
The claims of these patents cover the method of using onvansertib in combination with bevacizumab (bev) for the treatment of KRAS mutated metastatic colorectal cancer (mCRC) patients who have not previously been treated with bev.
We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated ongoing or planned 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.
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"), metastatic triple negative breast cancer ("mTNBC") and Chronic Myelomonocytic Leukemia ("CMML").
Our Lead Drug Candidate, Onvansertib Onvansertib is an oral, small molecule drug candidate that is highly specific for PLK1 inhibition with a 24-hour half-life.
Our clinical development programs incorporate tumor genomics and biomarker assays to refine patient selection and assessment of patient response to treatment. Our Lead Drug Candidate, Onvansertib Onvansertib is an oral, small molecule drug candidate that is highly specific for PLK1 inhibition with a 24-hour half-life.
MIT and we co-own this family. On November 17, 2021, we amended the Exclusive Patent License Agreement with MIT to include this patent family. Wherever possible, we seek to protect our inventions by filing U.S. patent applications as well as foreign counterpart applications in select countries.
Wherever possible, we seek to protect our inventions by filing U.S. patent applications as well as foreign counterpart applications in select countries.
In Phase 1b, approximately 14-16 patients will be treated 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 at www.clinicialtrials.gov .
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.
The pending patent applications include multiple international patent applications filed under the Patent Cooperation Treaty that may be used as the basis for multiple additional patent applications worldwide.
As of December 31, 2025, our owned and licensed intellectual property included 51 issued patents and 65 pending patent applications in the U.S. and abroad. The pending patent applications include multiple international patent applications filed under the Patent Cooperation Treaty that may be used as the basis for multiple additional patent applications worldwide.
Any patents issued in these families will expire between 2039 and 2045. One of the patent families includes U.S. Patent No. 12,144,813 with an expected expiration date of no earlier than 2043.
Our 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.
For more information, please visit NCT05450965 at www.clinicialtrials.gov . 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”).
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 at www.clinicialtrials.gov . 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.
The exclusive license agreement is part of our strategy to explore the efficacy of onvansertib in combination with anti-androgen drugs in cancers including prostate, breast, pancreatic, lung and gastrointestinal. The licensed MIT patent family includes U.S. Patent Nos. 9,566,280, 10,155,006, 10,772,898, and 12,115,171 which will expire in 2035, with patent term extension up to 2040. U.S.
The exclusive license agreement is part of our strategy to explore the efficacy of onvansertib in combination with an anti-androgen drug or a microtubule polymerization inhibitor in cancers including prostate, breast, pancreatic, lung and gastrointestinal. The family relating to the combination of a PLK inhibitor and an anti-androgen or androgen antagonistincludes U.S.
In addition, these objective responses were present only in bevacizumab naïve patients randomized to the experimental arms of onvansertib in combination with FOLFIRI and bevacizumab versus bevacizumab naïve patients randomized to the FOLFIRI and bevacizumab alone control arm. 7 mPDAC Program: Phase 1b/2 Investigator-Initiated Clinical Trial in First-Line mPDAC In February 2024, the FDA approved NALIRIFOX as a first-line treatment option for mPDAC.
The patients who remain on the CRDF-004 study are continuing to be monitored for efficacy as well as safety in the ongoing trial. Other Clinical Programs: Phase 1b/2 Investigator-Initiated Clinical Trial in First-Line mPDAC In February 2024, the FDA approved NALIRIFOX as a first-line treatment option for mPDAC.
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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.
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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, 6 including numerical differences between the onvansertib and SoC arms.
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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.
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The complete Phase 3 trial design will be finalized after discussion with the FDA upon sharing the full CRDF-004 trial results. 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.
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Control Arm (SoC alone) 20mg dose of onvansertib + SoC 30mg dose of onvansertib + SoC All onvansertib patients 33% ORR (3 of 9) 50% ORR (5 of 10) 64% ORR (7 of 11) 57% ORR (12 of 21) Spider Plots, displaying the change in tumor size from baseline for each patient over time, demonstrate deeper responses observed in patients receiving the 30mg dose of onvansertib in combination with the SoC compared to both the control arms and 20mg dose of onvansertib arms.
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The results as of the data cut-off date of January 22, 2026, are shown below.
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Note: Radiographic response determined per RECIST 1.1 by blinded independent central review. Spider plot reflects interim data as of November 26, 2024 from an ongoing trial and unlocked database. Onvansertib in combination with chemo/bevacizumab was well-tolerated and there have been no major or unexpected toxicities observed.
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Parameter SoC c (FOLFIRI/bev+FOLFOX/bev) (n=37) FOLFIRI/bev (n=19) Onv 20 mg +FOLFIRI/bev (n=18) Onv 30 mg +FOLFIRI/bev (n=18) Objective Response Rate (per BICR) a Confirmed Responders 16 8 8 13 Confirmed ORR (%) 43.2 42.1 44.4 72.2 p-value = 0.051 f (vs SoC) Progression Free Survival b Median PFS (months, 95% CI) 10.97 (9.43-15.44) 10.97 (7.52-NR) NR (7.49-NR) NR (9.72-NR) PFS HR (vs FOLFIRI/bev) 0.56 (0.18-1.73) d 0.38 (0.12-1.17) d PFS HR (vs SoC) 0.57 (0.21-1.58) e 0.37 (0.13-1.02) e p-value = 0.048 g (vs SoC) PFS Rate at 6 months (95% CI) 88.8 (77.4-100) 79.5 (61.1-100) 88.1 (73.9-100) 94.1 (83.6-100) 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. a ORR is confirmed responses b Progressive disease events were based on combined BICR and Investigator assessments due to very small number of events in BICR assessment.
Removed
Phase 1b/2 Clinical Trial in Second-Line KRAS-mutated mCRC 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.
Added
The earliest reported date was used for a conservative estimate. c SoC is the combination of the FOLFIRI/bev and FOLFOX/bev arms d PFS HR is the comparison of the onvansertib arm to FOLFIRI/bev e PFS HR is the comparison of the onvansertib arm to SoC f Fisher’s exact test g Log-rank test Onvansertib in combination with chemo/bevacizumab was well-tolerated and to date there have been no major or unexpected toxicities observed.
Removed
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).
Added
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).
Removed
For more information, please visit NCT03829410 at www.clinicialtrials.gov . 6 Data presented on August 7, 2023, provided an update of the ongoing TROV-054 Phase 1b/2 single arm clinical trial in KRAS-mutated metastatic colorectal cancer: • ORR across all evaluable patients was 29%, with 19 of 66 evaluable patients achieving an objective response.
Added
In June 2025, the investigator presented promising data from this trial at ASCO: • Patients enrolled in the trial received a median of 3 prior lines of chemotherapy. • 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. • 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. • Collectively, this clinical data further supports the potential exploration of the combination of onvansertib plus paclitaxel for the treatment of mTNBC.
Removed
Responses have been observed across multiple KRAS variants; • Median duration of response ("mDoR") across all evaluable patients was 12.0 months (95% confidence interval ("CI"): 8.9 – not reached); • Median progression free survival ("mPFS") across all evaluable patients was 9.3 months (95% CI: 7.8 – 14).
Added
For more information, please visit NCT05383196 at www.clinicialtrials.gov .
Removed
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; • 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.
Added
Phase 1 Investigator-Initiated Clinical Trial in CMML This phase I trial is designed to evaluate the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia and Myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap neoplasms that has come back (recurrent) or that does not respond to treatment (refractory).
Removed
In contrast, patients previously treated with bevacizumab (n=51) had an ORR of 16% and mPFS of 7.8 months; • Data on Treatment Emergent Adverse Events ("TEAEs") on the trial showed that onvansertib is well-tolerated when used in combination with FOLFIRI and bevacizumab.
Added
Data presented at the American Society of Hematology (ASH) meeting on December 8, 2025, from this ongoing Phase 1 dose-escalation trial (N=9) showed that onvansertib monotherapy was generally well tolerated and demonstrated preliminary efficacy in approximately 40% of patients.
Removed
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.
Added
One patient achieved an optimal marrow response at the 9 mg/m² dose and three patients achieved clinical benefit at 6 mg/m2 and 12 mg/m2.
Removed
There were no major or unexpected toxicities seen in the trial; • Data from the Phase 1b portion of this trial was published in the peer-reviewed journal Clinical Cancer Research, February 6, 2024 edition; • Data from the Phase 2 portion of this trial was published online in the peer-reviewed journal of Clinical Oncology on October 30, 2024.
Added
Dose expansion is currently open and recruiting at the 12 mg/m2 dose. 8 These findings, together with previously reported results from an investigator-sponsored trial in small cell lung cancer, support onvansertib’s single-agent activity across both hematologic and solid tumors. Identifying Biomarkers that Predict Patient Benefit Our laboratory in San Diego, California, enables us to optimize drug development and patient care.
Removed
Based on the interim results of the TROV-054 trial, we designed the ONSEMBLE trial (CRDF-003) as the next phase of our mCRC program.
Added
Any patents issued in these families will expire between 2039 and 2045. Our intellectual property includes two patent families licensed from MIT.
Removed
Upon further review of the clinical data from the bevacizumab naïve subgroup (those patients who did not receive bevacizumab in their first-line therapy), the preclinical data on the mechanism of action and the feedback from the FDA on our clinical development strategy, we made the decision to discontinue enrollment in the ONSEMBLE trial and to initiate the CRDF-004 clinical trial.
Added
On February 18, 2026, Nerviano sent us a written notice alleging that we are in material breach of the license agreement with respect to (i) alleged joint ownership of certain of our 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.
Removed
Phase 2 Clinical Trial in Second-Line RAS-mutated mCRC The ONSEMBLE trial (CRDF-003) was a Phase 2 randomized, open-label multi-center clinical trial of onvansertib in combination with SoC FOLFIRI and bevacizumab for the second-line treatment of patients with RAS-mutated mCRC. The ONSEMBLE trial completed enrollment in August 2023 as part of our shift to a first-line mCRC program.
Added
We are currently reviewing the notice and believe we have meritorious defenses to the allegations contained therein. The referenced Cardiff Patents are based on the results of our TROV-054 study with claims that cover the method of using onvansertib in combination with bevacizumab for the treatment of metastatic colorectal cancer patients who have not previously been treated with bevacizumab.
Removed
The primary objectives of the ONSEMBLE trial were to evaluate onvansertib’s safety and efficacy in combination with FOLFIRI and bevacizumab, as well as to evaluate two doses of onvansertib, 20mg and 30mg, given in combination with FOLFIRI and bevacizumab, against FOLFIRI and bevacizumab alone. The primary endpoint of the trial was ORR.
Added
We intend to vigorously defend our rights under the license agreement. If we are 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 our business, financial condition, and results of operations.
Removed
For more information, please visit NCT05593328 at www.clinicialtrials.gov . The ORR data from the randomized ONSEMBLE trial validates the findings observed in our earlier single-arm Phase 1b/2 KRAS-mutated mCRC trial (TROV-054). In the ONSEMBLE trial, objective responses were observed only in bevacizumab naïve patients, not bevacizumab exposed patients.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

61 edited+30 added−10 removed278 unchanged
Biggest changeIn many cases, product candidates in clinical development may fail to show desired safety and efficacy characteristics despite having favorably demonstrated such characteristics in preclinical studies or earlier stage clinical trials. 20 In addition, we may experience numerous unforeseen events during, or as a result of, preclinical studies and the clinical trial process, which could delay or impede our ability to advance the development of, receive regulatory approval for, or commercialize our product candidate, including, but not limited to: • communications with the FDA, or similar regulatory authorities in different countries, regarding the scope or design of a trial or trials; • regulatory authorities, including an IRB or Ethical Committee (“EC”), not authorizing us to commence or conduct a clinical trial at a prospective trial site; • enrollment in our clinical trials being delayed, or proceeding at a slower pace than we expected, because we have difficulty recruiting patients or participants dropping out of our clinical trials at a higher rate than we anticipated; • our third party contractors, upon whom we rely for conducting preclinical studies, clinical trials and manufacturing of our trial materials, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner; • having to suspend or ultimately terminate our clinical trials if participants are being exposed to unacceptable health or safety risks; • IRBs, ECs or regulators requiring that we hold, suspend or terminate our preclinical studies and clinical trials for various reasons, including non-compliance with regulatory requirements; and • the supply or quality of drug material necessary to conduct our preclinical studies or clinical trials being insufficient, inadequate or unavailable.
Biggest changeIn addition, we may experience numerous unforeseen events during, or as a result of, preclinical studies and the clinical trial process, which could delay or impede our ability to advance the development of, receive regulatory approval for, or commercialize our product candidate, including, but not limited to: • communications with the FDA, or similar regulatory authorities in different countries, regarding the scope or design of a trial or trials; • regulatory authorities, including an IRB or Ethical Committee (“EC”), not authorizing us to commence or conduct a clinical trial at a prospective trial site; • enrollment in our clinical trials being delayed, or proceeding at a slower pace than we expected, because we have difficulty recruiting patients or participants dropping out of our clinical trials at a higher rate than we anticipated; • our third party contractors, upon whom we rely for conducting preclinical studies, clinical trials and manufacturing of our trial materials, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner; • having to suspend or ultimately terminate our clinical trials if participants are being exposed to unacceptable health or safety risks; • IRBs, ECs or regulators requiring that we hold, suspend or terminate our preclinical studies and clinical trials for various reasons, including non-compliance with regulatory requirements; and • the supply or quality of drug material necessary to conduct our preclinical studies or clinical trials being insufficient, inadequate or unavailable. 21 Even if the data collected from preclinical studies or clinical trials involving our product candidates demonstrate a favorable safety and efficacy profile, such results may not be sufficient to support the submission of a NDA or BLA to obtain regulatory approval from the FDA in the U.S., or other similar foreign regulatory authorities in foreign jurisdictions, which is required to market and sell the product.
The laws include: 25 • the federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs; • federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, and which may apply to entities like us which provide coding and billing information to customers; • the federal Health Insurance Portability and Accountability Act of 1996, which prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; • the Federal Food, Drug, and Cosmetic Act, which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples; and • state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.
The laws include: • the federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs; • federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, and which may apply to entities like us which provide coding and billing information to customers; • the federal Health Insurance Portability and Accountability Act of 1996, which prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; • the Federal Food, Drug, and Cosmetic Act, which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples; and • state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.
These fluctuations may be due to various factors, many of which are beyond our control, including: • technological innovations or new products and services introduced by us or our competitors; • clinical trial results relating to our tests or those of our competitors; • announcements or press releases relating to the industry or to our own business or prospects; • coverage and reimbursement decisions by third party payors, such as Medicare and other managed care organizations; • regulation and oversight of our product candidates and services, including by the FDA, Centers for Medicare & Medicaid Services and comparable foreign agencies; • healthcare legislation; • intellectual property disputes; • additions or departures of key personnel; • sales of our common stock; • our ability to integrate operations, technology, products and services; • our ability to execute our business plan; • operating results below expectations; • loss of any strategic relationship; • industry developments; • economic and other external factors; • catastrophic weather and/or global disease outbreaks, such as the COVID-19 pandemic; and • period-to-period fluctuations in our financial results.
These fluctuations may be due to various factors, many of which are beyond our control, including: • technological innovations or new products and services introduced by us or our competitors; • clinical trial results relating to our tests or those of our competitors; • announcements or press releases relating to the industry or to our own business or prospects; • coverage and reimbursement decisions by third party payors, such as Medicare and other managed care organizations; • regulation and oversight of our product candidates and services, including by the FDA, Centers for Medicare & Medicaid Services and comparable foreign agencies; • healthcare legislation; • intellectual property disputes; • additions or departures of key personnel; • sales of our common stock; • our ability to integrate operations, technology, products and services; • our ability to execute our business plan; • operating results below expectations; • loss of any strategic relationship; • industry developments; • economic and other external factors; • catastrophic weather and/or global disease outbreaks, such as the COVID-19 pandemic; and 41 • period-to-period fluctuations in our financial results.
If our product candidate is approved for commercial sale by the FDA or other regulatory authorities, the degree of market acceptance of any approved product by physicians, healthcare professionals and third-party payors and our profitability and growth will depend on a number of factors, including: • demonstration of safety and efficacy; • changes in the practice guidelines and the standard of care for the targeted indication; • relative convenience and ease of administration; 29 • the prevalence and severity of any adverse side effects; • budget impact of adoption of our product on relevant drug formularies and the availability, cost and potential advantages of alternative treatments, including less expensive generic drugs; • pricing, reimbursement and cost effectiveness, which may be subject to regulatory control; • effectiveness of our or any of our partners’ sales and marketing strategies; • the product labeling or product insert required by the FDA or regulatory authority in other countries; and • the availability of adequate third-party insurance coverage or reimbursement.
If our product candidate is approved for commercial sale by the FDA or other regulatory authorities, the degree of market acceptance of any approved product by physicians, healthcare professionals and third-party payors and our profitability and growth will depend on a number of factors, including: • demonstration of safety and efficacy; • changes in the practice guidelines and the standard of care for the targeted indication; • relative convenience and ease of administration; • the prevalence and severity of any adverse side effects; • budget impact of adoption of our product on relevant drug formularies and the availability, cost and potential advantages of alternative treatments, including less expensive generic drugs; • pricing, reimbursement and cost effectiveness, which may be subject to regulatory control; • effectiveness of our or any of our partners’ sales and marketing strategies; • the product labeling or product insert required by the FDA or regulatory authority in other countries; and • the availability of adequate third-party insurance coverage or reimbursement.
Even though the results of preclinical studies and clinical trials that have been conducted or may conduct in the future may support further development of our product candidate, we may delay, suspend or terminate the future development of a product candidate at any time for strategic, business, financial or other reasons, including the determination or belief that the emerging profile of the product candidate is such that it may not receive FDA approval, gain meaningful market acceptance, generate a significant return to shareholders, or otherwise provide any competitive advantages in its intended indication or market.
Even though the results of preclinical studies and clinical trials that have been conducted or may conduct in the future may support further development of our product candidate, we may delay, suspend or terminate the future development of a product candidate at any time for strategic, business, financial or other reasons, including the 33 determination or belief that the emerging profile of the product candidate is such that it may not receive FDA approval, gain meaningful market acceptance, generate a significant return to shareholders, or otherwise provide any competitive advantages in its intended indication or market.
Despite these efforts, our product candidate may not: • offer therapeutic or other medical benefits over existing drugs or other product candidates in development to treat the same patient population; • be proven to be safe and effective in current and future preclinical studies or clinical trials; • have the desired effects; • be free from undesirable or unexpected effects; • meet applicable regulatory standards; 19 • be capable of being formulated and manufactured in commercially suitable quantities and at an acceptable cost; or • be successfully commercialized by us or by collaborators.
Despite these efforts, our product candidate may not: • offer therapeutic or other medical benefits over existing drugs or other product candidates in development to treat the same patient population; • be proven to be safe and effective in current and future preclinical studies or clinical trials; • have the desired effects; • be free from undesirable or unexpected effects; • meet applicable regulatory standards; • be capable of being formulated and manufactured in commercially suitable quantities and at an acceptable cost; or • be successfully commercialized by us or by collaborators.
We expect that our ability to compete effectively will depend upon our ability to: • successfully identify and develop key points of product differentiations from currently available therapies; • successfully and rapidly complete clinical trials and submit for and obtain all requisite regulatory approvals in a cost-effective manner; • maintain a proprietary position for our products and manufacturing processes and other related product technology; • attract and retain key personnel; 27 • develop relationships with physicians prescribing these products; and • build an adequate sales and marketing infrastructure for our product candidates.
We expect that our ability to compete effectively will depend upon our ability to: • successfully identify and develop key points of product differentiations from currently available therapies; • successfully and rapidly complete clinical trials and submit for and obtain all requisite regulatory approvals in a cost-effective manner; • maintain a proprietary position for our products and manufacturing processes and other related product technology; • attract and retain key personnel; • develop relationships with physicians prescribing these products; and • build an adequate sales and marketing infrastructure for our product candidates.
The uncertain nature, scope, magnitude, and duration of hostilities stemming from Russia’s military invasion of Ukraine, including the potential effects of such hostilities as well as sanctions, embargoes, asset freezes, cyber-attacks and other actions taken in response to such hostilities on the world economy and markets, have disrupted global markets and contributed to increased market volatility and uncertainty, which could have an adverse impact on macroeconomic and other factors that affect our business and supply chain.
The uncertain nature, scope, magnitude, and duration of hostilities stemming from Russia’s military invasion of Ukraine, including the potential effects of such hostilities as well as sanctions, embargoes, asset freezes, 37 cyber-attacks and other actions taken in response to such hostilities on the world economy and markets, have disrupted global markets and contributed to increased market volatility and uncertainty, which could have an adverse impact on macroeconomic and other factors that affect our business and supply chain.
Some of these risks include: • our third-party contractors failing to develop an acceptable formulation to support later-stage clinical trials for, or the commercialization of, our product candidates; • our contract manufacturers failing to manufacture our product candidate according to their own standards, our specifications, CGMPs, or otherwise manufacturing material that we or the FDA may deem to be unsuitable in our clinical trials; 30 • our contract manufacturers being unable to increase the scale of, increase the capacity for, or reformulate the form of our product candidate.
Some of these risks include: • our third-party contractors failing to develop an acceptable formulation to support later-stage clinical trials for, or the commercialization of, our product candidates; • our contract manufacturers failing to manufacture our product candidate according to their own standards, our specifications, CGMPs, or otherwise manufacturing material that we or the FDA may deem to be unsuitable in our clinical trials; • our contract manufacturers being unable to increase the scale of, increase the capacity for, or reformulate the form of our product candidate.
Sales of a substantial number of shares of our common stock may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate. 41 We may be subject to stockholder litigation, thereby diverting our resources, which could materially adversely affect our profitability and results of operations.
Sales of a substantial number of shares of our common stock may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate. We may be subject to stockholder litigation, thereby diverting our resources, which could materially adversely affect our profitability and results of operations.
We do not expect our product candidate to be commercialized by us or collaborators for at least several years. Our product candidate may exhibit undesirable side effects when used alone or in combination with other approved pharmaceutical products or investigational new drugs, which may delay or preclude further development or regulatory approval, or limit their use if approved.
We do not expect our product candidate to be commercialized by us or collaborators for at least several years. 20 Our product candidate may exhibit undesirable side effects when used alone or in combination with other approved pharmaceutical products or investigational new drugs, which may delay or preclude further development or regulatory approval, or limit their use if approved.
In-licensed compounds that appear promising in research or in preclinical studies may fail to progress into further preclinical studies or clinical trials. 31 If a product liability claim is successfully brought against us for uninsured liabilities, or such claim exceeds our insurance coverage, we could be forced to pay substantial damage awards that could materially harm our business.
In-licensed compounds that appear promising in research or in preclinical studies may fail to progress into further preclinical studies or clinical trials. If a product liability claim is successfully brought against us for uninsured liabilities, or such claim exceeds our insurance coverage, we could be forced to pay substantial damage awards that could materially harm our business.
ITEM 1A. RI SK FACTORS An investment in our securities involves a high degree of risk. An investor should carefully consider the risks described below as well as other information contained in this Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission (“SEC”).
ITEM 1A. RI SK FACTORS 18 An investment in our securities involves a high degree of risk. An investor should carefully consider the risks described below as well as other information contained in this Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission (“SEC”).
We face competition generally from established pharmaceutical and biotechnology companies, as well as from academic institutions, government agencies and private and public research institutions. Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.
We face competition generally from established pharmaceutical and biotechnology companies, as well as from academic institutions, government agencies and private and public research institutions. Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical 28 testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.
If we or our manufacturers are unable to purchase these materials after regulatory approval has been obtained for one of our products, the commercial launch of such product would be delayed or there would be a shortage in supply of such product, which would harm our ability to generate revenues from such product and achieve or sustain profitability.
If we or our manufacturers are unable to purchase these materials after regulatory approval has been obtained for one of our products, the commercial launch of such product would be delayed or there would 30 be a shortage in supply of such product, which would harm our ability to generate revenues from such product and achieve or sustain profitability.
By contrast, larger pharmaceutical and bio-pharmaceutical companies often have substantial staff with extensive experience in conducting clinical trials with multiple product candidates across multiple indications. In addition, they may have greater financial resources to compete for the same clinical 21 investigators and patients that we are attempting to recruit for our clinical trials.
By contrast, larger pharmaceutical and bio-pharmaceutical companies often have substantial staff with extensive experience in conducting clinical trials with multiple product candidates across multiple indications. In addition, they may have greater financial resources to compete for the same clinical investigators and patients that we are attempting to recruit for our clinical trials.
Satisfaction of these requirements typically takes several years and the time needed to satisfy them may vary substantially, based on the type, complexity and novelty of the pharmaceutical product. We cannot predict if or when we will submit an NDA for approval for our product candidate currently under development.
Satisfaction of these requirements typically takes several years and the time needed to satisfy them may vary substantially, based on the type, complexity and novelty of the pharmaceutical product. We cannot predict if or when we will submit an NDA for approval for our product 27 candidate currently under development.
Additionally, at any time we or our collaborators may voluntarily suspend or terminate the preclinical or clinical development of a product candidate, or withdraw any approved product from the market if we believe that it may pose an unacceptable safety risk to patients, or if the product candidate or approved product no longer meets 22 our business objectives.
Additionally, at any time we or our collaborators may voluntarily suspend or terminate the preclinical or clinical development of a product candidate, or withdraw any approved product from the market if we believe that it may pose an unacceptable safety risk to patients, or if the product candidate or approved product no longer meets our business objectives.
We may face substantial competition from other biotechnology and pharmaceutical companies, many of which may have greater resources then we have, in obtaining these in-licensing, sponsored research or acquisition opportunities. Additional in-licensing or acquisition opportunities may not be available to us on terms we find acceptable, if at all.
We may face substantial competition from other biotechnology and 32 pharmaceutical companies, many of which may have greater resources then we have, in obtaining these in-licensing, sponsored research or acquisition opportunities. Additional in-licensing or acquisition opportunities may not be available to us on terms we find acceptable, if at all.
Manufacturers of our product candidates may be unable to comply with these GMP requirements and with other FDA and foreign regulatory requirements, if any. 28 While we will oversee compliance by our contract manufacturers, ultimately, we will not have control over our manufacturers’ compliance with these regulations and standards.
Manufacturers of our product candidates may be unable to comply with these GMP requirements and with other FDA and foreign regulatory requirements, if any. While we will oversee compliance by our contract manufacturers, ultimately, we will not have control over our manufacturers’ compliance with these regulations and standards.
Our stock price may fluctuate widely as a result of any of the foregoing. 40 We have not paid dividends on our common stock in the past and do not expect to pay dividends on our common stock for the foreseeable future. Any return on investment may be limited to the value of our common stock.
Our stock price may fluctuate widely as a result of any of the foregoing. We have not paid dividends on our common stock in the past and do not expect to pay dividends on our common stock for the foreseeable future. Any return on investment may be limited to the value of our common stock.
In addition to our patents, we rely on contractual restrictions to protect our proprietary technology. We require our employees and third parties to sign confidentiality agreements and our employees are also required to sign agreements assigning to us all intellectual property arising from their work for us.
In addition to our patents, we rely on contractual restrictions to protect our proprietary technology. We require our employees and third parties to sign confidentiality agreements and our employees are also required to sign 38 agreements assigning to us all intellectual property arising from their work for us.
We cannot predict the extent of 18 these future net losses, or when we may attain profitability, if at all. If we are unable to generate significant revenue from onvansertib or attain profitability, we will not be able to sustain operations.
We cannot predict the extent of these future net losses, or when we may attain profitability, if at all. If we are unable to generate significant revenue from onvansertib or attain profitability, we will not be able to sustain operations.
To that end, we must be able to: • manage our clinical studies effectively; 32 • integrate additional management, administrative, manufacturing and regulatory personnel; • maintain sufficient administrative, accounting and management information systems and controls; and • hire and train additional qualified personnel.
To that end, we must be able to: • manage our clinical studies effectively; • integrate additional management, administrative, manufacturing and regulatory personnel; • maintain sufficient administrative, accounting and management information systems and controls; and • hire and train additional qualified personnel.
These problems include difficulties with production costs and yields, quality control, including stability of the product and quality assurance testing, shortages of qualified personnel, as well as compliance with federal, state and foreign regulations.
These problems include 29 difficulties with production costs and yields, quality control, including stability of the product and quality assurance testing, shortages of qualified personnel, as well as compliance with federal, state and foreign regulations.
Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of new drugs do not necessarily predict the results of later-stage clinical trials .
Failure can occur at any time during the clinical trial process. 24 The results of preclinical studies and early clinical trials of new drugs do not necessarily predict the results of later-stage clinical trials .
There have been several Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. Most recently, on August 16, 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law.
There have been several Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. On August 16, 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law.
We cannot be certain that additional material weaknesses or significant deficiencies in our internal controls will not be discovered in the future. 42 We incur significant costs as a result of operating as a public company and our management expects to continue to devote substantial time to public company compliance programs.
We cannot be certain that additional material weaknesses or significant deficiencies in our internal controls will not be discovered in the future. 43 We incur significant costs as a result of operating as a public company and our management expects to continue to devote substantial time to public company compliance programs.
Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security threats.
Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security 34 threats.
Moreover, in the event of an accident or if we otherwise fail to comply with applicable regulations, we could lose our permits or approvals or be held liable for damages or penalized with fines. 34 Healthcare reform measures could adversely affect our business.
Moreover, in the event of an accident or if we otherwise fail to comply with applicable regulations, we could lose our permits or approvals or be held liable for damages or penalized with fines. 35 Healthcare reform measures could adversely affect our business.
We will need to increase the size of our organization, and we may experience difficulties in managing growth. We are a small company with 33 employees as of December 31, 2024. Future growth of our company will impose significant additional responsibilities on members of management, including the need to identify, attract, retain, motivate and integrate highly skilled personnel.
We will need to increase the size of our organization, and we may experience difficulties in managing growth. We are a small company with 31 employees as of December 31, 2025. Future growth of our company will impose significant additional responsibilities on members of management, including the need to identify, attract, retain, motivate and integrate highly skilled personnel.
We are highly dependent upon our senior management and scientific staff, particularly Mark Erlander, our Chief Executive Officer (“CEO”). The loss of services of Dr. Erlander or one or more of our other members of senior management could delay or prevent the successful completion of our planned clinical trials or the commercialization of our product candidate.
We are highly dependent upon our senior management and scientific staff, particularly Mani Mohindru, our interim Chief Executive Officer (“CEO”). The loss of services of Dr. Mohindru or one or more of our other members of senior management could delay or prevent the successful completion of our planned clinical trials or the commercialization of our product candidate.
In order to successfully develop our product candidate, we must continuously supplement our research, clinical development, regulatory, medicinal chemistry, virology and manufacturing capabilities through the addition of key employees, consultants or third-party contractors to provide certain capabilities and skill sets that we do not possess.
We have limited experience in the discovery, development and manufacturing of therapeutic compounds. In order to successfully develop our product candidate, we must continuously supplement our research, clinical development, regulatory, medicinal chemistry, virology and manufacturing capabilities through the addition of key employees, consultants or third-party contractors to provide certain capabilities and skill sets that we do not possess.
Our product candidate could fail to receive regulatory approval for many reasons, including the following: • the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; • we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication; • the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; • the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; • the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere; • the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; • the FDA or comparable foreign regulatory authorities may fail to approve the companion diagnostics we contemplate developing with partners; and • the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. 24 This lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our product candidate, which would significantly harm our business, results of operations and prospects.
Our product candidate could fail to receive regulatory approval for many reasons, including the following: • the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; • we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication; • the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; • the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; • the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere; • the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; 25 • the FDA or comparable foreign regulatory authorities may fail to approve the companion diagnostics we contemplate developing with partners; and • the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
We are a clinical stage company and have incurred losses since our formation. As of December 31, 2024, we have an accumulated total deficit of approximately $384.2 million. For the fiscal years ended December 31, 2024 and 2023, we had a net loss attributable to common stockholders of approximately $45.5 million and $41.5 million, respectively.
We are a clinical stage company and have incurred losses since our formation. As of December 31, 2025, we have an accumulated total deficit of approximately $430.0 million. For the fiscal years ended December 31, 2025 and 2024, we had a net loss attributable to common stockholders of approximately $45.9 million and $45.5 million, respectively.
It is not possible to predict the broader consequences of this conflict, which could include further sanctions, embargoes, regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, the availability and cost of materials, supplies, labor, currency exchange rates and financial markets, all of which could negatively impact our business, financial condition and results of operations. 36 The increasing use of social media platforms presents new risks and challenges.
It is not possible to predict the broader consequences of this conflict, which could include further sanctions, embargoes, regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, the availability and cost of materials, supplies, labor, currency exchange rates and financial markets, all of which could negatively impact our business, financial condition and results of operations.
If we are unable to successfully advance or develop our product candidate, our business will be materially harmed. In the near-term, failure to successfully advance the development of our product candidate may have a material adverse effect on us. To date, we have not successfully developed or commercially marketed, distributed or sold any product candidate.
In the near-term, failure to successfully advance the development of our product candidate may have a material adverse effect on us. To date, we have not successfully developed or commercially marketed, distributed or sold any product candidate.
For that and other reasons, it is currently unclear how the IRA will be effectuated. 35 Individual states in the United States have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and other transparency measures, and, in some cases, measures designed to encourage importation from other countries and bulk purchasing.
Individual states in the United States have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and other transparency measures, and, in some cases, measures designed to encourage importation from other countries and bulk purchasing.
Any failure to protect our intellectual property rights could materially adversely affect our business, prospects and financial condition. 37 Our currently pending or future patent applications may not result in issued patents and any patents issued to us may be challenged, invalidated or held unenforceable.
Nevertheless, we cannot guarantee that these measures will be effective in protecting our intellectual property rights. Any failure to protect our intellectual property rights could materially adversely affect our business, prospects and financial condition. Our currently pending or future patent applications may not result in issued patents and any patents issued to us may be challenged, invalidated or held unenforceable.
While we maintain insurance to cover operational risks, such as cyber risk and technology outages, our insurance may not be sufficient to cover all liability described herein.
While we maintain insurance to cover operational risks, such as cyber risk and technology outages, our insurance may not be sufficient to cover all liability described herein. These risks will likely increase as we store and process more data.
Further, if such claims are proven valid, through litigation or otherwise, we may be required to pay substantial monetary damages, which can be tripled if the infringement is deemed willful, or be required to discontinue or significantly delay development, marketing, selling and licensing of the affected products and intellectual property rights. 38 Our competitors may have filed, and may in the future file, patent applications covering technology similar to ours.
Further, if such claims are proven valid, through litigation or otherwise, we may be required to pay substantial monetary damages, which can be tripled if the 39 infringement is deemed willful, or be required to discontinue or significantly delay development, marketing, selling and licensing of the affected products and intellectual property rights.
For example, during the year ended December 31, 2024, the closing price of our common stock ranged from a low of $1.46 to a high of $5.91.
For example, during the year ended December 31, 2025, the closing price of our common stock ranged from a low of $1.95 to a high of $4.78.
This evolution creates uncertainty and risk of noncompliance with regulations applicable to our business. For example, patients may use social media channels to report an alleged adverse event during a clinical trial.
Social media practices in the biopharmaceutical industry continue to evolve and regulations relating to such use are not always clear. This evolution creates uncertainty and risk of noncompliance with regulations applicable to our business. For example, patients may use social media channels to report an alleged adverse event during a clinical trial.
As of December 31, 2024, our cash, cash equivalents and short-term investments balance was approximately $91.7 million and our working capital was approximately $81.6 million.
As of December 31, 2025, our cash, cash equivalents and short-term investments balance was approximately $58.3 million and our working capital was approximately $43.7 million.
The IRA permits the Secretary of the Department of Health and Human Services (HHS) to implement many of these provisions through guidance, as opposed to regulation, for the initial years.
The IRA permits the Secretary of the Department of Health and Human Services (HHS) to implement many of these provisions through guidance, as opposed to regulation, for the initial years. For that and other reasons, it is currently unclear how the IRA will be effectuated.
Our reliance on third-party contract manufacturers exposes us to a number of risks, any of which could delay or prevent the completion of our preclinical studies or clinical trials, or the regulatory approval or commercialization of our product candidate, result in higher costs, or deprive us of potential product revenues.
We intend to rely on GMP, FDA validated third-party contractors, at least for the foreseeable future, to formulate and manufacture these preclinical and clinical materials. 31 Our reliance on third-party contract manufacturers exposes us to a number of risks, any of which could delay or prevent the completion of our preclinical studies or clinical trials, or the regulatory approval or commercialization of our product candidate, result in higher costs, or deprive us of potential product revenues.
If our stockholders sell, or the market perceives that our stockholders may sell for various reasons, including the ending of restriction on resale, substantial amounts of our common stock in the public market, including shares issued upon the exercise of outstanding options or warrants, the market price of our common stock could fall.
In addition, the lack of a robust resale market may require a stockholder who desires to sell a large number of shares of common stock to sell the shares in increments over time to mitigate any adverse impact of the sales on the market price of our stock. 42 If our stockholders sell, or the market perceives that our stockholders may sell for various reasons, including the ending of restriction on resale, substantial amounts of our common stock in the public market, including shares issued upon the exercise of outstanding options or warrants, the market price of our common stock could fall.
These risks will likely increase as we store and process more data. 33 Additionally, there are a number of state, federal and international laws protecting the privacy and security of health information and personal data.
Additionally, there are a number of state, federal and international laws protecting the privacy and security of health information and personal data.
Any approvals we may obtain may not cover all of the clinical indications for which we are seeking approval or may contain significant limitations on the conditions of use. 26 The FDA has substantial discretion in the NDA review process and may either refuse to file our NDA for substantive review or may decide that our data is insufficient to support approval of our product candidate for the claimed intended uses.
The FDA has substantial discretion in the NDA review process and may either refuse to file our NDA for substantive review or may decide that our data is insufficient to support approval of our product candidate for the claimed intended uses.
Any such patent application may have priority over our patent applications and could further require us to obtain rights to issued patents covering such technologies. There may be third-party patents, patent applications and other intellectual property relevant to our potential products that may block or compete with our potential products or processes.
There may be third-party patents, patent applications and other intellectual property relevant to our potential products that may block or compete with our potential products or processes.
Social media is increasingly being used to communicate about our clinical development programs and the diseases our product candidate is being developed to treat. We intend to utilize appropriate social media in connection with communicating about our development programs. Social media practices in the biopharmaceutical industry continue to evolve and regulations relating to such use are not always clear.
The increasing use of social media platforms presents new risks and challenges. Social media is increasingly being used to communicate about our clinical development programs and the diseases our product candidate is being developed to treat. We intend to utilize appropriate social media in connection with communicating about our development programs.
The data collected from clinical trials of our product 23 candidate may not be sufficient to support the filing of an NDA or to obtain regulatory approval in the United States or elsewhere.
Product candidates in later stages of clinical trials may fail to show safety and efficacy sufficient to support intended use claims despite having progressed through initial clinical testing. The data collected from clinical trials of our product candidate may not be sufficient to support the filing of an NDA or to obtain regulatory approval in the United States or elsewhere.
We, and our collaborators, must comply with extensive government regulations in order to advance our product candidate through the development process and ultimately obtain and maintain marketing approval for our products in the U.S. and abroad.
As a result, we may be at a competitive disadvantage that could delay the initiation, recruitment, timing, completion of our clinical trials and obtaining regulatory approvals, if at all, for our product candidate. 22 We, and our collaborators, must comply with extensive government regulations in order to advance our product candidate through the development process and ultimately obtain and maintain marketing approval for our products in the U.S. and abroad.
The ability to develop or market a pharmaceutical product outside of the U.S. is contingent upon receiving appropriate authorization from the respective foreign regulatory authorities. Foreign regulatory approval processes typically include many, if not all, of the risks and requirements associated with the FDA regulatory process for drug development and may include additional risks.
The ability to develop or market a pharmaceutical product outside of the U.S. is contingent upon receiving appropriate authorization from the respective foreign regulatory authorities.
We cannot assure you that clinical trials conducted in one country will be accepted by other countries or that an approval in one country or region will result in approval elsewhere. If our product candidate is unable to compete effectively with marketed drugs targeting similar indications as our product candidate, our commercial opportunity will be reduced or eliminated.
We cannot assure you that clinical trials conducted in one country will be accepted by other countries or that an approval in one country or region will result in approval elsewhere.
If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected.
Moreover, we could be subject to significant liability if any volunteer or patient suffers, or appears to suffer, adverse health effects as a result of participating in our clinical trials. 26 If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected.
Failure to obtain additional capital at acceptable terms would result in a material and adverse impact on our operations. Our product candidate, onvansertib, is in the early 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.
Our 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. If we are unable to successfully advance or develop our product candidate, our business will be materially harmed.
The results of prior preclinical studies or clinical trials are not necessarily predictive of the results we may observe in later stage clinical trials.
The results of prior preclinical studies or clinical trials are not necessarily predictive of the results we may observe in later stage clinical trials. In many cases, product candidates in clinical development may fail to show desired safety and efficacy characteristics despite having favorably demonstrated such characteristics in preclinical studies or earlier stage clinical trials.
If potential competitors are successful in completing drug development for their product candidates and obtain approval from the FDA, they could limit the demand for onvansertib. As a result, we may be at a competitive disadvantage that could delay the initiation, recruitment, timing, completion of our clinical trials and obtaining regulatory approvals, if at all, for our product candidate.
If potential competitors are successful in completing drug development for their product candidates and obtain approval from the FDA, they could limit the demand for onvansertib.
We have limited experience in the development of therapeutic product candidates and therefore may encounter difficulties developing our product candidate or managing our operations in the future. We have limited experience in the discovery, development and manufacturing of therapeutic compounds.
Foreign regulatory approval processes typically include many, if not all, of the risks and requirements associated with the FDA regulatory process for drug development and may include additional risks. 23 We have limited experience in the development of therapeutic product candidates and therefore may encounter difficulties developing our product candidate or managing our operations in the future.
We continue to examine the impact this tax reform legislation may have on our business. The impact of this tax reform on holders of our common stock is uncertain and could be adverse. 39 The rights of the holders of our common stock may be impaired by the potential issuance of preferred stock.
Future guidance from the Internal Revenue Service and other tax authorities with respect to any legislation may affect us, and certain aspects of such legislation could be repealed or modified or sunset in future years. The rights of the holders of our common stock may be impaired by the potential issuance of preferred stock.
Removed
Even if the data collected from preclinical studies or clinical trials involving our product candidates demonstrate a favorable safety and efficacy profile, such results may not be sufficient to support the submission of a NDA or BLA to obtain regulatory approval from the FDA in the U.S., or other similar foreign regulatory authorities in foreign jurisdictions, which is required to market and sell the product.
Added
Failure to obtain additional capital at acceptable terms would result in a material and adverse impact on our operations. Management has performed an analysis and concluded that there exists a substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing on terms acceptable to us, if at all.
Removed
Product candidates in later stages of clinical trials may fail to show safety and efficacy sufficient to support intended use claims despite having progressed through initial clinical testing.
Added
Our financial statements as of December 31, 2025 have been prepared under a going concern basis. Management has performed an analysis and concluded that there exists a substantial doubt about our ability to continue as a going concern.
Removed
Ultimately, our product candidate may prove to be unsafe for human use. Moreover, we could be subject to significant liability if any volunteer or patient suffers, or appears to suffer, adverse health effects as a result of participating in our clinical trials.
Added
Separately, our independent registered public accounting firm included in its opinion for the year ended December 31, 2025 an explanatory paragraph referring to our recurring losses from operations and expressing substantial doubt in our ability to continue as a going concern without additional capital becoming available.
Removed
We do not own or operate any manufacturing facilities. We intend to rely on GMP, FDA validated third-party contractors, at least for the foreseeable future, to formulate and manufacture these preclinical and clinical materials.
Added
Our ability to continue as a going concern is dependent upon our ability to obtain additional equity or debt financing, obtain government grants or reduce expenditures. Our financial statements as of December 31, 2025 did not include 19 any adjustments that might result from the outcome of this uncertainty.
Removed
Nevertheless, we cannot guarantee that these measures will be effective in protecting our intellectual property rights.
Added
The reaction of investors to the inclusion of a going concern statement in the accompanying financial statement, and our potential inability to continue as a going concern, in future years could materially adversely affect our share price and our ability to raise new capital or enter into strategic alliances.
Removed
U.S. federal income tax reform could adversely affect us. On December 22, 2017, President Trump signed into law the TCJA that significantly reforms the Internal Revenue Code of 1986, as amended.
Added
Dependence on Third-Party Consultants We rely heavily on third-party consultants and advisors to support key aspects of our operations, including research and development, regulatory strategy, clinical trial management, manufacturing, quality assurance, and business development. These consultants are not our employees and may have commitments to other organizations, which could limit their availability to us.
Removed
The TCJA, among other things, includes changes to U.S. federal tax rates, imposes significant additional limitations on the deductibility of interest, allows for the expensing of capital expenditures, and puts into effect the migration from a “worldwide” system of taxation to a territorial system.
Added
If we are unable to retain these consultants, replace them on commercially reasonable terms, or effectively manage their performance, our development programs, regulatory submissions, and overall business operations could be delayed or adversely affected.
Removed
We do not expect tax reform to have a material impact to our projection of minimal cash taxes or to our net operating losses.
Added
In addition, we have limited control over the timing, quality, and outcomes of the services provided by third-party consultants, and any failure by such consultants to perform in accordance with applicable regulatory standards or contractual obligations could expose us to reputational harm, increased costs, or regulatory enforcement actions.
Removed
Further, any eligibility we may have or may someday have for tax credits associated with the qualified clinical testing expenses arising out of the development of orphan drugs will be reduced to 25% as a result of the TCJA; thus, our net future taxable income may be affected.
Added
This lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our product candidate, which would significantly harm our business, results of operations and prospects.
Removed
In addition, the lack of a robust resale market may require a stockholder who desires to sell a large number of shares of common stock to sell the shares in increments over time to mitigate any adverse impact of the sales on the market price of our stock.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeOnce a potential incident has been confirmed, the Incident Response Coordinator will notify senior management that activation of the incident response plan is required and assign a severity rating, ranging from none to critical, based on the perceived impact. 43 Governance The Audit Committee has oversight responsibility for risks and incidents relating to cybersecurity threats, including compliance with disclosure requirements, cooperation with law enforcement, and related effects on financial and other risks , and it reports any findings and recommendations, as appropriate, to the full Board for consideration.
Biggest changeGovernance The Audit Committee has oversight responsibility for risks and incidents relating to cybersecurity threats, including compliance with disclosure requirements, cooperation with law enforcement, and related effects on financial and other risks , and it reports any findings and recommendations, as appropriate, to the full Board for consideration.
Senior management regularly discusses cyber risks and trends and, should they arise, any material incidents with the Audit Committee . Our Information Technology Lead is responsible for the strategic leadership and day-to-day management of our cybersecurity risk management program. The individual is working in that role for more than 10 years for the company.
Senior management regularly discusses cyber risks and trends and, should they arise, any material incidents with the Audit Committee . Our Information Technology Lead is responsible for the strategic leadership and day-to-day management of our cybersecurity risk management program. This individual has been working in that role for more than 10 years for the company.
Added
Once a potential incident has been confirmed, the Incident Response Coordinator will notify senior 44 management that activation of the incident response plan is required and assign a severity rating, ranging from none to critical, based on the perceived impact.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Removed
ITEM 3. LEGA L PROCEEDINGS From time to time, we may become involved in various lawsuits and legal proceedings that arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in matters may arise from time to time that may harm our business.
Added
ITEM 3. LEGA L PROCEEDINGS The information called for by this item is incorporated herein by reference to the information set forth in "Note 9. Commitments and Contingencies” in the Notes to Consolidated Financial Statements included in Item 8 of this Report.
Removed
As of the date of this report, management believes that there are no claims against us, which it believes will result in a material adverse effect on our business or financial condition.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeNumber of Stockholders As of February 20, 2025, we had approximately 58 stockholders of record of our common stock.
Biggest changeNumber of Stockholders As of February 19, 2026, we had approximately 57 stockholders of record of our common stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeOur 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. Liquidity and Capital Resources As of December 31, 2024, and December 31, 2023, we had working capital of $81.6 million and $67.0 million, respectively.
Biggest changeThe amount of interest income earned varies each period based on the balance of our accounts and interest rates. Liquidity and Capital Resources As of December 31, 2025, and December 31, 2024, we had working capital of $43.7 million and $81.6 million, respectively. We have incurred net losses since our inception and have negative operating cash flows.
The risk of completion of any program is high because of the many uncertainties involved in developing new drug candidates to market, including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of research and development expenses, and competing technologies being developed by organizations with significantly greater resources.
The risk of completion of any program is high because of the many uncertainties involved in developing new drug candidates to market, including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of research and development expenses, and competing technologies being developed by organizations with significantly greater resources.
ITEM 7. MANAGEMENT ’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Company Overview We are a clinical-stage biotechnology company, headquartered in San Diego, CA, leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers with the greatest unmet medical need.
ITEM 7. MANAGEMENT ’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Company Overview 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.
Results of Operations Years Ended December 31, 2024 and 2023 Revenues Total revenues were $0.7 million for the twelve months ended December 31, 2024, as compared to $0.5 million for the same period in 2023. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib.
Results of Operations Years Ended December 31, 2025 and 2024 Revenues Total revenues were $0.6 million for the year ended December 31, 2025, as compared to $0.7 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.
Our primary use of cash was from our net loss of $45.4 million, adjusted for non-cash items of $4.6 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. Net cash used in operating activities for the twelve months ended December 31, 2023, was $30.9 million.
Our primary use of cash was from our net loss of $45.9 million, adjusted for non-cash items of $5.7 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $2.2 million. Net cash used in operating activities for the year ended December 31, 2024, was $37.7 million.
We accrue costs based on estimated work completed in accordance with agreements established with our service providers. We determine the estimated costs through discussions with internal personnel and external 46 service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services.
We determine the estimated costs through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services.
Critical Accounting Policies and Estimates Our accounting policies are described in Part II, Item 8. Financial Statements—Note 2 Basis of Presentation and Summary of Significant Accounting Policies in this Annual Report on Form 10-K .
Financial Statements—Note 2 Basis of Presentation and Summary of Significant Accounting Policies in this Annual Report on Form 10-K .
Net cash provided by investing activities for the twelve months ended December 31, 2023 was $36.2 million, primarily related to maturities and sales in excess of purchases of marketable securities. Financing Activities Net cash provided by financing activities for the twelve months ended December 31, 2024 was $53.8 million, from the sale of common stock and employee stock options exercises.
Net cash provided by investing activities for the year ended December 31, 2024, was $13.7 million, primarily related to maturities and sales in excess of purchases of marketable securities. Financing Activities Net cash provided by financing activities for the year ended December 31, 2025, was $2.6 million, from the exercise of warrants and employee stock options exercises.
Cash Flow Summary Year Ended December 31, (in thousands) 2024 2023 Net cash used in operating activities $ (37,693 ) $ (30,887 ) Net cash provided by investing activities 13,728 36,195 Net cash provided by financing activities 53,780 — Net change in cash and equivalents $ 29,815 $ 5,308 Operating Activities Net cash used in operating activities for the twelve months ended December 31, 2024, was $37.7 million.
Cash Flow Summary Year Ended December 31, (in thousands) 2025 2024 Net cash used in operating activities $ (37,923 ) $ (37,693 ) Net cash provided by investing activities 1,342 13,728 Net cash provided by financing activities 2,581 53,780 Net change in cash and cash equivalents $ (34,000 ) $ 29,815 Operating Activities Net cash used in operating activities for the year ended December 31, 2025, was $37.9 million.
Research and Development Expenses Research and development expenses consisted of the following: Year Ended December 31, (in thousands) 2024 2023 Increase (Decrease) Salaries and staff costs $ 6,903 $ 5,930 $ 973 Stock-based compensation 1,660 1,279 381 Clinical trials, outside services, and lab supplies 26,472 23,686 2,786 Facilities and other 1,817 1,962 (145 ) Total research and development $ 36,852 $ 32,857 $ 3,995 Research and development expenses increased by $4.0 million for the twelve months ended December 31, 2024, compared to the same period in 2023.
Research and Development Expenses Research and development expenses consisted of the following: Year Ended December 31, (in thousands) 2025 2024 Increase (Decrease) Salaries and staff costs $ 7,131 $ 6,903 $ 228 Stock-based compensation 2,376 1,660 716 Clinical trials, outside services, and lab supplies 23,954 26,472 (2,518 ) Facilities and other 1,868 1,817 51 Total research and development $ 35,329 $ 36,852 $ (1,523 ) Research and development expenses decreased by $1.5 million for the year ended December 31, 2025, compared to the same period in 2024.
Selling, General and Administrative Expenses Selling, general and administrative expenses consisted of the following: Year Ended December 31, (in thousands) 2024 2023 Increase (Decrease) Salaries and staff costs $ 3,286 $ 3,531 $ (245 ) Stock-based compensation 3,100 3,230 (130 ) Outside services and professional fees 4,369 4,133 236 Facilities and other 1,727 2,149 (422 ) Total selling, general and administrative $ 12,482 $ 13,043 $ (561 ) Selling, general and administrative expenses decreased by $0.6 million for the twelve months ended December 31, 2024, compared to the same period in 2023.
Selling, General and Administrative Expenses Selling, general and administrative expenses consisted of the following: Year Ended December 31, (in thousands) 2025 2024 Increase (Decrease) Salaries and staff costs $ 3,973 $ 3,286 $ 687 Stock-based compensation 3,317 3,100 217 Outside services and professional fees 5,262 4,369 893 Facilities and other 1,672 1,727 (55 ) Total selling, general and administrative $ 14,224 $ 12,482 $ 1,742 Selling, general and administrative expenses increased by $1.7 million for the year ended December 31, 2025, compared to the same period in 2024.
We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated ongoing or planned 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.
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"), metastatic triple negative breast cancer ("mTNBC") and Chronic Myelomonocytic Leukemia ("CMML").
Based on our current projections we expect that our capital resources are sufficient to fund our operations into the first quarter of 2027.
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.
Our primary use of cash was from our net loss of $41.4 million, adjusted for non-cash items of $4.0 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $6.6 million.
Our primary use of cash was from our net loss of $45.4 million, adjusted for non-cash items of $5.1 million primarily related to stock-based compensation.
At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years. 48 Investing Activities Net cash provided by investing activities for the twelve months ended December 31, 2024 was $13.7 million, primarily related to maturities and sales in excess of purchases of marketable securities.
The net change in our operating assets and liabilities decreased cash used in operations by $2.6 million. 49 Investing Activities Net cash provided by investing activities for the year ended December 31, 2025, was $1.3 million, primarily related to maturities and sales in excess of purchases of marketable securities.
Net cash provided by financing activities for the twelve months ended December 31, 2023 was $0.
Net cash provided by financing activities for the year ended December 31, 2024, was $53.8 million from the net proceeds from the sale of common stock.
This patent is supported by the unexpected benefits of the treatment in such bev naïve patients. Our accumulated deficit through December 31, 2024 is $384.2 million. To date, we have generated minimal revenues, unrelated to onvansertib, and expect to incur additional losses to perform further research and development activities.
To date, we have generated minimal revenues, unrelated to onvansertib, and expect to incur additional losses to perform further research and development activities.
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Our common stock is listed on the Nasdaq Capital Market under the ticker symbol "CRDF". Recent Developments On December 10, 2024 we announced the sale of an aggregate of 15,384,619 shares of common stock in an oversubscribed underwritten registered direct offering, which resulted in gross proceeds of $40 million before underwriting discounts, commissions and expenses. The USPTO issued U.S.
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Our clinical development programs incorporate tumor genomics and biomarker assays to refine patient selection and assessment of patient response to treatment. Our common stock is listed on the Nasdaq Capital Market under the ticker symbol "CRDF". Our accumulated deficit through December 31, 2025 is $430.0 million.
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Patent No. 12,144,813 to us on November 19, 2024. The patent has an expected expiration date of no earlier than 2043. The patent claims cover the method of using onvansertib in combination with bevacizumab (“bev”) for the treatment of KRAS mutated mCRC patients who have not previously been treated with bev (“bev naïve”).
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Recent Developments Appointment of Interim Chief Executive Officer and Chief Accounting Officer On January 27, 2026, we announced that Mani Mohindru, PhD, a member of Cardiff Oncology’s Board of Directors since 2021 and a seasoned biotech executive, has been appointed interim Chief Executive Officer, effective immediately.
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The overall increase in expenses was primarily due to costs associated with 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 (research and development average headcount grew by 15% over the comparative period).
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Mark Erlander, PhD, Chief Executive Officer, and James Levine, Chief Financial Officer, have stepped down from their respective roles. As part of this transition, Brigitte Lindsay was promoted to the role of Chief Accounting Officer, ensuring continuity within the finance function. Critical Accounting Policies and Estimates Our accounting policies are described in Part II, Item 8.
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The overall decrease in expenses was primarily within facilities and other costs due to reduced insurance costs compared to the prior period. Salaries and staff costs decreased due to an employee severance agreement which was expensed during the prior period. Stock-based compensation expense decreased due to a modification of stock options that occurred during the prior period.
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We consider several elements including the key terms of the clinical trial agreements, budgets, contract amendments, and the progress of clinical trials toward completion (which includes consideration of patient 47 enrollment) in estimating the clinical trial accrual. We accrue costs based on estimated work completed in accordance with agreements established with our service providers.
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The increase in outside services and professional fees, was due to the settlement of litigation during the current period, offset by a decrease in corporate legal expenses compared to the prior period. 47 Interest Income, Net Interest income, net was $3.3 million for the twelve months ended December 31, 2024 as compared to $4.1 million for the same period of 2023.
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The overall decrease in expenses was primarily due to a reduction in clinical trial expenses and a decrease in preclinical activities. The increase in stock based compensation was due to new stock option grants during the current period.
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We have incurred net losses since our inception and have negative operating cash flows. As of December 31, 2024, we had $91.7 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 filing of this Form 10-K.
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The overall increase in expenses was primarily within professional fees and was primarily from strategic advisory services utilized during the current period and an increase in patent fees.
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Salaries and staff costs increased due to employee severance agreements which were expensed during the current period. 48 Interest Income Interest income was $3.1 million for the year ended December 31, 2025 as compared to $3.3 million for the same period of 2024. Our interest income is primarily from our short-term investment portfolios and money market accounts.
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As of December 31, 2025, we had $58.3 million in cash, cash equivalents and short-term investments.
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Management has performed an analysis and concluded that there exists a substantial doubt about the Company's ability to continue as a going concern, see Note 1 Business Overview and Liquidity to the financial statements for additional details.

Other CRDF 10-K year-over-year comparisons