CRDF 10-K & 10-Q changes, risk factors and insider trading
Cardiff Oncology, Inc. · Nasdaq · Biological Products, (No Diagnostic Substances) · CIK 1213037 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “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.”
New heading “Dependence on Third-Party Consultants”
New heading “Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.”
New heading “Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate.”
Removed heading “U.S. federal income tax reform could adversely affect us.”
Largest changes
“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.”see in full comparison
“Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate.”see in full comparison
“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. 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. …”see in full comparison
“Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.”see in full comparison
“On February 18, 2026, Nerviano sent us a written notice alleging that we are in material breach of the Nerviano Agreement with respect to (i) alleged joint ownership of certain of our patents and (ii) the filing of a joint invention continuation patent application. We are currently evaluating the notice and intend to respond within the applicable cure period set forth in the Nerviano Agreement. If we are unable to cure the alleged breach or successfully dispute the alleged breach within the applicable cure period, Nerviano may exercise its right to terminate the Nerviano Agreement. …”see in full comparison
Full comparison: every changed paragraph (18)
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.
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. 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. 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 any adjustments that might result from the outcome of this uncertainty. 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.
Our product candidate, onvansertib, is in the earlyearly-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.
Furthermore, we have adopted an operating model that largely relies on the outsourcing of a number of responsibilities and key activities to third-party consultants, and contract research and manufacturing organizations in order to advance the development of our product candidate. Therefore, our success depends in part on our ability to retain highly qualified key management, personnel, and directors to develop, implement and execute our business strategy, operate the company and oversee the activities of our consultants and contractors, as well as academic and corporate advisors or consultants to assist us in this regard. We are currently highly dependent upon the efforts of our management team. In order to develop our product candidate, we need to retain or attract certain personnel, consultants or advisors with experience in drug development activities that include a number of disciplines, including research and development, clinical trials, medical matters, government regulation of pharmaceuticals, manufacturing, formulation and chemistry, business development, accounting, finance, regulatory affairs, human resources and information systems. We are highly dependent upon our senior management and scientific staff, particularly MarkMani Erlander,Mohindru, our interim Chief Executive Officer (“CEO”). The loss of services of Dr. ErlanderMohindru 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.
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. 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. 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.
Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the FDA and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.
Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities. If a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
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. 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. Some of these risks include:
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. Some of these risks include:
On February 18, 2026, Nerviano sent us a written notice alleging that we are in material breach of the Nerviano Agreement with respect to (i) alleged joint ownership of certain of our patents and (ii) the filing of a joint invention continuation patent application. We are currently evaluating the notice and intend to respond within the applicable cure period set forth in the Nerviano Agreement. If we are unable to cure the alleged breach or successfully dispute the alleged breach within the applicable cure period, Nerviano may exercise its right to terminate the Nerviano Agreement. Any such termination would result in the loss of our license rights to onvansertib and any other intellectual property licensed thereunder, which would have a material adverse effect on our business, financial condition, results of operations, and prospects.
The cost of prescription pharmaceuticals in the United States has also been the subject of considerable discussion. 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, onOn August 16, 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law. 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). 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. Additionally, in April 2025, an executive order was signed directing the Secretary of HHS to take appropriate steps to, among other things, modify certain provisions of the Medicare Drug Price Negotiation Program, develop and implement a payment model to reduce the price of high-cost prescription drugs and biological products covered by Medicare, accelerate approval of generic and biosimilar products, and facilitate the ability of states to import pharmaceuticals from other countries, and in May 2025, an executive order was signed, among other things, directing the Secretary of HHS to propose rules that impose “most-favored-nation” pricing and take other measures to reduce the cost of prescription drugs. It is currently unclear whether and to what extent these measures will be implemented and what impact any such implementation would have on our business. Further, there can be no assurance that the current administration or future administrations will not pursue different or additional measures, such as those intended to more closely align U.S. drug prices with international drug prices (often referred to as “reference” or “international price index” drug pricing). Future price controls or other changes in pricing regulation or negative publicity related to the pricing of pharmaceutical drugs could restrict the amount that we are able to charge for our product candidates, which could render our product candidates, if approved, commercially unviable and materially adversely affect our ability to raise additional capital on acceptable terms.
Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate.
The tax regimes to which we are subject or under which we operate are unsettled and may be subject to significant change. The issuance of additional guidance related to existing or future tax laws, or changes to tax laws or regulations proposed or implemented by the current or a future U.S. presidential administration, Congress, or taxing authorities in other jurisdictions, including jurisdictions outside of the United States, could materially affect our tax obligations and effective tax rate. To the extent that such changes have a negative impact on us, including as a result of related uncertainty, these changes may adversely impact our business, financial condition, results of operations, and cash flows.
In July 2025, the OBBBA was signed into law, and it (along with other recent U.S. federal tax reform) has resulted in significant changes to the taxation of business entities including, among other changes, changes to the taxation of income derived from international operations, changes in the deduction and amortization of research and development expenditures, and limitations on the deductibility of business interest. 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.
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. 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. We do not expect tax reform to have a material impact to our projection of minimal cash taxes or to our net operating losses. 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. 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.
Management's Discussion & Analysis (MD&A)
New heading “Appointment of Interim Chief Executive Officer and Chief Accounting Officer”
Largest changes
We have incurred net losses since our inception and have negative operating cash flows. As of December 31,see in full comparison2024,2025, we had$91.7$58.3 million in cash, cash equivalents and short-terminvestments 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.investments. Based on our currentprojectionsprojections, we expect that our capital resources are sufficient to fund our operations into the first quarter of2027.2027, which is not sufficient to meet our funding requirements for at least the next 12 months following the issuance of our financial statements. Management has performed an analysis and concluded that there exists a substantial doubt about the Company's ability to continue as a going concern, see Note 1 Business Overview and Liquidity to the financial statements for additional details.
“Appointment of Interim Chief Executive Officer and Chief Accounting Officer”see in full comparison
Selling, general and administrative expensessee in full comparisondecreasedincreased by$0.6$1.7 million for thetwelve monthsyear ended December 31,2024,2025, compared to the same period in2023.2024. The overalldecreaseincrease in expenses was primarily withinfacilitiesprofessional fees andotherwascostsprimarilyduefromtostrategicreducedadvisoryinsuranceservicescostsutilizedcompared toduring thepriorcurrentperiod.period and an increase in patent fees. Salaries and staff costsdecreasedincreased due toanemployee severanceagreementagreements whichwaswere expensed during thepriorcurrent period.Stock-based compensation expense decreased due to a modification of stock options that occurred during the prior period. 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.
Research and development expensessee in full comparisonincreaseddecreased by$4.0$1.5 million for thetwelve monthsyear ended December 31,2024,2025, compared to the same period in2023.2024. The overallincreasedecrease in expenses was primarily due tocostsaassociatedreductionwithin clinicalprogramstrial expenses andoutsideaservicedecreasecostsinrelatedpreclinical activities. The increase in stock based compensation was due tothenewdevelopmentstockofoptionourgrantslead 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% overduring thecomparativecurrentperiod).period.
“The USPTO issued U.S. 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”). This patent is supported by the unexpected benefits of the treatment in such bev naïve patients.”see in full comparison
“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. Mark Erlander, PhD, Chief Executive Officer, and James Levine, Chief Financial Officer, have stepped down from their respective roles.”see in full comparison
Full comparison: every changed paragraph (22)
We are a clinical-stage biotechnology company, headquartered in San Diego, CA,company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers with the greatest unmet medical need. Our goal is to target tumor vulnerabilities with treatment combinations of onvansertib, our oral and highly selective PLK1 inhibitor, and standard-of-care ("SoC") therapeutics. We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated ongoing or planned trials in metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), andmetastatic triple negative breast cancer ("TNBCmTNBC") and Chronic Myelomonocytic Leukemia ("CMML"). 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. To date, we have generated minimal revenues, unrelated to onvansertib, and expect to incur additional losses to perform further research and development activities.
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. 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.
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. 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”). 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.
We accrue and expense research and development expenditures as incurred, which include costs related to clinical trial activities. We accrue costs for clinical trial activities based upon estimates of the services received and related expenses incurred that have yet to be invoiced by the Clinical Research Organizations ("CROs"), professional service providers, and other vendors providing clinical trial services (collectively, the “service providers”). 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 enrollment) in estimating the clinical trial accrual. 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 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 make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Due to the nature of estimates, we cannot assure you that we will not make changes to our estimates in the future as we become aware of additional information about the status or conduct of our clinical trial activities.
Total revenues were $0.7$0.6 million for the twelve monthsyear ended December 31, 2024,2025, as compared to $0.5$0.7 million for the same period in 2023.2024. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib. Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees.
Research and development expenses increaseddecreased by $4.0$1.5 million for the twelve monthsyear ended December 31, 2024,2025, compared to the same period in 2023.2024. The overall increasedecrease in expenses was primarily due to costsa associatedreduction within clinical programstrial expenses and outsidea servicedecrease costsin relatedpreclinical activities. The increase in stock based compensation was due to thenew developmentstock ofoption ourgrants 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% overduring the comparativecurrent period).period.
Selling, general and administrative expenses decreasedincreased by $0.6$1.7 million for the twelve monthsyear ended December 31, 2024,2025, compared to the same period in 2023.2024. The overall decreaseincrease in expenses was primarily within facilitiesprofessional fees and otherwas costsprimarily duefrom tostrategic reducedadvisory insuranceservices costsutilized compared toduring the priorcurrent period.period and an increase in patent fees. Salaries and staff costs decreasedincreased due to an employee severance agreementagreements which waswere expensed during the priorcurrent period. Stock-based compensation expense decreased due to a modification of stock options that occurred during the prior period. 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.
Interest Income, NetIncome
Interest income, netincome was $3.3$3.1 million for the twelve monthsyear ended December 31, 20242025 as compared to $4.1$3.3 million for the same period of 2023.2024. Our interest income is primarily from our short-term investment portfolios and money market accounts. The amount of interest income earned varies each period based on the balance of our accounts and interest rates.
We have incurred net losses since our inception and have negative operating cash flows. As of December 31, 2024,2025, we had $91.7$58.3 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.investments. Based on our current projectionsprojections, we expect that our capital resources are sufficient to fund our operations into the first quarter of 2027.2027, which is not sufficient to meet our funding requirements for at least the next 12 months following the issuance of our financial statements. Management has performed an analysis and concluded that there exists a substantial doubt about the Company's ability to continue as a going concern, see Note 1 Business Overview and Liquidity to the financial statements for additional details.
Net cash used in operating activities for the twelve monthsyear ended December 31, 2024,2025, was $37.7$37.9 million. Our primary use of cash was from our net loss of $45.4$45.9 million, adjusted for non-cash items of $4.6$5.7 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $3.2$2.2 million.
Net cash used in operating activities for the twelve monthsyear ended December 31, 2023,2024, was $30.9$37.7 million. Our primary use of cash was from our net loss of $41.4$45.4 million, adjusted for non-cash items of $4.0$5.1 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $6.6$2.6 million.
At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years.
Net cash provided by investing activities for the twelve monthsyear ended December 31, 20242025, was $13.7$1.3 million, primarily related to maturities and sales in excess of purchases of marketable securities.
Net cash provided by investing activities for the twelve monthsyear ended December 31, 20232024, was $36.2$13.7 million, primarily related to maturities and sales in excess of purchases of marketable securities.
Net cash provided by financing activities for the twelve monthsyear ended December 31, 20242025, was $53.8$2.6 million, from the saleexercise of common stockwarrants and employee stock options exercises.
Net cash provided by financing activities for the twelve monthsyear ended December 31, 20232024, was $0.$53.8 million from the net proceeds from the sale of common stock.
What changed in the latest 10-Q
Risk Factors
New heading “We Are Subject to Significant Litigation Risk and Cannot Predict the Outcome of Our Pending Lawsuit Against Our Licensor”
New heading “The Loss of Rights Under the Agreement Could Materially Disrupt Our Business Operations”
New heading “We May Not Be Able to Obtain or Maintain Permanent or Preliminary Injunctive Relief”
New heading “This Litigation Is Costly, Time-Consuming, and Could Divert Management Attention and Resources”
New heading “We May Need to Established Financial Reserves That May Prove Inadequate”
New heading “The Litigation May Affect Our Ability to Raise Capital or Enter Into Strategic Transactions”
New heading “We May Be Unable to Obtain Replacement License Rights on Acceptable Terms”
New heading “Litigation Outcomes Are Inherently Unpredictable and Subject to Appeal”
Largest changes
“We Are Subject to Significant Litigation Risk and Cannot Predict the Outcome of Our Pending Lawsuit Against Our Licensor”see in full comparison
“This Litigation Is Costly, Time-Consuming, and Could Divert Management Attention and Resources”see in full comparison
“The Litigation May Affect Our Ability to Raise Capital or Enter Into Strategic Transactions”see in full comparison
“Litigation Outcomes Are Inherently Unpredictable and Subject to Appeal”see in full comparison
“The pendency of this litigation could adversely affect our ability to raise additional equity or debt financing on favorable terms, or at all. Investors and lenders may perceive the litigation as a material contingent liability and may demand higher risk premiums, require additional covenants, or decline to participate in financing transactions until the matter is resolved. …”see in full comparison
“The Loss of Rights Under the Agreement Could Materially Disrupt Our Business Operations”see in full comparison
Full comparison: every changed paragraph (20)
There have been no material changes from the risk factors disclosed in our Form 10-K for the year ended December 31, 2025.2025, except for the following:
We Are Subject to Significant Litigation Risk and Cannot Predict the Outcome of Our Pending Lawsuit Against Our Licensor
We have initiated litigation against NMS alleging wrongful purported termination of the Agreement and other claims. NMS has responded with counterclaims. The outcome of litigation is inherently uncertain. There can be no assurance that we will prevail on any or all of our claims, that we will obtain the relief we are seeking, or that a court will agree with our legal interpretation of the Agreement or our characterization of NMS's conduct. If the court determines that NMS's termination was valid, we would lose the rights granted under the Agreement, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
The Loss of Rights Under the Agreement Could Materially Disrupt Our Business Operations
The Agreement granted us an exclusive license to conduct research and to develop, make, use, offer for sale, sell, and import products or otherwise exploit NMS’s intellectual property rights that are integral to our development of onvansertib. If the termination of the Agreement is ultimately upheld, or if we are unable to obtain preliminary injunctive relief requiring continuation of our licensed rights during the pendency of this litigation through specific performance, we may be required to:
cease or significantly curtail certain business operations or product offerings;
seek alternative technology, intellectual property, or proprietary assets, which may not be available on commercially reasonable terms or at all; and/or write down or impair the value of assets associated with our use of the licensed rights.
Any of the foregoing consequences could materially and adversely affect our business, financial condition, results of operations and prospects.
We May Not Be Able to Obtain or Maintain Permanent or Preliminary Injunctive Relief
We have sought preliminary injunctive relief to preserve our rights under the Agreement during the course of litigation. There is no guarantee that a court will grant such relief. Courts apply exacting standards to the issuance of preliminary injunctions, including requirements that the moving party demonstrate, among other things, a likelihood of success on the merits, irreparable harm, that the balance of equities favors relief, and that an injunction is in the public interest. Our inability to obtain such relief could result in NMS enforcing or attempting to enforce some or all of the termination provisions of the Agreement pending final adjudication, which could disrupt our ability to operate our business in the ordinary course and cause irreparable harm to our business and financial performance.
This Litigation Is Costly, Time-Consuming, and Could Divert Management Attention and Resources
Commercial litigation of this nature is expensive and time-consuming. We expect to incur significant legal fees and other litigation costs in connection with this dispute. These costs could be substantial and may continue for an extended period, as complex commercial litigation frequently takes multiple years to resolve at the trial court level, with potential additional time for appellate proceedings. In addition, the attention and resources of our senior management team may be diverted from day-to-day business operations in connection with discovery, depositions, court proceedings, and settlement negotiations. This diversion of resources could negatively affect our ability to execute on our strategic priorities and could adversely affect our business and results of operations.
We May Need to Established Financial Reserves That May Prove Inadequate
In accordance with applicable accounting standards, we may be required to establish reserves for this litigation to the extent a loss is probable and can be reasonably estimated. However, the actual costs and liabilities associated with this litigation may exceed any reserves we have established, and there can be no assurance that our reserves are adequate. Changes in our assessment of the likely outcome, or developments during the course of the litigation, may require us to increase our reserves, which could have a material adverse effect on our reported financial results in the period in which such reserves are increased.
The Litigation May Affect Our Ability to Raise Capital or Enter Into Strategic Transactions
The pendency of this litigation could adversely affect our ability to raise additional equity or debt financing on favorable terms, or at all. Investors and lenders may perceive the litigation as a material contingent liability and may demand higher risk premiums, require additional covenants, or decline to participate in financing transactions until the matter is resolved. Similarly, the litigation may complicate or delay our ability to engage in mergers, acquisitions, or other strategic transactions, as potential counterparties may be unwilling to proceed in the face of unresolved material litigation. These constraints could limit our strategic and financial flexibility.
We May Be Unable to Obtain Replacement License Rights on Acceptable Terms
If the alleged termination of the Agreement is ultimately upheld, we may attempt to license the same or similar rights from NMS or from alternative sources. There is no guarantee that we will be able to negotiate a new license with NMS, or that such a license would be available on commercially acceptable terms. Alternative sources of equivalent intellectual property or technology may not exist, may be protected by third-party rights, may be subject to other encumbrances, or may not be available to us on terms that allow us to operate our business profitably. The failure to obtain replacement rights could have a material adverse effect on our business.
Litigation Outcomes Are Inherently Unpredictable and Subject to Appeal
Even if we prevail at the trial court level, NMS may appeal such a ruling, which could result in a reversal or modification of a favorable judgment, require additional litigation costs, and extend the period of uncertainty. Conversely, if an initial ruling is adverse to us, we may elect to appeal, which would similarly extend the litigation timeline and associated costs and uncertainty. The appellate process can take years and may not result in a final resolution that is more favorable to us than the initial ruling.
Management's Discussion & Analysis (MD&A)
New heading “Safety/Tolerability”
New heading “Six Months Ended June 30, 2026 and 2025”
New heading “Research and Development Expenses”
New heading “Selling, General and Administrative Expenses”
New heading “Interest Income, Net”
Removed heading “Completed End-of-Phase 2 Meeting with the FDA and Aligned on the Design of the Phase 3 Registrational Trial in Patients with First-line RAS-mutated mCRC”
Largest changes
“Completed End-of-Phase 2 Meeting with the FDA and Aligned on the Design of the Phase 3 Registrational Trial in Patients with First-line RAS-mutated mCRC”see in full comparison
Full comparison: every changed paragraph (52)
We are a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology drug target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer ("mCRC"), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through investigator-initiated trials such as metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), and metastatic triple negative breast cancer ("mTNBC"). Additionally, onvansertib has also shown robustpromising single agent activity in an ongoing investigator-initiated trial in chronic myelomonocytic leukemia ("CMML"). These programs and our broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver improved clinical outcomes in patients.patients with cancer. Our clinical development programs incorporate tumor genomics and biomarker assays to refine patient selection and assessment of patient response to treatment.
In addition, in vivo combination studies have confirmed the positive results obtained in vitro and additive or synergistic effects on efficacy have been observed in xenograft models of onvansertib in combination with irinotecan, 5-fluorouracil ("5-FU"), abiraterone, PARP inhibitors, venetoclax, paclitaxel, orand bevacizumab.bevacizumab ("bev"). Combining onvansertib with standard of care ("SoC") cancer agents may provide opportunities for synergy with many cancer therapies.
There are several ongoing clinical trials of onvansertib in multipleselect cancer indications: one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, and investigator-initiated trials in first-line mPDAC, first-linerelapsed / refractory or advanced CMML as monotherapy, second-line relapsed SCLC as monotherapy, and second-line unresectable locally advanced or metastatic TNBC.
CRDF-004 is a Phase 2, randomized, open label multi-center clinical trial to assess the efficacy of two different doses of onvansertib (20mg20 mg and 30mg30 mg) in combination with FOLFIRI and bevacizumab/bev or FOLFOX and bevacizumab,/bev, compared with FOLFIRI/bev or FOLFOX and bevacizumab/bev SoC alone, for the treatment of confirmed mCRC in patients with a KRAS or NRAS mutation in the first-line setting. Trial endpoints include objective response rate ("ORR"), progression-free survival ("PFS") and duration of response ("DoR") together with pharmacokinetics, pharmacodynamics and safety assessments. SelectionThe primary goal of the recommendedclinical trial is to select the safe and efficacious dose of onvansertib plus appropriate standard of care regimen for the Phase 3 onvansertib dose will betrial based on a benefit-risk assessment of the totality of the evidence, including numerical differences between the onvansertib and SoC arms. The trial has enrolled 110 patients in the intent-to-treat ("ITT") population and is being conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies. For more information, please visit NCT06106308 at www.clinicialtrials.gov.
Data highlights from the ongoing Phase 2 trial were presented at the ASCO Meeting on June 2, 2026, using a data cut of March 18, 2026. Overall, results showed that the onvansertib 30 mg + FOLFIRI/bev dose regimen, demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in ORR and PFS compared to SoC alone, with no additive adverse events. In the ITT population, the dose selected for the registrational program, 30 mg onvansertib arm in combination with FOLFIRI/ bev achieved:
Primary endpoint of confirmed objective response rate of 72.2% (13/18), compared with 42.1% (8/19) for FOLFIRI/bev alone, a 30% improvement over SoC. The responses were deeper and more durable in the onvansertib arm.
Secondary endpoint of PFS hazard ratio ("HR") of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) vs. FOLFIRI/bev by Blinded Independent Central Review ("BICR") and investigator assessment ("IA"), respectively.
Median PFS not reached in 30 mg onvansertib + FOLFIRI/bev arm, but has been reached in both SoC arms. Four patients remain on onvansertib treatment beyond 15 months, including 2 beyond 20 months.
No meaningful differences in efficacy were observed between the onvansertib + FOLFOX/bev arms and FOLFOX/bev alone.
Safety/Tolerability
Onvansertib in combination with both chemotherapy (FOLFIRI or FOLFOX)/bev regimens was well-tolerated. There were no major or unexpected toxicities observed, and no additive adverse events reported. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and SoC arms.
The Phase 2 trial is still ongoing and as of a June 23, 2026 data cut-off, 12 patients remain on trial, with 8 patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC.
In April 2026 we completed our End-of-Phase 2 Type B meeting with the U.S. Food and Drug Administration ("FDA"). Incorporating FDA feedback, we have designed the registrational Phase 3 trial (CRDF-005) as a global randomized, controlled trial that will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus SoC FOLFIRI/bev in patients with RAS mutated mCRC. We expect to enroll approximately 640 patients across sites in the US, Europe and other regions. Additional details of the trial will be disclosed at the time of initiation of the trial.
Additionally, we have initiated the process of soliciting scientific advice from the European Medicines Agency ("EMA") on our Phase 3 plans. We remain on track with the manufacturing of clinical material and also with companion diagnostic related regulatory activities as we prepare for the registrational trial.
Data provided in the press release dated January 27, 2026 included updated data from the ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC. The 30 mg onvansertib + FOLFIRI/bev arm achieved a confirmed objective response rate (“ORR”) if 72.2% compared to 43.2% across the combined SoC arms. The 30 mg onvansertib dose in combination with FOLFIRI/bev also demonstrated marked improvement in progression-free survival (“PFS”) versus FOLFIRI/bev (HR: 0.38) and combined SoC of FOLFOX/bev and FOLFIRI/bev (HR: 0.37, p<0.05), with no significant added toxicity observed. The results as of the data cut-off date of January 22, 2026, are shown below.
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.
aORR is confirmed responses bProgressive disease events were based on combined BICR and Investigator assessments due to very small number of events in BICR assessment. The earliest reported date was used for a conservative estimate.
cSoC is the combination of the FOLFIRI/bev and FOLFOX/bev arms dPFS HR is the comparison of the onvansertib arm to FOLFIRI/bev ePFS HR is the comparison of the onvansertib arm to SoC fFisher’s exact test gLog-rank test We will report detailed updated data from our randomized Phase 2 CRDF-004 trial evaluating onvansertib in combination with FOLFIRI/bev or FOLFOX/bev in patients with first-line RAS-mutated mCRC in a rapid oral presentation at the ASCO Annual Meeting, taking place May 29–June 2 in Chicago.
Completed End-of-Phase 2 Meeting with the FDA and Aligned on the Design of the Phase 3 Registrational Trial in Patients with First-line RAS-mutated mCRC
In consultation with the U.S. Food and Drug Administration (FDA), Cardiff selected the 30 mg dose of onvansertib for evaluation with FOLFIRI/bev chemotherapy regimen for the Phase 3 trial in patients with first-line RAS-mutated mCRC. Additional details of the clinical trial will be shared by mid-2026.
We support certain investigator-initiated trials by supplying onvansertib to academic clinicians who conduct clinical trials independently. These studies allow us to tap into the expertise of independent clinicians and academic investigators to explore new therapeutic indications or new dosage regimens at a low cost to us. By facilitating independent research, we have the opportunity to gain valuable evidence and safety data that can inform future regulatory decisions or improve our understanding of onvansertib’s efficacy. Furthermore, supporting investigator-initiated trials actsact as a collaborative effort that strengthens relationships with KOLs.
In February 2024, the FDA approved NALIRIFOX as a first-line treatment option for mPDAC. As a result, we are currently supporting an investigator-initiated mPDAC Phase 1b/2 trial of onvansertib in combination with first-line SoC NALIRIFOX, which is open for enrollment at the University of Kansas Medical Center. The trail has completed enrollment, and data will be disclosed by the investigator after completion of the trial. For more information, please visit NCT06736717 at www.clinicaltrials.gov.
The primary objective in this study is to determine anti-tumor activity by measuring ORR. The secondary objectives are to determine treatment safety based on toxicities in participants who have received at least one dose of onvansertib, to determine anti-tumor activity by PFS, to determine anti-tumor activity by Disease Control Rate ("DCR"), toas determinewell as Overall Survival ("OS").
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.Baltimore Thecompleted trialenrollment is designed to enrollof 15 patients in Stage 1, with the study proceeding to Stage 2 if 2two or more Stage 1 patients achieve an objective response. Stage 2 is designed to enroll an additional 20 patients. The primary endpoint of the trial is ORR, while key secondary endpoints include PFS and OS. For more information, please visit NCT05450965 at www.clinicialtrials.gov.
Collectively, thisThese clinical data further supportssupport the potential exploration of the combination of onvansertib plus paclitaxel for the treatment of mTNBC.
This phasePhase 1 trial is designed to evaluate the safety, effectiveness, and best dose of onvansertib as a monotherapy for the treatment of patients with CMML and Myelodysplastic syndrome/myeloproliferative neoplasm ("MDS/MPN") overlap neoplasms that hashave come back (recurrent) or that doesdo not respond to treatment (refractory). For more information, please visit NCT05549661 at www.clinicialtrials.gov.
On April 9, 2026, we announced the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO. She will continue as a member of the Board of Directors. We also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect Cardiff'sour commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential.
Three Months Ended MarchJune 31,30, 2026 and 2025
Total revenues were $41,000$0.1 million for the three months ended MarchJune 31,30, 2026, as compared to $109,000$0.1 million for the sameprior period in 2025.period. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib. Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees.
Research and development expenses decreased by $3.7$5.7 million for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025. The overall decrease inof research and development expenses was primarily duerelated to the completion of clinical trials, as well as fewer patients still on treatment in our Phase 2 mCRC trial, and a reduction in clinicalpre-clinical trialactivities expensesas andwe afocus decreaseon inour preclinicalupcoming activities.Phase 3 mCRC trial.
Selling, general and administrative expenses increased by $2.1$0.5 million for the three months ended MarchJune 31,30, 2026, compared to the same period in 2025. The overall increase in expenses wasexpenses, primarily from employeeoutside severanceservices agreementsand recordedprofessional fees, is primarily related to salaries and staffattorney costs withinfor theour currentintellectual period.property dispute with NMS. The increasedecrease in stock basedstock-based compensation was duea result of the modificationdeparture of stockour optionsformer fromCEO employeeand severanceCFO agreements.during the first quarter of 2026, resulting in lower ongoing equity award expense.
Interest income, net was $0.5$0.4 million for the three months ended MarchJune 31,30, 2026 as compared to $0.9$0.8 million for the same period of 2025. Our interest income is primarily from our short-term investment portfolios and money market accounts. The amount of interest income earned varies each period based on the balance of our accounts and interest rates.
Six Months Ended June 30, 2026 and 2025
Revenues
Total revenues were $0.1 million for the six months ended June 30, 2026, as compared to $0.2 million for the same period in 2025. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib. Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees.
Research and Development Expenses
Research and development expenses consisted of the following:
Research and development expenses decreased by $9.4 million for the six months ended June 30, 2026, compared to the same period in 2025. The overall decrease of research and development expenses was related to the completion of clinical trials, as well as fewer patients still on treatment in our Phase 2 mCRC trial, and a reduction in pre-clinical activities as we focus on our upcoming Phase 3 mCRC trial.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consisted of the following:
Selling, general and administrative expenses increased by $2.6 million for the six months ended June 30, 2026, compared to the same period in 2025. The overall increase in expenses was primarily from employee severance agreements recorded to salaries and staff costs within the current period. The increase in outside services and professional fees is primarily related to attorney costs for our intellectual property dispute with NMS.
Interest Income, Net
Interest income, net was $0.9 million for the six months ended June 30, 2026 as compared to $1.8 million for the same period of 2025. Our interest income is primarily from our short-term investment portfolios and money market accounts. The amount of interest income earned varies each period based on the balance of our accounts and interest rates.
As of MarchJune 31,30, 2026, and December 31, 2025, we had working capital of $32.9$24.8 million and $43.7 million, respectively.
Subsequent to quarter end, on July 14, 2026, we completed a registered direct offering that generated gross proceeds of approximately $10.1 million. See Note 7, Subsequent Events, for additional information.
We have incurred net losses since our inception and have negative operating cash flows. As of MarchJune 31,30, 2026, we had $46.1$34.5 million in cash, cash equivalents and short-term investments. Based on our current projections, we expect that our capital resources are sufficient to fund our operations into the firstthird quarter of 2027, which is not sufficient to meet our funding requirements for at least the next 12 months following the issuance of our financial statements. Management has performed an analysis and concluded that there exists a substantial doubt about our ability to continue as a going concern, see Note 1 Business Organization and Overview - Going Concern Uncertainty to the financial statements for additional details.
Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026, was $12.3$24.1 million. Our primary use of cash was from our net loss of $12.3$21.6 million, adjusted for non-cash items of $1.8$2.9 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreasedincreased cash used in operations by $1.7$5.3 million.
Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2025, was $12.8$21.1 million. Our primary use of cash was from our net loss of $13.4$27.4 million, adjusted for non-cash items of $1.5$3.1 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $0.8$3.2 million.
Net cash provided by investing activities for the threesix months ended MarchJune 31,30, 2026 was $3.3$15.5 million, primarily related to maturities in excess of purchases of marketable securities.
Net cash used in investing activities for the threesix months ended MarchJune 31,30, 2025 was $14.6$19.6 million, primarily related to purchases in excess of maturities and sales of marketable securities.
Net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2026 was $105,000,$254,000, from sales of common stock, warrants and employee stock options exercises.
Net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2025 was $3,000, from employee stock options exercises.
CRDF insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 4 Form 4 filings (2 insiders, 2 trade dates, 776,352 shares, about $1.1M) and open-market sales in 0 filings. Net open-market shares: 776,352 (purchases minus sales); net value about $1.1M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-07-14 | Pace Gary W |
Open-market purchase | 687,285 | $1.46 | $1.0M |
| 2026-07-14 | Mohindru Mani |
Open-market purchase | 34,364 | $1.46 | $50.2K |
| 2026-06-18 | Mohindru Mani |
Open-market purchase | 24,703 | $1.21 | $29.9K |
| 2026-06-18 | Pace Gary W |
Open-market purchase | 30,000 | $1.22 | $36.6K |
Well-known investors holding CRDF (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 346,353 | $450.3K | 0.0% | Added 424% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 125,566 | $203.4K | — | Sold out |
| Millennium Management (Israel Englander) | 2026-06-30 | 134,517 | $174.9K | 0.0% | Added 484% |
| Two Sigma Investments | 2026-06-30 | 47,666 | $62.0K | 0.0% | Reduced 77% |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 28,385 | $36.9K | 0.0% | New position |
| Renaissance Technologies | 2026-06-30 | 13,942 | $18.1K | 0.0% | Reduced 86% |