Cardiff Oncology, Inc. filings document regulatory disclosures for a clinical-stage oncology company developing onvansertib and PLK1-inhibition programs. Recent Form 8-K reports cover financial results, business updates, Regulation FD presentation materials, CRDF-004 clinical disclosures in first-line RAS-mutated metastatic colorectal cancer and other material events tied to the company's development strategy.
The company's proxy and current reports also address board and executive governance, officer appointments and departures, separation agreements, compensation arrangements, equity awards and Nasdaq inducement grants. These filings include formal disclosure of risk themes common to clinical-stage biotechnology issuers, including clinical-trial uncertainty, financing needs, dependence on key personnel and operating disruptions.
Cardiff Oncology files its annual report describing a clinical‑stage pipeline centered on onvansertib, an oral, highly selective PLK1 inhibitor being tested across multiple cancers, led by a Phase 2 trial in first‑line RAS‑mutated metastatic colorectal cancer in partnership with Pfizer Ignite.
Updated CRDF‑004 data show a confirmed objective response rate of 72.2% for the 30 mg onvansertib plus FOLFIRI/bevacizumab arm versus 43.2% for standard of care, with a progression‑free survival hazard ratio of 0.37 versus standard of care and a generally well‑tolerated safety profile.
The company remains loss‑making, with a 2025 net loss of about $45.9 million, an accumulated deficit of roughly $430.0 million, cash and investments of $58.3 million, and substantial doubt about its ability to continue as a going concern, implying a need for additional capital. Cardiff also discloses a February 2026 notice from Nerviano alleging material breach of the onvansertib license; Cardiff disputes the claims but notes that an adverse outcome could jeopardize key intellectual property rights and materially harm its business.
Cardiff Oncology, Inc. reported that Chief Accounting Officer Lindsay Brigitte Ute acquired a grant of 200,000 stock options on February 13, 2026. The options were granted at an exercise price of $0.00 per share, reflecting a cost-free award rather than an open-market purchase.
Following this transaction, Ute held a total of 1,025,334 stock options directly. According to the vesting terms, 50,000 options vest on February 13, 2027, and 4,166 options vest monthly for the subsequent 36 months, spreading the remainder of the award over three years.
Mohindru Mani reported acquisition or exercise transactions in this Form 4 filing.
Cardiff Oncology, Inc. reported that Interim CEO and director Mani Mohindru received a grant of stock options. The award covers 200,000 stock options, recorded at a price of $0.0000 per option, and increases her directly held option position to 368,766 options following the transaction.
Cardiff Oncology chief accounting officer files initial holdings report. The Form 3 shows Brigitte Lindsay beneficially owns 27,431 shares of Cardiff Oncology common stock directly. She also holds multiple stock option awards on common stock with expiration dates from January 2028 through March 2035 and exercise prices ranging from $1.72 to $21.6 per share. Footnotes describe vesting schedules for each option grant, with portions already vested and additional shares vesting over monthly periods of up to 36 months.
Cardiff Oncology reported major leadership changes and a clinical program update. On January 27, 2026, longtime CEO Dr. Mark Erlander and CFO James Levine stepped down as part of a strategic leadership review. The Board appointed director Dr. Mani Mohindru as interim CEO and promoted Brigitte Lindsay, previously Senior Vice President, Finance, to Chief Accounting Officer.
The company also highlighted a positive update from CRDF-004, a randomized Phase 2 trial of its drug candidate onvansertib combined with standard-of-care regimens in first-line RAS‑mutated metastatic colorectal cancer. Details of the results are provided in an attached press release, which is largely incorporated by reference into this report.
Cardiff Oncology (CRDF) filed an 8-K stating it issued a press release announcing company highlights and financial results for the third quarter ended September 30, 2025. The press release was furnished as Exhibit 99.1.
The company’s common stock trades on The Nasdaq Stock Market under the symbol CRDF. The report was signed by Chief Executive Officer Mark Erlander on November 6, 2025.
Cardiff Oncology (CRDF) reported Q3 2025 results with royalty revenue of $0.12M and a net loss of $11.3M (basic and diluted net loss per share $0.17). Research and development expense was $8.2M (down year over year), while selling, general and administrative expense was $3.9M (up year over year).
Cash, cash equivalents and short-term investments totaled $60.6M as of September 30, 2025. Net cash used in operating activities was $32.0M for the nine months. Management states current resources are sufficient for at least the next 12 months and, based on projections, to fund operations into the first quarter of 2027. Total stockholders’ equity was $48.8M.
In its lead mCRC program, Phase 2 CRDF-004 showed blinded independent central review ORR as of July 8, 2025: control 30%, onvansertib 20mg + SoC 42%, and onvansertib 30mg + SoC 49%. The combination was described as well-tolerated. Shares outstanding were 67,360,564 as of October 30, 2025.
Cardiff Oncology, Inc. is registering 4,635,040 shares of its common stock under a Form S-8. This total includes 635,040 shares issuable upon vesting and exercise of stock options granted as inducement awards to employees under Nasdaq Listing Rule 5635(c)(4), and an additional 4,000,000 shares reserved for issuance under the company’s 2021 Omnibus Equity Incentive Plan.
The filing uses General Instruction E of Form S-8 to register additional securities of the same class as prior S-8 registrations and incorporates earlier reports and governance documents by reference. It also outlines Delaware law and company provisions for indemnification and insurance for directors and officers.
Cardiff Oncology, Inc. (CRDF) received a joint Schedule 13G/A from Commodore Capital LP and Commodore Capital Master LP reporting zero beneficial ownership of the issuer's common stock (CUSIP 14147L108). The filing lists each filers jurisdiction (Delaware and Cayman Islands), business addresses, and certifies the securities were not acquired to influence control of the company. The cover pages show 0.00 shares and 0.0% of the class for both filers. The document includes a signed joint filing agreement and certifications by Michael Kramarz as Managing Partner and Authorized Signatory.