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Cardiff Oncology — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Total operating expenses for the nine months ended September 30, 2026, were $32.0 million, a decrease of $9.5 million (23%) from $41.5 million in the same period of 2025.
    • Research and development expenses decreased by $12.5 million to $17.7 million for the nine months ended September 30, 2026, compared to $30.3 million in the prior year period.
    • Selling, general, and administrative (SG&A) expenses increased by $3.1 million to $14.3 million for the nine months ended September 30, 2026, compared to $11.2 million in the prior year period.
    • Net loss for the nine months ended September 30, 2026, was $30.4 million, compared to $38.6 million for the same period in 2025.
    • Net loss per common share (basic and diluted) was $0.43 for the nine months ended September 30, 2026, compared to $0.58 in the prior year period.
    • Net cash used in operating activities for the nine months ended September 30, 2026, was $33.9 million, an increase of $2.0 million from $31.9 million in the same period of 2025.
    • As of September 30, 2026, the company held approximately $33.8 million in cash, cash equivalents, and short-term investments.
    • Royalty revenues were $316,000 for the nine months ended September 30, 2026, compared to $350,000 in the prior year period.
  • Guidance and Future Outlook:

    • The company expects current cash resources to be sufficient to fund operations through the end of the third quarter of 2027.
    • Cardiff is preparing for a registrational Phase 3 trial in first-line RAS-mutated metastatic colorectal cancer (mCRC), with a potential start in the first quarter of 2027.
  • Business Segments and Product Lines:

    • The Phase 2 randomized trial evaluating onvansertib in combination with FOLFIRI/bevacizumab (bev) or FOLFOX/bev for first-line RAS-mutated mCRC remains ongoing.
    • Median progression-free survival (PFS) has not been reached in the 30 mg onvansertib + FOLFIRI/bev arm, compared to approximately 11 months in the combined standard-of-care (SoC) arms.
    • As of September 28, 2026, all patients remaining in the 30 mg onvansertib + FOLFIRI/bev arm have exceeded 21 months on treatment, with the longest duration exceeding 29 months.
    • Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials.
  • Market and Competitive Landscape:

    • There are currently no treatment options specifically approved for patients with pan RAS-mutated mCRC in the first-line setting.
    • The company views onvansertib as having the potential to become an important new treatment for this large, underserved patient population.
  • Risks and Challenges:

    • Risks include uncertainties associated with clinical development and regulatory approvals, the possibility that earlier clinical results may not predict future outcomes, and risks related to the timing, initiation, conduct, and completion of clinical trials.
    • The company faces risks related to its need for additional financing, dependence on key personnel and third parties, competition, and intellectual property risks.
    • There is no assurance that onvansertib will receive regulatory approval or prove commercially successful.
  • Management Commentary and Tone:

    • CEO Mani Mohindru, PhD, expressed encouragement regarding onvansertib's performance, noting that the benefit of the drug in combination with FOLFIRI/bev is becoming more evident as data matures.
    • Management highlighted the growing separation between the onvansertib and control arms in the ongoing trial.
  • Other Key Points:

    • In July 2026, the company completed a $10 million registered direct offering of common stock and warrants, raising net proceeds of approximately $9.1 million.
    • In September 2026, Cardiff and licensor Nerviano Medical Sciences S.r.l. (NMS) resolved all outstanding disputes regarding global rights to onvansertib and amended their 2017 exclusive license agreement.
    • In October 2026, the company appointed Leila Alland, MD, as interim Chief Medical Officer.
    • Management is scheduled to present at the UBS Global Biopharma Conference on November 16–17, 2026.
    • Updated data from an investigator-sponsored clinical trial in CMML will be presented at the American Society of Hematology (ASH) Annual Meeting on December 13, 2026.
Company
CARDIFF ONCOLOGY INC
Sector
Healthcare
Industry
Biotechnology