Cardiff Oncology, Inc.

What they do

Cardiff Oncology develops onvansertib, an oral, highly selective PLK1 inhibitor with a 24-hour half-life, in combination with standard-of-care therapies. The lead program is CRDF-004, a Phase 2 randomized trial of onvansertib plus FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line RAS-mutated mCRC, with investigator-initiated trials in mPDAC, SCLC, mTNBC and CMML. The company is clinical-stage and has no product revenue.

Revenue drivers

• Royalty revenue — Total revenues are sales- or usage-based royalties on other intellectual property licenses, unrelated to onvansertib; revenue was $0.1 million in Q2 2026 and $0.1 million in the six months ended June 30, 2026.
• Onvansertib (development stage) — Lead drug candidate in Phase 2 for first-line RAS-mutated mCRC and investigator-initiated trials; generates no product revenue.
• License and collaboration arrangements — CRDF-004 is conducted in partnership with Pfizer Ignite; revenue recognition from royalties depends on licensee sales timing.

Recent performance

Q2 2026 revenue was $0.1 million, flat versus Q2 2025, from royalty licenses unrelated to onvansertib. Research and development expense fell $5.7 million to $5.9 million for Q2 2026, and $9.4 million to $12.7 million for the six months, mainly from completed trials and fewer patients on treatment. SG&A rose $0.5 million to $3.8 million in Q2 2026, largely outside services and professional fees tied to the NMS intellectual property dispute. Interest income, net was $0.4 million in Q2 2026 versus $0.8 million a year earlier. At June 30, 2026, total assets were $37.3 million, liabilities $10.8 million, shareholder equity $26.5 million and cash $9.2 million.

Strategy

Following positive CRDF-004 Phase 2 data presented at ASCO in June 2026, Cardiff selected 30 mg onvansertib plus FOLFIRI/bevacizumab as the registrational dose and regimen. After a successful End-of-Phase 2 meeting with the FDA, the company aligned on key elements of a planned randomized Phase 3 trial, which it expects to initiate in Q1 2027 subject to securing additional financing. R&D spending has been reduced as the company focuses on the upcoming Phase 3 mCRC trial. The company completed a $10 million registered direct offering to extend its cash runway.

Risks

• Financing need — Initiation of the planned Phase 3 trial is subject to securing additional financing, and the company had $9.2 million of cash at June 30, 2026.
• Clinical failure risk — Onvansertib is unapproved and depends on Phase 3 success after a Phase 2 ORR of 72.2% for the 30 mg plus FOLFIRI/bev arm versus 42.1% for FOLFIRI/bev alone.
• IP litigation — SG&A increased in Q2 2026 primarily due to attorney costs for the intellectual property dispute with NMS.
• Regulatory and approval risk — The FDA's June 2023 Type C meeting accepted an interim ORR endpoint for accelerated approval, but the complete Phase 3 design will be finalized after sharing full CRDF-004 results.

Outlook

Management plans to initiate the registrational Phase 3 trial of 30 mg onvansertib plus FOLFIRI/bevacizumab in first-line RAS-mutated mCRC in Q1 2027, subject to securing additional financing. The company cites CRDF-004 data showing deep and durable tumor shrinkage, a well-tolerated safety profile and no additive adverse events. As of a June 23, 2026 data cut, 12 patients remained on the Phase 2 trial, including 8 in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms.