Cardiff Oncology, Inc.

Cardiff Oncology did not report full-quarter revenue, EPS, or gross margin on this call. It highlighted initial CRDF-004 data from the first 30 patients: 64% ORR for the 30 mg arm versus 33% ORR in control, plus the five deepest tumor regressions in the 30 mg group. The company said CRDF-004 enrollment has been closed to new screening patients and full enrollment should be completed in the next few weeks. Cash and short-term investments were $91.7 million at December 31, 2024, and operating cash use was $10.3 million in Q4 2024. Management expects the current cash balance to fund operations into the first quarter of 2027. The company also said it intends to release additional CRDF-004 clinical data in the first half of 2025 and is preparing for FDA discussions on dose selection and the registrational CRDF-005 trial.

Mark Erlander framed Q4 as a key quarter because of the initial CRDF-004 readout and the subsequent $40 million capital raise. He emphasized that the efficacy signal in first-line RAS-mutated mCRC looks biologically meaningful, highlighted onvansertib’s favorable tolerability versus prior PLK1 inhibitors, and pointed to Pfizer’s BREAKWATER path as validation of the company’s own registrational strategy. His tone was optimistic but measured, repeatedly stressing that the next update should be more mature and that FDA interaction will be the gating step for the next trial.

Jamie Levine focused on liquidity and the balance sheet, saying cash and short-term investments totaled $91.7 million at December 31, 2024, including the net proceeds from the $40 million financing completed in December. He said operating cash use was $10.3 million in Q4 2024, in line with the company’s typical quarterly burn, and reiterated runway into Q1 2027 based on the current spend forecast for ongoing clinical programs. He also noted the filing of a new S-3 shelf registration, clarifying that it did not involve issuing shares.

Analysts pressed management on when the next CRDF-004 update would arrive and how many patients would be mature for ORR and PFS; management said the goal is a more mature, substantive update in the first half of 2025, but PFS is likely too early for that window. Questions also focused on timing of dose selection and the FDA path for the registrational trial: management said it wants to meet FDA as soon as possible to discuss both the 20 mg vs. 30 mg dose and the design of CRDF-005. On BREAKWATER, management said Pfizer’s 61% vs. 40% ORR result was consistent with Cardiff’s early signal, and that fewer patients may be needed for accelerated approval than some investors might have assumed. A final question addressed competing KRAS/RAS programs; management said second-line KRAS G12C agents do not materially change the first-line mCRC opportunity and noted Cardiff is also watching pan-RAS efforts.