Cardiff Oncology (CRDF) Noble Capital Markets Emerging Growth Virtual Investor Conference summary

Clinical program highlights

• Onvansertib, an oral, highly selective PLK1 inhibitor, shows strong tolerability and efficacy in first-line RAS-mutated metastatic colorectal cancer, with a confirmed objective response rate of 49%, nearly 20% higher than control.

• Deep and durable responses were observed, including in patients with advanced disease, and some were referred to curative surgery after being considered unresectable.

• Safety profile is favorable, with minimal additive toxicity and high patient compliance due to oral administration.

• The CARDIFF-004 phase II trial completed enrollment in April, with a key data update expected in Q1 2026 to provide longer-term durability and progression-free survival results.

• Phase III trial design is underway, aiming for accelerated and full approval based on objective response rate and progression-free survival.

Mechanism of action and scientific rationale

• Onvansertib demonstrates 5,000-fold specificity for PLK1 over other PLKs, reducing toxicity compared to previous inhibitors.

• Preclinical studies show synergy between onvansertib and bevacizumab, inhibiting tumor angiogenesis and growth.

• The combination disrupts hypoxia-driven genetic programs in tumors, with findings published in JCO and supported by new patents extending protection to 2043.

• The focus on RAS-mutated colorectal cancer is based on synthetic lethality between PLK1 inhibition and RAS mutations, with additional synergy with standard chemotherapies.

• Investigator-initiated trials are ongoing in triple-negative breast cancer, small cell lung cancer, and pancreatic cancer.

Strategic partnerships and financial outlook

• Pfizer invested $15 million in 2021, holds over 3%, and provides input via the Scientific Advisory Board, with Pfizer Ignite acting as CRO for the phase II trial.

• Full ownership and control of onvansertib is retained, with no rights granted to Pfizer beyond the advisory relationship.

• Cash and investments as of June 30, 2025, total $71 million, funding operations into early 2027, with the next major data update expected in Q1 2026.