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Cardiff Oncology (CRDF) investor relations material
Cardiff Oncology Noble Capital Markets Emerging Growth Virtual Investor Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Lead asset overview and mechanism of action
Onvansertib is an oral, highly selective PLK1 inhibitor with 5,000-fold specificity over related kinases, enabling combination with chemotherapy due to low toxicity.
The drug’s unique mechanism allows it to target all RAS-mutant metastatic colorectal cancer (MCRC) subtypes, addressing a significant unmet need.
Preclinical studies show strong synergy between onvansertib and bevacizumab, inhibiting tumor angiogenesis and growth.
The mechanism involves shutting down the HIF1 alpha-driven hypoxic response, with two new U.S. patents extending protection to 2043.
Clinical trial data and program updates
The phase II CARDIFF-004 trial in first-line RAS-mutated MCRC showed a 49% confirmed objective response rate, nearly 20% higher than control.
Deep and durable responses were observed, including in difficult-to-treat patients, with some referred for curative surgery.
Early signs of improved progression-free survival (PFS) were noted, especially at the 30mg dose, with more mature data expected in Q1 2026.
Safety profile is favorable, with minimal additive toxicity and high patient compliance due to oral administration.
Phase III trial design is underway, aiming for accelerated and full approval endpoints based on objective response rate and PFS.
Strategic partnerships and financial position
Pfizer invested $15 million in 2021, holds over 3%, and provides trial support via Pfizer Ignite, but does not own rights to onvansertib.
The company retains full control of the asset and expects to be funded into early 2027, with $71 million in cash as of June 2025.
Next major clinical update from the 004 trial is expected in Q1 2026.
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