Cardiff Oncology (CRDF) H.C. Wainwright 28th Annual Global Investment Conference summary

Settlement and licensing agreement

• Reached an out-of-court settlement with Nerviano Medical Sciences, resolving all claims and disputes.

• Retained exclusive worldwide rights, inventorship, and unchanged royalty rates for onvansertib.

• Royalty period extended beyond the previous 2035 term, with Nerviano receiving a board observer seat.

Phase III trial design and regulatory alignment

• Phase III trial for onvansertib in first-line RAS mutated metastatic colorectal cancer will enroll about 640 patients, randomized 1:1.

• Primary endpoint is overall response rate (ORR), with progression-free survival (PFS) as a secondary endpoint.

• FDA allowed for potential accelerated approval based on ORR and durability, with full approval possible based on PFS.

• Study is powered with over 90% probability to show a clinically meaningful PFS difference.

Competitive landscape and scientific rationale

• Onvansertib targets all RAS mutations, unlike allele-specific inhibitors that address only small patient subsets.

• PLK1 inhibition offers a parallel pathway to RAS, potentially avoiding resistance seen with other approaches.