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Cardiff Oncology (CRDF) investor relations material
Cardiff Oncology H.C. Wainwright 28th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
- Vote to increase authorized shares aims to support future growth and financing flexibility.CRDF
Proxy filing - Shareholders will vote on a major increase in authorized shares at the October 2026 meeting.CRDF
Proxy filing - Vote sought to increase authorized shares and permit meeting adjournment if needed.CRDF
Proxy filing - Phase 2 success for onvansertib in mCRC; cash runway into Q3 2027, but litigation risk remains.CRDF
Q2 2026 - Onvansertib shows strong efficacy and safety in first-line RAS-mutated MCRC, with major updates due in Q1 2026.CRDF
Noble Capital Markets Emerging Growth Virtual Investor Conference - Advancing a well-tolerated PLK1 inhibitor to global phase III for RAS-mutated colorectal cancer.CRDF
Jefferies Global Healthcare Conference 2026 - 30 mg onvansertib plus FOLFIRI-BEV delivers 72.2% ORR and durable benefit in RAS-mutated mCRC.CRDF
Status update - Positive Phase 2 data, FDA alignment, and narrowed net loss offset by ongoing going concern risk.CRDF
Q1 2026 - Annual meeting covers director elections, auditor ratification, equity plan amendment, and say-on-pay.CRDF
Proxy filing
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