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

Nerviano settlement

• Out-of-court settlement resolves all claims; parties will collaborate on Phase III development of onvansertib, while exclusive worldwide rights, inventorship, patents and final decision-making remain unchanged.

• Royalty rates remain the same, but the royalty period was extended beyond the term previously expected to reach 2035; Nerviano receives a board observer seat.

Phase III trial in colorectal cancer

• Planned global registrational study: ~640 patients, randomized 1:1 to onvansertib 30 mg plus FOLFIRI/bevacizumab or FOLFIRI/bevacizumab alone; enrollment targets first-line patients prospectively selected for any RAS mutation.

• ASCO results showed ORR of 72% with onvansertib plus FOLFIRI/bevacizumab versus 42% in standard-of-care arms; the 30 mg dose and FOLFIRI/bevacizumab regimen were selected for Phase III.

• ORR analysis after all patients enroll could support accelerated approval if data are compelling; the study would continue for PFS assessment toward full approval.

• Phase II median PFS was 11-12 months in standard-of-care arms and unreached for onvansertib plus FOLFIRI/bevacizumab at ASCO; Phase III is powered at >90% to detect a clinically meaningful PFS difference.

• Typical enrollment may take 18-24 months, followed by additional time for PFS; timing depends on trial initiation and global enrollment plans.

Funding and launch plans

• Target remains to start the Phase III study in 1Q 2027, pending funding; regulatory discussions with the European agency are underway alongside FDA engagement.

• Funding options include capital markets, non-dilutive funding, collaborations and regional partnerships; estimated industry-standard trial costs cited at ~$200,000-$275,000 per patient.