Cardiff Oncology (Nasdaq: CRDF) and Italy-based Nerviano Medical Sciences S.r.l. (NMS) have settled their litigation and amended their 2017 exclusive license agreement covering global rights to onvansertib, an oral polo-like kinase 1 (PLK1) inhibitor that Cardiff is preparing to advance into a registrational Phase III trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). The amendment resolves all outstanding disputes between the two companies, with both parties agreeing to a mutual release of claims and a joint request to dismiss pending litigation in the US District Court for the Southern District of California with prejudice.
The dispute arose after NMS notified Cardiff in February 2026 that it believed the company had materially breached the license agreement by declining to name an NMS employee as a joint inventor on two US patents. Cardiff filed suit on May 19 seeking injunctive and declaratory relief, and NMS subsequently issued a notice on May 27 purporting to terminate the agreement, also alleging that Cardiff had failed to use commercially reasonable efforts to advance onvansertib.
The amendment gives NMS a more formal role in onvansertib's late-stage development through a board observer position, participation in Cardiff's Scientific Advisory Board, and development objectives tied to the planned Phase III program. Cardiff retains global development and commercialization rights, while the revised agreement clarifies and expands the royalty framework. The original 2017 agreement provided for Cardiff to pay development milestones of up to an aggregate of USD 15 million, commercial milestones, and royalties based on sales volume, according to Cardiff's public filings.
Granting a licensor board observer and Scientific Advisory Board access is structurally uncommon in standard exclusive license agreements and is more typical of equity investor or strategic co-development relationships. The arrangement gives NMS visibility into Cardiff's Phase III planning without transferring equity or altering the fundamental rights structure. NMS's institutional interest in preserving its downstream royalty position — consistent with its history of out-licensing kinase inhibitor intellectual property, including the enabling chemistry behind encorafenib and entrectinib — provides context for the settlement terms.