Cardiff Oncology Settles License Litigation, Amends Onvansertib License

What Happened Cardiff Oncology, Inc. announced that on September 14, 2026 it entered a Confidential Settlement Agreement and Release with Nerviano Medical Sciences, S.r.l. to resolve litigation (Cardiff Oncology, Inc. v. Nerviano Medical Sciences S.r.l., Case No. 3:26-cv-03131-RBM-JLB) arising from disputes over inventorship and performance under a March 13, 2017 license agreement for onvansertib. The parties agreed to dismiss the litigation with prejudice, exchanged mutual releases, made no admissions of liability and no monetary payments were exchanged. At the same time they executed an Amendment to the License Agreement that will become fully effective when the litigation dismissal is final.

Key Details

• Date: Settlement Agreement and Amendment executed September 14, 2026; litigation dismissal with prejudice is a condition to the Amendment becoming fully operative.
• Payments: No cash payment was made by either party to settle the litigation. The Amendment revises payment terms — an additional license fee on annual net sales may replace the prior royalty in certain cases, and it adds development milestone and potential performance-related payments tied to Cardiff’s upcoming Phase 3 program.
• Exclusivity & governance: The Amendment updates exclusivity during the royalty term (subject to exceptions), grants Nerviano a board observer seat and a seat on Cardiff’s Scientific Advisory Board, and strengthens reporting and Joint Development Committee provisions.
• Other material changes: revised post-termination royalty tiers (payable by Nerviano to Cardiff depending on development/approval stage), a revised assignment provision requiring Cardiff to pay Nerviano a percentage of transaction proceeds if rights are assigned before Phase 3 data readout, and termination-for-cause now requires a judicial or arbitral determination of material breach.

Why It Matters This filing resolves active litigation without cash settlement and changes the commercial and governance terms of the onvansertib license, including exclusivity, payment mechanics, milestone obligations tied to Cardiff’s forthcoming Phase 3 program, and new governance rights for Nerviano. Investors should note the amended economic and deal-protection terms could affect future revenues, milestone payments, and strategic transaction economics (e.g., sale or change of control) related to onvansertib.