aibioCardiff Oncology settles onvansertib license lawsuit with Nerviano Medical Sciences
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Cardiff Oncology settled its lawsuit against Nerviano Medical Sciences, the licensor of its lead drug onvansertib, on September 14, 2026. The case is dismissed with prejudice and the license is amended. Nerviano was the only defendant in the suit.
Key facts
- Company
- Cardiff Oncology, Inc. (NASDAQ: CRDF)
- News type
- Legal
- Primary source
- Cardiff Oncology Form 8-K dated September 14, 2026 (SEC EDGAR)
Cardiff Oncology, Inc. (Nasdaq: CRDF) said in an 8-K dated September 14, 2026 that it settled its lawsuit against Nerviano Medical Sciences S.r.l., the licensor of its lead drug onvansertib. The case, Cardiff Oncology, Inc. v. Nerviano Medical Sciences S.r.l., Case No. 3:26-cv-03131-RBM-JLB, was pending in the U.S. District Court for the Southern District of California. Cardiff filed it on May 19, 2026. Cardiff was the plaintiff, and Nerviano was the only defendant named in the suit. Neither the 8-K nor the 10-Q filed August 11, 2026 names an individual. The parties agreed to dismiss the case with prejudice under a confidential settlement, and the 8-K says no monetary payment was made by either side.
The dispute
The dispute grew out of a license agreement dated March 13, 2017 between Nerviano and Trovagene, Inc., Cardiff's predecessor by name change. It gave Cardiff an exclusive worldwide license to develop and commercialize onvansertib. On February 24, 2026, Nerviano gave written notice that it considered Cardiff in material breach, because Cardiff had not named a Nerviano employee, Dr. Barbara Valsasina, as a joint inventor on its U.S. Patent Nos. 12,144,813 and 12,263,173. Cardiff said there was no breach.
Cardiff's complaint sought an order requiring Nerviano to keep performing under the license and a declaration that Cardiff had not breached it. On May 27, 2026, Nerviano wrote that it was terminating the agreement. It added claims that Cardiff had failed to use commercially reasonable efforts to develop onvansertib and obtain approvals. Cardiff replied that the notice was legally ineffective, factually unsupported and procedurally improper.
Nerviano's counterclaims
On June 26, 2026, Nerviano filed counterclaims for correction of inventorship, declaratory judgments of joint invention and termination, breach of contract, and breach of the implied covenant of good faith and fair dealing. Cardiff is the defendant on those counterclaims.
Where it stands
Cardiff moved for a preliminary injunction on June 10, 2026 to stop Nerviano from terminating the agreement. Nerviano opposed on July 17 and Cardiff replied on July 24, and the 10-Q describes the motion as fully briefed and awaiting decision. On July 17, 2026, Cardiff moved to dismiss all counterclaims except the one on correction of inventorship. It also amended its complaint to add claims for breach of contract, unjust enrichment and unfair competition under California law.
On September 14, 2026, the parties signed a confidential settlement agreement and release. They agreed to dismiss the litigation with prejudice and to release related claims. Neither side admitted liability.
The amended license
As a condition of the settlement, the parties also signed an amendment to the license, which takes effect when the case is dismissed with prejudice. According to the 8-K, it sets an updated exclusivity framework for onvansertib during the royalty term and replaces the existing royalty with a license fee on annual net sales. It also adds development milestone and performance-related payments tied to Cardiff's planned Phase 3 program.
If Cardiff assigns the license before Phase 3 data are read out, including through a merger or change of control, it would owe Nerviano a percentage of the proceeds, depending on the timing of dosing in that trial. Nerviano gets a board observer seat and a seat on Cardiff's Scientific Advisory Board. Termination for cause now requires a judicial or arbitral determination of material breach.
What it means for shareholders
The 10-Q warned before the settlement that if the court found the termination valid, Cardiff would lose its license rights, which could materially harm the business. The company had recorded no accrual for the dispute because it did not consider a loss probable. The new payments land on a company short of cash. The 10-Q reports a net loss of $21,577 thousand for the first half of 2026 and $34.5 million in cash, cash equivalents and short-term investments at June 30, 2026. Cardiff expects that to fund operations only into the third quarter of 2027, and management concluded there is substantial doubt about its ability to continue as a going concern.