Cardiff Oncology settles Nerviano dispute, amends license
Cardiff Oncology and Nerviano settle their onvansertib dispute without payments and rewrite key license, tightening exclusivity and governance ahead of a planned Phase 3 program.
Rhea-AI Filing Summary
Cardiff Oncology, Inc. (CRDF) disclosed that on September 14, 2026 it entered into a Confidential Settlement Agreement and Release with Nerviano Medical Sciences to resolve litigation related to their 2017 exclusive license covering onvansertib. The parties agreed to a full mutual release of claims, dismissal of the case with prejudice, no admission of liability, and no monetary payment by either side.
Contemporaneously, the companies signed an Amendment to the License Agreement that will become effective once the litigation is dismissed. Key changes include an updated exclusivity framework preventing Nerviano and its affiliates from clinically developing or commercializing competing products or onvansertib during the royalty term (subject to exceptions), a revised royalty and additional license fee structure tied to annual net sales, new development milestones and potential performance-related payments for Cardiff’s planned Phase 3 program, and revised post‑termination royalty tiers payable by Nerviano to Cardiff. The amendment also gives Nerviano a board observer seat and a seat on Cardiff’s Scientific Advisory Board, strengthens joint governance and reporting provisions for onvansertib’s development, revises assignment economics in change‑of‑control scenarios before Phase 3 readout, and requires a judicial or arbitral determination of material breach before termination for cause.
Positive
- Litigation over onvansertib rights fully resolved with mutual releases, dismissal with prejudice, and no monetary payments, removing legal uncertainty around Cardiff’s lead asset.
- License economics and exclusivity clarified through updated royalty framework, additional sales-based license fees, and strengthened exclusivity on competing products during the royalty term.
- Strategic collaboration deepened via Nerviano’s board observer and Scientific Advisory Board roles and enhanced joint development governance around the planned Phase 3 program.
Negative
- Additional financial obligations introduced including new license fees on annual net sales, development milestones and potential performance-related payments, and transaction-proceeds sharing upon certain assignments before Phase 3 readout.
Insights
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8-K Event Classification
Key Figures
Key Terms
Exclusive License Agreement financial
royalty term financial
Phase 3 program medical
PLK1 inhibitor medical
RAS-mutated metastatic colorectal cancer medical
dismissal with prejudice regulatory
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What litigation did CRDF resolve with Nerviano on September 14, 2026?
Did Cardiff Oncology (CRDF) pay or receive any money in the Nerviano settlement?
How did the amended License Agreement affect onvansertib exclusivity for CRDF?
What new financial obligations does CRDF have under the amended Nerviano license?
How does the amendment impact CRDF’s potential M&A or change of control?
What governance rights did Nerviano gain at Cardiff Oncology (CRDF)?
When does the amended Nerviano license become effective for CRDF?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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Item 1.01. Entry into a Material Definitive Agreement.
On September 14, 2026, Cardiff Oncology, Inc. (the “Company”) and Nerviano Medical Sciences, S.r.l. (“Nerviano”) entered into a Confidential Settlement Agreement and Release (the “Settlement Agreement”) to resolve the litigation captioned Cardiff Oncology, Inc. v. Nerviano Medical Sciences S.r.l., Case No. 3:26-cv-03131-RBM-JLB, pending in the United States District Court for the Southern District of California (the “Litigation”). The Litigation arose out of a dispute between the parties concerning, among other things, inventorship of certain Company patents and the Company’s performance under the License Agreement, dated March 13, 2017, between Nerviano and Trovagene, Inc. (predecessor by name change to the Company) (the “License Agreement”), pursuant to which Nerviano granted the Company an exclusive worldwide license to develop and commercialize onvansertib.
Under the Settlement Agreement, the parties agreed to dismiss the Litigation with prejudice and to exchange mutual releases of claims relating to the Litigation and the License Agreement as in effect prior to its amendment. Neither party made any admission of liability, and no monetary payment was made by either party to the other in connection with the settlement of the Litigation.
Contemporaneously with the execution of the Settlement Agreement, and as a condition to its effectiveness, the Company and Nerviano also entered into an Amendment to License Agreement, dated as of September 14, 2026 (the “Amendment”), which amends certain provisions of the License Agreement. The material terms of the Amendment include, among others:
| ● | an updated exclusivity framework under which, subject to specified exceptions, neither Nerviano nor its affiliates may clinically develop or commercialize a competing product or the licensed molecule (onvansertib) during the royalty term; |
| ● | an additional license fee payable by the Company to Nerviano on annual net sales of any product that practices a valid claim of a Company patent, in lieu of (and not in addition to) the royalty otherwise payable under the License Agreement; |
| ● | development milestone and potential performance-related payment obligations related to Cardiff’s upcoming Phase 3 program as more fully described in the Amendment; |
| ● | revised post-termination royalty tiers payable by Nerviano to the Company, depending on the stage of development or regulatory approval achieved as of any termination of the License Agreement; |
| ● | a revised assignment provision under which the Company would owe Nerviano a percentage of transaction proceeds depending on the timing of dosing in the Company’s Phase III trial if the Company assigns its rights and obligations under the License Agreement, including by merger, consolidation, or change of control, before reading out Phase III data; |
| ● | a board observer seat and a seat on the Company’s Scientific Advisory Board for Nerviano, along with enhanced governance, reporting, and Joint Development Committee provisions relating to the ongoing development of onvansertib; and |
| ● | revised termination-for-cause provisions requiring a judicial or arbitral determination of material breach before the License Agreement may be terminated for cause. |
The Amendment will become fully operative and effective as of the date on which the Litigation is dismissed with prejudice, and will thereafter govern the parties’ ongoing license relationship. Except as amended by the Amendment, the terms of the License Agreement remain in full force and effect.
The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01. Regulation FD Disclosure.
On September 14, 2026, the Company issued a press release announcing the resolution of the Litigation and entering into the Amendment. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
| 10.1 | Amendment to License Agreement, dated as of September 14, 2026, by and between Cardiff Oncology, Inc. and Nerviano Medical Sciences, S.r.l.* | |
| 99.1 | Press release dated September 14, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
| * | Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10)(iv). |
| 2 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: September 14, 2026
| CARDIFF ONCOLOGY, INC. | ||
| By: | /s/ Mani Mohindru | |
| Mani Mohindru | ||
| Chief Executive Officer | ||
| 3 |
Exhibit 99.1
Cardiff Oncology and Nerviano Medical Sciences Amend their 2017 Exclusive License Agreement
Under the terms of the Amendment, all disputed issues are resolved
SAN DIEGO and NERVIANO, Italy, September 14, 2026 — Cardiff Oncology, Inc. (NASDAQ: CRDF) (“Cardiff”) and Nerviano Medical Sciences S.r.l. (“NMS”) today announced that they have reached a settlement and amended their 2017 Exclusive License Agreement, resolving all outstanding disputes between the two companies related to the global rights for onvansertib, Cardiff’s lead PLK1 inhibitor drug candidate, and establishing an expanded collaborative framework to support onvansertib’s continued clinical development.
Cardiff and NMS have agreed to a full and mutual release of all claims asserted in the litigation pending in the U.S. District Court for the Southern District of California. Cardiff and NMS plan to jointly request dismissal of all claims with prejudice.
“This Amendment strengthens our long-term rights to onvansertib as a promising treatment for cancer, beginning with first-line RAS-mutated metastatic colorectal cancer,” said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. “We are pleased to be entering into this agreement with NMS, which reflects our shared commitment to bringing onvansertib to patients with high unmet need.”
“We look forward to working with Cardiff to advance onvansertib into a global Phase 3 study in first-line RAS-mutated metastatic colorectal cancer and to bring this therapy to patients,” said Hugues Dolgos, PharmD, Chief Executive Officer of NMS Group S.r.l.
The Parties clarified and expanded on the royalty structure in the License Agreement. The agreement also includes development objectives related to Cardiff’s upcoming Phase 3 program, as well as rights for NMS to appoint a Board observer and join Cardiff’s Scientific Advisory Board.
About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated mCRC. In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC.
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Cardiff’s lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated mCRC, addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single-agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.
About NMS
NMS is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative oncology therapies. Building on a long-standing heritage in cancer biology and drug discovery, NMS combines a focused clinical-stage small-molecule portfolio with a differentiated ADC platform and an active discovery engine generating first-in-class oncology programs. NMS has operations in Italy, the United States, China and Hong Kong.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third-party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
For more information regarding Cardiff, please visit https://www.cardiffoncology.com.
Cardiff Investor Contact:
Candice Masse
Astr Partners
candice.masse@astrpartners.com
Cardiff Media Contact:
Amy Bonanno
Lyra Strategic Advisory
abonanno@lyraadvisory.com
For more information regarding NMS, please visit https://www.nervianoms.com/
NMS Media Contact:
mediarelations@nervianoms.com