Cardiff, NMS Settle Suit, Amend Onvansertib License

• Cardiff Oncology and Nerviano Medical Sciences amended their 2017 Exclusive License Agreement.
• The amendment resolves all outstanding disputes related to global rights for onvansertib.
• Cardiff and NMS plan to jointly request dismissal of all claims with prejudice in the U.S. District Court for the Southern District of California.
• NMS gains rights to appoint a Board observer and join Cardiff's Scientific Advisory Board.
• Cardiff selected the 30 mg dose of onvansertib combined with FOLFIRI/bevacizumab for a registrational trial in first-line RAS-mutated mCRC patients.

Settlement Terms

Cardiff Oncology and Nerviano Medical Sciences S.r.l. amended their 2017 Exclusive License Agreement. The amendment resolves all outstanding disputes related to global rights for onvansertib. Both companies plan to jointly request dismissal of all claims with prejudice.

The litigation was pending in the U.S. District Court for the Southern District of California. The settlement includes a full and mutual release of all claims asserted in the litigation.

Royalty and Development Terms

The amendment clarifies and expands the royalty structure in the License Agreement. It also includes development objectives related to Cardiff's upcoming Phase 3 program. NMS secured rights to appoint a Board observer and join Cardiff's Scientific Advisory Board.

Onvansertib Program

Onvansertib is Cardiff's lead PLK1 inhibitor drug candidate. It is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated mCRC. The drug is currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated mCRC.

Cardiff selected the 30 mg dose of onvansertib combined with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC. In the Phase 2 trial, onvansertib combined with FOLFIRI/bevacizumab demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone.

Executive Comment

This Amendment strengthens our long-term rights to onvansertib as a promising treatment for cancer, beginning with first-line RAS-mutated metastatic colorectal cancer.

— Mani Mohindru, President and Chief Executive Officer of Cardiff Oncology

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.

— Hugues Dolgos, Chief Executive Officer of NMS Group S.r.l.

Company Profiles

Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition. Its shares trade on Nasdaq under the ticker CRDF.

NMS is a clinical-stage biopharmaceutical company focused on discovery and development of innovative oncology therapies. NMS has operations in Italy, the United States, China and Hong Kong.