Cardiff Oncology, Inc.

Cardiff Oncology announced positive Phase 2 CRDF-004 data for onvansertib in first-line RAS-mutated metastatic colorectal cancer, presented at ASCO. Following a successful End-of-Phase 2 meeting, the company aligned with the FDA on key elements for a registrational Phase 3 trial, which is planned to start in Q1 2027, contingent on additional financing. The company also completed a $10 million Registered Direct offering, extending its cash runway into Q3 2027. For Q2 2026, Cardiff Oncology reported a net loss of $(9.2) million.

Cardiff Oncology, Inc. disclosed that Nerviano Medical Sciences S.r.l. (NMS) terminated the license agreement for onvansertib, the company's lead asset, due to alleged material breaches. Cardiff Oncology has filed a lawsuit against NMS and a motion for preliminary injunction to prevent the termination. The company also reported substantial doubt about its ability to continue as a going concern, with cash, cash equivalents, and short-term investments totaling $34.5 million as of June 30, 2026. For the second quarter of 2026, the net loss was $(9.2) million, and for the first six months, it was $(21.6) million. Post-period, the company completed a Registered Direct Offering, raising $10.1 million in gross proceeds.

Cardiff Oncology, Inc. completed a registered direct offering, raising approximately $10.05 million in gross proceeds. The company sold 8,571,429 shares of common stock and accompanying warrants to institutional investors at $1.05 per unit, and 721,649 shares and warrants to certain officers and directors at $1.455 per unit. The net proceeds are intended for working capital and general corporate purposes. H.C. Wainwright & Co. acted as the exclusive placement agent, receiving a 7.0% cash fee and warrants.

Cardiff Oncology, Inc. has announced positive interim results from its Phase 2 CRDF-004 trial for onvansertib in combination with chemotherapy and bevacizumab for first-line RAS-mutated metastatic colorectal cancer (mCRC). The presentation highlighted a 72% Objective Response Rate (ORR) with the 30 mg dose of onvansertib plus FOLFIRI/bevacizumab, a 30% improvement over the standard of care (SoC). Median Progression-Free Survival (PFS) was not reached in the onvansertib arm compared to 12.2 months for SoC. The company has selected the 30 mg onvansertib + FOLFIRI/bev combination for its registrational study, CRDF-005, which will have dual primary endpoints of ORR and PFS and is designed for potential accelerated approval. The safety profile was deemed clean, with no new or unexpected toxicities.

Cardiff Oncology, Inc. announced positive results from its Phase 2 CRDF-004 clinical trial evaluating onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC). The trial successfully achieved its primary goal, with the 30 mg onvansertib + FOLFIRI/bevacizumab arm demonstrating a 72.2% overall response rate (ORR) compared to 42.1% for standard-of-care (SoC), and median progression-free survival (PFS) not yet reached. Onvansertib was well-tolerated with no new toxicities, leading the company to plan a registrational trial in first-line RAS-mutated mCRC following a successful End-of-Phase 2 meeting with the FDA. An investor webcast is scheduled for June 3, 2026, to discuss the data and future plans.

Cardiff Oncology, Inc. announced that its management will present and participate in investor meetings at the Jefferies Global Healthcare Conference from June 2-4, 2026. President and CEO Mani Mohindru, PhD, will host a Fireside Chat on June 4, 2026, from 10:30 - 11:00 AM ET. Interested parties can access the live webcast and replay via the company's website.

Cardiff Oncology, Inc. is embroiled in a legal dispute with Nerviano Medical Sciences S.r.l. (NMS) regarding their License Agreement. Cardiff previously filed a lawsuit seeking to compel NMS to continue performance and a declaratory judgment that Cardiff did not breach the agreement. NMS subsequently informed Cardiff of its termination of the agreement, citing alleged material breaches related to patent inventorship and failure to use commercially reasonable efforts for onvansertib development. Cardiff has rejected NMS's termination notice, asserting it is legally ineffective and factually unsupported, and plans to continue performing under the agreement.

Cardiff Oncology announced it will host an investor webcast on June 3, 2026, to review updated data from its CRDF-004 randomized dose-finding Phase 2 clinical trial. This trial evaluates onvansertib in combination with standard-of-care regimens for first-line RAS-mutated metastatic colorectal cancer. The updated data will first be presented at the 2026 ASCO Annual Meeting on June 2, 2026, building on previous findings from January 2026. Onvansertib, an oral PLK1 inhibitor, is advancing toward a registrational trial, with the 30 mg dose selected for further development.

Cardiff Oncology, Inc. has filed a lawsuit against Nerviano Medical Sciences S.r.L (NMS) in the United States District Court for the Southern District of California. The lawsuit disputes NMS's allegation that Cardiff materially breached their license agreement for onvansertib. Cardiff seeks injunctive relief to compel NMS to continue performing under the agreement and a declaratory judgment that Cardiff did not commit a breach, specifically regarding the inventorship on U.S. Patent Nos. 12,144,813 and 12,263,173.

Cardiff Oncology announced its first-quarter 2026 financial results and provided a business update, highlighting significant progress in its clinical programs. The company successfully completed an End-of-Phase 2 meeting with the FDA, aligning on key design elements for its planned Phase 3 registrational trial for onvansertib in first-line RAS-mutated metastatic colorectal cancer, including selecting the 30 mg dose with FOLFIRI/bev. The company also reported a net loss of $(12.3) million for Q1 2026 and strengthened its executive team with key leadership appointments.