On August 11, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, reported financial results for the second quarter ended June 30, 2026, and provided a business update.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The second quarter was an important period of progress for Cardiff, highlighted by the presentation of positive Phase 2 data at ASCO (Free ASCO Whitepaper) and our continued progress in preparation for a planned registrational trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer," said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. "The updated CRDF-004 results reinforced our confidence in the selected registrational dose and regimen of 30 mg onvansertib in combination with FOLFIRI/bevacizumab. This regimen has demonstrated deep and durable tumor shrinkage over time, reflecting the synergistic mechanisms of action, while maintaining a well-tolerated safety profile with no overlapping or new toxicities when added to standard-of-care therapy."
Dr. Mohindru continued, "Following our successful End-of-Phase 2 meeting with the FDA, we are preparing to initiate the planned Phase 3 trial in the first quarter of 2027, subject to securing additional financing. We believe the totality of data generated to date strengthens onvansertib’s potential to become an important new treatment option for patients with first-line RAS-mutated metastatic colorectal cancer, an area where there remains significant unmet need."
Clinical and Regulatory Highlights
Presented Positive Results from Randomized, Controlled Phase 2 CRDF-004 Trial at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting
In June, Cardiff presented positive results from CRDF-004, its ongoing, randomized, controlled, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care ("SoC") regimens in patients with first-line RAS-mutated metastatic colorectal cancer ("mCRC"), in a rapid oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting.
The trial achieved its primary goal of selecting the efficacious and safe dose of onvansertib plus SoC regimen for the registrational program. The selected regimen, 30 mg onvansertib in combination with FOLFIRI/bevacizumab ("bev"), demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in confirmed objective response rate ("ORR") and progression-free survival ("PFS") compared to SoC alone, with no additive adverse events observed. Data highlights from the ongoing Phase 2 trial, based on a March 18, 2026 data cut, are listed below, with the full press release available here:
•
The 30 mg onvansertib plus FOLFIRI/bev arm achieved a confirmed ORR of 72.2% compared to 42.1% for FOLFIRI/bev alone, a 30% ORR improvement over SoC. The responses were deeper and more durable in the onvansertib arm.
•
Secondary endpoint of PFS hazard ratio ("HR") of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) for patients treated with 30 mg onvansertib plus FOLFIRI/bev vs. FOLFIRI/bev by Blinded Independent Central Review ("BICR") and investigator assessment ("IA"), respectively.
•
Four patients remained on onvansertib treatment beyond 15 months, including two patients beyond 20 months.
•
Onvansertib in combination with SoC regimens continued to be well-tolerated, with no major or unexpected toxicities and no additive adverse events observed.
The Phase 2 trial is still ongoing and as of a June 23, 2026 data cut, 12 patients remain on trial, with 8 patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC.
Completed Successful End-of-Phase 2 ("EoP2") Meeting with FDA and Advanced Phase 3 Readiness Activities
•
Following completion of a successful EoP2 meeting, Cardiff aligned with the FDA on key design elements for its planned registrational Phase 3 trial of onvansertib in first-line RAS-mutated mCRC.
•
The planned randomized, controlled Phase 3 trial is expected to evaluate 30 mg onvansertib in combination with FOLFIRI/bev compared to SoC FOLFIRI/bev as first-line therapy in patients with RAS-mutated mCRC. Cardiff is preparing to initiate the trial in the first quarter of 2027, subject to securing additional financing.
Preclinical Highlights
Presented New Preclinical Data at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting Supporting the Rationale for Onvansertib in Combination with Antibody-Drug Conjugates ("ADCs")
•
In April, Cardiff presented new preclinical data at the 2026 AACR (Free AACR Whitepaper) Annual Meeting supporting the rationale for onvansertib in combination with ADCs. The data demonstrated that onvansertib enhanced the activity of the HER2-targeted antibody-drug conjugate trastuzumab deruxtecan, driving tumor regression and overcoming resistance in HER2-low breast cancer models.
Corporate Update
•
In February 2026, the Company received written notice from its licensor, Nerviano Medical Sciences S.r.l. ("NMS"), alleging that the Company was in material breach of the license agreement. NMS subsequently purported to terminate the license agreement based on the Company’s alleged material breach. The Company filed a lawsuit in May 2026 in the U.S. District Court for the Southern District of California seeking a declaratory judgment that it is not in material breach and injunctive relief requiring NMS to continue performing under the license agreement. The Company believes that NMS’s purported termination is legally ineffective, factually unsupported and procedurally improper, and the Company plans to continue performing under the license agreement.
•
In July, Cardiff announced a $10 million registered direct offering of common stock and warrants to support working capital and general corporate purposes. The full press release is available here.
Second Quarter 2026 Financial Results
Liquidity, cash burn, and cash runway
As of June 30, 2026, Cardiff Oncology had approximately $34.5 million in cash, cash equivalents, and short-term investments. The amount as of June 30, 2026 does not include proceeds from the registered direct offering completed subsequent to quarter end.
Net cash used in operating activities for the six months ended June 30, 2026 was approximately $24.1 million, an increase of $3.0 million from $21.1 million for the same period in 2025.
Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into the third quarter of 2027.
Operating results
Total operating expenses were approximately $22.6 million for the six months ended June 30, 2026, a decrease of $6.8 million from $29.4 million for the same period in 2025. The decrease in operating expenses was primarily due to a decrease of $9.4 million in R&D expenses, mainly related to the completion of clinical trials, as well as fewer patients still on treatment in the Phase 2 mCRC trial, and a reduction in preclinical activities as the Company focuses on its upcoming Phase 3 mCRC trial. The decrease in expenses was partially offset by an increase of $2.6 million in SG&A expenses, primarily for employee severance agreements and corresponding modifications of stock options, as well as an increase in attorney costs related to Cardiff Oncology’s ongoing licensing dispute.
(Press release, Cardiff Oncology, AUG 11, 2026, View Source [SID1234669959])