On November 12, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company targeting RAS-mutated cancer by leveraging PLK1 inhibition, reported financial results for the third quarter ended September 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!

"We’re greatly encouraged by the performance of onvansertib in first-line RAS-mutated mCRC. As the data mature, the benefit of onvansertib in combination with FOLFIRI/bev is becoming more evident, with growing separation between the onvansertib and control arms," said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. "Building on the strength of these data, we are actively preparing for our upcoming registrational trial. There are currently no treatment options specifically approved for patients with pan RAS-mutated mCRC in the first-line setting and we believe onvansertib has the potential to become an important new treatment for these patients."

Clinical Highlights

Randomized Phase 2 Trial in First-Line RAS-Mutated Metastatic Colorectal Cancer ("mCRC") Ongoing

Cardiff’s randomized Phase 2 trial evaluating onvansertib in combination with FOLFIRI/ bevacizumab ("bev") or FOLFOX/bev as first-line therapy in patients with RAS-mutated mCRC remains ongoing. Median progression-free survival ("PFS") has not been reached in the 30 mg onvansertib + FOLFIRI/bev arm, the Company’s proposed Phase 3 regimen.

As of September 28, 2026, 6 patients remain on the FOLFIRI/bev regimen, with 5 patients in the onvansertib (20 or 30 mg) + FOLFIRI/bev arms and 1 patient on standard-of-care ("SoC") FOLFIRI/bev. Patients who remain in the 30 mg onvansertib + FOLFIRI/bev arm have been on treatment for at least 21 months, with the longest duration of treatment being over 29 months.

For comparison, the median PFS in the combined SoC arms has been reached at approximately 11 months, consistent with what has been historically reported.

Corporate Updates

·
In July, Cardiff completed 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.
·
In September, Cardiff and its licensor, Nerviano Medical Sciences S.r.l. ("NMS"), resolved all outstanding disputes regarding global rights to onvansertib and amended their 2017 exclusive license agreement. The full press release is available here.
·
In October, Cardiff appointed Leila Alland, MD, as interim Chief Medical Officer. Dr. Alland is a seasoned oncology executive who has served as Chief Medical Officer at several clinical-stage biotechnology companies and previously held leadership positions at AstraZeneca, Bristol Myers Squibb, Novartis and Schering-Plough, where she contributed to the development and approval of multiple oncology therapies. The full press release is available here.

Upcoming Events

·
Cardiff management will present at the UBS Global Biopharma Conference and participate in one-on-one investor meetings on November 16–17, 2026. Dr. Mohindru’s presentation is scheduled for November 16 at 2:40 p.m. GMT. A live webcast and replay will be available in the "Events" section of the Cardiff Oncology website.
·
Updated data from an investigator-sponsored clinical trial in CMML will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting on December 13, 2026.

Third Quarter 2026 Financial Results

Liquidity, cash burn, and cash runway

As of September 30, 2026, Cardiff Oncology had approximately $33.8 million in cash, cash equivalents, and short-term investments. Net cash used in operating activities for the nine months ended September 30, 2026 was approximately $33.9 million, an increase of $2.0 million from $31.9 million for the same period in 2025. In July 2026, the Company raised net proceeds of approximately $9.1 million in a registered direct offering. Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations to the end of the third quarter of 2027.

Operating results

Total operating expenses were approximately $32.0 million for the nine months ended September 30, 2026, a decrease of $9.5 million from $41.5 million for the same period in 2025. R&D expenses decreased by $12.5 million, reflecting the completion of clinical trials, fewer patients on treatment in the Phase 2 mCRC trial, a reduction in preclinical activities, and completion of chemistry, manufacturing and controls ("CMC") activities as the Company prepares for its planned Phase 3 mCRC trial. SG&A expenses increased by $3.1 million, driven by legal and professional fees related to the Company’s dispute with NMS, which was resolved on September 14, 2026, and also by employee severance costs. Net loss was $30.4 million, compared with $38.6 million for the prior year period.

(Press release, Cardiff Oncology, NOV 12, 2026, View Source [SID1234674668])