On May 4, 2023 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, reported financial results for the first-quarter ended March 31, 2023, and provided a business update (Press release, Cardiff Oncology, MAY 4, 2023, View Source [SID1234631019]).
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 are delighted to have dosed the first patient in our Phase 2 ONSEMBLE trial. This randomized trial will evaluate the efficacy of onvansertib combined with standard of care in patients with KRAS/NRAS-mutated mCRC, who historically have limited treatment options," said Mark Erlander, PhD, Chief Executive Officer of Cardiff Oncology. "In addition, we are excited to have appointed Fairooz Kabbinavar, MD, FACP, as our new Chief Medical Officer, who brings deep expertise in the treatment of patients with CRC as well as expertise in using bevacizumab in the clinical setting. We believe Dr. Kabbinavar adds significant value to our clinical development program for onvansertib. We also formally introduced the full membership of our Scientific Advisory Board, a group of highly esteemed oncology experts who are providing a diverse range of insights that strengthen our clinical programs."
Upcoming potential milestones
•Metastatic pancreatic ductal adenocarcinoma (mPDAC) data readout from Phase 2 trial expected in mid-2023
•Small cell lung cancer (SCLC) data readout from investigator-initiated (with UPMC) Phase 2 trial expected in mid-2023
•Triple negative breast cancer (TNBC) data readout from investigator-initiated (with Dana-Farber Cancer Institute) Phase 1b/2 trial expected in the fourth-quarter of 2023 or first-quarter of 2024
•mCRC randomized data readout from Phase 2 ONSEMBLE trial expected in the second-half of 2024
Company Highlights for the quarter ended March 31, 2023
•Announced the Appointment of Fairooz Kabbinavar, MD, FACP, as Chief Medical Officer. Dr. Kabbinavar oversees the clinical development program for the Company’s investigational drug onvansertib and reports directly to Chief Executive Officer, Mark Erlander, PhD.
•Formally introduced the full membership of its Scientific Advisory Board (SAB). The SAB is comprised of a distinguished group of academic and industry experts who bring depth and breadth of knowledge in oncology drug development, clinical trial design, translational science and clinical research. In most cases, these individuals have been advising the Company for several years and will now collectively serve a critical role as we advance the clinical development of
onvansertib. The Company anticipates that over time the membership of the SAB may expand to add additional expertise in new indications or stages of clinical development.
•Announced First Patient Dosed in ONSEMBLE Phase 2 Randomized Trial of Onvansertib in Patients with Metastatic Colorectal Cancer. The Phase 2 ONSEMBLE trial includes patients with mCRC who have a documented KRAS or NRAS mutation and have previously received one prior chemotherapy regimen with or without bevacizumab in the first line metastatic setting. Patients are being randomized to onvansertib plus FOLFIRI/bevacizumab versus FOLFIRI/bevacizumab (standard of care).
First-Quarter 2023 Financial Results
Liquidity, cash burn, and cash runway
As of March 31, 2023, Cardiff Oncology had approximately $97.0 million in cash, cash equivalents, and short-term investments.
Net cash used in operating activities for the first quarter of 2023 was approximately $8.7 million, a decrease of approximately $1.5 million from $10.2 million for the same period in 2022.
Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into 2025.
Operating results
Total operating expenses were approximately $12.1 million for the three months ended March 31 2023, an increase of $1.0 million from $11.1 million for the same period in 2022. The increase in operating expenses was primarily due to higher costs associated with clinical programs and outside service costs related to the development of the company’s lead drug candidate, salaries and staff costs primarily due to increased headcount.