On August 9, 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 second quarter ended June 30, 2023, and provided a business update (Press release, Cardiff Oncology, AUG 9, 2023, View Source [SID1234634110]).

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!

"2023 has been transformative for Cardiff Oncology, highlighted by the advancement of our lead program to the first-line mCRC setting and an expansion of our relationship with Pfizer," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "The shifting of our clinical development program to the first-line was a data-driven decision based on a strong signal from new clinical and preclinical findings, with agreement from the FDA. There are 48,000 new patients in the U.S. annually in the first-line RAS-mutated mCRC setting, with no ongoing clinical trials or new treatments approved in the past 20 years. We believe that there is a tremendous opportunity for onvansertib to provide a meaningful benefit to a substantial number of patients who are fighting cancer in challenging indications. Looking ahead, we anticipate commencing enrollment in our first-line trial this fall with interim topline data expected in mid-2024."

Upcoming expected milestones

mPDAC data readout from Phase 2 trial expected in Q3 ’23
SCLC data readout from Phase 2 trial expected in Q3 ’23 (investigator-initiated trial with UPMC)
First patient dosed in first-line mCRC trial expected fall ’23
TNBC data readout from Phase 1b/2 trial expected Q4 ’23/Q1 ’24 (investigator-initiated trial with Dana-Farber Cancer Institute)
First-line mCRC randomized data readout expected in mid-2024
Company highlights for the quarter ended June 30, 2023 and resent announcements

Announced new lead program in mCRC and expanded Pfizer relationship.
Cardiff Oncology will initiate a first-line trial, CRDF-004, a Phase 2 randomized trial generating preliminary safety and efficacy data and evaluating two different doses of onvansertib to confirm an optimal dose. Onvansertib will be added to standard-of-care consisting of FOLFIRI plus bevacizumab, or FOLFOX plus bevacizumab.
Contingent upon the results of CRDF-004, Cardiff Oncology will initiate CRDF-005, a Phase 3, randomized trial with registrational intent. The FDA has agreed that a seamless trial with objective response rate at an interim point is an acceptable endpoint to pursue accelerated approval, with progression-free survival and trend in overall survival being the endpoints for full approval.
Pfizer Ignite will be responsible for the clinical execution of the CRDF-004 trail, leveraging Pfizer’s significant R&D capabilities, scale and expertise.
Our new partnership with Pfizer Ignite expands the relationship established in November 2021 when Pfizer made an equity investment in Cardiff Oncology and nominated Adam Schayowitz, Ph.D., Vice President & Medicine Team Group Lead for Breast Cancer, Colorectal Cancer and Melanoma, Pfizer Global Product Development as a Scientific Advisory Board member.
Second Quarter 2023 Financial Results

Liquidity, cash burn, and cash runway

As of June 30, 2023, Cardiff Oncology had approximately $89.4 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the second quarter of 2023 was approximately $7.1 million, an increase of approximately $0.4 million from $6.7 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 $12.3 million for the three months ended June 30, 2023, an increase of $1.8 million from $10.5 million for the same period in 2022. The increase in operating expenses was primarily due to higher salaries and staff costs primarily due to increased headcount and stock-based compensation for additional grants to employees.