On November 4, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology company, developing new precision medicine treatment options for cancer patients in indications with the greatest unmet medical need including KRAS-mutated colorectal cancer, pancreatic cancer, and castrate-resistant prostate cancer, reported recent company highlights and financial results for the third quarter ended September 30, 2021 (Press release, Cardiff Oncology, NOV 4, 2021, View Source [SID1234594416]).

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"During the third quarter, the data we released from our Phase 1b/2 KRAS-mutated metastatic colorectal cancer trial showed meaningful improvements in treatment response and durability relative to historical controls," said Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology. "With radiographic responses achieved across multiple KRAS mutation variants, we believe these findings differentiate onvansertib from agents targeting individual KRAS mutations such as G12C."

Dr. Erlander added, "Beyond our KRAS-focused programs, we also continue to leverage onvansertib’s broadly applicable mechanism of action to advance its development as a platform molecule. By targeting PLK1, onvansertib inhibits DNA repair and processes that promote mitosis, positioning it to combine synergistically with a range of anti-cancer agents and potentially improve outcomes across a broad array of difficult-to-treat indications."

Program highlights for the quarter ended September 30, 2021, include:

KRAS-mutated Metastatic Colorectal Cancer (mCRC) Program:

Announced new data from Phase 1b/2 trial evaluating onvansertib plus FOLFIRI/bevacizumab continuing to show robust objective response rate and progression-free survival

The data were presented as part of a key opinion leader webinar and showed that trial participants treated with onvansertib plus standard-of-care FOLFIRI/bevacizumab had an objective response rate (ORR) and median progression-free survival (mPFS) that substantially exceeded those previously achieved with FOLFIRI/bevacizumab alone. Highlights from the webinar include:

Efficacy data in patients evaluable for disease response as of data cutoff date (July 2, 2021):

Patients treated per protocol at the recommended Phase 2 dose (RP2D; 15 mg/m2) across Phase 1b and Phase 2
7 of 19 (37%) achieved a confirmed partial response (PR; based on further follow-up of patients with an initial PR as of data cutoff date)
ORRs observed in historical control trials in similar patient populations treated with standard-of-care are 5-13%1-4
Patients evaluable for response treated at all dose levels (12 mg/m2, 15 mg/m2, 18 mg/m2) across Phase 1b and Phase 2
10 of 32 (31%) have achieved a confirmed PR (based on further follow-up of patients with an initial PR as of data cutoff date)
mPFS biomarker, and safety data as of cutoff date

mPFS across all response-evaluable patients (n = 32) is 9.4 months (95% confidence interval: 7.8 – not yet reached); which favorably compares to ~4.5-5.7 months reported in historical control trials in similar patient populations treated with standard-of-care1-4
PRs were observed across different KRAS mutation variants, including the 3 most common observed in colorectal cancer (G12D, G12V, G13D)
The combination of onvansertib and FOLFIRI/bevacizumab was shown to be well-tolerated with only 10% (49/490) of reported treatment-emergent adverse events being G3/G4
A replay of the key opinion leader webinar, which featured the clinical trial principal investigator, Heinz-Josef Lenz, M.D., FACP, USC Norris Comprehensive Cancer Center, key clinical advisor Afsaneh Barzi, M.D., Ph.D., City of Hope Comprehensive Cancer Center, and members of the Cardiff Oncology management team, can be viewed here.

Corporate Highlights:

Strengthened management team with the appointments of Katherine L. Ruffner, M.D., as chief medical officer and James E. Levine as chief financial officer

Dr. Ruffner is a US-trained hematologist/oncologist with over 25 years of clinical care, oncology, biotechnology and pharmaceutical drug development experience, most recently serving as vice president, clinical development for ALX Oncology. Mr. Levine was most recently the CFO of Cidara Therapeutics and has over two decades of corporate and investment banking experience in the biotechnology and pharmaceutical sectors.

Third Quarter 2021 Financial Results:

As of September 30, 2021, Cardiff Oncology had approximately $134 million in cash, cash equivalents, and short-term investments.

Total operating expenses were approximately $7.1 million for the three months ended September 30, 2021, an increase of $2.6 million from $4.5 million for the same period in 2020. The increase in operating expenses is attributed to advancing ongoing and new onvansertib clinical development programs and preclinical activities, additional outside services for legal fees mainly related to the expansion of our patent portfolio, recruiting fees and stock compensation expense.

Research and development expenses increased by approximately $1.3 million to $4.2 million for the three months ended September 30, 2021, from $2.9 million for the same period in 2020. The increase in research and development expenses was primarily due to advancing the onvansertib clinical and preclinical programs and recruitment fees to fill critical medical and clinical operations positions.

Selling, general and administrative expenses increased by approximately $1.3 million to $2.9 million for the three months ended September 30, 2021, from $1.6 million for the same period in 2020. The increase is attributed to increased outside services for legal fees related to the expansion of our patent portfolio, recruitment fees, and stock compensation expense.

Net cash used in operating activities for the third quarter of 2021 was approximately $5.5 million, an increase of approximately $2.0 million from $3.5 million for the same period in 2020.

References

Giessen et al., Acta Oncologica 2015, 54: 187-193
Cremolini et al., Lancet Oncol 2020, 21: 497–507
Antoniotti et al., Correspondence Lancet Oncol June 2020
Bennouna et al., Lancet Oncol 2013; 14: 29–37