Onvansertib effectively targets the once “undruggable” KRAS-mutation present in 50% of colorectal cancerNew Podcast

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Cardiff Oncology Reports Fourth Quarter and Full Year 2022 Results and Provides Business Update

Phase 1b/2 trial in lead KRAS-mutated metastatic colorectal cancer (mCRC) program continues to show our lead candidate onvansertib demonstrates an objective response rate, durability and progression-free survival that substantially exceed those seen in historical control trials

Strengthened leadership team with appointments of Fairooz Kabbinavar, MD, FACP, as CMO, Tod Smeal, Ph.D., as CSO and Charles Monahan, R.Ph., as SVP, regulatory affairs

Multiple data readouts expected from clinical programs and IITs in 2023

Strong cash financial position of approximately $105.3 million at December 31, 2022; projected runway into 2025

SAN DIEGO, March 2, 2023 /PRNewswire/ -- 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, today announced financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.

"2022 was an important year for demonstrating the benefits onvansertib could bring to patients with KRAS-mutated mCRC, an area where no targeted therapies are currently approved. The results of our Phase 1b/2 trial in KRAS-mutated mCRC continue to show onvansertib plus standard-of-care was well-tolerated and outperformed historical control trials on key endpoints including the durability of response. Furthermore, we observed an unexpectedly high objective response rate and progression-free survival in the bevacizumab-naïve subgroup of patients which will be evaluated in the ongoing ONSEMBLE trial," said Mark Erlander, PhD, chief executive officer of Cardiff Oncology. "Looking forward, this will be an important year for advancing our ONSEMBLE randomized Phase 2 trial and generating additional safety and efficacy signals from our other company-sponsored and investigator-initiated clinical programs."

"As we build on these findings and accelerate onvansertib's clinical development, we will benefit greatly from the deep clinical expertise of our new CMO, Dr. Fairooz Kabbinavar, who served as the lead investigator for two practice-changing trials of bevacizumab combinations leading to the approval of bevacizumab in mCRC," continued Dr. Erlander. "We are confident we can fund our onvansertib clinical programs into 2025, and we believe our clinical data supports our approach to leveraging PLK1 inhibition to address current gaps in cancer therapies and make an important contribution to oncology patient care." 

Upcoming potential milestones

  • mPDAC data readout from Phase 2 trial expected Q2/Q3 '23
  • SCLC data readout from investigator-initiated (with UPMC) Phase 2 trial expected Q2/Q3 '23
  • TNBC data readout from investigator-initiated (with Dana-Farber Cancer Institute) Phase 1b/2 trial expected Q4 '23/Q1 '24
  • mCRC randomized data readout from Phase 2 ONSEMBLE trial expected Q3/Q4 '24

Company highlights for the year ended December 31, 2022, and subsequent weeks include:

Full Year 2022 Financial Results:

Liquidity, cash burn, and cash runway

As of December 31, 2022, Cardiff Oncology had approximately $105.3 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the full year 2022 was approximately $33.8 million, an increase of approximately $10.8 million from $23.0 million for the same period in 2021.

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 $40.3 million for the full year ended December 31, 2022, an increase of $11.1 million from $29.2 million for the same period in 2021. The increase in operating expenses was primarily due to advancing the development of onvansertib through chemistry, manufacturing, and controls (CMC) activities, pharmacology and other development programs, salaries and staff costs primarily due to increased headcount, stock-based compensation for additional grants to employees and higher facility costs for insurance and the amending of our operation lease.


  1. H. Hurwitz, L. Fehrenbacher, W. Novotny, T. Cartwright, J. Hainsworth, W. Heim, J. Berlin, A. Baron, S. Griffing, E. Holmgren, N. Ferrara, G. Fyfe, B. Rogers, R. Ross, and F. Kabbinavar; Bevacizumab Plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal Cancer; The New England Journal of Medicine, Vol. 350, Jun 3, 2004, pp. 2335-2342.
  2. Fairooz F. Kabbinavar, Joseph Schulz, Michael McCleod, Taral Patel, John T. Hamm, J. Randolph Hecht, Robert Mass, Brent Perrou, Betty Nelson, and William F. Novotny; Addition of Bevacizumab to Bolus Fluorouracil and Leucovorin in First-Line Metastatic Colorectal Cancer: Results of a Randomized Phase II Trial; Journal of Clinical Oncology, Vol. 23, Jun 1, 2005, pp. 3697-3705.
  3. Giessen et al., Acta Oncologica 2015, 54: 187-193
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  7. Hansen et al., Cancers 2021, 13, 1031
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  11. Beretta et al., Med Oncol 2013, 30:486

About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as KRAS/NRAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in triple negative breast cancer (TNBC) and small cell lung cancer (SCLC). These programs and the Company's broader development strategy is designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858 952-7670   

Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
508 320-1110 

Media Contact:
Richa Kumari
Taft Communications
551 344-5592  


Cardiff Oncology, Inc.

Condensed Statements of Operations

(in thousands, except for per share amounts)

Year Ended December 31,



Royalty revenues

$                 386

$                 359

Costs and expenses:

Research and development



Selling, general and administrative



Total operating expenses



Loss from operations



Interest income, net



Gain (loss) from change in fair value of derivative financial instruments—warrants


Other income (expense), net



Net loss



Preferred stock dividend



Net loss attributable to common stockholders

$          (38,728)

$          (28,315)

Net loss per common share — basic and diluted

$              (0.89)

$              (0.73)

Weighted-average shares outstanding — basic and diluted




Cardiff Oncology, Inc.

Condensed Balance Sheets

(in thousands)

December 31,

December 31,


Current assets:

Cash and cash equivalents

$           16,347

$           11,943

Short-term investments



Accounts receivable and unbilled receivable



Prepaid expenses and other current assets



Total current assets



Property and equipment, net



Operating lease right-of-use assets



Other assets



Total Assets

$         116,191

$         149,544

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$              1,956

$              1,439

Accrued liabilities



Operating lease liabilities



Other current liabilities


Total current liabilities



Operating lease liabilities, net of current portion



Total Liabilities



Stockholders' equity



Total liabilities and stockholders' equity

$         116,191

$         149,544


Cardiff Oncology, Inc.

Condensed Statements of Cash Flows

(in thousands)

Year ended December 31,



Operating activities

Net loss

$          (38,704)

$          (28,291)

Adjustments to reconcile net loss to net cash used in operating activities:

Loss on disposal of fixed assets






Stock-based compensation expense



Amortization of premiums on short-term investments



Change in fair value of derivative financial instruments—warrants


Release of clinical trial funding commitment



Changes in operating assets and liabilities



Net cash used in operating activities



Investing activities:

Net capital expenditures



Net purchases, maturities and sales of short-term investments



Net cash provided by (used in) investing activities



Financing activities:

Proceeds from sales of common stock, net of expenses


Proceeds from exercise of options


Proceeds from exercise of warrants


Net cash provided by financing activities



Net change in cash and cash equivalents



Cash and cash equivalents—Beginning of period



Cash and cash equivalents—End of period

$           16,347

$           11,943


SOURCE Cardiff Oncology, Inc.