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Company Overview
−Removed: We are a clinical-stage biotechnology company, headquartered in San Diego, CA, leveraging Polo-like Kinase 1 (“PLK1”) inhibition to develop novel therapies across a range of cancers.
−Removed: Our lead asset is onvansertib, a PLK1 inhibitor that is being evaluated in combination with standard of care therapies in clinical programs targeting indications such as KRAS/NRAS-mutated metastatic colorectal cancer, metastatic pancreatic cancer, as well as investigator-initiated trials in triple negative breast cancer and small cell lung cancer.
−Removed: These programs and our broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the standard of care alone.
+Added: We are a clinical-stage biotechnology company, headquartered in San Diego, CA, leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers with the greatest unmet medical need.
+Added: Our goal is to target tumor vulnerabilities with treatment combinations of onvansertib, our oral and highly selective PLK1 inhibitor, and standard-of-care therapeutics.
+Added: We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma ("mPDAC"), and small cell lung cancer ("SCLC").
+Added: Our clinical development programs incorporate tumor genomics and biomarker assays to refine assessment of patient response to treatment.
Our common stock is listed on the Nasdaq Capital Market under the ticker symbol "CRDF".
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On February 2, 2023 we announced the appointment of Fairooz Kabbinavar, M.D., FACP, as Chief Medical Officer.
−Removed: On January 11, 2022 we announced the appointment of Tod Smeal, Ph.D., as Chief Scientific Officer and Charles Monahan, R.Ph., as Senior Vice President, Regulatory Affairs.
Our accumulated deficit through December 31, 2023 is $339.5 million.
−Removed: To date, we have generated minimal revenues and expect to incur additional losses to perform further research and development activities.
−Removed: Our drug development efforts are in their early stages, and we cannot make estimates of the costs or the time that our development efforts will take to complete, or the timing and amount of revenues related to the sale of our drugs.
−Removed: The risk of completion of any program is high because of the many uncertainties involved in developing new drug candidates to market, including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of
−Removed: research and development expenses, and competing technologies being developed by organizations with significantly greater resources.
+Added: To date, we have generated minimal revenues, unrelated to onvansertib, and expect to incur additional losses to perform further research and development activities.
+Added: Our drug development efforts are in their early stages, and we cannot make estimates of the costs or the time that our development efforts will take to complete, or the timing and amount of revenues related to the sale of our drug.
+Added: The risk of completion of any program is high because of the many uncertainties involved in developing new drug candidates to market, including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of research and development expenses, and competing technologies being developed by organizations with significantly greater resources.
Critical Accounting Estimate
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Our total revenues were $488,000 and $386,000 for the years ended December 31, 2023 and 2022, respectively.
−Removed: Revenues are from our annual minimum or sales-based royalties on other intellectual property licenses, unrelated to onvansertib.
+Added: Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib.
Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees.
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Research and development expenses increased by $5.8 million to $32.9 million for the year ended December 31, 2023 from $27.1 million for the year ended December 31, 2022.
−Removed: The overall increase in expenses was primarily related to CMC, clinical pharmacology and for studies to support the development of our lead drug candidate, onvansertib.
−Removed: Salaries and staff costs increased primarily due to additional hires in senior management and our clinical operations team (research and development average headcount grew by 93% over the comparative period).
−Removed: The increase in stock-based compensation is primarily due to additional stock option grants to employees granted subsequent to the prior period.
+Added: The overall increase in expenses was primarily due to costs associated with clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib.
+Added: Salaries and staff costs increased primarily from additional hires in senior management and our clinical operations team (research and development average headcount grew by 39% over the comparative period).
+Added: The increase in facilities and other costs is primarily due to increased allocation of facilities cost resulting from headcount growth compared to the prior period.
Selling, General and Administrative Expenses
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Total selling, general and administrative $ 13,043 $ 13,181 $ (138)
−Removed: Selling, general and administrative expenses increased by $1.3 million to $13.2 million for the year ended December 31, 2022, from $11.8 million for the year ended December 31, 2021.
−Removed: Salaries and staff costs increased due to merit increases and higher headcount (average headcount grew by 30% over the comparative period).
−Removed: The increase in stock-based compensation is primarily due to additional stock option grants to employees granted subsequent to the prior period.
−Removed: Facilities and other costs increased due to higher insurance costs and the amending of our operating lease.
−Removed: The decrease in outside services is primarily related to strategic valuation consulting related to our lead drug candidate, onvansertib performed during the prior period.
−Removed: Net loss and per share amounts were as follows:
−Removed: For the years ended December 31,
−Removed: (in thousands) 2022 2021 Increase/(Decrease)
−Removed: Net loss $ (38,704) $ (28,291) $ 10,413
−Removed: Preferred stock dividend (24) (24) —
−Removed: Net loss attributable to common stockholders $ (38,728) $ (28,315) $ 10,413
−Removed: Net loss per common share — basic and diluted $ (0.89) $ (0.73) $ 0.16
−Removed: Weighted-average shares outstanding — basic and diluted 43,600 39,030 4,570
−Removed: The increase of $10.4 million in net loss attributable to common shareholders was primarily the result of an increase in operating expenses for the year ended December 31, 2022 compared to the same period in the prior year.
−Removed: The $0.16 increase in basic and diluted net loss per share was impacted by the increase in net loss attributable to shareholders and was partially offset by the increase in weighted average shares outstanding resulting primarily from the issuance of approximately 2.7 million shares of common stock primarily from the conversion of Series E Convertible Preferred Stock during the twelve months ended December 31, 2022.
+Added: Selling, general and administrative expenses decreased by $138,000 to $13.0 million for the year ended December 31, 2023, from $13.2 million for the year ended December 31, 2022.
+Added: Salaries and staff costs increased due to an employee severance agreement.
+Added: The decrease in facilities and other costs was primarily due to reduced insurance costs compared to the prior period.
+Added: Interest Income, Net
+Added: Interest income, net was $4.1 million for the year ended December 31, 2023 as compared to $1.6 million for the year ended December 31, 2022.
+Added: The increase in interest income was primarily due to higher interest rates on our short-term investments portfolio for the year ended December 31, 2023 as compared to the same period of 2022.
Liquidity and Capital Resources
−Removed: As of December 31, 2022, we had $16.3 million in cash and cash equivalents and $88.9 million in short-term investments.
Net cash used in operating activities for the year ended December 31, 2023 was $30.9 million, compared to $33.8 million for the year ended December 31, 2022.
+Added: Our use of cash was primarily a result of the net loss of $41.4 million for the year ended December 31, 2023, adjusted for non-cash items related to stock-based compensation of $4.5 million.
+Added: The net change in our operating assets and liabilities was $6.6 million decreasing cash used in operations.
Our use of cash was primarily a result of the net loss of $38.7 million for the year ended December 31, 2022, adjusted for non-cash items mainly related to stock-based compensation of $4.3 million, and amortization of premiums on short-term investments of $0.6 million.
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At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years.
−Removed: Net cash provided by investing activities was $38.1 million primarily related to sales and maturities in excess of purchases of marketable securities, partially offset by purchases of capital equipment during the year ended December 31, 2022,
−Removed: compared to net cash used in investing activities of $131.4 million for net purchases of marketable securities during the same period in 2021.
−Removed: Net cash provided by financing activities was $0.1 million from the exercise of stock options during the year ended December 31, 2022, compared to $35.5 million of proceeds from the sale of common stock and proceeds from warrant exercises for the same period in 2021.
+Added: Net cash provided by investing activities was $36.2 million primarily related to sales and maturities in excess of purchases of marketable securities during the year ended December 31, 2023, compared to net cash used in investing activities of $38.1 million primarily related to sales and maturities in excess of purchases of marketable securities during the same period in 2022.
+Added: Net cash provided by financing activities was $0.0 million during the year ended December 31, 2023, compared to net cash provided by financing activities of $0.1 million for the same period in 2022.
As of December 31, 2023 and 2022, we had working capital of $67.0 million and $103.5 million, respectively.
−Removed: The decrease in working capital is primarily due to the net loss partially offset by the increase in cash and cash equivalents from financing activities during the year ended December 31, 2022.
We have incurred net losses since our inception and have negative operating cash flows.
As of December 31, 2023, we had $74.8 million in cash, cash equivalents and short-term investments and we believe we have sufficient cash to meet our funding requirements for at least the next 12 months following the issuance date of these financial statements.
−Removed: Based on our current projections we expect that our capital resources are sufficient to fund our operations into 2025.
+Added: Based on our current projections we expect that our capital resources are sufficient to fund our operations into the third quarter of 2025.
+Added: Our drug development efforts are in their early stages, and we cannot make estimates of the costs or the time that our development efforts will take to complete, or the timing and amount of revenues related to the sale of our drug candidates.
+Added: The risk of completion of any program is high because of the many uncertainties involved in developing new drug candidates to market, including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of research and development expenses, and competing technologies being developed by organizations with significantly greater resources.
For the foreseeable future, we expect to continue to incur losses and require additional capital to further advance our clinical trial programs and support our other operations.
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To the extent that we can raise additional funds by issuing equity securities, our stockholders may experience additional dilution.
−Removed: Our working capital requirements will depend upon numerous factors including but not limited to the nature, cost and timing of our research and development programs.
−Removed: To date, our sources of cash have been primarily limited to the sale of equity securities.
−Removed: We cannot be certain that additional funding will be available on acceptable terms, or at all.
−Removed: To the extent that we raise additional funds by issuing equity securities, our stockholders may experience significant dilution.
−Removed: If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of one or more product candidates, all of which may have a material adverse impact on our operations.
−Removed: We may also be required to (i) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available;
−Removed: or (ii) relinquish or otherwise dispose of rights to technologies, product candidates or products that we would otherwise seek to develop or commercialize ourselves on unfavorable terms.
−Removed: We are evaluating all options to raise additional capital, increase revenue, as well as reduce costs, in an effort to strengthen our liquidity position, which may include the following:
−Removed: (1) Raising capital through public and private equity offerings;
−Removed: (2) Introducing operation and business development initiatives to bring in new revenue streams;
−Removed: (3) Reducing operating costs by identifying internal synergies;
−Removed: and (4) Engaging in strategic partnerships.
−Removed: We continually assess our spending plans to effectively and efficiently address our liquidity needs.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.