10-Q
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
☒
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2025
☐
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
COMMISSION FILE NUMBER 001-35558
CARDIFF ONCOLOGY, INC.
(Exact Name of registrant as specified in its charter)
Delaware
27-2004382
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
11055 Flintkote Avenue , San Diego , California
92121
(Address of principal executive offices)
(Zip Code)
( 858 ) 952-7570
(Registrant’s telephone number, including area code)
Title of each class:
Trading Symbol(s)
Name of each exchange on which registered:
Common Stock
CRDF
The Nasdaq Stock Market LLC
Indicate by check mark whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐
Accelerated filer ☐
Non-accelerated filer ☒
Smaller reporting company ☒
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of May 1, 2025 , the issuer had 66,525,854 shares of Common Stock issued and outstanding.
Table of Contents
CARDIFF ONCOLOGY, INC.
Table of Contents
Page
PART I
FINANCIAL INFORMATION
3
Item 1.
Financial Statements (unaudited)
3
Condensed Balance Sheets
3
Condensed Statements of Operations
4
Condensed Statements of Comprehensive Loss
5
Condensed Statements of Stockholders’ Equity
6
Condensed Statements of Cash Flows
8
Notes to Condensed Financial Statements
9
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
15
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
19
Item 4.
Controls and Procedures
20
PART II
OTHER INFORMATION
21
Item 1.
Legal Proceedings
21
Item 1A.
Risk Factors
21
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
21
Item 3.
Defaults Upon Senior Securities
21
Item 4.
Mine Safety Disclosures
21
Item 5.
Other Information
21
Item 6.
Exhibits
21
SIGNATURES
22
2
Table of Contents
PART I. FIN ANCIAL INFORMATION
ITEM 1. FINANCIAL STAT EMENTS
CARDIFF ONCOLOGY, INC.
CONDENSED BALANC E SHEETS
(in thousands, except par value)
(Unaudited)
March 31,
2025
December 31,
2024
Assets
Current assets:
Cash and cash equivalents
$
24,095
$
51,470
Short-term investments
55,792
40,276
Accounts receivable and unbilled receivable
405
773
Prepaid expenses and other current assets
2,419
2,535
Total current assets
82,711
95,054
Property and equipment, net
805
898
Operating lease right-of-use assets
1,034
1,169
Other assets
257
69
Total Assets
$
84,807
$
97,190
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
3,629
$
4,821
Accrued liabilities
8,946
7,897
Operating lease liabilities
716
710
Total current liabilities
13,291
13,428
Operating lease liabilities, net of current portion
640
813
Total Liabilities
13,931
14,241
Commitments and contingencies (Note 6)
Stockholders’ equity
Preferred stock, $ 0.001 par value, 20,000 shares
authorized; 277 designated as Series A Convertible Preferred Stock;
61 shares outstanding at March 31, 2025 and December 31, 2024
with liquidation preference of $ 1,098 and $ 1,092 at
March 31, 2025 and December 31, 2024, respectively
—
—
Common stock, $ 0.0001 par value, 150,000 shares authorized; 66,526 and
66,524 shares issued and outstanding at March 31, 2025
and December 31, 2024, respectively
7
7
Additional paid-in capital
468,455
467,087
Accumulated other comprehensive gain
27
34
Accumulated deficit
( 397,613
)
( 384,179
)
Total stockholders’ equity
70,876
82,949
Total liabilities and stockholders’ equity
$
84,807
$
97,190
See accompanying notes to the unaudited condensed financial statements.
3
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CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended March 31,
2025
2024
Royalty revenues
$
109
$
205
Costs and expenses:
Research and development
10,477
8,008
Selling, general and administrative
4,014
3,130
Total operating expenses
14,491
11,138
Loss from operations
( 14,382
)
( 10,933
)
Other income (expense), net:
Interest income, net
941
926
Other income (expense), net
7
( 4
)
Total other income (expense), net
948
922
Net loss
( 13,434
)
( 10,011
)
Preferred stock dividend payable on Series A
Convertible Preferred Stock
( 6
)
( 6
)
Net loss attributable to common stockholders
$
( 13,440
)
$
( 10,017
)
Net loss per common share — basic and diluted
$
( 0.20
)
$
( 0.22
)
Weighted-average shares outstanding — basic
and diluted
66,524
44,678
See accompanying notes to the unaudited condensed financial statements.
4
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CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF COM PREHENSIVE LOSS
(in thousands)
(Unaudited)
Three Months Ended March 31,
2025
2024
Net loss
$
( 13,434
)
$
( 10,011
)
Other comprehensive loss:
Unrealized loss on securities available-
for-sale
( 7
)
( 65
)
Total comprehensive loss
( 13,441
)
( 10,076
)
Preferred stock dividend payable on Series A
Convertible Preferred Stock
( 6
)
( 6
)
Comprehensive loss attributable to common
stockholders
$
( 13,447
)
$
( 10,082
)
See accompanying notes to the unaudited condensed financial statements.
5
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CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF STOCKH OLDERS’ EQUITY
(in thousands)
(Unaudited)
Preferred
Stock
Shares
Preferred
Stock
Amount
Common
Stock
Shares
Common
Stock
Amount
Additional
Paid-In
Capital
Accumulated
Other
Comprehensive
Gain
Accumulated
Deficit
Total
Stockholders’
Equity
Balance, December 31, 2024
61
$
—
66,524
$
7
$
467,087
$
34
$
( 384,179
)
$
82,949
Stock-based compensation
—
—
—
—
1,365
—
—
1,365
Issuance of common stock upon
exercise of stock options
—
—
2
—
3
—
—
3
Other comprehensive loss
—
—
—
—
—
( 7
)
—
( 7
)
Net loss
—
—
—
—
—
—
( 13,434
)
( 13,434
)
Balance, March 31, 2025
61
$
—
66,526
$
7
$
468,455
$
27
$
( 397,613
)
$
70,876
6
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CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
(Unaudited)
Preferred
Stock
Shares
Preferred
Stock
Amount
Common
Stock
Shares
Common
Stock
Amount
Additional
Paid-In
Capital
Accumulated
Other
Comprehensive
Loss
Accumulated
Deficit
Total
Stockholders’
Equity
Balance, December 31, 2023
61
$
—
44,677
$
4
$
409,343
$
( 67
)
$
( 339,541
)
$
69,739
Modified-retrospective adoption of
ASU 2020-06
—
—
—
—
( 793
)
—
793
—
Stock-based compensation
—
—
—
—
1,124
—
—
1,124
Issuance of common stock upon
exercise of stock options
—
—
33
—
107
—
—
107
Other comprehensive loss
—
—
—
—
—
( 65
)
—
( 65
)
Net loss
—
—
—
—
—
—
( 10,011
)
( 10,011
)
Balance, March 31, 2024
61
$
—
44,710
$
4
$
409,781
$
( 132
)
$
( 348,759
)
$
60,894
See accompanying notes to the unaudited condensed financial statements.
7
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CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
Three Months Ended March 31,
2025
2024
Operating activities
Net loss
$
( 13,434
)
$
( 10,011
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
93
102
Stock-based compensation expense
1,365
1,124
Amortization of right-of-use assets
135
134
Accretion of discounts on short-term investments, net
( 137
)
( 156
)
Changes in operating assets and liabilities:
Accounts receivable and unbilled receivable
368
( 105
)
Prepaid expenses and other current assets
216
( 95
)
Other assets
( 188
)
4
Accounts payable and accrued liabilities
( 1,045
)
1,415
Operating lease liabilities
( 167
)
( 152
)
Net cash used in operating activities
( 12,794
)
( 7,740
)
Investing activities
Capital expenditures
—
( 80
)
Maturities of short-term investments
21,228
5,635
Purchases of short-term investments
( 35,812
)
( 919
)
Net cash provided by (used in) investing activities
( 14,584
)
4,636
Financing activities
Proceeds from exercise of options
3
107
Net cash provided by financing activities
3
107
Net change in cash and cash equivalents
( 27,375
)
( 2,997
)
Cash and cash equivalents—Beginning of period
51,470
21,655
Cash and cash equivalents—End of period
$
24,095
$
18,658
Supplementary disclosure of cash flow activity:
Supplemental disclosure of non-cash investing activities:
Purchases of unsettled short-term investments included in
accrued liabilities
$
902
$
—
See accompanying notes to the unaudited condensed financial statements.
8
Table of Contents
CARDIFF ONCOLOGY, INC.
NOTES TO CONDENSED FI NANCIAL STATEMENTS
(Unaudited)
1. Organization and Basis of Presentation
Business Organization and Overview
Cardiff Oncology, Inc. (“Cardiff Oncology” or the “Company”) headquartered in San Diego, California, is a clinical-stage biotechnology company leveraging Polo-like Kinase 1 (“PLK1”) inhibition, to develop novel therapies across a range of cancers. The Company’s lead asset is onvansertib, a PLK1 inhibitor that is being evaluated in combination with standard-of-care ("SoC") therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (“mCRC”), as well as investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (“mPDAC”), small cell lung cancer (“SCLC”), and triple negative breast cancer (“TNBC”). These programs and the Company’s broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to SoC alone. The Company's common stock is listed on the Nasdaq Capital Market under the ticker symbol "CRDF".
Basis of Presentation
The accompanying unaudited interim condensed financial statements of Cardiff Oncology have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The unaudited interim condensed financial statements reflect all adjustments consisting of normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and the results of its operations and cash flows for the periods presented. The unaudited condensed balance sheet at December 31, 2024, has been derived from the audited financial statements at that date but does not include all of the information and disclosures required by GAAP for annual financial statements. The operating results presented in these unaudited interim condensed financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2024, included in the Company’s annual report on Form 10-K filed with the SEC on February 27, 2025.
Liquidity
The Company has incurred net losses since its inception and has negative operating cash flows. As of March 31, 2025, the Company had $ 79.9 million in cash, cash equivalents and short-term investments and believes it has sufficient cash to meet its funding requirements for at least the next 12 months following the issuance date of these financial statements.
For the foreseeable future, the Company expects to continue to incur losses and require additional capital to further advance its clinical trial programs and support its other operations. The Company cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that the Company can raise additional funds by issuing equity securities, the Company’s stockholders may experience additional dilution.
2. Summary of Significant Accounting Policies
During the three months ended March 31, 2025, there have been no changes to the Company’s significant accounting policies as described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
Segment Reporting
The company operates in one business segment in the United States, which includes all activities related to the development of novel therapies across a range of cancers. The Company's chief operating decision-maker is its chief executive officer. The chief operating decision-maker allocates resources based on available cash, cash equivalents and short-term investments. The primary measure of performance reviewed by the chief operating decision-maker is net loss which is compared to the annual budget and quarterly forecasts.
All financial information required for segment reporting that is provided to the chief operating decision-maker is contained within the financial statements and notes to financial statements, with the exception of the disaggregated amounts contained in the table below:
9
Table of Contents
Three Months Ended March 31,
(in thousands)
2025
2024
Research and development:
Salaries and staff costs
$
1,969
$
1,868
Stock-based compensation
515
389
Clinical trials, outside services, and lab supplies
7,497
5,253
Facilities and other
496
498
Total research and development
$
10,477
$
8,008
Selling, general and administrative:
Salaries and staff costs
$
925
$
907
Stock-based compensation
850
735
Outside services and professional fees
1,798
983
Facilities and other
441
505
Total selling, general and administrative
$
4,014
$
3,130
Net Loss Per Share
Basic and diluted net loss per common share is determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. Preferred dividends are included in net loss attributable to common stockholders in the computation of basic and diluted earnings per share.
The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their effect was anti-dilutive:
March 31,
2025
2024
Options to purchase Common Stock
10,823,072
8,297,292
Warrants to purchase Common Stock
2,807,353
2,807,948
Series A Convertible Preferred Stock
877
877
13,631,302
11,106,117
Investment Securities
Investment transactions are recorded on the trade date, and purchases of investments that are settled after the balance sheet date are included in accrued liabilities. All investments have been classified as “available-for-sale” and are carried at fair value as determined based upon quoted market prices or pricing models for similar securities at period end. Investments with contractual maturities less than 12 months at the balance sheet date are considered short-term investments. Investments with contractual maturities beyond one year are also classified as short-term due to the Company’s ability to liquidate the investment for use in operations within the next 12 months.
Realized gains and losses on investment securities are included in earnings and are derived using the specific identification method for determining the cost of securities sold. The Company has not realized any significant gains or losses on sales of available-for-sale investment securities during any of the periods presented. As all the Company’s investment holdings are in the form of debt securities or certificates of deposit, unrealized gains and losses that are determined to be temporary in nature are reported as a component of accumulated other comprehensive loss. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the establishment of a new cost basis for the security. Interest income is recognized when earned and is included in investment income, as are the amortization of purchase premiums and accretion of purchase discounts on investment securities.
Recent Accounting Pronouncement Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, “Improvements to Income Tax Disclosures.” ASU 2023-09 requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024 and for private businesses for annual periods beginning after December 15, 2025, with early adoption permitted. The Company is currently evaluating the impact of this guidance on its financial statement disclosures.
10
Table of Contents
In November 2024, the FASB issued ASU 2024-03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures.” The update requires disclosure of specific expense categories in the notes to the financial statements at interim and annual reporting periods. The update requires disaggregated information about certain prescribed expense categories underlying any relevant income statement expense caption. The amendments in this update are effective for public entities for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027. The amendments may be adopted either prospectively or retrospectively. Early adoption is permitted. The Company is currently evaluating the impact of this guidance on its financial statement disclosures.
3 . Fair Value Measurements
The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of March 31, 2025, and December 31, 2024:
Fair Value Measurements at
March 31, 2025
(in thousands)
Quoted Prices in Active Markets for Identical Assets and Liabilities
(Level 1)
Significant Other Observable Inputs
(Level 2)
Significant Unobservable Inputs
(Level 3)
Total
Assets:
Money market fund
$
9,988
$
—
$
—
$
9,988
U.S. treasury securities
9,506
—
—
9,506
Total included in cash and cash equivalents
19,494
—
—
19,494
Available for sale investments:
Corporate debt securities
—
33,242
—
33,242
Commercial paper
—
316
—
316
U.S. treasury securities
20,234
—
—
20,234
U.S. government agencies
—
2,000
—
2,000
Total available for sale investments
20,234
35,558
—
55,792
Total assets measured at fair value on a recurring basis
$
39,728
$
35,558
$
—
$
75,286
Fair Value Measurements at
December 31, 2024
(in thousands)
Quoted Prices in Active Markets for Identical Assets and Liabilities
(Level 1)
Significant Other Observable Inputs
(Level 2)
Significant Unobservable Inputs
(Level 3)
Total
Assets:
Money market fund
$
50,499
$
—
$
—
$
50,499
U.S. treasury securities
393
—
—
393
Total included in cash and cash equivalents
50,892
—
—
50,892
Available for sale investments:
Corporate debt securities
—
23,489
—
23,489
Commercial paper
—
313
—
313
U.S. treasury securities
16,474
—
—
16,474
Total available for sale investments
16,474
23,802
—
40,276
Total assets measured at fair value on a recurring basis
$
67,366
$
23,802
$
—
$
91,168
The Company’s policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 3 during the three months ended March 31, 2025 .
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4. Supplementary Balance Sheet Information
Investments available for sale
Investments available for sale consisted of the following:
As of March 31, 2025
(in thousands)
Amortized Cost
Gross Unrealized Gains
Gross Unrealized Losses
Fair Market Value
Maturity less than 1 year:
Corporate debt securities
$
22,507
$
23
$
( 2
)
$
22,528
Commercial paper
316
—
—
316
U.S. treasury securities
20,234
1
( 1
)
20,234
Total maturity less than 1 year
43,057
24
( 3
)
43,078
Maturity 1 to 2 years:
Corporate debt securities
10,709
8
( 3
)
10,714
U.S. government agencies
1,999
1
—
2,000
Total maturity 1 to 2 years
12,708
9
( 3
)
12,714
Total short-term investments
$
55,765
$
33
$
( 6
)
$
55,792
As of December 31, 2024
(in thousands)
Amortized Cost
Gross Unrealized Gains
Gross Unrealized Losses
Fair Market Value
Maturity less than 1 year:
Corporate debt securities
$
17,192
$
27
$
( 1
)
$
17,218
Commercial paper
312
1
—
313
U.S. treasury securities
16,475
3
( 4
)
16,474
Total maturity less than 1 year
33,979
31
( 5
)
34,005
Maturity 1 to 2 years:
Corporate debt securities
6,263
11
( 3
)
6,271
Total maturity 1 to 2 years
6,263
11
( 3
)
6,271
Total short-term investments
$
40,242
$
42
$
( 8
)
$
40,276
We periodically review our portfolio of debt securities to determine if any investment is impaired due to credit loss or other potential valuation concerns. For debt securities where the fair value of the investment is less than the amortized cost basis, we have assessed at the individual security level for various quantitative factors including, but not limited to, the nature of the investments, changes in credit ratings, interest rate fluctuations, industry analyst reports, and the severity of impairment. Unrealized losses in investments available for sale debt securities at March 31, 2025, were substantially due to changes in interest rates, not due to increased credit risks associated with specific securities. Accordingly, we have not recorded an allowance for credit losses. It is not more likely than not that we will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity.
There were no unrealized loss positions greater than one year as of March 31, 2025 and December 31, 2024.
Property and equipment
Property and equipment consisted of the following:
(in thousands)
As of March 31,
2025
As of December 31,
2024
Furniture and office equipment
$
1,053
$
1,053
Leasehold improvements
2,568
2,568
Laboratory equipment
1,414
1,414
Property and equipment, gross
5,035
5,035
Less—accumulated depreciation
( 4,230
)
( 4,137
)
Property and equipment, net
$
805
$
898
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Accrued Liabilities
Accrued liabilities consisted of the following:
(in thousands)
As of March 31,
2025
As of December 31,
2024
Clinical trials
$
5,664
$
4,443
Accrued compensation
1,299
2,746
Unsettled investments payable
902
—
Research agreements and services
662
478
Other accrued liabilities
419
230
Total accrued liabilities
$
8,946
$
7,897
5. Stockholders’ Equity
Stock Options
Stock-based compensation expense related to Cardiff Oncology equity awards have been recognized in operating results as follows:
Three Months Ended March 31,
(in thousands)
2025
2024
Included in research and development expense
$
515
$
389
Included in selling, general and administrative
expense
850
735
Total stock-based compensation expense
$
1,365
$
1,124
The unrecognized compensation cost related to non-vested stock options outstanding at March 31, 2025, net of estimated forfeitures, was $ 12.8 million, which is expected to be recognized over a weighted-average remaining vesting period of 3.1 years. The weighted-average remaining contractual term of outstanding options as of March 31, 2025, was approximately 7.8 years. The total fair value of stock options vested during the three months ended March 31, 2025 and 2024, were $ 2.1 million and $ 1.4 million, respectively.
The estimated fair value of stock option awards was determined on the date of grant using the Black-Scholes option valuation model with the following weighted-average assumptions during the following periods indicated:
Three Months Ended March 31,
2025
2024
Risk-free interest rate
4.06
%
4.04
%
Dividend yield
0
%
0
%
Expected volatility of Cardiff Oncology common stock
106
%
107
%
Expected term
6.1 years
5.8 years
A summary of stock option activity and changes in stock options outstanding is presented below:
Total Options
Weighted-Average
Exercise Price
Per Share
Intrinsic
Value
Balance outstanding, December 31, 2024
8,334,765
$
3.88
$
11,668,989
Granted
2,490,202
$
3.58
Exercised
( 1,672
)
$
1.72
Forfeited and expired
( 223
)
$
516.96
Balance outstanding, March 31, 2025
10,823,072
$
3.80
$
4,704,171
Exercisable at March 31, 2025
5,448,050
$
4.35
$
2,995,890
Vested and expected to vest at March 31, 2025
10,549,833
$
3.82
$
4,590,620
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2021 Equity Incentive Plan
In June 2021, the Company's stockholders approved the 2021 Omnibus Equity Incentive Plan ("2021 Plan"). As of March 31, 2025 the number of authorized shares in the 2021 Plan is equal to the sum of (i) 8,150,000 shares, plus (ii) the number of shares of Common Stock reserved, but unissued under the 2014 Plan; and (iii) the number of shares of Common Stock underlying forfeited awards under the 2014 Plan. As of March 31, 2025 , there were 668,803 shares available for issuance under the 2021 Plan.
2014 Equity Incentive Plan
Subsequent to the adoption of the 2021 Plan, no additional equity awards can be made under the terms of the 2014 Plan.
Inducement Grants
The Company issues equity awards to certain new employees as inducement grants outside of its 2021 Plan. As of March 31, 2025, an aggregate of 1,380,248 shares were issuable upon the exercise of inducement grant stock options approved by the Company.
Warrants
A summary of warrant activity and changes in warrants outstanding, classified as equity is presented below:
Total Warrants
Weighted-Average Exercise Price Per Share
Weighted-Average Remaining Contractual Term
Balance outstanding, December 31, 2024
2,807,353
$
2.40
0.9 years
Balance outstanding, March 31, 2025
2,807,353
$
2.40
0.7 years
6. Commitments and Contingencies
Executive Agreements
Certain executive agreements provide for severance payments in case of terminations without cause or certain change of control scenarios.
Research and Development Agreements
In March 2017, the Company entered into a license agreement with Nerviano which granted the Company development and commercialization rights to NMS-1286937, which Cardiff Oncology refers to as onvansertib. Terms of the agreement also provide for the Company to pay development and commercial milestones, and royalties based on sales volume. These potential development milestones include: (a) dosing of the first subject in the first Phase III Clinical Trial for the first Product, a registration enabling Phase II Clinical Trial, or after completion of a Phase II Clinical Trial that is used as the basis for an NDA submission; and (b) upon filing of the first NDA or equivalent for the first product candidate. During the three months ended March 31, 2025 and 2024 no milestone or royalty payments were made.
The Company is a party to various agreements under which it licenses technology on an exclusive basis in the field of oncology therapeutics. These agreements include License fees, Royalties and Milestone payments. For the three months ended March 31, 2025 and 2024, payments have not been material. The Company also has a legacy license agreement in the field of oncology diagnostics under which royalty payments are due to the Company. These royalty payments are calculated as a percent of revenue.
Litigation
From time to time, the Company may become involved in various lawsuits and legal proceedings that arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in matters may arise from time to time that may harm the Company’s business. As of the date of this report, management believes that there are no claims against the Company, which could result in a material adverse effect on the Company’s business or financial condition.
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ITEM 2. MANAGEMENT’S DISCUSSION AN D ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-Looking Statements
This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding the future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions.
In addition, our business and financial performance may be affected by the factors that are discussed under “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2024, filed on February 27, 2025. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for us to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
The following discussion and analysis is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the financial statements and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q. This discussion should not be construed to imply that the results discussed herein will necessarily continue into the future, or that any conclusion reached herein will necessarily be indicative of actual operating results in the future. Such discussion represents only the best present assessment of our management.
Overview
We are a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers with the greatest unmet medical need. Our goal is to target tumor vulnerabilities with treatment combinations of onvansertib, our oral and highly selective PLK1 inhibitor, and standard-of-care ("SoC") therapeutics. 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"), small cell lung cancer ("SCLC"), and triple negative breast cancer ("TNBC"). Our clinical development programs incorporate tumor genomics and biomarker assays to refine assessment of patient response to treatment.
Our Lead Drug Candidate, Onvansertib
Onvansertib is an oral, small molecule drug candidate that is highly specific for PLK1 inhibition with a 24-hour half-life.
We believe the attributes of onvansertib described below, as well as early clinical evidence of favorable safety and efficacy, with expected on-target, manageable and tolerable side effects, may prove beneficial in addressing clinical therapeutic needs across a variety of cancers:
• Onvansertib is highly potent and highly selective against the PLK1 enzyme (IC 50 = 2nM; IC 50 is the concentration for 50% inhibition), compared to prior PLK1 inhibitors that were pan-inhibitors of several PLK targets. Low or no activity of onvansertib was observed on a panel of 63 kinases (IC50>500 nM), including the PLK members PLK2 and PLK3 (IC 50 >10,000 nM);
• Onvansertib is orally bioavailable, allowing for relative ease and flexibility of dosing;
• Onvansertib has a relatively short drug half-life of 24 hours, allowing for flexible dosing and scheduling that has demonstrated a favorable safety profile across multiple clinical trials.
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In vitro studies have shown synergistic effects when onvansertib was administered in combination with different cytotoxic agents including microtubule-targeting agents, topoisomerase 1 inhibitors, antimetabolites, alkylating agents, proteasome inhibitors, kinase inhibitors, PARP inhibitors, BCL-2 inhibitors, and androgen biosynthesis inhibitors.
In addition, in vivo combination studies have confirmed the positive results obtained in vitro and additive or synergistic effects on efficacy have been observed in xenograft models of onvansertib in combination with irinotecan, 5-fluorouracil ("5-FU"), abiraterone, PARP inhibitors, venetoclax, paclitaxel, or bevacizumab. Combining onvansertib with SoC cancer agents may provide opportunities for synergy with many cancer therapies.
There are several ongoing clinical trials of onvansertib in multiple indications: one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, and investigator-initiated trials in first-line mPDAC, relapsed SCLC and unresectable locally advanced or metastatic TNBC.
RAS-mutated mCRC Program:
CRDF-004 Randomized Clinical Trial in First-Line RAS-mutated mCRC
CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial of onvansertib in combination with SoC FOLFIRI and bevacizumab or SoC FOLFOX and bevacizumab for the first-line treatment of patients with RAS-mutated mCRC. The primary objectives of the CRDF-004 trial are to evaluate onvansertib’s safety and efficacy in combination with the SoC, as well as to evaluate two doses of onvansertib, 20mg and 30mg, given in combination with SoC, against SoC alone. The primary endpoint of the trial is objective response rate ("ORR"). Progression-free survival and duration of response will be secondary endpoints. This trial is conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies. Enrollment of approximately 90 evaluable patients was completed in April 2025. For more information, please visit NCT06106308 at www.clinicialtrials.gov .
Contingent upon the results of CRDF-004, we plan to initiate CRDF-005, a Phase 3, randomized trial with registrational intent. The FDA has agreed that a seamless trial with an interim endpoint of ORR, with duration of response, is acceptable to pursue accelerated approval, with progression-free survival and lack of detriment on overall survival being the endpoints for full approval.
Data presented on December 10, 2024 provided initial results from the ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated metastatic colorectal cancer. ORR, as of the data cut-off date of November 26, 2024, are shown below.
Control Arm (SoC alone)
20mg dose of onvansertib + SoC
30mg dose of onvansertib + SoC
All onvansertib patients
33% ORR
(3 of 9)
50% ORR
(5 of 10)
64% ORR
(7 of 11)
57% ORR
(12 of 21)
Note: Radiographic response determined per RECIST 1.1 by blinded independent central review from an ongoing trial and unlocked database.
Onvansertib in combination with chemo/bevacizumab was well-tolerated and there have been no major or unexpected toxicities observed.
Phase 1b/2 Clinical Trial in Second-Line KRAS-mutated mCRC
TROV-054, a Phase 1b/2 open-label multi-center clinical trial of onvansertib in combination with SoC FOLFIRI and bevacizumab for the second-line treatment of patients with KRAS-mutated mCRC, completed enrollment in October 2022.
The primary objectives of this trial were to evaluate the Dose-Limiting Toxicities ("DLTs"), maximum tolerated dose ("MTD") and recommended Phase 2 dose ("RP2D") of onvansertib in combination with FOLFIRI and bevacizumab (Phase 1b) and to continue to assess the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab patients with KRAS-mutated mCRC (Phase 2). For more information, please visit NCT03829410 at www.clinicialtrials.gov .
On August 7, 2023, we presented data from the TROV-054 Phase 1b/2 single arm clinical trial in KRAS-mutated metastatic colorectal cancer:
• ORR across all evaluable patients was 29%, with 19 of 66 evaluable patients achieving an objective response. Responses have been observed across multiple KRAS variants;
• Median duration of response ("mDoR") across all evaluable patients was 12.0 months (95% confidence interval ("CI"): 8.9 – not reached);
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• Median progression free survival ("mPFS") across all evaluable patients was 9.3 months (95% CI: 7.8 – 14). Historical control trials of different drug combinations, including the SoC of FOLFIRI with bevacizumab, in similar patient populations have shown ORR and mPFS of 5 – 13% and ~4.5 – 6.7 months, respectively;
• A subgroup analysis of patients who were bevacizumab naïve when they entered second-line therapy vs. patients who had received prior bevacizumab in first-line therapy showed that patients who were bevacizumab naïve (n=15) had an ORR of 73% and mPFS of 15 months, which is well above historical controls. In contrast, patients previously treated with bevacizumab (n=51) had an ORR of 16% and mPFS of 7.8 months;
• Data on Treatment Emergent Adverse Events ("TEAEs") on the trial showed that onvansertib is well-tolerated when used in combination with FOLFIRI and bevacizumab. The more severe, grade 4 TEAEs are either neutropenia or leukopenia, which are common events in patients treated with FOLFIRI and bevacizumab. None of the patients with grade 4 TEAEs discontinued treatment due to their condition and all resolved without issue. There were no major or unexpected toxicities seen in the trial;
• Data from the Phase 1b portion of this trial was published in the peer-reviewed journal Clinical Cancer Research, February 6, 2024 edition;
• Data from the Phase 2 portion of this trial was published online in the peer-reviewed journal of Clinical Oncology on October 30, 2024.
mPDAC Program:
Phase 1b/2 Investigator-Initiated Clinical Trial in First-Line mPDAC
In February 2024, the FDA approved NALIRIFOX as a first-line treatment option for mPDAC. As a result, we are currently supporting an investigator-initiated mPDAC Phase 1b/2 trial of onvansertib in combination with first-line SoC NALIRIFOX, which is now open for enrollment at the University of Kansas Medical Center. The trial replaced a previously planned two-cohort, non-randomized Phase 2 trial of onvansertib in combination with first-line SoC Gemzar ® and Abraxane ® . For more information, please visit NCT06736717 at www.clinicaltrials.gov.
The primary objective in this study is to determine anti-tumor activity by measuring Overall Response Rate (ORR). The secondary objectives are to determine treatment safety based on toxicities in participants who have received at least one dose of onvansertib, to determine anti-tumor activity by Progression Free Survival (PFS), to determine anti-tumor activity by Disease Control Rate (DCR), to determine Overall Survival (OS).
Other Clinical Programs:
Phase 2 Investigator-Initiated Clinical Trial in SCLC
A single-arm, two-stage, Phase 2 trial of onvansertib monotherapy in patients with relapsed SCLC is open for enrollment at the University of Maryland, Baltimore. The trial is designed to enroll 15 patients in Stage 1, with the study proceeding to Stage 2 if 2 or more Stage 1 patients achieve an objective response. Stage 2 is designed to enroll an additional 20 patients. The primary endpoint of the trial is ORR, while key secondary endpoints include PFS and overall survival. For more information, please visit NCT05450965 at www.clinicialtrials.gov .
An examination of the safety data from the first six patients by the institutional review board confirmed the trial can continue to enroll as planned. Preliminary efficacy data for seven patients presented on September 26, 2023, showed one confirmed partial response (“PR”), three stable disease (“SD”) and three progressive disease (“PD”). The disease control rate (“DCR”), including PR and SD, is 57% (4 of 7 patients).
Phase 1b Investigator-Initiated Clinical Trial in TNBC
A single-arm, Phase 1b trial of onvansertib in combination with paclitaxel in patients with unresectable locally advanced or metastatic TNBC at Dana Farber Cancer Institute ("DFCI") has completed enrollment. The trial was designed to treat approximately 14-16 patients with different doses of onvansertib in combination with a fixed dose of paclitaxel to determine the maximum tolerated dose and the safety and efficacy of onvansertib in combination with paclitaxel. For more information, please visit NCT05383196 at www.clinicialtrials.gov .
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Critical Accounting Policies
Our accounting policies are described in ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS of our Annual Report on Form 10-K as of and for the year ended December 31, 2024, filed with the SEC on February 27, 2025. There have been no changes to our critical accounting policies since December 31, 2024.
RESULTS OF OPERATIONS
Three Months Ended March 31, 2025 and 2024
Revenues
Total revenues were $0.1 million for the three months ended March 31, 2025, as compared to $0.2 million for the same period in 2024. 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.
Research and Development Expenses
Research and development expenses consisted of the following:
Three Months Ended March 31,
(in thousands)
2025
2024
Increase
(Decrease)
Salaries and staff costs
$
1,969
$
1,868
$
101
Stock-based compensation
515
389
126
Clinical trials, outside services, and lab supplies
7,497
5,253
2,244
Facilities and other
496
498
(2
)
Total research and development
$
10,477
$
8,008
$
2,469
Research and development expenses increased by $2.5 million for the three months ended March 31, 2025, compared to the same period in 2024. The overall increase in expenses was primarily due to costs associated with our CRDF 004 clinical trial, clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consisted of the following:
Three Months Ended March 31,
(in thousands)
2025
2024
Increase
(Decrease)
Salaries and staff costs
$
925
$
907
$
18
Stock-based compensation
850
735
115
Outside services and professional fees
1,798
983
815
Facilities and other
441
505
(64
)
Total selling, general and administrative
$
4,014
$
3,130
$
884
Selling, general and administrative expenses increased by $0.9 million for the three months ended March 31, 2025, compared to the same period in 2024. The overall increase in expenses was primarily from professional fees related to strategic advisory services utilized during the current period.
Interest Income, Net
Interest income, net was $0.9 million for the three months ended March 31, 2025 as compared to $0.9 million for the same period of 2024. Our interest income is primarily from our short-term investment portfolios and money market accounts. The amount of interest income earned varies each period based on the balance of our accounts and interest rates.
LIQUIDITY AND CAPITAL RESOURCES
As of March 31, 2025, and December 31, 2024, we had working capital of $69.4 million and $81.6 million, respectively.
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We have incurred net losses since our inception and have negative operating cash flows. As of March 31, 2025, we had $79.9 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 this Quarterly Report on Form 10-Q. Based on our current projections, we expect that our capital resources are sufficient to fund our operations into the first quarter of 2027.
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. 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. We cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that we can raise additional funds by issuing equity securities, our stockholders may experience additional dilution.
Cash Flow Summary
Three Months Ended March 31,
(in thousands)
2025
2024
Net cash used in operating activities
$
(12,794
)
$
(7,740
)
Net cash provided by (used in) investing activities
(14,584
)
4,636
Net cash provided by financing activities
3
107
Net change in cash and equivalents
$
(27,375
)
$
(2,997
)
Operating Activities
Net cash used in operating activities for the three months ended March 31, 2025, was $12.8 million. Our primary use of cash was from our net loss of $13.4 million, adjusted for non-cash items of $1.5 million primarily related to stock-based compensation. The net change in our operating assets and liabilities increased cash used in operations by $0.8 million.
Net cash used in operating activities for the three months ended March 31, 2024, was $7.7 million. Our primary use of cash was from our net loss of $10.0 million, adjusted for non-cash items of $1.2 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $1.1 million.
At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years.
Investing Activities
Net cash used in investing activities for the three months ended March 31, 2025 was $14.6 million, primarily related to purchases in excess of maturities of marketable securities.
Net cash provided by investing activities for the three months ended March 31, 2024 was $4.6 million, primarily related to maturities in excess of purchases of marketable securities.
Financing Activities
Net cash provided by financing activities for the three months ended March 31, 2025 was $3,000, from employee stock options exercises.
Net cash provided by financing activities for the three months ended March 31, 2024 was $0.1 million, from the sale of common stock and employee stock options exercises.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
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ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We have performed an evaluation under the supervision and with the participation of our management, including our principal executive officer (CEO) and principal financial officer (CFO), of the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of March 31, 2025, to provide reasonable assurance that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives as specified above. Management does not expect, however, that our disclosure controls and procedures will prevent or detect all errors and fraud. Any control system, no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable, not absolute, assurance that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within our company have been detected.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting during the three months ended March 31, 2025, that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER I NFORMATION
ITEM 1. LEGAL PROCE EDINGS
None.
ITEM 1A. RI SK FACTORS
There have been no material changes from the risk factors disclosed in our Form 10-K for the year ended December 31, 2024.
ITEM 2. UNREGISTERED SALE S OF EQUITY SECURITIES AND USE OF PROCEEDS
None .
ITEM 3. DEFAULTS UPON S ENIOR SECURITIES
None.
ITEM 4. MINE SAFET Y DISCLOSURES
Not applicable.
ITEM 5. OTHER IN FORMATION
During the three months ended March 31, 2025 , none of the Company’s directors or officers adopted or terminated any “Rule 10b5-1 trading arrangements” or any “non-Rule 10b5-1 trading arrangements,” as each term is defined in Item 408 of Regulation S-K.
ITEM 6. EX HIBITS
Exhibit
Number
Description of Exhibit
31.1
Certification of Principal Executive Officer required by Rule 13a-14(a)/15d-14(a) under the Exchange Act.
31.2
Certification of Principal Financial Officer required by Rule 13a-14(a)/15d-14(a) under the Exchange Act.
32.1
Certification of Principal Executive Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2
Certification of Principal Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.
101.SCH
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
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SIGNA TURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
CARDIFF ONCOLOGY, INC.
May 8, 2025
By:
/s/ Mark Erlander
Mark Erlander
Chief Executive Officer
CARDIFF ONCOLOGY, INC.
May 8, 2025
By:
/s/ James Levine
James Levine
Chief Financial Officer
22
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.