STOCK TITAN

Cardiff Oncology (NASDAQ: CRDF) posts Q1 loss, warns on cash and details onvansertib data

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
10-Q

Rhea-AI Filing Summary

Cardiff Oncology reported a net loss of $12.3 million for the quarter ended March 31, 2026, on royalty revenue of just $41,000. Operating expenses were $12.9 million, with research and development down to $6.8 million and selling, general and administrative expenses up to $6.1 million, largely from severance and stock-based compensation.

The company ended the quarter with $46.1 million in cash, cash equivalents and short‑term investments and used $12.3 million in operating cash, and management concluded there is substantial doubt about its ability to continue as a going concern beyond the next 12 months without new financing. Cardiff advanced its lead PLK1 inhibitor onvansertib, highlighting strong Phase 2 data in first‑line RAS‑mutated metastatic colorectal cancer and alignment with the FDA on a Phase 3 design, but also disclosed a license dispute with Nerviano that could, if unresolved, lead to termination of the onvansertib license and materially harm the business.

Positive

  • None.

Negative

  • Going‑concern uncertainty: With $46.1 million in cash, cash equivalents and short‑term investments and quarterly operating cash use of $12.3 million, management concludes there is substantial doubt about the company’s ability to continue as a going concern without additional financing.
  • License dispute on lead asset: Nerviano has alleged material breach of the onvansertib license regarding certain patents and may seek termination if unresolved, which the company states would have a material adverse effect on its business, financial condition and results of operations.
  • Ongoing sizable losses: The company generated only $41,000 in royalty revenue and reported a net loss attributable to common stockholders of $12.4 million for the quarter, continuing a pattern of significant operating losses with no product revenue.

Insights

Strong onvansertib data are outweighed by funding and license risks.

Cardiff Oncology continues to generate compelling clinical signals from onvansertib, particularly in first‑line RAS‑mutated metastatic colorectal cancer, where a 30 mg regimen delivered a 72.2% confirmed response rate versus 43.2% for standard of care and improved progression‑free survival metrics.

However, quarterly revenue was only $41,000 and the net loss reached $12.3 million. With $46.1 million in cash, cash equivalents and short‑term investments and $12.3 million in operating cash outflow this quarter, management projects funding only into Q1 2027 and explicitly raises substantial doubt about going concern.

Risk is amplified by Nerviano’s written notice alleging material breach of the onvansertib license and the possibility of termination, which the company disputes. Future disclosures on resolving this dispute and securing new capital will be central to assessing the durability of the onvansertib program.

Cost cuts help but cannot offset going‑concern and IP uncertainty.

Research and development spending fell from $10.5 million to $6.8 million, mainly from lower clinical and preclinical activity, showing tighter cost control. Yet selling, general and administrative expenses rose to $6.1 million, driven by severance and option modifications for departing executives.

Stock‑based compensation increased to $1.66 million, including $0.5 million from option modifications. Leadership transitions were followed by appointments of a new CEO, CFO and COO, which may stabilize management. Nonetheless, the formal going‑concern warning and the disclosed risk that the Nerviano license could be terminated are materially negative governance and risk‑profile developments.

Investors will likely focus on subsequent filings for evidence of strengthened internal controls, capital‑raising actions, and any change in status of the Nerviano license as key indicators of financial and operational resilience.

Royalty revenue $41,000 Three months ended March 31, 2026
Net loss $12.3 million Three months ended March 31, 2026
R&D expense $6.8 million Q1 2026 research and development
SG&A expense $6.1 million Q1 2026 selling, general and administrative
Cash, cash equivalents and short-term investments $46.1 million As of March 31, 2026
Operating cash outflow $12.3 million Net cash used in operating activities, Q1 2026
Shares outstanding 68,369,896 shares Common stock issued and outstanding as of May 7, 2026
CRDF-004 ORR (30 mg arm) 72.2% Confirmed objective response rate vs 43.2% SoC in RAS-mutated mCRC
going concern financial
"Management has performed an analysis and concluded that there exists a substantial doubt about the Company's ability to continue as a going concern."
A going concern is a business that is expected to continue its operations and meet its obligations for the foreseeable future, rather than shutting down or selling off assets. This assumption matters to investors because it indicates stability and ongoing profitability, making the business a more reliable investment. Think of it as believing a restaurant will stay open and serve customers, rather than closing down suddenly.
Polo-like Kinase 1 medical
"advancing innovative cancer treatments focused on Polo-like Kinase 1 (“PLK1”) inhibition, a validated oncology target"
objective response rate medical
"The 30 mg onvansertib + FOLFIRI/bev arm achieved a confirmed objective response rate (“ORR”) of 72.2% compared to 43.2% across the combined SoC arms."
The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.
progression-free survival medical
"The 30 mg onvansertib dose ... demonstrated marked improvement in progression-free survival (“PFS”) versus FOLFIRI/bev"
Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.
Series A Convertible Preferred Stock financial
"277 designated as Series A Convertible Preferred Stock; 61 shares outstanding at March 31, 2026"
Series A convertible preferred stock is a class of shares sold in an early funding round that gives investors a mix of protection and upside: it pays a priority claim over common shares if the company is sold or closes, but can be converted into ordinary shares to share in future growth. Think of it like a hybrid between a safer stake and a ticket to ownership; it matters to investors because it affects who controls the company, how future gains are split, and how much their investment is protected from downside.
stock-based compensation financial
"Stock-based compensation expense related to Cardiff Oncology equity awards have been recognized in operating results as follows"
Stock-based compensation is when a company pays employees, directors or consultants with shares or the right to buy shares instead of or in addition to cash. It matters to investors because issuing stock or options spreads ownership thinner (like cutting a pie into more slices), which can reduce each existing share’s claim on profits and can also change reported earnings; investors watch it to assess true cost of running the business and how management is incentivized.
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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, 2026

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 7, 2026, the issuer had 68,369,896 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

16

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

21

 

 

 

Item 4.

Controls and Procedures

21

 

 

 

PART II

OTHER INFORMATION

23

 

 

 

Item 1.

Legal Proceedings

23

 

 

 

Item 1A.

Risk Factors

23

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

23

 

 

 

Item 3.

Defaults Upon Senior Securities

23

 

 

 

Item 4.

Mine Safety Disclosures

23

 

 

 

Item 5.

Other Information

23

 

 

 

Item 6.

Exhibits

23

 

 

 

SIGNATURES

24

 

2


Table of Contents

PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

CARDIFF ONCOLOGY, INC.

CONDENSED BALANCE SHEETS

(in thousands, except par value)

(Unaudited)

 

 

March 31,
2026

 

 

December 31,
2025

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

8,544

 

 

$

17,470

 

Short-term investments

 

 

37,512

 

 

 

40,834

 

Accounts receivable and unbilled receivable

 

 

191

 

 

 

182

 

Prepaid expenses and other current assets

 

 

1,095

 

 

 

1,642

 

Total current assets

 

 

47,342

 

 

 

60,128

 

Property and equipment, net

 

 

491

 

 

 

578

 

Operating lease right-of-use assets

 

 

495

 

 

 

629

 

Other assets

 

 

844

 

 

 

549

 

Total Assets

 

$

49,172

 

 

$

61,884

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

5,480

 

 

$

8,087

 

Accrued liabilities

 

 

8,337

 

 

 

7,577

 

Operating lease liabilities

 

 

646

 

 

 

730

 

Total current liabilities

 

 

14,463

 

 

 

16,394

 

Operating lease liabilities, net of current portion

 

 

 

 

 

102

 

Total Liabilities

 

 

14,463

 

 

 

16,496

 

 

 

 

 

 

 

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, 2026 and December 31, 2025
   with liquidation preference of $
1,123 and $1,117 at
   March 31, 2026 and December 31, 2025, respectively

 

 

 

 

 

 

Common stock, $0.0001 par value, 150,000 shares authorized; 68,370 and
   
68,305 shares issued and outstanding at March 31, 2026
   and December 31, 2025, respectively

 

 

7

 

 

 

7

 

Additional paid-in capital

 

 

477,126

 

 

 

475,361

 

Accumulated other comprehensive gain (loss)

 

 

(49

)

 

 

50

 

Accumulated deficit

 

 

(442,375

)

 

 

(430,030

)

Total stockholders’ equity

 

 

34,709

 

 

 

45,388

 

Total liabilities and stockholders’ equity

 

$

49,172

 

 

$

61,884

 

 

See accompanying notes to the unaudited condensed financial statements.

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CARDIFF ONCOLOGY, INC.

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(Unaudited)

 

 

Three Months Ended March 31,

 

 

2026

 

 

2025

 

Royalty revenues

 

$

41

 

 

$

109

 

Costs and expenses:

 

 

 

 

 

 

Research and development

 

 

6,765

 

 

 

10,477

 

Selling, general and administrative

 

 

6,126

 

 

 

4,014

 

Total operating expenses

 

 

12,891

 

 

 

14,491

 

 

 

 

 

 

 

Loss from operations

 

 

(12,850

)

 

 

(14,382

)

 

 

 

 

 

 

Other income (expense), net:

 

 

 

 

 

 

Interest income

 

 

506

 

 

 

941

 

Other income (expense), net

 

 

(1

)

 

 

7

 

Total other income (expense), net

 

 

505

 

 

 

948

 

 

 

 

 

 

 

Net loss

 

 

(12,345

)

 

 

(13,434

)

 

 

 

 

 

 

Preferred stock dividend payable on Series A
   Convertible Preferred Stock

 

 

(6

)

 

 

(6

)

 

 

 

 

 

 

Net loss attributable to common stockholders

 

$

(12,351

)

 

$

(13,440

)

 

 

 

 

 

 

Net loss per common share — basic and diluted

 

$

(0.18

)

 

$

(0.20

)

 

 

 

 

 

 

Weighted-average shares outstanding — basic
   and diluted

 

 

68,350

 

 

 

66,524

 

 

See accompanying notes to the unaudited condensed financial statements.

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CARDIFF ONCOLOGY, INC.

CONDENSED STATEMENTS OF COMPREHENSIVE LOSS

(in thousands)

(Unaudited)

 

 

Three Months Ended March 31,

 

 

2026

 

 

2025

 

Net loss

 

$

(12,345

)

 

$

(13,434

)

Other comprehensive loss:

 

 

 

 

 

 

Unrealized loss on securities available-
   for-sale

 

 

(99

)

 

 

(7

)

Total comprehensive loss

 

 

(12,444

)

 

 

(13,441

)

 

 

 

 

 

 

Preferred stock dividend payable on Series A
   Convertible Preferred Stock

 

 

(6

)

 

 

(6

)

 

 

 

 

 

 

Comprehensive loss attributable to common
   stockholders

 

$

(12,450

)

 

$

(13,447

)

 

See accompanying notes to the unaudited condensed financial statements.

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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
Gain (Loss)

 

 

Accumulated
Deficit

 

 

Total
Stockholders’
Equity

 

Balance, December 31, 2025

 

 

61

 

 

$

 

 

 

68,305

 

 

$

7

 

 

$

475,361

 

 

$

50

 

 

$

(430,030

)

 

$

45,388

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,660

 

 

 

 

 

 

 

 

 

1,660

 

Issuance of common stock upon
   exercise of stock options

 

 

 

 

 

 

 

 

65

 

 

 

 

 

 

105

 

 

 

 

 

 

 

 

 

105

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(99

)

 

 

 

 

 

(99

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,345

)

 

 

(12,345

)

Balance, March 31, 2026

 

 

61

 

 

$

 

 

 

68,370

 

 

$

7

 

 

$

477,126

 

 

$

(49

)

 

$

(442,375

)

 

$

34,709

 

 

 


 

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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
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

 

 

See accompanying notes to the unaudited condensed financial statements.

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CARDIFF ONCOLOGY, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

 

 

Three Months Ended March 31,

 

 

2026

 

 

2025

 

Operating activities

 

 

 

 

 

 

Net loss

 

$

(12,345

)

 

$

(13,434

)

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

 

 

 

 

 

 

Depreciation

 

 

87

 

 

 

93

 

Stock-based compensation expense

 

 

1,660

 

 

 

1,365

 

Amortization of right-of-use assets

 

 

134

 

 

 

135

 

Accretion of discounts on short-term investments, net

 

 

(93

)

 

 

(137

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable and unbilled receivable

 

 

(9

)

 

 

368

 

Prepaid expenses and other current assets

 

 

606

 

 

 

216

 

Other assets

 

 

(295

)

 

 

(188

)

Accounts payable and accrued liabilities

 

 

(1,847

)

 

 

(1,045

)

Operating lease liabilities

 

 

(186

)

 

 

(167

)

Net cash used in operating activities

 

 

(12,288

)

 

 

(12,794

)

 

 

 

 

 

 

Investing activities

 

 

 

 

 

 

Maturities of short-term investments

 

 

15,826

 

 

 

21,228

 

Purchases of short-term investments

 

 

(12,569

)

 

 

(35,812

)

Net cash provided by (used in) investing activities

 

 

3,257

 

 

 

(14,584

)

 

 

 

 

 

 

Financing activities

 

 

 

 

 

 

Proceeds from exercise of options

 

 

105

 

 

 

3

 

Net cash provided by financing activities

 

 

105

 

 

 

3

 

Net change in cash and cash equivalents

 

 

(8,926

)

 

 

(27,375

)

Cash and cash equivalents—Beginning of period

 

 

17,470

 

 

 

51,470

 

Cash and cash equivalents—End of period

 

$

8,544

 

 

$

24,095

 

 

 

 

 

 

 

 

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.

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CARDIFF ONCOLOGY, INC.

NOTES TO CONDENSED FINANCIAL 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 advancing innovative cancer treatments focused on Polo-like Kinase 1 (“PLK1”) inhibition, a validated oncology target with practice-changing potential. The Company’s lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (“mCRC”), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through investigator-initiated trials such as metastatic pancreatic ductal adenocarcinoma (“mPDAC”), small cell lung cancer (“SCLC”), metastatic triple negative breast cancer (“mTNBC”), and chronic myelomonocytic leukemia ("CMML"). These programs and the Company’s broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver improved clinical outcomes for patients. 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, 2025, 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, 2025, included in the Company’s annual report on Form 10-K filed with the SEC on February 24, 2026.

Going Concern Uncertainty

The Company has incurred net losses since its inception and has negative operating cash flows. As of March 31, 2026, the Company had $46.1 million in cash, cash equivalents and short-term investments, which is not sufficient to meet its funding requirements for at least the next 12 months following the filing of this form 10-Q. Management has performed an analysis and concluded that there exists a substantial doubt about the Company's ability to continue as a going concern. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

The Company's ability to continue as a going concern is dependent upon its ability to obtain additional equity or debt financing, obtain government grants or reduce expenditures. 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, 2026, 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, 2025.

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

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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:

 

 

 

Three Months Ended March 31,

 

(in thousands)

 

2026

 

 

2025

 

Research and development:

 

 

 

 

 

 

Salaries and staff costs

 

$

1,744

 

 

$

1,969

 

Stock-based compensation

 

 

319

 

 

 

515

 

Clinical trials, outside services, and lab supplies

 

 

4,260

 

 

 

7,497

 

Facilities and other

 

 

442

 

 

 

496

 

Total research and development

 

$

6,765

 

 

$

10,477

 

Selling, general and administrative:

 

 

 

 

 

 

Salaries and staff costs

 

$

2,929

 

 

$

925

 

Stock-based compensation

 

 

1,341

 

 

 

850

 

Outside services and professional fees

 

 

1,429

 

 

 

1,798

 

Facilities and other

 

 

427

 

 

 

441

 

Total selling, general and administrative

 

$

6,126

 

 

$

4,014

 

Net Loss Per Share

Basic and diluted net loss per common share is determined by dividing net loss attributable 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. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.

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,

 

 

 

2026

 

 

2025

 

Options to purchase Common Stock

 

 

10,929,508

 

 

 

10,823,072

 

Warrants to purchase Common Stock

 

 

432

 

 

 

2,807,353

 

Series A Convertible Preferred Stock

 

 

877

 

 

 

877

 

 

 

10,930,817

 

 

 

13,631,302

 

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 interest income, net, as are the amortization of purchase premiums and accretion of purchase discounts on investment securities.

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Table of Contents

 

Recent Accounting Pronouncement Not Yet Adopted

In November 2024, the FASB issued ASU 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures, to enhance the transparency of certain expense 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, 2026, and December 31, 2025:

 

 

Fair Value Measurements at
March 31, 2026

 

(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

 

$

8,359

 

 

$

 

 

$

 

 

$

8,359

 

Total included in cash and cash equivalents

 

 

8,359

 

 

 

 

 

 

 

 

 

8,359

 

 

 

 

 

 

 

 

 

 

 

 

 

Available for sale investments:

 

 

 

 

 

 

 

 

 

 

 

 

Certificate of deposit

 

 

 

 

 

698

 

 

 

 

 

 

698

 

Corporate debt securities

 

 

 

 

 

22,487

 

 

 

 

 

 

22,487

 

Commercial paper

 

 

 

 

 

1,566

 

 

 

 

 

 

1,566

 

U.S. government agencies

 

 

 

 

 

1,891

 

 

 

 

 

 

1,891

 

U.S. treasury securities

 

 

10,870

 

 

 

 

 

 

 

 

 

10,870

 

Total available for sale investments

 

 

10,870

 

 

 

26,642

 

 

 

 

 

 

37,512

 

 

 

 

 

 

 

 

 

 

 

 

 

Total assets measured at fair value on a recurring basis

 

$

19,229

 

 

$

26,642

 

 

$

 

 

$

45,871

 

 

 

Fair Value Measurements at
December 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

 

$

17,169

 

 

$

 

 

$

 

 

$

17,169

 

Total included in cash and cash equivalents

 

 

17,169

 

 

 

 

 

 

 

 

 

17,169

 

 

 

 

 

 

 

 

 

 

 

 

 

Available for sale investments:

 

 

 

 

 

 

 

 

 

 

 

 

Certificate of deposit

 

 

 

 

 

143

 

 

 

 

 

 

143

 

Corporate debt securities

 

 

 

 

 

28,669

 

 

 

 

 

 

28,669

 

Commercial paper

 

 

 

 

 

413

 

 

 

 

 

 

413

 

U.S. government agencies

 

 

 

 

 

2,876

 

 

 

 

 

 

2,876

 

U.S. treasury securities

 

 

8,733

 

 

 

 

 

 

 

 

 

8,733

 

Total available for sale investments

 

 

8,733

 

 

 

32,101

 

 

 

 

 

 

40,834

 

 

 

 

 

 

 

 

 

 

 

 

 

Total assets measured at fair value on a recurring basis

 

$

25,902

 

 

$

32,101

 

 

$

 

 

$

58,003

 

 

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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, 2026, and 2025.

4. Supplementary Balance Sheet Information

Investments available for sale

Investments available for sale consisted of the following:

 

 

 

As of March 31, 2026

 

(in thousands)

 

Amortized Cost

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair Market Value

 

Maturity less than 1 year:

 

 

 

 

 

 

 

 

 

 

 

 

Certificate of deposit

 

$

698

 

 

$

 

 

$

 

 

$

698

 

Corporate debt securities

 

 

13,196

 

 

 

4

 

 

 

(11

)

 

 

13,189

 

Commercial paper

 

 

1,566

 

 

 

 

 

 

 

 

 

1,566

 

U.S. government agencies

 

 

1,891

 

 

 

 

 

 

 

 

 

1,891

 

U.S. treasury securities

 

 

6,553

 

 

 

1

 

 

 

(2

)

 

 

6,552

 

Total maturity less than 1 year

 

 

23,904

 

 

 

5

 

 

 

(13

)

 

 

23,896

 

Maturity 1 to 2 years:

 

 

 

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

 

9,328

 

 

 

3

 

 

 

(33

)

 

 

9,298

 

U.S. treasury securities

 

 

4,329

 

 

 

2

 

 

 

(13

)

 

 

4,318

 

Total maturity 1 to 2 years

 

 

13,657

 

 

 

5

 

 

 

(46

)

 

 

13,616

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total short-term investments

 

$

37,561

 

 

$

10

 

 

$

(59

)

 

$

37,512

 

 

 

As of December 31, 2025

 

(in thousands)

 

Amortized Cost

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair Market Value

 

Maturity less than 1 year:

 

 

 

 

 

 

 

 

 

 

 

 

Certificate of deposit

 

$

143

 

 

$

 

 

$

 

 

$

143

 

Corporate debt securities

 

 

23,699

 

 

 

18

 

 

 

(2

)

 

 

23,715

 

Commercial paper

 

 

413

 

 

 

 

 

 

 

 

 

413

 

U.S. government agencies

 

 

2,872

 

 

 

4

 

 

 

 

 

 

2,876

 

U.S. treasury securities

 

 

4,798

 

 

 

2

 

 

 

 

 

 

4,800

 

Total maturity less than 1 year

 

 

31,925

 

 

 

24

 

 

 

(2

)

 

 

31,947

 

Maturity 1 to 2 years:

 

 

 

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

 

4,940

 

 

 

15

 

 

 

(1

)

 

 

4,954

 

U.S. treasury securities

 

 

3,919

 

 

 

14

 

 

 

 

 

 

3,933

 

Total maturity 1 to 2 years

 

 

8,859

 

 

 

29

 

 

 

(1

)

 

 

8,887

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total short-term investments

 

$

40,784

 

 

$

53

 

 

$

(3

)

 

$

40,834

 

 

The Company periodically reviews its 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, 2026, were substantially due to changes in interest rates, not due to increased credit risks associated with specific securities. Accordingly, the Company has 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, 2026 and December 31, 2025.

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Property and equipment

Property and equipment consisted of the following:

 

(in thousands)

 

As of March 31,
2026

 

 

As of December 31,
2025

 

Furniture and office equipment

 

$

1,051

 

 

$

1,051

 

Leasehold improvements

 

 

2,568

 

 

 

2,568

 

Laboratory equipment

 

 

1,426

 

 

 

1,426

 

Property and equipment, gross

 

 

5,045

 

 

 

5,045

 

Less—accumulated depreciation

 

 

(4,554

)

 

 

(4,467

)

Property and equipment, net

 

$

491

 

 

$

578

 

 

Depreciation expense for property and equipment recognized in operating results are as follows:

 

 

 

Three Months Ended March 31,

 

(in thousands)

 

2026

 

 

2025

 

Total depreciation expense

 

$

87

 

 

$

93

 

Accrued Liabilities

Accrued liabilities consisted of the following:

 

(in thousands)

 

As of March 31,
2026

 

 

As of December 31,
2025

 

Clinical trials

 

$

2,933

 

 

$

3,805

 

Accrued compensation

 

 

4,528

 

 

 

2,430

 

Unsettled investments payable

 

 

 

 

 

744

 

Research agreements and services

 

 

268

 

 

 

311

 

Other accrued liabilities

 

 

608

 

 

 

287

 

Total accrued liabilities

 

$

8,337

 

 

$

7,577

 

 

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)

 

2026

 

 

2025

 

Included in research and development expense

 

$

319

 

 

$

515

 

Included in selling, general and administrative expense

 

 

1,341

 

 

 

850

 

Total stock-based compensation expense

 

$

1,660

 

 

$

1,365

 

 

The unrecognized compensation cost related to non-vested stock options outstanding at March 31, 2026, net of estimated forfeitures, was $6.0 million, which is expected to be recognized over a weighted-average remaining vesting period of 2.7 years. The weighted-average remaining contractual term of outstanding options as of March 31, 2026, was approximately 6.6 years. The total fair value of stock options vested during the three months ended March 31, 2026 and 2025, were $2.2 million and $2.1 million, respectively.

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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 assumptions during the following periods indicated:

 

 

 

Three Months Ended March 31,

 

 

 

2026

 

 

2025

 

Risk-free interest rate

 

3.67% - 3.97%

 

 

 

4.06

%

Dividend yield

 

 

0

%

 

 

0

%

Expected volatility

 

101% - 102%

 

 

 

106

%

Expected term (in years)

 

5.9

 

 

6.1

 

The weighted-average fair value per share of all options granted during the three months ended March 31, 2026 and 2025, estimated as of the grant date using the Black-Scholes option valuation model, was $1.29 and $2.99 per share, respectively.

 

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, 2025

 

 

10,757,293

 

 

$

3.87

 

 

$

2,678,115

 

Granted

 

 

1,000,000

 

 

$

1.60

 

 

 

 

Exercised

 

 

(64,761

)

 

$

1.63

 

 

 

 

Forfeited

 

 

(645,472

)

 

$

3.35

 

 

 

 

Expired

 

 

(117,552

)

 

$

13.13

 

 

 

 

Balance outstanding, March 31, 2026

 

 

10,929,508

 

 

$

3.60

 

 

$

58,756

 

Exercisable at March 31, 2026

 

 

6,854,799

 

 

$

3.99

 

 

$

39,223

 

Vested and expected to vest at March 31, 2026

 

 

10,687,453

 

 

$

3.63

 

 

$

57,081

 

 

2021 Equity Incentive Plan

In June 2021, the Company's stockholders approved the 2021 Omnibus Equity Incentive Plan ("2021 Plan"). As of March 31, 2026, the number of authorized shares in the 2021 Plan is equal to the sum of (i) 12,150,000 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, 2026, there were 4,613,468 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, 2026, an aggregate of 1,515,216 shares were issuable upon the exercise of inducement grant stock options approved by the Company.

Stock Option Modifications

The Company recorded $0.5 million of additional stock based compensation expense during the three months ended March 31, 2026 from stock option modifications. These modifications were the result of separation agreements entered into with Dr. Mark Erlander, former CEO, and James Levine, former CFO, on March 27, 2026 ("Agreement Date"). The modification date and valuation inputs were based on the Agreement Date. Dr. Erlander's stock options will continue to vest through June 11, 2026, and all vested options will be exercisable until June 11, 2027. Mr. Levine's vested stock options will be exercisable until March 27, 2027. All of the additional stock based compensation expense from these modifications was recorded during the three months ended March 31, 2026.

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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, 2025

 

 

432

 

 

$

348.48

 

 

0.6 years

Balance outstanding, March 31, 2026

 

 

432

 

 

$

348.48

 

 

0.3 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 the Company refers to as onvansertib. Terms of the agreement also provide for the Company to pay development milestones up to an aggregate of $15 million, 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, 2026, and 2025, 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, 2026, and 2025, 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.

License Agreement

As disclosed on February 24, 2026, the Company received a written notice from Nerviano alleging that it is in material breach of the license agreement with respect to (i) alleged joint ownership of certain of Cardiff's U.S. patents nos. 12.144.813 and 12.263.173 (the “Cardiff Patents”) and (ii) the filing of a joint invention continuation patent application. The Company does not believe that there has been any breach of the license agreement and is currently engaged in discussions with Nerviano.

The claimed inventions of the Cardiff Patents were based on innovations from the Company’s TROV-054 study with claims that cover methods of using onvansertib in combination with bevacizumab for the treatment of metastatic colorectal cancer patients who have not previously been treated with bevacizumab. If the Company is unable to resolve the allegations, then the Company will be required to vigorously defend its rights under the license agreement. Furthermore, if the Company is unable to resolve the dispute with Nerviano, the license agreement may be terminated. This would have a material adverse effect on the Company’s business, financial condition, and results of operations, which cannot be reasonably estimated at this time.

 

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ITEM 2. MANAGEMENT’S DISCUSSION AND 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, 2025, filed on February 24, 2026. 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 advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology drug target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer ("mCRC"), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through investigator-initiated trials such as metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), and metastatic triple negative breast cancer ("mTNBC"). Additionally, onvansertib has also shown robust single agent activity in an investigator-initiated trial in chronic myelomonocytic leukemia ("CMML"). These programs and our broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver improved clinical outcomes in patients. Our clinical development programs incorporate tumor genomics and biomarker assays to refine patient selection and assessment of patient response to treatment.

Our Lead Drug Candidate, Onvansertib

We believe the attributes of onvansertib and its 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. Key attributes of onvansertib include:

Highly potent and highly selective against the PLK1 enzyme (IC50 = 2nM; IC50 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 (IC50>10,000 nM);
Orally bioavailable, allowing for relative ease and flexibility of dosing;
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 standard of care ("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, first-line CMML as monotherapy, second-line relapsed SCLC as monotherapy, and second-line 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, randomized, open label multi-center clinical trial to assess the efficacy of two different doses of onvansertib (20mg and 30mg) in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab, compared with FOLFIRI or FOLFOX and bevacizumab SoC alone, for the treatment of confirmed mCRC in patients with a KRAS or NRAS mutation in the first-line setting. Trial endpoints include objective response rate ("ORR"), progression-free survival ("PFS") and duration of response ("DoR") together with pharmacokinetics, pharmacodynamics and safety assessments. Selection of the recommended Phase 3 onvansertib dose will be based on a benefit-risk assessment of the totality of the evidence, including numerical differences between the onvansertib and SoC arms. The trial enrolled 110 patients in the intent-to-treat ("ITT") population and is conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies. For more information, please visit NCT06106308 at www.clinicialtrials.gov.

Data provided in the press release dated January 27, 2026 included updated data from the ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC. The 30 mg onvansertib + FOLFIRI/bev arm achieved a confirmed objective response rate (“ORR”) if 72.2% compared to 43.2% across the combined SoC arms. The 30 mg onvansertib dose in combination with FOLFIRI/bev also demonstrated marked improvement in progression-free survival (“PFS”) versus FOLFIRI/bev (HR: 0.38) and combined SoC of FOLFOX/bev and FOLFIRI/bev (HR: 0.37, p<0.05), with no significant added toxicity observed. The results as of the data cut-off date of January 22, 2026, are shown below.

Parameter

SoCc (FOLFIRI/bev+FOLFOX/bev) (n=37)

SoC

FOLFIRI/bev

(n=19)

Onv 20 mg

+FOLFIRI/bev

(n=18)

Onv 30 mg

+FOLFIRI/bev

(n=18)

Objective Response Rate (per BICR)a

Confirmed Responders

16

  8

  8

13

Confirmed ORR (%)

43.2

42.1

44.4

72.2

p-value = 0.051f (vs SoC)

Progression Free Survivalb

Median PFS (months, 95% CI)

10.97 (9.43-15.44)

10.97 (7.52-NR)

NR (7.49-NR)

NR (9.72-NR)

PFS HR (vs FOLFIRI/bev)

 

 

0.56 (0.18-1.73)d

0.38 (0.12-1.17)d

PFS HR (vs SoC)

 

 

0.57 (0.21-1.58)e

0.37 (0.13-1.02)e

p-value = 0.048g (vs SoC)

PFS Rate at 6 months (95% CI)

88.8 (77.4-100)

79.5 (61.1-100)

88.1 (73.9-100)

94.1 (83.6-100)

 

Bev=bevacizumab; BICR=Blinded Independent Central Review; CI=confidence interval; HR=hazard ratio; NR=not reached; Onv=onvansertib; ORR=objective response rate; PFS=progression-free survival; SoC=standard of care.

aORR is confirmed responses

bProgressive disease events were based on combined BICR and Investigator assessments due to very small number of events in BICR assessment. The earliest reported date was used for a conservative estimate.

cSoC is the combination of the FOLFIRI/bev and FOLFOX/bev arms

dPFS HR is the comparison of the onvansertib arm to FOLFIRI/bev

ePFS HR is the comparison of the onvansertib arm to SoC

fFisher’s exact test

gLog-rank test

 

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We will report detailed updated data from our randomized Phase 2 CRDF-004 trial evaluating onvansertib in combination with FOLFIRI/bev or FOLFOX/bev in patients with first-line RAS-mutated mCRC in a rapid oral presentation at the ASCO Annual Meeting, taking place May 29–June 2 in Chicago.

Completed End-of-Phase 2 Meeting with the FDA and Aligned on the Design of the Phase 3 Registrational Trial in Patients with First-line RAS-mutated mCRC

In consultation with the U.S. Food and Drug Administration (FDA), Cardiff selected the 30 mg dose of onvansertib for evaluation with FOLFIRI/bev chemotherapy regimen for the Phase 3 trial in patients with first-line RAS-mutated mCRC. Additional details of the clinical trial will be shared by mid-2026.

 

Other Clinical Programs:

We support certain investigator-initiated trials by supplying onvansertib to academic clinicians who conduct clinical trials independently. These studies allow us to tap into the expertise of independent clinicians and academic investigators to explore new therapeutic indications or new dosage regimens at a low cost to us. By facilitating independent research, we have the opportunity to gain valuable evidence and safety data that can inform future regulatory decisions or improve our understanding of onvansertib’s efficacy. Furthermore, supporting investigator-initiated trials acts as a collaborative effort that strengthens relationships with KOLs.

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 open for enrollment at the University of Kansas Medical Center. For more information, please visit NCT06736717 at www.clinicaltrials.gov.

The primary objective in this study is to determine anti-tumor activity by measuring 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 PFS, to determine anti-tumor activity by Disease Control Rate ("DCR"), to determine Overall Survival ("OS").

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 OS. 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 DCR, including PR and SD, is 57% (4 of 7 patients).

Phase 1b Investigator-Initiated Clinical Trial in mTNBC

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.

 

In June 2025, the investigator presented promising data from this trial at ASCO:

Patients enrolled in the trial received a median of 3 prior lines of chemotherapy.
Onvansertib in combination with paclitaxel demonstrated 40% objective response rate by RECIST 1.1 at RP2D of 18mg/m2 (n=10), with two confirmed partial responses and two unconfirmed partial responses.

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The combination of onvansertib and paclitaxel was well-tolerated and demonstrated a safe and manageable toxicity profile with myelosuppression being the most common adverse event.
Collectively, this clinical data further supports the potential exploration of the combination of onvansertib plus paclitaxel for the treatment of mTNBC.

 

Phase 1 Investigator-Initiated Clinical Trial in CMML

This phase 1 trial is designed to evaluate the safety, effectiveness, and best dose of onvansertib as a monotherapy for the treatment of patients with CMML and Myelodysplastic syndrome/myeloproliferative neoplasm ("MDS/MPN") overlap neoplasms that has come back (recurrent) or that does not respond to treatment (refractory). For more information, please visit NCT05549661 at www.clinicialtrials.gov.

 

Data presented at the American Society of Hematology ("ASH") meeting on December 8, 2025, from this ongoing Phase 1 dose-escalation trial (N=9) showed that onvansertib monotherapy was generally well-tolerated and demonstrated preliminary efficacy in approximately 40% of patients. One patient achieved an optimal marrow response at the 9 mg/m² dose and three patients achieved clinical benefit at 6 mg/m2 and 12 mg/m2. Dose expansion is currently open and recruiting at the 12 mg/m2 dose.

These findings, together with previously reported results from an investigator-sponsored trial in small cell lung cancer, support onvansertib’s single-agent activity across both hematologic and solid tumors.

Recent Updates

Appointment of Chief Executive Officer, Chief Financial Officer, and Chief Operating Officer

On April 9, 2026, we announced the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO. She will continue as a member of the Board of Directors. We also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect Cardiff's commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential.

Presented Preclinical Data on PLK1 Inhibitor Onvansertib in Combination with Her2-Targeted ADC at AACR Annual Meeting

On April 19, 2026, we presented new preclinical data in a poster at the American Association for Cancer Research ("AACR"). The data highlight the potential of onvansertib in combination with the HER-2 targeted antibody-drug conjugate ("ADC"), trastuzumab deruxtecan ("T-DXd"), demonstrating robust antitumor activity and the ability to overcome resistance in HER2-low breast cancer models.

Critical Accounting Estimates

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, 2025, filed with the SEC on February 24, 2026. There have been no changes to our critical accounting estimates since December 31, 2025.

RESULTS OF OPERATIONS

Three Months Ended March 31, 2026 and 2025

Revenues

Total revenues were $41,000 for the three months ended March 31, 2026, as compared to $109,000 for the same period in 2025. 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:

 

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Three Months Ended March 31,

 

(in thousands)

 

2026

 

 

2025

 

 

Increase
(Decrease)

 

Salaries and staff costs

 

$

1,744

 

 

$

1,969

 

 

$

(225

)

Stock-based compensation

 

 

319

 

 

 

515

 

 

 

(196

)

Clinical trials, outside services, and lab supplies

 

 

4,260

 

 

 

7,497

 

 

 

(3,237

)

Facilities and other

 

 

442

 

 

 

496

 

 

 

(54

)

Total research and development

 

$

6,765

 

 

$

10,477

 

 

$

(3,712

)

 

Research and development expenses decreased by $3.7 million for the three months ended March 31, 2026, compared to the same period in 2025. The overall decrease in expenses was primarily due to a reduction in clinical trial expenses and a decrease in preclinical activities.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consisted of the following:

 

 

 

Three Months Ended March 31,

 

(in thousands)

 

2026

 

 

2025

 

 

Increase
(Decrease)

 

Salaries and staff costs

 

$

2,929

 

 

$

925

 

 

$

2,004

 

Stock-based compensation

 

 

1,341

 

 

 

850

 

 

 

491

 

Outside services and professional fees

 

 

1,429

 

 

 

1,798

 

 

 

(369

)

Facilities and other

 

 

427

 

 

 

441

 

 

 

(14

)

Total selling, general and administrative

 

$

6,126

 

 

$

4,014

 

 

$

2,112

 

 

Selling, general and administrative expenses increased by $2.1 million for the three months ended March 31, 2026, compared to the same period in 2025. The overall increase in expenses was primarily from employee severance agreements recorded to salaries and staff costs within the current period. The increase in stock based compensation was due the modification of stock options from employee severance agreements.

Interest Income, Net

Interest income, net was $0.5 million for the three months ended March 31, 2026 as compared to $0.9 million for the same period of 2025. 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, 2026, and December 31, 2025, we had working capital of $32.9 million and $43.7 million, respectively.

We have incurred net losses since our inception and have negative operating cash flows. As of March 31, 2026, we had $46.1 million in cash, cash equivalents and short-term investments. Based on our current projections, we expect that our capital resources are sufficient to fund our operations into the first quarter of 2027, which is not sufficient to meet our funding requirements for at least the next 12 months following the issuance of our financial statements. Management has performed an analysis and concluded that there exists a substantial doubt about our ability to continue as a going concern, see Note 1 Business Organization and Overview - Going Concern Uncertainty to the financial statements for additional details.

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

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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)

 

2026

 

 

2025

 

Net cash used in operating activities

 

$

(12,288

)

 

$

(12,794

)

Net cash provided by (used in) investing activities

 

 

3,257

 

 

 

(14,584

)

Net cash provided by financing activities

 

 

105

 

 

 

3

 

Net change in cash and cash equivalents

 

$

(8,926

)

 

$

(27,375

)

 

Operating Activities

Net cash used in operating activities for the three months ended March 31, 2026, was $12.3 million. Our primary use of cash was from our net loss of $12.3 million, adjusted for non-cash items of $1.8 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $1.7 million.

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 decreased cash used in operations by $0.8 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 provided by investing activities for the three months ended March 31, 2026 was $3.3 million, primarily related to maturities in excess of purchases of marketable securities.

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 and sales of marketable securities.

Financing Activities

Net cash provided by financing activities for the three months ended March 31, 2026 was $105,000, from employee stock options exercises.

Net cash provided by financing activities for the three months ended March 31, 2025 was $3,000, from employee stock options exercises.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

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, 2026, 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.

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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, 2026, that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHER INFORMATION

The information called for by this item is incorporated herein by reference to the information set forth in "Note 6. Commitments and Contingencies” in the Notes to Consolidated Financial Statements included in Item 1 of this Report.

ITEM 1A. RISK FACTORS

There have been no material changes from the risk factors disclosed in our Form 10-K for the year ended December 31, 2025.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

During the three months ended March 31, 2026, 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. EXHIBITS

 

Exhibit

Number

 

Description of Exhibit

 

 

 

10.1

 

Separation Agreement dated March 27, 2026 by and between Cardiff Oncology, Inc. and Mark Erlander.

 

 

 

10.2

 

Separation Agreement dated March 27, 2026 by and between Cardiff Oncology, Inc. and James Levine.

 

 

 

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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SIGNATURES

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 14, 2026

By:

/s/ Mani Mohindru

 

 

Mani Mohindru

 

 

Chief Executive Officer

 

 

(Principal Executive Officer)

 

 

 

 

CARDIFF ONCOLOGY, INC.

 

 

 

May 14, 2026

By:

/s/ Josh Muntner

 

 

Josh Muntner

 

 

Chief Financial Officer

 

 

(Principal Financial Officer)

 

24


FAQ

How did Cardiff Oncology (CRDF) perform financially in the quarter ended March 31, 2026?

Cardiff Oncology reported a net loss of $12.3 million on royalty revenue of $41,000 for the quarter. Operating expenses totaled $12.9 million, and the company generated $0.5 million of interest income from its cash and short‑term investment balances.

What is Cardiff Oncology’s cash position and runway as of March 31, 2026?

Cardiff Oncology held $46.1 million in cash, cash equivalents and short‑term investments at March 31, 2026. It used $12.3 million in operating cash during the quarter and expects these resources to fund operations into the first quarter of 2027, prompting a going‑concern warning.

Why did Cardiff Oncology issue a going‑concern warning in its Q1 2026 10-Q?

Management concluded there is substantial doubt about Cardiff Oncology’s ability to continue as a going concern because current cash of $46.1 million is not sufficient to meet funding requirements for at least 12 months without new equity, debt financing, grants, or significant expense reductions.

What were the key drivers of Cardiff Oncology’s research and development and SG&A expenses?

Research and development expenses decreased to $6.8 million, mainly from lower clinical trial and preclinical spending. Selling, general and administrative expenses rose to $6.1 million, driven by employee severance arrangements and higher $1.34 million stock‑based compensation linked to stock option modifications.

What clinical results did Cardiff Oncology report for onvansertib in RAS-mutated mCRC?

In the CRDF‑004 Phase 2 trial, the 30 mg onvansertib plus FOLFIRI/bevacizumab arm showed a confirmed objective response rate of 72.2% versus 43.2% for combined standard‑of‑care arms, and hazard ratios for progression‑free survival around 0.37–0.38 compared with standard regimens.

What is the status of Cardiff Oncology’s license agreement with Nerviano for onvansertib?

Nerviano sent a written notice alleging material breach of the onvansertib license relating to joint patent ownership and a continuation application. Cardiff Oncology disagrees and is in discussions, but acknowledges that failure to resolve the dispute could lead to termination and materially harm its business.

Who are the new executives appointed at Cardiff Oncology in early 2026?

Cardiff Oncology appointed Mani Mohindru, PhD, as President and CEO, Josh Muntner as Chief Financial Officer, and Ajay Aggarwal, MD, MBA as Chief Operating Officer. These appointments follow prior executive separations and are intended to lead the onvansertib development program.