Cardiff Oncology (NASDAQ: CRDF) cuts R&D spend but flags going concern risk
Cardiff Oncology, Inc. reported continued operating losses while progressing its lead PLK1 inhibitor, onvansertib, through Phase 2 development in RAS-mutated metastatic colorectal cancer and other investigator-initiated trials. For the quarter ended June 30, 2026, royalty revenue was $104,000 and net loss was $9.2 million, compared with $13.9 million a year earlier, as research and development expenses fell to $5.9 million from $11.6 million due to trial completions and reduced preclinical work.
For the first six months of 2026, net loss was $21.6 million and operating cash outflows were $24.1 million. As of June 30, 2026, Cardiff held $34.5 million in cash, cash equivalents and short-term investments and disclosed that this is not sufficient to meet funding requirements for at least 12 months after issuance, leading management to conclude there is substantial doubt about its ability to continue as a going concern. Subsequent to quarter-end, the company raised $10.1 million in gross proceeds via a registered direct offering of common stock and warrants. Cardiff also highlighted ongoing litigation with its onvansertib licensor NMS regarding alleged termination of the license agreement, noting that an adverse outcome could materially impact its business.
Positive
- Research and development expenses cut by $9.4 million year-to-date to $12.7 million, largely from completed trials and narrowed preclinical work, which lowers cash burn while the company prepares a Phase 3 registrational program in RAS-mutated metastatic colorectal cancer.
- New financing adds $10.1 million gross proceeds through a July 2026 registered direct offering of common stock and warrants, supplementing the June 30, 2026 cash, cash equivalents and short-term investments balance of $34.5 million and supporting near-term development plans.
Negative
- Going concern warning: with $34.5 million in cash, cash equivalents and short-term investments and projected funding only into the third quarter of 2027, management concluded there is substantial doubt about the company’s ability to continue as a going concern.
- Core PLK1 license under litigation challenge: dispute with Nerviano Medical Sciences over alleged termination of the onvansertib license could, if NMS prevails, result in loss of key rights and have a material adverse effect on business and prospects.
- High cash burn persists despite cost reductions, with net cash used in operating activities of $24.1 million in the first six months of 2026 and cumulative deficit increasing to $451.6 million as of June 30, 2026.
- Rising general and administrative costs: selling, general and administrative expenses increased by $2.6 million year-to-date to $9.9 million, driven by severance costs and legal fees related to the NMS intellectual property dispute.
Filing Explained
Existing holders face dilution from 8,571,429 investor shares, 721,649 insider shares, and warrants for the same amounts in the completed financing.
Cardiff Oncology completed the July 14 registered direct offering, covering 8,571,429 investor shares and 721,649 insider shares, each with warrants for the same number of shares; this increases dilution exposure for existing common holders.
The warrants are not immediately exercisable: exercise begins on the later of six months after issuance or the date an authorized-share increase is accepted by Delaware after stockholder approval. The company must file a proxy within 45 days after closing and hold additional meetings every 60 days if approval is not obtained.
The NMS license dispute remains unresolved. The company’s preliminary-injunction motion was fully briefed and awaiting decision, while NMS filed counterclaims and the company filed an amended complaint on
If NMS’s termination is upheld, the company says it would lose rights integral to onvansertib development; it has recorded no accrual because a loss is not considered probable, and it cannot estimate a potential loss amount.
Key Figures
Key Terms
going concern financial
PLK1 inhibition medical
Phase 2 trial medical
registered direct offering financial
Blinded Independent Central Review medical
objective response rate medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
How did Cardiff Oncology (CRDF) perform financially in Q2 2026?
What is Cardiff Oncology’s (CRDF) cash runway and going concern status?
What major litigation risk does Cardiff Oncology (CRDF) face regarding onvansertib?
How is Cardiff Oncology (CRDF) funding its clinical programs after Q2 2026?
What progress is Cardiff Oncology (CRDF) making with onvansertib in colorectal cancer?
Why did Cardiff Oncology’s (CRDF) R&D expenses fall sharply in 2026?
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
(Mark One)
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
COMMISSION FILE NUMBER
(Exact Name of registrant as specified in its charter)
|
||
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification No.) |
|
|
|
|
||
(Address of principal executive offices) |
|
(Zip Code) |
|
|
|
( |
||
(Registrant’s telephone number, including area code) |
||
Title of each class: |
|
Trading Symbol(s) |
|
Name of each exchange on which registered: |
|
|
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.
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).
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 ☐ |
|
|
|
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 August 6, 2026, the issuer had
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 |
17 |
|
|
|
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
23 |
|
|
|
Item 4. |
Controls and Procedures |
23 |
|
|
|
PART II |
OTHER INFORMATION |
24 |
|
|
|
Item 1. |
Legal Proceedings |
24 |
|
|
|
Item 1A. |
Risk Factors |
24 |
|
|
|
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
25 |
|
|
|
Item 3. |
Defaults Upon Senior Securities |
25 |
|
|
|
Item 4. |
Mine Safety Disclosures |
25 |
|
|
|
Item 5. |
Other Information |
25 |
|
|
|
Item 6. |
Exhibits |
26 |
|
|
|
SIGNATURES |
27 |
|
2
Table of Contents
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CARDIFF ONCOLOGY, INC.
CONDENSED BALANCE SHEETS
(in thousands, except par value)
(Unaudited)
|
|
June 30, |
|
|
December 31, |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Short-term investments |
|
|
|
|
|
|
||
Accounts receivable and unbilled receivable |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
|
|
|
|
||
Total current assets |
|
|
|
|
|
|
||
Property and equipment, net |
|
|
|
|
|
|
||
Operating lease right-of-use assets |
|
|
|
|
|
|
||
Other assets |
|
|
|
|
|
|
||
Total Assets |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
|
|
$ |
|
||
Accrued liabilities |
|
|
|
|
|
|
||
Operating lease liabilities |
|
|
|
|
|
|
||
Total current liabilities |
|
|
|
|
|
|
||
Operating lease liabilities, net of current portion |
|
|
|
|
|
|
||
Total Liabilities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Commitments and contingencies (Note 6) |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Stockholders’ equity: |
|
|
|
|
|
|
||
Preferred stock, $ |
|
|
|
|
|
|
||
Common stock, $ |
|
|
|
|
|
|
||
Additional paid-in capital |
|
|
|
|
|
|
||
Accumulated other comprehensive gain (loss) |
|
|
( |
) |
|
|
|
|
Accumulated deficit |
|
|
( |
) |
|
|
( |
) |
Total stockholders’ equity |
|
|
|
|
|
|
||
Total liabilities and stockholders’ equity |
|
$ |
|
|
$ |
|
||
See accompanying notes to the unaudited condensed financial statements.
3
Table of Contents
CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Royalty revenues |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income (expense), net |
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|||
Total other income (expense), net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Preferred stock dividend payable on Series A |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss attributable to common stockholders |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per common share — basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average shares outstanding — basic |
|
|
|
|
|
|
|
|
|
|
|
|
||||
See accompanying notes to the unaudited condensed financial statements.
4
Table of Contents
CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
(Unaudited)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized loss on securities available- |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Total comprehensive loss |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Preferred stock dividend payable on Series A |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Comprehensive loss attributable to common |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
See accompanying notes to the unaudited condensed financial statements.
5
Table of Contents
CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
(Unaudited)
|
|
Preferred |
|
|
Preferred |
|
|
Common |
|
|
Common |
|
|
Additional |
|
|
Accumulated |
|
|
Accumulated |
|
|
Total |
|
||||||||
Balance, December 31, 2025 |
|
|
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||||
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Issuance of common stock upon |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, March 31, 2026 |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|||||
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Issuance of common stock, net |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, June 30, 2026 |
|
|
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|||||
(1)
6
Table of Contents
CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
(Unaudited)
|
|
Preferred |
|
|
Preferred |
|
|
Common |
|
|
Common |
|
|
Additional |
|
|
Accumulated |
|
|
Accumulated |
|
|
Total |
|
||||||||
Balance, December 31, 2024 |
|
|
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||||
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Issuance of common stock upon |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, March 31, 2025 |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||||||
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, June 30, 2025 |
|
|
|
|
$ |
— |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||||
See accompanying notes to the unaudited condensed financial statements.
7
Table of Contents
CARDIFF ONCOLOGY, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
|
|
Six Months Ended June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Operating activities |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
||
Depreciation |
|
|
|
|
|
|
||
Stock-based compensation expense |
|
|
|
|
|
|
||
Amortization of right-of-use assets |
|
|
|
|
|
|
||
Accretion of discounts on short-term investments, net |
|
|
( |
) |
|
|
( |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Accounts receivable and unbilled receivable |
|
|
( |
) |
|
|
|
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
||
Other assets |
|
|
( |
) |
|
|
( |
) |
Accounts payable and accrued liabilities |
|
|
( |
) |
|
|
|
|
Operating lease liabilities |
|
|
( |
) |
|
|
( |
) |
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Investing activities |
|
|
|
|
|
|
||
Capital expenditures |
|
|
( |
) |
|
|
( |
) |
Maturities of short-term investments |
|
|
|
|
|
|
||
Purchases of short-term investments |
|
|
( |
) |
|
|
( |
) |
Sales of short-term investments |
|
|
|
|
|
|
||
Net cash provided by (used in) investing activities |
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
||
Financing activities |
|
|
|
|
|
|
||
Proceeds from sale of common stock |
|
|
|
|
|
|
||
Payment of issuance costs |
|
|
( |
) |
|
|
|
|
Proceeds from exercise of options |
|
|
|
|
|
|
||
Net cash provided by financing activities |
|
|
|
|
|
|
||
Net change in cash and cash equivalents |
|
|
( |
) |
|
|
( |
) |
Cash and cash equivalents—Beginning of period |
|
|
|
|
|
|
||
Cash and cash equivalents—End of period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Supplementary disclosure of cash flow activity: |
|
|
|
|
|
|
||
Supplemental disclosure of non-cash investing activities: |
|
|
|
|
|
|
||
Acquisition of property and equipment included in accounts payable and accrued |
|
$ |
|
|
$ |
|
||
See accompanying notes to the unaudited condensed financial statements.
8
Table of Contents
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 and deliver improved clinical outcomes for patients with cancer. 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 June 30, 2026, the Company had $
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 six months ended June 30, 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
9
Table of Contents
measure of performance reviewed by the chief operating decision-maker is net loss which is compared to the annual budget and quarterly forecasts.
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Research and development: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Salaries and staff costs |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Clinical trials, outside services, and lab supplies |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Facilities and other |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Selling, general and administrative: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Salaries and staff costs |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Outside services and professional fees |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Facilities and other |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total selling, general and administrative |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
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:
|
|
June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Options to purchase Common Stock |
|
|
|
|
|
|
||
Warrants to purchase Common Stock |
|
|
|
|
|
|
||
Series A Convertible Preferred Stock |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
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.
10
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 June 30, 2026, and December 31, 2025:
|
|
Fair Value Measurements at |
|
|||||||||||||
(in thousands) |
|
Quoted Prices in Active Markets for Identical Assets and Liabilities |
|
|
Significant Other Observable Inputs |
|
|
Significant Unobservable Inputs |
|
|
Total |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market fund |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total included in cash and cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Available for sale investments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Certificate of deposit |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Commercial paper |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. government agencies |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. treasury securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total available for sale investments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total assets measured at fair value on a recurring basis |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
Fair Value Measurements at |
|
|||||||||||||
(in thousands) |
|
Quoted Prices in Active Markets for Identical Assets and Liabilities |
|
|
Significant Other Observable Inputs |
|
|
Significant Unobservable Inputs |
|
|
Total |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market fund |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total included in cash and cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Available for sale investments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Certificate of deposit |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Commercial paper |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. government agencies |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. treasury securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total available for sale investments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total assets measured at fair value on a recurring basis |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
11
Table of Contents
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 six months ended June 30, 2026, and 2025.
4. Supplementary Balance Sheet Information
Investments available for sale
Investments available for sale consisted of the following:
|
|
As of June 30, 2026 |
|
|||||||||||||
(in thousands) |
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Market Value |
|
||||
Maturity less than 1 year: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Certificate of deposit |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Commercial paper |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. government agencies |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. treasury securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total maturity less than 1 year |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Maturity 1 to 2 years: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
U.S. treasury securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total maturity 1 to 2 years |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total short-term investments |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
|
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 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Commercial paper |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. government agencies |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. treasury securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total maturity less than 1 year |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Maturity 1 to 2 years: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
U.S. treasury securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total maturity 1 to 2 years |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total short-term investments |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
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 June 30, 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
12
Table of Contents
Property and equipment
Property and equipment consisted of the following:
(in thousands) |
|
As of June 30, |
|
|
As of December 31, |
|
||
Furniture and office equipment |
|
$ |
|
|
$ |
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Laboratory equipment |
|
|
|
|
|
|
||
Property and equipment, gross |
|
|
|
|
|
|
||
Less—accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
||
Depreciation expense for property and equipment recognized in operating results are as follows:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Total depreciation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Accrued Liabilities
Accrued liabilities consisted of the following:
(in thousands) |
|
As of June 30, |
|
|
As of December 31, |
|
||
Clinical trials |
|
$ |
|
|
$ |
|
||
Accrued compensation |
|
|
|
|
|
|
||
Unsettled investments payable |
|
|
|
|
|
|
||
Research agreements and services |
|
|
|
|
|
|
||
Other accrued liabilities |
|
|
|
|
|
|
||
Total accrued liabilities |
|
$ |
|
|
$ |
|
||
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 June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Included in research and development expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Included in selling, general and administrative expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The unrecognized compensation cost related to non-vested stock options outstanding at June 30, 2026, net of estimated forfeitures, was $
13
Table of Contents
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:
|
|
Six Months Ended June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Risk-free interest rate |
|
|
|
|
||||
Dividend yield |
|
|
% |
|
|
% |
||
Expected volatility |
|
|
|
|
||||
Expected term (in years) |
|
|
|
|
||||
The weighted-average fair value per share of all options granted during the six months ended June 30, 2026 and 2025, estimated as of the grant date using the Black-Scholes option valuation model, was $
A summary of stock option activity and changes in stock options outstanding is presented below:
|
|
Total Options |
|
|
Weighted-Average |
|
|
Intrinsic |
|
|||
Balance outstanding, December 31, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|||
Granted |
|
|
|
|
$ |
|
|
|
|
|||
Exercised |
|
|
( |
) |
|
$ |
|
|
|
|
||
Forfeited |
|
|
( |
) |
|
$ |
|
|
|
|
||
Expired |
|
|
( |
) |
|
$ |
|
|
|
|
||
Balance outstanding, June 30, 2026 |
|
|
|
|
$ |
|
|
$ |
|
|||
Exercisable at June 30, 2026 |
|
|
|
|
$ |
|
|
$ |
|
|||
Vested and expected to vest at June 30, 2026 |
|
|
|
|
$ |
|
|
$ |
|
|||
2021 Equity Incentive Plan
In June 2021, the Company's stockholders approved the 2021 Omnibus Equity Incentive Plan ("2021 Plan"). As of June 30, 2026, the number of authorized shares in the 2021 Plan is equal to the sum of (i)
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 June 30, 2026, an aggregate of
Stock Option Modifications
The Company recorded $
14
Table of Contents
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 |
|
|
|
|
$ |
|
|
|||
Balance outstanding, June 30, 2026 |
|
|
|
|
$ |
|
|
|||
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 Medical Sciences S.r.l. (“NMS”) (the “Agreement”) 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 $
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 six months ended June 30, 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, except for the following:
License Agreement
On February 24, 2026, the Company received a written notice from NMS alleging that the Company is in material breach of the Agreement because the Company did not name NMS employee Dr. Barbara Valsasina as a joint inventor on the Company’s U.S. Patent Nos. 12,144,813 and 12,263,173 (the “Cardiff Patents”) and did not agree to file a joint invention continuation patent application or, in the alternative, execute a power of attorney so NMS could do so. The Company maintains there was no breach and that the Agreement does not require the Company to name NMS employees on inventions made exclusively by the Company, or to make what the Company believes are false or inaccurate representations regarding inventorship to the U.S. Patent and Trademark Office.
On May 19, 2026, the Company filed a lawsuit against NMS disputing NMS’s allegation that the Company materially breached the Agreement by declining to name NMS employee Dr. Barbara Valsasina as a joint inventor of the Cardiff Patents. The complaint, filed in the United States District Court for the Southern District of California, seeks injunctive relief requiring NMS to continue performing under the Agreement, a declaratory judgment that the Company did not breach the Agreement, and additional relief.
On May 27, 2026, the Company was informed in writing by NMS that NMS was terminating the Agreement pursuant to Section 11.3 of the Agreement. NMS alleges that the Company materially breached the Agreement by failing to correct or give NMS a power of attorney to correct the inventorship of the Cardiff Patents to include NMS employee Dr. Barbara Valsasina as a joint inventor in breach of, inter alia, Section 10.2(c) of the Agreement. In addition, NMS alleges that the Company has failed to use Commercially
15
Table of Contents
Reasonable Efforts (as defined in the Agreement) to conduct development activities and to obtain Regulatory Approvals (as defined in the Agreement) for onvansertib in material breach of Sections 7.3, 7.5 and 7.9 of the Agreement. The Company promptly responded to NMS that the notice of termination is legally ineffective, factually unsupported and procedurally improper, and that the Company will continue to perform under the Agreement.
On June 10, 2026, the Company filed a motion for preliminary injunction requesting the District Court to enjoin NMS from purporting to terminate the Agreement and other interference. NMS opposed the motion on July 17, 2026 and the Company replied in support of the motion on July 24, 2026. The motion is fully briefed and awaiting decision. NMS answered the complaint and filed counterclaims on June 26, 2026, asserting counterclaims for correction of inventorship, declaratory judgments of joint invention and termination, breach of contract, and breach of implied covenant of good faith and fair dealing. The Company moved to dismiss all counts except for NMS’s counterclaim for a correction of inventorship on July 17, 2026. The Company also filed an amended complaint on July 17, 2026, adding additional claims for breach of contract, unjust enrichment, and unfair competition in violation of California Business & Professions Code § 17200 seeking monetary and other relief.
The outcome of litigation is inherently uncertain. There can be no assurance that the Company will prevail on any or all of its claims, that it will obtain the relief it is seeking, or that a court will agree with the Company’s legal interpretation of the Agreement or its characterization of NMS's conduct. If the court determines that NMS's termination was valid, the Company would lose the rights granted under the Agreement, which could have a material adverse effect on its business, financial condition, results of operations, and prospects. At this time, the Company has not recorded an accrual related to this matter, as a loss is not considered probable. Although an unfavorable outcome is reasonably possible, the Company cannot reasonably estimate the amount of any potential loss or range of loss, if any.
7. Subsequent Events
Registered Direct Offering
On July 14, 2026, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional investors, pursuant to which the Company agreed to sell to such investors
In addition, the Company entered into the Purchase Agreement with certain of its officers and directors (the “Insiders”), pursuant to which the Company agreed to sell to such Insiders
The Common Warrants have an exercise price of $
16
Table of Contents
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 promising single agent activity in an ongoing investigator-initiated trial in chronic myelomonocytic leukemia ("CMML"). These programs and our broader development strategy are designed to target tumor vulnerabilities and deliver improved clinical outcomes in patients with cancer. 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:
17
Table of Contents
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, and bevacizumab ("bev"). Combining onvansertib with standard of care ("SoC") cancer agents may provide opportunities for synergy with many cancer therapies.
There are ongoing clinical trials of onvansertib in select cancer indications: one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, and investigator-initiated trials in first-line mPDAC, relapsed / refractory or advanced 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 (20 mg and 30 mg) in combination with FOLFIRI/bev or FOLFOX/bev, compared with FOLFIRI/bev or FOLFOX/bev SoC alone, for the treatment of 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. The primary goal of the clinical trial is to select the safe and efficacious dose of onvansertib plus appropriate standard of care regimen for the Phase 3 trial based on a benefit-risk assessment of the totality of the evidence, including numerical differences between the onvansertib and SoC arms. The trial has enrolled 110 patients in the intent-to-treat ("ITT") population and is being 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 highlights from the ongoing Phase 2 trial were presented at the ASCO Meeting on June 2, 2026, using a data cut of March 18, 2026. Overall, results showed that the onvansertib 30 mg + FOLFIRI/bev dose regimen, demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in ORR and PFS compared to SoC alone, with no additive adverse events. In the ITT population, the dose selected for the registrational program, 30 mg onvansertib arm in combination with FOLFIRI/ bev achieved:
No meaningful differences in efficacy were observed between the onvansertib + FOLFOX/bev arms and FOLFOX/bev alone.
Safety/Tolerability
Onvansertib in combination with both chemotherapy (FOLFIRI or FOLFOX)/bev regimens was well-tolerated. There were no major or unexpected toxicities observed, and no additive adverse events reported. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and SoC arms.
The Phase 2 trial is still ongoing and as of a June 23, 2026 data cut-off, 12 patients remain on trial, with 8 patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC.
In April 2026 we completed our End-of-Phase 2 Type B meeting with the U.S. Food and Drug Administration ("FDA"). Incorporating FDA feedback, we have designed the registrational Phase 3 trial (CRDF-005) as a global randomized, controlled trial that will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus SoC FOLFIRI/bev in patients with RAS mutated mCRC. We expect to enroll approximately 640 patients across sites in the US, Europe and other regions. Additional details of the trial will be disclosed at the time of initiation of the trial.
18
Table of Contents
Additionally, we have initiated the process of soliciting scientific advice from the European Medicines Agency ("EMA") on our Phase 3 plans. We remain on track with the manufacturing of clinical material and also with companion diagnostic related regulatory activities as we prepare for the registrational trial.
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 act 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, at the University of Kansas Medical Center. The trail has completed enrollment, and data will be disclosed by the investigator after completion of the trial. 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, Disease Control Rate ("DCR"), as well as 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 at the University of Maryland, Baltimore completed enrollment of 15 patients in Stage 1, with the study proceeding to Stage 2 if two 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:
19
Table of Contents
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 have come back (recurrent) or that do 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 our 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 June 30, 2026 and 2025
Revenues
Total revenues were $0.1 million for the three months ended June 30, 2026, as compared to $0.1 million for the prior period. 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 June 30, |
|
|||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
Increase |
|
|||
Salaries and staff costs |
|
$ |
1,847 |
|
|
$ |
2,134 |
|
|
$ |
(287 |
) |
Stock-based compensation |
|
|
470 |
|
|
|
672 |
|
|
|
(202 |
) |
Clinical trials, outside services, and lab supplies |
|
|
3,162 |
|
|
|
8,306 |
|
|
|
(5,144 |
) |
Facilities and other |
|
|
436 |
|
|
|
468 |
|
|
|
(32 |
) |
Total research and development |
|
$ |
5,915 |
|
|
$ |
11,580 |
|
|
$ |
(5,665 |
) |
20
Table of Contents
Research and development expenses decreased by $5.7 million for the three months ended June 30, 2026, compared to the same period in 2025. The overall decrease of research and development expenses was related to the completion of clinical trials, as well as fewer patients still on treatment in our Phase 2 mCRC trial, and a reduction in pre-clinical activities as we focus on our upcoming Phase 3 mCRC trial.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consisted of the following:
|
|
Three Months Ended June 30, |
|
|||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
Increase |
|
|||
Salaries and staff costs |
|
$ |
915 |
|
|
$ |
849 |
|
|
$ |
66 |
|
Stock-based compensation |
|
|
450 |
|
|
|
1,011 |
|
|
|
(561 |
) |
Outside services and professional fees |
|
|
2,009 |
|
|
|
1,062 |
|
|
|
947 |
|
Facilities and other |
|
|
430 |
|
|
|
396 |
|
|
|
34 |
|
Total selling, general and administrative |
|
$ |
3,804 |
|
|
$ |
3,318 |
|
|
$ |
486 |
|
Selling, general and administrative expenses increased by $0.5 million for the three months ended June 30, 2026, compared to the same period in 2025. The overall increase in expenses, primarily from outside services and professional fees, is primarily related to attorney costs for our intellectual property dispute with NMS. The decrease in stock-based compensation was a result of the departure of our former CEO and CFO during the first quarter of 2026, resulting in lower ongoing equity award expense.
Interest Income, Net
Interest income, net was $0.4 million for the three months ended June 30, 2026 as compared to $0.8 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.
Six Months Ended June 30, 2026 and 2025
Revenues
Total revenues were $0.1 million for the six months ended June 30, 2026, as compared to $0.2 million 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:
|
|
Six Months Ended June 30, |
|
|||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
Increase |
|
|||
Salaries and staff costs |
|
$ |
3,591 |
|
|
$ |
4,103 |
|
|
$ |
(512 |
) |
Stock-based compensation |
|
|
788 |
|
|
|
1,187 |
|
|
|
(399 |
) |
Clinical trials, outside services, and lab supplies |
|
|
7,422 |
|
|
|
15,803 |
|
|
|
(8,381 |
) |
Facilities and other |
|
|
879 |
|
|
|
964 |
|
|
|
(85 |
) |
Total research and development |
|
$ |
12,680 |
|
|
$ |
22,057 |
|
|
$ |
(9,377 |
) |
Research and development expenses decreased by $9.4 million for the six months ended June 30, 2026, compared to the same period in 2025. The overall decrease of research and development expenses was related to the completion of clinical trials, as well as fewer patients still on treatment in our Phase 2 mCRC trial, and a reduction in pre-clinical activities as we focus on our upcoming Phase 3 mCRC trial.
21
Table of Contents
Selling, General and Administrative Expenses
Selling, general and administrative expenses consisted of the following:
|
|
Six Months Ended June 30, |
|
|||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
Increase |
|
|||
Salaries and staff costs |
|
$ |
3,844 |
|
|
$ |
1,775 |
|
|
$ |
2,069 |
|
Stock-based compensation |
|
|
1,792 |
|
|
|
1,861 |
|
|
|
(69 |
) |
Outside services and professional fees |
|
|
3,438 |
|
|
|
2,860 |
|
|
|
578 |
|
Facilities and other |
|
|
856 |
|
|
|
836 |
|
|
|
20 |
|
Total selling, general and administrative |
|
$ |
9,930 |
|
|
$ |
7,332 |
|
|
$ |
2,598 |
|
Selling, general and administrative expenses increased by $2.6 million for the six months ended June 30, 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 outside services and professional fees is primarily related to attorney costs for our intellectual property dispute with NMS.
Interest Income, Net
Interest income, net was $0.9 million for the six months ended June 30, 2026 as compared to $1.8 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 June 30, 2026, and December 31, 2025, we had working capital of $24.8 million and $43.7 million, respectively.
Subsequent to quarter end, on July 14, 2026, we completed a registered direct offering that generated gross proceeds of approximately $10.1 million. See Note 7, Subsequent Events, for additional information.
We have incurred net losses since our inception and have negative operating cash flows. As of June 30, 2026, we had $34.5 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 third 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 at all. To the extent that we can raise additional funds by issuing equity securities, our stockholders may experience additional dilution.
Cash Flow Summary
|
|
Six Months Ended June 30, |
|
|||||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
Net cash used in operating activities |
|
$ |
(24,053 |
) |
|
$ |
(21,122 |
) |
Net cash provided by (used in) investing activities |
|
|
15,526 |
|
|
|
(19,567 |
) |
Net cash provided by financing activities |
|
|
254 |
|
|
|
3 |
|
Net change in cash and cash equivalents |
|
$ |
(8,273 |
) |
|
$ |
(40,686 |
) |
22
Table of Contents
Operating Activities
Net cash used in operating activities for the six months ended June 30, 2026, was $24.1 million. Our primary use of cash was from our net loss of $21.6 million, adjusted for non-cash items of $2.9 million primarily related to stock-based compensation. The net change in our operating assets and liabilities increased cash used in operations by $5.3 million.
Net cash used in operating activities for the six months ended June 30, 2025, was $21.1 million. Our primary use of cash was from our net loss of $27.4 million, adjusted for non-cash items of $3.1 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $3.2 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 six months ended June 30, 2026 was $15.5 million, primarily related to maturities in excess of purchases of marketable securities.
Net cash used in investing activities for the six months ended June 30, 2025 was $19.6 million, primarily related to purchases in excess of maturities and sales of marketable securities.
Financing Activities
Net cash provided by financing activities for the six months ended June 30, 2026 was $254,000, from sales of common stock, warrants and employee stock options exercises.
Net cash provided by financing activities for the six months ended June 30, 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 June 30, 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.
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 June 30, 2026, that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
23
Table of Contents
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
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, except for the following:
We Are Subject to Significant Litigation Risk and Cannot Predict the Outcome of Our Pending Lawsuit Against Our Licensor
We have initiated litigation against NMS alleging wrongful purported termination of the Agreement and other claims. NMS has responded with counterclaims. The outcome of litigation is inherently uncertain. There can be no assurance that we will prevail on any or all of our claims, that we will obtain the relief we are seeking, or that a court will agree with our legal interpretation of the Agreement or our characterization of NMS's conduct. If the court determines that NMS's termination was valid, we would lose the rights granted under the Agreement, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
The Loss of Rights Under the Agreement Could Materially Disrupt Our Business Operations
The Agreement granted us an exclusive license to conduct research and to develop, make, use, offer for sale, sell, and import products or otherwise exploit NMS’s intellectual property rights that are integral to our development of onvansertib. If the termination of the Agreement is ultimately upheld, or if we are unable to obtain preliminary injunctive relief requiring continuation of our licensed rights during the pendency of this litigation through specific performance, we may be required to:
Any of the foregoing consequences could materially and adversely affect our business, financial condition, results of operations and prospects.
We May Not Be Able to Obtain or Maintain Permanent or Preliminary Injunctive Relief
We have sought preliminary injunctive relief to preserve our rights under the Agreement during the course of litigation. There is no guarantee that a court will grant such relief. Courts apply exacting standards to the issuance of preliminary injunctions, including requirements that the moving party demonstrate, among other things, a likelihood of success on the merits, irreparable harm, that the balance of equities favors relief, and that an injunction is in the public interest. Our inability to obtain such relief could result in NMS enforcing or attempting to enforce some or all of the termination provisions of the Agreement pending final adjudication, which could disrupt our ability to operate our business in the ordinary course and cause irreparable harm to our business and financial performance.
This Litigation Is Costly, Time-Consuming, and Could Divert Management Attention and Resources
Commercial litigation of this nature is expensive and time-consuming. We expect to incur significant legal fees and other litigation costs in connection with this dispute. These costs could be substantial and may continue for an extended period, as complex commercial litigation frequently takes multiple years to resolve at the trial court level, with potential additional time for appellate proceedings. In addition, the attention and resources of our senior management team may be diverted from day-to-day business operations in connection with discovery, depositions, court proceedings, and settlement negotiations. This diversion of resources could negatively affect our ability to execute on our strategic priorities and could adversely affect our business and results of operations.
We May Need to Established Financial Reserves That May Prove Inadequate
In accordance with applicable accounting standards, we may be required to establish reserves for this litigation to the extent a loss is probable and can be reasonably estimated. However, the actual costs and liabilities associated with this litigation may exceed any reserves we have established, and there can be no assurance that our reserves are adequate. Changes in our assessment of the likely outcome, or developments during the course of the litigation, may require us to increase our reserves, which could have a material adverse effect on our reported financial results in the period in which such reserves are increased.
24
Table of Contents
The Litigation May Affect Our Ability to Raise Capital or Enter Into Strategic Transactions
The pendency of this litigation could adversely affect our ability to raise additional equity or debt financing on favorable terms, or at all. Investors and lenders may perceive the litigation as a material contingent liability and may demand higher risk premiums, require additional covenants, or decline to participate in financing transactions until the matter is resolved. Similarly, the litigation may complicate or delay our ability to engage in mergers, acquisitions, or other strategic transactions, as potential counterparties may be unwilling to proceed in the face of unresolved material litigation. These constraints could limit our strategic and financial flexibility.
We May Be Unable to Obtain Replacement License Rights on Acceptable Terms
If the alleged termination of the Agreement is ultimately upheld, we may attempt to license the same or similar rights from NMS or from alternative sources. There is no guarantee that we will be able to negotiate a new license with NMS, or that such a license would be available on commercially acceptable terms. Alternative sources of equivalent intellectual property or technology may not exist, may be protected by third-party rights, may be subject to other encumbrances, or may not be available to us on terms that allow us to operate our business profitably. The failure to obtain replacement rights could have a material adverse effect on our business.
Litigation Outcomes Are Inherently Unpredictable and Subject to Appeal
Even if we prevail at the trial court level, NMS may appeal such a ruling, which could result in a reversal or modification of a favorable judgment, require additional litigation costs, and extend the period of uncertainty. Conversely, if an initial ruling is adverse to us, we may elect to appeal, which would similarly extend the litigation timeline and associated costs and uncertainty. The appellate process can take years and may not result in a final resolution that is more favorable to us than the initial ruling.
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 June 30, 2026, none of the Company’s directors or officers
25
Table of Contents
ITEM 6. EXHIBITS
Exhibit Number |
|
Description of Exhibit |
|
|
|
4.1 |
|
Form of Common Warrant (incorporated by reference to Exhibit 4.1 filed on Form 8-K on July 16, 2026) |
|
|
|
4.2 |
|
Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.2 filed on Form 8-K on July 16, 2026) |
|
|
|
10.1 |
|
Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 filed on Form 8-K on July 16, 2026) |
|
|
|
10.2 |
|
Employment Agreement dated August 10, 2026 between Mani Mohindru, Ph.D. and Cardiff Oncology, Inc. |
|
|
|
10.3 |
|
Employment Agreement dated August 10, 2026 between Joshua Muntner and Cardiff Oncology, Inc. |
|
|
|
10.4 |
|
Employment Agreement dated August 10, 2026 between Ajay Aggarwal, M.D. and Cardiff Oncology, Inc. |
|
|
|
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) |
26
Table of Contents
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. |
|
|
|
|
August 11, 2026 |
By: |
/s/ Mani Mohindru |
|
|
Mani Mohindru |
|
|
Chief Executive Officer |
|
|
(Principal Executive Officer) |
|
|
|
|
CARDIFF ONCOLOGY, INC. |
|
|
|
|
August 11, 2026 |
By: |
/s/ Josh Muntner |
|
|
Josh Muntner |
|
|
Chief Financial Officer |
|
|
(Principal Financial Officer) |
27