UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
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TRANSITION REPORT PURSUANT TO 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)
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
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(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 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 every Interactive Data File required to be submitted 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 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 the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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
As of August 4, 2025, the registrant had
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Auditor Firm Id: 596 |
Auditor Name: CohnReznick LLP |
Auditor Location: Melville, NY U.S.A. |
Table of Contents
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Page |
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PART I. |
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Item 1. |
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Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) |
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Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) |
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Notes to Unaudited Condensed Consolidated Financial Statements |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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PART II. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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| Signatures | 23 |
Compass Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(In thousands, except par value)
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June 30, (unaudited) |
December 31, (Note 1) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ | $ | ||||||
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Marketable securities |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease, right-of-use ("ROU") asset |
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Restricted cash |
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Total assets |
$ | $ | ||||||
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
$ | $ | ||||||
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Accrued expenses |
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Operating lease obligations, current portion |
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Total current liabilities |
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Operating lease obligations, long-term portion |
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Total liabilities |
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Commitments and contingencies (Note 7) |
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Stockholders' equity: |
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Common stock, $ |
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Additional paid-in-capital |
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Accumulated other comprehensive income |
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Accumulated deficit |
( |
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Total stockholders' equity |
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Total liabilities and stockholders' equity |
$ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Compass Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except per share data)
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Three Months Ended |
Six Months Ended |
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2025 |
2024 |
2025 |
2024 |
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Licensing revenue |
$ | $ | $ | $ | ||||||||||||
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Operating expenses: |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
( |
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Other income |
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
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Net loss per share - basic and diluted |
$ | ( |
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Basic and diluted weighted average shares outstanding |
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Other comprehensive loss: |
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
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Unrealized gain (loss) on marketable securities |
( |
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Comprehensive loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Compass Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)
(In thousands)
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Common Stock |
Additional |
Accumulated Other Comprehensive |
Accumulated |
Total |
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Shares |
Amount |
Capital |
(Loss) Income |
Deficit |
Equity |
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Balance at December 31, 2024 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||
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Share-based awards, net of tax remittance |
( |
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Stock-based compensation |
— | |||||||||||||||||||||||
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Unrealized loss on marketable securities |
— | ( |
) | ( |
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Net loss |
— | ( |
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Balance at March 31, 2025 |
( |
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Stock-based compensation |
— | |||||||||||||||||||||||
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Unrealized loss on marketable securities |
— | |||||||||||||||||||||||
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Net loss |
— | ( |
) | ( |
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Balance at June 30, 2025 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||
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Balance at December 31, 2023 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||
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Common shares issued, net of costs of $ |
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Share-based awards, net of tax remittance |
( |
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Stock-based compensation |
— | |||||||||||||||||||||||
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Unrealized loss on marketable securities |
— | ( |
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Net loss |
— | ( |
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Balance at March 31, 2024 |
( |
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Stock-based compensation |
— | |||||||||||||||||||||||
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Unrealized loss on marketable securities |
— | ( |
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Net loss |
— | ( |
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Balance at June 30, 2024 |
$ | $ | $ | ( |
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) | $ | |||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Compass Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows (Unaudited)
(In thousands)
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For the Six Months |
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2025 |
2024 |
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Cash flows from operating activities: |
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Net loss |
$ | ( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Share-based compensation |
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Amortization of premium and discount on marketable securities |
( |
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ROU asset amortization |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
( |
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Accounts payable |
( |
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Accrued expenses |
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Operating lease liability |
( |
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Net cash used in operating activities |
( |
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Cash flows from investing activities: |
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Purchase of property and equipment |
( |
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Purchases of marketable securities |
( |
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Proceeds from sale or maturities of marketable securities |
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Net cash provided by investing activities |
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Cash flows from financing activities: |
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Proceeds from issuance of common stock |
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Issuance costs from issuance of common stock |
( |
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Taxes paid related to net shares settlement of RSUs |
( |
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Net cash (used in) provided by financing activities |
( |
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Net change in cash, cash equivalents and restricted cash |
( |
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Cash, cash equivalents and restricted cash at beginning of period |
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Cash, cash equivalents and restricted cash at end of period |
$ | $ | ||||||
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Reconciliation of cash, cash equivalents and restricted cash to the Condensed Consolidated Balance Sheets |
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Cash and cash equivalents |
$ | $ | ||||||
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Restricted cash |
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| Total cash, cash equivalents and restricted cash | $ | $ | ||||||
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Supplemental disclosure of cash flow information |
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Unrealized loss on marketable securities |
$ | ( |
) | $ | ( |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Compass Therapeutics, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements
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1. |
Nature of Business and Basis of Presentation |
Compass Therapeutics, Inc. (“Compass” or the “Company”) is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Our scientific focus is on the relationship between angiogenesis and the immune system. Our pipeline includes novel product candidates that leverage our understanding of the tumor microenvironment, including both angiogenesis-targeted agents and immune-oncology focused agents. These product candidates are designed to optimize critical biological pathways required for an effective anti-tumor response to cancer. These pathways include modulation of the microvasculature via angiogenesis-targeted agents; induction of a potent immune response via activators on effector cells in the tumor microenvironment; and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. We plan to advance our product candidates through clinical development as both standalone therapies and in combination with our proprietary drug candidates as long as their continued development is supported by clinical and nonclinical data. References to Compass or the Company herein include Compass Therapeutics, Inc. and its wholly owned subsidiaries.
The Company is subject to risks and uncertainties common to companies in the biotechnology and pharmaceutical industries. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s technology will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants.
In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s consolidated financial position as of June 30, 2025 and its consolidated results of operations, comprehensive loss and changes in stockholders’ equity for the three and six months ended June 30, 2025 and 2024 and cash flows for the six months ended June 30, 2025 and 2024. Operating results for the three and six months ended June 30, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025.
The unaudited condensed consolidated financial statements include the accounts of Compass Therapeutics, Inc. and its subsidiaries, and have been prepared by the Company in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. The condensed consolidated balance sheet at December 31, 2024 has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements. Accordingly, these condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “Annual Report”).
Liquidity
Since our inception, we have devoted substantially all of our efforts to organizing and staffing our Company, business planning, raising capital, research and development activities, building our intellectual property portfolio and providing general and administrative support for these operations. We have funded our operations with proceeds from the sale of our equity securities and borrowing from debt arrangements. Through June 30, 2025, we have received $
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2. |
Summary of Significant Accounting Policies |
There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report.
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3. |
Fair Value Measurements |
The following tables represent the Company’s financial assets that are measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
| Fair Value Measurements as of June 30, 2025 (000's): | ||||||||||||||||
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Quoted Prices in |
Significant Other |
Significant |
Fair Value |
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Assets |
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Corporate bonds |
$ | $ | $ | $ | ||||||||||||
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Commercial paper |
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Certificates of deposit |
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U.S. government treasuries |
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Asset-backed securities |
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Money market funds (cash equivalents) |
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Total assets |
$ | $ | $ | $ | ||||||||||||
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Fair Value Measurements as of December 31, 2024 (000's): |
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Quoted Prices in |
Significant Other |
Significant |
Fair Value |
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Assets |
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Corporate bonds |
$ | $ | $ | $ | ||||||||||||
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Commercial paper |
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Certificates of deposit |
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U.S. government treasuries |
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Asset-backed securities |
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Money market funds (cash equivalents) |
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Total assets |
$ | $ | $ | $ | ||||||||||||
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4. |
Marketable Securities |
The objectives of the Company’s investment policy are to ensure the safety and preservation of invested funds, as well as to maintain liquidity sufficient to meet cash flow requirements. The Company invests its excess cash in securities issued by financial institutions, commercial companies, and government agencies that management believes to be of high credit quality in order to limit the amount of its credit exposure. The Company has not realized any net losses from its investments.
Unrealized gains and losses on investments that are available for sale are recognized in accumulated other comprehensive (loss) income, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are included in other income in the condensed consolidated statements of operations and comprehensive loss and are determined using the specific identification method with transactions recorded on a trade date basis. The Company classifies marketable securities that are available for use in current operations as current assets on the condensed consolidated balance sheet.
The following tables summarize marketable securities held (in thousands):
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Fair Value Measurements as of June 30, 2025 Using: |
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Amortized Cost |
Unrealized gains |
Unrealized Losses |
Fair Value |
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Assets |
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Corporate bonds |
$ | $ | $ | ( |
) | $ | ||||||||||
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Commercial paper |
( |
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Certificates of deposit |
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U.S. government treasuries |
( |
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Asset-backed securities |
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Total assets |
$ | $ | $ | ( |
) | $ | ||||||||||
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Fair Value Measurements as of December 31, 2024 Using: |
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Amortized Cost |
Unrealized gains |
Unrealized Losses |
Fair Value |
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Assets |
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Corporate bonds |
$ | $ | $ | ( |
) | $ | ||||||||||
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Commercial paper |
( |
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Certificates of deposit |
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U.S. government treasuries |
( |
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Asset-backed securities |
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Total assets |
$ | $ | $ | ( |
) | $ | ||||||||||
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As of |
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June 30, 2025 |
December 31, 2024 |
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Maturing in one year or less |
$ | $ | ||||||
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Maturing after one year through two years |
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Total |
$ | $ | ||||||
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5. |
Property and Equipment |
Property and equipment consist of the following (in thousands):
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June 30, |
December 31, |
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Equipment |
$ | $ | ||||||
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Leasehold improvements |
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Software |
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Furniture and fixtures |
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Total property and equipment–at cost |
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Less: Accumulated depreciation |
( |
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Property and equipment, net |
$ | $ | ||||||
Depreciation and amortization expense for each of the six months ended June 30, 2025 and 2024 was $
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6. |
Accrued Expenses |
Accrued expenses consist of the following (in thousands):
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June 30, |
December 31, |
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2025 |
2024 |
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Project expenses |
$ | $ | ||||||
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Compensation and benefits |
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Other |
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Total accrued expenses |
$ | $ | ||||||
The increase in project expenses is primarily from $
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7. |
Commitments and Contingencies |
Leases
The Company has evaluated its leases under ASC 842, Leases, and determined that it has one lease that is classified as an operating lease. The classification of this lease is consistent with the Company’s determination under the previous accounting standard.
When available, the Company will use the rate implicit in the lease to discount lease payments to present value; however, the Company’s current lease does not provide an implicit rate. Therefore, the Company used its incremental borrowing rate of
The Company has operating lease for its corporate office and laboratory facility (“Facility”) that was signed in December 2020. The Company moved into the Facility in January 2021. The Facility lease has an initial term of years and five months, beginning on January 1, 2021.
The terms of the Facility lease were modified effective September 27, 2024 through the execution of a new lease. The modified terms extended the non-cancelable lease term through May 2031. The modified terms also included the right to use an additional
Lease costs related to the Facility were $
The table below presents the undiscounted cash flows for the lease term. The undiscounted cash flows are reconciled to the operating lease liabilities recorded on the condensed consolidated balance sheet (in thousands):
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(000's) |
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Remainder of 2025 |
$ | |||
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Years ending December 31, |
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2026 |
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2027 |
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2028 |
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2029 |
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2030 |
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Thereafter |
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Total minimum lease payments |
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Less: amount of lease payments representing interest |
( |
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Present value of future minimum lease payments |
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Less: operating lease obligations, current portion |
( |
) | ||
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Operating lease obligations, long-term portion |
$ | |||
Defined Contribution Plan
The Company has a 401(k) defined contribution plan (the “401(k) Plan”) for substantially all its employees. Eligible employees may make pre-tax or post-tax (Roth) contributions to the 401(k) Plan up to statutory limits. The Company matches employee contributions to the plan up to
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8. |
Stock-Based Compensation |
Stock-based compensation expense for the three and six months ended June 30, 2025 and 2024 was classified in the condensed consolidated statement of operations as follows (in thousands):
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Three Months Ended June 30, |
Six Months Ended June 30, |
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2025 |
2024 |
2025 |
2024 |
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(000’s) |
(000’s) |
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Research and development |
$ | $ | $ | $ | ||||||||||||
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General and administrative |
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Total |
$ | $ | $ | $ | ||||||||||||
As of June 30, 2025, the remaining unrecognized stock-based compensation cost from all plans to be recognized in future periods totaled $
2020 Plan
In June 2020, the Company’s board of directors adopted the 2020 Stock Option and Incentive Plan (the “2020 Plan”) and reserved
The 2020 Plan authorizes the board of directors or a committee of the board to grant incentive stock options, nonqualified stock options, restricted stock awards and restricted stock units ("RSUs") to eligible officers, employees, consultants and directors of the Company. Options generally vest over a period of years and have a contractual life of years from the date of grant.
Stock Options:
The following table summarizes the stock option activity for the 2020 Plan:
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Weighted |
Weighted |
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Number of |
Average |
Average |
Aggregate |
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Unvested |
Exercise |
Remaining |
Intrinsic |
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Options |
Price |
Contractual |
Value |
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(000's) |
Per Share |
Term (in years) |
($000's) |
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Outstanding at December 31, 2024 |
$ | $ | ||||||||||||||
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Granted |
$ | |||||||||||||||
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Exercised |
$ | — | — | |||||||||||||
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Forfeited/canceled |
$ | — | — | |||||||||||||
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Outstanding at June 30, 2025 |
$ | $ | ||||||||||||||
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Vested at June 30, 2025 |
$ | $ | ||||||||||||||
For the six months ended June 30, 2025, the weighted average grant date fair value for options granted was $
For the six months ended June 30, 2024, the weighted average grant date fair value for options granted was $
The weighted average assumptions used in the Black-Scholes pricing model to determine the fair value of stock options granted during the six months ended June 30, 2025 and 2024 were as follows:
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Six Months Ended June 30, |
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2025 |
2024 |
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Expected term (in years) |
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Risk-free rate |
% | % | ||||||
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Expected volatility |
% | % | ||||||
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Expected dividend yield |
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RSUs:
The following table summarizes the RSU activity for the 2020 Plan:
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Shares |
Weighted |
Weighted |
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Unvested, December 31, 2024 |
$ | $ | ||||||||||
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Granted |
||||||||||||
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Vested |
( |
) | ( |
) | ||||||||
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Forfeited or canceled |
— | |||||||||||
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Unvested, June 30, 2025 |
$ | $ | ||||||||||
The weighted average price per share is the weighted grant price based on the closing market price of each of the stock grants. The weighted average fair value is the weighted average share price times the number of shares.
As of June 30, 2025, the remaining unrecognized compensation cost related to RSUs to be recognized in future periods totaled $
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9. |
Related Parties and Related-Party Transactions |
There were no material related party transactions during the six months ended June 30, 2025 and 2024.
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10. |
Other Income |
Other income consists exclusively of interest income of $
|
11. |
License, Research and Collaboration Agreements |
Collaboration Agreements
ABL Bio Corporation ("ABL Bio") Agreement
In November 2018, the Company and ABL Bio, a South Korean biotechnology company, entered into an exclusive global (excluding South Korea) license agreement which granted the Company a license to tovecimig (ABL001), ABL Bio’s bispecific antibody targeting DLL4 and VEGF-A. Under the terms of the agreement, the two companies would jointly develop tovecimig, with ABL Bio responsible for development of tovecimig throughout the end of Phase 1 clinical trials and the Company responsible for the development of tovecimig from Phase 2 and onward. ABL Bio received a $
In May 2021, the Company and ABL Bio terminated license agreements to several preclinical assets. As a result of the return of these assets to ABL Bio and termination of the license agreements, the Company is eligible to receive royalty payments if ABL Bio develops or licenses two bispecific antibodies that were previously licensed to the Company.
Adimab Agreement
The Company entered into a collaboration agreement with Adimab, LLC on October 16, 2014. The agreement includes provisions for payment of royalties at rates ranging in the single digits as a percentage of future net sales within a specified term from the first commercial sale for certain antibodies, including our product candidate, CTX-471. There were milestone payments made during the first six months of 2025. As of June 30, 2025, future potential milestone payments in connection with this agreement amounted to $
|
12. |
Segment Information |
Segment reporting is prepared on the same basis that our chief executive officer, who is our Chief Operating Decision Maker (CODM), manages the business, makes operating decisions and assesses performance. The Company operates in one segment. The Company’s business is research and development of drug candidates. Costs, including supplies, outsourced development, and other research and development costs are tracked by major program. While internal personnel costs are tracked by program for overall program spending, it is not broken out for management review. Facility and equipment costs are not allocated to programs. Research and development expenses are summarized by program in the table below:
|
Three Months Ended June 30, |
Six Months Ended June 30, |
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|
2025 |
2024 |
2025 |
2024 |
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(000's) |
(000's) |
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Licensing revenue |
$ | $ | $ | $ | ||||||||||||
|
Personnel |
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|
General |
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|
Tovecimig |
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CTX-471 |
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|
CTX-8371 |
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CTX-10726 |
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Research and development |
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Personnel |
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General |
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Stock-based compensation |
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General and administrative |
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Other income |
||||||||||||||||
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion of the financial condition and results of operations of Compass Therapeutics, Inc. should be read in conjunction with the financial statements and the notes to those statements included in this Quarterly Report on Form 10-Q for the three and six months ended June 30, 2025. Some of the information contained in this discussion and analysis, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risk, uncertainties and assumptions. You should read the “Risk Factors” section of this Quarterly Report on Form 10-Q and the “Risk Factors” section included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
We are a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics. Our scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. Our pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These pathways include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. We plan to advance our product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data.
Our pipeline comprises three clinical product candidates and one candidate in investigational new drug application (“IND”) enabling studies. Our lead product candidate, tovecimig (formerly known as CTX-009), is a bispecific antibody targeting Delta-like ligand 4 (“DLL4”), a ligand of Notch-1, and vascular endothelial growth factor A (“VEGF-A”). Simultaneous blockade of the VEGF-A and the Notch pathways is known to turn productive angiogenesis into non-productive angiogenesis, which leads to tumor shrinkage and apoptosis. CTX-471, is an agonistic antibody targeting a member of the tumor necrosis factor receptor superfamily member 9 (TNFRSF9), also known as CD-137, a co-stimulatory receptor which is mostly expressed on activated, but not on resting, T-cells and NK cells. CTX-8371, is a bispecific antibody targeting the programmed cell death protein-1 (“PD-1”), an inhibitory immune checkpoint receptor and its ligand PD-L1, two validated immune-oncology targets. In addition, we are in the process of IND enabling studies with CTX-10726, a bispecific antibody targeting PD-1 and VEFG-A. For a more detailed description, see our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
Recent Developments
Tovecimig (DLL4 x VEGF-A bispecific) Phase 2/3 study in patients with BTC shows decreasing rate of OS events
In the ongoing Phase 2/3 study of tovecimig in patients with advanced biliary tract cancer, fewer deaths have been observed than originally modeled, which we believe may suggest that tovecimig could be affecting overall survival (“OS”) in the patient population. The pre-specified number of pooled OS events (80%) required to trigger the analyses of the secondary endpoints, including OS and progression-free survival (PFS), has not yet been met and the Company now expects these analyses to occur in Q1 2026.
We previously announced in April 2025 that the study met its primary endpoint, with tovecimig in combination with paclitaxel achieving a 17.1% overall response rate (“ORR”), including one complete response and three additional patients with 100% reduction in target tumor burden, compared to a 5.3% ORR for paclitaxel alone (p=0.031). The study also showed differences between treatment arms for other efficacy measures, including progressive disease (“PD”) rates of 16.2% in patients on tovecimig in combination with paclitaxel versus 42.1% in patients on paclitaxel alone. We also announced that the safety profile of tovecimig in this study to date was consistent with prior studies of tovecimig. An independent Data Monitoring Committee (DMC) reviewed safety data at four separate (pre-specified) DMC meetings and, after each meeting, recommended continuation of the study without modification.
CTX-8371 (PD-1 x PD-L1 bispecific) Phase 1 data supports cohort expansion in patients with NSCLC and triple negative breast cancer
We are planning to initiate cohort expansions in patients with non-small cell lung cancer (“NSCLC”) and triple-negative breast cancer. This cohort expansion is based on two deep responses observed in the CTX-8371 Phase 1 dose-escalation study, with one of five patients with NSCLC achieving complete resolution of all measurable target tumor lesions, and one of three patients with TNBC achieving over 90% reduction in target tumor lesions. We expect to initiate this part of the study in the fourth quarter of 2025, with data reported in 2026. We are currently enrolling the fifth and final dose level in the dose-escalation study with no dose-limiting toxicities observed to date. Detailed results are expected to be presented at a medical meeting in the fourth quarter of 2025.
CTX-10726 (PD-1 x VEGF-A bispecific) demonstrates superiority to ivonescimab in preclinical studies
CTX-10726 demonstrated superiority in both PD-1 potency and anti-tumor response compared to ivonescimab in mouse models compared to ivonescimab. We plan to submit an IND for CTX-10726 in the fourth quarter of 2025 and expect to announce clinical data in 2026. CTX-10726 was discovered in-house and utilizes the VEGF-A component from tovecimig and the PD-1 component of CTX-8371, which are both currently in clinical trials. By using existing components, we have been able to leverage our current expertise with CMC processes, creating manufacturing yields at commercial scale early in the process.
OPERATING ACTIVITIES
We have funded our operations primarily with proceeds from the sale of our equity securities. Through June 30, 2025, we have received $430 million in gross proceeds from the sale of equity securities.
We have incurred significant operating losses since inception and have not generated any revenue from the sale of products and we do not expect to generate any revenue from the sale of products in the near future, if at all. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of our treatments and any future product candidates. Our net losses were $19.9 million and $13.1 million for the three months ended June 30, 2025 and 2024, respectively. Our net losses were $36.5 million and $23.9 million for the six months ended June 30, 2025 and 2024, respectively. We had an accumulated deficit of $401.2 million on June 30, 2025. We expect to continue to incur significant expenses for at least the next several years as we advance through clinical development, develop additional product candidates and seek regulatory approval of any product candidates that complete clinical development. In addition, if we obtain marketing approval for any product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. We may also incur expenses in connection with the in-licensing or acquisition of additional product candidates.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through equity and debt financings, or other capital sources, which may include collaborations with other companies or other strategic transactions. As of June 30, 2025, we had $101 million in cash, cash equivalents and marketable securities. We expect that such cash resources will enable us to fund our operating expenses and capital expenditure requirements into 2027. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, reduce or eliminate the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions.
Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Components of Results of Operations
Research and Development
Research and development expenses consist primarily of costs incurred in connection with the development of our product candidates, tovecimig, CTX-471, CTX-8371 and CTX-10726. We expense research and development costs as incurred. These expenses include:
|
● |
clinical expenses including Contract Research Organizations (“CRO”), consultants that conduct our clinical trials, as well as investigative sites; |
|
● |
manufacturing expenses including Contract Manufacturing Organizations (“CMO”), consultants that are primarily engaged to develop and manufacture drug substance and product for our clinical trials, as well as the cost of acquiring and manufacturing clinical trial materials, including manufacturing registration and validation batches; |
|
● |
employee-related expenses including salaries, related benefits and equity-based compensation expense for employees engaged in research and development functions; |
|
● |
other research and development expenses including preclinical study costs and expenses incurred under agreements with organizations that support our platform program development; |
|
● |
costs related to compliance with quality and regulatory requirements; and |
|
● |
facilities and equipment expenses. |
Advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase substantially in connection with our planned clinical development activities in the future. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any future product candidates.
The successful development and commercialization of product candidates is highly uncertain. This is due to the numerous risks and uncertainties associated with product development and commercialization.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related costs for personnel in executive, finance, business development and administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters, professional fees for accounting, auditing, tax, insurance, administrative travel expenses, selling and marketing costs and other operating costs.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our business operations.
Other Income
Other income consists of interest income on marketable securities.
Results of Operations
Comparison of the Three Months Ended June 30, 2025 and 2024
The following table summarizes our results of operations for the three months ended June 30, 2025 and 2024 (in thousands):
|
Three Months Ended June 30, |
||||||||||||
|
2025 |
2024 |
Change |
||||||||||
|
(000’s) |
||||||||||||
|
Licensing Revenue |
$ | — | $ | 850 | $ | (850 | ) | |||||
|
Operating expenses: |
||||||||||||
|
Research and development |
16,415 | 11,174 | 5,241 | |||||||||
|
General and administrative |
4,651 | 4,721 | (70 | ) | ||||||||
|
Total operating expenses |
21,066 | 15,895 | 5,171 | |||||||||
|
Loss from operations |
(21,066 | ) | (15,045 | ) | (6,021 | ) | ||||||
|
Other income |
1,185 | 1,969 | (784 | ) | ||||||||
|
Net loss |
$ | (19,881 | ) | $ | (13,076 | ) | $ | (6,805 | ) | |||
Licensing Revenue
There was no licensing revenue for the three months ended June 30, 2025. Licensing revenue was $850 thousand for the three months ended June 30, 2024. The licensing revenue consisted of a $1 million milestone payment from Elpiscience for completing a Phase 1 trial in China. This license revenue is reported net of a 15% sublicense royalty due ABL Bio (see footnote 11 of the financial statements in this Quarterly Report on Form 10-Q for further information on this sublicense agreement).
Research and Development Expenses
Research and development expenses increased by $5.2 million, or 47%, for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. Manufacturing expenses increased $5.7 million, primarily related to tovecimig and CTX-10726.
We track outsourced development, personnel costs and other research and development costs of specific programs. Research and development expenses are summarized by program in the table below (in thousands):
|
Three Months Ended June 30, |
||||||||
|
2025 |
2024 |
|||||||
|
(000’s) |
||||||||
|
Tovecimig |
$ | 8,112 | $ | 7,699 | ||||
|
CTX-471 |
2,854 | 1,312 | ||||||
|
CTX-8371 |
1,512 | 872 | ||||||
|
CTX-10726 |
2,133 | — | ||||||
|
Unallocated research and development expenses |
1,804 | 1,291 | ||||||
|
Total research and development expenses |
$ | 16,415 | $ | 11,174 | ||||
General and Administrative Expenses
General and administrative expenses were $4.7 million for the three months ended June 30, 2025 and 2024.
Other income
Other income decreased by $0.8 million or 40% for the three months ended June 30, 2025 as compared to the same period in 2024. Other income consisted exclusively of interest income, which decreased based on a lower cash and marketable securities balance.
Comparison of the Six Months Ended June 30, 2025 and 2024
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands):
|
Six Months Ended June 30, |
||||||||||||
|
2025 |
2024 |
Change |
||||||||||
|
(000’s) |
||||||||||||
|
Licensing Revenue |
$ | — | $ | 850 | $ | (850 | ) | |||||
|
Operating expenses: |
||||||||||||
|
Research and development |
29,476 | 20,695 | 8,781 | |||||||||
|
General and administrative |
9,556 | 7,969 | 1,587 | |||||||||
|
Total operating expenses |
39,032 | 28,664 | 10,368 | |||||||||
|
Loss from operations |
(39,032 | ) | (27,814 | ) | (11,218 | ) | ||||||
|
Other income |
2,518 | 3,951 | (1,433 | ) | ||||||||
|
Net loss |
$ | (36,514 | ) | $ | (23,863 | ) | $ | (12,651 | ) | |||
Licensing Revenue
There was no licensing revenue for the six months ended June 30, 2025. Licensing revenue was $850 thousand for the six months ended June 30, 2024. The licensing revenue consisted of a $1 million milestone payment from Elpiscience for completing a Phase 1 trial in China. This license revenue is reported net of a 15% sublicense royalty due ABL Bio (see footnote 11 of the financial statements in this Quarterly Report on Form 10-Q for further information on this sublicense agreement).
Research and Development Expenses
Research and development expenses increased by $8.8 million, or 42%, for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. Manufacturing expenses increased $8.2 million, primarily related to tovecimig and CTX-10726.
We track outsourced development, personnel costs and other research and development costs of specific programs. Research and development expenses are summarized by program in the table below (in thousands):
|
Six Months Ended June 30, |
||||||||
|
2025 |
2024 |
|||||||
|
(000’s) |
||||||||
|
Tovecimig |
$ | 15,045 | $ | 13,380 | ||||
|
CTX-471 |
4,759 | 2,455 | ||||||
|
CTX-8371 |
2,451 | 1,857 | ||||||
|
CTX-10726 |
3,410 | — | ||||||
|
Unallocated research and development expenses |
3,811 | 3,003 | ||||||
|
Total research and development expenses |
$ | 29,476 | $ | 20,695 | ||||
General and Administrative Expenses
General and administrative expenses increased $1.6 million, or 20% for the six months ended June 30, 2025 as compared to the same period in 2024. This increase primarily came from an increase of $1.6 million of share-based compensation expense.
Other income
Other income decreased by $1.4 million or 36% for the six months ended June 30, 2025 as compared to the same period in 2024. Other income consisted exclusively of interest income which decreased based on a lower cash and marketable securities balance.
Liquidity and Capital Resources
Since our inception, we have devoted substantially all of our efforts to organizing and staffing our Company, business planning, raising capital, research and development activities, building our intellectual property portfolio and providing general and administrative support for these operations. We have funded our operations primarily with proceeds from the sale of our equity securities. Through June 30, 2025, we have received $430 million in gross proceeds from the sale of equity securities. As of June 30, 2025, we had cash, cash equivalents and marketable securities of $101 million.
Cash Flows
The following table shows a summary of our cash flows for the periods indicated (in thousands):
|
Six Months Ended June 30, |
||||||||
|
2025 |
2024 |
|||||||
|
(000’s) |
||||||||
|
Cash used in operating activities |
$ | (25,040 | ) | $ | (24,642 | ) | ||
|
Cash provided by investing activities |
5,228 | 2,384 | ||||||
|
Cash provided by (used in) financing activities |
(815 | ) | 17,434 | |||||
|
Net change in cash and cash equivalents |
$ | (20,627 | ) | $ | (4,824 | ) | ||
Operating Activities
During the six months ended June 30, 2025, we used $25.0 million of cash in operating activities, resulting from our net loss of $36.5 million partially offset by the change in operating assets and liabilities of $5.5 million and non-cash charges of $5.9 million (primarily from share-based compensation expense of $5.3 million).
During the six months ended June 30, 2024, we used $24.6 million of cash in operating activities, resulting from our net loss of $23.9 million minus the change in operating assets and liabilities of $4.7 million, partially offset by non-cash charges of $3.9 million (primarily from share-based compensation expense of $4.1 million).
Investing Activities
During the six months ended June 30, 2025, $5.2 million of cash was provided by investing activities related to the net sale of marketable securities. During the six months ended June 30, 2024, $2.4 million of cash was provided by investing activities, related to the net sale of marketable securities.
Financing Activities
During the six months ended June 30, 2025, $0.8 million of cash was used in financing activities due to taxes paid by the company for settlement of RSU shares. During the six months ended June 30, 2024, $17.4 million of cash was provided by financing activities. This primarily included $17.6 million of net cash from sale of common stock under an ATM Agreement, after issuance costs.
Future Funding Requirements
We expect our expenses to increase substantially in connection with our ongoing activities. The timing and amount of our operating expenditures will depend largely on:
|
● |
the initiation, progress, timing, costs and results of clinical trials for our product candidates or any future product candidates we may develop; |
|
● |
the initiation, progress, timing, costs and results of nonclinical studies for our product candidates or any future product candidates we may develop; |
|
● |
our ability to maintain our relationships with key collaborators; |
|
● |
the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more nonclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously been agreed to; |
|
● |
the cost to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing any patents or other intellectual property rights; |
|
● |
the effect of competing technological and market developments; |
|
● |
the costs of continuing to grow our business, including hiring key personnel and maintain or acquiring operating space; |
|
● |
market acceptance of any approved product candidates, including product pricing, as well as product coverage and the adequacy of reimbursement by third-party payors; |
|
● |
the cost of acquiring, licensing or investing in additional businesses, products, product candidates and technologies; |
|
● |
the cost and timing of selecting and validating a manufacturing site for commercial-scale manufacturing; and |
|
● |
the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval and that we determine to commercialize. |
We believe that our existing cash, cash equivalents and marketable securities as of filing of this Quarterly Report on Form 10-Q will enable us to fund our operating expenses and capital expenditure requirements into 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Our current plans, which may change based on clinical or preclinical results, include studies for tovecimig, CTX-471, and CTX-8371 and IND enabling studies for CTX-10726. We expect that we will require additional funding to complete the clinical development of these programs including the payment of developmental milestones, commercializing our product candidates, if we receive regulatory approval, and pursuing in-licenses or acquisitions of other product candidates. If we receive regulatory approval for tovecimig, CTX-471, CTX-8371, CTX-10726 or other product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize these product candidates ourselves.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity and debt financings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interest may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specified actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not applicable since we are a smaller reporting company.
Item 4. Controls and Procedures.
Management’s Evaluation of Our Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer), evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of June 30, 2025. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2025, our Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer) concluded that, as of such date, our disclosure controls and procedures were effective.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, that occurred during the quarter ended June 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
As of the date of this Quarterly Report on Form 10-Q, we are not involved in any material legal proceedings. However, from time to time, we could be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless of the outcome, legal proceedings can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
In addition to the other information set forth in this report, you should carefully consider the risk factors discussed in Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which could materially affect our business, financial condition, or results of operations. There has been no material change in the risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, with the exception of the addition of the following risk factors:
Adverse global conditions, including economic uncertainty and tariffs, may negatively impact our financial results.
Global conditions, dislocations in the financial markets, or inflation could adversely impact our business. In addition, the global macroeconomic environment has been and may continue to be negatively affected by, among other things, instability in global economic markets, increased U.S. trade tariffs and trade disputes with other countries, instability in the global credit markets, supply chain weaknesses, instability in the geopolitical environment, political tensions, and foreign governmental debt concerns. Such challenges have caused, and may continue to cause, uncertainty and instability in local economies and in global financial markets, which may adversely affect our business.
Executive actions on drug pricing could negatively impact our ability to obtain adequate reimbursement for our products, if and when they are approved.
On April 15, 2025, the Trump Administration published Executive Order 14273, “Lowering Drug Prices by Once Again Putting Americans First,” which generally directs the federal government to take measures to reduce drug prices, including eliminating the so-called “pill penalty” under the Inflation Reduction Act that creates a distinction between small molecule and large molecule products for purposes of determining when a drug may be eligible for drug price negotiation. On May 12, 2025, the Trump Administration published Executive Order 14297, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” which generally, among other things, directs the federal government to establish and communicate most-favored-nation price targets to pharmaceutical manufacturers to bring prices for American patients in line with comparably developed nations. Further, the Executive Order directs the federal government to support regulatory paths to allow direct-to-patient sales for companies that meet these targets. It also states that the Administration will take additional aggressive action (for example, examining whether marketing approvals should be modified or rescinded or opening the door for individual drug importation waivers) should manufacturers fail to offer American consumers the most-favored-nation lowest price. It also directs the Secretary of Commerce and the U.S. Trade Representative to “take all necessary and appropriate action to ensure foreign countries are not engaged in any act, policy, or practice that may be unreasonable or discriminatory or that may impair United States national security . . . including by suppressing the price of pharmaceutical products below fair market value in foreign countries.” Notably, a similar “Most Favored Nation” pricing rule enacted under the first Trump Administration was subject to an injunction resulting from judicial challenges to the rule, which was formally rescinded by the former Biden Administration in August 2021. For more information, see the section titled, “Business - Government Regulation - Current and future healthcare reform legislation” in our Annual Report on Form 10-K.
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.
During the three-month period ended June 30, 2025, of our directors or officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934, as amended) adopted, terminated or modified a Rule 10b5-1 trading arrangement or any “non-Rule 10b5-1 trading agreement” (as defined in Item 408(c) of Regulation S-K).
|
Exhibit Number |
|
Description |
|
3.1 |
||
|
3.2 |
||
|
31.1* |
|
|
|
31.2* |
|
|
|
32.1** |
|
|
|
32.2** |
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|
|
101.INS |
|
Inline XBRL Instance Document – the instance document does not appear in Interactive Data File because its XBRL tags are embedded within the Inline XBRL Document |
|
101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
|
|
101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
|
|
101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
|
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101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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* |
Filed herewith. |
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** |
This exhibit is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall such exhibits be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act or the Exchange Act, except as otherwise stated in such filing. |
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Indicates a management contract or any compensatory plan, contract or arrangement. |
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Compass Therapeutics, Inc. |
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Date: August 11, 2025 |
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By: |
/s/ Thomas Schuetz |
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Thomas Schuetz |
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Principal Executive Officer |
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Date: August 11, 2025 |
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By: |
/s/ Barry Shin |
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Barry Shin Principal Financial Officer |
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Date: August 11, 2025 |
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By: |
/s/ Neil Lerner |
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Neil Lerner |
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Principal Accounting Officer |
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