Compass Therapeutics (CMPX) boosts cash runway as tovecimig wins FDA Orphan status
Compass Therapeutics (CMPX) reported a deeper quarterly loss while strengthening its balance sheet and advancing its lead cancer drug. For the three months ended March 31, 2026, net loss was $18.3 million versus $16.6 million a year earlier, driven mainly by higher general and administrative expenses of $6.9 million, including increased stock-based compensation, while research and development spending was relatively stable at $13.4 million.
Cash, cash equivalents and marketable securities totaled $195 million, and the company believes this will fund operations into 2028. In its oncology pipeline, tovecimig showed statistically significant improvement in overall response rate in second-line biliary tract cancer in a Phase 2/3 study and received FDA Orphan Drug Designation, and the company plans to meet with the FDA ahead of a potential BLA submission.
Positive
- Tovecimig clinical progress and Orphan status: The lead asset achieved a statistically significant overall response rate improvement in a Phase 2/3 biliary tract cancer study and received FDA Orphan Drug Designation, and the company plans to meet with the FDA ahead of a potential BLA submission.
- Strong cash runway: Cash, cash equivalents and marketable securities of $195 million as of March 31, 2026 are expected to fund operating expenses and capital expenditure requirements into 2028, reducing near-term financing pressure.
Negative
- None.
Insights
Tovecimig data and Orphan status are the key positives; finances look solid but loss-making.
Compass Therapeutics remains a clinical-stage company with no product revenue and a quarterly net loss of $18.3 million. Operating expenses reached $20.3 million, mainly research and development and higher stock-based compensation in general and administrative functions.
Importantly, tovecimig achieved a statistically significant overall response rate benefit in second-line biliary tract cancer and now has FDA Orphan Drug Designation. The company intends to discuss a potential BLA with the FDA, which, if successful, could move it toward its first commercial product.
On the balance sheet, cash, cash equivalents and marketable securities of $195 million are expected to fund operations into 2028. Actual impact will depend on regulatory interactions and future trial and commercialization costs disclosed in subsequent filings.
Key Figures
Key Terms
Orphan Drug Designation regulatory
biliary tract cancer medical
pre-funded warrants financial
at-the-market (“ATM”) offering financial
ASC 842, Leases financial
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
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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 _________________
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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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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
As of April 30, 2026, the registrant had
Table of Contents
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PART I. |
FINANCIAL INFORMATION |
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Item 1. |
Financial Statements (Unaudited) |
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Condensed Consolidated Balance Sheets (Unaudited) |
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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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Condensed Consolidated Statements of Cash Flows (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. |
Quantitative and Qualitative Disclosures About Market Risk |
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Item 4. |
Controls and Procedures |
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PART II. |
OTHER INFORMATION |
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Item 1. |
Legal Proceedings |
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Item 1A. |
Risk Factors |
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Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
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Item 3. |
Defaults Upon Senior Securities |
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Item 4. |
Mine Safety Disclosures |
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Item 5. |
Other Information |
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Item 6. |
Exhibits |
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PART I—FINANCIAL INFORMATION
Item 1. Financial Statements
Compass Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(In thousands, except par value)
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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 Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per share data)
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Three Months Ended |
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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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Balance at December 31, 2025 |
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Common stock issued upon exercise of options |
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Net loss |
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Balance at March 31, 2026 |
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Balance at December 31, 2024 |
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Stock-based awards, net of tax remittance |
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Net loss |
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Balance at March 31, 2025 |
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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)
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Cash flows from financing activities: |
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Proceeds from exercise of common stock |
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Taxes paid related to net shares settlement of RSUs |
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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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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. The Company’s scientific focus is on the relationship between angiogenesis and the immune system. The 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 components required for an effective anti-tumor response to cancer. These 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. The Company plans to advance its product candidates through clinical development as both standalone therapies and in combination with its 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 March 31, 2026 and its consolidated results of operations, comprehensive loss, changes in stockholders’ equity and cash flows for the three months ended March 31, 2026 and 2025. Operating results for the three months ended March 31, 2026 are not necessarily indicative of the results that may be expected for the year ending December 31, 2026.
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, 2025 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, 2025 (the “Annual Report”).
Liquidity
Since inception, the Company has devoted substantially all its efforts to organizing and staffing, business planning, raising capital, research and development activities, building intellectual property portfolio and providing general and administrative support for these operations. The Company has funded its operations with proceeds from the sale of equity securities and borrowing from debt arrangements. Through March 31, 2026, the Company has 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):
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Quoted Prices in |
Significant Other |
Significant |
Fair Value |
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Assets |
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Total assets |
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Fair Value Measurements as of December 31, 2025: |
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Significant Other |
Significant |
Fair Value |
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Assets |
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Commercial paper |
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Certificates of deposit |
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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 March 31, 2026 Using: |
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Unrealized |
Fair Value |
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Fair Value Measurements as of December 31, 2025 Using: |
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Fair Value |
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Total assets |
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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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March 31, |
December 31, |
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Equipment |
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Leasehold improvements |
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Software |
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Property and equipment, net |
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Depreciation and amortization expense for each of the three months ended March 31, 2026 and 2025 was $
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Accrued Expenses |
Accrued expenses consist of the following (in thousands):
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March 31, |
December 31, |
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Project expenses |
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Total accrued expenses |
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Project expenses includes $
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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.
The terms of the Company’s only corporate office and laboratory facility (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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Remainder of 2026 |
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Years ending December 31, |
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2027 |
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2028 |
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2029 |
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2030 |
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2031 |
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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 months ended March 31, 2026 and 2025 was classified in the condensed consolidated statement of operations as follows (in thousands):
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Three Months Ended March 31, |
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2026 |
2025 |
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Research and development |
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General and administrative |
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Total |
$ | $ | ||||||
As of March 31, 2026, 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 four years and have a contractual life of ten years from the date of grant.
2025 Inducement Plan
In December 2025, the Company’s board of directors adopted the Compass Therapeutics, Inc. 2025 Inducement Plan (the “Inducement Plan”). The maximum number of shares of Stock reserved and available for issuance under the Inducement Plan is four million shares. As of March 31, 2026, a total of two million options were granted as part of the Inducement Plan to two new officers as a material inducement for those officers to join the Company.
Stock Options:
The following table summarizes the stock option activity for the 2020 Plan and 2025 Inducement 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, 2025 |
$ | $ | ||||||||||||||
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Granted |
$ | |||||||||||||||
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Exercised |
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Forfeited/canceled |
$ | — | — | |||||||||||||
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Outstanding at March 31, 2026 |
$ | $ | ||||||||||||||
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Vested at March 31, 2026 |
$ | $ | ||||||||||||||
For the three months ended March 31, 2026, the weighted average grant date fair value for options granted was $
For the three months ended March 31, 2025, 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 three months ended March 31, 2026 and 2025 were as follows:
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Three Months Ended March 31, |
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2026 |
2025 |
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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 and 2025 Inducement Plan:
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Shares |
Weighted |
Weighted |
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Unvested, December 31, 2025 |
$ | $ | ||||||||||
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Granted |
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Vested |
( |
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Forfeited or canceled |
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Unvested, March 31, 2026 |
$ | $ | ||||||||||
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 March 31, 2026, the remaining unrecognized compensation cost related to RSUs to be recognized in future periods totaled $
|
9. |
Stockholders’ Equity |
2025 Underwritten Offering
On August 12, 2025, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC, Piper Sandler & Co., and Guggenheim Securities, LLC, as representatives (the “Representatives”) of the underwriters named therein (the “Underwriters”), pursuant to which the Company agreed to issue and sell an aggregate of (a)
The 2025 Pre-Funded Warrants were determined to be equity classified. Accordingly, proceeds from the offering were allocated to common stock, the 2025 Pre-Funded Warrants on a relative fair value basis and were recorded in stockholders’ equity. As of March 31, 2026, all of the 2025 Pre-Funded Warrants remain outstanding.
|
10. |
Basic and Diluted Net Loss Per Share |
Basic net loss per share has been computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock plus potentially dilutive securities outstanding during the period. Potential shares of common stock exercisable for little or no consideration are included in both basic and diluted weighted-average number of shares of common stock outstanding.
During the three months ended March 31, 2026, basic and diluted weighted-average number of shares outstanding were
The computation of diluted net loss per share for the three months ended March 31, 2026 excluded
|
Three Months Ended March 31, |
||||||||
|
2026 |
2025 |
|||||||
|
Stock options |
||||||||
|
Restricted stock units |
||||||||
|
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 no milestone payments made during the first quarter of 2026. As of March 31, 2026, 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, 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 (in thousands):
|
Three-Months Ended March 31, |
||||||||
|
2026 |
2025 |
|||||||
|
Personnel |
$ | $ | ||||||
|
General |
||||||||
|
Tovecimig |
||||||||
|
CTX-471 |
||||||||
|
CTX-8371 |
||||||||
|
CTX-10726 |
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Research and development |
||||||||
|
Personnel |
||||||||
|
General |
||||||||
|
General and administrative |
||||||||
|
Interest income |
||||||||
|
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 months ended March 31, 2026. 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, 2025, 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 to treat multiple human diseases. 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 components required for an effective anti-tumor response. These 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 four clinical product candidates. 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. CTX-10726 is a bispecific antibody targeting PD-1 and VEFG-A, also two validated immune-oncology targets. For a more detailed description, see our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
Recent Developments
Tovecimig results in Phase 2/3 Study in the Second Line Setting for Patients with BTC
In April 2025, we announced that the study met its primary endpoint of overall response rate (“ORR”). Tovecimig in combination with paclitaxel achieved a 17.1% ORR, including one complete response, compared to a 5.3% ORR for paclitaxel alone, in patients with biliary tract cancer (“BTC”) treated in the second-line setting. The difference in ORR between the two treatment arms, the primary endpoint of the study, was statistically significant (p=0.031), and all responses were assessed by blinded independent central radiology review.
In April 2026, we announced the following additional information related to the study:
|
● |
Progression-Free Survival (secondary endpoint): 4.7 months for tovecimig combination compared to 2.6 months for paclitaxel alone (HR=0.44, p<0.0001).. |
|
● |
Overall Survival (secondary endpoint): Analysis was confounded by high crossover from the control arm (n=31) and markedly prolonged survival of these crossover patients after receiving tovecimig. The OS of the patients randomized to the tovecimig combination arm (n=111), which does not include the OS of these crossover patients later treated with tovecimig, had a median of 8.9 months. |
|
● |
PFS Before / After Crossover (secondary endpoint): Patients treated with tovecimig after crossing from the control arm progressed after a median 3.5 months (PFS2) in the third line setting. These same 31 patients, when initially randomized to paclitaxel alone (PFS1), had progressed after a median of 1.9 months in the second line setting (HR=0.36, p=0.0016). |
|
● |
OS Crossover vs. Non-Crossover (post hoc subset analysis): In an analysis of OS in all patients initially randomized to the paclitaxel control arm (n=57), crossover patients who subsequently received tovecimig demonstrated a statistically significant improvement in median OS of 12.8 months compared to 6.1 months for non-crossover patients who received only paclitaxel (HR=0.54, p=0.04). |
|
● |
Pooled OS of All Patients Treated with Tovecimig (post hoc subset analysis): For all patients treated with tovecimig, including both crossover patients and patients initially randomized to the tovecimig combination arm (n=142), the pooled median OS was 9.8 months. The median OS for patients randomized to the paclitaxel alone who did not crossover (n=26) was 6.1 months. |
|
● |
Safety: Tovecimig was generally well tolerated and the safety profile was consistent with prior studies, with no new safety signals identified. |
We intend to meet with the U.S. Food and Drug Administration (“FDA”) to discuss these data in advance of a planned BLA submission.
Tovecimig received Orphan Drug Designation from the FDA in April 2026 for the treatment of patients with BTC. Orphan Drug Designation provides certain development incentives, including tax credits for qualified clinical testing, exemption from FDA user fees, and eligibility for seven years of market exclusivity upon approval.
OPERATING ACTIVITIES
We have funded our operations primarily with proceeds from the sale of our equity securities. Through March 31, 2026, we have received $568 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 therapies and any future product candidates. Our net losses were $18.3 million and $16.6 million for the three months ended March 31, 2026 and 2025, respectively. We had an accumulated deficit of $449.5 million on March 31, 2026. 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 March 31, 2026, we had $195 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 2028. 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.
At-The-Market (“ATM”) Offering
In the first quarter of 2025, there were no issuances of common stock through our Open Market Sale AgreementSM with Jefferies LLC (“Jefferies ATM Agreement”). In December 2025, we entered into a Sales Agreement for our ATM offering with Leerink Partners LLC and Cantor Fitzgerald & Co (the “2026 ATM Agreement”) and the prior Jefferies ATM Agreement was terminated. In the first quarter of 2026, we did not sell any shares of common stock under the 2026 ATM Agreement.
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 pre-clinical 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 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.
Interest Income
Interest income consists of interest income on marketable securities.
Results of Operations
Comparison of the Three Months Ended March 31, 2026 and 2025
The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025 (in thousands):
|
Three Months Ended March 31, |
||||||||||||
|
2026 |
2025 |
Change |
||||||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
$ | 13,390 | $ | 13,054 | $ | 336 | ||||||
|
General and administrative |
6,909 | 4,912 | 1,997 | |||||||||
|
Total operating expenses |
20,299 | 17,966 | 2,333 | |||||||||
|
Loss from operations |
(20,299 | ) | (17,966 | ) | (2,333 | ) | ||||||
|
Interest income |
1,982 | 1,333 | 649 | |||||||||
|
Net loss |
$ | (18,317 | ) | $ | (16,633 | ) | $ | (1,684 | ) | |||
Research and Development Expenses
Research and development expenses increased by $0.3 million, or 3%, for the three months ended March 31, 2026 compared to the three months ended March 31, 2025.
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 March 31, |
||||||||
|
2026 |
2025 |
|||||||
|
Tovecimig |
$ | 5,529 | $ | 6,934 | ||||
|
CTX-471 |
2,636 | 1,905 | ||||||
|
CTX-8371 |
1,251 | 940 | ||||||
|
CTX-10726 |
1,438 | 1,278 | ||||||
|
Unallocated research and development expenses |
2,536 | 1,997 | ||||||
|
Total research and development expenses |
$ | 13,390 | $ | 13,054 | ||||
General and Administrative Expenses
General and administrative expenses increased by $2.0 million or 41% for the three months ended March 31, 2026 as compared to the same period in 2025. The increase was due to a $2.0 million increase in stock-based compensation expense.
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 March 31, 2026, we have received $568 million in gross proceeds from the sale of equity securities. As of March 31, 2026, we had cash, cash equivalents and marketable securities of $195 million.
Cash Flows
The following table shows a summary of our cash flows for the periods indicated (in thousands):
|
Three Months Ended March 31, |
||||||||
|
2026 |
2025 |
|||||||
|
Cash used in operating activities |
$ | (17,269 | ) | $ | (13,208 | ) | ||
|
Cash provided by investing activities |
38,429 | 11,588 | ||||||
|
Cash provided by (used in) financing activities |
3,365 | (815 | ) | |||||
|
Net change in cash and cash equivalents |
$ | 24,525 | $ | (2,435 | ) | |||
Operating Activities
During the three months ended March 31, 2026, we used $17.3 million of cash in operating activities, resulting from our net loss of $18.3 million and the change in operating assets and liabilities of $4.2 million partially offset by non-cash charges of $5.2 million (primarily from share-based compensation expense of $5.1 million).
During the three months ended March 31, 2025, we used $13.2 million of cash in operating activities, resulting from our net loss of $16.6 million partially offset by the change in operating assets and liabilities of $0.5 million and non-cash charges of $2.9 million (primarily from share-based compensation expense of $2.5 million).
Investing Activities
During the three months ended March 31, 2026, $38.4 million of cash was provided by investing activities related to the net sales of marketable securities. During the three months ended March 31, 2025, $11.6 million of cash was used in investing activities related to the net sale of marketable securities.
Financing Activities
During the three months ended March 31, 2026, $3.9 million of cash was provided by financing activities due to the exercise of stock options, partially offset by $0.5 million of taxes paid by the Company for settlement of RSU shares. During the three months ended March 31, 2025, $0.8 million of cash was used in financing activities due to taxes paid by the Company for settlement of RSU shares.
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 2028. 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 pre-clinical results, include studies for tovecimig, CTX-471, CTX-8371 and 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.
Critical Accounting Estimates
Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States ("GAAP"). The preparation of our consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of revenue and expenses during the reporting period. We base our estimates on historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
During the three months ended December 31, 2026, there were no material changes to our critical accounting estimates described under "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in the Annual Report.
Recently Issued and Adopted Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations in disclosed in Note 2, “Summary of Significant Accounting Policies” to our condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Smaller Reporting Company Status
We are a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act. We may continue to be a smaller reporting company if either (i) the market value of our shares held by non-affiliates is less than $250 million as of the last business day of the most recently completed second fiscal quarter or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates was less than $700 million as of the last business day of the most recently completed second fiscal quarter. As a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and have reduced disclosure obligations regarding executive compensation, and if we are a smaller reporting company with less than $100 million in annual revenue, we would not be required to obtain an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
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 Exchange Act, as of March 31, 2026. 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 March 31, 2026, 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 March 31, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
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.
Item 1A. Risk 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, 2025, 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, 2025.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
During the three-month period ended March 31, 2026, none 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).
Item 6. Exhibits.
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Exhibit Number |
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Description |
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3.1 |
Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K filed with the SEC on June 23, 2020). |
|
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3.2 |
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.3 to the Current Report on Form 8-K filed with the SEC on June 23, 2020). |
|
| 4.1 | Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the SEC on August 13, 2025). | |
| 10.1# | Employment Agreement between Compass Therapeutics, Inc. and Arjun Prasad, dated January 1, 2026 (incorporated by reference to Exhibit 10.17 to the Annual Report on Form 10-K filed with the SEC on March 5, 2026. | |
| 10.2# | Employment Agreement between Compass Therapeutics, Inc. and Cynthia Sirard, dated January 1, 2026 (incorporated by reference to Exhibit 10.18 to the Annual Report on Form 10-K filed with the SEC on March 5, 2026. | |
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31.2* |
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Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
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. |
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101.INS |
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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 |
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101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
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101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
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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) |
|
* |
Filed herewith. |
|
** |
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. |
|
# |
Indicates a management contract or any compensatory plan, contract or arrangement. |
SIGNATURES
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: May 5, 2026 |
By: |
/s/ Thomas Schuetz |
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Thomas Schuetz |
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Principal Executive Officer |
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Date: May 5, 2026 |
By: |
/s/ Barry Shin |
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Barry Shin Principal Financial Officer |
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Date: May 5, 2026 |
By: |
/s/ Neil Lerner |
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Neil Lerner |
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Principal Accounting Officer |
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