PART I. FINANCIAL INFORMATION This section provides the unaudited condensed consolidated financial information, including financial statements and management's discussion and analysis, for Compass Therapeutics, Inc [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements and accompanying notes for Compass Therapeutics, Inc. and its subsidiaries [Condensed Consolidated Balance Sheets (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) This table provides a snapshot of the Company's financial position, detailing assets, liabilities, and stockholders' equity at specific dates | Metric | June 30, 2025 (unaudited) (in thousands) | December 31, 2024 (Note 1) (in thousands) | | :-------------------------------- | :--------------------------------------- | :-------------------------------------- | | **Assets** | | | | Cash and cash equivalents | $22,856 | $43,483 | | Marketable securities | $78,093 | $83,239 | | Total current assets | $106,195 | $132,751 | | Total assets | $116,698 | $140,403 | | **Liabilities** | | | | Accounts payable | $2,595 | $2,249 | | Accrued expenses | $10,992 | $6,287 | | Total current liabilities | $13,858 | $8,874 | | Total liabilities | $23,491 | $15,170 | | **Stockholders' Equity** | | | | Total stockholders' equity | $93,207 | $125,233 | | Total liabilities and stockholders' equity | $116,698 | $140,403 | [Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(Unaudited)) This statement outlines the Company's revenues, expenses, and net loss over specific reporting periods | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :----------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Licensing revenue | $— | $850 | $— | $850 | | Research and development expenses | $16,415 | $11,174 | $29,476 | $20,695 | | General and administrative expenses | $4,651 | $4,721 | $9,556 | $7,969 | | Total operating expenses | $21,066 | $15,895 | $39,032 | $28,664 | | Loss from operations | $(21,066) | $(15,045) | $(39,032) | $(27,814) | | Other income | $1,185 | $1,969 | $2,518 | $3,951 | | Net loss | $(19,881) | $(13,076) | $(36,514) | $(23,863) | | Net loss per share - basic and diluted | $(0.14) | $(0.10) | $(0.26) | $(0.17) | | Comprehensive loss | $(19,863) | $(13,077) | $(36,516) | $(23,991) | [Condensed Consolidated Statements of Stockholders' Equity (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Unaudited)) This statement details changes in the Company's equity accounts, including common stock, additional paid-in capital, and accumulated deficit Stockholders' Equity (in thousands) | Metric (in thousands) | Balance at Dec 31, 2024 | Balance at Mar 31, 2025 | Balance at Jun 30, 2025 | | :---------------------- | :---------------------- | :---------------------- | :---------------------- | | Common Stock | $14 | $14 | $14 | | Additional Paid-in Capital | $489,692 | $491,391 | $494,182 | | Accumulated Other Comprehensive (Loss) Income | $210 | $190 | $208 | | Accumulated Deficit | $(364,683) | $(381,316) | $(401,197) | | Total Stockholders' Equity | $125,233 | $110,279 | $93,207 | - Total stockholders' equity decreased from **$125.2 million** at December 31, 2024, to **$93.2 million** at June 30, 2025, primarily due to a net loss of **$36.5 million** for the six months ended June 30, 2025, partially offset by stock-based compensation[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities Cash Flow Summary (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(25,040) | $(24,642) | | Net cash provided by investing activities | $5,228 | $2,384 | | Net cash (used in) provided by financing activities | $(815) | $17,434 | | Net change in cash, cash equivalents and restricted cash | $(20,627) | $(4,824) | | Cash, cash equivalents and restricted cash at end of period | $23,424 | $19,404 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide additional information and explanations for the figures presented in the financial statements [1. Nature of Business and Basis of Presentation](index=8&type=section&id=1.%20Nature%20of%20Business%20and%20Basis%20of%20Presentation) This section describes the Company's core business as a clinical-stage biopharmaceutical company and its financial reporting basis - Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, with a scientific focus on the relationship between angiogenesis and the immune system[25](index=25&type=chunk) - The Company has funded operations primarily through equity securities sales, receiving **$430 million** in gross proceeds through June 30, 2025[29](index=29&type=chunk)[65](index=65&type=chunk) - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled **$101 million**, expected to fund operations into 2027[29](index=29&type=chunk)[67](index=67&type=chunk)[87](index=87&type=chunk) [2. Summary of Significant Accounting Policies](index=8&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the key accounting principles and methods used in preparing the financial statements - There have been no material changes to the significant accounting policies previously disclosed in the Company's Annual Report[30](index=30&type=chunk) [3. Fair Value Measurements](index=9&type=section&id=3.%20Fair%20Value%20Measurements) This section details the fair value hierarchy and measurements for the Company's financial assets and liabilities Fair Value of Assets (in thousands) | Asset Category | Fair Value as of June 30, 2025 (in thousands) | Fair Value as of December 31, 2024 (in thousands) | | :--------------- | :------------------------------------------ | :--------------------------------------------- | | Corporate bonds | $61,175 | $44,963 | | Commercial paper | $9,415 | $12,084 | | Certificates of deposit | $918 | $15,269 | | U.S. government treasuries | $2,734 | $4,399 | | Asset-backed securities | $3,851 | $6,524 | | Money market funds | $3,730 | $23,880 | | Total assets | $81,823 | $107,119 | [4. Marketable Securities](index=9&type=section&id=4.%20Marketable%20Securities) This section provides information on the Company's investments in marketable securities, including their fair values and maturities - The Company invests excess cash in high-credit quality securities to ensure safety, preservation of funds, and liquidity[32](index=32&type=chunk) Marketable Securities (in thousands) | Marketable Securities (in thousands) | Fair Value as of June 30, 2025 | Fair Value as of December 31, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Corporate bonds | $61,175 | $44,963 | | Commercial paper | $9,415 | $12,084 | | Certificates of deposit | $918 | $15,269 | | U.S. government treasuries | $2,734 | $4,399 | | Asset-backed securities | $3,851 | $6,524 | | Total assets | $78,093 | $83,239 | | Maturing in one year or less | $42,338 | $56,386 | | Maturing after one year through two years | $35,755 | $26,853 | [5. Property and Equipment](index=10&type=section&id=5.%20Property%20and%20Equipment) This section details the Company's property and equipment, net of accumulated depreciation Property and Equipment (in thousands) | Property and Equipment (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Equipment | $4,734 | $4,716 | | Leasehold improvements | $1,612 | $1,612 | | Software | $364 | $364 | | Furniture and fixtures | $22 | $22 | | Total property and equipment–at cost | $6,732 | $6,714 | | Less: Accumulated depreciation | $(6,601) | $(6,361) | | Property and equipment, net | $131 | $353 | - Net property and equipment decreased from **$353 thousand** at December 31, 2024, to **$131 thousand** at June 30, 2025, primarily due to accumulated depreciation[36](index=36&type=chunk) [6. Accrued Expenses](index=11&type=section&id=6.%20Accrued%20Expenses) This section provides a breakdown of the Company's accrued expenses, including project and compensation-related costs Accrued Expenses (in thousands) | Accrued Expenses (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------ | :------------ | :---------------- | | Project expenses | $8,604 | $2,873 | | Compensation and benefits | $2,004 | $2,793 | | Other | $384 | $621 | | Total accrued expenses | $10,992 | $6,287 | - Total accrued expenses increased by **$4.7 million** to **$10.99 million** at June 30, 2025, from **$6.29 million** at December 31, 2024, primarily due to an **$8.2 million** increase in accrued manufacturing expenses, including **$3.6 million** for CTX-10726 contractual obligations[37](index=37&type=chunk) [7. Commitments and Contingencies](index=11&type=section&id=7.%20Commitments%20and%20Contingencies) This section outlines the Company's contractual obligations, including operating leases and 401(k) matching contributions - The Company's operating lease for its corporate office and laboratory facility was modified effective September 27, 2024, extending the non-cancelable term through May 2031 and adding 10,724 square feet[41](index=41&type=chunk) - Right-of-use assets increased by **$9.9 million** due to the lease modification, totaling **$9.8 million** as of June 30, 2025[41](index=41&type=chunk) Undiscounted Lease Cash Flows (in thousands) | Undiscounted Lease Cash Flows (in thousands) | Amount | | :------------------------------------------- | :----- | | Remainder of 2025 | $382 | | Years ending December 31, 2026 | $1,588 | | Years ending December 31, 2027 | $2,204 | | Years ending December 31, 2028 | $2,249 | | Years ending December 31, 2029 | $2,294 | | Years ending December 31, 2030 | $2,356 | | Thereafter | $995 | | Total minimum lease payments | $12,068 | | Present value of future minimum lease payments | $9,904 | - The Company matches employee 401(k) contributions up to 6% of salary, with matching contributions of **$0.1 million** for each of the three months ended June 30, 2025 and 2024, and **$0.2 million** for each of the six months ended June 30, 2025 and 2024[44](index=44&type=chunk) [8. Stock-Based Compensation](index=12&type=section&id=8.%20Stock-Based%20Compensation) This section details the stock-based compensation expense recognized and the activity of stock options and restricted stock units Stock-Based Compensation Expense (in thousands) | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $857 | $458 | $1,664 | $1,382 | | General and administrative | $1,934 | $1,663 | $3,641 | $2,742 | | Total | $2,791 | $2,121 | $5,305 | $4,124 | - Total unrecognized stock-based compensation cost as of June 30, 2025, was **$24.8 million**[45](index=45&type=chunk) Stock Option Activity (2020 Plan) | Stock Option Activity (2020 Plan) | Outstanding at Dec 31, 2024 | Granted (6M ended Jun 30, 2025) | Outstanding at Jun 30, 2025 | | :-------------------------------- | :-------------------------- | :------------------------------ | :-------------------------- | | Number of Unvested Options (000's) | 14,062 | 4,482 | 18,544 | | Weighted Average Exercise Price | $2.83 | $3.61 | $3.02 | | Aggregate Intrinsic Value ($000's) | $579 | $2 | $7,064 | - As of June 30, 2025, the total unrecognized compensation cost related to outstanding options was **$19.5 million**, to be recognized over a weighted average period of 1.5 years[48](index=48&type=chunk) RSU Activity (2020 Plan) | RSU Activity (2020 Plan) | Unvested, Dec 31, 2024 | Vested (6M ended Jun 30, 2025) | Unvested, Jun 30, 2025 | | :----------------------- | :--------------------- | :------------------------------ | :--------------------- | | Shares (000's) | 3,766 | (823) | 2,943 | | Weighted Average Price Per Share | $2.41 | $2.48 | $2.39 | | Weighted Average Fair Value ($000's) | $9,076 | $(2,042) | $7,034 | - As of June 30, 2025, the remaining unrecognized compensation cost related to RSUs was **$5.3 million**, expected to be recognized over a weighted average period of 1.4 years[51](index=51&type=chunk) [9. Related Parties and Related-Party Transactions](index=14&type=section&id=9.%20Related%20Parties%20and%20Related-Party%20Transactions) This section confirms the absence of material related party transactions during the reporting periods - There were no material related party transactions during the six months ended June 30, 2025 and 2024[52](index=52&type=chunk) [10. Other Income](index=14&type=section&id=10.%20Other%20Income) This section reports the Company's other income, primarily consisting of interest income from marketable securities Other Income (Interest Income) (in thousands) | Other Income (Interest Income) (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Interest Income | $1,185 | $1,969 | $2,518 | $3,951 | - Other income, consisting exclusively of interest income, decreased by **40%** for the three months ended June 30, 2025, and by **36%** for the six months ended June 30, 2025, compared to the same periods in 2024, due to a lower cash and marketable securities balance[53](index=53&type=chunk)[81](index=81&type=chunk)[86](index=86&type=chunk) [11. License, Research and Collaboration Agreements](index=14&type=section&id=11.%20License,%20Research%20and%20Collaboration%20Agreements) This section describes the Company's key licensing and collaboration agreements, including potential milestone payments and royalties - The Company has an exclusive global license agreement with ABL Bio for tovecimig (ABL001), a bispecific antibody targeting DLL4 and VEGF-A, with potential milestone payments up to **$96 million** for development/regulatory and **$303 million** for commercial in oncology, plus tiered single-digit royalties[54](index=54&type=chunk) - The Company is eligible to receive royalty payments from ABL Bio for two bispecific antibodies previously licensed to Compass, following the termination of license agreements for preclinical assets in May 2021[55](index=55&type=chunk) - A collaboration agreement with Adimab, LLC includes provisions for single-digit royalties on future net sales for certain antibodies, including CTX-471, with future potential milestone payments of **$2.0 million** as of June 30, 2025[56](index=56&type=chunk) [12. Segment Information](index=15&type=section&id=12.%20Segment%20Information) This section clarifies that the Company operates as a single segment and provides a breakdown of research and development expenses by program - The Company operates in one segment focused on research and development of drug candidates[57](index=57&type=chunk) R&D Expenses by Program (in thousands) | R&D Expenses by Program (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Tovecimig | $7,749 | $6,413 | $14,426 | $10,911 | | CTX-471 | $1,760 | $828 | $2,459 | $1,507 | | CTX-8371 | $1,044 | $605 | $1,573 | $1,191 | | CTX-10726 | $1,736 | $— | $2,473 | $— | | Research and development (Total) | $16,415 | $11,174 | $29,476 | $20,695 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the Company's financial condition, operational results, and future funding requirements [Overview](index=16&type=section&id=Overview) This section introduces Compass Therapeutics as a clinical-stage biopharmaceutical company focused on oncology and its product pipeline - Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics targeting angiogenesis, the immune system, and tumor growth[59](index=59&type=chunk) - The pipeline includes three clinical product candidates: tovecimig (DLL4 x VEGF-A bispecific), CTX-471 (CD-137 agonistic antibody), CTX-8371 (PD-1 x PD-L1 bispecific), and CTX-10726 (PD-1 x VEGF-A bispecific) in IND-enabling studies[60](index=60&type=chunk) [Recent Developments](index=16&type=section&id=Recent%20Developments) This section highlights recent clinical trial updates and preclinical study results for the Company's key product candidates - Tovecimig (DLL4 x VEGF-A bispecific) Phase 2/3 study in advanced biliary tract cancer (BTC) shows a decreasing rate of overall survival (OS) events, suggesting a potential positive effect on OS[61](index=61&type=chunk) - The tovecimig study met its primary endpoint in April 2025, achieving a **17.1%** overall response rate (ORR) in combination with paclitaxel, compared to **5.3%** for paclitaxel alone (p=0.031)[62](index=62&type=chunk) - CTX-8371 (PD-1 x PD-L1 bispecific) Phase 1 data supports cohort expansion in non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC) based on two deep responses observed[63](index=63&type=chunk) - CTX-10726 (PD-1 x VEGF-A bispecific) demonstrated superiority in PD-1 potency and anti-tumor response compared to ivonescimab in preclinical studies; IND submission is planned for Q4 2025, with clinical data expected in 2026[64](index=64&type=chunk) [Operating Activities](index=17&type=section&id=OPERATING%20ACTIVITIES) This section discusses the Company's historical operating losses, accumulated deficit, and future funding needs - The Company has incurred significant operating losses since inception, with net losses of **$19.9 million** and **$13.1 million** for the three months ended June 30, 2025 and 2024, respectively[66](index=66&type=chunk) - Net losses for the six months ended June 30, 2025 and 2024 were **$36.5 million** and **$23.9 million**, respectively, leading to an accumulated deficit of **$401.2 million** as of June 30, 2025[66](index=66&type=chunk) - Substantial additional funding will be required to support continuing operations and growth strategy, expected to be financed through equity and debt financings, collaborations, or strategic transactions[67](index=67&type=chunk) [Components of Results of Operations](index=17&type=section&id=Components%20of%20Results%20of%20Operations) This section defines the primary components of the Company's financial results, including research and development, general and administrative expenses, and other income - Research and development expenses include clinical, manufacturing, employee-related, preclinical study, quality/regulatory compliance, and facilities/equipment costs, expensed as incurred[69](index=69&type=chunk)[70](index=70&type=chunk) - General and administrative expenses primarily cover salaries, legal fees, professional fees, administrative travel, and selling/marketing costs[74](index=74&type=chunk) - Other income consists exclusively of interest income on marketable securities[76](index=76&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) This section provides a detailed comparison of the Company's financial performance across different reporting periods [Comparison of the Three Months Ended June 30, 2025 and 2024](index=20&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares the Company's financial results for the three-month periods ended June 30, 2025 and 2024 Financial Performance (in thousands) | Metric (in thousands) | 2025 | 2024 | Change | | :-------------------- | :--- | :--- | :----- | | Licensing Revenue | $— | $850 | $(850) | | 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 decreased by **$850 thousand** to **$0** for the three months ended June 30, 2025, as the prior year included a **$1 million** milestone payment from Elpiscience (net of sublicense royalty)[78](index=78&type=chunk) - Research and development expenses increased by **$5.2 million** (**47%**) to **$16.4 million**, primarily due to a **$5.7 million** increase in manufacturing expenses related to tovecimig and CTX-10726[79](index=79&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=21&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares the Company's financial results for the six-month periods ended June 30, 2025 and 2024 Financial Performance (in thousands) | Metric (in thousands) | 2025 | 2024 | Change | | :-------------------- | :--- | :--- | :----- | | Licensing Revenue | $— | $850 | $(850) | | 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) | - Research and development expenses increased by **$8.8 million** (**42%**) to **$29.5 million**, driven by an **$8.2 million** increase in manufacturing expenses for tovecimig and CTX-10726[84](index=84&type=chunk) - General and administrative expenses increased by **$1.6 million** (**20%**) to **$9.6 million**, primarily due to a **$1.6 million** increase in share-based compensation expense[85](index=85&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the Company's current cash position, future funding needs, and sources of capital - As of June 30, 2025, the Company had **$101 million** in cash, cash equivalents, and marketable securities, which is expected to fund operating expenses and capital expenditure requirements into 2027[87](index=87&type=chunk)[94](index=94&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------- | :----------------------------- | :----------------------------- | | 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) | - Cash used in operating activities was **$25.0 million** for the six months ended June 30, 2025, primarily due to a net loss of **$36.5 million**, partially offset by non-cash charges and changes in operating assets and liabilities[89](index=89&type=chunk) - Cash provided by investing activities was **$5.2 million** for the six months ended June 30, 2025, related to the net sale of marketable securities[91](index=91&type=chunk) - Cash used in financing activities was **$0.8 million** for the six months ended June 30, 2025, due to taxes paid for RSU share settlements, compared to **$17.4 million** provided in the prior year from common stock issuance[92](index=92&type=chunk) - The Company anticipates requiring additional funding to complete clinical development, commercialize product candidates, and pursue in-licenses or acquisitions, with financing expected through equity/debt, collaborations, or strategic alliances[94](index=94&type=chunk)[95](index=95&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Compass Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The Company is exempt from providing quantitative and qualitative disclosures about market risk as it is a smaller reporting company[97](index=97&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the management's evaluation of the Company's disclosure controls and procedures and reports on any changes in internal control over financial reporting [Management's Evaluation of Our Disclosure Controls and Procedures](index=24&type=section&id=Management's%20Evaluation%20of%20Our%20Disclosure%20Controls%20and%20Procedures) This section confirms management's assessment of the effectiveness of the Company's disclosure controls and procedures - As of June 30, 2025, management, including the CEO and CFO, concluded that the Company's disclosure controls and procedures were effective[98](index=98&type=chunk) [Changes in Internal Control over Financial Reporting](index=24&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports on any material changes in the Company's internal control over financial reporting during the quarter - There were no material changes in internal control over financial reporting during the quarter ended June 30, 2025[99](index=99&type=chunk) PART II. OTHER INFORMATION This section includes additional information such as legal proceedings, risk factors, equity sales, and other required disclosures [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) This section states that the Company is not currently involved in any material legal proceedings, while acknowledging the potential for ordinary course legal activities - As of the filing date, the Company is not involved in any material legal proceedings, though it may be subject to various legal proceedings and claims in the ordinary course of business[102](index=102&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) This section highlights new risk factors related to adverse global conditions and executive actions on drug pricing, supplementing previously disclosed risks - New risk factors include potential negative impacts from adverse global conditions, such as economic uncertainty, tariffs, and geopolitical instability[104](index=104&type=chunk) - Executive actions on drug pricing, such as Executive Orders 14273 and 14297, could negatively impact the Company's ability to obtain adequate reimbursement for its products if approved[105](index=105&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section indicates that there were no unregistered sales of equity securities or use of proceeds to report during the period - There were no unregistered sales of equity securities or use of proceeds to report[107](index=107&type=chunk) [Item 3. Defaults Upon Senior Securities](index=26&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms that the Company has not defaulted on any senior securities - There were no defaults upon senior securities[108](index=108&type=chunk) [Item 4. Mine Safety Disclosures](index=26&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable to the Company - Mine safety disclosures are not applicable to the Company[109](index=109&type=chunk) [Item 5. Other Information](index=26&type=section&id=Item%205.%20Other%20Information) This section reports that no directors or officers adopted, terminated, or modified Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading agreements during the quarter - No directors or officers adopted, terminated, or modified Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading agreements during the three-month period ended June 30, 2025[110](index=110&type=chunk) [Item 6. Exhibits](index=26&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including corporate documents, certifications, and XBRL-related files - The exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, certifications of principal executive and financial officers (31.1, 31.2, 32.1, 32.2), and various Inline XBRL documents[111](index=111&type=chunk) [Signatures](index=28&type=section&id=Signatures) This section contains the required signatures of the Company's Principal Executive Officer, Principal Financial Officer, and Principal Accounting Officer, certifying the filing of the report - The report is signed by Thomas Schuetz (Principal Executive Officer), Barry Shin (Principal Financial Officer), and Neil Lerner (Principal Accounting Officer) on August 11, 2025[114](index=114&type=chunk)

[Corporate Update and Highlights](index=1&type=section&id=Compass%20Therapeutics%20Reports%202025%20Second%20Quarter%20Financial%20Results%20and%20Provides%20Corporate%20Update) Compass Therapeutics reported positive clinical trial updates for key pipeline candidates and maintained a strong cash position [CEO Statement and Overall Summary](index=1&type=section&id=CEO%20Statement%20and%20Overall%20Summary) Compass Therapeutics reported positive clinical trial updates for its key pipeline candidates, including tovecimig and CTX-8371, and ended the quarter with a strong cash position - The analysis for secondary endpoints (progression-free survival and overall survival) for the tovecimig Phase 2/3 trial is now guided for Q1 2026, delayed from original projections due to fewer deaths observed in the study[3](index=3&type=chunk) - The Phase 1 study of CTX-8371 (PD-1 x PD-L1 bispecific) has shown two deep and confirmed partial responses, prompting the initiation of expansion cohorts in non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC) in Q4 2025[4](index=4&type=chunk) - Preclinical data for CTX-10726 (PD-1 x VEGF bispecific) suggests superiority to a leading candidate, ivonescimab, with an IND submission planned for Q4 2025[4](index=4&type=chunk) - The company's balance sheet remains strong, ending Q2 with **$101 million** in cash and marketable securities, which is expected to fund operations into 2027[4](index=4&type=chunk)[6](index=6&type=chunk)[17](index=17&type=chunk) [Development Pipeline Updates](index=1&type=section&id=Development%20Pipeline%20Updates) The company provided updates on its clinical pipeline, detailing progress for key candidates and anticipated milestones [Tovecimig (DLL4 and VEGF-A bispecific antibody)](index=1&type=section&id=Tovecimig%20(DLL4%20and%20VEGF-A%20bispecific%20antibody)) The Phase 2/3 COMPANION-002 study in biliary tract cancer (BTC) successfully met its primary endpoint of overall response rate, with secondary endpoint analysis rescheduled to Q1 2026 - In April 2025, the randomized Phase 2/3 COMPANION-002 study met its primary endpoint, showing tovecimig plus paclitaxel significantly improved overall response rate compared to paclitaxel alone in BTC patients[5](index=5&type=chunk) - The analysis of secondary endpoints, including Overall Survival (OS) and Progression-Free Survival (PFS), is now expected in Q1 2026 because the pre-specified number of deaths (80% pooled mortality) has not yet been reached[3](index=3&type=chunk)[6](index=6&type=chunk)[11](index=11&type=chunk) - A Phase 2 basket study of tovecimig in a broader set of DLL4+ cancers (e.g., gastric, ovarian, renal) is expected to begin following the secondary endpoint data analysis from the COMPANION-002 trial[11](index=11&type=chunk) [CTX-8371 (PD-1 x PD-L1 bispecific antibody)](index=2&type=section&id=CTX-8371%20(PD-1%20x%20PD-L1%20bispecific%20antibody)) The Phase 1 dose-escalation study demonstrated significant anti-tumor activity, leading to planned expansion cohorts in NSCLC and TNBC in Q4 2025 - Two deep partial responses were observed in the first four dosing cohorts (n=12): a **100% reduction** in target lesions for an NSCLC patient and a **>90% reduction** for a TNBC patient[4](index=4&type=chunk)[6](index=6&type=chunk)[11](index=11&type=chunk) - Expansion cohorts focusing on NSCLC and TNBC are planned to initiate in Q4 2025[4](index=4&type=chunk)[11](index=11&type=chunk) - Detailed results from the Phase 1 dose-escalation study are expected to be reported at a medical meeting in Q4 2025, with data from the cohort expansion stage anticipated in 2026[11](index=11&type=chunk) [CTX-10726 (PD-1 x VEGF-A bispecific antibody)](index=2&type=section&id=CTX-10726%20(PD-1%20x%20VEGF-A%20bispecific%20antibody)) Preclinical data indicates CTX-10726 is superior to ivonescimab, with an Investigational New Drug (IND) application planned for Q4 2025 - Demonstrated superior tumor control and PD-1 inhibition compared to ivonescimab in head-to-head preclinical studies[4](index=4&type=chunk)[11](index=11&type=chunk) - An IND submission for CTX-10726 is expected in Q4 2025, with initial clinical data anticipated in 2026[6](index=6&type=chunk)[11](index=11&type=chunk) - CTX-10726 was discovered in-house and leverages Compass's expertise in bispecific antibody drug development, including manufacturing processes which are already at commercially viable yields[4](index=4&type=chunk) [CTX-471 (CD137 agonist antibody)](index=2&type=section&id=CTX-471%20(CD137%20agonist%20antibody)) Compass plans to initiate a Phase 2 trial for CTX-471, a CD137 agonist antibody, in the second half of 2025 - A Phase 2 trial of CTX-471 is expected to be initiated in the second half of 2025[11](index=11&type=chunk) - The trial will enroll patients with tumors expressing NCAM (CD56)[11](index=11&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) Compass Therapeutics reported increased net losses in Q2 and H1 2025 due to higher R&D expenses, with cash sufficient into 2027 [Second Quarter 2025 Financial Performance](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Performance) For the second quarter of 2025, Compass reported an increased net loss of **$19.9 million** ($0.14 per share), primarily driven by higher R&D expenses Net Loss Overview | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | **Net Loss** | $19.9M | $13.1M | $36.5M | $23.9M | | **Net Loss per Share** | $0.14 | $0.10 | $0.26 | $0.17 | [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Total operating expenses increased in Q2 and the first six months of 2025 compared to the prior year, driven by higher R&D costs [Research and Development (R&D) Expenses](index=3&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) R&D expenses rose by **47%** to **$16.4 million** in Q2 2025, primarily due to increased manufacturing costs for clinical trial materials R&D Expense Summary | Period | R&D Expense | Prior Year Period | % Change | | :--- | :--- | :--- | :--- | | Q2 2025 | $16.4M | $11.2M | +47% | | H1 2025 | $29.5M | $20.7M | +42% | - The increase was primarily attributable to additional manufacturing expenses for tovecimig and CTX-10726[13](index=13&type=chunk) [General and Administrative (G&A) Expenses](index=3&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) G&A expenses remained flat at **$4.7 million** for Q2 2025 but increased by **20%** for the first six months due to higher share-based compensation G&A Expense Summary | Period | G&A Expense | Prior Year Period | % Change | | :--- | :--- | :--- | :--- | | Q2 2025 | $4.7M | $4.7M | 0% | | H1 2025 | $9.6M | $8.0M | +20% | [Cash Position and Runway](index=3&type=section&id=Cash%20Position) As of June 30, 2025, Compass held **$101 million** in cash and marketable securities, expected to fund operations into 2027 Cash and Marketable Securities | Date | Cash & Marketable Securities | | :--- | :--- | | June 30, 2025 | $101.0M | | Dec 31, 2024 | $126.7M | - The current cash position provides an anticipated cash runway into 2027[4](index=4&type=chunk)[17](index=17&type=chunk) - During the first six months of 2025, **$25 million** of net cash was used in operating activities[17](index=17&type=chunk)

Core Viewpoint - Compass Therapeutics, Inc. reported its second quarter 2025 financial results and provided updates on its clinical and pre-clinical programs, highlighting progress in its oncology-focused pipeline and a strong cash position to support operations into 2027 [1][11][17]. Financial Performance - The net loss for Q2 2025 was $19.9 million, or $0.14 per share, compared to a net loss of $13.1 million, or $0.10 per share, for the same period in 2024, marking an increase in loss of approximately 51% [11][22]. - For the first six months of 2025, the net loss was $36.5 million, or $0.26 per share, compared to $23.9 million, or $0.17 per share, for the same period in 2024, reflecting a 53% increase in loss [11][22]. - As of June 30, 2025, the company had $101 million in cash and marketable securities, down from $127 million at the end of 2024, providing a cash runway into 2027 [17][24]. Clinical Development Updates - The Phase 2/3 trial of tovecimig met its primary endpoint, showing fewer deaths than initially projected, which may indicate a positive impact on overall survival [2][5][6]. - In the Phase 1 study of CTX-8371, two confirmed partial responses were observed, including a complete resolution of target lesions in a non-small cell lung cancer patient and over 90% reduction in a triple-negative breast cancer patient [3][5]. - CTX-10726 is on track for IND submission in Q4 2025, with initial preclinical data suggesting it may outperform ivonescimab in PD-1 inhibition and anti-tumor activity [3][12]. Research and Development Expenses - R&D expenses for Q2 2025 were $16.4 million, an increase of 47% from $11.2 million in Q2 2024, primarily due to additional manufacturing costs related to tovecimig and CTX-10726 [13]. - For the first half of 2025, R&D expenses totaled $29.5 million, up 42% from $20.7 million in the same period in 2024 [13]. General and Administrative Expenses - G&A expenses for Q2 2025 were $4.7 million, consistent with Q2 2024, while for the first half of 2025, G&A expenses increased by 20% to $9.6 million compared to $8.0 million in the same period in 2024, attributed to higher share-based compensation [14].

Company Overview - Compass Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on oncology, developing proprietary antibody-based therapeutics to treat various human diseases [3] - The company emphasizes the relationship between angiogenesis, the immune system, and tumor growth, aiming to create a robust pipeline of novel product candidates [3] - Founded in 2014 and headquartered in Boston, Massachusetts, Compass Therapeutics is advancing its product candidates through clinical development as standalone therapies and in combination with other proprietary antibodies [3] Upcoming Financial Results and Updates - Compass Therapeutics will release its financial results for the quarter ended June 30, 2025, and provide updates on the ongoing tovecimig Phase 2/3 study, clinical data for CTX-8371, and preclinical data for CTX-10726 on August 11, 2025, at 8:00 AM ET [1] - A webcast and conference call will be held to discuss these updates, with a replay available for 90 days on the company's Events page [2]

Tovecimig Clinical Trial Results (COMPANION-002 Study) - The COMPANION-002 study is a Phase 2/3 registrational-intent study in patients with BTC who have received one prior line of therapy[9] - In the Intent-to-Treat population, the Overall Response Rate (ORR) for Tovecimig + Paclitaxel was 17.1% (19 out of 111 patients) compared to 5.3% (3 out of 57 patients) for Paclitaxel alone, with a two-sided p-value of 0.031[12] - The Complete Response (CR) rate in the Tovecimig + Paclitaxel arm was 0.9% (1 out of 111 patients), while the Partial Response (PR) rate was 16.2% (18 out of 111 patients)[12] - Stable Disease (SD) was observed in 44.1% of patients (49 out of 111) in the Tovecimig + Paclitaxel arm compared to 33.3% (19 out of 57) in the Paclitaxel arm[12] - Progressive Disease (PD) was observed in 16.2% of patients (18 out of 111) in the Tovecimig + Paclitaxel arm compared to 42.1% (24 out of 57) in the Paclitaxel arm[12] Tovecimig Development and Potential - Tovecimig is a bispecific antibody targeting DLL4 and VEGF-A, designed to disrupt tumor vessel formation and angiogenesis[6, 7] - The company anticipates top-line Phase 2/3 data for PFS, OS, and DoR in Q4 2025[25] - Tovecimig has the potential to become a standard of care in 2L BTC, with PFS, OS and DoR data expected in Q4 2025[18] Market and Unmet Needs - There are significant unmet needs in current treatments for BTC, with approximately 85% of 2L patients having limited treatment options[19, 20] - Incidence of BTC is significant, with an estimated ~23,000 cases annually[22] - Projected ~100,000 incidence of liver and intrahepatic bile duct cancer by 2040[23]

Summary of Compass Therapeutics Conference Call Company Overview - **Company**: Compass Therapeutics (CMPX) - **Industry**: Biotechnology, specifically focused on monoclonal antibody discovery and development in oncology - **Location**: Boston, Massachusetts - **Current Pipeline**: Three drugs in clinical trials, including: - Tevesimig (DLL4 VEGF A bispecific antibody) - CT-471 (next-gen CD137 agonist antibody) - CT-172 (PD-1 PD-L1 bispecific antibody) - Upcoming: CT-10726 (VEGF PD-1 bispecific antibody) to enter the clinic later this year [4][5][6] Key Points and Arguments Tevesimig Clinical Trial - **Trial Design**: Randomized trial in advanced biliary tract cancer patients who have received one prior line of therapy, comparing Tevesimig plus Paclitaxel versus Paclitaxel alone [8] - **Primary Endpoint**: Overall response rate; key secondary endpoints include progression-free survival (PFS), overall survival (OS), and duration of response [9] - **Results**: - Combination arm response rate: 17.1% with a disease control rate above 60% - Control arm response rate: 5.3% with a disease control rate less than 40% - Statistically significant difference (P = 0.031) [10] - **Follow-up**: Median follow-up of 15 months; projections indicate mortality levels will not be reached until at least 19 months of follow-up [15] Regulatory and Future Plans - **FDA Interaction**: Plans to meet with the FDA post-PFS and OS data disclosure in Q4; aiming for full approval based on the current study [20][21] - **BLA Submission Timeline**: Anticipated in the first half of next year, with a potential launch in the second half of 2026 [25] - **Safety Profile**: Consistent with expectations; monitored by an independent data monitoring committee [27] Upcoming Data and Studies - **MD Anderson Study**: Investigator-sponsored study adding Tevesimig to frontline therapy; preliminary results expected by year-end [22] - **Biomarker Analysis**: Plans for retrospective analysis of DLL4 expression and genomic markers to inform future studies [30][32] PD-1 VEGF Bispecific Antibody - **Development Status**: IND filing planned for Q4; preclinical data suggests superior PD-1 blockade compared to competitors [41][48] - **Market Interest**: High interest in the bispecific space, with ongoing discussions regarding potential partnerships [50] Other Programs - **CT-471**: Focus on NCAM expressing tumors; plans for a basket study targeting neuroendocrine tumors and small cell lung cancer [61] - **Financial Position**: $113 million in cash at the end of Q1, providing runway into 2027 [64] Important but Overlooked Content - **Clinical Significance**: A hazard ratio less than 0.6 for OS and PFS would be considered clinically meaningful, with comparisons to existing therapies [19] - **Market Dynamics**: The competitive landscape for bispecific antibodies is rapidly evolving, with a focus on differentiation through unique epitopes and mechanisms of action [41][45] - **Investor Focus**: Key milestones include PFS and OS readouts, dose escalation study results, and IND filings, which are critical for future funding and partnerships [65]

Financial Data and Key Metrics Changes - The company reported a significant increase in the overall response rate for its lead drug, tevesimig, in the second line biliary tract cancer study, with a response rate of 17.1% compared to 5.3% for the control arm, indicating a more than tripling of the response rate [12][13] - The study also showed a statistically significant difference with a p-value of 0.031, highlighting the drug's efficacy [13] Business Line Data and Key Metrics Changes - The lead program, tevesimig, is a bispecific antibody targeting DLL4 and VEGF A, which has shown promising results in clinical trials [4][7] - The company is also advancing CTX-471, a monoclonal antibody agonist targeting CD137, which has shown a 28% response rate in a post-PD-1 patient population [22][23] Market Data and Key Metrics Changes - The company identified a significant unmet medical need in the second line biliary tract cancer market, where there are currently no labeled therapies for the majority of patients [11] - The basket study for tevesimig in DLL4 positive cancers is expected to explore a range of solid tumor indications, indicating a broad market opportunity [19] Company Strategy and Development Direction - The company aims to leverage its unique StitchMaps platform to develop next-generation antibody therapeutics, focusing on dual blockade strategies to enhance efficacy in oncology [3][7] - Future plans include a Phase II basket study for tevesimig and potential label expansion studies following its approval [19] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the upcoming readouts for progression-free survival and overall survival, indicating a positive outlook for tevesimig's clinical development [17] - The company is optimistic about the performance of the control arm in clinical trials, suggesting a potential treatment effect that could lead to fewer deaths than initially expected [17] Other Important Information - The company has fast track status for tevesimig, which could expedite its approval process, with potential approval in the second half of 2026 [19][32] - The company is also developing CTX-8371, a PD-1 PD-L1 bispecific antibody, which is currently in Phase I studies and is expected to present clinical data in the second half of the year [29] Q&A Session Summary Question: Can you provide an overview of tevesimig's clinical data? - The overall response rate for tevesimig plus paclitaxel was 17.1%, significantly higher than the 5.3% for paclitaxel alone, with a statistically significant p-value of 0.031 [12][13] Question: What is the rationale behind the DLL4 positive cancers basket study? - DLL4 notch signaling is involved in various malignancies, and the company aims to explore the efficacy of tevesimig in these cancers due to its demonstrated monotherapy activity [19] Question: What are the upcoming catalysts for the company? - Key upcoming catalysts include readouts from the tevesimig study, the initiation of several important clinical trials, and data from the CTX-471 basket study [34]

Summary of Compass Therapeutics Conference Call Company Overview - **Company**: Compass Therapeutics (CMPX) - **Location**: Boston - **Industry**: Monoclonal antibody discovery and development in oncology - **Pipeline**: Three drugs in clinical trials, with a fourth drug expected to submit for IND later this year [4][5][6] Key Programs and Developments - **Lead Program**: Tavessimig (formerly CTX009), a DLL4 VEGF A bispecific antibody - Achieved primary endpoint in a randomized study for advanced biliary tract cancer with an overall response rate of 17.1% compared to 5.3% for the control arm [4][13] - Statistically significant difference with p = 0.031 [13] - Ongoing analysis for progression-free survival (PFS) and overall survival (OS) expected later this year [14][19] - **Second Program**: Monoclonal antibody agonist of CD137 (referred to as "four seventy one") - Presented data showing responses in post-PD-1 patients, including a 28% response rate in melanoma [35][36] - Planning for an NCAM positive basket study to begin later this year [37] - **Third Program**: PD-1 PD-L1 bispecific antibody - Currently in dose escalation phase one, with no dose-limiting toxicities reported [41][42] - Expected to share phase one data at a scientific meeting in the second half of this year [42] - **Fourth Program**: VEGF PD-1 bispecific antibody - Pre-IND interaction with the FDA completed, aiming for IND submission in Q4 [49] Market Insights - **Market Size**: Estimated 23,000 patients with biliary tract cancer (BTC) in the U.S. annually, with about 15,000 expected to reach second-line therapy [30][31] - **Commercialization Strategy**: Compass is preparing to commercialize Tavessimig independently while exploring strategic partnerships [31] Competitive Landscape - No labeled second-line therapies for biliary tract cancer in the U.S., with existing treatments primarily being targeted therapies [32][33] Financials and Milestones - **Cash Position**: Approximately $113 million as of Q1, providing runway into 2027 [50] - **Key Milestones**: - PFS and OS readout from the randomized biliary tract cancer study expected in early Q4 [52] - Initiation of the basket study for "four seventy one" in April [55] - IND filing for the PD-1 VEGF bispecific expected in Q4 [55] Additional Considerations - Market reaction to the data has been mixed, with some investors expecting higher response rates [15][16] - The company emphasizes the importance of the full data set before considering accelerated approval discussions with the FDA [20][21] - The differentiation of their bispecific antibodies is highlighted, with claims of superior potency compared to competitors [47][48]

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q1 2025 financials show a net loss of $16.6 million, up from $10.8 million in Q1 2024, and decreased total assets [Condensed Consolidated Balance Sheets (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) Total assets decreased to $131.5 million by March 31, 2025, from $140.4 million, due to reduced cash and securities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $41,048 | $43,483 | | Marketable securities | $71,587 | $83,239 | | **Total Assets** | **$131,451** | **$140,403** | | Accrued expenses | $13,214 | $6,287 | | **Total Liabilities** | **$21,172** | **$15,170** | | **Total Stockholders' Equity** | **$110,279** | **$125,233** | [Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(Unaudited)) Q1 2025 net loss increased to $16.6 million from $10.8 million in Q1 2024, due to higher operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $13,054 | $9,522 | | General and administrative | $4,912 | $3,248 | | **Total operating expenses** | **$17,966** | **$12,770** | | Loss from operations | ($17,966) | ($12,770) | | Other income | $1,333 | $1,983 | | **Net loss** | **($16,633)** | **($10,787)** | | Net loss per share | ($0.12) | ($0.08) | [Condensed Consolidated Statements of Stockholders' Equity (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Unaudited)) Stockholders' equity decreased to $110.3 million from $125.2 million, primarily due to the $16.6 million net loss - The primary drivers for the change in stockholders' equity during the first quarter of 2025 were the net loss of **$16.6 million** and stock-based compensation of **$2.5 million**[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) Q1 2025 saw $13.2 million cash used in operations, $11.6 million from investing, leading to a $2.4 million net cash decrease Summary of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($13,208) | ($13,888) | | Net cash provided by (used in) investing activities | $11,588 | ($4,099) | | Net cash (used in) provided by financing activities | ($815) | $17,433 | | **Net change in cash and cash equivalents** | **($2,435)** | **($554)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's oncology focus, cash runway into Q1 2027, collaboration agreements, and stock compensation - The company is a clinical-stage, oncology-focused biopharmaceutical company developing antibody-based therapeutics, focusing on the relationship between angiogenesis and the immune system[21](index=21&type=chunk) - As of March 31, 2025, the company had **$113 million** in cash, cash equivalents, and marketable securities, which is expected to fund operations and capital expenditures into the **first quarter of 2027**[25](index=25&type=chunk) - Accrued project expenses increased significantly to **$11.4 million** as of March 31, 2025, from **$2.9 million** at year-end 2024, primarily due to **$10.4 million** in accrued manufacturing expenses for tovecimig[35](index=35&type=chunk) - Under the ABL Bio agreement for tovecimig, Compass may be required to pay up to **$96 million** in development/regulatory milestones and **$303 million** in commercial milestones for oncology indications[51](index=51&type=chunk) - As of March 31, 2025, the company has **$27.6 million** in remaining unrecognized stock-based compensation cost to be recognized in future periods[43](index=43&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses pipeline, tovecimig's Phase 2/3 success, Q1 2025 net loss of $16.6 million, and funding into Q1 2027 - The company's pipeline includes three clinical candidates (tovecimig, CTX-471, CTX-8371) and one in IND-enabling studies (CTX-10726)[57](index=57&type=chunk) - On April 1, 2025, the company announced that its lead candidate, tovecimig, met the primary endpoint in a Phase 2/3 study for biliary tract cancer (BTC), showing a statistically significant improvement in Overall Response Rate (ORR) of **17.1%** versus **5.3%** for paclitaxel alone (p=**0.031**)[58](index=58&type=chunk) - The company expects to report secondary endpoints for the tovecimig study, including PFS, OS, and DoR, in the **fourth quarter of 2025**[59](index=59&type=chunk) - With **$113 million** in cash, cash equivalents, and marketable securities as of March 31, 2025, the company expects to fund operations into the **first quarter of 2027**[63](index=63&type=chunk)[87](index=87&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Q1 2025 operating expenses increased by $5.2 million to $18.0 million, driven by higher R&D and G&A costs Comparison of Operations (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $13,054 | $9,522 | $3,532 | | General and administrative | $4,912 | $3,248 | $1,664 | | **Total operating expenses** | **$17,966** | **$12,770** | **$5,196** | | **Net loss** | **($16,633)** | **($10,787)** | **($5,846)** | - The **$3.5 million** increase in R&D expenses was primarily due to **$2.0 million** more in manufacturing expenses for tovecimig and **$1.3 million** for the new CTX-10726 program[75](index=75&type=chunk) R&D Expenses by Program (in thousands) | Program | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Tovecimig | $6,934 | $5,681 | | CTX-471 | $1,905 | $1,144 | | CTX-8371 | $940 | $985 | | CTX-10726 | $1,278 | $— | | Unallocated R&D | $1,997 | $1,712 | | **Total R&D Expenses** | **$13,054** | **$9,522** | - General and administrative expenses increased by **$1.7 million (51%)**, mainly from **$1.0 million** more in stock compensation expense and higher bonus expense[77](index=77&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company had $113 million in cash, with Q1 2025 operations using $13.2 million, funding into Q1 2027 - The company has funded operations primarily through the sale of equity securities, receiving **$430 million** in gross proceeds through March 31, 2025[80](index=80&type=chunk) Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Cash used in operating activities | ($13,208) | ($13,888) | | Cash provided by (used in) investing activities | $11,588 | ($4,099) | | Cash (used in) provided by financing activities | ($815) | $17,433 | - Future funding requirements are substantial and depend on factors like clinical trial progress, regulatory approvals, and commercialization costs. The company may need to raise additional funds, which could lead to dilution or restrictive covenants[86](index=86&type=chunk)[88](index=88&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - The company is a smaller reporting company and is not required to provide the information under this item[90](index=90&type=chunk) [Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[91](index=91&type=chunk) - No changes occurred in the internal control over financial reporting during the quarter ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, these controls[92](index=92&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) As of the filing date, the company is not involved in any material legal proceedings - The company is not currently involved in any material legal proceedings[95](index=95&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors, except for a new risk concerning potential adverse impact of U.S. tariff programs - A new risk factor has been added regarding recently announced U.S. tariff programs, which could lead to trade tensions and have a material adverse effect on global economic conditions and the company's operations[96](index=96&type=chunk)[97](index=97&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[99](index=99&type=chunk) [Defaults Upon Senior Securities](index=24&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[100](index=100&type=chunk) [Mine Safety Disclosures](index=24&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[101](index=101&type=chunk) [Other Information](index=24&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, terminated, or modified Rule 10b5-1 trading arrangements during Q1 2025 - No directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement during the three-month period ended March 31, 2025[102](index=102&type=chunk) [Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including corporate documents and officer certifications

[Corporate Update and Q1 2025 Highlights](index=1&type=section&id=Compass%20Therapeutics%20Reports%202025%20First%20Quarter%20Financial%20Results%20and%20Provides%20Corporate%20Update) [Key Achievements](index=1&type=section&id=Key%20Achievements) Compass Therapeutics achieved key clinical milestones for its pipeline candidates and maintained a strong **$113 million** cash position - Tovecimig met its primary endpoint in the Phase 2/3 COMPANION-002 study for patients with biliary tract cancer (BTC), reinforcing its potential to address a significant treatment gap[3](index=3&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - The company is advancing CTX-10726, a PD-1 x VEGF-A bispecific antibody, with an Investigational New Drug (IND) filing expected in Q4 2025 and clinical data anticipated in 2026[3](index=3&type=chunk)[5](index=5&type=chunk) - CTX-8371, a PD-1 x PD-L1 bispecific, has progressed to the fourth dosing cohort in its Phase 1 study, with data expected to be shared later in 2025[3](index=3&type=chunk)[11](index=11&type=chunk) - The company maintained a strong balance sheet, ending Q1 2025 with **$113 million** in cash and marketable securities, which is expected to fund operations into the first quarter of 2027[3](index=3&type=chunk)[5](index=5&type=chunk)[14](index=14&type=chunk) [Development Pipeline Updates](index=1&type=section&id=Development%20Pipeline%20Updates) [Tovecimig (DLL4 and VEGF-A bispecific antibody)](index=1&type=section&id=Tovecimig%20%28DLL4%20and%20VEGF-A%20bispecific%20antibody%29) Tovecimig demonstrated a statistically significant **17.1%** ORR in BTC, with secondary endpoint data and new trials planned for 2025 Overall Response Rate (ORR) in COMPANION-002 Study | Metric | Tovecimig + Paclitaxel | Paclitaxel Alone | p-value | | :--- | :--- | :--- | :--- | | Overall Response Rate (ORR) | 17.1% | 5.3% | 0.031 | | Progressive Disease (PD) Rate | 16.2% | 42.1% | N/A | - Analyses of secondary endpoints, including progression-free survival (PFS), overall survival (OS), and duration of response (DoR), are expected in Q4 2025[3](index=3&type=chunk)[11](index=11&type=chunk) - The first patient has been dosed in an Investigator Sponsored Trial (IST) at MD Anderson Cancer Center, evaluating tovecimig in the first-line setting for BTC[3](index=3&type=chunk)[5](index=5&type=chunk)[11](index=11&type=chunk) - A Phase 2 basket study of tovecimig is planned to replace the colorectal cancer study, targeting a broader set of DLL4+ cancers like gastric, ovarian, and renal[11](index=11&type=chunk) [CTX-10726 (PD-1 x VEGF-A bispecific antibody)](index=2&type=section&id=CTX-10726%20%28PD-1%20x%20VEGF-A%20bispecific%20antibody%29) CTX-10726, a tetravalent PD-1 x VEGF-A bispecific, is on track for Q4 2025 IND submission and 2026 clinical data - CTX-10726 is a tetravalent bispecific antibody engineered to synergistically block VEGF-A and inhibit PD-1, showing potent preclinical activity[11](index=11&type=chunk) - A pre-IND meeting with the FDA was successfully completed, with an IND submission expected in Q4 2025[5](index=5&type=chunk)[11](index=11&type=chunk) [CTX-471 (CD137 agonist antibody)](index=2&type=section&id=CTX-471%20%28CD137%20agonist%20antibody%29) CTX-471, a CD137 agonist, showed durable responses, leading to a planned Phase 2 trial in NCAM-expressing tumors in H2 2025 - CTX-471 is a CD137 agonist antibody that binds to a unique epitope of the 4-1BB co-stimulatory molecule[11](index=11&type=chunk) - A Phase 2 trial of CTX-471 is planned for the second half of 2025, focusing on patients with tumors expressing NCAM (CD56)[11](index=11&type=chunk) [CTX-8371 (PD-1 x PD-L1 bispecific antibody)](index=2&type=section&id=CTX-8371%20%28PD-1%20x%20PD-L1%20bispecific%20antibody%29) CTX-8371, a PD-1 x PD-L1 bispecific, is progressing in its Phase 1 study with no DLTs, and preliminary data expected in H2 2025 - CTX-8371 is a bispecific checkpoint inhibitor that simultaneously targets PD-1 and PD-L1, featuring a unique mechanism involving the cleavage of cell surface PD-1[11](index=11&type=chunk) - The Phase 1 dose-escalation study has advanced to the fourth dosing cohort with no dose-limiting toxicities (DLTs) observed. Preliminary data is anticipated in H2 2025[5](index=5&type=chunk)[11](index=11&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=Financial%20Results) [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) Compass Therapeutics reported a Q1 2025 net loss of **$16.6 million** (**$0.12** per share), an increase from **$10.8 million** in Q1 2024 Net Loss and Net Loss per Share | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Loss | $16.6 million | $10.8 million | | Net Loss per Share | $0.12 | $0.08 | [Expense Analysis](index=3&type=section&id=Expense%20Analysis) Operating expenses increased in Q1 2025, with R&D up **37%** to **$13.1 million** and G&A up **51%** to **$4.9 million** Operating Expenses | Expense Category | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expenses | $13.1 million | $9.5 million | +37% | | G&A Expenses | $4.9 million | $3.2 million | +51% | - The increase in R&D expenses was primarily due to **$2.5 million** in spending on manufacturing for tovecimig and CTX-10726, plus **$0.9 million** in personnel costs[12](index=12&type=chunk) - The increase in G&A expenses was mainly attributable to a **$1.3 million** rise in personnel costs, which included **$1.0 million** related to share-based compensation[13](index=13&type=chunk) [Cash Position](index=3&type=section&id=Cash%20Position) Compass Therapeutics held **$113 million** in cash as of March 31, 2025, a decrease from **$127 million** at year-end 2024, with a runway into Q1 2027 - Cash and marketable securities totaled **$113 million** as of March 31, 2025, compared to **$127 million** on December 31, 2024[14](index=14&type=chunk) - The company anticipates its current cash position will fund operations into the first quarter of 2027[5](index=5&type=chunk)[14](index=14&type=chunk) - Net cash used in operating activities during the first three months of 2025 was **$13 million**[14](index=14&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a Q1 2025 net loss of **$16.6 million** and an operating loss of **$18.0 million**, with net loss per share increasing to **$0.12** Condensed Consolidated Statements of Operations (In thousands, except per share data) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | (In thousands, except per share data) | **2025** | **2024** | | **Operating expenses:** | | | | Research and development | $13,054 | $9,522 | | General and administrative | $4,912 | $3,248 | | **Loss from operations** | **($17,966)** | **($12,770)** | | Other income | $1,333 | $1,983 | | **Net loss** | **($16,633)** | **($10,787)** | | **Net loss per share - basic and diluted** | **($0.12)** | **($0.08)** | [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$131.5 million** as of March 31, 2025, while total liabilities increased to **$21.2 million** and equity decreased to **$110.3 million** Condensed Consolidated Balance Sheets (In thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | (In thousands) | | | | **Assets** | | | | Cash and cash equivalents | $41,048 | $43,483 | | Marketable securities | $71,587 | $83,239 | | **Total current assets** | **$124,145** | **$132,751** | | **Total assets** | **$131,451** | **$140,403** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $14,900 | $8,874 | | **Total liabilities** | **$21,172** | **$15,170** | | **Total stockholders' equity** | **$110,279** | **$125,233** |