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Compass Therapeutics, Inc. (CMPX) Morgan Stanley 23rd Annual Global Healthcare Transcript
Seeking Alpha· 2025-09-10 06:06
Company Overview - Compass Therapeutics is a monoclonal antibody development and discovery company located in Boston, Massachusetts [2] - The company has three drugs currently in clinical trials, which include two bispecific antibodies and one monoclonal antibody [2] - A fourth drug is expected to have an Investigational New Drug (IND) application filed in the next quarter [2] Lead Program - The lead program of Compass Therapeutics is a DLL4 VEGF-A bispecific antibody named tovecimig [2] - Recent announcements regarding the lead program were made earlier this year [2]
Compass Therapeutics, Inc. (CMPX) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-09-10 06:06
Company Overview - Compass Therapeutics is a monoclonal antibody development and discovery company located in Boston, Massachusetts [2] - The company has three drugs currently in clinical trials, which include two bispecific antibodies and one monoclonal antibody [2] - A fourth drug is expected to have an Investigational New Drug (IND) application filed in the next quarter [2] Lead Program - The lead program of Compass Therapeutics is a DLL4 VEGF-A bispecific antibody named tovecimig [2] - Recent announcements regarding the development of tovecimig were made earlier this year [2]
Compass Therapeutics (NasdaqCM:CMPX) FY Conference Transcript
2025-09-09 22:37
Summary of Compass Therapeutics FY Conference Call Company Overview - **Company**: Compass Therapeutics - **Ticker**: NasdaqCM:CMPX - **Location**: Boston, Massachusetts - **Industry**: Monoclonal antibody development and discovery in oncology - **Pipeline**: Three drugs in clinical trials (two bispecific antibodies and one monoclonal antibody), with a fourth drug expected to file an IND in the next quarter [2][3] Key Pipeline Developments - **Tavecimab**: - Lead program, a DLL4-VEGF8 bispecific antibody - Achieved primary endpoint of overall response rate in a randomized trial - Notable results: 17.1% response rate in combination arm vs. 5.3% in control arm, statistically significant with a p-value of 0.031 [10][11] - Ongoing randomized trial of Tavecimab plus paclitaxel vs. paclitaxel alone in advanced biliary tract cancer [8] - Significant unmet medical need in biliary tract cancer, with no labeled second-line standard of care [9] - Expected data analysis for progression-free survival (PFS) and overall survival (OS) in Q1 2026 [10][12] - **Monoclonal Antibody 471**: - Next-generation CD137 agonist antibody - Presented data showing responses in difficult-to-treat patient populations, including melanoma and small cell lung cancer [3][4] - **PD1-PDL1 Bispecific Antibody (H371)**: - Early phase I study showing deep responses in patients with non-small cell lung cancer and triple-negative breast cancer [24][25] - Mechanism of action involves dual ligand and receptor blockade, significantly more potent than single agents [22] - **PD1-VEGF8 Bispecific Antibody (10726)**: - Expected IND filing in Q4 2025, with potential clinical data in 2026 [31] - Preclinical studies suggest it may outperform established therapies like Ivernizumab [30] Financial and Operational Highlights - **Recent Financing**: - Completed a $138 million upsized financing, extending cash runway into 2028 [36][37] - Funds will support multiple upcoming milestones, including data readouts and clinical trials for Tavecimab, H371, and 10726 [37] - **Manufacturing Capabilities**: - Developed bispecific manufacturing expertise, achieving commercial-ready yields [32][33] - Yields for bispecific antibodies are significantly higher than traditional monoclonal antibodies [33] Market Opportunity - **Biliary Tract Cancer**: - Approximately 25,000 new cases annually in the U.S., with a significant unmet need for second-line therapies [9][17] - Tavecimab positioned to become the second-line standard of care [9] - **Potential Expansion**: - Plans for a phase II basket study of Tavecimab in various DLL4-positive cancers, including colorectal and ovarian cancers [18][19] Investor Sentiment - **Key Points of Interest**: - Investors are particularly focused on the progress of Tavecimab and the unexpected positive outcomes from H371 [38] - The company is perceived as undervalued based on Tavecimab alone, with potential for increased valuation following positive data readouts [38] Conclusion - Compass Therapeutics is advancing a robust pipeline of innovative therapies targeting significant unmet needs in oncology, with promising early data and a strong financial position to support ongoing development and potential market entry.
Compass Therapeutics (NasdaqCM:CMPX) FY Conference Transcript
2025-09-08 16:02
Compass Therapeutics (NasdaqCM:CMPX) FY Conference September 08, 2025 11:00 AM ET Company ParticipantsSara Nik - VP & Equity Research - BiotechThomas Schuetz - Co-Founder, Director & CEOSara NikOkay, good morning everyone, and welcome to our next session. I'll be your moderator, Sarah Nick, an Equity Research VP at H. C. Wainwright. And it's my pleasure to introduce our next presenter, Thomas Schutz, CEO of Compass Therapeutics, a clinical stage oncology focused pharmaceutical biopharmaceutical company focu ...
Compass Therapeutics (CMPX) 2025 Conference Transcript
2025-09-03 19:10
Summary of Compass Therapeutics Conference Call Company Overview - **Company**: Compass Therapeutics (CMPX) - **Industry**: Biotechnology, specifically focused on monoclonal antibody discovery and development in oncology [2][3] Key Achievements and Milestones - **Current Pipeline**: Three drugs in clinical trials with a fourth IND submission expected later in 2025 [3] - **Lead Program**: Tivesamig, a DLL4 VEGF A bispecific antibody, has met primary endpoints in a randomized study for advanced biliary tract cancer [3] - **Survival Data**: Recent updates indicate fewer deaths than projected in the study, with overall survival (OS) and progression-free survival (PFS) data expected in Q1 2026 [3][17] - **Efficacy Signals**: Phase I study of PD-1 PD-L1 bispecific antibody (8,371) shows deep responses in patients with non-small cell lung cancer and triple-negative breast cancer [4] Regulatory and Approval Path - **Regulatory Benchmarks**: No specific benchmarks from the FDA; however, a hazard ratio of 0.6 is targeted for significant treatment effect [9][10] - **Approval Strategy**: Plans to seek full approval based on PFS and OS data, with no discussions for accelerated approval [11][12] - **Control Arm**: Paclitaxel was chosen as the control arm based on FDA guidance, as there is no standard of care for the patient population [18] Safety Profile - **Adverse Events**: Common adverse event is hypertension, similar to Avastin; independent data safety monitoring committee has not identified new safety signals [19][20] Commercial Opportunity - **Market Size**: Estimated 15,000 new patients annually in the U.S. for second-line biliary tract cancer, with a potential market exceeding $3 billion annually [25] - **Commercial Strategy**: Plans to commercialize the drug independently in the U.S. with a targeted sales force of around 50 people [28] Manufacturing and Readiness - **Manufacturing Yields**: Achieved fivefold higher production yields compared to traditional monoclonal antibodies, with cost of goods comparable to small molecules [30][31] Future Outlook - **2026 Goals**: Successful readout from the randomized trial of Tivesamig, FDA interaction, and potential license application; further development of PD-1 PD-L1 bispecific antibody and next-generation bispecific antibody [47][48] Competitive Landscape - **Market Dynamics**: Despite competition in the PD-1/PD-L1 space, there is room for better drugs, and the company aims to define niche indications for its products [36][39] Conclusion - **Financial Position**: Compass Therapeutics has a strong cash position of approximately $230 million, providing a runway into 2028 to support ongoing and future clinical programs [48]
Compass Therapeutics to Participate in Upcoming September Investor Events
Globenewswire· 2025-08-26 12:00
Company Overview - Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases [4] - The company focuses on the relationship between angiogenesis, the immune system, and tumor growth, aiming to create a robust pipeline of novel product candidates [4] - Founded in 2014 and headquartered in Boston, Massachusetts, Compass Therapeutics plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies [4] Upcoming Investor Events - Compass Therapeutics will participate in several investor events in September 2025, including: - Citi's 2025 Biopharma Back to School Conference on September 2, 2025, in Boston, MA [2] - Cantor Global Healthcare Conference on September 3, 2025, in New York, NY, at 2:10 PM ET [2] - H.C. Wainwright 27 Annual Global Investment Conference on September 8, 2025, in New York, NY, at 11 AM ET [2] - Morgan Stanley 23 Annual Global Healthcare Conference on September 9, 2025, in New York, NY, at 5:35 PM ET [3] - Webcast links for the Cantor and H.C. Wainwright conferences are provided for investor access [2][3]
Compass Therapeutics Announces Pricing of Upsized $120 Million Public Offering
Globenewswire· 2025-08-13 02:28
Group 1 - Compass Therapeutics, Inc. announced a public offering of 33,290,000 shares of common stock priced at $3.00 per share, along with pre-funded warrants for 6,710,000 shares priced at $2.9999 each, expecting gross proceeds of approximately $120 million [1][2] - The offering is expected to close on or about August 14, 2025, subject to customary closing conditions, with underwriters granted a 30-day option to purchase an additional 6,000,000 shares [1][2] - The net proceeds will be used for commercial readiness preparations, funding research and clinical development of product candidates, and general corporate purposes [2] Group 2 - Jefferies, Piper Sandler, and Guggenheim Securities are acting as joint active bookrunning managers for the offering, with additional firms serving as lead and co-managers [3] - A shelf registration statement for the securities was filed with the SEC on August 30, 2024, and declared effective on September 6, 2024, with a preliminary prospectus supplement already filed [4] Group 3 - Compass Therapeutics is a clinical-stage biopharmaceutical company focused on oncology, developing proprietary antibody-based therapeutics targeting multiple diseases [6] - The company’s scientific focus includes the relationship between angiogenesis, the immune system, and tumor growth, with a robust pipeline of product candidates designed to target critical biological pathways for effective anti-tumor responses [6]
Compass Therapeutics Announces Proposed Public Offering
GlobeNewswire News Room· 2025-08-12 20:01
Core Viewpoint - Compass Therapeutics, Inc. has announced a public offering of its common stock and pre-funded warrants to raise capital for commercial readiness, research, and clinical development of its product candidates [1][2]. Group 1: Offering Details - The public offering includes common stock and pre-funded warrants, with all shares being offered by Compass [1]. - Compass plans to grant underwriters a 30-day option to purchase additional shares under the same terms [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for initial preparations for commercial readiness, funding research and clinical development of product candidates, and general corporate purposes [2]. Group 3: Company Overview - Compass Therapeutics is a clinical-stage biopharmaceutical company focused on oncology, developing proprietary antibody-based therapeutics for multiple diseases [5]. - The company’s scientific focus includes the relationship between angiogenesis, the immune system, and tumor growth, with a robust pipeline targeting critical biological pathways for effective anti-tumor responses [5]. - Founded in 2014 and headquartered in Boston, Massachusetts, Compass aims to advance its product candidates through clinical development as standalone therapies and in combination with other proprietary antibodies [5].
Compass Therapeutics(CMPX) - 2025 Q2 - Earnings Call Transcript
2025-08-11 13:00
Financial Data and Key Metrics Changes - The company ended Q2 2025 with $101 million in cash, providing a runway into 2027 for executing on various programs [34] - The overall response rate for the lead program, Tivesimig, was reported at 17.1%, significantly higher than the control arm [9][10] Business Line Data and Key Metrics Changes - Tivesimig showed a tripling of the overall response rate compared to the control arm, with a p-value of 0.031 [9] - CTX-8371, the PD-1/PD-L1 bispecific antibody, reported two deep partial responses in early cohorts, indicating promising early efficacy [6][19] Market Data and Key Metrics Changes - The ongoing randomized trial for Tivesimig in patients with advanced biliary tract cancer has fewer total deaths than projected, suggesting better-than-expected survival outcomes [11][12] - The company plans to initiate cohort expansions for CTX-8371 in non-small cell lung cancer and triple-negative breast cancer later this year [33] Company Strategy and Development Direction - The company aims to file a license application for Tivesimig in 2026, following a robust interaction with the FDA [31][106] - Future studies will explore indications where both VEGF targeting and PD-1 targeting have shown effectiveness, such as renal cell and gastric cancer [79] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of Tivesimig to extend overall survival in patients, despite the current lower-than-expected mortality rate [40][14] - The company is focused on advancing its pipeline, with multiple milestones expected over the next six quarters [30][31] Other Important Information - The company has fast track designation for Tivesimig, which may lead to priority review upon filing [31] - Preclinical data for CTX-10,726 showed superior tumor control compared to leading drug candidates in its class [27][29] Q&A Session Summary Question: Is there a chance that decreased deaths in the study reflect performance due to drug crossover? - Management confirmed that about half of the patients in the control arm crossed over after progression, and statistical methods will adjust for this in the overall survival analysis [39][40] Question: Can you clarify the timeline for PFS analysis? - Management indicated that the 80% event threshold will not be reached until Q1 2026, and they expect to present a priority dataset at that time [48][50] Question: What is the status of the BLA submission process? - The company is on track with its CMC process and does not foresee it being a limiting factor for BLA submission [55] Question: How confident is the company in the demographics of the study? - Management stated that randomization was stratified by key prognostic variables, which should balance demographics across treatment arms [73] Question: What are the plans for the dose expansion cohorts for CTX-8371? - The company plans a small randomized study of approximately 50 patients to explore different doses in the expansion cohorts [102]
Compass Therapeutics(CMPX) - 2025 Q2 - Quarterly Report
2025-08-11 11:01
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)