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** |

Core Insights - Compass Therapeutics reported positive progress in its clinical trials, particularly achieving the primary endpoint in the COMPANION-002 trial for tovecimig in biliary tract cancer (BTC) [2][4][5] - The company has a strong financial position with $113 million in cash and marketable securities, providing a cash runway into 2027 [2][13] Clinical Development Updates - Tovecimig (DLL4 x VEGF-A bispecific antibody) achieved a 17.1% overall response rate (ORR) in the COMPANION-002 trial, significantly higher than the 5.3% ORR for paclitaxel alone [4][5] - The first patient has been dosed in an Investigator Sponsored Trial (IST) at The University of Texas MD Anderson Cancer Center for tovecimig in the first-line setting for BTC [2][4] - CTX-10726, a PD-1 x VEGF-A bispecific antibody, is on track for an IND filing expected in Q4 2025, with clinical data anticipated in 2026 [2][10] - CTX-8371, a PD-1 x PD-L1 bispecific antibody, has progressed to the fourth dosing cohort in a Phase 1 study, with data expected in the second half of 2025 [2][10] Financial Performance - The net loss for Q1 2025 was $16.6 million, or $0.12 per share, compared to a net loss of $10.8 million, or $0.08 per share, in Q1 2024 [9][18] - Research and Development (R&D) expenses increased by 37% to $13.1 million in Q1 2025, primarily due to additional spending on clinical trials [10][18] - General and Administrative (G&A) expenses rose by 51% to $4.9 million, largely due to increased personnel costs [12][18] Cash Position - As of March 31, 2025, the company had $113 million in cash and marketable securities, down from $127 million at the end of 2024, indicating a cash runway into 2027 [13][20]

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's scientific focus is on the interplay between angiogenesis, the immune system, and tumor growth, with a pipeline targeting critical biological pathways for effective anti-tumor responses [3] - Founded in 2014 and headquartered in Boston, Massachusetts, Compass Therapeutics aims to advance its product candidates through clinical development as standalone therapies and in combination with other proprietary antibodies [3] Upcoming Investor Events - Compass Therapeutics will participate in the Citizens Life Sciences Conference on May 8, 2025, at 1:30 PM ET in New York, NY [2] - The company will also attend the H.C. Wainwright 3rd Annual BioConnect Investor Conference at NASDAQ on May 20, 2025, at 11:30 AM ET, also in New York, NY [2] - Presentations from these events will be archived for 90 days on Compass's Events page [2]

Core Insights - Compass Therapeutics presented promising preclinical data on CTX-471, a CD137 agonist antibody, at the AACR Annual Meeting, indicating enhanced efficacy in models of immune checkpoint failure through simultaneous blockade of neo-angiogenesis [1][2][3] Company Overview - Compass Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing proprietary antibody-based therapeutics for oncology, with a scientific emphasis on the interplay between angiogenesis, the immune system, and tumor growth [10] Product Development - CTX-471 is currently in a Phase 1b clinical trial for patients with solid tumors that have progressed after at least three months on approved PD-1 or PD-L1 inhibitors, showing partial responses in melanoma, small cell lung cancer, and mesothelioma [5][6] - The combination of CTX-471 with tovecimig, an investigational bispecific antibody targeting DLL4 and VEGF-A, demonstrated significant anti-tumor activity in resistant murine models, suggesting potential clinical benefits for patients who have failed checkpoint inhibitors [6][9] Mechanism of Action - The combination therapy of CTX-471 and tovecimig enhances innate and adaptive anti-tumor immunity, leading to increased tumor cell killing and improved interferon signaling, which may provide therapeutic advantages in previously resistant cancer types [3][6] Clinical Trials - Tovecimig is being evaluated in the ongoing Phase 2/3 trial (COMPANION-002) in combination with paclitaxel for patients with advanced metastatic or recurrent biliary tract cancers, showing promise in heavily pre-treated patients resistant to anti-VEGF therapies [9]

Core Insights - Compass Therapeutics, Inc. presented promising preclinical data on CTX-471, a CD137 agonist antibody, at the AACR Annual Meeting, indicating enhanced efficacy in models of immune checkpoint failure through simultaneous blockade of neo-angiogenesis [1][2][3] Company Overview - Compass Therapeutics is a clinical-stage biopharmaceutical company focused on developing proprietary antibody-based therapeutics for oncology, with a scientific emphasis on the interplay between angiogenesis, the immune system, and tumor growth [10] Product Development - CTX-471 is currently in a Phase 1b clinical trial for patients with solid tumors that have progressed after at least three months on approved PD-1 or PD-L1 inhibitors, showing partial responses in melanoma, small cell lung cancer, and mesothelioma [5] - The combination of CTX-471 with tovecimig has demonstrated significant anti-tumor efficacy in murine models resistant to conventional immune checkpoint inhibitors, suggesting a potential therapeutic regimen for patients who have failed checkpoint inhibitors [7][9] Mechanism of Action - The combination therapy appears to enhance innate and adaptive anti-tumor immunity, including increased tumor cell killing and interferon signaling, which may provide clinical benefits for patients previously unresponsive to standard treatments [3][7] Ongoing Trials - The ongoing COMPANION-002 trial is evaluating the efficacy of tovecimig in combination with paclitaxel for patients with previously treated, unresectable advanced metastatic or recurrent biliary tract cancers [9]

Core Insights - Compass Therapeutics, Inc. has initiated an Investigator Sponsored Trial (IST) for tovecimig (CTX-009), a bispecific antibody targeting DLL4 and VEGF-A, in patients with biliary tract cancer (BTC) [1][2] - The trial is being conducted at The University of Texas MD Anderson Cancer Center and aims to evaluate the efficacy and safety of tovecimig in combination with standard first-line treatments [1][2] - The company has also reported that tovecimig met the primary endpoint in a separate Phase 2/3 study, with results for secondary endpoints expected in Q4 2025 [2] Company Overview - Compass Therapeutics is a clinical-stage biopharmaceutical company focused on developing antibody-based therapeutics for oncology [4] - The company aims to target critical biological pathways involved in tumor growth and immune response, with a pipeline designed to address multiple human diseases [4] - Founded in 2014 and headquartered in Boston, Massachusetts, Compass Therapeutics is advancing its product candidates through clinical development [4] Product Information - Tovecimig is designed to block DLL4 and VEGF-A signaling pathways, which are essential for angiogenesis and tumor vascularization [3] - Preclinical and early clinical data suggest that tovecimig has shown robust anti-tumor activity across various solid tumors, including cholangiocarcinoma and pancreatic cancer [3] - The ongoing COMPANION-002 trial is evaluating tovecimig in combination with paclitaxel for previously treated advanced metastatic BTC [3] Trial Details - The IST will involve approximately 50 patients with unresectable or metastatic BTC, assessing safety and tolerability alongside a standard regimen of gemcitabine, cisplatin, and durvalumab [2] - The primary objectives include evaluating 6-month progression-free survival and determining the maximum tolerated dose of tovecimig [2] - Secondary objectives will assess overall response rate, duration of response, progression-free survival, and overall survival [2]