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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-39696 COMPASS THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delawa ...

[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)

BOSTON, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, will release its financial results for the quarter ended June 30, 2025 and host a webcast and conference call to provide an update on the ongoing tovecimig Phase 2/3 study, clinical data for CTX-8371 and preclinical data for CTX-10726, on Monday, August 11, 2025, at 8:00 a.m. ET. Call Details: Date: Monday, Augus ...

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]

Compass Therapeutics (CMPX) 2025 Conference May 08, 2025 01:30 PM ET Speaker0 so we're gonna go ahead and get started on time. Again, welcome to the second day of the Citizens Life Science Conference. It's my pleasure to introduce the next presenting company which is Compass Therapeutics. Presenting for the company or having our discussion is Doctor. Tom Schutz, CEO of Compass. Welcome Tom, really appreciate your time. Speaker1 Thanks, Ren. Thanks for inviting us. Speaker0 So, you know, people in the audien ...

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** |