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Compass Therapeutics, Inc.

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Business Summary

Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company dedicated to developing proprietary antibody-based therapeutics for various human diseases, with a scientific emphasis on the interplay between angiogenesis, the immune system, and tumor growth. The company's business model revolves around advancing its pipeline of novel product candidates through clinical development and potential commercialization, both as standalone therapies and in combination with other drugs or proprietary pipeline antibodies. Revenue generation is currently not from product sales, but rather from licensing agreements and potential future product commercialization. The primary customer segments are patients with various cancers, with an initial focus on biliary tract cancer (BTC) and colorectal cancer (CRC), and a future interest in autoimmune diseases. The company also leverages its proprietary StitchMabs™ platform for discovery and development .

The company's pipeline includes four clinical product candidates. Tovecimig (formerly CTX-009) is a bispecific antibody targeting Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A), designed to turn productive angiogenesis into non-productive angiogenesis, leading to tumor shrinkage and apoptosis . CTX-471 is an agonistic antibody targeting CD-137 (4-1BB), a co-stimulatory receptor on activated T-cells and NK cells, aiming to become a next-generation immune-oncology treatment . CTX-8371 is a bispecific antibody targeting programmed cell death protein-1 (PD-1) and its ligand PD-L1, which are validated immune-oncology targets . Lastly, CTX-10726 is a novel, tetravalent bispecific antibody targeting PD-1 and VEGF-A, developed in-house .

Tovecimig is currently in a randomized Phase 2/3 trial in the United States for patients with biliary tract cancer (BTC) who have received one prior treatment regimen. The trial met its primary endpoint with an overall response rate (ORR) of 17.1% for tovecimig in combination with paclitaxel, including one complete response, compared to a 5.3% ORR for paclitaxel alone, a statistically significant difference with p=0.031 . In a Phase 2 monotherapy study for advanced, metastatic colorectal cancer (CRC), tovecimig demonstrated a 5% ORR (2 out of 40 patients) in heavily pre-treated patients, with a disease control rate (DCR) of 68% (27 out of 40), median progression-free survival (PFS) of 3.9 months, and median overall survival (OS) of 10.2 months .

CTX-471, an agonistic antibody targeting CD137, demonstrated monotherapy activity in its Phase 1 program in post-PD-1/PD-L1 patient populations across melanoma, small cell lung cancer (SCLC), and mesothelioma, including one complete response . The ORR in the subset of patients with advanced melanoma was 27% (3 of 11) . A potential biomarker of activity, neural cell adhesion molecule (NCAM or CD56), was identified, with data showing a correlation between NCAM levels in baseline tumor cell biopsies and disease control .

CTX-8371, a bispecific antibody targeting PD-1 and PD-L1, is in a first-in-human Phase 1 clinical trial. In the dose escalation portion, it demonstrated three confirmed responses out of 15 patients across non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and Hodgkin lymphoma (HL), with no dose-limiting toxicities observed . Preclinical studies showed CTX-8371 outperformed single PD-1 or PD-L1 inhibitors and their combinations in T-cell activation assays and tumor growth control in mouse xenografts .

CTX-10726, a PD-1 x VEGF-A bispecific antibody, received FDA clearance for its IND in Q1 2026 and initiated a Phase 1 dose escalation study . Preclinical studies indicated CTX-10726 exhibits several-fold more potent PD-1 blockade compared to other drugs in its class and demonstrated superior anti-tumor activity compared to benchmark biosimilar anti-VEGF or PD-1 antibodies in xenograft and syngeneic models .

For the fiscal year ended December 31, 2025, the company reported no licensing revenue , a net loss of $66.489 million , and a comprehensive loss of $66.419 million . Basic and diluted net loss per share was $0.42 . Research and development expenses increased to $55.969 million from $42.342 million in 2024 , while general and administrative expenses increased to $16.870 million from $15.133 million in 2024 . Total operating expenses were $72.839 million . The company had cash and cash equivalents of $30.643 million and marketable securities of $178.263 million , totaling $209 million in cash, cash equivalents, and marketable securities as of December 31, 2025 . Total liabilities were $22.797 million .

Year-over-year, licensing revenue decreased from $850 thousand in 2024 to $0 in 2025 . Research and development expenses increased by $13.627 million , primarily due to a $14.2 million increase in manufacturing expenses related to tovecimig and CTX-10726 . General and administrative expenses increased by $1.737 million , mainly due to approximately $0.7 million in commercialization expenses and $0.5 million in advisory fees . Net loss widened from $49.375 million in 2024 to $66.489 million in 2025 . Cash used in operating activities increased to $49.143 million in 2025 from $44.855 million in 2024 .

During 2025, the company completed an underwritten public offering on August 12, 2025, issuing 33,290,000 shares of common stock at $3.00 per share and pre-funded warrants for up to 6,710,000 shares at $2.9999 per warrant, with an exercise price of $0.0001 per share. The underwriters exercised their option to purchase an additional 6,000,000 shares. The company received aggregate net proceeds of $129.3 million after deducting underwriting discounts and commissions of $8.3 million and other offering costs of $0.4 million . In December 2025, the company terminated its Open Market Sale Agreement with Jefferies LLC and entered into a new Sales Agreement for its ATM offering with Leerink Partners LLC and Cantor Fitzgerald & Co .

Business Outlook

Management expects to report additional top-line data from the Phase 2/3 study of tovecimig in combination with paclitaxel in BTC patients in April 2026, including progression-free survival (PFS) and overall survival (OS) analyses, following the prespecified event threshold of 80% overall survival events being reached in Q1 2026 .

The company intends to expand the development of tovecimig beyond BTC to additional solid tumor indications with significant unmet need and a mechanistic rationale for using an angiogenic inhibitor, such as colorectal cancer (CRC), ovarian cancer, gastric cancer, renal cell carcinoma, and hepatocellular carcinoma . Following positive clinical data in later lines of therapy, the plan is to study tovecimig in earlier settings in all indications where data support it . Additionally, the company is developing a plan to study the combination of tovecimig with its novel bispecific checkpoint inhibitor, CTX-8371, and with other checkpoint inhibitors . A Phase 2 basket study of tovecimig in a broader set of patients with DLL4+ cancers, potentially including gastric, ovarian, renal, hepatocellular, and colorectal cancers, is expected to initiate mid-2026, following a comprehensive analysis of the complete data set from the COMPANION-002 BTC trial .

For CTX-471, a Phase 2 basket study in patients with NCAM+ tumors is expected to initiate in mid-2026, based on the results of the monotherapy and combination arms of the Phase 1 trial and the identification of NCAM as a potential biomarker of activity .

Regarding CTX-8371, cohort expansions are currently enrolling patients with triple-negative breast cancer (TNBC) (n=28) and non-small cell lung cancer (NSCLC) (n=28) in the post-checkpoint inhibitor setting, with an expansion cohort in patients with Hodgkin lymphoma (HL) (n=12) expected to begin shortly . Half of the patients in each tumor type will be dosed at 3.0 mg/kg and half at 10.0 mg/kg . Initial data from these cohort expansions, along with available data from the Phase 1 dose-escalation portion, are expected to be presented at a major medical conference in the first half of 2026 .

For CTX-10726, the Phase 1 dose escalation study, which received FDA IND clearance in Q1 2026, will be open for enrollment in Q1 2026 . This multi-center study will include four doses (0.3, 1.0, 3.0, and 10.0 mg/kg) in a 3+3 format and will enroll patients with locally advanced, unresectable or metastatic malignancies, including renal cell carcinoma, gastroesophageal cancer, hepatocellular carcinoma, and endometrial cancer, where standard of care therapies have failed . The company expects to accelerate the development of CTX-10726 by leveraging its experience with tovecimig (VEGF-A component) and CTX-8371 (PD-1 component) .

The company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances through clinical development, develops additional product candidates, and seeks regulatory approval . If marketing approval is obtained, significant commercialization expenses related to product manufacturing, marketing, sales, and distribution are anticipated . The company also expects general and administrative expenses to increase as it expands commercial operations and supports growing research and development efforts .

As of December 31, 2025, the company had $209 million in cash, cash equivalents, and marketable securities . Based on current research and development plans, these cash resources are expected to fund operating expenses and capital expenditure requirements into 2028 . The company will need additional funding to complete clinical development, commercialize products if approved, and pursue in-licenses or acquisitions . Future funding requirements will depend on factors such as the scope, timing, progress, and costs of discovery, preclinical development, and clinical trials; manufacturing costs; the extent of collaborations; intellectual property costs; and commercialization expenses .

Risk Factors

The company faces significant risks including a limited operating history, no products approved for commercial sale, and a history of significant losses, with an accumulated deficit of $431 million as of December 31, 2025 . Substantial additional financing will be required to pursue business objectives, and failure to obtain this capital could force delays or termination of product development and commercialization efforts . Clinical development is a lengthy, expensive, and unpredictable process, with positive results from preclinical studies and early-stage trials not being predictive of future outcomes . The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable, and failure to obtain approval would materially harm the business . Even if approved, product candidates may fail to achieve market acceptance by physicians, patients, and third-party payors . The successful commercialization depends on adequate coverage and reimbursement levels, and failure to obtain these could limit marketability and revenue generation . The company faces significant competition from larger, better-funded biotechnology and pharmaceutical companies, and its operating results will suffer if it fails to compete effectively . Intellectual property protection is crucial, and the inability to obtain and maintain broad patent protection, or challenges to existing patents, could allow competitors to commercialize similar products . Product liability lawsuits pose a risk, potentially leading to substantial liabilities and limiting commercialization . Cybersecurity incidents, data breaches, and disruptions to information technology systems could compromise sensitive information and expose the company to liability . New and evolving technologies, such as artificial intelligence, may present risks and challenges, including cybersecurity risks and increased compliance burdens from regulations like the EU's Artificial Intelligence Act . Changes in healthcare legislation, such as the Inflation Reduction Act of 2022 (IRA) and recent CMS proposals (GLOBE, GUARD, GENEROUS), could increase commercialization costs, impact pricing, and reduce demand for products .

Management Priorities

Management's message emphasizes the company's identity as a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, with a scientific focus on the relationship between angiogenesis, the immune system, and tumor growth . A key strategic priority is to advance product candidates through clinical development and commercialization, both as standalone therapies and in combination with proprietary pipeline antibodies, based on supportive clinical and nonclinical data . Another strategic priority involves selectively pursuing strategic partnerships with leading biopharmaceutical companies to accelerate preclinical and clinical development and commercialization in a capital-efficient manner, maximizing pipeline value . Management explicitly states that the company has incurred significant operating losses since inception and does not expect to generate revenue from product sales in the near future, if at all . They anticipate that existing cash, cash equivalents, and marketable securities of $209 million as of December 31, 2025, will fund operating expenses and capital expenditure requirements into 2028 .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 1, Business — Overview
  3. [3] Item 1, Business — Overview
  4. [4] Item 1, Business — Overview
  5. [5] Item 1, Business — Overview
  6. [6] Item 1, Business — Overview
  7. [7] Item 1, Business — Phase 2 Trial of Tovecimig in CRC – United States
  8. [8] Item 1, Business — CTX-471 (CD137 or 4-1BB agonist antibody)
  9. [9] Item 1, Business — Phase 1b
  10. [10] Item 1, Business — Biomarker discovery
  11. [11] Item 1, Business — Phase 1 and Development Plans for CTX-8371
  12. [12] Item 1, Business — Discovery and Preclinical Activity for CTX-8371
  13. [13] Item 1, Business — CTX-10726 (PD-1 x VEGF-A Bispecific Antibody)
  14. [14] Item 1, Business — Discovery and Preclinical Activity for CTX-10726
  15. [15] Item 7, MD&A — Licensing revenue
  16. [16] Item 7, MD&A — Net loss
  17. [17] Item 8, Consolidated Statements of Operations and Comprehensive Loss — Comprehensive loss
  18. [18] Item 7, MD&A — Net loss per share - basic and diluted
  19. [19] Item 7, MD&A — Research and development expenses
  20. [20] Item 7, MD&A — Research and development expenses
  21. [21] Item 7, MD&A — General and administrative expenses
  22. [22] Item 7, MD&A — General and administrative expenses
  23. [23] Item 7, MD&A — Total operating expenses
  24. [24] Item 8, Consolidated Balance Sheets — Cash and cash equivalents
  25. [25] Item 8, Consolidated Balance Sheets — Marketable securities
  26. [26] Item 7, MD&A — Financial Overview
  27. [27] Item 8, Consolidated Balance Sheets — Total liabilities
  28. [28] Item 7, MD&A — Licensing revenue
  29. [29] Item 7, MD&A — Research and development expenses
  30. [30] Item 7, MD&A — Research and development expenses
  31. [31] Item 7, MD&A — General and administrative expenses
  32. [32] Item 7, MD&A — General and administrative expenses
  33. [33] Item 7, MD&A — Net loss
  34. [34] Item 7, MD&A — Operating Activities
  35. [35] Item 7, MD&A — Underwritten Offering
  36. [36] Item 7, MD&A — At-The-Market (ATM) Offering
  37. [37] Item 1, Business — Phase 2/3 Trial of Tovecimig with Paclitaxel in BTC – United States
  38. [38] Item 1, Business — Beyond BTC, we intend to expand the development of tovecimig to additional solid tumor indications with significant unmet need and a mechanistic rationale for using an angiogenic inhibitor, such as colorectal cancer (“CRC”), ovarian cancer, gastric cancer, renal cell carcinoma, and hepatocellular carcinoma.
  39. [39] Item 1, Business — Following the generation of positive clinical data in later lines of therapy, we plan to study tovecimig in earlier settings in all indications where the data support it.
  40. [40] Item 1, Business — In addition, we are developing a plan to study the combination of tovecimig with our novel bispecific checkpoint inhibitor, CTX-8371, and with other checkpoint inhibitors.
  41. [41] Item 1, Business — Additional Development Plans for Tovecimig
  42. [42] Item 1, Business — Additional Development Plans for CTX-471
  43. [43] Item 1, Business — Phase 1 and Development Plans for CTX-8371
  44. [44] Item 1, Business — Phase 1 and Development Plans for CTX-8371
  45. [45] Item 1, Business — Phase 1 and Development Plans for CTX-8371
  46. [46] Item 1, Business — CTX-10726 (PD-1 x VEGF-A Bispecific Antibody)
  47. [47] Item 1, Business — CTX-10726 (PD-1 x VEGF-A Bispecific Antibody)
  48. [48] Item 1, Business — CTX-10726 (PD-1 x VEGF-A Bispecific Antibody)
  49. [49] Item 7, MD&A — Financial Overview
  50. [50] Item 7, MD&A — Financial Overview
  51. [51] Item 7, MD&A — General and administrative expenses
  52. [52] Item 7, MD&A — Liquidity and Capital Resources
  53. [53] Item 7, MD&A — Liquidity and Capital Resources
  54. [54] Item 7, MD&A — Future Funding Requirements
  55. [55] Item 7, MD&A — Funding Requirements
  56. [56] Item 1A, Risk Factors — Risks Related to Our Financial Position and Need for Additional Capital
  57. [57] Item 1A, Risk Factors — We will require substantial additional financing to pursue our business objectives, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations.
  58. [58] Item 1A, Risk Factors — Clinical development involves a lengthy and expensive process with uncertain outcomes. We may incur additional costs and experience delays in developing and commercializing or be unable to develop or commercialize our current and future product candidates.
  59. [59] Item 1A, Risk Factors — The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be materially harmed.
  60. [60] Item 1A, Risk Factors — Even if a current or future product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  61. [61] Item 1A, Risk Factors — The successful commercialization of our product candidates will depend in part on the extent to which third-party payors, including governmental authorities and private health insurers, provide coverage and adequate reimbursement levels, as well as implement pricing policies favorable for our product candidates. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
  62. [62] Item 1A, Risk Factors — We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  63. [63] Item 1A, Risk Factors — If we are unable to obtain and maintain patent protection for our product candidates, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our product candidates may be adversely affected.
  64. [64] Item 1A, Risk Factors — Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product candidates.
  65. [65] Item 1A, Risk Factors — We depend on our information technology systems, and any failure of these systems could harm our business. Cybersecurity incidents, data breaches, loss of data, and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business, results of operations and financial condition.
  66. [66] Item 1A, Risk Factors — Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  67. [67] Item 1A, Risk Factors — Enacted healthcare legislation, changes in healthcare law and implementation of regulations, as well as changes in healthcare policy, may increase the difficulty and cost for us to commercialize our product candidates, may impact our business in ways that we cannot currently predict, could affect the prices we may set, and could have a material adverse effect on our business and financial condition.
  68. [68] Item 7, MD&A — Overview
  69. [69] Item 1, Business — Our Strategy
  70. [70] Item 1, Business — Our Strategy
  71. [71] Item 7, MD&A — Financial Overview
  72. [72] Item 7, MD&A — Financial Overview

Analysis on 5/20/2026