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Caris Life Sciences, Inc.

CAI
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Business Summary

Caris Life Sciences, Inc. is a patient-centric, next-generation AI TechBio company and precision medicine pioneer focused on developing and commercializing innovative solutions to transform healthcare through comprehensive molecular information and AI/ML algorithms, primarily in oncology . The company's core business model revolves around generating revenue from its molecular profiling solutions and pharma research and development services . As of December 31, 2025, Caris has performed sequencing on over 1,000,000 cases, building what it believes to be one of the largest and most comprehensive multi-modal clinico-genomic datasets in oncology, including genomic data, clinical data, digitized slide images, and remnant tissue . This extensive dataset, combined with high-performance computing and AI/ML algorithms, is leveraged for signature identification, drug target discovery, and to develop advanced precision medicine diagnostic solutions across the cancer care continuum .

The company's product portfolio, currently focused on oncology, includes three main platforms: the MI Profile Platform, Caris Assure Platform, and Precision Whole Genome Platform . The MI Profile Platform offers whole exome sequencing (WES) and whole transcriptome sequencing (WTS) tissue-based molecular profiling solutions, including MI Cancer Seek, which is an FDA-approved companion diagnostic . Caris Assure Platform provides WES/WTS blood-based molecular profiling solutions . The Precision Whole Genome Platform includes whole genome sequencing (WGS) blood- and tissue-based profiling solutions, with assays like Caris Detect, Caris WGS MRD, and Caris ChromoSeq under development .

For the fiscal year ended December 31, 2025, Caris Life Sciences reported total revenue of $649.0 million , an increase from $550.0 million in 2024 . Cost of revenue for Molecular Profiling Services was $208.0 million in 2025, up from $178.0 million in 2024 . Cost of revenue for Pharma Research and Development Services was $12.0 million in 2025, compared to $10.0 million in 2024 . Gross profit for 2025 was $429.0 million , representing a gross margin of 66.1% . This compares to a gross profit of $362.0 million and a gross margin of 65.8% in 2024 . Operating expenses included selling and marketing expenses of $180.0 million , general and administrative expenses of $190.0 million , and research and development expenses of $120.0 million for 2025. The company reported an operating loss of $61.0 million in 2025 , an improvement from an operating loss of $105.0 million in 2024 . Net loss for 2025 was $68.1 million , significantly reduced from a net loss of $281.9 million in 2024 . Diluted EPS was -$0.24 for 2025, compared to -$1.09 for 2024 . As of December 31, 2025, cash and cash equivalents totaled $796.3 million , and short-term marketable securities were $2.3 million . Total debt outstanding under the 2023 Term Loan was approximately $400.0 million .

Year-over-year, total revenue increased by $99.0 million, or 18.0% . Molecular Profiling Services revenue grew from $464.0 million in 2024 to $547.0 million in 2025, an increase of 17.9% . Pharma Research and Development Services revenue increased from $86.0 million in 2024 to $102.0 million in 2025, a rise of 18.6% . The gross margin slightly expanded from 65.8% in 2024 to 66.1% in 2025 . The operating loss improved from $105.0 million in 2024 to $61.0 million in 2025 , and the net loss decreased from $281.9 million to $68.1 million . The company's accumulated deficit as of December 31, 2025, was $2.5 billion .

During 2025, Caris commercially launched MI Cancer Seek in January , which obtained FDA approval as a companion diagnostic and tumor profiling device in November 2024 . The company also initiated the broad commercial launch of Caris Assure for therapy selection in the first quarter of 2024 . Caris entered into an exclusive license arrangement with Washington University in St. Louis in October 2024 to develop Caris ChromoSeq for hematological cancers . Additionally, the company determined in 2025 to pursue whole genome sequencing for certain assays under development, including Caris Detect, Caris WGS MRD, and Caris ChromoSeq . An IPO was completed in June 2025 . The company also submitted data evaluating the effects of interfering substances and a study regarding formalin-fixed paraffin-embedded block and slide stability duration claims for MI Cancer Seek in early November 2025, as required by the FDA .

Business Outlook

Caris Life Sciences expects to drive continued adoption and use of its tissue-based profiling solutions and expand its blood-based profiling offerings into early detection, minimal residual disease (MRD), and monitoring . The company plans to utilize data from existing solutions to develop new solutions with additional revenue streams . A key component of the long-term business strategy is realizing the potential of blood-based solutions across disease states . The commercial launch of Caris Detect, a WGS-based multi-cancer early detection (MCED) assay, is expected in the first half of 2026, with a planned self-pay model at a price of $3,500 . The company is validating Caris Detect through the Achieve 1 study, an approximately 3,000-subject case-control study, and is actively enrolling approximately 25,000 subjects in Achieve 2, a subsequent study .

The company aims to leverage its platform to provide solutions to biopharma companies to advance personalized medicine and accelerate novel therapeutic development . This includes expanding and enriching its clinico-genomic datasets to drive breakthrough science and develop new solutions . Caris also plans to maximize market reach through its regulatory approval and reimbursement strategy . The company intends to capitalize on the ultimate potential of Caris Detect and its broader innovation platform in other chronic disease states beyond oncology, such as cardiology, neurology, and metabolic conditions .

Regarding margin trajectory and cost structure, the company expects to continue incurring significant expenses for the foreseeable future, including costs for R&D activities, scaling R&D infrastructure, expanding laboratory capacity, and building sales, marketing, and distribution infrastructure . The company also anticipates significant costs for clinical and regulatory initiatives, obtaining marketing authorization, and managing reimbursement .

In terms of capital allocation, Caris had $796.3 million in cash and cash equivalents and $2.3 million in short-term marketable securities as of December 31, 2025 . The company may consider raising additional capital in the future to expand its business, meet existing obligations, pursue acquisitions or strategic investments, or for other reasons . This includes funding development and marketing efforts for new or future solutions, expanding technologies into other cancer management and detection solutions for other chronic disease states, and acquiring or licensing existing and future technologies . The company's ability to incur additional indebtedness is currently restricted by the terms of its 2023 Term Loan Agreement, under which $400.0 million aggregate principal amount of debt was outstanding as of December 31, 2025 . The company does not intend to pay dividends for the foreseeable future .

Management has flagged several structural headwinds and execution risks. The commercial success of any solutions, including MI Profile and Caris Assure, depends on market acceptance, including by government and commercial payers . Obtaining coverage and adequate reimbursement is an unpredictable, challenging, time-consuming, and costly process, with no assurance of consistent coverage or adequate reimbursement . The company's early detection solution, Caris Detect, is not currently covered by Medicare, and while recent legislation creates an alternative pathway for FDA-approved MCED tests beginning in 2028, the reimbursement rate may not adequately cover costs . Caris does not currently plan to seek Medicare coverage for Caris Detect, which could impact its commercial adoption and ability to compete . The company is also developing capabilities for MRD tracking and treatment monitoring, but there is no assurance of successful studies, trials, FDA approval, or Medicare coverage .

Risk Factors

The precision medicine industry is highly competitive and subject to rapid change, with numerous companies offering or seeking to offer molecular profiling, early detection, MRD tracking, treatment monitoring, biopharma services, and genomic data and AI services, some of which may have substantially greater financial and other resources . The company has incurred significant losses since inception, with net losses of $68.1 million in 2025 and $281.9 million in 2024, and an accumulated deficit of $2.5 billion as of December 31, 2025, and may continue to incur losses . Commercial market acceptance of current or future solutions, including MI Cancer Seek, Caris Assure, and Caris Detect, is not assured and depends on factors like clinical utility, adoption by clinicians and biopharma companies, and payer coverage and reimbursement . Operational failures or technological issues in complex biochemical and bioinformatics processes, or fluctuations in external variables, may result in lower sensitivity and specificity rates or a higher number of failed tests . The company relies on a limited number of third-party suppliers, or in many cases sole suppliers, for next-generation sequencers, lab materials, reagents, and supplies, including Illumina as the sole supplier of NGS instruments and sequencing reagent kits, and disruptions could impair operations . The regulation of laboratory-developed tests (LDTs) in the United States remains uncertain, and changes could require the company to cease marketing LDT solutions or incur significant costs for FDA marketing authorization . Cybersecurity risks, including threats from various actors and evolving techniques, could compromise information technology systems or data, leading to operational disruption, data loss, regulatory investigations, litigation, fines, and reputational harm . The company is subject to government investigations, claims, audits, and litigation, such as a Civil Investigative Demand from the DOJ in March 2025 regarding compliance with Medicare's 14-day rule, which could result in substantial penalties, damages, or exclusion from federal healthcare programs . Failure to obtain and maintain intellectual property protection, or allegations of infringement, misappropriation, or violation of third-party intellectual property rights, could block sales of solutions, force royalty payments, or lead to expensive and time-consuming litigation . The company has substantial indebtedness, with approximately $400.0 million outstanding under the 2023 Term Loan as of December 31, 2025, which increases the risk of being unable to meet debt service requirements and limits financial flexibility .

Management Priorities

Management emphasizes a patient-centric ethos that has guided the company since its inception, aiming to combine vast molecular information with data-driven insights to realize precision medicine's potential and drive superior patient outcomes . The company's strategic priorities include driving the continued adoption and use of its tissue-based profiling and expanding blood-based profiling offerings into early detection, minimal residual disease (MRD), and monitoring . Management also highlights the plan to utilize data generated by existing solutions to develop new solutions with additional revenue and to leverage its platform to provide solutions to biopharma companies to advance personalized medicine and accelerate novel therapeutic development . A key focus is to continue expanding and enriching clinico-genomic datasets to drive breakthrough science and develop new solutions, while maximizing market reach through regulatory approval and reimbursement strategy . The company expects to launch Caris Detect, a WGS-based multi-cancer early detection assay, as an LDT in the first half of 2026, with a self-pay model at a price of $3,500 .

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 — Our Caris Molecular Intelligence Solutions — MI Profile—Our WES/WTS Tissue-Based Profiling Solutions
  7. [7] Item 1, Business — Our Caris Molecular Intelligence Solutions — Caris Assure—Our WES/WTS Blood-Based Solution
  8. [8] Item 1, Business — Our Caris Molecular Intelligence Solutions — Precision Whole Genome Platform—Our WGS Tissue- and Blood-Based Profiling Solutions
  9. [9] Item 7, MD&A — Consolidated Results
  10. [10] Item 7, MD&A — Consolidated Results
  11. [11] Item 7, MD&A — Consolidated Results
  12. [12] Item 7, MD&A — Consolidated Results
  13. [13] Item 7, MD&A — Consolidated Results
  14. [14] Item 7, MD&A — Consolidated Results
  15. [15] Item 7, MD&A — Consolidated Results
  16. [16] Item 7, MD&A — Consolidated Results
  17. [17] Item 7, MD&A — Consolidated Results
  18. [18] Item 7, MD&A — Consolidated Results
  19. [19] Item 7, MD&A — Consolidated Results
  20. [20] Item 7, MD&A — Consolidated Results
  21. [21] Item 7, MD&A — Consolidated Results
  22. [22] Item 7, MD&A — Consolidated Results
  23. [23] Item 7, MD&A — Consolidated Results
  24. [24] Item 7, MD&A — Liquidity and Capital Resources
  25. [25] Item 7, MD&A — Liquidity and Capital Resources
  26. [26] Item 1A, Risk Factors — Risks Related to Our Indebtedness
  27. [27] Item 7, MD&A — Consolidated Results
  28. [28] Item 7, MD&A — Consolidated Results
  29. [29] Item 7, MD&A — Consolidated Results
  30. [30] Item 7, MD&A — Consolidated Results
  31. [31] Item 7, MD&A — Consolidated Results
  32. [32] Item 7, MD&A — Consolidated Results
  33. [33] Item 1A, Risk Factors — We have incurred significant losses since inception, may incur losses in the future, and may not be able to generate sufficient revenue to achieve and maintain profitability.
  34. [34] Item 1, Business — Our Caris Molecular Intelligence Solutions — MI Profile—Our WES/WTS Tissue-Based Profiling Solutions
  35. [35] Item 1, Business — Our Caris Molecular Intelligence Solutions — MI Profile—Our WES/WTS Tissue-Based Profiling Solutions
  36. [36] Item 1A, Risk Factors — Our future success and growth will depend in part on market acceptance and commercial success of our MI Cancer Seek, Caris Assure, Caris Detect and other solutions. We may be unsuccessful in continuing the commercialization and growing the adoption of these solutions, which would adversely affect our business, financial condition, results of operations, and growth prospects.
  37. [37] Item 1, Business — Our Caris Molecular Intelligence Solutions — Precision Whole Genome Platform—Our WGS Tissue- and Blood-Based Profiling Solutions
  38. [38] Item 1, Business — Our Caris Molecular Intelligence Solutions — Precision Whole Genome Platform—Our WGS Tissue- and Blood-Based Profiling Solutions
  39. [39] Item 1A, Risk Factors — We have incurred significant losses since inception, may incur losses in the future, and may not be able to generate sufficient revenue to achieve and maintain profitability.
  40. [40] Item 1A, Risk Factors — Our solutions may not perform as expected, and the results of our validation studies or our clinical trials may not support the launch or use of certain of our solutions as planned and may not comply with the requirements, or be replicated in later trials required, for any necessary or desirable marketing authorizations. This could adversely affect our business, financial condition, results of operations, and growth prospects.
  41. [41] Item 1, Business — Our Strategies
  42. [42] Item 1, Business — Our Strategies
  43. [43] Item 1A, Risk Factors — Our future success and growth will depend in part on market acceptance and commercial success of our MI Cancer Seek, Caris Assure, Caris Detect and other solutions. We may be unsuccessful in continuing the commercialization and growing the adoption of these solutions, which would adversely affect our business, financial condition, results of operations, and growth prospects.
  44. [44] Item 1, Business — Our Caris Molecular Intelligence Solutions — Precision Whole Genome Platform—Our WGS Tissue- and Blood-Based Profiling Solutions
  45. [45] Item 1, Business — Our Caris Molecular Intelligence Solutions — Precision Whole Genome Platform—Our WGS Tissue- and Blood-Based Profiling Solutions
  46. [46] Item 1, Business — Our Strategies
  47. [47] Item 1, Business — Our Strategies
  48. [48] Item 1, Business — Our Strategies
  49. [49] Item 1, Business — Our Strategies
  50. [50] Item 1A, Risk Factors — We have incurred significant losses since inception, may incur losses in the future, and may not be able to generate sufficient revenue to achieve and maintain profitability.
  51. [51] Item 1A, Risk Factors — We have incurred significant losses since inception, may incur losses in the future, and may not be able to generate sufficient revenue to achieve and maintain profitability.
  52. [52] Item 1A, Risk Factors — If we seek and fail to obtain additional financing, we may be unable to execute on our business strategies and our growth prospects could be harmed.
  53. [53] Item 1A, Risk Factors — If we seek and fail to obtain additional financing, we may be unable to execute on our business strategies and our growth prospects could be harmed.
  54. [54] Item 1A, Risk Factors — If we seek and fail to obtain additional financing, we may be unable to execute on our business strategies and our growth prospects could be harmed.
  55. [55] Item 1A, Risk Factors — We have incurred substantial indebtedness, and we may not generate sufficient cash flow from operations to meet our debt service requirements, continue our operations, and pursue our growth strategy, and we may be unable to raise capital when needed or on acceptable terms.
  56. [56] Item 1A, Risk Factors — We do not intend to pay dividends for the foreseeable future, and our investors may never obtain a return on their investment.
  57. [57] Item 1A, Risk Factors — Our current or future solutions may not achieve or maintain sufficient commercial market acceptance.
  58. [58] Item 1A, Risk Factors — If our solutions, or solutions we develop in the future, do not receive coverage and/or adequate reimbursement from third-party payers, including government and commercial payers, our ability to expand access to our solutions beyond our existing sales channels, and thus our overall commercial success, will be limited.
  59. [59] Item 1A, Risk Factors — Molecular Signature Tests, MRD/Monitoring and Screening and Early Detection Intended Uses for Our Solutions
  60. [60] Item 1A, Risk Factors — Molecular Signature Tests, MRD/Monitoring and Screening and Early Detection Intended Uses for Our Solutions
  61. [61] Item 1A, Risk Factors — Molecular Signature Tests, MRD/Monitoring and Screening and Early Detection Intended Uses for Our Solutions
  62. [62] Item 1A, Risk Factors — Risks Related to Our Business and Industry — The precision medicine industry is highly competitive and subject to rapid change.
  63. [63] Item 1A, Risk Factors — Risks Related to Our Business and Industry — We have incurred significant losses since inception, may incur losses in the future, and may not be able to generate sufficient revenue to achieve and maintain profitability.
  64. [64] Item 1A, Risk Factors — Risks Related to Our Business and Industry — Our current or future solutions may not achieve or maintain sufficient commercial market acceptance.
  65. [65] Item 1A, Risk Factors — Risks Related to Our Business and Industry — Our solutions may not perform as expected, and the results of our validation studies or our clinical trials may not support the launch or use of certain of our solutions as planned and may not comply with the requirements, or be replicated in later trials required, for any necessary or desirable marketing authorizations. This could adversely affect our business, financial condition, results of operations, and growth prospects.
  66. [66] Item 1A, Risk Factors — Risks Related to Our Business and Industry — We rely on a limited number of third-party suppliers or, in many cases, sole suppliers, for some of our next-generation sequencers, lab materials, reagents, and supplies, and we may not be able to find replacements or immediately transition to alternative suppliers if necessary.
  67. [67] Item 1A, Risk Factors — Risks Related to Regulation and Legal Compliance — We have current solutions marketed as laboratory-developed tests (LDT) and plan to launch future solutions as LDTs. The regulation of LDT products in the United States remains subject to significant uncertainty, and if we fail to comply with any new or existing legal requirements with respect to our LDT solutions, our business, financial condition, and results of operations could be adversely affected.
  68. [68] Item 1A, Risk Factors — Risks Related to Our Business and Industry — If our information technology systems or those of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits, and other adverse consequences.
  69. [69] Item 1A, Risk Factors — Risks Related to Regulation and Legal Compliance — We have been, are currently, and in the future may be the subject of government investigations, claims, audits, whistleblower and payer audits, overpayment and recoupment efforts and other litigation in the course of our business that could adversely affect our business and financial results.
  70. [70] Item 1A, Risk Factors — Risks Related to Intellectual Property — If we are unable to obtain and maintain intellectual property protection for our technology, or if the scope of the intellectual property protection we obtain is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to our solutions, and our ability to successfully commercialize our solutions may be impaired.
  71. [71] Item 1A, Risk Factors — Risks Related to Our Indebtedness — We have incurred substantial indebtedness, and we may not generate sufficient cash flow from operations to meet our debt service requirements, continue our operations, and pursue our growth strategy, and we may be unable to raise capital when needed or on acceptable terms.
  72. [72] Item 1, Business — The Caris Advantage
  73. [73] Item 1, Business — Our Strategies
  74. [74] Item 1, Business — Our Strategies
  75. [75] Item 1, Business — Our Strategies
  76. [76] Item 1, Business — Our Caris Molecular Intelligence Solutions — Precision Whole Genome Platform—Our WGS Tissue- and Blood-Based Profiling Solutions

Analysis on 5/22/2026