Skip to main content

Caris Life Sciences, Inc.

For the period ended Sep 30, 2025. Filed Nov 5, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 5, 2025

CAI$25.23-3.1%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-12.

0002019410-25-000012

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-05.

0002019410-25-000028

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 172 previous paragraphs and 174 current paragraphs.

120 unchanged; 41 reworded; 12 added; 11 removed; 0 previous and 1 current paragraphs rearranged.

Tables are not compared: 20 previous and 20 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (12)

Current report

Total revenue was $216.8 million for the three months ended September 30, 2025, compared to $101.6 million for the three months ended September 30, 2024, an increase of $115.2 million, or 113.4%.

Current report

Molecular profiling services revenue increased to $207.6 million for the three months ended September 30, 2025, from $93.8 million for the three months ended September 30, 2024, an increase of $113.8 million, or 121.3%.

Current report

Interest income was $7.4 million for the three months ended September 30, 2025, compared to $1.7 million for the three months ended September 30, 2024, an increase of $5.6 million, or 322.0%. This increase was primarily due to a higher amount of cash earning interest in our bank accounts..

Current report

Interest expense was $13.5 million for the three months ended September 30, 2025, compared to $13.8 million for the three months ended September 30, 2024, a decrease of $0.3 million, or 2.1%. This decrease was primarily due to lower interest rate associated with the 2023 Term Loan.

Current report

Changes in fair value of financial instruments were $(2.1) million for the three months ended September 30, 2025, compared to $5.1 million for the three months ended September 30, 2024, a decrease of $7.2 million, or 140.6%.

Current report

Other income (expense), net was $(0.1) million for the three months ended September 30, 2025, compared to $0.0 million for the three months ended September 30, 2024, a decrease of $0.1 million, or 340.5%. This decrease was primarily due to changes in gains and losses from foreign exchange rate differences.

Current report

Comparison of the Nine Months Ended September 30, 2025 and 2024

Current report

Total revenue was $519.1 million for the nine months ended September 30, 2025, compared to $282.3 million for the nine months ended September 30, 2024, an increase of $236.8 million, or 83.9%.

Current report

Molecular profiling services revenue increased to $484.6 million for the nine months ended September 30, 2025, from $254.7 million for the nine months ended September 30, 2024, an increase of $229.9 million, or 90.3%.

Current report

Interest income was $9.5 million for the nine months ended September 30, 2025, compared to $6.2 million for the nine months ended September 30, 2024, an increase of $3.3 million, or 54.1%. This increase was primarily due to higher amounts of cash earning interest in our bank accounts.

Current report

Changes in fair value of financial instruments were $(52.3) million for the nine months ended September 30, 2025, compared to $6.1 million for the nine months ended September 30, 2024, a decrease of $58.4 million, or 961.8%.
Removed paragraphs (11)

Previous report

Total revenue was $181.4 million for the three months ended June 30, 2025, compared to $100.0 million for the three months ended June 30, 2024, an increase of $81.3 million, or 81.3%.

Previous report

Molecular profiling services revenue increased to $162.9 million for the three months ended June 30, 2025, from $87.7 million for the three months ended June 30, 2024, an increase of $75.3 million, or 85.9%.

Previous report

Interest income was $1.6 million for the three months ended June 30, 2025, compared to $2.6 million for the three months ended June 30, 2024, a decrease of $1.0 million, or 38.7%. This decrease was primarily due to reduced interest rates.

Previous report

Interest expense was $19.2 million for the three months ended June 30, 2025, compared to $13.7 million for the three months ended June 30, 2024, an increase of $5.5 million, or 40.5%. This increase was primarily due to increased amortization of debt discount associated with the 2025 Convertible Notes.

Previous report

Changes in fair value of financial instruments was $(17.9) million for the three months ended June 30, 2025, compared to $12.0 million for the three months ended June 30, 2024, a decrease of $29.9 million, or 248.9%. This decrease is mainly driven by the increase in warrant and derivative fair values associated with the IPO that occurred during the three months ended June 30, 2025.

Previous report

Other expense, net was $18.3 million for the three months ended June 30, 2025, compared to $0.1 million for the three months ended June 30, 2024, an increase of $18.2 million, or 12,897.9%. This increase was primarily due to the debt extinguishment expense of the 2025 Convertible Note recorded of $17.9 million upon the IPO, incurred during the three months ended June 30, 2025.

Previous report

Total revenue was $302.3 million for the six months ended June 30, 2025, compared to $180.7 million for the six months ended June 30, 2024, an increase of $121.6 million, or 67.3%.

Previous report

Molecular profiling services revenue increased to $277.0 million for the six months ended June 30, 2025, from $160.9 million for the six months ended June 30, 2024, an increase of $116.1 million, or 72.2%.

Previous report

Interest income was $2.1 million for the six months ended June 30, 2025, compared to $4.4 million for the six months ended June 30, 2024, a decrease of $2.3 million, or 51.9%. This decrease was primarily due to reduced investments in marketable securities.

Previous report

Changes in fair value of financial instruments was $(50.2) million for the six months ended June 30, 2025, compared to $0.9 million for the six months ended June 30, 2024, a decrease of $51.1 million, or 5,464.4%. This decrease is mainly driven by the increase in warrant and derivative fair values during the six months ended June 30, 2025.
Reworded paragraphs (41)

Previous wording

We founded Caris in 2008 with the belief and vision that combining a vast set of consistently generated molecular information with robust data-driven insights could realize the potential of precision medicine for patients. We have spent the last 17 years developing and building our portfolio of comprehensive, proprietary molecular profiling solutions and generating what we believe to be one of the largest and most comprehensive multi-modal clinico-genomic datasets in oncology based on the more than 6.5 million tests we have run on over 849,000 cases, which have generated measurements of over 38 billion molecular markers. Our platform is purpose-built to leverage the convergence of next-generation sequencing (“NGS”), artificial intelligence (“AI”) and machine learning (“ML”) technologies, and high-performance computing. The power of our differentiated Caris platform has enabled us to develop the latest generation of advanced precision medicine diagnostic solutions designed to address the entire cancer care continuum, including early detection, minimal residual disease (“MRD”) tracking, therapy selection, and treatment monitoring, as well as to create molecular signatures and discover and develop novel precision medicine therapeutics.

Current wording

We founded Caris in 2008 with the belief and vision that combining a vast set of consistently generated molecular information with robust data-driven insights could realize the potential of precision medicine for patients. We have spent the last 17 years developing and building our portfolio of comprehensive, proprietary molecular profiling solutions and generating what we believe to be one of the largest and most comprehensive multi-modal clinico-genomic datasets in oncology based on the millions of tests we have run on over 959,000 cases. Our platform is purpose-built to leverage the convergence of next-generation sequencing (“NGS”), artificial intelligence (“AI”) and machine learning (“ML”) technologies, and high-performance computing. The power of our differentiated Caris platform has enabled us to develop the latest generation of advanced precision medicine diagnostic solutions designed to address the entire cancer care continuum, including early detection, minimal residual disease (“MRD”) tracking, therapy selection, and treatment monitoring, as well as to create molecular signatures and discover and develop novel precision medicine therapeutics.

Previous wording

Our global annual clinical case volume has been growing rapidly, with year-over-year growth of 29% in 2022, 32% in 2023, 26% in 2024, and 26% through the second quarter of 2025. With our broad commercial launch of Caris Assure for therapy selection in the first quarter of 2024 and the FDA approval of MI Cancer Seek as a companion diagnostic in the fourth quarter of 2024 followed by the broad commercial launch of MI Cancer Seek in the first quarter of 2025 as the NGS component of MI Profile, we believe that increased profiling volumes will meaningfully contribute to our growth in 2025 and beyond.

Current wording

Our global annual clinical case volume has been growing rapidly, with year-over-year growth of 29% in 2022, 32% in 2023, 26% in 2024, and 23% through the third quarter of 2025. With our broad commercial launch of Caris Assure for therapy selection in the first quarter of 2024 and the FDA approval of MI Cancer Seek as a companion diagnostic in the fourth quarter of 2024 followed by the broad commercial launch of MI Cancer Seek in the first quarter of 2025 as the NGS component of MI Profile, we believe that increased profiling volumes will meaningfully contribute to our growth in 2025 and beyond.

Previous wording

For the three months ended June 30, 2025 and 2024, we generated total revenue of $181.4 million and $100.0 million, respectively, and incurred net losses of $71.8 million and $66.2 million, respectively. For the six months ended June 30, 2025 and 2024, we generated total revenue of $302.3 million and $180.7 million, respectively, and incurred net losses of $174.4 million and $177.2 million, respectively. Our Adjusted EBITDA was $16.7 million and $(50.9) million for the three months ended June 30, 2025 and 2024, respectively, and $(19.5) million and $(121.0) million for the six months ended June 30, 2025 and 2024. While we have achieved positive Adjusted EBITDA for the three months ended June 30, 2025, we may incur additional net losses in the near future, and our expenses will increase as we continue to invest in developing new solutions, expand our organization, and increase our marketing efforts to continue to drive market adoption of our solutions. These investments, together with general and administrative expenses, have resulted in negative cash flows from operations of $24.0 million and $136.9 million for the six months ended June 30, 2025 and 2024, respectively. Our free cash flow was $(28.1) million and $(141.2) million for the six months ended June 30, 2025 and 2024, respectively. For additional information regarding Adjusted EBITDA and free cash flow, non-GAAP financial measures, see “—Non-GAAP Financial Measures.” Additionally, as of June 30, 2025, we had cash, cash equivalents, restricted cash and marketable securities of $724.9 million, and the aggregate principal amount of debt outstanding under our existing term loan was $400.0 million. For additional information regarding our liquidity and capital resources, see “—Liquidity and Capital Resources.”

Current wording

For the three months ended September 30, 2025 and 2024, we generated total revenue of $216.8 million and $101.6 million, respectively, and incurred net income (loss) of $24.3 million and $(67.7) million, respectively. For the nine months ended September 30, 2025 and 2024, we generated total revenue of $519.1 million and $282.3 million, respectively, and incurred net losses of $150.0 million and $244.9 million, respectively. Our Adjusted EBITDA was $51.2 million and $(45.6) million for the three months ended September 30, 2025 and 2024, respectively, and $31.7 million and $(166.6) million for the nine months ended September 30, 2025 and 2024. While we have achieved net profit for the three months ended September 30, 2025, we may incur net losses in the near future, and our expenses will increase as we continue to invest in developing new solutions, expand our organization, and increase our marketing efforts to continue to drive market adoption of our solutions. These investments, together with general and administrative expenses, have resulted in positive (negative) cash flows from operations of $38.4 million and $(206.3) million for the nine months ended September 30, 2025 and 2024, respectively. Our free cash flow was $27.2 million and $(212.4) million for the nine months ended September 30, 2025 and 2024, respectively. For additional information regarding Adjusted EBITDA and free cash flow, non-GAAP financial measures, see “—Non-GAAP Financial Measures.” Additionally, as of September 30, 2025, we had cash, cash equivalents, restricted cash and marketable securities of $759.3 million, and the aggregate principal amount of debt outstanding under our existing term loan was $400.0 million. For additional information regarding our liquidity and capital resources, see “—Liquidity and Capital Resources.”

Previous wording

•Market acceptance and commercial success of our solutions. Our success and future growth will depend on maintaining and expanding market acceptance of our molecular profiling solutions along with commercial success of these solutions across existing and new customers. Our MI Profile and Caris Assure case volumes have continued to increase over time. Such changes in our case volumes and the pricing of our solutions, however, are not impacted by the cancer type. For the three months ended June 30, 2025 and 2024, the number of clinical cases was 50,032 and 40,998, respectively. For the six months ended June 30, 2025 and 2024, the number of clinical cases was 95,890 and 75,900, respectively. We commercially launched our MI Cancer Seek solution in January 2025 as the WES/WTS NGS component of MI Profile. We initiated the broad commercial launch of Caris Assure for therapy selection in the first quarter of 2024, and realizing the potential of Caris Assure across the cancer treatment continuum is a key component of our business strategy. The commercial success of Caris Assure will depend upon, among other things, additional clinical trials that demonstrate the effectiveness of Caris Assure, particularly for early detection, multi-cancer early detection (“MCED”), MRD tracking, and treatment monitoring, and the continued adoption of Caris Assure by patients, the medical community, and third-party payers. In addition, we expect that our ability to maintain and expand our sales, marketing, and distribution capabilities to support the increased adoption of our molecular profiling solutions will play a key factor in our success.

Current wording

•Market acceptance and commercial success of our solutions. Our success and future growth will depend on maintaining and expanding market acceptance of our molecular profiling solutions along with commercial success of these solutions across existing and new customers. Our MI Profile and Caris Assure case volumes have continued to increase over time. Changes in our case volumes and the pricing of our solutions, however, are generally not impacted by the cancer type. For the three months ended September 30, 2025 and 2024, the number of clinical cases was 50,763 and 42,956, respectively. For the nine months ended September 30, 2025 and 2024, the number of clinical cases was 146,653 and 118,856, respectively. We commercially launched our MI Cancer Seek solution in January 2025 as the WES/WTS NGS component of MI Profile. We initiated the broad commercial launch of Caris Assure for therapy selection in the first quarter of 2024, and realizing the potential of Caris Assure across the cancer treatment continuum is a key component of our business strategy. The commercial success of Caris Assure will depend upon, among other things, additional clinical trials that demonstrate the effectiveness of Caris Assure, particularly for early detection, multi-cancer early detection (“MCED”), MRD tracking, and treatment monitoring, and the continued adoption of Caris Assure by patients, the medical community, and third-party payers. In addition, we expect that our ability to maintain and expand our sales, marketing, and distribution capabilities to support the increased adoption of our molecular profiling solutions will play a key factor in our success.

Previous wording

•Biopharma partners. Our revenue also depends on our ability to maintain and expand relationships with our biopharma partners and attract new biopharma partners. As we continue to develop these relationships, we expect to support a growing number of projects and continue to have opportunities to offer our platform to such customers for development and research services. For the three months ended June 30, 2025 and the six months ended June 30, 2025, our year-over-year growth in pharma research and development services revenue has been 49% and 28%, respectively.

Current wording

•Biopharma partners. Our revenue also depends on our ability to maintain and expand relationships with our biopharma partners and attract new biopharma partners. As we continue to develop these relationships, we expect to support a growing number of projects and continue to have opportunities to offer our platform to such customers for development and research services. For the three months ended September 30, 2025 and the nine months ended September 30, 2025, our year-over-year growth in pharma research and development services revenue has been 18% and 25%, respectively.

Previous wording

•Payer coverage and reimbursements. Our revenue and future revenue growth will depend on our success in achieving broad coverage and adequate reimbursement for our solutions from third-party payers. Coverage and reimbursement by third-party payers, including managed care organizations, private health insurers, and government healthcare programs for the types of solutions we offer can be limited and uncertain and may depend on a number of factors, including a payer’s determination that a product is appropriate, medically necessary, and cost-effective. Each payer will make its own decision as to whether to establish a policy or enter into a contract to cover our products and the amount it will reimburse for such products. While the average selling prices (“ASPs”) for Caris Assure, MI Tumor Seek Hybrid and MI Cancer Seek reimbursed by a particular payer are determined by our arrangements with that payer and do not materially differ by cancer type, any fluctuation or differences in coverage and reimbursement among our third-party payers may impact our ASPs and gross margins. Moreover, if we are unable to obtain and/or maintain broad coverage and adequate reimbursement for our solutions from third-party payers, we may not be able to effectively increase our clinical case volume and our revenue would be impacted.

Current wording

•Payer coverage and reimbursements. Our revenue and future revenue growth will depend on our success in achieving broad coverage and adequate reimbursement for our solutions from third-party payers. Coverage and reimbursement by third-party payers, including managed care organizations, private health insurers, and government healthcare programs for the types of solutions we offer can be limited and uncertain and may depend on a number of factors, including a payer’s determination that a product is appropriate, medically necessary, and cost-effective. Each payer will make its own decision as to whether to establish a policy or enter into a contract to cover our products and the amount it will reimburse for such products. While the average selling prices (“ASPs”) for Caris Assure, MI Tumor Seek Hybrid and MI Cancer Seek reimbursed by a particular payer are determined by our arrangements with that payer and do not materially differ by cancer type, any fluctuation or differences in coverage and reimbursement among our third-party payers may impact our overall ASPs and gross margins. Moreover, if we are unable to obtain and/or maintain broad coverage and adequate reimbursement for our solutions from third-party payers, we may not be able to effectively increase our clinical case volume and our revenue would be impacted.

Previous wording

Other expense, net consists of items related to foreign currency gains and losses, debt extinguishment expense and additional immaterial items.

Current wording

Other income (expense), net consists of items related to foreign currency gains and losses, debt extinguishment expense and additional immaterial items.

Previous wording

This increase in revenue was primarily due to the increase in ASP of our MI Profile solution, driven by the launch of MI Cancer Seek and associated higher reimbursement, as well as the increase in clinical cases associated with MI Profile and Caris Assure for therapy selection from 36,426 and 4,572 cases, respectively, for the three months ended June 30, 2024, to 42,886 and 7,146 cases, respectively, for the three months ended June 30, 2025, a total increase of

Current wording

This increase in revenue was primarily due to the increase in ASP of our MI Profile solution, driven by the launch of MI Cancer Seek and associated higher reimbursement, as well as the increase in clinical cases associated with MI Profile and Caris Assure for therapy selection from 38,409 and 4,547 cases, respectively, for the three months ended

Previous wording

9,034 cases, or 22.0%. We believe the growth in MI Profile clinical case volume is driven by increased market acceptance and adoption of MI Profile by ordering physicians year over year, and increased market acceptance and adoption of Caris Assure following its broad commercial launch in the first quarter of 2024.

Current wording

September 30, 2024, to 43,226 and 7,537 cases, respectively, for the three months ended September 30, 2025, a total increase of 7,807 cases, or 18.2%. We believe the growth in MI Profile clinical case volume is driven by increased market acceptance and adoption of MI Profile by ordering physicians year over year, and increased market acceptance and adoption of Caris Assure following its broad commercial launch in the first quarter of 2024.

Previous wording

Revenue from clinical cases for patients covered by Medicare represented approximately 49.7% and 40.1% of our molecular profiling services revenue for the three months ended June 30, 2025 and 2024, respectively due to mix.

Current wording

Revenue from clinical cases for patients covered by Medicare represented approximately 39.4% and 38.6% of our molecular profiling services revenue for the three months ended September 30, 2025 and 2024, respectively, due to mix.

Previous wording

Pharma research and development services revenue increased to $18.5 million for the three months ended June 30, 2025, from $12.4 million for the three months ended June 30, 2024, an increase of $6.1 million, or 49.1%. The increase is mainly driven by increased deal activities in the strategic data pillar.

Current wording

Pharma research and development services revenue increased to $9.2 million for the three months ended September 30, 2025, from $7.8 million for the three months ended September 30, 2024, an increase of $1.4 million, or 18.3%. The increase is mainly driven by increased deal activities in the strategic data pillar.

Previous wording

Cost of services - Molecular profiling serv ices was $65.3 million for the three months ended June 30, 2025, compared to $59.4 million for the three months ended June 30, 2024, an increase of $5.9 million, or 9.9%.

Current wording

Cost of services - Molecular profiling serv ices was $67.0 million for the three months ended September 30, 2025, compared to $54.8 million for the three months ended September 30, 2024, an increase of $12.2 million, or 22.2%.

Previous wording

The Caris Assure laboratory contributed to the majority of the increase. The Caris Assure increase was primarily driven by an increase in materials and related testing costs of $3.1 million, $0.8 million increase in utilities, rent, and allocated overhead, and an increase in labor costs of $0.6 million, due to the increased volume.

Current wording

The Caris Assure laboratory contributed to the majority of the increase. The Caris Assure increase was primarily driven by an increase in materials and related testing costs of $6.8 million, $1.3 million increase in utilities, rent, and allocated overhead, and an increase in labor costs of $1.0 million, due to the increased volume.

Previous wording

Cost of services - Pharma research and development services was $2.4 million for the three months ended June 30, 2025, compared to $3.1 million for the three months ended June 30, 2024, a decrease of $0.7 million, or (21.9)%. The decrease was driven primarily by a decrease within costs associated with the research services of $0.7 million.

Current wording

Cost of services - Pharma research and development services was $2.3 million for the three months ended September 30, 2025, compared to $2.4 million for the three months ended September 30, 2024, a decrease of $0.1 million, or 2.1%. The decrease was driven primarily by a decrease within costs associated with the research services of $0.1 million.

Previous wording

Gross profit, calculated as total revenue less cost of services, was $113.7 million for the three months ended June 30, 2025, compared to $37.6 million for the three months ended June 30, 2024, an increase of $76.1 million, or 202.7%, primarily due to the increase in molecular profiling services revenue.

Current wording

Gross profit, calculated as total revenue less cost of services, was $147.5 million for the three months ended September 30, 2025, compared to $44.4 million for the three months ended September 30, 2024, an increase of $103.1 million, or 232.1%, primarily due to the increase in molecular profiling services revenue.

Previous wording

Selling and marketing expenses were $42.3 million for the three months ended June 30, 2025, compared to $38.7 million for the three months ended June 30, 2024, an increase of $3.5 million, or 9.2%. This increase was primarily due to a $2.9 million increase in personnel costs to support existing solutions, and a $0.5 million increase in professional services and travel and marketing expenses.

Current wording

Selling and marketing expenses were $41.3 million for the three months ended September 30, 2025, compared to $36.8 million for the three months ended September 30, 2024, an increase of $4.5 million, or 12.3%. This increase was primarily due to a $2.9 million increase in personnel costs to support existing solutions, and a $1.3 million increase in professional services and travel and marketing expenses.

Previous wording

General and administrative expenses were $64.4 million for the three months ended June 30, 2025, compared to $41.1 million for the three months ended June 30, 2024, an increase of $23.3 million, or 56.7%. This increase was primarily due to an increase of $20.3 million in stock-based compensation expense, primarily driven by awards with an IPO-related vesting condition, $2.0 million increase in labor costs and benefits associated with an expansion of personnel, a $0.7 million increase in consulting, audit and legal professional fees, a $1.4 million increase related to utilities and cloud computing usages, offset by a $2.0 million decrease in depreciation expense.

Current wording

General and administrative expenses were $52.0 million for the three months ended September 30, 2025, compared to $40.9 million for the three months ended September 30, 2024, an increase of $11.1 million, or 27.2%. This increase was primarily due to an increase of $4.3 million in stock-based compensation expense, a $3.9 million increase in labor costs and benefits associated with an expansion of personnel, a $4.1 million increase in consulting, audit and legal professional fees, a $0.8 million increase in insurance expenses, and a $0.8 million increase in travel expenses, offset by a $2.6 million decrease in depreciation expense.

Previous wording

Research and development expenses were $25.0 million for the three months ended June 30, 2025, compared to $24.8 million for the three months ended June 30, 2024, an increase of $0.3 million, or 1.0%. The increase was primarily driven by an increase of $3.5 million in labor costs, benefits and stock-based compensation, offset by a reduction of $2.5 million in material and reference testing costs associated with the development of Caris Assure and FDA submission of MI Cancer Seek.

Current wording

Research and development expenses were $21.6 million for the three months ended September 30, 2025, compared to $27.6 million for the three months ended September 30, 2024, a decrease of $6.0 million, or 21.8%. The decrease was primarily driven by a reduction of $6.2 million in material and reference testing costs associated with the development of Caris Assure and FDA submission of MI Cancer Seek, and a $0.6 million reduction in allocated overhead, offset by an increase of $1.4 million in labor costs, benefits and stock-based compensation.

Previous wording

This increase in revenue was primarily due to the increase in ASP of our MI Profile solution, driven by the launch of MI Cancer Seek and associated higher reimbursement, as well as the increase in clinical cases associated with MI Profile and Caris Assure for therapy selection from 69,521 and 6,379 cases, respectively, for the six months ended June 30, 2024, to 82,934 and 12,956 cases, respectively, for the six months ended June 30, 2025, a total increase of 19,990 cases, or 26.3%. We believe the growth in MI Profile clinical case volume is driven by increased market acceptance and adoption of MI Profile by ordering physicians year over year, and increased market acceptance and adoption of Caris Assure following its broad commercial launch in the first quarter of 2024.

Current wording

This increase in revenue was primarily due to the increase in ASP of our MI Profile solution, driven by the launch of MI Cancer Seek and associated higher reimbursement, as well as the increase in clinical cases associated with MI Profile and Caris Assure for therapy selection from 107,930 and 10,926 cases, respectively, for the nine months ended September 30, 2024, to 126,160 and 20,493 cases, respectively, for the nine months ended September 30, 2025, a total increase of 27,797 cases, or 23.4%. We believe the growth in MI Profile clinical case volume is driven by increased market acceptance and adoption of MI Profile by ordering physicians year over year, and increased market acceptance and adoption of Caris Assure following its broad commercial launch in the first quarter of 2024.

Previous wording

Revenue from clinical cases for patients covered by Medicare represented approximately 51.6% and 40.3% of our molecular profiling services revenue for the six months ended June 30, 2025 and 2024, respectively.

Current wording

Revenue from clinical cases for patients covered by Medicare represented approximately 46.4% and 39.7% of our molecular profiling services revenue for the nine months ended September 30, 2025 and 2024, respectively.

Previous wording

Pharma research and development services revenue increased to $25.3 million for the six months ended June 30, 2025, from $19.8 million for the six months ended June 30, 2024, an increase of $5.5 million, or 27.6%. The increase is mainly driven by increased deal activities in the strategic data pillar.

Current wording

Pharma research and development services revenue increased to $34.6 million for the nine months ended September 30, 2025, from $27.7 million for the nine months ended September 30, 2024, an increase of $6.9 million, or 25.0%. The increase is mainly driven by increased deal activities in the strategic data pillar.

Previous wording

Cost of services - Molecular profiling serv ices was $126.2 million for the six months ended June 30, 2025, compared to $112.3 million for the six months ended June 30, 2024, an increase of $13.9 million, or 12.4%.

Current wording

Cost of services - Molecular profiling serv ices was $193.2 million for the nine months ended September 30, 2025, compared to $167.1 million for the nine months ended September 30, 2024, an increase of $26.1 million, or 15.6%.

Previous wording

The Caris Assure laboratory contributed to $12.3 million of the increase. The Caris Assure increase was primarily driven by an increase in materials and related testing costs of $8.0 million, $2.1 million increase in utilities, rent, and allocated overhead, and an increase in labor costs of $1.7 million, due to the increased volume from broad launch in the first quarter of 2024.

Current wording

The Caris Assure laboratory contributed $20.9 million of the increase. The Caris Assure increase was primarily driven by an increase in materials and related testing costs of $14.8 million, $3.5 million increase in utilities, rent, and allocated overhead, and an increase in labor costs of $2.7 million, due to the increased volume from broad launch in the first quarter of 2024.

Previous wording

Cost of services - Pharma research and development services was $5.4 million for the six months ended June 30, 2025, compared to $4.7 million for the six months ended June 30, 2024, an increase of $0.6 million, or 13.1%. The increase was driven primarily by an increase within costs associated with the delivery of data licensing and target discovery services of $2.5 million, offset by a reduction in delivering research services of $1.9 million, driven by lower research volume.

Current wording

Cost of services - Pharma research and development services was $7.7 million for the nine months ended September 30, 2025, compared to $7.1 million for the nine months ended September 30, 2024, an increase of $0.6 million, or 8.0%. The increase was driven primarily by an increase in utilities of $0.5 million.

Previous wording

Gross profit, calculated as total revenue less cost of services, was $170.7 million for the six months ended June 30, 2025, compared to $63.7 million for the six months ended June 30, 2024, an increase of $107.1 million, or 168.2%, primarily due to the increase in molecular profiling services revenue.

Current wording

Gross profit, calculated as total revenue less cost of services, was $318.3 million for the nine months ended September 30, 2025, compared to $108.1 million for the nine months ended September 30, 2024, an increase of $210.2 million, or 194.5%, primarily due to the increase in molecular profiling services revenue.

Previous wording

Selling and marketing expenses were $82.1 million for the six months ended June 30, 2025, compared to $78.3 million for the six months ended June 30, 2024, an increase of $3.8 million, or 4.8%. This increase was primarily due to a $5.1 million increase in personnel costs to support existing solutions, offset by a $1.7 million decrease in travel and marketing expenses.

Current wording

Selling and marketing expenses were $123.4 million for the nine months ended September 30, 2025, compared to $115.1 million for the nine months ended September 30, 2024, an increase of $8.3 million, or 7.2%. This increase was primarily due to a $8.0 million increase in personnel costs to support existing solutions and a $0.7 million increase in professional services, offset by a $0.8 million decrease in travel and marketing expenses.

Previous wording

General and administrative expenses were $116.5 million for the six months ended June 30, 2025, compared to $85.4 million for the six months ended June 30, 2024, an increase of $31.1 million, or 36.4%. This increase was primarily due to an increase of $29 million in stock-based compensation, primarily driven by expense from awards with an IPO-related vesting condition, a $4.9 million increase in labor costs and benefits associated with an expansion of personnel, a $2.1 million increase in consulting, audit and legal professional fees, and a $3.4 million increase related to utilities and cloud computing usages, offset by a $9.2 million decrease in depreciation expense.

Current wording

General and administrative expenses were $168.5 million for the nine months ended September 30, 2025, compared to $126.3 million for the nine months ended September 30, 2024, an increase of $42.2 million, or 33.4%. This increase was primarily due to an increase of $33.3 million in stock-based compensation, primarily driven by expense from awards with an IPO-related vesting condition, an $8.9 million increase in labor costs and benefits associated with an expansion of personnel, a $6.2 million increase in consulting, audit and legal professional fees, a $2.3 million increase related to utilities and cloud computing usages, a $0.9 million increase in insurance expenses, and a $2.6 million increase in travel expenses, offset by an $11.9 million decrease in depreciation expense.

Previous wording

Research and development expenses were $48.1 million for the six months ended June 30, 2025, compared to $59.2 million for the six months ended June 30, 2024, a decrease of $11.1 million, or 18.7%. The decrease was primarily driven by a reduction of $12.2 million in material and reference testing costs associated with the development of Caris Assure and FDA submission of MI Cancer Seek, a reduction of $0.6 million in labor costs and benefits, and a $0.8 million reduction in allocated overhead, offset by an increase in stock-based compensation of $3.3 million from awards with an IPO-related vesting condition.

Current wording

Research and development expenses were $69.7 million for the nine months ended September 30, 2025, compared to $86.8 million for the nine months ended September 30, 2024, a decrease of $17.1 million, or 19.7%. The decrease was primarily driven by a reduction of $18.4 million in material and reference testing costs associated with the development of Caris Assure and FDA submission of MI Cancer Seek, a reduction of $0.6 million in labor costs and benefits, and a $1.4 million reduction in allocated overhead, offset by a $4.1 million increase in labor costs, benefits, and stock-based compensation primarily from awards with an IPO-related vesting condition.

Previous wording

Interest expense was $32.0 million for the six months ended June 30, 2025, compared to $23.0 million for the six months ended June 30, 2024, an increase of $9.0 million, or 39.3%. This increase was primarily due to increased interest expense associated with $200.0 million of additional borrowing under the 2023 Term Loan, which was drawn on March 5, 2024, and increased amortization of debt discount associated with the 2025 Convertible Notes.

Current wording

Interest expense was $45.5 million for the nine months ended September 30, 2025, compared to $36.8 million for the nine months ended September 30, 2024, an increase of $8.7 million, or 23.8%. This increase was primarily due to increased interest expense associated with $200.0 million of additional borrowing under the 2023 Term Loan, which was drawn on March 5, 2024, and increased amortization of debt discount associated with the 2025 Convertible Notes.

Previous wording

Other expense, net was $18.4 million for the six months ended June 30, 2025, compared to $0.4 million for the six months ended June 30, 2024, an increase of $18.0 million, or 5,003.9%. This increase was primarily due to the debt extinguishment expense of the 2025 Convertible Notes recorded of $17.9 million upon the IPO, during the six months ended June 30, 2025.

Current wording

Other expense, net was $18.4 million for the nine months ended September 30, 2025, compared to $0.3 million for the nine months ended September 30, 2024, an increase of $18.1 million, or 5,616.7%. This increase was primarily due to the debt extinguishment expense of the 2025 Convertible Notes recorded of $17.9 million upon the IPO, during the nine months ended September 30, 2025.

Previous wording

The following table provides a reconciliation of net loss, the most directly comparable financial measure presented in accordance with GAAP, to Adjusted EBITDA for the periods presented:

Current wording

The following table provides a reconciliation of net income (loss), the most directly comparable financial measure presented in accordance with GAAP, to Adjusted EBITDA for the periods presented:

Previous wording

We have incurred net losses and negative cash flows from operations since inception. We may incur additional net losses in the near future, and our expenses will increase as we continue to invest in developing new solutions, expand our organization, and increase our marketing efforts to continue to drive market adoption of our solutions. As of June 30, 2025, we had an accumulated deficit of $2.7 billion.

Current wording

In the aggregate, we have incurred net losses and negative cash flows from operations since inception. We may incur net losses in the near future, and our expenses will increase as we continue to invest in developing new solutions, expand our organization, and increase our marketing efforts to continue to drive market adoption of our solutions. As of September 30, 2025, we had an accumulated deficit of $2.6 billion.

Previous wording

To date, we have funded our operations principally from the issuance of stock in private financings, issuance of common stock through our IPO, term loan borrowings and convertible debt, and through revenue from molecular profiling and pharma research and development services. As of June 30, 2025, we had cash and cash equivalents of $718.9 million and short-term marketable securities of $2.2 million. We believe our existing cash and cash equivalents, which includes the net proceeds from our Pre-IPO Financing (as defined below) and the IPO, and anticipated cash flows from operations will provide sufficient capital and liquidity to fund our operating expenses and capital expenditure requirements for at least the next 12 months. We may, however, continue to require additional capital to meet our operational needs. See “—Indebtedness” and “—Cash Requirements” below for additional information regarding our cash requirements and various factors that may impact our liquidity and capital resources.

Current wording

To date, we have funded our operations principally from the issuance of stock in private financings, issuance of common stock through our IPO, term loan borrowings and convertible debt, and through revenue from molecular profiling and pharma research and development services. As of September 30, 2025, we had cash and cash equivalents of $753.2 million and short-term marketable securities of $2.3 million. We believe our existing cash and cash equivalents, which includes the net proceeds from our Pre-IPO Financing (as defined below) and the IPO, short-term marketable securities, and anticipated cash flows from operations will provide sufficient capital and liquidity to fund our operating expenses and capital expenditure requirements for at least the next 12 months. We may, however, continue to require additional capital to meet our operational needs. See “—Indebtedness” and “—Cash Requirements” below for additional information regarding our cash requirements and various factors that may impact our liquidity and capital resources.

Previous wording

Net cash used in operating activities during the six months ended June 30, 2025 was $24.0 million, which was primarily due to a net loss of $174.4 million, offset by a net change in our operating assets and liabilities of $11.9 million and net non-cash charges of $138.4 million. The net change in our operating assets and liabilities was primarily the result of a $37.0 million decrease in accounts receivable, offset by a $2.6 million increase in supplies, a $1.9 million decrease in accounts payable, a $2.3 million increase in prepaid expenses and other current assets, and a $18.7 million decrease in accrued expenses and other liabilities. Net non-cash charges primarily consisted of $13.5 million of depreciation and amortization expense, $43.0 million of stock-based compensation expense (including $19.5 million of stock-based compensation expense associated with RSUs vested upon the IPO), $2.9 million of non-cash operating lease expense, $9.7 million in amortization of debt discount costs, a $50.2 million loss within changes in the fair value of financial instruments associated with our IPO, and a $17.9 million loss on debt extinguishment associated with our IPO.

Current wording

Net cash used in operating activities during the nine months ended September 30, 2025 was $38.4 million, which was due to a net change in our operating assets and liabilities of $26.0 million and net non-cash charges of $162.5 million, offset by a net loss of $150.0 million. The net change in our operating assets and liabilities was primarily the result of a $61.2 million decrease in accounts receivable, offset by a $11.1 million increase in supplies, a $1.2 million decrease in accounts payable, a $4.8 million increase in prepaid expenses and other current assets, and a $17.8 million decrease in accrued expenses and other liabilities. Net non-cash charges primarily consisted of $18.3 million of depreciation and amortization expense, $56.6 million of stock-based compensation expense (including $19.5 million of stock-based compensation expense associated with RSUs vested upon the IPO), $4.3 million of non-cash operating lease expense, $12.2 million in amortization of debt discount costs, a $52.3 million loss within changes in the fair value of financial instruments associated with our IPO, and a $17.9 million loss on debt extinguishment associated with our IPO.

Previous wording

Net cash used in operating activities during the six months ended June 30, 2024 was $136.9 million, which was primarily due to a net loss of $177.2 million and a net change in our operating assets and liabilities of $5.3 million, offset by net non-cash charges of $45.7 million. The net change in our operating assets and liabilities was primarily the result of a $16.9 million increase in accounts receivable, and a $1.4 million increase in prepaid expenses and other current assets, offset by a $2.6 million increase in accounts payable, a $2.4 million increase in accrued expenses and other liabilities, and a $7.5 million decrease in supplies. Net non-cash charges, primarily consisted of $29.3 million of depreciation and amortization expense, $8.9 million of stock-based compensation expense, $2.9 million of non-cash operating lease expense, and $3.3 million in amortization of debt discount costs, offset by a $0.9 million gain within changes in the fair value of financial instruments.

Current wording

Net cash used in operating activities during the nine months ended September 30, 2024 was $206.3 million, which was primarily due to a net loss of $244.9 million and a net change in our operating assets and liabilities of $22.1 million, offset by net non-cash charges of $60.8 million. The net change in our operating assets and liabilities was primarily the result of a $15.0 million increase in accounts receivable, a $14.0 million decrease in accrued expenses and other liabilities, and a $2.2 million increase in prepaid expenses and other current assets, offset by a $5.1 million increase in accounts payable and a $4.2 million decrease in supplies. Net non-cash charges primarily consisted of $39.8 million of depreciation and amortization expense, $13.7 million of stock-based compensation expense, $4.2 million of non-cash operating lease expense, and $5.1 million in amortization of debt discount costs, offset by a $6.1 million gain within changes in the fair value of financial instruments.

Previous wording

Net cash used in investing activities during the six months ended June 30, 2025 was $4.1 million, which was primarily due to purchases of property and equipment of $4.1 million.

Current wording

Net cash used in investing activities during the nine months ended September 30, 2025 was $11.2 million, which was due to purchases of property and equipment of $11.2 million.

Previous wording

Net cash provided by investing activities during the six months ended June 30, 2024 was $57.1 million, which was primarily due to maturities of marketable securities of $61.4 million, offset by purchases of property and equipment of $4.3 million.

Current wording

Net cash provided by investing activities during the nine months ended September 30, 2024 was $55.2 million, which was due to maturities of marketable securities of $61.4 million, offset by purchases of property and equipment of $6.2 million.

Previous wording

Net cash provided by financing activities during the six months ended June 30, 2025 was $682.7 million, which was primarily due to proceeds from exercises of stock options of $2.6 million, issuance of Series E Preferred Stock, net of issuance costs, of $87.6 million, issuance of Series F Preferred Stock, net of issuance costs, of $33.6 million, issuance of convertible notes, net of issuance costs, of $27.9 million, issuance of warrants of $10.3 million, and proceeds from the IPO, net of underwriting discounts and commissions, of $528.5 million, offset by the payment of taxes withheld from net settlement of exercised options of $1.7 million, payment of deferred offering costs of $2.0 million, and payments from debt modification of $4.0 million.

Current wording

Net cash provided by financing activities during the nine months ended September 30, 2025 was $661.6 million, which was primarily due to proceeds from the IPO, net of underwriting discounts and commissions, of $528.5 million, offset by the payment of taxes withheld from net settlement of exercised options of exercised options of $18.2 million, payment of deferred offering costs of $7.7 million, and payments from debt modification of $4.0 million, issuance of Series E Preferred Stock, net of issuance costs, of $87.6 million, issuance of Series F Preferred Stock, net of issuance costs, of $33.6 million, issuance of convertible notes, net of issuance costs, of $27.9 million, issuance of warrants of $10.3 million, and exercises of stock options of $3.8 million.

Previous wording

Net cash provided by financing activities during the six months ended June 30, 2024 was $200.0 million, which was primarily due to proceeds from issuance of additional borrowings under the 2023 Term Loan Agreement on March 5, 2024, net of issuance costs, of $200.0 million.

Current wording

Net cash provided by financing activities during the nine months ended September 30, 2024 was $200.1 million, which was primarily due to proceeds from issuance of additional borrowings under the 2023 Term Loan Agreement on March 5, 2024, net of issuance costs, of $200.0 million, proceeds from exercises of stock options of $1.3 million, offset by the payment of deferred offering costs of $1.0 million.

Previous wording

Prior to our stock being publicly traded, the fair value of stock option awards as of the date of the grant was estimated by applying the Black-Scholes option pricing model. The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions, which determine the fair value of stock-based awards. These assumptions include the following:

Current wording

The fair value of stock option awards as of the date of the grant was estimated by applying the Black-Scholes option pricing model. The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions, which determine the fair value of stock-based awards. These assumptions include the following:

Showing the first 40 of 41 pairs. Open the source sections for the rest.

Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations