[Part I - Financial Information](index=5&type=section&id=Part%20I%20-%20Financial%20Information) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for June 30, 2025, reflect significant changes driven by the June 2025 IPO, including a substantial increase in cash, a shift from shareholders' deficit to positive equity, and strong revenue growth despite continued net losses - **Net IPO proceeds of $459.5 million** from 23,529,412 shares at $21.00, plus **$68.9 million** from over-allotment[34](index=34&type=chunk) - All outstanding redeemable convertible preferred stock converted into **211,378,638 common shares** upon IPO[36](index=36&type=chunk) - A **one-for-four reverse stock split** of common stock was effective June 1, 2025, with all share and per-share data retroactively adjusted[33](index=33&type=chunk) [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, reflects significant financial improvement post-IPO, with cash increasing to **$720.4 million** and a **$2.5 billion shareholders' deficit** converting to **$452.9 million positive equity** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents, and restricted cash | $720,444 | $65,442 | | Total current assets | $833,319 | $215,729 | | **Total assets** | **$955,058** | **$343,734** | | **Liabilities & Equity** | | | | Total current liabilities | $90,180 | $165,423 | | Total liabilities | $502,154 | $620,921 | | Redeemable convertible preferred stock | $0 | $2,221,651 | | Total shareholders' equity (deficit) | $452,904 | $(2,498,838) | | **Total liabilities, redeemable convertible preferred stock, and shareholders' equity (deficit)** | **$955,058** | **$343,734** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q2 2025, total revenue increased **81.3% year-over-year to $181.4 million**, but the company reported a net loss of **$71.8 million**, slightly higher than Q2 2024, due to increased operating and other IPO-related expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | 6 Months 2025 | 6 Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $181,398 | $100,049 | $302,314 | $180,727 | | Loss from Operations | $(17,989) | $(67,011) | $(75,940) | $(159,234) | | Net Loss | $(71,790) | $(66,186) | $(174,370) | $(177,214) | | Net Loss per Share | $(7.97) | $(2.54) | $(12.80) | $(6.34) | - A **$384.4 million deemed dividend** on Series D preferred stock significantly increased net loss attributable to common shareholders for the three and six months ended June 30, 2025[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities improved to **$24.1 million**, while financing activities provided **$682.7 million**, primarily from the IPO, resulting in a **$654.7 million net increase in cash** Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(24,050) | $(136,851) | | Net cash provided by (used in) investing activities | $(4,075) | $57,050 | | Net cash provided by financing activities | $682,687 | $199,979 | | **Net increase in cash, cash equivalents, and restricted cash** | **$654,659** | **$120,191** | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies and significant financial events, including the company's business as an AI TechBio and precision medicine firm, pre-IPO financing, IPO specifics, revenue recognition, and long-term debt, including a **$400 million term loan** - Revenue is primarily derived from **Molecular profiling services** (MI Profile and Caris Assure) and **Pharma research and development services**[44](index=44&type=chunk) - In April 2025, the company raised **$167.7 million** through private financing, including convertible notes, warrants, and Series E and F preferred stock[29](index=29&type=chunk) - As of June 30, 2025, a **$400 million term loan** was outstanding, due January 2028, with an interest rate of **10.8%**[169](index=169&type=chunk)[171](index=171&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=53&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management highlights the company's strong revenue growth driven by molecular profiling solutions and increased clinical case volumes, achieving positive Adjusted EBITDA in Q2 2025, with IPO proceeds significantly strengthening liquidity for future operations and R&D investments - Global annual clinical case volume grew **26% year-over-year** through Q2 2025[203](index=203&type=chunk) - The launches of **Caris Assure** (Q1 2024) and **MI Cancer Seek** (Q1 2025) are anticipated as significant growth drivers[203](index=203&type=chunk) Key Financial Metrics (in millions) | Metric | Q2 2025 | Q2 2024 | 6 Months 2025 | 6 Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $181.4 | $100.0 | $302.3 | $180.7 | | Net Loss | $(71.8) | $(66.2) | $(174.4) | $(177.2) | | Adjusted EBITDA | $16.7 | $(50.9) | $(19.5) | $(121.0) | | Free Cash Flow | N/A | N/A | $(28.1) | $(141.2) | [Results of Operations](index=59&type=section&id=Results%20of%20Operations) Q2 2025 revenue increased **81.3% year-over-year to $181.4 million**, primarily from **85.9% growth in Molecular Profiling services** due to higher ASPs and increased clinical case volume, while operating expenses rose due to IPO-related stock-based compensation Revenue Comparison - Q2 2025 vs Q2 2024 (in thousands) | Revenue Stream | Q2 2025 | Q2 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Molecular profiling services | $162,924 | $87,656 | $75,268 | 85.9% | | Pharma research and development services | $18,474 | $12,393 | $6,081 | 49.1% | | **Total revenue** | **$181,398** | **$100,049** | **$81,349** | **81.3%** | - Molecular Profiling revenue growth was driven by **higher MI Profile ASP (+$50.3 million)**, **increased MI Profile volume (+$14.3 million)**, and **Caris Assure volume and ASP growth (+$10.7 million)**[234](index=234&type=chunk) - General and administrative expenses increased by **$23.3 million (56.7%)** in Q2 2025, primarily due to a **$20.3 million increase in IPO-related stock-based compensation**[242](index=242&type=chunk) [Liquidity and Capital Resources](index=72&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$718.9 million in cash and equivalents**, with IPO proceeds and existing capital expected to fund operations for at least the next 12 months, alongside **$400 million in outstanding term loan debt** maturing in 2028 - As of June 30, 2025, the company had **$718.9 million in cash and cash equivalents** and an **accumulated deficit of $2.7 billion**[280](index=280&type=chunk)[281](index=281&type=chunk) - Net cash provided by financing activities for the first six months of 2025 was **$682.7 million**, primarily from **IPO net proceeds ($528.5 million)** and pre-IPO financing[288](index=288&type=chunk) - The company has a **$400.0 million term loan** due January 2028, with an interest rate of **10.8%** as of June 30, 2025[290](index=290&type=chunk)[292](index=292&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=77&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks include interest rate risk on its **$400 million variable-rate debt**, where a **100 basis point increase** would raise annual interest expense by **$4.0 million**, while foreign currency and inflation risks are currently not significant - The company faces interest rate risk on its **$400.0 million variable-rate debt**, where a **100 basis point increase** would raise annual interest expense by **$4.0 million**[312](index=312&type=chunk) - Foreign currency risk is minimal as substantially all revenue is generated in the United States[314](index=314&type=chunk) [Item 4. Controls and Procedures](index=78&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of June 30, 2025, due to a material weakness in internal control over financial reporting, specifically a lack of qualified accounting resources, with remediation efforts underway - Disclosure controls and procedures were **not effective** as of June 30, 2025, due to a material weakness in internal control over financial reporting[317](index=317&type=chunk) - The material weakness stems from insufficient qualified accounting resources with technical expertise for complex transactions[317](index=317&type=chunk) - Remediation efforts include hiring experienced accounting and finance personnel and implementing enhanced review controls[319](index=319&type=chunk) [Part II - Other Information](index=81&type=section&id=Part%20II%20-%20Other%20Information) [Item 1. Legal Proceedings](index=81&type=section&id=Item%201.%20Legal%20Proceedings) In March 2025, the company received a Civil Investigative Demand from the U.S. Department of Justice regarding a False Claims Act investigation into Medicare's 14-day rule compliance, with the outcome currently uncertain - In March 2025, the company received a Civil Investigative Demand from the U.S. Department of Justice for a False Claims Act investigation[322](index=322&type=chunk) - The investigation focuses on compliance with Medicare's "14-day rule" for date of service[322](index=322&type=chunk) [Item 1A. Risk Factors](index=81&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks, including intense competition, a history of substantial losses, reliance on product market acceptance, uncertain third-party payer reimbursement, potential LDT regulatory changes, supply chain dependency, cybersecurity threats, significant indebtedness, CEO voting power concentration, and internal control weaknesses - The company has a history of significant losses, with a **net loss of $174.4 million** for the first six months of 2025 and an **accumulated deficit of $2.7 billion** as of June 30, 2025[332](index=332&type=chunk) - Uncertainty of coverage and reimbursement from third-party payers, including Medicare, poses a significant commercial risk[360](index=360&type=chunk) - Reliance on **Illumina** as the sole supplier for NGS instruments and reagents presents a significant supply chain risk[385](index=385&type=chunk) - The Founder, Chairman, and CEO, David D. Halbert, beneficially owns approximately **44.1% of outstanding common stock**, significantly influencing shareholder matters[646](index=646&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=176&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details unregistered equity sales, including **$30.0 million in convertible notes** and preferred stock issued in April 2025 that converted to common stock upon the IPO, and the use of **$519.5 million net proceeds** from the June 2025 IPO - In Q2 2025, the company issued convertible notes, Series E & F Preferred Stock, and warrants in unregistered transactions, all converting to common stock upon the IPO[685](index=685&type=chunk)[692](index=692&type=chunk) - The June 2025 IPO generated **$519.5 million in net proceeds** after deducting discounts and expenses[687](index=687&type=chunk) [Item 5. Other Information](index=179&type=section&id=Item%205.%20Other%20Information) On August 8, 2025, Caris MPI, Inc. extended its Phoenix, Arizona clinical laboratory lease until August 31, 2031, with no Rule 10b5-1 trading arrangements adopted or terminated by directors or officers during the quarter - On August 8, 2025, the company extended the lease for its Phoenix, Arizona clinical laboratory until **August 31, 2031**[695](index=695&type=chunk)

Financial Performance - Total revenue increased by 81% year-over-year, reaching $181.4 million in Q2 2025, compared to $100 million in Q2 2024[11] - Molecular Profiling Services revenue grew by 86% year-over-year, amounting to $162.9 million in Q2 2025, up from $87.7 million in Q2 2024[11] - Pharma R&D Services revenue increased by 49% year-over-year, reaching $18.5 million in Q2 2025, compared to $12.4 million in Q2 2024[11] - Clinical ASP improved by 52%, rising from $2,138 in Q2 2024 to $3,256 in Q2 2025[15] - Gross margin increased by 2,514 basis points year-over-year, reaching 62.7% in Q2 2025[15, 42] - Adjusted EBITDA turned positive, reaching $16.7 million in Q2 2025, compared to a loss of $50.9 million in Q2 2024[15, 34] - Free Cash Flow turned positive, reaching $5.9 million in Q2 2025, compared to a loss of $65.5 million in Q2 2024[15, 34] Operational Highlights - Clinical volume grew by 22%, with 50,032 clinical cases completed in Q2 2025[15] - The company's molecular dataset surpassed 900,000+ comprehensive tumor patient profiles, including over 529,000 Whole Exomes and 580,000 Whole Transcriptomes[15, 21] - Caris Assure ASP increased 58.7% year-over-year to $2,519 in Q2 2025[40] - MI Profile ASP increased 53.1% year-over-year to $3,379 in Q2 2025[40] Strategic Initiatives - The Partner Oncology Alliance (POA) expanded to 97 sites with over 1,100 publications[15, 23] - A landmark Caris Assure study was published, validating the single assay across the cancer care continuum[15, 26]

Revenue Growth - Total revenue for Q2 2025 was $181.4 million, an increase of 81.3% compared to $100.0 million in Q2 2024[7] - Molecular profiling services revenue grew by 85.9% to $162.9 million from $87.7 million year-over-year[8] - The company expects full year 2025 revenue to be between $675.0 million and $685.0 million, representing growth of 64% to 66% compared to 2024[13] - Total revenue for Q2 2025 reached $181.4 million, a 81.3% increase from $100.0 million in Q2 2024[23] - Molecular profiling services generated $162.9 million in revenue, up 85.5% from $87.7 million in the same quarter last year[23] Financial Performance - Gross margin improved to 62.7%, up 2,514 basis points from 37.5% in the prior year[5] - Adjusted EBITDA was positive at $16.7 million, a 132.8% improvement from a loss of $50.9 million in Q2 2024[12] - Net loss for Q2 2025 was $71.8 million, including a one-time expense of $37.1 million related to the IPO[11] - Net loss for the first half of 2025 was $174.4 million, compared to a net loss of $177.2 million in the first half of 2024[27] - The company reported a comprehensive loss of $71.4 million for Q2 2025, compared to a comprehensive loss of $66.1 million in Q2 2024[23] Cash Flow and Liquidity - Cash provided by operating activities was $7.3 million, a significant improvement from a cash used of $62.9 million in the prior year[12] - Cash, cash equivalents, and restricted cash increased to $720.4 million as of June 30, 2025, from $65.4 million at the end of 2024[25] - Total assets surged to $955.1 million as of June 30, 2025, compared to $343.7 million at the end of 2024[25] - Net cash provided by operating activities for Q2 2025 was $7,288,000, a recovery from negative $62,926,000 in Q2 2024[30] - Free cash flow for Q2 2025 was $5,902,000, compared to negative $65,514,000 in Q2 2024[30] Expenses - Selling and marketing expenses rose to $42.3 million in Q2 2025, an increase of 9.9% from $38.7 million in Q2 2024[23] - Research and development expenses were $25.0 million for the first half of 2025, slightly down from $24.8 million in the same period last year[23] - Interest expense increased to $19,208,000 in Q2 2025 from $13,674,000 in Q2 2024[29] - Stock-based compensation expense rose to $28,293,000 in Q2 2025 from $4,485,000 in Q2 2024[29] - Depreciation and amortization expense decreased to $6,409,000 in Q2 2025 from $11,610,000 in Q2 2024[29] Shareholder and Market Activity - The company raised $519.5 million in net proceeds from its initial public offering in June 2025[5] - The company issued Series E and F Preferred Stock, raising $121.2 million in net proceeds during the first half of 2025[27] - The weighted-average shares used in computing net loss per share increased to 64.9 million in Q2 2025 from 35.4 million in Q2 2024[23] Clinical and Operational Metrics - Clinical therapy selection volume is projected to grow by 19% to 21% compared to the previous year[13] - Total clinical case volume reached 50,032, an increase of 22.0% from 40,998 in the prior year[5] Other Financial Metrics - Changes in fair value of financial instruments showed a gain of $17,870,000 in Q2 2025, contrasting with a loss of $12,000,000 in Q2 2024[29] - Interest income decreased to $1,618,000 in Q2 2025 from $2,640,000 in Q2 2024[29] - Other expense, net, increased to $18,341,000 in Q2 2025 from $141,000 in Q2 2024[29]

Core Insights - Caris Life Sciences reported a significant increase in total revenue for Q2 2025, reaching $181.4 million, which is an 81.3% increase compared to $100.0 million in Q2 2024 [5][9][10] - The growth in revenue was primarily driven by an 85.9% increase in molecular profiling services revenue, amounting to $162.9 million [6][9] - The company achieved a gross margin of 62.7%, up from 37.5% in the previous year, reflecting improved operational efficiency [7][9] Financial Performance - Total revenue for Q2 2025 was $181,398,000, compared to $100,049,000 in Q2 2024, marking an increase of $81,349,000 [4][5] - Molecular profiling services revenue was $162,924,000 in Q2 2025, up from $87,656,000 in Q2 2024, representing an 85.9% increase [4][6] - Total clinical case volume increased by 22.0%, reaching 50,032 cases in Q2 2025 [4][9] - The total gross margin improved to 62.7%, a 25.2% increase year-over-year [4][9] - Operating expenses rose to $131,674,000, an increase of 25.9% from $104,565,000 in Q2 2024 [4][8] - The net loss for Q2 2025 was $71,790,000, compared to a net loss of $66,186,000 in Q2 2024 [10][11] Cash Flow and Liquidity - Net cash provided by operating activities was $7,288,000 for Q2 2025, a significant improvement from a net cash used of $62,926,000 in Q2 2024 [11][27] - Free cash flow for Q2 2025 was $5,902,000, compared to a negative free cash flow of $65,514,000 in Q2 2024 [27] - The company raised $519.5 million in net proceeds from its initial public offering in June 2025 [9] Future Outlook - Caris Life Sciences expects full-year 2025 revenue to be between $675 million and $685 million, indicating a growth of 64% to 66% compared to 2024 [12] - Clinical therapy selection volume is projected to grow by 19% to 21% compared to the previous year [12]

Core Insights - Caris Life Sciences has developed and validated a new version of Caris GPSai™, a deep learning AI tool that enhances diagnostic accuracy for cancers of unknown primary (CUP) and misclassified tumors [1][2][3] Group 1: Technology and Methodology - Caris GPSai™ utilizes deep learning and whole exome and whole transcriptome sequencing (WES/WTS) to improve the precision of tumor origin predictions and identify potential misdiagnoses [2][4] - The tool was trained on WES/WTS data from over 200,000 cases and can classify tumors into 90 categories, achieving 95.0% accuracy in non-CUP cases and reporting tissue of origin in 84.0% of CUP cases [3][4] Group 2: Clinical Impact - In clinical use over eight months, GPSai changed the diagnosis for 704 patients, with 86.1% of these cases impacting treatment eligibility based on Level 1 clinical evidence [4][5] - 53.6% of surveyed physicians reported altering treatment plans due to the insights provided by GPSai, highlighting its significant influence on patient care [4][5] Group 3: Company Overview - Caris Life Sciences is a leading AI TechBio company focused on precision medicine, utilizing advanced AI and machine learning to analyze complex molecular data for improved healthcare solutions [6][7] - The company aims to transform healthcare through comprehensive molecular profiling and has established a large-scale clinico-genomic database to support its initiatives [6][7]

Company Overview - Caris Life Sciences is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer [2] - The company is headquartered in Irving, Texas, with additional offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan, and Basel, Switzerland [3] - Caris provides services in the U.S. and other international markets through its own operations and distributor partners [3] Financial Reporting - Caris Life Sciences will report its second quarter 2025 financial results on August 12, 2025 [1] - A conference call and live webcast will be held at 3:30 p.m. CT (4:30 p.m. ET) to discuss these financial results [1] - A replay of the webcast will be available shortly after the call on the Investor Relations section of the Caris Life Sciences website [1] Technological Capabilities - The company utilizes comprehensive molecular profiling, including Whole Exome and Whole Transcriptome Sequencing, combined with advanced AI and machine learning algorithms [2] - Caris has developed a large-scale, multimodal clinico-genomic database and computing capability to analyze the molecular complexity of diseases [2] - This integration of next-generation sequencing, AI, machine learning technologies, and high-performance computing enables the development of advanced precision medicine diagnostic solutions [2]

Core Insights - Caris Life Sciences published original data in the New England Journal of Medicine validating findings on tumor-infiltrating clonal hematopoiesis (TI-CH), reinforcing its leadership in precision oncology [1][2] - The study highlighted the clinical challenge of TI-CH, which involves blood-derived mutations infiltrating tumor tissue, potentially leading to misinterpretation and inappropriate treatment decisions [2][3] Company Overview - Caris Life Sciences is a leading AI TechBio company focused on precision medicine, developing innovative solutions to transform healthcare through comprehensive molecular profiling and advanced AI applications [5][6] - The company has built a large-scale clinico-genomic database of over 500,000 samples, enabling the analysis of molecular complexity in diseases [5] Research Findings - The analysis included 3,255 matched tumor-blood NGS samples, confirming that TI-CH is prevalent across solid tumors, particularly in non-small cell lung cancer (NSCLC), where approximately 23% of patients are affected [3] - Patients with TI-CH face a 30% higher risk of death compared to those without TI-CH, emphasizing the importance of accurate treatment decisions based on true tumor biology [3][4] Leadership Statements - David Spetzler, President of Caris, emphasized the importance of collaboration in validating studies to enhance clinically meaningful insights for oncologists and patients [3] - George W. Sledge, Jr., Chief Medical Officer, noted that understanding clonal hematopoietic mutations is critical for improving treatment responses and patient outcomes [4]

Group 1 - Caris Life Sciences announced an increase in the price range for its upcoming IPO to $19 to $20 per share, aiming to raise a total of $459 million [1][2] - The company plans to issue 23.5 million shares, with insiders intending to purchase $75 million worth of shares, representing 16% of the offering [1] - The revised fundraising amount is expected to be 15% higher than the original estimate [1] Group 2 - Founded in 2008, Caris Life Sciences reported revenue of $452 million for the 12 months ending March 31, 2025 [2] - The company is set to list on NASDAQ under the ticker symbol "CAI" [2] - The IPO is being managed by a consortium of banks including Bank of America Securities, JPMorgan, Goldman Sachs, Citigroup, TD Cowen, Evercore ISI, and Guggenheim Securities, with pricing expected to occur during the week of June 16, 2025 [2]

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on June 16, 2025. Registration No. 333-287551 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CARIS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Texas 8071 85-2077369 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer ...

Amendment No. 1 TABLE OF CONTENTS As filed with the Securities and Exchange Commission on June 9, 2025. Registration No. 333-287551 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CARIS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Texas 8071 85-2077369 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer ...