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1、S-1/A 1 tm2415719-16_s1a.htm S-1/ATABLE OF CONTENTSAs filed with the Securities and Exchange Commission on June 9,2025.Registration No.333-287551 UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington,D.C.20549Amendment No.1to FORM S-1REGISTRATION STATEMENTUNDERTHE SECURITIES ACT OF 1933 CARIS LI

2、FE SCIENCES,INC.(Exact name of registrant as specified in its charter)Texas 8071 85-2077369 (State or other jurisdiction ofincorporation or organization)(Primary Standard IndustrialClassification Code Number)(I.R.S.EmployerIdentification Number)750 W.John Carpenter FreewaySuite 800Irving,TX 75039Tel

3、ephone:(866)771-8946(Address,including zip code,and telephone number,including area code,of registrants principal executive offices)David D.HalbertFounder,Chairman,and Chief Executive OfficerCaris Life Sciences,Inc.750 W.John Carpenter Freeway,Suite 800Irving,TX 75039Telephone:(866)771-8946(Name,add

4、ress,including zip code,and telephone number,including area code,of agent for service)Copies to:Nathan AjiashviliAlison HaggertySamer ZabanehLatham&Watkins LLP1271 Avenue of the AmericasNew York,NY 10020Telephone:(212)906-1200 J.Russel DentonGinger AppleberryMichael R.SullivanCaris Life Sciences,Inc

5、.750 W.John Carpenter Freeway,Suite 800Irving,TX 75039Telephone:(866)771-8946 Eric BlanchardDivakar GuptaCharles S.KimCooley LLP500 Boylston StreetBoston,MA 02116Telephone:(617)937-2300 Approximate date of commencement of proposed sale to the public:As soon as practicable after the effective date of

6、 this registration statement.If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Actof 1933,check the following box.If this Form is filed to register additional securities for an offering pursuant to Rule

7、 462(b)under the Securities Act,check the following box and listthe Securities Act registration statement number of the earlier effective registration statement for the same offering.If this Form is a post-effective amendment filed pursuant to Rule 462(c)under the Securities Act,check the following

8、box and list the Securities Actregistration statement number of the earlier effective registration statement for the same offering.If this Form is a post-effective amendment filed pursuant to Rule 462(d)under the Securities Act,check the following box and list the Securities Actregistration statemen

9、t number of the earlier effective registration statement for the same offering.Indicate by check mark whether the registrant is a large accelerated filer,an accelerated filer,a non-accelerated filer,a smaller reporting company,oran emerging growth company.See the definitions of“large accelerated fil

10、er,”“accelerated filer,”“smaller reporting company”and“emerging growth company”in Rule 12b-2 of the Exchange Act.Large accelerated filer Accelerated filer Non-accelerated filer Smaller reporting company Emerging growth company If an emerging growth company,indicate by check mark if the registrant ha

11、s elected not to use the extended transition period for complying with anynew or revised financial accounting standards provided pursuant to Section 7(a)(2)(B)of the Securities Act.The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effecti

12、ve date until the Registrant shall filea further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a)of the Securities Act of1933,as amended,or until the Registration Statement shall become effective on such date as th

13、e Commission,acting pursuant to said Section 8(a),may determine.2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm1/361ence Meets Artificial Intelligence Arizona blood lab;the entrance lobby of Caris Phoenix,Arizona

14、 tissue lab;tissue sample storage in Caris Phoenix,Arizona tissue lab;a Caris laboratory technician preparing a centrifuge for Caris Assure profiling of patient blood samples;a Caris laboratory technician preparing patient blood samples for Caris Assure profiling;a Caris laboratory technician microd

15、issecting a patient tissue sample in preparation for MI Profile analysis;Caris laboratory technicians in our Phoenix,Arizona blood lab;sequencing machines in Caris Phoenix,Arizona blood lab.(1)CitigroupTABLE OF CONTENTSSubject to CompletionPreliminary Prospectus dated June 9,2025P R O S P E C T U S2

16、3,529,412 SharesCaris Life Sciences,Inc.Common Stock This is Caris Life Sciences,Inc.s initial public offering.We are selling 23,529,412 shares of our common stock.We expect the public offering price to be between$16.00 and$18.00 per share.Currently,no public market exists for shares of ourcommon st

17、ock.We have applied to list our common stock on the Nasdaq Global Select Market(“Nasdaq”)under the symbol“CAI.”Immediately following the completion of this offering,David D.Halbert,our Founder,Chairman,and Chief Executive Officer,will beneficially own approximately 41.7%of our outstanding shares of

18、common stock,and our existing executive officers(includingMr.Halbert),directors,holders of more than 5%of our outstanding capital stock,and their respective affiliates will collectively beneficiallyown approximately 63.6%of our outstanding shares of common stock,in each case,based on an assumed init

19、ial public offering price of$17.00 per share,which is the midpoint of the price range set forth on this cover page,and assuming no exercise by the underwriters of theiroption to purchase additional shares of our common stock.As a result,Mr.Halbert as well as our other existing executive officers,dir

20、ectors,and principal shareholders,if acting together,will be able to control all matters submitted to our shareholders for approval,including theelection of directors,amendments to our certificate of formation and bylaws,and the approval of significant corporate transactions.See“Principal Shareholde

21、rs”for additional information.At our request,the underwriters have reserved up to 5%of the shares of common stock offered by this prospectus,excluding theadditional shares that the underwriters have a 30-day option to purchase,for sale,at the initial public offering price,to certain individualsident

22、ified by management,including certain of our directors,officers,employees,and certain other parties related to us.See“Underwriting Reserved Share Program.”We are an“emerging growth company”as defined under the federal securities laws and,as such,have elected to comply with certainreduced reporting r

23、equirements for this prospectus and may elect to do so in future filings.See“Prospectus SummaryImplications of Being anEmerging Growth Company.”Investing in our common stock involves risks that are described in the“Risk Factors”sectionbeginning on page 21 of this prospectus.Per Share Total Public of

24、fering price$Underwriting discount$Proceeds,before expenses,to us$We refer you to“Underwriting”for additional information regarding underwriting compensation.The underwriters may also exercise their option to purchase up to an additional 3,529,411 shares of common stock from us,at thepublic offering

25、 price,less the underwriting discount,for 30 days after the date of this prospectus.Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of thesesecurities or determined if this prospectus is truthful or complete.Any representation to the con

26、trary is a criminal offense.Certain entities affiliated with Neuberger Berman Investment Advisers LLC(collectively,“Neuberger Berman”)have indicated aninterest in purchasing up to$75.0 million of shares of our common stock being offered in this offering at the initial public offering price andon the

27、 same terms as the other purchasers in this offering.However,because indications of interest are not binding agreements orcommitments to purchase,the underwriters could determine to sell more,fewer,or no shares to Neuberger Berman,and Neuberger Bermancould determine to purchase more,fewer,or no shar

28、es in this offering.The underwriters will receive the same underwriting discounts andcommissions on any of our shares of common stock purchased by Neuberger Berman as they will from any other shares of common stocksold to the public in this offering.The shares will be ready for delivery on or about,

29、2025.BofA SecuritiesJ.P.MorganGoldman Sachs&Co.LLC TD Cowen Evercore ISI Guggenheim Securities BTIG Wolfe|Nomura Alliance The date of this prospectus is,2025.The information in this preliminary prospectus is not complete and may be changed.These securities may not be sold until the registration stat

30、ement filed withthe Securities and Exchange Commission is effective.This preliminary prospectus is not an offer to sell,nor does it seek an offer to buy these securities in anyjurisdiction where the offer or sale is not permitted.(1)2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov

31、/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm2/361TABLE OF CONTENTS2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm3/361TABLE OF CONTENTSfiling,Data&Technology 849,000+Unique Cases Profiled

32、6.5+Million Total Tests Completed 13+Quadrillion Datapoints Generated 38+Billion Molecular Markers Measured 220+AI-Powered Tools Utilized 51+Petabytes of Genomic Data 4.4+Million Digitized Slides for Interpretation&AI Training 580,000+Matched Molecular&Clinical Outcomes Database 23,000+Genes Analyze

33、d per Order(WES/WTS)Commercial Reach 5,550+Regularly Ordering Oncologists(4+orders in the last 12 months)100+Biopharma Partners 270+Commercial Sales Team Members 96 Caris Precision Oncology Alliance Members 90+Payer Reimbursement Contracts 60%Cases Ordered Electronically Publications,Patents&People

34、1,050+Publications 200+Patents Granted(100+additional pending)1,700+Employees Data points are as of March 31,2025.2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm4/361TABLE OF CONTENTS(Thousands*)Clinical Cases Bi

35、opharma&External Research Cases 172.6 31%CAGR 136.9 2019-2024 103.4 162.9 77.5 30%Year-Over-Year Growth Rate 128.8 61.5 97.3 47.3 45.1 36.5 75.3 59.9 45.9 34.9 42.8 2019 2020 2021 2022 2023 2024 Q1 2024 Q1 2025*Figures reflect case volume for the periods presented.Figures may not sum precisely due t

36、o rounding.2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm5/361TABLE OF CONTENTSillions*)Molecular Profiling Services Pharma Research&Development Services$412.3 28%CAGR 2019-2024$306.1$258.5$120.5$114.1$163.9$155

37、.3$192.3$181.5$238.6$278.7$349.1 50%Year-Over-Year Growth Rate$120.9$80.7$114.1$73.2$6.4 2019$8.6 2020$10.8 2021$19.9 2022 2023 2024$7.4$6.8 Q1 2024 Q1 2025($79.1)($175.8)($324.0)($320.8)($341.4)($281.9)($111.0)($102.6)NET(LOSS)*Figures reflect revenue for the periods presented.Figures may not sum p

38、recisely due to rounding.2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm6/361TABLE OF CONTENTS TABLE OF CONTENTS PAGE LETTER FROM DAVID DEAN HALBERT,FOUNDER,CHAIRMAN,AND CEO iii PROSPECTUS SUMMARY 1 RISK FACTORS

39、21 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 99 MARKET AND INDUSTRY DATA 101 USE OF PROCEEDS 102 DIVIDEND POLICY 103 CAPITALIZATION 104 DILUTION 106 MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION ANDRESULTS OF OPERATIONS 109 BUSINESS 136 MANAGEMENT 211 EXECUTIVE COMPENSATION 221

40、CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS 231 PRINCIPAL SHAREHOLDERS 235 DESCRIPTION OF CAPITAL STOCK 238 SHARES ELIGIBLE FOR FUTURE SALE 247 MATERIAL U.S.FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S.HOLDERS OFOUR COMMON STOCK 252 UNDERWRITING 256 LEGAL MATTERS 267 EXPERTS 267 CHANGE IN IND

41、EPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 268 WHERE YOU CAN FIND ADDITIONAL INFORMATION 269 INDEX TO FINANCIAL STATEMENTS F-1 Neither we nor the underwriters have authorized anyone to provide any information or to make anyrepresentations other than those contained in this prospectus or in any free

42、writing prospectuses prepared byor on behalf of us or to which we have referred you.We and the underwriters take no responsibility for andcan provide no assurance as to the reliability of,any other information that others may give you.Thisprospectus is an offer to sell only the shares of common stoc

43、k offered hereby,but only under circumstancesand in jurisdictions where it is lawful to do so.The information contained in this prospectus or in anyapplicable free writing prospectus is current only as of its date,regardless of its time of delivery or any saleof shares of our common stock.Our busine

44、ss,financial condition,results of operations,and prospects mayhave changed since that date.For investors outside the United States:Neither we nor the underwriters have done anything thatwould permit this offering or possession or distribution of this prospectus or any free writing prospectus wemay p

45、rovide to you in connection with this offering in any jurisdiction where action for that purpose isrequired,other than in the United States.You are required to inform yourselves about and to observe anyrestrictions relating to this offering and the distribution of this prospectus and any such free w

46、ritingprospectus outside of the United States.i2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm7/361TABLE OF CONTENTS TRADEMARKS,TRADE NAMES AND SERVICE MARKSThis prospectus includes our trademarks and trade names

47、,including,without limitation,Caris Life Sciences,Caris,Caris Discovery,Caris Assure,MI Profile,Molecular Intelligence,Caris Precision Oncology Alliance,MI Tumor Seek,MI Tumor Seek Hybrid,ABCDai,CODEai,ESPai,MI Cancer Seek,GPSai,FOLFIRSTai,Caris ChromoSeq,MGMTai,and our logo,whichare protected under

48、 applicable intellectual property laws and are our property.This prospectus also containstrademarks,trade names,and service marks of other companies,which are the property of their respectiveowners.Solely for convenience,trademarks,trade names,and service marks referred to in this prospectus,includi

49、ng logos,artwork,and other visual displays,may appear without the,or symbols,but suchreferences are not intended to indicate in any way that we or the applicable owner will not assert,to thefullest extent under applicable law,our or its rights or the rights of the applicable licensor to thesetradema

50、rks,trade names,and service marks.We do not intend our use or display of other partiestrademarks,trade names or service marks to imply a relationship with,or endorsement or sponsorship of usby,any other parties.ROUNDING ADJUSTMENTSCertain monetary amounts,percentages,and other figures included elsew

51、here in this prospectushave been subject to rounding adjustments.Accordingly,figures shown as totals in certain tables or chartsmay not be the arithmetic aggregation of the figures that precede them,and figures expressed as percentagesin the text may not total 100%or,as applicable,when aggregated ma

52、y not be the arithmetic aggregation ofthe figures that precede them.ii SM2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm8/361TABLE OF CONTENTS LETTER FROM DAVID DEAN HALBERT,FOUNDER,CHAIRMAN,AND CEOHello,my name

53、is David Dean Halbert,and I am the Founder,Chairman,and CEO of Caris LifeSciences.Caris is the first and only company that Ive founded without a business model.Our only purposeis to help patients live longer and have a better quality of life by applying personalized medicine to disease.We believe th

54、at precise,data-driven,and personalized molecular information is crucial to eradicatingchronic health conditions.As a science-focused company,Caris has been at the forefront of precision medicine from thebeginning and has driven the industry forward through our focus on science and investments intot

55、echnology,instrumentation,facilities,and people.When I started Caris,next-generation sequencing,andother technologies needed to realize the benefits of personalized medicine,did not exist.However,we havebenefited from tremendous advances in sequencing technology,cloud computing,and AI technologies t

56、opower our expertise and insights in molecular biology.We believe that these advances provide anunmatched resource to develop the next generation of precision medicine solutions.Our platform is built on the premise that more data enables us to answer questions about biologythat could not be answered

57、 until now due to limited or narrow information.In the course of completing over6.5 million tests on over 849,000 cases,we have generated over 13 quadrillion molecular datapoints andmeasured over 38 billion molecular markers.We measure billions of data points per clinical case usingCaris Assure,our

58、universal blood-based whole exome/whole transcriptome sequencing solution,that wehave created based on our vast experience in tissue sequencing.We are utilizing this tremendous amount ofmolecular information to pioneer the transition from intuitive medicine,where decisions for cancer patientsare mad

59、e based on prior experience or intuition,to empirical medicine,where decisions are based on thegenetic make-up of each persons disease.Driven by over 17 years of innovation to help build a better world,we have gained vast expertise insequencing and data interpretation.We believe we were the first to

60、 offer comprehensive molecular profilingas standard practice when we launched whole transcriptome sequencing in 2019,the first to offer wholeexome sequencing as standard practice when we introduced our whole exome sequencing solution in 2020,and the first to offer whole exome and whole transcriptome

61、 sequencing in blood when we broadly launchedCaris Assure in the first quarter of 2024.We have utilized AI and machine learning algorithms across our dataset to identify approximately915,000 unique pathogenic mutations,of which only approximately 17,000 were previously identified,withapproximately 1

62、30 novel pathogenic mutations found on average in each person.We can now identify apersons circulating pathogenic mutations and enable the design of a customized individualized therapy tothat specific set of mutations.So,it becomes an individualized,customized immunotherapy.We believe thisis going t

63、o create the opportunity for physicians to use our solutions to effectively prevent various chronicdiseases before they ever get started at the earliest of stages.It is a very exciting time because technology has finally advanced to the point where it enables thisbig idea.This is not something that

64、could have been thought of in 2008 or even 2018 because thetechnologies were not available.Such as large sequencing capacity,AI,and the cloud,all of which have tobe utilized to look at all of the different aberrations that are occurring at the molecular level with theoutcomes.So over time,its just g

65、oing to get better and better and better.We run the same assay in bothblood and tissue on every eligible patient sample every day,so the only changes to the assay will be at thebioinformatic level utilizing specially-designed algorithms to provide new insights.While we specialize in oncology today,w

66、e also believe that since we have designed the CarisAssure platform as a universal assay that runs on every coding gene in the blood,it can be utilized toidentify alterations that drive other chronic disease states such as cardiovascular disease,neurologicalconditions,metabolic disorders,and many ot

67、hers.We exist in a very exciting time of unprecedented technological disruption to benefit mankind and“go where no man has gone before”something I have described as the molecular revolutionleading meto be bullish on humanity.Never before have we seen a convergence of molecular sequencing power,sophi

68、sticated AI technologies,and massive computer processing capabilities.We will continue to harnessthese and other advanced technologies,pushing the boundaries of what is possible and leading the precisionmedicine revolution in healthcare.iii2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.

69、sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm9/361TABLE OF CONTENTS We feel honored to have served hundreds of thousands of patients in their battle against cancer.Iwould like to thank our Caris Life Sciences family for their tireless work to help our patients and to bu

70、ild acompany that is actively changing the practice of medicine.We are excited about our future and welcomenew shareholders that share our vision and passion to improve the human condition.David Dean Halbert,D.Sc.(h.c.)Founder,Chairman,and CEO iv2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps

71、:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm10/361TABLE OF CONTENTS PROSPECTUS SUMMARYThis summary highlights selected information contained elsewhere in this prospectus and isqualified in its entirety by the more detailed information and financial statements inc

72、luded elsewhere in thisprospectus.It does not contain all of the information that may be important to you and your investmentdecision.You should carefully read this entire prospectus,including the sections titled“Risk Factors,”“Managements Discussion and Analysis of Financial Condition and Results o

73、f Operations,”and“SpecialNote Regarding Forward-Looking Statements”and our financial statements and related notes includedelsewhere in this prospectus before making an investment decision.In this prospectus,unless contextrequires otherwise,references to“we,”“us,”“our,”“Caris,”or“the Company”refer to

74、 Caris LifeSciences,Inc.and its wholly owned subsidiaries.OverviewWe are a leading,patient-centric,next-generation AI TechBio company and precision medicinepioneer.We develop and commercialize innovative solutions to transform healthcare through the use ofcomprehensive molecular information and arti

75、ficial intelligence/machine learning algorithms at scale.Ourentire portfolio of precision medicine solutions is designed to benefit patients,with an initial focus ononcology,and serves the clinical,academic,and biopharma markets.We founded Caris in 2008 with the belief and vision that combining a va

76、st set of consistentlygenerated molecular information with robust data-driven insights could realize the potential of precisionmedicine for patients.We have spent the last 17 years developing and building our portfolio ofcomprehensive,proprietary molecular profiling solutions and generating what we

77、believe to be one of thelargest and most comprehensive multi-modal clinico-genomic datasets in oncology based on the more than6.5 million tests we have run on over 849,000 cases,which have generated measurements of over 38 billionmolecular markers.Our platform is purpose-built to leverage the conver

78、gence of next-generationsequencing(“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 latestgeneration of advanced precision medicine diagnostic solutions designed to a

79、ddress the entire cancer carecontinuum,including early detection,minimal residual disease(“MRD”)tracking,therapy selection,andtreatment monitoring,as well as to create molecular signatures and discover and develop novel precisionmedicine therapeutics.Our current commercial product portfolio is focus

80、ed on oncology and consists of MIProfile,our tissue-based molecular profiling solution that has generated the majority of our revenue to date,and Caris Assure,our novel,universal blood-based molecular profiling solution that was broadly launchedin the first quarter of 2024 for therapy selection.Dysf

81、unctionality at the molecular level underlies every chronic disease,and this dysfunction is nowmeasurable using techniques such as NGS.Cells are embedded within highly complex biological networksthat govern all aspects of life,including how these cells grow,divide,interact,and die.These biologicalne

82、tworks and their inherent functions,as well as dysfunctions,are controlled and directed at the molecularlevel.The precise molecular origins or contributors to a given biological dysfunction,however,are oftenunknown,and a comprehensive molecular profile is necessary to determine these origins.The cen

83、tral dogmaof molecular biology states that genetic information flows in one direction,from DNA,to RNA,to proteins.Our approach is designed to accurately capture the full breadth of the DNA and RNA coding information incells as well as protein expression through immunohistochemical(“IHC”)tests,constr

84、ucting a fulsomemosaic of disease,and ultimately unlocking the potential for precision medicine therapeutics to guideindividualized patient diagnoses and treatment.We believe we are well-positioned to realize the full potential of our vision and optimally leverageour vast datasets due to the recent

85、convergence of several advancements in biology,medicine,andtechnology:(1)the medical communitys understanding and appreciation of the molecular nature of cancerhas accelerated in recent years,resulting in a continued increase in molecular profiling of different cancertypes and stages;(2)NGS costs ha

86、ve declined,making NGS more accessible to the healthcare ecosystem;(3)cloud-computing architecture has enabled massive scalability,distributed real-time collaboration,andgreater cost efficiency for the analysis of previously unmanageable amounts of data;and(4)AI and MLcomputational capabilities have

87、 advanced to allow more effective interrogation of large biological datasets.We believe that our early foresight to generate comprehensive data at scale over the past many years andbuild a robust,foundational infrastructure have uniquely positioned Caris to leverage the benefits of these 12025/6/10

88、09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm11/361TABLE OF CONTENTS biological and technological advances to deliver transformative and advanced innovations in precisionmedicine and patient care into the future.Our purp

89、ose-built,proprietary multi-omic profiling solutions capture and analyze molecularinformation from tissue and blood in a comprehensive manner.We provide whole exome sequencing(“WES”)(all 23,000 encoding DNA genes)and whole transcriptome sequencing(“WTS”)(all 61,000 RNAtranscripts that encode protein

90、s)on every eligible patient sample(a sample provided by ordering physiciansthat contains sufficient genetic material for profiling).Since launching our WTS solution in 2019 and WESsolution in 2020,we have performed over 500,000 WES and WTS cases through May 2025,which webelieve is more than any othe

91、r company.We sequence at a sector-leading depth of coverage,which directlycorrelates with increased accuracy and detection of low frequency molecular markers of relevance.MICancer Seek,our U.S.Food and Drug Administration(FDA)-approved companion diagnostic assay toidentify cancer patients who may be

92、nefit from treatment with targeted therapies(a component of MIProfile),consistently reaches 1,500 times depth of coverage for clinically relevant DNA genes,which is ahigher sequencing depth than other assays available in the marketplace based on reported depths ofcoverage,and 300 times depth of cove

93、rage for the whole exome.Caris Assure features a raw averagesequencing depth of 8,000 times for clinically relevant genes,similarly a higher sequencing depth than otherassays available in the marketplace based on reported depths of coverage.We generate tens of billions ofdatapoints per clinical case

94、 to reveal an individualized molecular blueprint of the patients disease.Webelieve this approach best positions us to provide actionable treatment pathways from targeted therapies todrive superior clinical outcomes for patients while also generating a rich dataset to power insights andinnovation.To

95、our knowledge,we remain the only genomic profiling company to consistently utilize WESand WTS as standard practice on every eligible patient sample.We also evaluate protein molecular markersthrough an extensive menu of IHC tests performed in a tumor-type specific manner,which in combinationwith WES

96、and WTS,provide a comprehensive view of a patients disease.Our in-depth profiling of patient samples has led to the creation of what we believe to be one of thelargest and most comprehensive multi-modal clinico-genomic datasets in oncology,including genomic data,clinical data,digitized slide images,

97、and remnant tissue.As of March 31,2025,we have run more than6.5 million tests on over 849,000 cases,which have generated measurements of over 38 billion molecularmarkers.Leveraging high-powered computing and AI/ML algorithms,we,and our biopharma and researchpartners who use our data and bioinformati

98、cs services,analyze our datasets to determine the key molecularcharacteristics of a particular disease or dysfunction that drives disease,enabling signature identificationand drug target discovery.As a leader in the transition to WES/WTS sequencing through our launch of aWTS solution in 2019 and a W

99、ES solution the following year,we believe we have more molecular data andinformation than any other company and are well-positioned to make precision medicine widely accessible.Our molecular profiling solutions and the data generated by our multi-omic technology platformprovide value to our more tha

100、n 100 biopharma partners,such as Moderna,AbbVie,Xencor,and MerckKGaA,through partnerships that aim to increase the probability of technical and regulatory success of theirtherapeutic pipelines.In addition to biopharma,we leverage our datasets to partner with outside academiccenters and researchers t

101、o further advance precision oncology research.The Caris Precision OncologyAlliance(“Caris POA”),which we established in 2015,is a growing network of leading cancer centers andresearch consortia across the globe that collaborate to advance precision oncology and biomarker-drivenresearch,with its memb

102、ers working together to establish and optimize standards of care for moleculartesting through innovative research to improve clinical outcomes for cancer patients.As of March 31,2025,the Caris POA was comprised of 96 members,including 45 National Cancer Institute(“NCI”)-designatedcomprehensive cance

103、r centers.This academic-industry collaborative network has been exceptionallyproductive with over 145 peer-reviewed manuscripts published since the beginning of 2022.Closeconnectivity with this vast network of key opinion leaders(“KOLs”)in oncology clinical care,research,anddrug development has enab

104、led us to remain at the forefront of precision oncology and closely attuned to thekey needs of the most sophisticated researchers.Our Caris platform is designed to create a virtuous cycle that can enable continued innovation andimproved impact for patients and physicians.We believe our comprehensive

105、 approach to profiling willcontinue to drive demand for our genomic profiling capabilities,leading to further expansion of our clinico-genomic datasets,which provide additional valuable inputs to develop and enhance our solutions,with the 22025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.

106、sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm12/361TABLE OF CONTENTS ultimate goal of contributing to improved patient results.This continuous feedback loop enabled us todevelop Caris Assure,which utilized genomic data generated by MI Profile to inform our blood-basedbi

107、oinformatics algorithms,allowing us to detect previously unknown features and signals in the blood thatprovide advanced insights into disease development.We believe we will be able to further leverage thisprocess to continue meaningful innovation in precision oncology as well as other chronic diseas

108、e states,including cardiology,neurology,and metabolic conditions.Our global annual clinical case volume has been growing rapidly,with year-over-year growth of29%in 2022,32%in 2023,26%in 2024,and 31%in the first quarter of 2025,primarily driven by MIProfile.With our broad commercial launch of Caris A

109、ssure for therapy selection in the first quarter of 2024and the FDA approval of MI Cancer Seek as a companion diagnostic in the fourth quarter of 2024 followedby the broad commercial launch of MI Cancer Seek in the first quarter of 2025 as the NGS component ofMI Profile,we believe that increased pro

110、filing volumes will meaningfully contribute to our growth in 2025and beyond.For the years ended December 31,2024 and 2023,we generated total revenue of$412.3 millionand$306.1 million,respectively.For the three months ended March 31,2025 and 2024,we generated totalrevenue of$120.9 million and$80.7 mi

111、llion,respectively.We have incurred net losses and negative cashflows from operations since inception.For the years ended December 31,2024 and 2023,we incurred netlosses of$257.1 million and$341.4 million,respectively.For the three months ended March 31,2025 and2024,we incurred net losses of$102.6 m

112、illion and$111.0 million,respectively.Our Adjusted EBITDA was$(189.6)million and$(255.3)million for the years ended December 31,2024 and 2023,respectively.OurAdjusted EBITDA was$(36.2)million and$(70.1)million for the three months ended March 31,2025 and2024,respectively.For additional information r

113、egarding Adjusted EBITDA,a non-GAAP financial measure,see“Managements Discussion and Analysis of Financial Condition and Results of OperationsNon-GAAPFinancial Measures.”We expect to incur additional net losses in the near future,and our expenses willincrease as we continue to invest in developing n

114、ew solutions,expand our organization,and increase ourmarketing efforts to continue to drive market adoption of our solutions.These investments,together withgeneral and administrative expenses,have resulted in negative cash flows from operations of$245.2million,$276.1 million,$31.3 million,and$73.9 m

115、illion for the years ended December 31,2024 and 2023and the three months ended March 31,2025 and 2024,respectively.Our free cash flow was$(253.6)millionand$(298.4)million for the years ended December 31,2024 and 2023,respectively,and,$(34.0)millionand$(75.7)million for the three months ended March 3

116、1,2025 and 2024,respectively.For additionalinformation regarding free cash flow,a non-GAAP financial measure,see“Managements Discussion andAnalysis of Financial Condition and Results of OperationsNon-GAAP Financial Measures.”Additionally,as of March 31,2025,we had cash,cash equivalents,and short-ter

117、m marketable securities of$33.4 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“Managements Discussion andAnalysis of Financial Condition and Results of Operatio

118、nsLiquidity and Capital Resources.”Industry OverviewAddressing the complexity of cancer remains a major challenge in healthcare and a critical area ofunmet medical need,despite enormous investments in research and development(“R&D”),and theintroduction of new oncology therapeutics and treatments.The

119、 molecular revolution is upending thetraditional paradigm of complex workflows of diagnosis,treatment,and monitoring of diseases,whichlargely uses a symptomatic,reactive approach to medicine.Over the last several decades,significantadvances in genomics,proteomics,molecular technology,and computing p

120、ower have enabled acomprehensive,multi-omic approach to the molecular profiling of diseases,both efficiently and at scale.The information provided by comprehensive molecular profiling is driving a revolution in medicine,wheremolecular information is used to guide individualized patient diagnoses and

121、 treatment.Comprehensive molecular profiling entails evaluating thousands of potential biomarkers,includingDNA,RNA,proteins,and other molecular and clinical information for characteristics unique to a particularpatients disease.Given the complexity of a cancers origin and drivers,comprehensive molec

122、ularinformation incorporating DNA,RNA,and protein profiles can help provide the most robust picture of apatients disease and potential treatment pathways.WES/WTS streamlines the patient experience andclinical decision-making and offers increased value to patients,physicians,and payers.We believeWES/

123、WTS 32025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm13/361TABLE OF CONTENTS provides the most efficient and cost-effective way to obtain the maximum information on a patients cancerat the start of the patient jou

124、rney.It enables accurate identification of a greater number of actionablegenomic alterations that can be leveraged to match patients to the most effective treatments,yielding ahigher probability of response and providing comprehensive predictive and prognostic information.While the molecular revolut

125、ion has already changed the way cancer is being diagnosed and treated,we believe that molecular testing faces several major challenges in its current form,which have hinderedbroader adoption of precision oncology.These challenges include:(1)targeted panels are subject to missinginformation and signi

126、ficant variability;(2)lack of consistent RNA profiling;(3)lack of clonalhematopoiesis(“CH”)derived variant subtraction technology in current blood assays,contributing to theinability to identify false positive mutations that are not tumor-derived;(4)disparate data sets collectedacross testing modali

127、ties;(5)logistical drawbacks and sensitivity limitations of current MRD assays;and(6)false positives and a lack of early-stage sensitivity with current multi-cancer early detection(“MCED”)assays.As a result of these challenges,clinicians may make critical treatment decisions based onincomplete and/o

128、r inaccurate information and analytics,potentially resulting in suboptimal outcomes.Webelieve that our comprehensive molecular profiling solutions and the data generated by our multi-omictechnology platform is well-suited to address the limitations and challenges of todays molecular testingalternati

129、ves.The Caris PlatformWe are leading a molecular revolution and developing the latest generation of advanced precisionmedicine information solutions that we believe have applicability across the care continuum for a broadrange of conditions.The fundamental differentiation of the Caris platform and o

130、ur business model is thedepth,breadth,and scale of data,including how that data is integrated vertically and horizontally across ourbusiness,as well as the resulting innovation which it fuels.Our multi-omic technology platform is built on the following pillars:(1)Caris Assure;(2)MIProfile;(3)Caris D

131、iscovery;(4)Caris Strategic Data;and(5)Caris Infrastructure.These five pillars aredesigned to work together to create a virtuous cycle that can enable continued innovation and improvedimpact for patients and physicians.We believe our comprehensive approach to profiling will continue todrive demand f

132、or our genomic profiling capabilities,leading to further expansion of our clinico-genomicdatasets,which provide additional valuable inputs to develop and enhance our solutions,with the ultimategoal of contributing to improved patient results.We believe this continuing cycle will deepen ourcompetitiv

133、e advantage and allow us to achieve meaningful innovation and business success in precisiononcology,while illuminating a path to precision medicine for other chronic disease states,includingcardiology,neurology,and metabolic conditions.42025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec

134、.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm14/361TABLE OF CONTENTS We believe our growth and competitive differentiation are driven by the five pillars of our platform,each of which are both a product of the upstream data and a foundation to further innovation and datage

135、neration across the platform:Caris Assure.Our universal blood-based WES/WTS profiling solution is designed to deploy asingle assay across the entire continuum of cancer care,including early detection,MRDtracking,therapy selection,and treatment monitoring,and generates over 42 billion datapoints,span

136、ning 168,000 molecular markers,per clinical case.We leveraged our experience and datafrom MI Profile to create Caris Assure,which enables us to understand how a patients diseasestarted,what therapies the tumor may be sensitive to,how the tumor is transforming to resisttherapies,and how best to contr

137、ol or cure the disease.MI Profile.Our tissue-based profiling solution for therapy selection includes MI Cancer Seek,our FDA-approved companion diagnostic WES/WTS profiling assay,and IHC proteinexpression testing.Our WES/WTS profiling solution generates over 28.8 billion datapoints,spanning 84,000 mo

138、lecular markers,per clinical case.Caris Discovery.The combination of our data and our AI enables us to discover previouslyunknown drug targets for antibody-directed therapies(such as antibody drug conjugates,degrader-antibody conjugates,and T-cell engagers),small molecules,targeted proteindegradatio

139、n,synthetic lethal interactions,and cell therapy.In addition,we believe CarisDiscovery is well-positioned for neoantigen discovery for personalized therapy developmentgiven our ability to detect variants,insertions,and deletions by WES and to assess geneexpression and detect fusions by WTS on every

140、patients tumor.Caris Strategic Data.As of March 31,2025,we have run more than 6.5 million tests that havemeasured over 38 billion molecular markers from over 13 quadrillion datapoints.To assist uswith analyzing the data we generate,we utilize over 220 AI and AI/ML tools across our 52025/6/10 09:19tm

141、2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm15/361TABLE OF CONTENTS clinical testing,R&D,and biopharma business.These tools include over 50 clinical sequencingautomation and variant calling AIs,over 100 RNA expression AI signa

142、tures,approximately 20multi-omic AI/ML therapy response predictors,two ADAPT target discovery AI/MLalgorithms,37 digital image AI/ML classifiers,and 12 AI/ML support tools.The breadth anddepth of our data assets,along with our ability to create algorithms and discover signatures,represent a deep com

143、petitive moat for us.Caris Infrastructure.We have a well-developed laboratory,R&D,and sales infrastructure thatwe believe is foundational to our business.Our infrastructure includes substantial testingcapacity and a dedicated workforce to support our R&D efforts,sales activity,and expansion.Our Mark

144、et Opportunity and Vision for Leveraging Molecular InformationWe believe we are well-positioned to initially pursue a total addressable market in U.S.oncology ofapproximately$150 billion through the provision of precision medicine solutions across the entire cancercare continuum,as well as offerings

145、 to support biopharma drug discovery and development.While ourtissue-based molecular profiling solution for cancer therapy has generated the majority of our revenue todate,we believe the launch of our blood-based profiling offering for therapy selection,our expansion of ourblood-based profiling offe

146、ring beyond therapy selection in particular,and further leveraging our platform toprovide solutions to biopharma companies will enable us to benefit significantly from this large marketopportunity.Our estimated total addressable U.S.oncology market,which is based on a market study byNephron Research

147、 LLC that we commissioned,is comprised of opportunities in the following areas:Early detection:approximately$100 billion.Therapy selection:approximately$8 billion.MRD tracking and treatment monitoring:approximately$28 billion.Core biopharma services:approximately$4 billion.Data services for biopharm

148、a:approximately$10 billion.We also believe there is a large market opportunity for our platform in other chronic disease statesbeyond oncology,including cardiology,neurology,and metabolic conditions,based on the fundamentalpremise that approaching blood-based disease detection with a comprehensive W

149、ES/WTS approach enablesexamination of biomarkers that go beyond oncology.For additional information,see“BusinessOurMarket Opportunity and Vision for Leveraging Molecular Information.”The Caris AdvantageWe believe our approach is differentiated and we have a competitive advantage because:We purpose-b

150、uilt our Caris platform to put the patient first and make comprehensive precisionmedicine a reality.We are a leading provider of tissue-based molecular profiling,including through our FDA-approvedcompanion diagnostic tissue-based profiling solution,MI Cancer Seek.Our novel,universal blood-based prof

151、iling solution,Caris Assure,is unique in the market and poisedfor rapid adoption.We have built what we believe to be one of the largest and most comprehensive multi-modal clinico-genomic datasets in oncology.Our first mover advantage,specialized commercial channel,robust infrastructure,and deep rese

152、archcollaborations enable our leadership and provide us with the ability to scale for future growth.We are led by a founder with significant experience building and scaling businesses in the healthcareindustry and a management team with scientific expertise.62025/6/10 09:19tm2415719-16_s1a-block-44.

153、7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm16/361TABLE OF CONTENTS Our StrategiesTo achieve our goal of leading a molecular revolution and developing the next generation ofprecision medicine information solutions for a broad range of conditions acro

154、ss the care continuum,we planto:Drive the continued adoption and use of our tissue-based profiling and expand blood-based profilingoffering into early detection,MRD,and monitoring.Utilize the data generated by our existing solutions to develop new solutions with additional revenueusing our existing

155、sales channel.Leverage our platform to provide solutions to biopharma companies to drive advances in personalizedmedicine and accelerate the development of novel therapeutics.Continue to expand and enrich our clinico-genomic datasets to drive breakthrough science anddevelop new solutions.Maximize ma

156、rket reach through our regulatory approval and reimbursement strategy.Capitalize on the ultimate potential of our novel,universal blood-based profiling solution,CarisAssure,and broader innovation platform in other chronic disease states beyond oncology,includingin cardiology,neurology,and metabolic

157、conditions.Caris AssureOur Universal Blood-Based Profiling SolutionCaris Assure is our novel,universal blood-based solution that is purpose-built to extend across theentire continuum of cancer treatment,including early detection,monitoring of MRD and recurrent cancers,and precision selection of mole

158、cularly targeted therapies.Caris Assure also has applications in therapeuticdiscovery and development.We believe Caris Assure represents the most comprehensive blood-basedsolution on the market,featuring over 23,000 gene coverage at a raw average sequencing depth of coverageof 8,000 times for clinic

159、ally relevant genes,as compared to other blood-based offerings in the market thatonly assess 500 to 1,000 genes from DNA.Caris Assure performs WES and WTS for every eligible patientblood sample.We integrate WES and WTS with sophisticated AI and ML technologies to offer diagnostic,prognostic,and pred

160、ictive utility in a single test.For therapy selection,in addition to sequencing cell-free DNA and cell-free RNA isolated from theplasma to identify somatic tumor variants,Caris Assure also sequences genomic nucleic acid(gDNA andgRNA)isolated from the white blood cells,or buffy coat,from each sample.

161、Sequencing the buffy coat inaddition to the plasma allows Caris Assure to identify incidental germline mutations as well as CHmutations.CH mutations are age-related non-malignant mutations that occur in a substantial portion of thepopulation,are not cancer-derived and are present in both the plasma

162、and buffy coat and cannot beidentified from sequencing plasma alone.Caris Assure“subtracts”CH mutations in the reporting of somatictumor variants.This lessens the risk of incorrectly interpreting CH or germline mutations as tumor-derivedand results in fewer false positive diagnoses and more accurate

163、 and effective treatment recommendations.We believe that CH subtraction is of critical importance to ensure optimal cancer care because of theprevalence of CH mutations.By identifying and distinguishing variants that are not from the tumor itselfand,therefore not relevant to therapeutic decision-mak

164、ing,the CH subtraction feature of Caris Assurefurther separates our solution from other liquid biopsy tests currently on the market that do not sequence thewhite blood cells and therefore cannot definitively distinguish CH mutations from tumor-derived mutations.To our knowledge,Caris Assure is the o

165、nly commercially available tissue-naive blood-based profiling assaythat directly accounts for CH mutations instead of using algorithmic approximations,which we believegives Caris Assure a differentiated ability to drive improved therapy selection.Customers for Caris Assure include treating physician

166、s as well as researchers and biopharmacompanies.The same benefits that blood-based WES,WTS,and CH subtraction bring to patients in theclinical setting also offer significant and previously unavailable advantages to biopharma companies.We initiated a broad commercial launch of Caris Assure for therap

167、y selection in the first quarter of2024 and currently offer the solution as a laboratory developed test(“LDT”),which the FDA hashistorically considered a form of medical device,as an in vitro diagnostic(“IVD”)test intended for clinicaluse and 72025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/

168、www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm17/361TABLE OF CONTENTS designed,manufactured,and used within a single laboratory.The FDA has historically exercisedenforcement discretion and not required marketing authorization for certain kinds of LDTs.Accordingly,weh

169、ave not obtained FDA marketing authorization for Caris Assure.We may decide to seek FDA marketingauthorization for certain of our solutions in the future,including Caris Assure for therapy selection,depending in part on the ultimate outcome of litigation over the FDAs authority over LDTs.For additio

170、nalinformation,see“BusinessGovernment RegulationU.S.Food and Drug Administration”and“RiskFactorsWe have current solutions marketed as LDTs and plan to launch future solutions as LDTs.Theregulation of LDT products in the United States remains subject to significant uncertainty,and if we fail tocomply

171、 with any new or existing legal requirements governing our LDT solutions,our business,financialcondition,and results of operations could be adversely affected.”We have Medicare reimbursement andvarious levels of commercial payer adoption and/or reimbursement coverage for Caris Assure for therapysele

172、ction across the United States.The current pricing of Caris Assure for therapy selection underMedicares Molecular Diagnostic Services Program(“MolDX”)is$3,649.Caris Assure for therapy selection is available in all U.S.states(other than New York,where weintend to apply in 2025 for approval from New Y

173、ork States Clinical Laboratory Evaluation Program(“NYCLEP”)and in Puerto Rico.We also offer Caris Assure for therapy selection internationally throughdistributors and direct contracts with hospital systems,where permitted by applicable regulations.Our Differentiated Approach to Address the Entire Ca

174、ncer Care Continuum Through a Single Blood TestOur universal approach to blood-based profiling is unique.Liquid biopsies can be used across thecare continuum,including for:therapy selection in the advanced/metastatic setting;MRD and monitoring inthe curative/adjuvant setting;and early detection in t

175、he diagnosis setting.Because many of our competitorsliquid biopsy assays are designed to address only a single portion of this care continuum,in order to developproducts for other portions of the care continuum,our competitors must invest in the development of newwet lab assays and generate disparat

176、e datasets across the patient journey for patients,oncologists,andresearchers.In contrast,Caris Assure is designed as a single test applicable across the entire patient journey.To our knowledge,there is no other assay on the market that can be applied as broadly as Caris Assure.Webelieve that our ap

177、proach will enable us to scale our R&D infrastructure to analyze increasingly largertesting volumes,process expanding datasets,and reach economies of scale in liquid biopsy across the entirecancer care continuum.We believe that one of the most promising uses for Caris Assure is for detection of canc

178、er at veryearly stages,such as stage 1 or stage 2.Our detection of cancer at very early stages would enable cliniciansto treat disease sooner,which could significantly improve patient outcomes.We believe that Caris Assurefor early detection of cancers will initially be available for early detection

179、of certain types of cancers,suchas breast cancer and colon cancer,and then we intend to expand Caris Assure for full MCED indications.Inan internal validation study conducted by us,the performance of our Assure Blood-based Cancer Detectionai(“ABCDai”)for MCED(“ABCDai-MCED”)demonstrated a high level

180、of sensitivity at a specificity thatreduces the burden of false positives.For additional information on the validation study,see“Business Our SolutionsCaris AssureOur Universal Blood-Based Profiling SolutionCaris Assure for EarlyDetection.”For MRD,our detection methodology based on ABCDai takes a tu

181、mor nave approach,andtherefore does not require a bespoke panel to be created to track the recurrence of a patients tumor.Thisapproach means that our MRD assay can be used without the need for a tissue sample and enables fasterturn-around-time,enabling patients to be informed of additional therapy s

182、ooner to combat their disease.MI ProfileOur Tissue-Based Profiling SolutionMI Profile is our tissue-based molecular profiling solution for cancer therapy selection,with overone million tests performed on approximately 146,500 clinical cases in 2024 and an additionalapproximately 40,000 clinical case

183、s in the three months ended March 31,2025.As of March 31,2025,wehave performed over 6.5 million tissue-based tests on over 790,000 clinical cases since inception.MIProfile includes MI Cancer Seek,our FDA-approved companion diagnostic WES/WTS NGS assay,and IHCprotein expression testing.82025/6/10 09:

184、19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm18/361TABLE OF CONTENTS Customers for MI Profile include treating physicians as well as researchers and biopharmacompanies.The information generated from profiling the patients t

185、issue is used to create an interpretativereport based on our bioinformatics pipeline and recommend individualized therapies for cancer patients.Our goal is to maximize the information generated and corresponding clinical utility for patients from thelimited available tumor tissue.Molecular profiling

186、 also has broad applications for our biopharma partners,including prospective screening,retrospective testing and deep translational analyses,stratification ofpatients for existing or future trials,and treatment monitoring.We have obtained Medicare and commercial reimbursement for MI Profile.We have

187、 also obtained apremarket approval(“PMA”)from the FDA for a companion diagnostic and tumor profiling designation forMI Cancer Seek,a WES/WTS NGS assay that uses the whole exome for tumor mutational burden(“TMB”)calling,and for which we have obtained a Proprietary Laboratory Analyses(“PLA”)code,Curre

188、ntProcedural Terminology(CPT)code 0211U,at a reimbursement rate of$8,455.In the first quarter of2025,we began to market MI Cancer Seek as the WES/WTS NGS component of MI Profile.We haveobtained Medicare coverage for MI Cancer Seek for CPT code 0211U under the NGS NCD.We currentlyoffer MI Tumor Seek

189、Hybrid,which is a WES/WTS NGS LDT assay,as an alternative assay if a specimendoes not meet the eligibility requirements for MI Cancer Seek.MI Profile,including our MI Cancer Seek assay and proprietary clinical molecular signaturesGPSai and FOLFIRSTai,is available in all U.S.states and in Puerto Rico

190、.We also offer MI Profileinternationally in over 40 countries through distributors and direct contracts with hospital systems,wherepermitted by applicable regulations.Caris DiscoveryCaris Discovery is our drug target and therapeutic discovery business.Caris Discovery leveragesour profiling solutions

191、,multi-modal clinico-genomic datasets,wet lab facilities,proprietary Adaptive 92025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm19/361TABLE OF CONTENTS Dynamic Artificial Polyligand Targeting(“ADAPT”)platform,and A

192、I/ML-enabled in silico analyses toidentify potential drug targets and develop therapeutics.We launched Caris Discovery in 2022 to partnerwith biopharma partners to address the lack of novel cancer-specific targets and the herding of biopharmapipelines around a discrete number of lower-risk targets.C

193、aris Discovery is disease-and modality-agnosticand can be applied to any therapeutic modality,including antibody-directed therapies(such as antibody drugconjugates,degrader-antibody conjugates,and T-cell engagers),small molecules,targeted proteindegradation,synthetic lethal interactions,and cell the

194、rapy.We have achieved external validation of ourCaris Discovery approach through strategic partnerships with established biopharma companies,such asMerck KGaA and Xencor,to develop therapeutics against novel targets that emanate from our molecularinsights and proprietary technology.In addition,we be

195、lieve Caris Discovery is well-positioned forneoantigen discovery for personalized therapy development given our ability to detect variants,insertions,and deletions by WES and to assess gene expression and detect fusions by WTS on every patients tumor.Our proprietary repositories of tissue and data,e

196、ach of which we believe to be at an unmatchedscale,are a resource that could not have been amassed without our underlying commercial profilingbusiness,and as such are a significant differentiator and enabler of our discovery efforts.Caris Strategic DataData and molecular information are at the core

197、of every aspect of our business.Our team of morethan 60 data scientists deploy our proprietary advanced AI/ML algorithms to decipher unique features fromour resulting clinico-genomic datasets,helping us decode and further unravel the molecular complexity ofdisease.Our 17-year history of utilizing AI

198、 and ML algorithms,together with the breadth and depth of ourclinico-genomic datasets,provide us a significant advantage in sophisticated analysis of cancer,and afoundation that we believe will have applications in additional disease states.The tremendous amount of data generated through our profili

199、ng solutions,which we havedeidentified for research use,provides us a differentiated capability to advance precision oncology researchthrough many business models.For example,we launched our data licensing business in late 2022,throughwhich we license deidentified data that we have generated from ou

200、r clinical profiling business to biopharmacompanies with the aim of generating insights directly responsible for superior clinical outcomes forpatients.We have a rich pipeline of data opportunities that we believe will deliver new partnerships,as wecontinue to introduce biopharma companies to this u

201、nique data offering.Additionally,through the CarisPOA,which is a growing network of leading cancer centers and research consortia across the globe,wesupport research partner engagement,collaboration opportunities,and the advancement of precisiononcology research.Since its establishment in 2015,the C

202、aris POA has grown to comprise 96 members as ofMarch 31,2025,including 45 NCI-designated comprehensive cancer centers that work collaborativelytoward a common goal:to advance tumor profiling and establish and optimize standards of care formolecular testing through innovative research to improve clin

203、ical outcomes for cancer patients.We estimatethat the members of the Caris POA have over 3,000 oncologists in over 650 locations that treat more than650,000 new cancer patients annually.Future AssaysCaris aims to develop the next generation of precision medicine tools that will allow us to transitio

204、nfrom intuitive medicine to empirical medicine.As a leader in the transition to WES/WTS sequencingthrough our launch of a WTS solution in 2019 and a WES solution the following year,we believe we havemore molecular data and information than any other company and are well-positioned to make precisionm

205、edicine widely accessible.For example,we are developing Caris ChromoSeq,an assay to detect andanalyze hematological(blood)cancers using whole genome sequencing(“WGS”)and WTS.We areinternally validating this assay and developing it for commercial launch.We are also working to developand validate the

206、plasma portion of our Caris Assure assay for full germline testing.Additionally,we areusing our molecular data to develop ESPai,an AI/ML algorithm to predict the risk of recurrence of early-stage breast cancer.We have obtained the samples and clinical data from the National Surgical AdjuvantBreast a

207、nd Bowel Project and the ECOG-ACRIN Cancer Research Group.We are currently in the process ofcreating two AI/ML models for ESPai using these samples and are working to obtain additional samples forexternal 102025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/20194

208、10/000110465925057593/tm2415719-16_s1a.htm20/361TABLE OF CONTENTS validation studies.We are initially creating a model for late recurrence(five to 15 years followingdiagnosis),but we are also in the beginning stages of creating a model for early recurrence(zero to fiveyears following diagnosis).Cari

209、s InfrastructureWe believe our well-developed laboratory,R&D,and sales infrastructure is foundational to ourbusiness.We have substantial testing capacity,including over 275,000 square feet of space across fourprecision medicine laboratories with throughput capabilities of over one trillion reads per

210、 day generated by50 NovaSeq sequencing systems.We believe this capacity provides us with ample capability to manage ourcurrent operations and future growth.We also have a dedicated R&D infrastructure,including a specializedlaboratory and over 200 employees dedicated to R&D efforts.In addition to our

211、 internal research,weregularly partner with outside academic centers and researchers,including through the Caris POA.Additionally,to support our sales activity and expansion,as of March 31,2025,we have assembled atargeted sales organization in the United States of over 270 sales team members and nea

212、rly 50 highly trainedPh.D.or M.D.molecular science liaisons(“MSLs”)who focus on physician and provider education.Webelieve that our robust,foundational infrastructure,together with our expansive multi-modal clinico-genomic datasets,has uniquely positioned Caris to deliver transformative and advanced

213、 innovations inprecision medicine and patient care into the future.Summary Risk FactorsParticipating in this offering involves substantial risk.Our ability to execute our strategy is alsosubject to certain risks.The risks described under the heading“Risk Factors”included elsewhere in thisprospectus

214、may cause us not to realize the full benefits of our strengths or may cause us to be unable tosuccessfully execute all or part of our strategy.Some of the most significant challenges and risks we faceinclude the following:The precision medicine industry is highly competitive and subject to rapid cha

215、nge.We have incurred significant losses since inception,expect to incur losses in the future,andmay not be able to generate sufficient revenue to achieve and maintain profitability.Our current or future solutions may not achieve or maintain sufficient commercial marketacceptance.Our solutions may no

216、t perform as expected,and the results of our validation studies or ourclinical trials may not support the launch or use of our solutions and may not comply with therequirements,or be replicated in later trials required,for any necessary or desirable marketingauthorizations.This could adversely affec

217、t our business,financial condition,results ofoperations,and growth prospects.Our current revenue is primarily generated from the continued adoption and use of our tissue-based profiling solution.Our future success and growth will depend in part on market acceptance and commercialsuccess of our MI Ca

218、ncer Seek and Caris Assure solutions.We may be unsuccessful incontinuing the commercialization of MI Cancer Seek or Caris Assure,which would adverselyaffect our business,financial condition,results of operations,and growth prospects.If we are unable to support demand for MI Profile,Caris Assure,and

219、any other solutions wedevelop,including ensuring that we have adequate capacity to meet increased demand,or if weare unable to successfully manage our anticipated growth,our business could suffer.Our results of operations may fluctuate significantly,which makes our future results ofoperations diffic

220、ult to predict and could cause our results of operations to fall belowexpectations or any guidance we may provide.If our solutions,or solutions we develop in the future,do not receive adequate coverage andreimbursement from third-party payers,including government and commercial payers,our 112025/6/1

221、0 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm21/361TABLE OF CONTENTS ability to expand access to our solutions beyond our existing sales channels,and thus ouroverall commercial success,will be limited.Our billing,colle

222、ctions,and claims processing activities are complex and time-consuming,andany delay in transmitting and collecting claims or failure to comply with applicable billingrequirements could have an adverse effect on our future revenue.We rely on a limited number of third-party suppliers or,in many cases,

223、sole suppliers,for someof our next-generation sequencers,lab materials,reagents,and supplies,and we may not beable to find replacements or immediately transition to alternative suppliers if necessary.If we or our partners fail to comply with healthcare and other applicable laws and regulations,we co

224、uld face substantial penalties and sanctions and our business,reputation,financialcondition,and results of operations could be adversely affected.If we are unable to obtain and maintain intellectual property protection for our technology,orif the scope of the intellectual property protection we obta

225、in is not sufficiently broad,ourcompetitors could develop and commercialize technology and products similar or identical toour solutions,and our ability to successfully commercialize our solutions may be impaired.We have incurred substantial indebtedness,and we may not generate sufficient cash flow

226、fromoperations to meet our debt service requirements,continue our operations,and pursue ourgrowth strategy,and we may be unable to raise capital when needed or on acceptable terms.After this offering,our executive officers,directors,and principal shareholders,including,inparticular,David D.Halbert,o

227、ur Founder,Chairman,and Chief Executive Officer,willcontinue to have the ability to control or significantly influence matters submitted toshareholders for approval,which could limit the ability of our other shareholders to affect theoutcome of key corporate decisions and transactions,including a ch

228、ange of control.Before you invest in our common stock,you should carefully consider all the information in thisprospectus,including matters set forth in the section titled“Risk Factors.”Corporate InformationWe were founded in 2008 when we entered the field of precision oncology through our acquisiti

229、onof Molecular Profiling Institute,a Delaware-incorporated molecular life sciences company.We wereincorporated under the laws of the Cayman Islands in October 2011 as Caris Life Sciences,Ltd.and inJuly 2020,we changed our name to Caris Life Sciences,Inc.and re-domiciled to be incorporated in Texas.O

230、ur principal executive offices are located at 750 West John Carpenter Freeway,Suite 800,Irving,Texas 75039,and our telephone number is(866)771-8946.Our website address .The information on,or that can be accessed through,our website is notincorporated into this prospectus.You should not consider info

231、rmation contained on our website to be partof this prospectus in deciding whether to purchase shares of our common stock.Implications of Being an Emerging Growth CompanyWe qualify as an“emerging growth company”as defined in the Jumpstart Our Business StartupsAct of 2012,as amended(the“JOBS Act”).We

232、will remain an emerging growth company until the earliestto occur of:(i)the last day of the fiscal year in which we have at least$1.235 billion in total annual grossrevenue;(ii)the last day of the fiscal year in which we are deemed to be a“large accelerated filer”asdefined in Rule 12b-2 under the Se

233、curities Exchange Act of 1934,as amended(the“Exchange Act”),whichwould occur if the market value of our common stock held by non-affiliates exceeded$700 million as of thelast business day of the second fiscal quarter of such year;(iii)the date on which we have issued more than$1.0 billion in non-con

234、vertible debt securities during the prior three-year period;and(iv)the last day of thefiscal year ending after the fifth anniversary of the date of the completion of this offering.An emerginggrowth company may take advantage of specified reduced reporting requirements and is relieved of certainother

235、 significant requirements that are otherwise generally applicable to public companies.As an emerginggrowth company:122025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm22/361TABLE OF CONTENTS we will present in this

236、prospectus only two years of audited financial statements,plus anyrequired unaudited financial statements,and related managements discussion and analysis offinancial condition and results of operations;we will avail ourselves of the exemption from the requirement to obtain an attestation andreport f

237、rom our auditors on the assessment of our internal control over financial reportingpursuant to Section 404 of the Sarbanes-Oxley Act of 2002(“SOX Section 404”);we will provide less extensive disclosure about our executive compensation arrangements;andwe will not be required to hold shareholder non-b

238、inding advisory votes on executivecompensation or golden parachute arrangements.Accordingly,the information contained herein may be different than the information you receivefrom our competitors that are public companies or other public companies in which you hold stock.In addition,the JOBS Act prov

239、ides that an emerging growth company can delay the adoption ofnew or revised accounting standards until those standards would otherwise apply to private companies.Wehave elected to avail ourselves of this extended transition period for complying with new or revisedaccounting standards and,as a resul

240、t,our results of operations and financial statements may not becomparable to those of companies that have adopted the new or revised accounting standards.132025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm23/361TAB

241、LE OF CONTENTS THE OFFERINGCommon stock offered by us23,529,412 shares.Option to purchase additional shares ofcommon stockWe have granted the underwriters an option for a period of30 days to purchase up to 3,529,411 additional shares of ourcommon stock.Common stock to be outstandingimmediately after

242、 this offering297,109,837 shares(or 300,639,248 shares if the underwritersexercise their option to purchase additional shares of commonstock in full).Reserved share programAt our request,the underwriters have reserved up to 5%of theshares of common stock offered by this prospectus,excludingthe addit

243、ional shares that the underwriters have a 30-dayoption to purchase,for sale,at the initial public offering price,to certain individuals identified by management,includingcertain of our directors,officers,employees and certain otherparties related to us.If these persons purchase reserved sharesit wil

244、l reduce the number of shares of common stock availablefor sale to the general public.Any reserved shares of commonstock that are not so purchased will be offered by theunderwriters to the general public on the same terms as theother shares of common stock offered by this prospectus.Formore informat

245、ion,see“Underwriting Reserved ShareProgram.”Use of proceedsWe estimate that the net proceeds from this offering will beapproximately$364.6 million(or$420.4 million if theunderwriters exercise their option to purchase additionalshares of common stock in full),based on an assumed initialpublic offerin

246、g price of$17.00 per share,which is themidpoint of the price range set forth on the cover page of thisprospectus,after deducting estimated underwriting discountsand commissions and estimated offering expenses payable byus.We intend to use the net proceeds from this offering forgeneral corporate purp

247、oses,including working capital,operating expenses,and capital expenditures.We also intendto use approximately$5.0 million of the net proceeds tosatisfy our anticipated tax withholding and remittanceobligations related to the RSU Net Settlement(as definedbelow).We will have broad discretion in the wa

248、y that we usethe net proceeds from this offering.See the section titled“Useof Proceeds”for additional information.Indication of interestNeuberger Berman has indicated an interest in purchasing upto$75.0 million of shares of our common stock being offeredin this offering at the initial public offerin

249、g price and on thesame terms as the other purchasers in this offering.However,because indications of interest are not binding agreements orcommitments to purchase,the underwriters could determine tosell more,fewer,or no shares to Neuberger Berman,andNeuberger Berman could determine to purchase more,

250、fewer,or no shares in this offering.The underwriters will receive thesame underwriting discounts and commissions on 142025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm24/361TABLE OF CONTENTS any of our shares of co

251、mmon stock purchased by NeubergerBerman as they will from any other shares of common stocksold to the public in this offering.Risk factorsSee the section titled“Risk Factors”beginning on page 21 andthe other information included in this prospectus for adiscussion of factors you should consider caref

252、ully beforedeciding to invest in our common stock.Proposed Nasdaq trading symbol“CAI”The number of shares of our common stock to be outstanding after this offering is based on273,580,425 shares of our common stock outstanding as of March 31,2025,after giving effect to(i)theWarrant Net Exercises,(ii)

253、the Series E and F Issuance,(iii)the Preferred Stock Conversion,(iv)theissuance of the 2025 Convertible Notes and the related Notes Conversion,and(v)the RSU Net Settlement(each as defined below),and excludes:24,113,482 shares of our common stock issuable upon the exercise of options outstandingunder

254、 our 2020 Incentive Plan,as amended and restated(the“2020 Plan”),as of March 31,2025,at a weighted-average exercise price of$10.18 per share;249,999 shares of our common stock issuable upon the exercise of options granted under our2020 Plan subsequent to March 31,2025,at an exercise price per share

255、equal to the initialpublic offering price;236,290 shares of our common stock issuable upon the vesting and settlement of restrictedstock units(“RSUs”)outstanding under our 2020 Plan as of March 31,2025 that are subject tovesting conditions that are not satisfied in connection with this offering;16,0

256、85,145 shares of our common stock reserved for future issuance under our 2025 IncentiveAward Plan(the“2025 Plan”),based on an assumed initial public offering price of$17.00 pershare,which is the midpoint of the price range set forth on the cover page of this prospectus,which 2025 Plan will become ef

257、fective in connection with this offering,as well as shares ofour common stock that may be issued pursuant to provisions of our 2025 Plan thatautomatically increase the share reserve under our 2025 Plan(see the section titled“ExecutiveCompensation”for additional information);and2,734,474 shares of ou

258、r common stock reserved for future issuance under our 2025 EmployeeStock Purchase Plan(the“ESPP”),based on an assumed initial public offering price of$17.00per share,which is the midpoint of the price range set forth on the cover page of thisprospectus,which ESPP will become effective in connection

259、with this offering,as well asshares of our common stock that may be issued pursuant to provisions in our ESPP thatautomatically increase the share reserve under our ESPP.Unless otherwise indicated,all information in this prospectus assumes:a one-for-four reverse stock split of our common stock effec

260、ted as of June 1,2025;the net issuance of 14,724,370 shares of our Series C preferred stock upon the cashlessexercise,based on an assumed initial public offering price of$17.00 per share,which is themidpoint of the price range set forth on the cover page of this prospectus,of warrantsoutstanding as

261、of March 31,2025 at a weighted-average exercise price of$1.76 per share,which warrants are exercisable to purchase,at the holders election,shares of either ourcommon stock or our Series C preferred stock and would have expired upon the completion ofthis offering unless earlier exercised(the“Series C

262、 Warrant Net Exercise”);the net issuance of 968,316 shares of our common stock issuable upon the cashless exercise ofwarrants issued in April 2025 at an exercise price of$0.04 per share(the“2025 Warrants”),based on an assumed initial public offering price of$17.00 per share,which is the midpoint oft

263、he price range set forth on the cover page of this prospectus(the“2025 Warrant Net Exercise”and together with the Series C Warrant Net Exercise,the“Warrant Net Exercises”);152025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-1

264、6_s1a.htm25/361TABLE OF CONTENTS the conversion of(i)all shares of our convertible preferred stock outstanding as of March 31,2025(including the 14,724,370 shares of Series C preferred stock issued upon the Series CWarrant Net Exercise)and(ii)all shares of our Series E and Series F convertible prefe

265、rredstock issued and sold in April 2025(such issuance and sale,the“Series E and F Issuance”),into an aggregate of 234,102,110 shares of our common stock,based on an assumed initialpublic offering price of$17.00 per share,which is the midpoint of the price range set forth onthe cover page of this pro

266、spectus,which conversion will occur immediately prior to and inconnection with the completion of this offering(the“Preferred Stock Conversion”);the issuance of 2,521,004 shares of our common stock upon the conversion of seniorconvertible notes issued by us in April 2025(the“2025 Convertible Notes”),

267、based on anassumed initial public offering price of$17.00 per share,which is the midpoint of the pricerange set forth on the cover page of this prospectus,which conversion will occur immediatelyprior to and in connection with the completion of this offering(the“Notes Conversion”);the net issuance of

268、 751,464 shares of our common stock underlying RSUs outstanding underour 2020 Plan that will vest in connection with this offering,after giving effect to thewithholding of 296,786 shares of our common stock to satisfy the estimated tax withholdingand remittance obligations(based on an assumed initia

269、l public offering price of$17.00 pershare,which is the midpoint of the price range set forth on the cover page of this prospectus,and an assumed tax withholding rate of 28.3%)(the“RSU Net Settlement”);the effectiveness of our amended and restated certificate of formation and the adoption of ouramend

270、ed and restated bylaws,each of which will occur immediately prior to the completion ofthis offering;no exercise by the underwriters of their option to purchase additional shares of common stock;andno exercise of outstanding options or settlement of outstanding RSUs except as describedabove.The numbe

271、r of shares of our common stock to be issued upon(i)the Preferred Stock Conversion,(ii)the 2025 Warrant Net Exercise,and(iii)the Notes Conversion,in each case,will vary based on theactual initial public offering price per share.In addition,the assumed 28.3%tax withholding rate applicableto the RSU N

272、et Settlement used in this prospectus is an estimated blended withholding rate for all of theRSUs that will vest in connection with this offering.The estimates in this prospectus relating to the RSUNet Settlement and related share withholding may differ from actual results due to,among other things,

273、theactual initial public offering price and other terms of this offering,actual forfeitures through the date of thisprospectus,and actual tax withholding rates.For illustrative purposes,the table below shows the number of shares of our common stock to beissued upon the occurrence of the foregoing tr

274、ansactions,based on an assumed initial public offering priceof$17.00 per share,which is the midpoint of the price range set forth on the cover page of this prospectus,and certain other prices as set forth in the table,and,in each case,assuming the number of shares offered byus,as set forth on the co

275、ver page of this prospectus,remains the same.We will not know the actual initialpublic offering price and,as a result,the final number of shares of common stock to be issued in thesetransactions or the total number of shares of common stock to be outstanding immediately after thisoffering,until the

276、determination of the initial public offering price and other terms of this offering atpricing.Initial PublicOffering Price Number of Shares of Common Stockto be Issued Upon the Preferred StockConversion,the 2025 WarrantNet Exercise,and the Notes Conversion Common Stockto be OutstandingImmediatelyAft

277、er this Offering$16.00 244,181,083 303,699,490$17.00 237,591,430 297,109,837$18.00 231,713,573 291,231,980$19.00 226,438,213 285,956,620$20.00 221,677,246 281,195,653 162025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a

278、.htm26/361TABLE OF CONTENTS SUMMARY CONSOLIDATED FINANCIAL AND OTHER DATAThe following tables set forth a summary of our historical consolidated financial and other data asof,and for the periods ended on,the dates indicated.The summary consolidated statements of operationsdata for the years ended De

279、cember 31,2024 and 2023 and the summary consolidated balance sheet data asof December 31,2024 are derived from our audited consolidated financial statements and related notesincluded elsewhere in this prospectus.The summary consolidated statements of operations data for the threemonths ended March 3

280、1,2025 and 2024 and the summary consolidated balance sheet data as of March 31,2025 are derived from our unaudited condensed consolidated financial statements and related notes includedelsewhere in this prospectus.In our opinion,the unaudited interim financial statements have been preparedon a basis

281、 consistent with our audited financial statements and contain all adjustments,consisting only ofnormal and recurring adjustments,necessary for a fair presentation of such interim financial statements.Our historical results are not necessarily indicative of results that may be expected in the future.

282、You should read these data together with our financial statements and related notes appearing elsewhere inthis prospectus and the information in the section titled“Managements Discussion and Analysis ofFinancial Condition and Results of Operations.”Three Months Ended March 31,Years Ended December 31

283、,2025 2024 2024 2023 (in thousands,except share andper share data)Consolidated Statements of Operations Data:Revenue:Molecular profiling services$114,081$73,233$349,115$278,748 Pharma research and development services 6,834 7,444 63,145 27,380 Total revenue 120,915 80,677 412,260 306,128 Costs and o

284、perating expenses:Cost of servicesMolecular profiling services 60,894 52,894 223,075 207,509 Cost of servicesPharma research anddevelopment services 2,958 1,669 10,403 9,309 Selling and marketing expense 39,829 39,609 152,602 142,925 General and administrative expense 52,119 44,354 169,386 149,053 R

285、esearch and development expense 23,066 34,376 113,916 116,883 Total costs and operating expenses 178,867 172,902 669,382 625,679 Loss from operations (57,952 (92,225 (257,122 (319,551 Other income(expense),net:Interest income 503 1,768 7,122 11,258 Interest expense (12,782 (9,290 (50,025 (31,610 Cha

286、nges in fair value of financial instruments (32,333 (11,064 18,484 11,094 Other expense,net (17 (219 (349 (12,606 Total other expense,net (44,629 (18,804 (24,768 (21,864 Loss before income taxes and provision for incometaxes (102,581 (111,028 (281,890 (341,415 Provision for income taxes Net loss$(10

287、2,581$(111,028$(281,890$(341,415 Adjustments of redeemable convertible preferredstock to redemption value (24,262 (23.113 (96,367 (121,112 Net loss attributable to common shareholders$(127,043$(134,141$(378,257$(462,527 Net loss per share attributable to commonshareholders,basic and diluted$(3.57$(3

288、.80$(10.66$(13.24 17)(1)2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm27/361(1)(2)TABLE OF CONTENTS Three Months Ended March 31,Years Ended December 31,2025 2024 2024 2023 (in thousands,except share andper share

289、 data)Weighted-average shares used to compute net lossper share attributable to common shareholders,basic and diluted 35,623,042 35,313,037 35,496,832 34,942,691 Pro forma net loss per share attributable to commonshareholders,basic and diluted(unaudited)$(0.37$(3.20 Weighted-average shares used to c

290、ompute pro formanet loss per share attributable to commonshareholders,basic and diluted(unaudited)273,965,936 273,839,726 See Note 12 to our consolidated financial statements included elsewhere in this prospectus for an explanationof the method used to calculate our historical basic and diluted net

291、loss per share attributable to commonshareholders and the weighted-average number of shares of common stock used in the computation of theseper share amounts.Gives effect to(i)the Warrant Net Exercises,(ii)the Series E and F Issuance,(iii)the Preferred StockConversion,(iv)the issuance of the 2025 Co

292、nvertible Notes and the related Notes Conversion,(v)the RSUNet Settlement,and(vi)the reduction of the compound derivative liability bifurcated from the 2023 TermLoan.The following table sets forth the computation of our unaudited pro forma basic and diluted net loss pershare,which does not include s

293、hares being offered in this offering:Three Months EndedMarch 31,2025 Year EndedDecember 31,2024 (in thousands,except shareand per share data)Numerator:Net loss attributable to common shareholders$(127,043$(378,257 Pro forma adjustment related to deemed dividend from Series C and Dredeemable converti

294、ble preferred stock from the triggering of downrounding (573,734 Pro forma adjustment to record stock-based compensation expenserelated to RSUs for which the performance-based vesting conditionswill be satisfied in connection with this offering (19,689 Other miscellaneous pro forma adjustments (1,29

295、5 Pro forma adjustment to record the reduction of fair value ofderivative liability associated with the 2023 Term Loan 17,451 Pro forma adjustment to reverse the adjustments of Series C and Dredeemable convertible preferred stock to redemption value 24,462 96,367 Pro forma adjustment related to the

296、reversal of the change in fair valueof derivative liabilities (11,393 Pro forma adjustment related to the reversal of the change in fair valueof warrant liabilities (7,091 Pro forma net loss$(102,581$(877,640 Denominator:Weighted-average shares used in computing net loss per shareattributable to com

297、mon shareholders,basic and diluted 35,623,042 35,496,832 Pro forma adjustment to reflect the Preferred Stock Conversion 229,694,421 229,694,421 Pro forma adjustment to reflect the Series C Warrant Net Exercise 4,407,689 4,407,689 Pro forma adjustment to reflect the 2025 Warrant Net Exercise 968,316

298、968,316 18(1)(1)(2)(1)(2)(a)(b)(c)2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm28/361(a)(b)(c)(d)(1)(2)TABLE OF CONTENTS Three Months EndedMarch 31,2025 Year EndedDecember 31,2024 (in thousands,except shareand

299、per share data)Pro forma adjustment to reflect the Notes Conversion 2,521,004 2,521,004 Pro forma adjustment to reflect the RSU Net Settlement 751,464 751,464 Weighted-average shares used in computing pro forma net loss pershare,basic and diluted 273,965,936 273,839,726 Pro forma net loss per share,

300、basic and diluted$(0.37$(3.20 Gives effect to conversion price adjustments for the Series C preferred stock and Series D preferredstock,in each case based on an assumed initial public offering price of$17.00 per share,which isthe midpoint of the price range set forth on the cover page of this prospe

301、ctus.The change in the fairvalue of the shares of preferred stock triggered by such conversion price adjustments is considereda deemed dividend and thus excluded from the computation of pro forma net loss per shareattributable to common shareholders.Gives effect to(i)the cash bonus payable upon a su

302、ccessful initial public offering,as furtherdescribed in the section titled“Executive Compensation,”and(ii)expenses associated with theissuance of the 2025 Warrants.Gives effect to the reduction of the fair value of the compound derivative liability bifurcated fromthe 2023 Term Loan.The fair value is

303、 mainly driven by the prepayment amortization feature of the2023 Term Loan,which,upon consummation of this offering,has a de minimis value.Each$1.00 increase in the assumed initial public offering price of$17.00 per share,which is themidpoint of the price range set forth on the cover page of this pr

304、ospectus,would decrease the proforma net loss per share for the three months ended March 31,2025 and the year ended December31,2024,by approximately$0.01 and$0.14,respectively.Each$1.00 decrease in the assumedinitial public offering price of$17.00 per share,which is the midpoint of the price range s

305、et forthon the cover page of this prospectus,would increase the pro forma net loss per share for the threemonths ended March 31,2025 and the year ended December 31,2024,by approximately$0.01 and$0.13,respectively.Pro forma adjustments in this footnote are illustrative only and will be adjustedbased

306、on the actual initial public offering price and other terms of this offering determined atpricing.As of March 31,2025 Actual Pro Forma Pro FormaAs Adjusted (in thousands)Consolidated Balance Sheet Data:Cash,cash equivalents,and restricted cash$32,704$185,531$546,292 Working capital 8,679 157,516 517

307、,696 Total assets 291,583 444,410 799,349 Total liabilities 645,335 519,292 509,631 Redeemable convertible preferred stock 2,246,113 Total shareholders(deficit)equity (2,599,865 (74,882 289,718 Gives effect to(i)the Warrant Net Exercises,(ii)the Series E and F Issuance,(iii)the Preferred StockConver

308、sion,(iv)the issuance of the 2025 Convertible Notes and the related Notes Conversion,(v)the RSUNet Settlement,and(vi)the reduction of the compound derivative liability bifurcated from the 2023 TermLoan.Gives effect to(i)the pro forma adjustments described in footnote(1)above,(ii)the sale by us of 23

309、,529,412shares of common stock in this offering at an assumed initial public offering price of$17.00 per share,whichis the midpoint of the price range set forth on the cover page of this prospectus,after deducting estimatedunderwriting discounts and commissions and estimated offering expenses payabl

310、e by us,net of$1.4 million of 19(d)(1)(2)(3)(4)2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shttps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm29/361(3)(4)TABLE OF CONTENTS offering expenses paid as of March 31,2025 and(iii)the use of approximately$5.0 million

311、of the net proceedsfrom this offering to satisfy our anticipated tax withholding and remittance obligations related to the RSU NetSettlement.Each$1.00 increase(decrease)in the assumed initial public offering price of$17.00 per share,which is themidpoint of the price range set forth on the cover page

312、 of this prospectus,would increase(decrease)thepro forma as adjusted amount of each of cash,cash equivalents,and restricted cash,working capital,totalassets,and total shareholders(deficit)equity by approximately$21.9 million,assuming the number of sharesoffered by us,as set forth on the cover page o

313、f this prospectus,remains the same and after deducting estimatedunderwriting discounts and commissions and estimated offering expenses payable by us.Similarly,eachincrease(decrease)of 1,000,000 in the number of shares of common stock we are offering would increase(decrease)the pro forma as adjusted

314、amount of each of cash,cash equivalents,and restricted cash,workingcapital,total assets,and total shareholders(deficit)equity by approximately$15.8 million,assuming theassumed initial public offering price per share remains the same and after deducting estimated underwritingdiscounts and commissions

315、 and estimated offering expenses payable by us.Pro forma adjustments in thisfootnote and the footnotes above,as well as the related information in the balance sheet data,are illustrativeonly and will be adjusted based on the actual initial public offering price and other terms of this offeringdeterm

316、ined at pricing.The pro forma as adjusted cash,cash equivalents,and restricted cash amount includesthe employer portion of the withholding tax obligation of approximately$0.2 million related to the RSU NetSettlement at the assumed initial public offering price of$17.00 per share,which is the midpoin

317、t of the pricerange set forth on the cover page of this prospectus.We define working capital as current assets,less current liabilities.See our consolidated financial statementsand related notes included elsewhere in this prospectus for further details regarding our current assets andcurrent liabili

318、ties.Non-GAAP Financial Measures Three Months Ended March 31,Years Ended December 31,2025 20242024 2023 (in thousands)Adjusted EBITDA$(36,216$(70,062$(189,566$(255,309 Free cash flow$(34,027$(75,663$(253,643$(298,419 We use Adjusted EBITDA and free cash flow,financial measures not calculated in acco

319、rdance withgenerally accepted accounting principles in the United States(“GAAP”)to supplement our consolidatedfinancial statements,which are presented in accordance with GAAP.We believe the non-GAAP financialmeasures we use,Adjusted EBITDA and free cash flow,are useful in evaluating our performance

320、andliquidity.Our non-GAAP financial measures have limitations as analytical tools,however,and you shouldnot consider them in isolation or as substitutes for analysis of our results as reported under GAAP.We define Adjusted EBITDA as net loss,adjusted to exclude interest income,interest expense,chang

321、es in fair value of financial instruments,other expense,net,the provision for(benefit from)incometaxes,depreciation and amortization,and stock-based compensation expense.We use Adjusted EBITDA inconjunction with GAAP measures as part of our overall assessment of our performance,including thepreparat

322、ion of our annual operating budget and quarterly forecasts,to evaluate the effectiveness of ourbusiness strategies,and to communicate with our board of directors concerning our financial performance.We believe Adjusted EBITDA provides useful information to investors and others in understanding andev

323、aluating our operating results in the same manner as our management team and board of directors.Adjusted EBITDA provides a useful measure for period-to-period comparisons of our business,as itremoves the effect of certain non-cash expenses and certain variable charges.We define free cash flow asnet

324、cash used in operating activities less purchases of property and equipment.We believe free cash flow isa useful measure of liquidity that provides an additional basis for assessing our ability to generate cash.Foradditional information regarding Adjusted EBITDA and free cash flow,including a reconci

325、liation of thesemeasures to the most directly comparable financial measure calculated in accordance with GAAP,see thesection titled“Managements Discussion and Analysis of Financial Condition and Results of OperationsNon-GAAP Financial Measures.”20)2025/6/10 09:19tm2415719-16_s1a-block-44.7915797shtt

326、ps:/www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm30/361TABLE OF CONTENTS RISK FACTORSInvesting in our common stock involves risk.You should carefully consider the risks describedbelow,as well as the other information in this prospectus,including our financial statem

327、ents and the relatednotes and the section titled“Managements Discussion and Analysis of Financial Condition and Results ofOperations”in this prospectus,before deciding whether to invest in our common stock.This prospectus alsocontains forward-looking statements that involve risks and uncertainties.S

328、ee the section titled“SpecialNote Regarding Forward-Looking Statements.”The occurrence of any of the events or developmentsdescribed below could harm our business,financial condition,results of operations,and growth prospects.In such an event,the market price of our common stock could decline,and yo

329、u may lose all or part of yourinvestment.Additional risks and uncertainties not presently known to us or that we currently deemimmaterial also may impair our business operations.Risks Related to Our Business and IndustryThe precision medicine industry is highly competitive and subject to rapid chang

330、e.Our industry is highly competitive and characterized by rapid changes,including technological andscientific breakthroughs,frequent new product introductions and enhancements,and evolving industrystandards.Our future success will depend on our ability to compete successfully and keep pace with thee

331、volving needs of physicians,patients,and our biopharma partners on a timely and cost-effective basis andto pursue new market opportunities that develop as a result of technological and scientific advances.Inrecent years,there have been numerous advances in technologies relating to the diagnosis and

332、treatment ofcancer and advances in methods used to analyze large amounts of genomic information.We mustcontinuously enhance our proprietary profiling and signature offerings and develop new solutions in a cost-effective way to achieve meaningful innovation in precision oncology and other chronic dis

333、ease states.If wedo not update our suite of solutions to reflect new scientific knowledge or technological advancements,including as they relate to precision medicine,therapeutic developments,or relevant validation studies orclinical trials,adoption and use of our current solutions and any new solutions we may develop coulddecline,which would adversely affect our business,financial condition,and r