SecProbe.io

CORRESP
 1
 filename1.htm

 Caris
Life Sciences, Inc.

 750 W. John Carpenter Freeway

 Suite 800

 Irving, TX 75039

 June 13, 2025

 VIA EDGAR

 U.S. Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, N.E.

 Washington, D.C. 20549-6010

 Attention: Lauren Nguyen

 Juan Grana

 Michael Fay

 Tayyaba Shafique

 Re: Caris Life Sciences, Inc.
 Registration
Statement on Form S-1, as amended (File No. 333- 287551)

 Request for Acceleration of Effective Date

 To the addressees set forth above:

 In accordance with Rule 461
under the Securities Act of 1933, as amended, Caris Life Sciences, Inc. (the " Company ") hereby requests
acceleration of the effective date of the above-referenced Registration Statement on Form S-1, as amended (File No. 333-287551)
(the " Registration Statement "). The Company respectfully requests that the Registration Statement become effective
as of 4:00 p.m., Eastern Time, on June 17, 2025, or as soon as practicable thereafter, or at such other time as the Company or
its legal counsel may request by telephone to the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission
(the " Commission "). Once the Registration Statement has been declared effective, please orally confirm that
event with our counsel, Latham & Watkins LLP, by calling Nathan Ajiashvili at (212) 906-2916.

 We understand that the staff
of the Commission will consider this request as confirmation by the Company that it is aware of its responsibilities under the federal
securities laws as they relate to the issuance of the securities covered by the Registration Statement. If you have any questions regarding
the foregoing, please contact Nathan Ajiashvili of Latham & Watkins LLP at the number set forth above.

 Thank you for your assistance in this matter.

 Sincerely,

 Caris Life Sciences, Inc .

 By:
 /s/ J. Russel Denton

 Name:
 J. Russel Denton

 Title:
 Senior Vice President, General Counsel, and Secretary

 cc: David D. Halbert, Founder, Chairman, and Chief Executive Officer, Caris Life Sciences, Inc.
 Brian J. Brille, Vice Chairman, and Executive Vice President,
Caris Life Sciences, Inc.

 Luke Power, Senior Vice President, Chief Financial Officer,
and Chief Accounting Officer, Caris Life Sciences, Inc.

 Nathan Ajiashvili, Esq., Latham & Watkins LLP

 Alison Haggerty, Esq., Latham & Watkins LLP

 Eric Blanchard, Esq., Cooley LLP

 Divakar Gupta, Esq., Cooley LLP

 Charles S. Kim, Esq., Cooley LLP

CORRESP
 1
 filename1.htm

 June 13, 2025

 VIA EDGAR

 United States Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, N.E.

 Washington, D.C. 20549-6010

 Attention:
 Lauren Nguyen

 Juan Grana

 Michael Fay

 Tayyaba Shafique

 Re:
 Caris Life Sciences, Inc.

 Registration Statement on Form S-1, as amended

 File No. 333-287551

 Acceleration Request

 Requested Date: June 17, 2025

 Requested Time: 4:00 P.M. Eastern Time

 Ladies and Gentlemen:

 In accordance with Rule 461 under the Securities
Act of 1933, as amended (the " Act "), we, as representatives of the several underwriters, hereby join in the request
of Caris Life Sciences, Inc. (the " Company ") for acceleration of the effective time of the above-referenced Registration
Statement, requesting effectiveness as of 4:00 P.M., Eastern Time, on June 17, 2025, or at such later time as the Company or its
outside counsel, Latham & Watkins LLP, may request via telephone call to the staff of the Division of Corporation Finance of
the Securities and Exchange Commission.

 Pursuant to Rule 460 under the Act, please
be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus to underwriters, dealers,
institutions and others, prior to the requested effective time of the Registration Statement.

 We, the undersigned, as representatives of the
several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied
and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.

 [Signature Page Follows]

 Very truly yours,

 BOFA SECURITIES, INC.

 J.P. MORGAN SECURITIES LLC

 GOLDMAN SACHS & CO. LLC

 CITIGROUP GLOBAL MARKETS INC.

 As representatives of the underwriters

 BOFA SECURITIES, INC.

 By:
 /s/ Michael Liloia

 Name: Michael Liloia

 Title: Director

 J.P. MORGAN SECURITIES LLC

 By:
 /s/ David Ke

 Name: David Ke

 Title: Managing Director

 GOLDMAN SACHS & CO.
 LLC

 By:
 /s/ Lyla Bibi Maduri

 Name: Lyla Bibi Maduri

 Title: Managing Director

 CITIGROUP GLOBAL MARKETS INC.

 By:
 /s/ Tai Hah

 Name: Tai Hah

 Title: Global Head of MedTech

 [Signature Page to Underwriters'
Acceleration Request]

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 April 16, 2025

David D. Halbert
Chairman, Founder & Chief Executive Officer
Caris Life Sciences, Inc.
750 W. John Carpenter Freeway
Suite 800
Irving, TX 75039

 Re: Caris Life Sciences, Inc.
 Amendment No. 4 to Draft Registration Statement on Form S-1
 Submitted April 4, 2025
 CIK No. 0002019410
Dear David D. Halbert:

 We have reviewed your amended draft registration statement and have the
following
comments.

 Please respond to this letter by providing the requested information and
either
submitting an amended draft registration statement or publicly filing your
registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing the information you provide in response to this letter
and your
amended draft registration statement or filed registration statement, we may
have additional
comments.

Amendment No. 4 to Draft Registration Statement on Form S-1
Risk Factors
We have been, are currently, and in the future may be the subject of government
investigations, claims, audits, whistleblower and payer..., page 57

1. We note your disclosure that "in March 2025, the Company received a CID
from the
 DOJ in connection with an investigation under the False Claims Act
regarding the
 Company's compliance with Medicare's date of service rule (also referred
to as the 14-
 day rule)." Please revise to provide additional background regarding the
CID, the
 scope of the investigation and your compliance with Medicare's date of
service rule.
 April 16, 2025
Page 2

Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations
Molecular Profiling Services Revenue, page 117

2. We note the many references in your filing to over 45 NCI-designated
comprehensive
 cancer centers being members of the Caris POA and these centers appear
to be "key
 opinion leaders." We note here the increased market acceptance by
ordering
 physicians. Please tell us the number of NCI-designated comprehensive
cancer centers
 that have ordering physicians, for each period presented, and the
consideration you
 have given to discussing this and any related information pursuant to
Item 303 of
 Regulation S-K.
Business
Our Strategies, page 146

3. We note your disclosure on page 147 that "[you] are currently using an
AI/ML
 approach and data and slides images from more than 10,000 breast cancer
patients to
 develop ESPai, a new algorithm to predict the risk of recurrence for
early stage breast
 cancer patients." Please revise to clarify the current stage of
development of ESPai,
 and explain how you source the data and slide images from more than
10,000 breast
 cancer patients.
Caris Strategic Data, page 170

4. We note your disclosure on page 172 regarding a study that you recently
published,
 which "demonstrated the power of [y]our real-world clinical and genomic
dataset,
 augmented through agreements with external providers of clinical
outcomes data, to
 drive clinical insight". Please revise to provide additional detail
regarding the study
 including: the date(s) and location(s) of the study; how participants
were
 selected; how results were measured; key assumptions; and whether
statistical
 significance was demonstrated, including supporting p-values, as
appropriate.
 Please contact Tayyaba Shafique at 202-551-2110 or Michael Fay at
202-551-3812 if
you have questions regarding comments on the financial statements and related
matters. Please contact Juan Grana at 202-551-6034 or Lauren Nguyen at
202-551-3642 with
any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of
Industrial Applications and
 Services
cc: Nathan Ajiashvili, Esq.
</TEXT>
</DOCUMENT>

January 10, 2025
David D. Halbert
Chairman, Founder & Chief Executive Officer
Caris Life Sciences, Inc.
750 W. John Carpenter Freeway
Suite 800
Irving, TX 75039
Re:Caris Life Sciences, Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted December 20, 2024
CIK No. 0002019410
Dear David D. Halbert:
            We have reviewed your amended draft registration statement and have the following
comments.
            Please respond to this letter by providing the requested information and either
submitting an amended draft registration statement or publicly filing your registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing the information you provide in response to this letter and your
amended draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, any references to prior comments are to comments in
our September 26, 2024 letter.
Amendment No. 2 to Draft Registration Statement on Form S-1
Prospectus Summary, page 1
1.We note your disclosure that FDA approval of MI Cancer Seek as a companion
diagnostic was obtained in the fourth quarter of 2024. Please disclose when you intend
to commercially launch MI Cancer Seek. Please also revise to clarify the timing of
your submission of the Caris Assure for therapy application for approval from New
York State's Clinical Laboratory Evaluation Program.

January 10, 2025
Page 2
Risk Factors
Our solutions may not perform as expected, and the results of our validation studies or our
clinical trials may not support the launch or..., page 20
2.We note your disclosure that the FDA included certain conditions of approval and
limitations in the PMA approval letter for MI Cancer Seek. Please revise to discuss
these conditions and limitations.
Management's Discussion And Analysis Of Financial Condition And Results Of Operations
Molecular Profiling Services Revenue, page 111
3.We note your response to prior comment 5 and your updated disclosure around
increased adoption of MI Profile by ordering physicians. Please revise your discussion
to describe whether the increase in clinical cases associated with MI Profile is a result
of an increased effort by your sales team, or natural market acceptance. Your
discussion should provide an investor with information on any known trends or
uncertainties that would impact revenue from continuing operations. Refer to Item
303(b)(2)(ii) of Regulation S-K.
4.In addition, we note your sales team has grown from 185 employees at the end of
2020 to over 270. Please describe for us and in your filing, as appropriate, the extent
to which any increase in your sales team contributed to the increase in clinical cases
and revenue. Also, please describe for us the structure of your sales team and any
metrics used to evaluate their performance and effectiveness related to clinical cases,
and provide us this information.
5.We note from your website the Caris POA has working groups across 13 oncology
specialties. Please describe to us the extent to which you quantify clinical cases or
revenue across any oncology specialties or any other type of classifications and
provide us this information for the periods presented. If there is any such information,
please tell us whether there is any related material information that would be required
to be provided under Item 303 of Regulation S-K.
6.In addition, we note on page F-13 the table of major payers. Please briefly clarify the
facts and circumstances related to these payers and the corresponding revenue, and
provide any other information pursuant to Item 303 of Regulation S-K.
Business
Our Market Opportunity and Vision for Leveraging Molecular Information, page 132
7.We note your response to comment 8, including your disclosure on page 134 that
you've assumed five tests for each trial participant, including one therapy selection
test per standard of care, and your disclosure that "[a]ssuming approximately 25 Phase
1b trials progress to Phase 2 each year...with each trial having two partners per
customary industry practice (a specialty lab and a distributable kit) and an average
contract price of $10 million based on third-party industry research...and an average
reimbursement per patient of $10,000 based on third-party industry research, [you]
estimate the addressable U.S. market for commercial services that include
identification of patients for approved therapies is approximately $300 million."
Please revise to clarify what you mean by "per standard of care" and disclose the
"third-party industry research" referenced.

January 10, 2025
Page 3
8.Please revise to balance your total addressable market presentation here by disclosing
that your revenues to date are primarily derived from molecular profiling services.
Please also make corresponding revisions to your Summary section.
Our Solutions, page 141
9.We note your response to comment 9. We also note your disclosure on page 148 that
"[i]n a validation study [you] conducted in collaboration with leading cancer centers
analyzing nearly 12,000 patients with advanced cancer across 48 tumor types, nearly
four out of 10 patients had at least one pathogenic or likely pathogenic CH variant
among reportable clinical genes. The study found a median rate of CH variant
classification of 17% for patients ranged from 65 to 69, 29% for patients aged 70 to
74, 33% for patients aged 75 to 79, and 50% for patients 80 years of age and older.
High CH rates were notably detected in BRCA2, BRCA1, CHEK2, and ATM." Please
revise to disclose the date of the study and the leading cancer centers that you
collaborated with to conduct the study.
HEME Assay, page 156
10.Please revise to disclose the material terms of your exclusive license arrangement with
Washington University in St. Louis, and file the license agreement as an exhibit to this
registration statement. Please also revise to provide the p-values for the results of the
2021 study published by WashU and clarify whether you plan to submit the licensed
assay for FDA approval or whether you intend to commercialize the assay as an LDT.
Consolidated Financial Statements of Caris Life Sciences, Inc.
Note 2. Summary of Significant Accounting Policies and Estimates, page F-8
11.Please revise your disclosure to identify the legal structure of the Caris POA and to
provide your accounting policies related to the Caris POA.
12.As it relates to each payer referred to on page F-13, please tell us:

•the type of business represented by the payer;
•whether the payer is the obligor of your services;
•whether you, including Caris POA, have multiple contracts with the payer and, if
so, how you considered ASC 606-10-25-9; and
•whether the payer has access to your datasets and, if so, how you evaluated the
existence of a performance obligation, as set forth in ASC 606-10-25-14 through
25-22.

January 10, 2025
Page 4
            Please contact Tayyaba Shafique at 202-551-2110 or Michael Fay at 202-551-3812 if
you have questions regarding comments on the financial statements and related
matters. Please contact Juan Grana at 202-551-6034 or Lauren Nguyen at 202-551-3642 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Alison Haggerty, Esq.

September 26, 2024
David D. Halbert
Chairman, Founder & Chief Executive Officer
Caris Life Sciences, Inc.
750 W. John Carpenter Freeway
Suite 800
Irving, TX 75039
Re:Caris Life Sciences, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted September 12, 2024
CIK No. 0002019410
Dear David D. Halbert:
            We have reviewed your amended draft registration statement and have the following
comments.
            Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on EDGAR.
If you do not believe a comment applies to your facts and circumstances or do not believe an
amendment is appropriate, please tell us why in your response.
            After reviewing the information you provide in response to this letter and your amended
draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, any references to prior comments are to comments in our
July 5, 2024 letter.
Amendment No. 1 to Draft Registration Statement on Form S-1
Letter from Chairman, Founder, and CEO, page iii
1.We note your revised disclosure in response to prior comment 1 and reissue in part. Please
revise to explain the connection between AdvancePCS's sale in 2004 and this offering,
and include balancing disclosure that prior performance is not indicative of your future
results.
You disclose that you believe you were the first to offer comprehensive molecular
profiling for "every patient when we launched whole transcriptome sequencing in 2019"
and "the first to offer whole exome sequencing for every patient when we introduced our
whole exome sequencing solution in 2020." Please revise to provide context for the 2.

September 26, 2024
Page 2
disclosure by explaining your reference to "every patient" and describe how this
distinguishes you from your competitors, as appropriate.
Prospectus Summary, page 1
3.We note your response to comment 11, and your disclosure on page 2 that samples are
provided by ordering physicians that contain sufficient genetic material for profiling. As
your disclosure highlights your profiling solutions, please revise, either here or elsewhere
in the registration statement, to clarify how you determine the eligibility of patient
samples.
Management's Discussion And Analysis Of Financial Condition And Results Of Operations
Our Business Model, page 103
4.We note your response to comment 13. We also note your revised disclosure that "[u]nder
the strategic partnerships, targets discovered and validated by [you] can be pursued by
[y]our biopharma partners to conduct their own preclinical and clinical research, as well
as the eventual development and commercialization of drug candidates. [Yo]ur biopharma
partners are also able to combine their relevant technology and/or engineering capabilities
to design and manufacture therapies for the treatment of cancer." Please revise to briefly
explain how you determine which targets are shared with your biopharma partners and
elaborate further on how they combine their technology and engineering capabilities to
design and manufacture therapies for the treatment of cancer.
Molecular Profiling Services Revenue, page 109
5.We have reviewed your revised disclosure in response to comment 15. Please also revise
your disclosure to discuss and analyze the increase in clinical cases associated with MI
Profile and provide any other information that would be material to an understanding of
the increase in cases and revenue. Refer to Item 303 of Regulation S-K.
6.In addition, in tabular form, please separately quantify the impact from the decline in
selling prices and the increase in volume to your increase in revenue. Refer to Item
303(b)(2)(iii) of Regulation S-K.
Business
Overview, page 121
7.We note your response to comment 16. Please revise to discuss the timetable for Caris
Assure's application to MCED, MRD tracking, and treatment monitoring. Please also
clarify why you are planning to submit a PMA for Caris Assure for therapy selection.
We note your response to comment 17. Please revise to address the following points
regarding each of the clinical and biopharma settings comprising the $150 billion total
addressable market:

•We note your disclosure on page 130 that "[b]ased on U.S. Census Bureau data, the
45 to 75 years-old cohort who would be eligible for screening for cervical, breast,
colon, lung, and prostate cancers represents approximately 112 million people in
the United States." Please revise to discuss how you determined eligibility for
screening for these cancers.8.

September 26, 2024
Page 3
•Please revise your disclosures on pages 130 through 132 to explain the assumptions
underlying the number of tests that could be administered annually to patients. For
example, we note your disclosure on page 131 that "there is increasing evidence that
patients could be eligible for at least two tests a year during therapy." We also note
your disclosure on page 131 assuming "a range of two to three tests annually for each
patient" and "five tests (one therapy selection test and four monitoring tests) for each
trial participant."
•We note your disclosure on page 131 that "based on these newly- diagnosed patient,
recurrent patient, and repeat testing patient cohorts, we estimate the total addressable
U.S. market for therapy selection is comprised of approximately two million unique
patient profiles annually and...amounts to approximately $8 billion." Please
disclose the number of diagnosed patient, recurrent patient and repeat testing patients.
•We note your disclosure on page 132 assuming that "approximately 25 Phase 1b trials
progress to Phase 2 each year, with each trial having two partners (a specialty lab and
a distributable kit)" and "a rate of rare mutation of 4.0% within the population of
newly-diagnosed cancer patients in the United States with advanced-stage solid tumor
cancers". We also note your disclosure on page 132 that you "estimate that
approximately $70 billion of the $262 billion spent in 2023 represented R&D
investments in discovery, pre- trial costs, and real-world evidence, areas where
matched genomic data has demonstrated use cases for biopharma applications".
Please revise to discuss the basis for each of these assumptions and estimates.
•We note your disclosures on pages 130 through 132 regarding assumed pricing for
your solutions, tests, and average reimbursement rates. Please revise to briefly discuss
the basis for each of these assumed amounts.
•Finally, please clarify whether your access to such markets would depend in part
upon FDA clearance or approval.
Our Solutions, page 138
9.We note your response to comment 20. Please revise your disclosures to further
discuss the parties conducting the studies, including whether the parties are affiliates or
partners of Caris.
10.We note your response to comment 22, including your disclosure on page 147 that
analytical validation for GPSai and FOLFIRSTai enabled you to offer the solutions as
LDTs. Please revise to briefly discuss the importance of analytical validation in
connection with the marketing of LDTs.
Consolidated Financial Statements
Molecular Profiling Services, page F-10
We note your revised disclosure in response to comment 31 as it relates to how
you estimate variable consideration under a portfolio approach for third-party payers and
patients with similar reimbursement characteristics. Please describe to us in further detail
how you determined your disclosure meets the requirements of Topic 606. Specifically,
please address ASC 606-10-50-1 which sets forth, in part, that an entity shall disclose
quantitative and qualitative information about the significant judgments and changes in
judgments made in applying the guidance in the Topic. As part of your response, please 11.

September 26, 2024
Page 4
identify the significant judgments, and the quantitative and qualitative information about
these judgments, as it relates to you estimating variable consideration and assessing
whether an estimate of variable consideration is constrained. Also refer to ASC 606-10-
50-17 and 50-20.
12.In addition, please clarify your disclosure to address whether there are any types of
warranties, as set forth in ASC 606-10-50-12(e).
General
13.We note your response to comment 33. Please revise your gatefold graphics to identify
the laboratories, technologies and people, and briefly explain how these images are
representative of your business.
            Please contact Tayyaba Shafique at 202-551-2110 or Michael Fay at 202-551-3812 if you
have questions regarding comments on the financial statements and related matters. Please
contact Juan Grana at 202-551-6034 or Lauren Nguyen at 202-551-3642 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Alison Haggerty, Esq.

July 5, 2024
David D. Halbert
Chairman, Founder & Chief Executive Officer
Caris Life Sciences, Inc.
750 W. John Carpenter Freeway
Suite 800
Irving, TX 75039
Re:Caris Life Sciences, Inc.
Draft Registration Statement on Form S-1
Submitted June 10, 2024
CIK No. 0002019410
Dear David D. Halbert:
            We have reviewed your draft registration statement and have the following comment(s).
            Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on EDGAR.
If you do not believe a comment applies to your facts and circumstances or do not believe an
amendment is appropriate, please tell us why in your response.
            After reviewing the information you provide in response to this letter and your amended
draft registration statement or filed registration statement, we may have additional comments.
Draft Registration Statement on Form S-1
Letter from Chairman, Founder, and CEO, page iii
1.Please revise or explain the connection between AdvancePCS's sale in 2004 and this
offering, and include balancing disclosure that prior performance is not indicative of your
future results.
Prospectus Summary, page 1
We note that you make various statements throughout the registration statement regarding
your leadership in your field and the efficacy of your products including, but not limited
to, the following:

Page iii: "We were both the first comprehensive molecular profiling service and the
first to offer whole exome and whole transcriptome sequencing for every patient for •2.

July 5, 2024
Page 2
both tissue- and blood-based profiling."
•Page iii: "[W]e were first to offer an AI-based drug response predictor for metastatic
colorectal cancer patients as well as the first to offer biomarker-driven clinical trials
matching and right-in-time clinical trial service."
•Page 1: "We are a leading, patient-centric, next-generation AI TechBio company and
precision medicine pioneer."
•Page 1: "We have spent the last 16 years developing and building our portfolio of
comprehensive, proprietary molecular profiling solutions and generating one of the
largest and most comprehensive multi-modal clinico-genomic datasets in oncology."
•Page 2: "We sequence at sector-leading depth of coverage, which directly correlates
with increased accuracy and detection of low frequency molecular markers of
relevance."
•Page 2: "As the leader in the transition to WES/WTS sequencing, we believe we have
more molecular data and information than any other company and are well-positioned
to make precision medicine widely accessible."
•Page 2: "The Caris Precision Oncology Alliance (“Caris POA”), which we
established in 2015, is now one of the leading research and data organizations in
precision medicine in the United States and is comprised of over 90 members,
including over 40 leading National Cancer Institute (“NCI”)-designated
comprehensive cancer centers."

Please revise your disclosure throughout the prospectus to provide the basis for any
statements, including those above, related to leadership in your field and the efficacy of
your products. Please also ensure you disclose any relevant metrics on which these
statements are based and any material assumptions.
3.We note the disclosure that your current commercial product portfolio is focused on
oncology and consists of MI Profile, your tissue-based molecular profiling solution, and
Caris Assure, your blood-based molecular profiling solution for therapy selection. Please
revise to clarify that the majority of your current revenues is generated from your tissue-
based molecular profiling solution.
4.Please revise to explain and substantiate how your Caris platform drives "superior"
clinical outcomes for patients and benefits from a virtuous cycle that enables continued
innovation and impact.
5.Please balance your summary disclosures by including a discussion of your substantial
indebtedness and current sources of liquidity. Please also expand your discussion of your
net losses for the years ended December 31, 2023 and 2022 to briefly discuss your costs
and operating expenses.
The Caris Platform, page 3
6.Please revise to provide additional context for your business description by clarifying that
you have not yet obtained FDA marketing authorization for any of your solutions,
including MI Cancer Seek and Caris Assure. We note your disclosure on page 54.

July 5, 2024
Page 3
Risk Factors
Our billing, collections, and claims processing activities are complex and time-consuming, and
any delay in transmitting ..., page 27
7.We note your disclosure that you "are currently in litigation that [you] initiated with
United Healthcare, regarding United Healthcare’s ability to recoup payments made for MI
Profile, relating to the use of allegedly incorrect billing codes." To provide additional
context for the risk factor disclosure, please revise to disclose the amounts of the
payments that United Healthcare is seeking to recoup.
If our facilities or those of our third-party collaborators are insufficient or become inoperable, our
ability to provide our solutions ..., page 30
8.We note your disclosure that "[i]n 2020, [you] began the process of constructing a new
laboratory facility in Irving, Texas to increase product development and operational
capacity." Please revise to discuss the timeline for completion of the facility and
obtaining, if applicable, CLIA accreditation. We also note your disclosure on page 58
that "[b]oth of the Phoenix laboratory facilities hold independent CLIA Certificates of
Accreditation" while your "laboratory facility in Irving, Texas holds a CLIA Certificate of
Registration." Please revise to explain the difference between CLIA accreditation and
registration.
Our amended and restated certificate of formation will provide that the Business Court in the First
Business Court Division ..., page 85
9.We note your disclosure that the forum selection provision in your amended and restated
certificate of formation may have the effect of discouraging lawsuits against you and
your directors, officers or other employees. Please revise this risk factor to disclose that
there is also a risk that your forum selection provision may result in increased costs for
investors to bring a claim.
Use of Proceeds, page 93
10.We note the disclosure that you "have no specific plan for the net proceeds from this
offering, or any significant portion thereof. However, we intend to use the net proceeds
from this offering for general corporate purposes, including working capital, operating
expenses, and capital expenditures." You also disclose on page 110 that you believe your
existing cash and cash equivalents and anticipated cash flows from operations, "together
with the net proceeds from this offering," will provide sufficient capital and liquidity to
fund your operating expenses and capital expenditure requirements for at least the next
12 months after the completion of this offering. As applicable, please provide further
detail regarding the use of the proceeds towards your indebtedness. Please refer to
Instruction 4 to Item 504 of Regulation S-K.
Management's Discussion And Analysis Of Financial Condition And Results Of Operations
Overview, page 100
We note your disclosure that you "remain the only genomic profiling company to
consistently utilize WES and WTS as standard practice on every eligible patient sample."
Please revise, either here or elsewhere in the registration statement, to explain how you 11.

July 5, 2024
Page 4
determine the eligibility of patient samples. Please also discuss how the patient samples
are sourced.
Our Business Model, page 101
12.We note your disclosure that you "have robust Medicare and broad commercial
reimbursement for MI Profile, with over 255 million covered lives in the United States".
Please revise to explain what you mean by "broad commercial reimbursement".
13.We note your disclosure that you "also generate revenue utilizing [y]our Caris Platform to
provide R&D services for biopharma partners, who [you] partner with to help improve the
efficiency and success of their therapeutic development and clinical programs." Please
revise to discuss the specific services offered to your biopharma partners. Please also
disclose the terms of any material contracts with your biopharma partners, including your
research partnerships with Moderna, AbbVie, Xencor, and Merck KGaA, and file any
such contracts as exhibits to this registration statement or provide your analysis as to why
such contracts are not required to be filed. Refer to Item 601(b)(10) of Regulation S-K.
Cost of Services, page 107
14.We note as part of your discussions of costs and operating expenses you sometimes
quantify the components of an increase or decrease without providing further
quantification or insight. For example, as part of your discussion of the cost of molecular
profiling services you set forth, in part, the MI Profile tissue laboratory contributed a
$15.6 million increase in materials, $10.4 million increase in laboratory labor costs,
$5.4 million related to equipment leases and maintenance, and $1.8 million in other costs,
including costs related to freight and third-party laboratory software. Please revise your
discussion to provide additional quantitative and qualitative information related to the
significant costs and expenses you identify, including quantifying the related underlying
amount and providing any related discussion and analysis to enhance an investor's
understanding of your results of operations, consistent Item 303 of Regulation S-K.
Management's Discussion And Analysis Of Financial Condition And Results Of Operations
Molecular Profiling Services Revenue, page 107
15.We note your 16.9% increase in revenue was primarily due to the increase in clinical
cases associated with MI Profile and Caris Assure for therapy selection from 97,039 and
223 cases to 128,168 and 663 cases, a total increase of 31,569 cases or 32.5%. Please
revise your disclosure to provide additional information to better allow investors to view
the registrant from management’s perspective, as set forth in Item 303(a) of Regulation S-
K. Please:

•revise your discussion to describe the underlying reasons for the increase in clinical
cases associated with MI Profile and provide any other information that would be
material to an understanding of the increase in cases and revenue;
•discuss in further detail why revenue increased 16.9% when cases increased 32.5%,
and any known trends related to the decline in average selling price and change in
payer mix. Quantify the impact from the decline in selling prices; and
•Discuss the reasons why international revenue declined, as set forth on page F-40.

July 5, 2024
Page 5
Business
Overview, page 118
16.Please revise to clearly disclose the current stage of development and/or
commercialization of each of your products and product candidates. In particular, please
disclose which products are currently being sold, when they commenced sales, and in
which markets the products are being sold. Consider providing this information in
narrative and tabular format for ease of reference. We also note your disclosure that MI
Profile is your "market-leading tissue-based molecular profiling solution" and that Caris
Assure is your "novel, universal blood-based molecular profiling solution". Please revise
to explain by what metric MI Profile is "market-leading". Please also discuss the timetable
for Caris Assure's application to MCED, MRD tracking, and treatment monitoring.
17.Please revise your disclosure regarding your estimated total addressable U.S. market to
discuss the assumptions underlying each of the elements comprising the $150 Billion
TAM. As an example only, we note your disclosure on page 128 that you "expect
biopharma companies to keep increasing the allocation of their total research and
development (“R&D”) investment, which totaled $262 billion in 2023" and that you
"estimate the total addressable U.S. market for this opportunity is approximately
$10 billion." Please explain the basis for your total addressable market opportunity
estimate. As applicable, please also revise the disclosure on page 5.
Caris Assure - Our Universal Blood-Based Profiling Solution, page 134
18.Please revise to further explain how many of your competitors’ offerings are "siloed" and
"require continued investment for the development of new products and generate
disparate datasets across the patient journey for patients, oncologists, and researchers."
Our Solutions, page 134
19.Please revise to more clearly explain the use of Caris Assure vis-a-vis MI Profile for
molecular profiling. We note your disclosure that MI Profile is a tissue-based molecular
profiling solution including WES/WTS NGS assay and IHC protein expression testing,
and that Caris Assure is a universal blood-based solution providing WES and WTS for
every eligible patient sample. In particular, please explain if there is any overlap between
Caris Assure and MI Profile regarding commercial use, and further discuss the advantages
or disadvantages to blood-based versus tissue-based molecular profiling. For example, we
note your disclosure on page 134 that "Caris Assure has many more opportunities for
testing relative to tissue profiling."
20.Please revise your disclosures on pages 136-138 to further discuss the studies cited. In
particular, please disclose the date of the studies and the parties conducting the studies,
including whether the parties are affiliates or partners of Caris.
21.We note your disclosure on page 142 that you "use IHC testing to complement [y]our
WES/WTS profiling both to inform decisions regarding therapy selection as well as to act
as confirmatory testing in circumstances where [y]our GPSai algorithm indicates a
different diagnosis than that indicated in the patient record prior to [y]our profiling."
Please revise to further discuss how IHC testing is employed.
We note your disclosure on page 142 that you "clinically validated FOLFIRST using a 22.

July 5, 2024
Page 6
real-world evidence dataset collected from the Caris POA registry." We also note your
disclosure that "GPSai was trained and validated through retrospective profiling data from
over 250,000 clinical cases using the outside pathologist diagnosis as the baseline." Please
revise to explain the significance of a clinical validation, and also disclose the regulatory
body or entity that provided the validations.
23.We note your tabular disclosure on page 144 regarding the performance of MI Tumor
Seek Hybrid. Please revise to discuss the relevance of the PPA, NPA and OPA
percentages in the table.
Data for Biopharma, page 148
24.We note your disclosure that you "license deidentified data that [you] have generated
from [y]our clinical profiling business to biopharma companies with the aim of generating
insights directly responsible for superior clinical outcomes for patients." Please revise to
briefly explain the process through which you deidentify your patient data.
Caris Molecular AI Launches & Signature Pipeline, page 152
25.Please revise to briefly discuss each of the products listed in the pipeline table. In
particular, please disclose which products are currently being sold, when they commenced
sales, and in which markets the products are being sold. Please also clarify the stages of
development included in the pipeline, such as "development", "external validation" and
"launch." Finally, please also describe the external validation and disclose if any
regulatory approvals have been obtained, sought or are required for the products.
Intellectual Property, page 155
26.Please expand your disclosure relating to your patent portfolio and identify for each
material patent and patent application, as applicable, the scope and technology of each
such patent or patent application, the type of patent protection, jurisdiction,