SecProbe.io

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.

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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.

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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.

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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
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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.

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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,