0000000000-25-000245.txt : 20250828
0000000000-25-000245.hdr.sgml : 20250828
20250110103609
ACCESSION NUMBER: 0000000000-25-000245
CONFORMED SUBMISSION TYPE: UPLOAD
PUBLIC DOCUMENT COUNT: 2
FILED AS OF DATE: 20250110
FILED FOR:
COMPANY DATA:
COMPANY CONFORMED NAME: Caris Life Sciences, Inc.
CENTRAL INDEX KEY: 0002019410
STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071]
ORGANIZATION NAME: 08 Industrial Applications and Services
EIN: 852077369
STATE OF INCORPORATION: TX
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: UPLOAD
SEC FILE NUMBER: 377-07265
BUSINESS ADDRESS:
STREET 1: 750 W JOHN CARPENTER FREEWAY
STREET 2: SUITE 800
CITY: IRVING
STATE: TX
ZIP: 75039
BUSINESS PHONE: (866) 771-8946
MAIL ADDRESS:
STREET 1: 750 W JOHN CARPENTER FREEWAY
STREET 2: SUITE 800
CITY: IRVING
STATE: TX
ZIP: 75039
PUBLIC REFERENCE ACCESSION NUMBER: 0001104659-24-069897
LETTER
1
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TEXT-EXTRACT
2
filename2.txt
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.