SEC Comment Letter 0000000000-24-009680 to Ceribell, Inc. (CBLL) (CIK 0001861107) (CBLL)
Ceribell, Inc. (CBLL) (CIK 0001861107)
Date: Aug. 23, 2024 · CIK: 0001861107 · Accession: 0000000000-24-009680
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August 23, 2024
Xingjuan (Jane) Chao
Chief Executive Officer
Ceribell, Inc.
360 N. Pastoria Avenue
Sunnyvale, CA 94085
Re:Ceribell, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted August 5, 2024
CIK No. 0001861107
Dear Xingjuan (Jane) Chao:
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 22, 2024, letter.
Amendment No. 1 to Draft Registration Statement on Form S-1 submitted August 5, 2024
Prospectus Summary
Overview, page 1
1.We note your response to comment 3 and your revised disclosure on page 94, but your
revisions are not completely responsive to our comment. Please revise your prospectus
summary to disclose how patient care and clinical outcomes are measured. Footnote
disclosure or cross-references may be appropriate.
Market Opportunity, page 3
We note your revisions in response to comment 4, including your amended disclosure on
page 95. Please revise your prospectus summary to briefly describe the basis for your 2.
August 23, 2024
Page 2
estimate of your addressable market opportunity. A cross reference or footnote disclosure
may be appropriate. Also, your response indicates that the company does not believe "the
average selling prices of the hardware and software components of its solution is
information that is material to an understanding of the Company's estimate of its total
annual addressable market opportunity, in the context of the other details included in
Amendment No. 1. The Company has determined the average selling price for the
hardware and software components of its solution in light of the value of its solution,
competitive benefits, market dynamics, customer demand, competitive pressures and
other relevant factors." Please further explain why the average selling prices of hardware
and software components of the company's product are not material to an understanding
of the company's total annual addressable market opportunity, given that the market
opportunity of $2 billion appears to be tied to your ability to sell your hardware and
software at a certain average price.
Risk Factors
We rely on third parties . . . , page 32
3.We note your revisions in response to prior comment 7. To the extent that any of these
collaboration agreements are material, please identify the relevant agreement and include
a description of the material terms of each of these agreements in your filing, including
rights and obligations, financial terms including amounts paid to date, aggregate
milestone amounts to be paid or received, the royalty range and term, as applicable, term,
and termination provisions. Please also file these agreements as exhibits.
Use of Proceeds, page 61
4.We note your disclosure that you "currently intend to use the net proceeds from this
offering to fund sales and marketing efforts, fund research and product development
activities, conduct or sponsor clinical studies, and for general corporate purposes,
including working capital, operating expenses, and capital expenditures." Please revise to
clarify the approximate amount of your net proceeds for each of the principal purposes
listed in your disclosure, if known. Please also clarify the products for which you intend
to "conduct or sponsor clinical studies," and the stage of development you expect to reach
with proceeds from the offering.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Liquidity and Capital Resources
Sources of Liquidity, page 80
Please revise your disclosure in this section to provide additional detail about the material
terms of the relevant loans, including, as discussed in your revised disclosure on page F-
23, that the SVB Loan carries a variable per-annum interest rate at the Prime Rate subject
to the floor of 6.00%, the Horizon Loan carries a variable per-annum interest rate at the
Prime Rate plus 2.75%, subject to the floor of 9.25%, and that the Company is also
required to pay end-of-term fees of 4.0% per tranche drawn on the Maturity Date or upon
repayment of the amounts due to the Lenders under the VLSA. In addition, please
disclose that the Revolving Facility includes additional fees of $300,000 million that are
payable regardless of whether any amounts are drawn. As a related matter, we note your
disclosure on page F-23 that "[u]pon execution of the VLSA, the Company paid to the 5.
August 23, 2024
Page 3
Lenders $245,000 and issued warrants to purchase 106,263 shares of the Company’s
Series C-1 Preferred Stock at a price of $4.47 per share ('Initial Warrants')." Please revise
your disclosure here to include a discussion of these terms.
Business
Invest in further growing our base of clinical evidence, page 91
6.We note your revisions and response to prior comment 15, but we are not persuaded by
your response. Please revise to identify the studies you are sponsoring and
supporting, including the parties that will perform the studies, the trial design, and
primary end points of the studies.
Other Potential Opportunities Beyond Seizures, page 95
7.We note your revised disclosure in response to comments 19, 20, and 25, including that
you have not yet applied for marketing authorization from the FDA for the use of the
Ceribell System relating to delirium or ischemic stroke, and that prior to
commercialization within these indications, you would need to apply for and obtain the
required marketing authorizations. Please revise to clearly disclose when you expect to
apply for marketing authorizations from the FDA, that you have no intended timeline for
commercialization of the services related to these two indications, and that there is no
guarantee you will obtain the required authorizations. Please also clarify how you
determined, based on the average selling price of your headband, that expansion of your
indications could represent an incremental, multi-billion-dollar market opportunity, given
that your headbands have not been used for these indications and that you have no
timeline for commercialization of your Ceribell System relating to these indications.
Finally, provide a brief description of the ongoing research and active clinical studies, if
any, related to these two indications. In this regard, we note your disclosure on page 118.
Our Addressable Market Opportunity in Seizures, page 95
8.We note your response to comment 18. Please revise to state, as you do in your response,
that you do not have specific, intended timing at this stage of development: (i) for
pursuing additional regulatory clearances in Europe, or (ii) to commercialize your product
in Europe.
Our Clinical Results and Economic Evidence, page 101
9.We note your footnote disclosure on page 117 including "Study was supported,
sponsored, or funded by Ceribell." Please clarify the difference between supported,
sponsored, or funded, and clarify which of the studies noted in the table are included in
each category.
Intellectual Property, page 120
10.We note your revisions in response to prior comment 27; however, these revisions do not
appear to be completely responsive to our comment. Please revise your intellectual
property disclosure to clearly describe in tabular form, for each material patent or group
of patents or pending patent applications: (i) the specific products, product groups, and
technologies to which such patents relate, (ii) whether the patents are owned or licensed,
(iii) the type of patent protection, (iv) patent expiration dates, and (v) jurisdiction.
August 23, 2024
Page 4
Underwriting
Directed Share Program, page 165
11.We note your disclosure here and throughout the prospectus regarding your directed share
program. Please revise your prospectus to clarify, where appropriate:
•whether the participating employees in the directed share program include any
directors, officers, business associates, and related persons;
•the "certain minimum requirements" for the directed share program; and
•the risks associated with the participants of the directed share program not being
subject to a 180-day lock-up restriction.
In addition, please expand your disclosure to address the process that prospective
participants will follow to participate in the program, the manner by which you will
communicate with prospective participants about the program, when and how you will
determine the allocation for the program, whether such allocation will change depending
on the interest level of potential participants, and any other material features of the
program.
Financial Statements
Note 2. Summary of Significant Accounting Policies, page F-8
12.You disclose that you provide product warranties at page 117. Please revise to provide all
required disclosures under ASC 460-10-50 related to product warranties, where
applicable.
Please contact Li Xiao at 202-551-4391 or Kristin Lochhead at 202-551-3664 if you have
questions regarding comments on the financial statements and related matters. Please contact
Nicholas O'Leary at 202-551-4451 or Katherine Bagley at 202-551-2545 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Kathleen M. Wells, Esq.