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United States securities and exchange commission logo
June 2, 2021
Rachel Haurwitz, Ph.D.
President and Chief Executive Officer
Caribou Biosciences, Inc.
2929 7th Street, Suite 105
Berkeley, California 94710
Re: Caribou
Biosciences, Inc.
Draft Registration
Statement on Form S-1
Submitted May 7,
2021
CIK No. 0001619856
Dear Dr. Haurwitz:
We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so
we may better
understand your disclosure.
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 our comments apply 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 these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1. Your statements that
your allogeneic CAR-T cell therapies have "best-in-class" potential
imply the likelihood of
regulatory approval and comparisons to other products and
product candidates. The
statements are speculative in light of their regulatory status.
Please remove the
"best-in-class" references.
2. Please make the
following changes to your pipeline table:
Include all
clinical stages that must be completed before commercialization (i.e., add
columns for Phases
2 and 3).
We note the table
entitled "Programs under AbbVie collaboration" with
Rachel Haurwitz, Ph.D.
FirstName LastNameRachel Haurwitz, Ph.D.
Caribou Biosciences, Inc.
Comapany
June 2, 2021NameCaribou Biosciences, Inc.
June 2,
Page 2 2021 Page 2
FirstName LastName
"undisclosed" targets that are only discussed briefly in your
description of your
collaboration and license agreement with AbbVie. To the extent
these are material
programs, disclose the targets and provide descriptions of these
programs. Otherwise,
please remove them from the table or explain the basis for your
belief that they are
material and should be included in your pipeline table.
Please explain what is involved in "lead optimization" and why
you believe this is a
separate and distinct development phase, as opposed to part of
the discovery
phases. While we will consider your response, we do not currently
believe that
the lead optimization is distinct from the discovery phase and
should thus be depicted
under the discovery column. A textual discussion of the program
is likely a more
appropriate place to make distinctions regarding different
segments within a
particular phase.
3. We note your disclosure here and throughout the filing that you are
focused on advancing
treatments for "clinically validated targets." Please balance these
statements throughout
your registration statement with the disclosure on page 22 that no
products that use novel
genome-editing technologies have advanced into clinical trials or
received marketing
approval in the United States.
4. You note on page 2 and throughout your filing that the February 2021
collaboration
with AbbVie is " is an external validation of our chRDNA
genome-editing technology."
Please revise this statement and similar statements on pages 98 and
116 to remove the
"external validation" language, as efficacy determinations are the
exclusive purview of the
FDA or other regulators.
5. Please balance your disclosure on page 2 and throughout your filing
that "CB-010 is
currently being evaluated in a phase 1 clinical trial in patients with
relapsed or refractory
B cell non-Hodgkin lymphoma" with the fact that you have not yet
enrolled patients in
this trial. We note your disclosure to this effect on page 26.
Risk Factors
Our rights to develop and commercialize our product candidates are subject...,
page 57
6. Please provide additional risk factor disclosure about the dispute
with Intellia
Therapeutics. Specifically, disclose whether your inability to reach a
"final resolution"
with Intellia would hinder your ongoing Phase 1 trial of CB-010 and
whether you would
be able to continue clinical development of CB-010 if this dispute is
not resolved.
Industry and Market Data, page 88
7. We note your statements regarding market data used in the prospectus,
including that the
sources of the information do not guarantee the accuracy or
completeness of the
information and that investors are cautioned "not to give undue
weight" to estimates.
Please revise these statements to eliminate any implication that
investors are not entitled
to rely on the information included in your registration statement.
Rachel Haurwitz, Ph.D.
FirstName LastNameRachel Haurwitz, Ph.D.
Caribou Biosciences, Inc.
Comapany
June 2, 2021NameCaribou Biosciences, Inc.
June 2,
Page 3 2021 Page 3
FirstName LastName
Results of Operations
Licensing and Collaboration Revenue, page 104
8. Please describe and quantify for us revenue by license and
collaboration agreement for
each period presented that includes reference to related information
in Note 4. In addition,
clarify whether the "Private Company" is a related party, as
referenced on page F-8, or an
unaffiliated company, as referenced on page F-21. Revise your
disclosure accordingly.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation Expense, page 112
9. Once you have an estimated offering price range, please explain to us
the reasons for any
differences between recent valuations of your common stock leading up
to the planned
offering and the midpoint of your estimated offering price range. This
information will
facilitate our review of your accounting for stock compensation.
Please discuss with the
Staff how to submit your response.
Business
Strategic Agreements, page 143
10. Please revise the descriptions of your strategic agreements as
appropriate to revise any
references to "low-double-digit" and "mid-double-digit" royalties to a
royalty range within
ten percentage points (for example, between twenty and thirty percent)
and to disclose
the expected expiry of the last-to-expire patent licensed under the
agreements.
11. With respect to the Collaboration and License Agreement with AbbVie,
please disclose
the fee that AbbVie must pay to expand from two Program Slots and the
maximum
aggregate commercial milestones you may receive under the agreement.
12. With respect to your Exclusive License Agreement with MSKCC, please
revise your
disclosure to clarify whether the IPO would trigger a success payment.
13. Please expand your discussion of the ProMab Agreement to disclose the
upfront payment,
royalty term, and termination provisions.
14. With respect to the Pioneer Agreement, please disclose the "certain
events" that permit
either party to terminate the agreement.
Intellectual Property, page 147
15. Please expand your intellectual property discussion to disclose the
number and type of
patents that cover each of your product candidates and programs,
whether they are owned
or licensed, the related jurisdiction, and the expiration year.
Rachel Haurwitz, Ph.D.
FirstName LastNameRachel Haurwitz, Ph.D.
Caribou Biosciences, Inc.
Comapany
June 2, 2021NameCaribou Biosciences, Inc.
June 2,
Page 4 2021 Page 4
FirstName LastName
Legal Proceedings
Intellia Arbitration, page 167
16. Please disclose, if known, a general timeframe for when you expect to
negotiate economic
terms based on the revised scope of the leaseback and whether you
believe that agreeing
to these terms will resolve the conflict underlying the Intellia
Arbitration. If not, please
expand your disclosure to discuss how the interim award determining
that the two patent
families are included in the Intellia License Agreement impacts any
licenses or
sublicenses that you have granted, if at all.
Licensing Agreement Transaction, page 193
17. You disclose that you have a license agreement with a "private
company" controlled by
Anterra that provides for milestone payments and royalty payments for
future sales of
licensed products. Please disclose the material terms of the license
agreement, including
the milestone payments and the royalty range, and file the agreement
as an exhibit or tell
us why you believe such filing is not required. Refer to Item
601(b)(10) of Regulation S-
K.
Principal Stockholders, page 197
18. Please identify in footnotes to the table all natural persons who have
voting and/or
investment power over the shares held by F-Prime Capital Partners.
Financial Statements
Note 2. Summary of Significant Accounting Policies
Revenues, page F-9
19. Please expand your disclosures to describe the nature of your
performance
obligation associated with maintenance fees and when you satisfy your
performance
obligation. In this regard, while you disclose herein that you
recognize revenues
associated with annual maintenance fees on a point in time basis on
each anniversary date,
you also disclose on page F-23 that your deferred revenue primarily
results from customer
payments received upfront for maintenance fees because these
performance obligations
are satisfied over time. Please address this apparent discrepancy.
Refer to your disclosure
on page 111 as well.
General
20. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications.
Rachel Haurwitz, Ph.D.
Caribou Biosciences, Inc.
June 2, 2021
Page 5
You may contact Franklin Wyman at 202-551-3660 or Jeanne Baker at
202-551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Dillon Hagius at 202-551-7967 or Irene Paik at 202-551-6553 with any
other questions.
Sincerely,
FirstName LastNameRachel Haurwitz, Ph.D.
Division of
Corporation Finance
Comapany NameCaribou Biosciences, Inc.
Office of Life
Sciences
June 2, 2021 Page 5
cc: Ashok Mukhey
FirstName LastName