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August 29, 2024
Carsten Brunn, Ph.D.
Chief Executive Officer
Cartesian Therapeutics, Inc.
704 Quince Orchard Road
Gaithersburg, MD 20878
Re: Cartesian Therapeutics, Inc.
Registration Statement on Form S-1
Filed August 2, 2024
File No. 333-281204
Dear Carsten Brunn Ph.D.:
We have reviewed your registration statement and have the following
comments.
Please respond to this letter by amending your registration statement
and providing the
requested information. 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 any amendment to your registration statement and the
information you
provide in response to this letter, we may have additional comments.
Registration Statement on Form S-1
Prospectus Summary
Company Overview, page 4
1. Please explain the term "durable clinical benefit" as used on page 4 to
briefly describe the
results of your Phase 2 clinical trial of Descartes-08 in patients with
myasthenia gravis.
Please also explain the term "clinically meaningful" as used on page 56,
and throughout
your business section, to describe results observed from your clinical
trials.
Risk Factors
Anti-takeover provisions in our charter documents and under Delaware law...,
page 35
2. We note that your forum selection provision identifies the Court of
Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any
derivative
action. Please disclose whether this provision applies to actions
arising under the
Securities Act or Exchange Act. In that regard, we note that Section 27
of the Exchange
Act creates exclusive federal jurisdiction over all suits brought to
enforce any duty or
August 29, 2024
Page 2
liability created by the Exchange Act or the rules and regulations
thereunder, and Section
22 of the Securities Act creates concurrent jurisdiction for federal and
state courts over all
suits brought to enforce any duty or liability created by the Securities
Act or the rules and
regulations thereunder. If the provision applies to Securities Act
claims, please also revise
your prospectus to state that there is uncertainty as to whether a court
would enforce such
provision and that investors cannot waive compliance with the federal
securities laws and
the rules and regulations thereunder. If this provision does not apply
to actions arising
under the Securities Act or Exchange Act, please also ensure that the
exclusive forum
provision in your governing documents states this clearly, or tell us
how you will inform
investors in future filings that the provision does not apply to any
actions arising under the
Securities Act or Exchange Act. Please also expand your risk factor to
indicate that the
forum selection provision may increase costs for shareholders to bring a
claim.
Management's Discussion of Financial Condition and Results of Operations
Results of Operations
Comparison of the Three Months Ended March 31, 2024 and 2023, page 41
3. Please revise to address the following regarding your disclosure on page
39 that you track
your external research and development costs on a program-by-program
basis:
Please expand your disclosure of the changes in research and
development expenses
for each period presented to separately quantify the costs incurred
for each of your
key research and development programs.
For the research and development expenses that you do not track by
program, provide
a breakdown by type or nature of expense.
Provide a background discussion of the "strategic reprioritization"
that you reference
on pages 41 and 42.
Confirm that you will provide similar disclosure in your future
periodic filings.
Comparison of the Years Ended December 31, 2023 and 2022, page 42
4. We note you included audited financial statements for the three fiscal
years ended
December 31, 2023 of Cartesian Therapeutics, Inc. in your filing.
However, you have
only included an annual discussion of the Company's results of
operations and cash flows
for the year ended December 31, 2023 compared to the year ended December
31, 2022.
Please include a discussion of the results of operations and cash flows
for the year ended
December 31, 2022 compared to the year ended December 31, 2021, or
expand your
disclosure to provide a statement that identifies the location in a
prior filing where the
omitted discussion may be found. See Instruction (b)1 to Item 303 of
Regulation S-K.
Business
Overview, page 54
5. We note the inclusion of Descartes-08 for the treatment of pediatric
autoimmune diseases
in your pipeline table. Given the limited disclosure related to this
program in your
business section, please explain why it is sufficiently material to your
business to warrant
inclusion in your pipeline table. If it is material, please expand your
disclosure in the
Business section to provide a more fulsome discussion of this program
and shorten the
corresponding bar in your pipeline table, as disclosure on page 60
indicates you have not
August 29, 2024
Page 3
yet filed an IND for this indication. Alternatively, remove any programs
that are not
currently material from your pipeline table on page 55.
6. Please remove the statements on page 55 and 56 and elsewhere claiming
that Descartes-
08 was observed to be "safe" and demonstrated a "favorable safety
profile" as safety
determinations are within the sole discretion of the FDA and comparable
foreign
regulators.
Our Product Candidates
Descartes-08, page 57
7. Please remove any references to your Descartes-8 product candidate being
potentially
"first-in-class" as this is speculative in light of your current
regulatory status.
Clinical Development, page 58
8. Please revise this section to disclose if any serious adverse events
were observed in your
clinical trials of Descartes-08 and quantify them, if applicable.
Descartes-15, page 60
9. Please provide narrative disclosure explaining what is depicted in the
graphic appearing
on page 61.
Intellectual Property, page 61
10. Please revise to disclose the types of patent protection for the
material patents and patent
applications disclosed in this section. Please also disclose the
potential expiration dates, if
granted, for the fourteen patent applications related to your mRNA CAR-T
technology
and other developments in your mRNA cell therapy pipeline.
Key Agreements, page 62
11. We note your disclosure that the Biogen Agreement will expire when all
claims of all
issued patents within the patents and patent applications licensed to
you under the Biogen
Agreement have expired and that the NCI License Agreement terminates
upon the
expiration of the last to expire of the patent rights licensed
thereunder. Please revise to
clarify when the patents and patent applications under the Biogen
Agreement are expected
to expire and when the patent rights licensed under the NCI License
Agreement are
expected to expire. Please also disclose the exclusivity provisions
related to these
agreements.
Astellas License Agreement, page 63
12. Please revise your discussion of the Astellas License Agreement to
disclose the current
status of this agreement as of the latest practicable date. In this
regard, we note your
disclosure appearing on page 40 stating that you were notified by
Astellas of their
intention to terminate the Astellas Agreement effective June 6, 2024. If
the agreement has
been terminated, clearly disclose this and tell us why it is appropriate
for you to discuss
the agreement in this section. If the agreement remains in place, please
file this agreement
as exhibit to your registration statement. Refer to Item 601 of
Regulation S-K for
guidance.
August 29, 2024
Page 4
General
13. We note your disclosure on page 126 that your Selling Stockholders may
sell all or a
portion of the Resale Shares to or through underwriters or purchases by
a broker-dealer as
principal and resale by the broker-dealer for its account. Please
confirm your
understanding that the retention by a selling stockholder of an
underwriter would
constitute a material change to your plan of distribution requiring a
post-effective
amendment. Refer to your undertaking provided pursuant to Item
512(a)(1)(iii) of
Regulation S-K.
14. The forepart of your prospectus should consist of the cover page,
summary and risk
factors sections. Please relocate the sections "About This Prospectus"
and "Cautionary
Note Concerning Forward-Looking Statements" appearing after the table of
contents to a
more appropriate location in the prospectus.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
Please contact Tracie Mariner at 202-551-3744 or Kevin Vaughn at
202-551-3494 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Tyler Howes at 202-551-3370 or Tim Buchmiller at 202-551-3635 with any
other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Sarah C. Griffiths, Esq.