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September 16, 2024
Carsten Brunn, Ph.D.
Chief Executive Officer
Cartesian Therapeutics, Inc.
704 Quince Orchard Road
Gaithersburg, MD 20878
Re: Cartesian Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed September 9, 2024
File No. 333-281204
Dear Carsten Brunn Ph.D.:
We have reviewed your amended 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.
Amendment No. 1 to Registration Statement on Form S-1
Prospectus Summary
Company Overview, page 3
1. We note your response to prior comment 1 and reissue in part. Please
revise your
prospectus summary to define the term "durable clinical benefit" as used
here and
throughout the prospectus. In your revisions, please also briefly
discuss the objective
results underlying your conclusion that you observed a "durable clinical
benefit" in
your Phase 2 clinical trial in patients with myasthenia gravis.
Risk Factors
Anti-takeover provisions in our charter documents and under Delaware law...,
page 34
2. We note your response to prior comment 2 and reissue in part. Please
further revise this
risk factor to clearly state whether this provision applies to actions
arising under the
Securities Act or Exchange Act. If this provision does not apply to
actions arising under
September 16, 2024
Page 2
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.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, page 42
3. We have read your response to prior comment three. Please address the
following points:
As requested in the prior comment, please expand your disclosure of
research and
development expenses that you do not track by program to provide a
breakdown by
type or nature of expense for each period presented.
You indicate in your response that the phrase strategic
reprioritization, on page 45
of the Amended Registration Statement, is being used to describe the
shift in the
Company s focus following the Merger to devote substantially all of
its financial
resources and efforts to developing its mRNA-based therapies for the
treatment of
autoimmune diseases. Please expand your disclosure here to include
this information.
Confirm in your response that, to the extent you do track expenses
by program in the
future, you will separately disclose the amount of such expenses by
program.
Business
Clinical Development, page 62
4. We note disclosure in this section stating that adverse events observed
in your clinical
trial of Descartes-08 were "transient and mostly mild." We also note
that the table on page
64 indicates that three of the adverse events observed were reported as
Serious Adverse
Events. Please revise the narrative disclosure appearing in this section
to clearly disclose
the number of Serious Adverse Events observed in your clinical trials of
Descartes-08.
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.