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United States securities and exchange commission logo
September 15, 2023
David Lucchino
President and Chief Executive Officer
Frequency Therapeutics, Inc.
75 Hayden Avenue, Suite 300
Lexington, MA 02421
Re: Frequency
Therapeutics, Inc.
Amendment No. 1 to
Registration Statement on Form S-4
Filed September 1,
2023
File No. 333-273490
Dear David Lucchino:
We have reviewed your amended 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 amending your registration
statement and providing the
requested information. 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 any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Unless we note
otherwise, our references to prior comments are to comments in our
August 23, 2023 letter.
Amendment No. 1 to Registration Statement on Form S-4 filed September 1,
2023
Prospectus Summary
Korro Bio, Inc., page 14
1. Please revise this
section or elsewhere in your registration statement, as appropriate, to
disclose (i) how Korro
Bio currently expects to allocate the proceeds from the Pre-Closing
Financing and Frequency
Net Cash among its development programs and (ii) how far
Korro Bio currently
expects to reach in its development programs with these proceeds.
Korro Bio's Pipeline, page 16
2. We note your response
to prior comment 14. Please provide us with an analysis as to why
each of the four
programs other than Korro Bio's AATD program is sufficiently material
David Lucchino
Frequency Therapeutics, Inc.
September 15, 2023
Page 2
to Korro Bio to merit inclusion in the pipeline chart on an individual
basis. In your
analysis, please address the projections disclosed elsewhere in the
prospectus which do
not appear to contemplate Korro Bio recognizing material revenue from
any program
other than the AATD program prior to December 31, 2045. Please also
tell us the
amounts of proceeds from the Pre-Closing Financing and Frequency Net
Cash that are
anticipated to be allocated to each of these programs. Alternatively,
please remove these
programs from the pipeline chart.
Korro Bio's Strategy, page 19
3. We note your response to prior comment 16 and revised disclosure.
Please revise here and
on page 289 to provide the basis for your statements that Korro Bio
has position as a
leader in RNA editing.
Background of the Merger, page 156
4. We note your response to prior comment 19 and revised disclosure.
Please revise further
to disclose why the Frequency Board modified its position regarding
the valuation of
Korro Bio and Frequency's equity premium. Alternatively, please
advise.
Financial Analyses, page 177
5. We note your response to prior comment 22 and re-issue in part. Please
disclose the stage
of development of each company presented in the comparable company
analysis. Please
also present the estimated enterprise value for each selected company
in the comparable
company analysis and disclose whether TD Cowen applied any discount
factor to
companies at a more advanced stage of development than Korro Bio. You
may state that
individual estimated enterprise values of each selected company were
not independently
determinative or utilized in deriving the results of TD Cowen's
selected publicly traded
companies analysis.
6. We note your response to prior comment 23. Please revise to disclose
whether TD
Cowen's DCF analysis incorporated the possibility that Korro Bio's
products are not
approved and/or Korro Bio does not achieve profitability.
Certain Unaudited Financial Projections for Korro Bio, page 179
7. We note your response to prior comment 24 and re-issue. Please revise to
disclose the
extent to which the Frequency Board considered the Korro Bio Projections
in making its
decision to approve the Merger. To the extent the Frequency Board
considered the Korro
FirstName LastNameDavid Lucchino
Bio Projections, please disclose whether the Frequency Board determined
that the time
Comapany NameFrequency
period Therapeutics,
and revenue figures presentedInc.
in the projections were
reasonable and, if so, the
reasons
September underlying
15, 2023 Page 2these determinations.
FirstName LastName
David Lucchino
FirstName LastNameDavid
Frequency Therapeutics, Inc.Lucchino
Comapany 15,
September NameFrequency
2023 Therapeutics, Inc.
September
Page 3 15, 2023 Page 3
FirstName LastName
Key Advantages of Oligonucleotide-Based ADAR-Mediated RNA Editing as a
Therapeutic
Modality, page 292
8. We note your response to prior comment 29 and re-issue. We note your
disclosure in the
graphic that oligo-based RNA editing has precedented delivery,
tolerability and
manufacturing as well as multiple approved products. Please revise the
graphic
to reconcile these claims with your statements in Risk Factors that
Korro Bio is uncertain
how it will deliver product candidates to target tissues, RNA editing
is a novel technology
that has not yet been validated for human therapeutic use, Korro Bio
is not aware of
clinical trials being completed by third parties using RNA editing or
similar technologies,
regulators have not established definitive guidelines for
oligonucleotide drugs and no gene
editing therapeutic product has been approved in the U.S. or Europe.
Patent Portfolio, page 318
9. We note your response to prior comment 32 and re-issue in part. Please
revise to disclose
for each material patent and patent application the subject matter to
which such patents or
patent applications relate and the type of patent protection. In your
revisions, please
discuss the patent protection for your lead product candidate(s).
You may contact Sasha Parikh at 202-551-3627 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Cindy Polynice at 202-551-8707 or Alan Campbell at 202-551-4224 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Jennifer Yoon, Esq.