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United States securities and exchange commission logo
August 23, 2023
David Lucchino
President and Chief Executive Officer
Frequency Therapeutics, Inc.
75 Hayden Avenue, Suite 300
Lexington, MA 02421
Re: Frequency
Therapeutics, Inc.
Registration
Statement on Form S-4
Filed July 27, 2023
File No. 333-273490
Dear David Lucchino:
We have reviewed your 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.
Registration Statement on Form S-4 filed July 27, 2023
Questions and Answers, page 2
1. Please revise this
section, where appropriate, as well as the Prospectus Summary, to
disclose Frequency s
net cash as of the most recent practicable date and to describe and
quantify the factors
that could affect Frequency s net cash between this date and the
closing date of the
Merger.
2. Please revise this
section, where appropriate, to briefly and clearly reflect your disclosure
elsewhere in the proxy
statement/prospectus that the combined company will pursue the
business of Korro Bio
while attempting to sell the assets related to Frequency s current
business.
3. Please revise this
section, where appropriate, to include the ownership of the combined
David Lucchino
FirstName LastNameDavid
Frequency Therapeutics, Inc.Lucchino
Comapany
August 23, NameFrequency
2023 Therapeutics, Inc.
August
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company on a fully-diluted basis.
4. Please revise this section, where appropriate, as well as the
Prospectus Summary, to
disclose the material terms of the Pre-Closing Financing.
Q: What are the CVRs being issued to Frequency stockholders?, page 4
5. Please revise the response to this question, as well as your
disclosure on page 214, to
disclose the fees payable to the Rights Agent, when those fees will be
paid and the party
responsible for paying the fees.
Prospectus Summary
Korro Bio, Inc., page 13
6. Your discussion of Korro Bio should present a balanced view of the
company and its
current stage of development. Please revise your Prospectus Summary to
include a more
balanced discussion of Korro Bio. Your discussion of Korro Bio s
strengths and benefits
should be balanced with equally prominent disclosure of weaknesses and
challenges. By
way of example only:
Reflect your disclosure on page 100 that the risk of failure of
Korro Bio s programs is
high.
Reflect your disclosure on page 101 that Korro Bio is uncertain
regarding the
delivery of product candidates to target tissues, the level of
editing efficiency
required for disease impact, its ability to achieve
pharmacological activity in humans
and the safety of its edits.
Clarify that it will be many years before Korro Bio
commercializes a product
candidate, if ever.
Reflect your disclosure on pages 103 and 116 that RNA editing
is a novel technology
that is not yet clinically validated for human therapeutic use,
Korro Bio is not aware
of any clinical trials for safety or efficacy having been
completed by any third party
using RNA editing and that no gene editing therapeutic product
has been approved in
the U.S. or Europe.
Reflect your disclosure on page 108 that the feasibility of
developing product
candidates using Korro Bio s approach is preliminary and
limited.
Reflect your disclosure on page 115 that regulators have not
yet established any
definitive guidelines related to overall development
considerations for
oligonucleotide drugs.
7. We note your statements regarding Korro Bio s performance (e.g.
Korro Bio s programs
harness the body s natural RNA editing process to effect a
precise yet transient single
base edit , Korro Bio can edit the transcriptome with high
efficiency and specificity ,
etc.). Please revise throughout this section and the section titled
Korro Bio s Business to
clarify, if true, that the performance claims related to Korro Bio and
its technology have
only been observed in preclinical studies and that Korro Bio has yet
to submit an IND to
David Lucchino
FirstName LastNameDavid
Frequency Therapeutics, Inc.Lucchino
Comapany
August 23, NameFrequency
2023 Therapeutics, Inc.
August
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FirstName LastName
the FDA or commence a clinical trial. Your clarifying disclosure
should be equally as
prominent as the performance claims.
8. We note in your disclosure you state "Korro Bio s AATD product
candidate is a
proprietary oligonucleotide that utilizes an established lipid
nanoparticle, or LNP, based
delivery system administered intravenously to transiently restore
production of normal
A1AT in liver hepatocytes." Please revise to disclose whether this
product candidate
delivery system has been finalized and to reflect your disclosure on
page 109 that LNPs
have not been clinically proven to deliver oligonucleotides for RNA
editing.
9. We note your references here and throughout to Korro Bio s life
changing medicines
and claims that Korro Bio s product candidates have the potential to
establish a new
standard of care. These characterizations appears to be premature
given Korro Bio s
current stage of development. Please remove them.
10. Please revise here and throughout to provide the basis for your claim
that Korro Bio has
assembled the preeminent suite of technologies and capabilities
to build its OPERA
platform.
11. Please revise here and throughout to provide the basis for your claim
that Korro Bio s
approach can repair pathogenic SNVs, engineer de novo SNVs and change
amino acids on
proteins to endow them with desired properties while preserving their
broader functional
capabilities.
Korro Bio's Pipeline, page 15
12. Please revise your pipeline chart here and on page 284 to ensure that
the Phase 1, Phase 2
and Phase 3 columns are at least as wide as each of the other columns
in the chart.
13. Your disclosure indicates that Korro Bio will need to complete
additional preclinical work
before it submits an IND for its AATD product candidate. Please
shorten the AATD
pipeline arrow here and on page 284 accordingly.
14. We note that you have included multiple rows in your pipeline chart
for programs that are
minimally discussed in the prospectus and for which Korro Bio has yet
to identify a
product candidate. Please remove these programs from the chart.
Alternatively, please
provide us with an analysis as to why each of these programs is
sufficiently material to the
business of the combined company as to merit inclusion in the pipeline
chart.
Korro Bio's Strategy, page 17
15. We note your statement that Korro Bio intends to rapidly advance
its AATD product
candidate into the clinic. Please revise this statement here and on
page 286 as well as any
similar disclosure to remove any implication that Korro Bio will be
successful in
developing its product candidate in a rapid or accelerated
manner as such statements are
speculative.
16. Please revise here and on page 286 to provide the basis for your
statements that Korro Bio
David Lucchino
FirstName LastNameDavid
Frequency Therapeutics, Inc.Lucchino
Comapany
August 23, NameFrequency
2023 Therapeutics, Inc.
August
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FirstName LastName
has a leadership position in RNA editing and genetic medicines.
Background of the Merger, page 153
17. Please revise this section to describe the negotiations related to the
Pre-Closing Financing.
18. Your disclosure elsewhere in the prospectus indicates that Korro Bio
sold additional
shares of Series B-2 Preferred Stock during the quarter ended March
31, 2023. Please
disclose the valuation ascribed to Korro Bio in this financing and
disclose whether
Frequency s board of directors considered this valuation in its
evaluation of the Merger.
To the extent that Frequency s board did not consider this
valuation, please explain why.
19. Your disclosure throughout this section indicates that the Frequency
Board believed that
Korro Bio s valuation should be lower and that it directed TD Cowen
to inform J.P.
Morgan that an equity premium for Frequency below $20.7 million would
not be
acceptable. However, the final terms of the transaction appear to
contain a valuation of
Korro Bio that is higher than the initial valuations reviewed by
Frequency s board and a
Frequency equity premium that is capped at $15.0 million unless
Frequency s Net Cash
exceeds $25.0 million and could be as low as $12.5 million. Please
revise this section to
disclose why the Frequency Board modified its position on these
issues. Alternatively,
please advise.
20. Your disclosure indicates that on July 11, 2023, the parties agreed to
a sliding equity
premium scale for Frequency which would apply a $12.5 million to $20.0
million
premium, depending on Frequency s level of net cash. However, this
sliding scale does
not appear to match the terms of the definition of Frequency Equity
Value on page 192.
Please revise your disclosure. Alternatively, please advise.
21. Please revise this section, as well as your disclosure on page 20, to
disclose why the
Frequency Board did not retain a third-party financial advisor who had
not been
previously involved in the transaction to provide a fairness opinion.
Financial Analyses, page 174
22. Please revise your disclosure regarding the publicly traded companies
analysis as follows:
Disclose in more detail how TD Cowen identified each comparable
company and
why these companies were deemed to be relevant for the
purposes of analysis.
Disclose the stage of development of each company in the
analysis as well as each
company s estimated enterprise value. To the extent that
clinical-stage companies are
included in the analysis, please explain why TD Cowen included
companies that are
at a more advanced stage of development than Korro Bio and
whether TD Cowen
applied any discount factor to these companies.
23. Please revise your disclosure regarding TD Cowen s DCF analysis to
disclose why TD
Cowen believed that an analysis of the cash flows over 22 years was
reasonable.
David Lucchino
FirstName LastNameDavid
Frequency Therapeutics, Inc.Lucchino
Comapany
August 23, NameFrequency
2023 Therapeutics, Inc.
August
Page 5 23, 2023 Page 5
FirstName LastName
Certain Unaudited Financial Projections for Korro Bio, page 176
24. Please revise here and/or on page 165, as appropriate, 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 Bio
Projections,
please disclose whether the Frequency Board determined that the time
period and revenue
figures presented in the projections were reasonable and, if so, the
reasons underlying
these determinations.
25. Please revise to discuss the assumptions underlying the projections
with more granularity.
For example, disclose whether the projections consider market
competition for Korro
Bio s product candidates and whether the projections incorporate any
possibility of Korro
Bio s product candidates failing to obtain marketing approval,
market acceptance or
insurance coverage.
26. Please disclose and explain the bases for and the nature of the
material assumptions that
underlie the line items presented in the financial projections. Please
ensure the level of
detail provided is sufficient enough for an investor to evaluate and
understand the
reasonableness of the assumptions, uncertainties and/or contingencies
underlying the
projections as well as the inherent limitations on the reliability of
projections in order to
make informed investment decisions. Please specifically address the
growth rates as well
as identify the material product revenue streams underlying these
projections.
27. We note your disclaimer that the Korro Bio Projections will not be
updated even in the
event that any or all of the assumptions underlying such prospective
financial information
are no longer appropriate. This disclaimer does not appear to be
appropriate. Please
remove it.
Korro Bio's Business, page 282
28. Please revise this section to describe the material terms of Korro Bio
s agreement with
Genevant and file the agreement as an exhibit to your registration
statement.
Key Advantages of Oligonucleotide-Based ADAR-Mediated RNA Editing as a
Therapeutic
Modality, page 288
29. 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
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.
Similarly revise the
bullets at the bottom of page 289.
David Lucchino
Frequency Therapeutics, Inc.
August 23, 2023
Page 6
Fit-for-purpose delivery, page 292
30. Please revise this bullet to clarify whether Korro Bio has tested any
of these delivery
technologies for its product candidates and to clarify whether any
approved RNA editing
drugs utilize these technologies.
Korro Bio's Approach to Overcome the Limitations: Transiently Correcting the
SERPINA1
Variant on RNA, page 300
31. Please remove Figure 12 as the claims in this graphic appear to be
premature given Korro
Bio s current stage of development.
Patent Portfolio, page 313
32. Please revise to disclose for each material patent and patent
application the subject matter
to which such patents or patent applications relate, the expiration
date, the type of patent
protection and applicable jurisdictions.
Principal Stockholders of the Combined Company, page 423
33. Please revise to disclose the natural persons who hold voting and/or
dispositive power
over the shares held by each of the institutions disclosed in the
beneficial ownership table.
Korro Bio, Inc.
Notes to Condensed Consolidated Financial Statements
Note 10. Genevant Agreement, page F-96
34. Please revise your disclosure in the filing to disaggregate the
aggregate total of $40.5
million potential payments to separately quantify payments by
clinical, regulatory and
commercial milestones.
Exhibits
FirstName LastNameDavid Lucchino
Comapany
35. NameFrequency
Please Therapeutics,
file the offer letter Inc. and the employment agreement
with Mr.
with Dr. Aiyar
AugustAgarwal
23, 2023asPage
exhibits
6 to your registration statement.
FirstName LastName
David Lucchino
FirstName LastNameDavid
Frequency Therapeutics, Inc.Lucchino
Comapany
August 23, NameFrequency
2023 Therapeutics, Inc.
August
Page 7 23, 2023 Page 7
FirstName LastName
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.
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.