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August 13, 2019
David L. Lucchino
Chief Executive Officer
Frequency Therapeutics, Inc.
19 Presidential Way, 2nd Floor
Woburn, MA 01801
Re: Frequency Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted July 19, 2019
CIK No. 0001703647
Dear Mr. Lucchino:
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
Implications of being an emerging growth company, page 5
1. 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.
Use of proceeds, page 65
2. We note that the net proceeds will be used to fund the clinical
development of FX-322 to
include your planned Phase 2a clinical trial. Please revise your
disclosure to specify how
far in the clinical development you expect to reach with the net
proceeds.
David L. Lucchino
FirstName Therapeutics, Inc. Lucchino
Frequency LastNameDavid L.
Comapany NameFrequency Therapeutics, Inc.
August 13, 2019
August 13, 2019 Page 2
Page 2
FirstName LastName
Management's discussion and analysis of financial condition and results of
operations
Critical accounting policies and use of estimates
Determination of fair value of common stock, page 88
3. Once you have an estimated offering price or range, please explain to
us the reasons for
any differences between the recent valuations of your common stock and
the estimated
offering price. This information will help facilitate our review of
your accounting for
equity issuance including stock compensation and beneficial conversion
features.
Impact and prevalence of hearing loss, page 96
4. We note that the prospectus includes information from a commissioned
study. Please
identify the party who prepared the study and revise the exhibit index
to indicate that you
will file a consent from such party pursuant to Rule 436 of the
Securities Act.
Astellas Pharma, Inc., page 111
5. We note your disclosure that you may be entitled to double-digit
royalties on any future
product sales in the licensed territory. Please revise your
description of royalty rates to
provide a range that does not exceed ten percent.
Massachusetts Institute of Technology, page 111
6. We note your disclosure that you are required to pay certain annual
license maintenance
fees. Please revise to disclose the general range of the annual
license maintenance fees.
7. We note your disclosure that you are subject to certain development
timeline obligations.
Please revise to disclose these development timeline obligations or,
alternatively, advise
why such obligations are not material to the company. Please also
revise the
Massachusetts Eye and Ear Infirmary and The Scripps Research Institute
(California
Institute for Biomedical Research) sections on page 112 accordingly.
Massachusetts Eye and Ear Infirmary, page 112
8. We note your disclosure that you are required to pay certain annual
license maintenance
fees and a minimum annual royalty payment after first commercial sale.
Please revise to
disclose the general range of these fees and payments.
The Scripps Research Institute, page 113
9. We note your disclosure that you are required to make certain funding
payments to
support Scripps's research activities. Please revise to disclose the
general range of the
funding payments.
David L. Lucchino
Frequency Therapeutics, Inc.
August 13, 2019
Page 3
General
10. Please provide us mockups of any pages that include any additional
pictures or graphics to
be presented, including any accompanying captions. Please keep in
mind, in scheduling
your printing and distribution of the preliminary prospectus, that we
may have comments
after our review of these materials.
You may contact Andi Carpenter at 202-551-3645 or Sharon Blume at
202-551-3474 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Donald Field at 202-551-3680 or Dietrich King at 202-551-8071 with any
other
questions.
FirstName LastNameDavid L. Lucchino Sincerely,
Comapany NameFrequency Therapeutics, Inc.
Division of
Corporation Finance
August 13, 2019 Page 3 Office of
Healthcare & Insurance
FirstName LastName