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United States securities and exchange commission logo
January 5, 2021
William Cao, Ph.D.
Chief Executive Officer
Gracell Biotechnologies Inc.
Building 12, Block B. Phase II
Biobay Industrial Park
218 Sangtian St.
Suzhou Industrial Park, 215123
People's Republic of China
Re: Gracell
Biotechnologies Inc.
Amendment No. 1 to
Registration
Statement on Form F-1
Filed January 4,
2021
File No. 333-251494
Dear Dr. Cao:
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
December 30, 2020 letter.
Amendment No. 1 to Registration Statement on Form F-1
Prospectus Summary, page 1
1. We reissue comment 2
and comment two of our prior letter. Our comments regarding
claims of safety and
efficacy apply to the text as well as the graphics. Revise the graphics
on pages 3 and 154-156
to eliminate claims of:
"improved
transduction efficiency,"
"potential to
eliminate HvG without extra immunosuppresive therapeutics,"
William Cao, Ph.D.
Gracell Biotechnologies Inc.
January 5, 2021
Page 2
"potential to eradicate cancer cells as a standalone therapy,"
"fast remission."
"greater T cell potency,"
"enhanced . . . tumor cell clearance activities,"
"potential to eradicate caner cells as a standalone therapy,"
"potential to achieve fast remission and avoid anti-CD52
therapy and potentially
HSCT," and
"potential to . . . enhance potency . . . [and] improve
safety."
Our Clinical Development Pipeline, page 5
2. We reissue comment 4. Revise the table to provide an arrow that shows
your product
development in China and the U.S., as distinct from the IIT being
conducted in China.
Your pipeline table continues to overstate the development status of
these products that is
within your control.
Summary Risk Factors, page 8
3. We reissue comment 1 in part. Revise the first page of the summary to
further clarify and
highlight the risk that you will be delisted from the Nasdaq. For
example, in the summary
risk factors on page 9, you state, "The enactment of the Holding
Foreign Companies
Accountable Act will result in prohibitions on the trading of the ADSs
on The
Nasdaq Global Market or other U.S. exchange if our auditor fails to be
inspected by the
PCAOB for three consecutive years." Clarify the degree of risk, to the
extent possible.
For example, explain whether it is possible, under current laws and
regulations for your
auditor to be inspected by the PCAOB.
Capitalization, page 115
4. The reported amounts for issued and outstanding ordinary shares and
total shareholders
equity on a pro forma as adjusted basis as of September 30, 2020
do not appear to
correctly reflect the adjustment for the sale of ordinary shares in
this offering. Please
revise the capitalization table accordingly or provide us a
reconciliation of total
shareholders' equity from a pro forma basis to a pro forma as adjusted
basis. In addition,
please revise your calculations and related disclosures in the
document for consistency, as
applicable. For instance, the number of ordinary shares to be
outstanding after the offering
on page 15 is not consistent with the number of ordinary shares
reflected in the
capitalization table after pro forma adjustments
Management
Compensation of Directors andCao,
FirstName LastNameWilliam Executive
Ph.D. Officers, page 215
Comapany
5. ReviseNameGracell Biotechnologies
to provide the compensationInc.
information for the last full
financial year, as required
by Item 4.a. of
January 5, 2021 Page 2 Form F-1 and Item 6.B. of Form 20-F.
FirstName LastName
William Cao, Ph.D.
FirstName LastNameWilliam
Gracell Biotechnologies Inc. Cao, Ph.D.
Comapany
January NameGracell Biotechnologies Inc.
5, 2021
January
Page 3 5, 2021 Page 3
FirstName LastName
Item 7. Recent Sales of Unregistered Securities, page II-1
6. We note the recent option grants. Revise the option grant disclosure
to provide the
information required by Item 701 of Regulation S-K, including the
dates such option
grants were made and exercised (if applicable) and the terms of
exercise.
You may contact Franklin Wyman at (202) 551-3660 or Sasha Parikh at
(202) 551-
3627 if you have questions regarding comments on the financial statements and
related
matters. Please contact Abby Adams at (202) 551-6902 or Celeste Murphy at (202)
551-3257
with any other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Will Cai, Esq.