United States securities and exchange commission logo
March 25, 2021
Feng Tian
Chairman, President and Chief Executive Officer
Ambrx Biopharma Inc.
10975 North Torrey Pines Road
La Jolla, California 92037
Re: Ambrx Biopharma
Inc.
Amendment No. 1 to
Draft Registration Statement on Form F-1
Submitted March 15,
2021
CIK No. 0001836056
Dear Dr. Tian:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form F-1, Submitted
March 15. 2021
Summary
Overview, page 1
1. We note your response
to our prior comment number 2. Please balance your Summary
disclosure by
referencing the fact that each participant in the ACE-Breast-01 and ACE-
Gastric-01 trials
reported one or more drug-related adverse effects, and 80% did so in the
ACE-Pan tumor-01 trial.
2. We note your response
to our prior comment number 3 and the related revisions to the
prospectus. Please
further revise your disclosure to briefly explain the accelerated
approval process you
refer to, including the requirements thereof.
Feng Tian
Ambrx Biopharma Inc.
March 25, 2021
Page 2
Our Product Pipeline, page 3
3. We note your response to our prior comment number 5. Given the second
footnote to your
pipeline table indicates you expect to rely on the ACE-PAN-Tumor-01 Phase
1 study as a
predicate for the Phase 2/3 clinical trials for Post-T-OM1 and 2L,
Pre-T-DM1, please
revise to explain whether you have discussed such approach with the FDA
or comparable
regulators.
Exhibits
4. We note your response to our prior comment number 19. You disclose that
you anticipate
the first two steps of the Reorganization will be completed prior to the
completion of this
offering and the third step of the Reorganization will be completed prior
to a to-be-
provided date in 2021. If the Reorganization will be completed after the
completion of this
offering, then please file the Shanghai Option Agreement as an exhibit.
Alternatively, if
the Reorganization will be completed and the Agreement terminated prior
to
effectiveness, then revise your disclosure to clarify this point.
You may contact Michael Fay at 202-551-3812 or Brian Cascio at
202-551-3676 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Margaret Schwartz at 202-551-7153 or Laura Crotty at 202-551-7614 with
any other
questions.
Sincerely,
FirstName LastNameFeng Tian
Division of
Corporation Finance
Comapany NameAmbrx Biopharma Inc.
Office of Life
Sciences
March 25, 2021 Page 2
cc: Sean Clayton, Esq.
FirstName LastName