United States securities and exchange commission logo
November 4, 2022
Howard Berman, Ph.D.
Chief Executive Officer
Coya Therapeutics, Inc.
5850 San Felipe St. Suite 500
Houston, TX 77057
Re: Coya Therapeutics,
Inc.
Amendment No. 2 to
Draft Registration
Statement on Form S-1
Submitted October
28, 2022
CIK No. 0001835022
Dear Howard Berman:
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. 2 to Draft Registration Statement on Form S-1 submitted
October 28, 2022
Prospectus Summary, page 1
1. We note your revised
disclosure in response to prior comment 1, which we reissue in
part. With respect to
the second study that you disclose was conducted in the third quarter
of 2022 for COYA 201 in
a humanized in vitro model of liver inflammation and fibrosis,
please disclose whether
the primary endpoints of this second study were met or whether
this study is ongoing.
As appropriate, please also expand your disclose under "COYA
201" starting on page
74 to provide the material information regarding the results of this
second study.
Howard Berman, Ph.D.
Coya Therapeutics, Inc.
November 4, 2022
Page 2
We rely on third parties to manufacture our product candidates..., page 34
2. We note your revised disclosure on page 34 in response to prior comment
3 that you have
entered into a binding term sheet with a third party supplier for the
supply of the fusion
protein for your COYA 302 product candidate. Please clarify whether you
rely on a
single-source supplier or a limited number of third parties who supply
the fusion protein
and if so, please identify such principal supplier or manufacturer.
Refer to Item
101(h)(4)(v) of Regulation S-K.
Our Pipeline, page 67
3. We note your revised pipeline table on page 3 in response to prior
comment 2, which we
reissue in part. Please also revise your pipeline table on page 67 to
include a separate
column for the Phase 3 trial.
COYA 302, page 71
4. We note your response to prior comment 5. Please revise your disclosure
on page 72 to
clarify, if true, that the preclinical trials conducted by Dr. Appel
were not powered for
statistical significance.
COYA 101, page 76
5. We note your response to prior comment 7, which we reissue in part. For
the Phase 1
study of your COYA 101 product candidate, please clarify whether this
study was
powered to show statistical significance. If the Phase 1 study was
powered for statistical
significance, please provide p-values for the results. Please also
provide the p-values for
the data shown in the table on page 79.
You may contact Tara Harkins at 202-551-3639 or Kevin Kuhar at
202-551-3662 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jane Park at 202-551-7439 or Tim Buchmiller at 202-551-3635 with any
other questions.
Sincerely,
FirstName LastNameHoward Berman, Ph.D.
Division of
Corporation Finance
Comapany NameCoya Therapeutics, Inc.
Office of Life
Sciences
November 4, 2022 Page 2
cc: Steven M. Skolnick, Esq.
FirstName LastName