United States securities and exchange commission logo
October 19, 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. 1 to
Draft Registration
Statement on Form S-1
Submitted October
7, 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 1 to Form S-1 Draft Registration Statement Submitted on
October 7, 2022
Prospectus Summary, page 1
1. We note your revised
disclosure in response to prior comment 6 that death in certain
animals was observed at
the highest dose for your COYA 201 product candidate. Please
revise here and
elsewhere in the prospectus to specify the number of deaths observed in
your preclinical mouse
study. Please also clarify whether the primary endpoints for your
preclinical and
clinical trials were met, as applicable.
Howard Berman, Ph.D.
FirstName LastNameHoward Berman, Ph.D.
Coya Therapeutics, Inc.
Comapany
October 19,NameCoya
2022 Therapeutics, Inc.
October
Page 2 19, 2022 Page 2
FirstName LastName
Our Pipeline, page 3
2. We note your response to prior comment 8, which we reissue in part.
Please revise your
pipeline table here and on page 67 to include a separate column for
Phase 3 trial.
We rely on third parties to manufacture our product candidates..., page 34
3. We acknowledge your revised disclosure in response to prior comment
12. We note that
you have entered into a material transfer agreement with ThermoFisher
Scientific to
manufacture your autologous Treg cell therapy. Please expand your
disclosure on the
materiality of your arrangement with ThermoFisher Scientific. If
material, please disclose
the material terms of the agreement and file such agreement as an
exhibit to the
registration statement or provide analysis as to why it would not be
required under Item
601(b)(10) of Regulation S-K. Please also identify the foreign
pharmaceutical
manufacture for the supply of the antibody for the COYA 302 product
candidate.
If securities or industry analysts do not publish research or reports..., page
45
4. We note your revised disclosure in response to prior comment 14, which
we reissue in
part. Please revise your disclosure to indicate that you may not
obtain analyst coverage.
COYA 302, page 70
5. We note your response to prior comment 20, which we reissue in part.
We refer to your
disclosure on page 70 relating to preclinical in vitro and proof of
concept human clinical
studies conducted by Dr. Appel for your COYA 302 product candidate,
which showed
"adequate tolerability" and "promising clinical activity" in patients
with
neurodegenerative diseases. Please expand your disclosure to discuss
the design, scope,
primary endpoints and whether any adverse events were observed;
whether the studies
were powered to show statistical significance; and revise your
characterizations of the
preclinical trials to discuss the data, rather than drawing
conclusions from the results.
COYA 101, page 73
6. We note the deleted reference to constructive feedback from the FDA on
page 74
in response to prior comment 24, which we reissue in part. We note two
remaining
references to recommendations made by the FDA relating to your Phase 1
study on page
76. Please revise accordingly or expand your disclosure to discuss the
feedback received
from the FDA.
7. We note your expanded disclosure of the Phase 1 and Phase 2a studies
of your COYA 101
product candidate, which include references to standard deviations.
Please expand your
disclosure to address related statistical significance and/or
p-values. Please also discuss
the meaning of the asterisks, where appropriate, in the graphics on
page 77.
Howard Berman, Ph.D.
FirstName LastNameHoward Berman, Ph.D.
Coya Therapeutics, Inc.
Comapany
October 19,NameCoya
2022 Therapeutics, Inc.
October
Page 3 19, 2022 Page 3
FirstName LastName
Methodist License Agreement, page 80
8. We note your revised disclosure in response to prior comment 27, which
we reissue in
part. We refer to your disclosure on page 81 of royalties equal to
high-single digit to
"low-double digit" percentages of annual worldwide net sales of such
licensed product.
Please revise your disclosure to give investors a reasonable idea of
the amount of the
royalty rate that does not exceed ten percentage points.
ARScience Bioetherapeutics, Inc. License Agreement, page 81
9. We note your disclosure of your license agreement with ARScience
Biotherapeutics, Inc.
Please revise your disclosure on page 81 to disclose the upfront fee
and the aggregate
amounts paid to date under the agreement.
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,
Division of
Corporation Finance
Office of Life
Sciences
cc: Steven M. Skolnick, Esq.