United States securities and exchange commission logo
September 15, 2022
Howard Berman, Ph.D.
Chief Executive Officer
Coya Therapeutics, Inc.
5850 San Felipe St. Suite 500
Houston, TX 77057
Re: Coya Therapeutics,
Inc.
Draft Registration
Statement on Form S-1
Submitted August
19, 2022
CIK No. 0001835022
Dear Dr. Berman:
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
Cover Page
1. We note your disclosure
on page 41 that after this offering, certain of your current
stockholders will
continue to own a significant percentage of the company "for the
foreseeable future,
including the outcome of matters requiring stockholder approval." If
you will be a
"controlled company" as defined under the relevant Nasdaq listing rules,
please disclose that on
your cover page and disclose whether you intend to rely on any
exemptions as a
controlled company. If applicable, please include risk factor disclosure
that discusses the
effect, risks and uncertainties of being designated a controlled company
including, but not
limited to, the result that you may elect not to comply with certain
corporate governance
requirements.
Howard Berman, Ph.D.
Coya Therapeutics, Inc.
September 15, 2022
Page 2
Prospectus Summary, page 1
2. Please clarify the meaning of scientific or technical terms the first
time they are used in
order to ensure that lay readers will understand the disclosure. For
example, please briefly
explain what you mean by autologous, allogeneic, exosomes,
self-tolerance,
and CD4+CD25high hFOXP3+ cells. Please also clarify the meaning of
scientific or
technical terms the first time they are used in the Business section,
such as leukapheresis
and mesenchymal cell derived exosomes.
3. We refer to your disclosure on page F-15 relating to certain milestone
requirements
pursuant to the Methodist License agreement that are triggered upon
the completion of the
Phase 2a clinical trial and a successful end-of-Phase 2 meeting with
the FDA. Please
clarify in the Summary when you completed your Phase 1 and 2a clinical
trials for your
COYA 101 product candidate and conducted an end-of-Phase 2 meeting
with the FDA, as
applicable. Please also revise to disclose that you have received
Orphan Drug
Designation for your COYA 101 product candidate as disclosed on page
21.
4. We note your disclosure here and elsewhere in the prospectus that you
are currently
seeking non-dilutive funding sources in the form of a government grant
or through a
partnership with an established pharmaceutical company to advance your
COYA 101
product candidate into Phase 2b clinical trial for the treatment of
ALS. You also state on
page 16 that if you are unable to receive such non-dilutive funding,
you may delay or
terminate the clinical development of COYA 101. We also refer to your
disclosure on
page 48 that you will only allocate proceeds from this offering if you
successfully receive
non-dilutive funding. Please expand your disclosure, where
appropriate, to discuss the
reasons for seeking non-dilutive funding for your COYA 101 product
candidate, your
decision to make allocations of net proceeds of this offering to COYA
101 contingent
upon receipt of non-dilutive funding, and whether you have applied to
any government
grants or strategic partnerships to date.
5. We refer to your references to COYA 300 as your lead product candidate,
for which you
are currently conducting IND-enabling studies. We also note that COYA
101 is your
most clinically advanced product candidate to date. Please expand your
disclosure, where
appropriate, to discuss your designation of COYA 300 as your lead
product candidate. In
this regard, we note that for the Phase 2a study for COYA 101, your Treg
cell therapy
required taking Tregs from patients and growing those cells out to
"produce at least 2
billion Treg cells from each study participant." If the cost or
scalability of your
FirstName LastNameHoward Berman, Ph.D.
manufacturing process is a barrier to further studies for COYA 101 with
a larger number
Comapany NameCoyaplease
of participants, Therapeutics,
include Inc.
a brief discussion of that, or any other
material challenges,
in an15,
September appropriate
2022 Pagelocation
2 in your prospectus.
FirstName LastName
Howard Berman, Ph.D.
FirstName LastNameHoward Berman, Ph.D.
Coya Therapeutics, Inc.
Comapany 15,
September NameCoya
2022 Therapeutics, Inc.
September
Page 3 15, 2022 Page 3
FirstName LastName
6. Please revise the Summary to provide clear descriptions of the primary
endpoints for your
preclinical and clinical trials and whether any serious adverse events
were observed. We
refer to your disclosure on page 20 relating to fatalities observed in
your preclinical mouse
models. Please revise your disclosure here, page 20 and the Business
section to clarify for
which product candidate the fatalities were observed.
7. We note on page 6 that you will effect a stock split on xx, 2022. If
the stock split will
occur prior to effectiveness of the registration statement, please
revise your historical
financial statements to reflect the stock split based upon the
guidance in ASC 260-10-55-
12 and SAB Topic 4(C). This also applies to your capitalization table
on page 50. Please
also note the need for your independent auditor to reference and
dual-date their audit
opinion for the aforementioned stock split.
Our Pipeline, page 2
8. Please revise your pipeline table here and on page 66 to include a
separate column for
Phase 3 trial. In addition, we note the inclusion of your COYA 206
program in the fifth
row of your pipeline table. Given the status of development and the
undisclosed target,
please explain why this program is sufficiently material to your
business to warrant
inclusion in your Summary pipeline table. If it is material, please
expand your disclosure
in your Business section to provide a more fulsome discussion of this
program, including
a description of preclinical studies or development activities
conducted. Alternatively,
remove any programs that are not currently material from your pipeline
table.
Risks Associated with our Business, page 2
9. We note your disclosure on page 17 that you do not currently own,
lease or operate a
principal laboratory, research and development or manufacturing
facility of your own and
currently collaborate with various research institutions to perform
research and
development for your products, including The Methodist Hospital.
Please highlight this
risk in your summary risk factors.
Utilizing Treg cells represents a novel approach to the treatment of
neurodegenerative and auto
immune diseases..., page 15
10. We note your reference in the second bullet point of this risk factor
to your planned solid
tumor trial. Please expand your disclosure elsewhere to disclose the
material aspects of
this planned trial or revise your disclosure as appropriate.
Howard Berman, Ph.D.
FirstName LastNameHoward Berman, Ph.D.
Coya Therapeutics, Inc.
Comapany 15,
September NameCoya
2022 Therapeutics, Inc.
September
Page 4 15, 2022 Page 4
FirstName LastName
We may not identify or discover other product candidates and may fail to
capitalize on programs
or product candidates..., page 22
11. We note your reference to your "NK cell manufacturing platform."
Please define NK.
We rely on third parties to manufacture our product candidates..., page 33
12. We note your disclosure on page 33 that you do not currently have any
agreements with
third-party manufacturers of your product candidates. Please also
disclose whether you
are dependent on any single or limited number of suppliers for your
raw materials. If so,
please expand your disclosure to discuss your sources, including the
names of any
principal suppliers. See Item 101(h)(4)(v) of Regulation S-K. To the
extent you have
experienced shortages of any raw materials, please expand your
discussion to discuss the
specific circumstances and the impact on your operations.
If our license agreement with The Methodist Hospital is terminated, we could
lose our rights...,
page 34
13. We note your disclosure on page 34 relating to the termination
provisions and the single-
digit royalty payments you make under the Methodist License Agreement.
However, we
refer to your disclosure on page F-15 that Methodist also has the
right to terminate the
license agreement or convert the license to a non-exclusive license if
you do not achieve
certain milestones. You also disclose on page F-15 that you are
required to make tiered
royalty payments ranging from high single-digit to low double-digit
percentages of annual
worldwide net sales and single-digit royalty payments for certain
licensed services. Please
revise your risk factor disclosure and page 76 accordingly.
If securities or industry analysts do not publish research or reports about our
business..., page 44
14. Your disclosure indicates that you currently have limited research
coverage by analysts.
Please confirm if you currently are covered by analysts. If you are
not currently covered,
please revise your disclosure to indicate that you may not obtain
analyst coverage.
Our Amended Charter will provide that the Court of Chancery of the State of
Delaware..., page
45
15. We note your disclosure on page 45 that the forum selection in your
amended charter may
limit a stockholder s ability to bring a claim in a judicial forum
that it finds favorable for
disputes with you and may discourage such lawsuits. Please revise to
disclose that there is
also a risk that your forum selection provision may result in
increased costs for investors
to bring a claim.
Howard Berman, Ph.D.
FirstName LastNameHoward Berman, Ph.D.
Coya Therapeutics, Inc.
Comapany 15,
September NameCoya
2022 Therapeutics, Inc.
September
Page 5 15, 2022 Page 5
FirstName LastName
Use of Proceeds, page 48
16. We note that one use of proceeds for your offering will be to advance
COYA 101 towards
a Phase 2 trial in the event you are successful in receiving
non-dilutive funding from
government grants or from a strategic partner. If known, please
quantify, or provide a
range, of the non-dilutive funding you would need to receive before
advancing COYA
101 towards a Phase 2 trial.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, page 57
17. We note the statement on page 55 that you do not track internal
research and development
expenses by product candidate or by platform. However, on page 57 you
have provided
the expenses by therapeutic program. Please revise the statement on
page 55 to clarify
how you track these expenses and correct the apparent inconsistency in
these disclosures.
18. In this regard, given the importance of your research and development
expenses to your
operations, please revise to also include disaggregated quantified
disclosure by the nature
of expense for each period presented.
Critical Accounting Policies
Stock-Based Compensation, page 61
19. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the initial public offering and the estimated offering price.
This information will help
facilitate our review of your accounting for equity issuances
including stock
compensation. Please discuss with the staff how to submit your
response.
COYA 300, page 68
20. We refer to your disclosure on page 68 relating to the data from the
FTD development
program and preclinical in vitro and in vivo testing to support the
development of your
COYA 300 product candidate. Please expand your disclosure to discuss
the design,
scope, primary endpoints of your preclinical trials, as applicable,
and whether any adverse
events were observed. Please also clarify whether the preclinical in
vitro and in vivo data
generated to date also supports the development of your COYA 202
product candidate,
and if so, please revise your disclosure accordingly.
Our Treg-Derived Exosomes Technology Platform, page 68
21. We note your disclosure on page 68 that your strategy is to
simultaneously develop both
COYA 300 and COYA 202 for the treatment of FTD and you also state that
you expect to
initiate the Phase 1 trial for COYA 300 in the first half of 2023.
Please also clarify when
you intend to conduct a Phase 1 trial for COYA 202.
Howard Berman, Ph.D.
Coya Therapeutics, Inc.
September 15, 2022
Page 6
22. We note your disclosure relating to preclinical studies you are
currently conducting for
your COYA 204 and 205 product candidates. Please expand your
disclosure of the design
and scope of your preclinical studies.
23. We note your disclosure that Treg exosomes contain different types of
cargo, such as
proteins, lipids and nucleic acid. If you may use a variety of
substances as a product
candidate and there would be challenges to your obtaining intellectual
property rights
covering such substances or combinations thereof, such as composition
of matter patents,
please include appropriate risk factor disclosure.
COYA 101, page 71
24. Please clearly disclose the primary and secondary endpoints of your
Phase 1 clinical study
in ALS patients, as applicable. We also refer to your disclosure on
pages 72 and 73 that
you received constructive feedback from a pre-IND meeting with the
FDA, which
provided a clear path for the planning and implementation of the
clinical product
manufacturing. Please expand your disclosure to discuss the feedback
you received from
the FDA.
25. If you have graphical representations of the data from your studies
that would be material
to investors, please present them in this section.
Competition, page 75
26. We note your disclosure on pages 23 and 75 that many of your
competitors have similar
products that focus on the same diseases and conditions that your
current and future
pipeline product candidates address and may address in the future.
Please expand your
disclosure to identify your existing competitors and their products
and disclose whether
any of your competitors are also developing Treg therapies,
Treg-derived
exosomes and/or biologics for the treatment of various
neurodegenerative diseases.
Methodist License Agreement, page 76
27. Please revise your disclosure relating to the Methodist License
Agreement to specify the
amount of the annual license maintenance fee, the termination
provisions, when the last-
to-expire licensed patent is scheduled to expire and the aggregate
amounts paid to date
(including the payment of any up-front or execution fees), as well as
expanded disclosure
of the milestone requirements. We also note your disclosure on page 64
of tiered royalties
FirstName LastNameHoward Berman, Ph.D.
ranging from high-single to low-double digit percentages. Please revise
your disclosure to
Comapany NameCoya
provide Therapeutics,
the number of tiers andInc.
a reasonable idea of the amount of
the royalty rates that
does not exceed ten
September 15, 2022 Page 6 percentage points.
FirstName LastName
Howard Berman, Ph.D.
FirstName LastNameHoward Berman, Ph.D.
Coya Therapeutics, Inc.
Comapany 15,
September NameCoya
2022 Therapeutics, Inc.
September
Page 7 15, 2022 Page 7
FirstName LastName
Government Regulation, page 77
28. We note your disclosure on page 32 concerning the risks related to the
use and handling of
hazardous materials and compliance with environmental regulation.
Please include a
discussion of material regulation applicable to your business and
plans. Refer to Item
101(h)(4)(ix) and (xi) of Regulation S-K.
Patent Rights, page 77
29. For each patent listed, please revise to clarify whether each such
patent is owned or
licensed and the applicable jurisdiction. Please ensure that the type
of patent protection
(such as composition of matter, use or process) is clearly identified
for each patent. For
example, the type of patent protection is not clearly disclosed for
the third patent under the
COYA 101 and the COYA 206 Intellectual Property Portfolios.
30. We note your disclosure on page 77 of six patent rights. However, we
refer to your
disclosure on pages 35 and 76 that your patent estate includes two
pending U.S.
provisional patent applications, one U.S. non-provisional patent
application, five foreign
patent applications and four pending PCT applications. Please advise
whether disclosure
of these twelve pending patent applications are disclosed in this
section or revise your
disclosure accordingly.
Management, page 89
31. The disclosure throughout your prospectus indicates that you have
a scientific advisory board. If material, please include disclosure in
an appropriate
location that describes the role or function of your scientific
advisory board, identifies
each member, and indicates whether there are any rules of procedures
governing this
board. Please also disclose how members of the scientific advisory
board are
compensated.
Summary of the 2021 Equity Incentive Plan, page 95
32. We note your disclosure on page 96 that the plan administrator of the
2021 Equity
Incentive Plan has the authority to modify (reprice) the purchase
price or the exercise
price of any outstanding award. Please disclose if repricings could be
implemented
without stockholder approval. If so, please include appropriate risk
factor disclosure,
including whether proxy advisory firms could find such repricing
without stockholder
approval contrary to a performance-based pay philosophy.
Policies and Procedures for Related Party Transactions, page 104
33. Please disclose the standards that will be applied in determining
whether to approve any
of the transactions described in this section. Refer to Item
404(b)(1)(ii) of Regulation S-
K.
Howard Berman, Ph.D.
Coya Therapeutics, Inc.
September 15, 2022
Page 8
License Agreement, page F-15
34. We note that certain milestone requirements under the Methodist License
refer to "the
effective date on page F-15. Please revise your disclosure to clarify
the meaning of the
effective date for such milestones.
Exhibit Index, page II-3
35. We note your disclosure that you acquired Nicoya Health, Inc. in
December 2020. Please
file the merger agreement as an exhibit or tell us why such agreement is
not required to be
filed. See Item 601(b)(2) and (10) of Regulation S-K.
General
36. Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance
on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain, copies
of those
communications.
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
September 15, 2022 Page 8
cc: Steven M. Skolnick, Esq.
FirstName LastName