SecProbe.io

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 Acceleration Request

 August 18, 2025
 VIA EDGAR United States Securities and Exchange
Commission Division of Corporation Finance 100 F Street,
N.E. Washington, D.C. 20549

 Re:
 Coya Therapeutics, Inc. (the “Company”)
 Registration Statement on Form S-3 (File
 No. 333-289511) Ladies and Gentlemen:
 In accordance with Rule 461 under the Securities Act of 1933, as amended, the Company hereby requests that the above-referenced Registration
Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission at 4:15 p.m., Eastern Time, on August 19, 2025, or as soon as practicable thereafter.
 Please call Hannah Pastore of Lowenstein Sandler LLP at (212) 419-5854 to confirm the effectiveness of
the Registration Statement or with any questions.

 Very truly yours,

 COYA THERAPEUTICS, INC.

 By:

 /s/ Arun Swaminathan

 Name:

 Arun Swaminathan

 Title:

 Chief Executive Officer
 (Principal Executive Officer)

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 August 13, 2025

Arun Swaminathan
Chief Executive Officer
Coya Therapeutics, Inc.
5850 San Felipe St., Suite 500
Houston, TX 77057

 Re: Coya Therapeutics, Inc.
 Registration Statement on Form S-3
 Filed August 12, 2025
 File No. 333-289511
Dear Arun Swaminathan:

 This is to advise you that we have not reviewed and will not review your
registration
statement.

 Please refer to Rules 460 and 461 regarding requests for acceleration.
We remind you
that the company and its management are responsible for the accuracy and
adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action
by the staff.

 Please contact Jessica Dickerson at 202-551-8013 with any questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
cc: Daniel C. Porco, Esq.
</TEXT>
</DOCUMENT>

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CORRESP

 November 26, 2024

VIA EDGAR

 United States Securities and Exchange
Commission

 Division of Corporation Finance

 100 F Street,
N.E.

 Washington, D.C. 20549

 Re:

 Coya Therapeutics, Inc. (the “Company”)

Registration Statement on Form S-3 (File No. 333-283366)

 Ladies and Gentlemen:

In accordance with Rule 461 under the Securities Act of 1933, as amended, the Company hereby requests that the above-referenced Registration
Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission at 4:00 p.m., Eastern Time, on November 29, 2024, or as soon as practicable thereafter.

Please call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the
effectiveness of the Registration Statement or with any questions.

Very truly yours,

 COYA THERAPEUTICS, INC.

By:

 /s/ Arun Swaminathan

Name:

Arun Swaminathan

Title:

 Chief Executive Officer

 (Principal Executive
Officer)

November 25, 2024
Arun Swaminathan
Chief Executive Officer
Coya Therapeutics, Inc.
5850 San Felipe St. Suite 500
Houston, TX 77057
Re:Coya Therapeutics, Inc.
Registration Statement on Form S-3
Filed November 20, 2024
File No. 333-283366
Dear Arun Swaminathan:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Doris Stacey Gama at 202-551-3188 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Steven Skolnick, Esq.

CORRESP
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CORRESP

 June 20, 2024

VIA EDGAR

 United States Securities and Exchange
Commission

 Division of Corporation Finance

 100 F Street,
N.E.

 Washington, D.C. 20549

Re:
 Coya Therapeutics, Inc. (the “Company”)

Registration Statement on Form S-3 (File No. 333- 280235)

Ladies and Gentlemen:

 In accordance with Rule
461 under the Securities Act of 1933, as amended, the Company hereby requests that the above-referenced Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission at 5:00 p.m.,
Eastern Time, on June 21, 2024, or as soon as practicable thereafter.

 Please call Steven M. Skolnick of Lowenstein Sandler LLP at
(973) 597-2476 to confirm the effectiveness of the Registration Statement or with any questions.

Very truly yours,

COYA THERAPEUTICS, INC.

By:

/s/ Howard Berman

Name:

Howard Berman

Title:

Chief Executive Officer

(Principal Executive Officer)

United States securities and exchange commission logo
June 18, 2024
Howard Berman
Chief Executive Officer
Coya Therapeutics, Inc.
5850 San Felipe St. Suite 500
Houston, TX 77057
Re:Coya Therapeutics, Inc.
Registration Statement on Form S-3
Filed June 14, 2024
File No. 333-280235
Dear Howard Berman:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Steven M. Skolnick, Esq.

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CORRESP

 January 10, 2024

VIA EDGAR

 United States Securities and Exchange
Commission

 Division of Corporation Finance

 100 F Street,
N.E.

 Washington, D.C. 20549

Re:
 Coya Therapeutics, Inc. (the “Company”)

Registration Statement on Form S-3 (File
No. 333-276374)

 Ladies and Gentlemen:

In accordance with Rule 461 under the Securities Act of 1933, as amended, the Company hereby requests that the above-referenced Registration
Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission at 5:00 p.m., Eastern Time, on January 12, 2024, or as soon as practicable thereafter.

Please call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the
effectiveness of the Registration Statement or with any questions.

Very truly yours,

COYA THERAPEUTICS, INC.

By:

/s/ Howard Berman

Name:

Howard Berman

Title:

 Chief Executive Officer

 (Principal
Executive Officer)

United States securities and exchange commission logo
January 9, 2024
Howard Berman
Chief Executive Officer
Coya Therapeutics, Inc.
5850 San Felipe St. Suite 500
Houston, TX 77057
Re:Coya Therapeutics, Inc.
Registration Statement on Form S-3
Filed January 4, 2024
File No. 333-276374
Dear Howard Berman:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Jessica Dickerson at 202-551-8013 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Steven M. Skolnick, Esq.

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December 23, 2022

VIA EDGAR

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

Re: Coya Therapeutics, Inc.

     Registration Statement on Form S-1

File No. 333-268482

Acceleration Request

Requested Date:December 28, 2022

Requested Time:4:00 p.m. Eastern Time (US)

Ladies and Gentlemen:

In connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representative of the underwriters, hereby join in the request of Coya Therapeutics, Inc. that the effective date of the Registration Statement be accelerated so that it will be declared effective at 4:00 p.m., Eastern Time (US), on December 28, 2022, or at such later time as the Company or its outside counsel, Lowenstein Sandler LLP, may request via a telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission.

Pursuant to Rule 460 under the Act, we wish to advise you that we have distributed approximately 355 copies of the Preliminary Prospectus dated December 12, 2022 through the date hereof, to underwriters, dealers, institutions and others.

The undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.

Very truly yours,

Acting on behalf of itself and the several Underwriters

CHardan capital markets, llc

By:  /s/ Shai Gerson

Name:Shai Gerson

Title:

Managing Partner of Capital Markets

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December 23, 2022

VIA EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549

Attn:

Tara Harkins

Kevin Kuhar

Jane Park

Tim Buchmiller

Re:

Coya Therapeutics, Inc.

Registration Statement on Form S-1

File No. 333-268482

Acceleration Request

Requested Date:

December 28, 2022

Requested Time:

4:00 p.m. Eastern Time

Dear Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, Coya Therapeutics, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the “Commission”) at the “Requested Date” and “Requested Time” set forth above or as soon as practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff.

Please call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with any questions.

Sincerely,

COYA THERAPEUTICS, INC.

By:

/s/ Howard Berman

Name:

 Howard Berman

Title:

 Chief Executive Officer

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Steven M. Skolnick

One Lowenstein Drive

Partner

Roseland, New Jersey 07068

T:          973 597 2476

F:           973 597 2477

E:           sskolnick@lowenstein.com

December 12, 2022

VIA EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

Mail Stop 3030

Washington, DC 20549

Attn:

Tara Harkins

Kevin Kuhar

Jane Park

Tim Buchmiller

Re:

Coya Therapeutics, Inc.

Amendment No. 1 to Registration Statement on Form S-1
Filed December 5, 2022
File No. 333-268482

Ladies and Gentlemen:

On behalf of Coya Therapeutics, Inc. (the “Company”), we are hereby responding to the letter, dated December 9, 2022 (the “Comment Letter”), from the staff (the “Staff”) of the Division of Corporation Finance, Office of Life Sciences, of the Securities and Exchange Commission (the “Commission”),  regarding the Company’s Amendment No. 1 to Registration Statement on Form S-1, filed on December 5, 2022 (the “Registration Statement”). In response to the Comment Letter and to update certain information in the Registration Statement, the Company is publicly filing a revised registration statement with the Commission (the “Revised Registration Statement”). For ease of reference, set forth below in bold are the comments of the Staff with respect to the Registration Statement, as reflected in the Comment Letter. The Company’s response is set forth below each comment. Capitalized terms used herein have the meanings set forth in the Registration Statement unless defined herein.

Securities and Exchange Commission

Division of Corporation Finance

December 12, 2022

Page 2

The Company has authorized us to respond to the Comment Letter as follows:

Amendment No. 1 to Registration Statement on Form S-1 filed December 5, 2022

Risks Related to Our Securities and the Offering, page 42

1.

We note recent instances of extreme stock price run-ups followed by rapid price declines and stock price volatility seemingly unrelated to company performance following a number of recent initial public offerings, particularly among companies with relatively smaller public floats. Revise to include a separate risk factor addressing the potential for rapid and substantial price volatility and any known factors particular to your offering that may add to this risk and discuss the risks to investors when investing in stock where the price is changing rapidly. Clearly state that such volatility, including any stock-run up, may be unrelated to your actual or expected operating performance and financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing the value of your stock.

Response: The Company respectfully acknowledges the Staff’s comment and has amended the Revised Registration Statement on page 43 to include a risk factor discussing the referenced risk(s).

The Company supplementally advises the Staff that now that the Company and its Underwriters have an estimated share price for the offering, as reflected in the Revised Registration Statement, the Company is able to respond to the Staff’s Comment 19 from the Staff’s letter dated September 15, 2022 (the “Original Comment Letter”). For the convenience of the Staff, we have recited the prior comment from the Staff in the Original Comment Letter in bold type and have followed the comment with the Company’s response.

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.

Response: The Company advises the Staff that it estimates a price of $5.00 per share and Warrant (the “Preliminary Offering Price”) for its IPO, after giving effect to a reverse stock split that the Company has implemented on December 12, 2022, as set forth in the Amended Registration Statement (the “Stock Split”). The share numbers and per share prices set forth below reflect the Stock Split and are all presented on a post-Stock Split basis, unless otherwise indicated.

Securities and Exchange Commission

Division of Corporation Finance

December 12, 2022

Page 3

Determining the Fair Value of Common Stock Prior to the IPO

For an explanation of how the Company determined the fair value of the common stock underlying its equity issuances prior to the offering, the Company respectfully refers the Staff to the discussion of its general approach set forth on page 54 of the Registration Statement in “Management’s Discussion and Analysis of Financial Condition and Results of Operation— Fair Value of Common Stock and Stock-Based Compensation.” The Company accounts for grants of stock options to employees and non-employees based on the options’ grant date fair value and the Company recognizes compensation expense over the vesting periods. The Company estimates the fair value of stock options as of the date of grant using the Black-Scholes option pricing model and it estimates the fair value of its common stock by referencing arms-length transactions inclusive of the common stock underlying which occurred on or near the valuation date(s). To determine the fair value of the common stock underlying option grants, the Board considered a variety of factors including, among other things, timely valuations of the common stock prepared by an independent third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation.  Given the absence of a public trading market for the common stock , the Board exercised reasonable judgment and considered a number of objective and subjective factors to determine the best estimate of the fair value of the common stock, including important developments in the Company’s operations, such as progress on initial new drug (“IND”) submissions and clinical data read-outs, its stage of development, valuations performed by an independent third party valuation firm, sales of the Company’s preferred stock and convertible notes, actual operating results and financial performance, the conditions in the life sciences and biotechnology industry sectors and the economy in general, the stock price performance and volatility of comparable public companies, the lack of liquidity of the common stock, and the likelihood of achieving a liquidity event, such as an initial public offering or sale.

The Company has included the table below to facilitate the Staff’s review, which is a complete list of all grants of stock options  to purchase the Company’s common stock since its inception, as adjusted for the 1-for-5.6955 reverse stock split of the Company’s outstanding shares of common stock, which occurred on December 12, 2022.

Securities and Exchange Commission

Division of Corporation Finance

December 12, 2022

Page 4

Grant Date

Number of

options

granted

Exercise

price per

share of

common

stock

Estimated

fair

value per

share of

common

stock (1)

February 22,2021

200,155

$

1.09

$

1.71

March 31, 2021

17,557

$

1.09

$

1.71

April 10, 2021

17,557

$

1.09

$

1.71

May 17, 2021

10,532

$

1.09

$

1.71

May 24, 2021

2,633

$

1.09

$

1.71

June 7, 2021

17,557

$

1.09

$

1.71

June 10, 2021

17,557

$

1.09

$

1.71

October 31, 2021

66,040

$

1.09

$

1.71

November 15, 2021

6,145

$

1.09

$

1.71

June 28, 2022

151,433

$

3.48

$

3.48

Summary of Methods Used

For all options granted in 2021, the Company utilized the fair value of its common stock as determined by a third-party valuation specialist from a report dated January 5, 2021 (“January 2021 valuation”). For all options granted in 2022, the Company utilized the fair value of its common stock as determined by a third-party valuation specialist from a report dated April 5, 2022 (“April 2022 valuation”). For the January 2021 valuation and April 2022 valuation, the Company employed a market approach by way of an option pricing method (“OPM”) framework. Given the very wide range of possible future exit events, the Company utilized an OPM, through a process known as the back-solve method for inferring and allocating the equity value predicated on the most recent financing. Application of the OPM back-solve method involves making assumptions for the expected time to liquidity, volatility and risk-free rate and then solving for the value of equity such that the value for the referenced financing equals the amount paid which is then discounted for a lack of marketability (“DLOM”). At the time of these valuations, the Company had yet to begin their process towards an IPO, and as such, management believed that the OPM framework was most appropriate.

Summary of Valuations

For the January 2021 valuation, the Company employed an OPM method implied by the terms of the Company’s Series A convertible preferred stock financing that initially closed in December 2020 (the “Series A Financing”). For the January 2021 valuation and for purposes of the OPM allocation of total equity value determined with reference to the Series A Financing, the Company assumed a weighted average 34% volatility rate and a 3.1-year estimated term. The Company then reflected a DLOM of 50% to arrive at an original fair value of $1.09 per share valuation.

Securities and Exchange Commission

Division of Corporation Finance

December 12, 2022

Page 5

As part of the preparation of the financial statements necessary for inclusion in this prospectus, we reassessed for financial reporting purposes, on a retrospective basis, the fair value of our common stock for each share-based award granted in 2021, which had an original fair value of $1.09 per share.  In their review of our calendar year 2021 financial reporting, the Board and management noted, among many important factors, the Company’s rapid progress over the course of the year in its research and development programs, clinical programs, and overall business strategy. While this progress could not have been reasonably anticipated during interim assessments of fair value, at year end the Board and management judged that a reassessment was appropriate.  For purposes of this reassessment, we evaluated our original inputs and the methodologies used to determine our enterprise value, the methods we used to allocate enterprise value and the timing of those valuations.  The Board determined a reassessed fair value of $1.71 per share. We utilized the above reassessed fair value of $1.71 per share to determine the stock-based compensation expense which is recorded in our financial statements.

For the April 2022 valuation, the Company employed an OPM method implied by the terms of the Series A Financing and its recent convertible debt financing that occurred in early 2022 (“2022 Convertible Notes”). For the April 2022 valuation and for purposes of the OPM allocation of total equity value determined with reference to the Series A Financing and the 2022 Convertible Notes, the Company assumed a weighted average 95% volatility rate and a 2.5-year estimated term. The Company then reflected a DLOM of 30% to arrive at a $3.48 per share valuation.

The Company has not granted any options since June 28, 2022 and does not currently intend to grant any options prior to the IPO.

Explanation of Difference Between the FMV of Common Stock Prior to the IPO and the Midpoint Price

As is typical in initial public offerings, the Preliminary Offering Price is based in part on the underwriters’ quantitative and qualitative analysis that differs from the valuation methodology used by the Company. Among the factors that the Underwriters considered in setting the Preliminary Offering Price were the following:

•

an analysis of the typical valuation ranges seen in comparable public companies in the Company’s industry, as well as a broader set of valuation ranges seen in recent IPOs;

•

the general condition of the securities markets and the recent market prices of publicly traded common stock of comparable companies;

•

the enhanced liquidity of the Company’s common stock following an IPO;

•

an assumption that there would be a receptive public trading market for an early preclinical stage pharmaceutical company such as the Company; and

Securities and Exchange Commission

Division of Corporation Finance

December 12, 2022

Page 6

•

an assumption that there would be sufficient demand for the Company’s common stock to support an offering of the size contemplated by the Company.

As discussed above, the Company’s analysis prior to the IPO indicated the fair value of the Company’s common stock to be $3.48 per share , which was the fair value the Company used for all of its recent equity issuances. Given the lack of clarity around a future liquidity event, and the lack of significant program progression or additional significant funding received, in the judgment of the Board, there were no internal or external developments that would indicate that the fair value of the Company’s common stock would have increased from April 5, 2022.

The Company submits that the primary reasons for the difference between the fair value per share used for the stock options granted within the last year and the Preliminary Offering Price are:

•

Differences in the valuation methodologies, assumptions and inputs used by the underwriters in their valuation analysis discussed with the Company and used to determine the Preliminary Offering Price, which assumes a successful IPO as of today’s date with no weighting attributed to any other outcome for the Company’s business, such as remaining a privately held company, compared to the valuation methodologies, assumptions and inputs used in the valuations determined by the Board as described above in connection with the description of methodologies used.

•

The Preliminary Offering Price necessarily assumes that the IPO has occurred and a public market for the Company’s common stock has been created and, therefore, excludes any marketability or liquidity discount for the Company’s common stock, which was appropriately taken into account in the Board’s determinations of fair value.

•

The Company’s consideration of various objective and subjective factors in the previous fair value determinations, as described above, that were not applicable to the determination of the Preliminary Offering Price.

•

The expected proceeds of a successful IPO would substantially increase the Company’s cash balances. In addition, the completion of an IPO would potentially provide the Company with readier access to the public equity markets.

Additionally, the Company respectfully advises the Staff that the Preliminary Offering Price reflects the fact that investors may be willing to purchase shares in the IPO at a per share price that takes into account other factors that were not expressly considered in the Company’s prior valuations as a private company, and are not objectively determinable and that valuation models are not able to quantify with any level of certainty.

Based on the Preliminary Offering Price, the current status of the financial markets and continued uncertainty as to whether the Company will be able to complete its planned IPO within the Preliminary Offering Price, or at all, the Company respectfully submits that the fair value of

Securities and Exchange Commission

Division of Corporation Finance

December 12, 2022

Page 7

its common stock as determined by the Board is reasonable and consistent with the Company’s and the underwriters’ estimates of the Preliminary Offering Pric

United States securities and exchange commission logo
December 9, 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 Registration Statement on Form S-1
Filed December 5, 2022
File No. 333-268482
Dear Howard Berman:
            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 November 29, 2022 letter.
Amendment No. 1 to Form S-1 filed December 5, 2022
Risks Related to Our Securities and the Offering, page 42
1.We note recent instances of extreme stock price run-ups followed by rapid price declines
and stock price volatility seemingly unrelated to company performance following a
number of recent initial public offerings, particularly among companies with relatively
smaller public floats.  Revise to include a separate risk factor addressing the potential for
rapid and substantial price volatility and any known factors particular to your offering that
may add to this risk and discuss the risks to investors when investing in stock where the
price is changing rapidly.  Clearly state that such volatility, including any stock-run up,
may be unrelated to your actual or expected operating performance and financial
condition or prospects, making it difficult for prospective investors to assess the rapidly

 FirstName LastNameHoward Berman, Ph.D.
 Comapany NameCoya Therapeutics, Inc.
 December 9, 2022 Page 2
 FirstName LastName
Howard Berman, Ph.D.
Coya Therapeutics, Inc.
December 9, 2022
Page 2
changing value of your stock.
            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.

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Steven M. Skolnick

One Lowenstein Drive

Partner

Roseland, New Jersey 07068

T:          973 597 2476

F:           973 597 2477

E:           sskolnick@lowenstein.com

December 5, 2022

VIA EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

Mail Stop 3030

Washington, DC 20549

Attn:

Tara Harkins

Kevin Kuhar

Jane Park

Tim Buchmiller

Re:

Coya Therapeutics, Inc.

Registration Statement on Form S-1
Filed November 18, 2022
File No. 333-268482

Ladies and Gentlemen:

On behalf of Coya Therapeutics, Inc. (the “Company”), we are hereby responding to the letter, dated November 29, 2022 (the “Comment Letter”), from the staff (the “Staff”) of the Division of Corporation Finance, Office of Life Sciences, of the Securities and Exchange Commission (the “Commission”),  regarding the Company’s Registration Statement on Form S-1, filed on November 18, 2022 (the “Registration Statement”). In response to the Comment Letter and to update certain information in the Registration Statement, the Company is publicly filing a revised registration statement with the Commission (the “Revised Registration Statement”). For ease of reference, set forth below in bold are the comments of the Staff with respect to the Registration Statement, as reflected in the Comment Letter. The Company’s response is set forth below each comment. Capitalized terms used herein have the meanings set forth in the Registration Statement unless defined herein.

The Company has authorized us to respond to the Comment Letter as follows:

Registration Statement on Form S-1 filed November 18, 2022

COYA 201, page 76

1.

We note your revised disclosure on page 77 in response to prior comment 1 that a significant decrease in the secretion of pro-inflammatory cytokines and a significant increase in the secretion of anti-inflammatory cytokines. Please expand your disclosure of the second study to discuss the data from the results to support the conclusions drawn.

Securities and Exchange Commission

Division of Corporation Finance

December 5, 2022

Page 2

Response: The Company respectfully acknowledges the Staff’s comment and has amended the Revised Registration Statement on page 80 to expand the disclosure of the second study.

Methodist License Agreement, page 85

2.

We note your disclosure on page 67 that you amended the Methodist License Agreement in September 2022. Please revise your disclosure on page 85 accordingly and also file such amendment as an exhibit to the registration  statement as required by Item 601(b)(10) of Regulation S-K or tell us why it is not material.

Response: The Company respectfully acknowledges the Staff’s comment and has amended the Revised Registration Statement on page 89 to clarify that the Methodist License Agreement was executed in 2020 and later amended and restated in September 2022. The effective date of the amended and restated agreement is the date on which the agreement was originally signed in 2020. We have filed the amended and restated agreement with the registration statement as Exhibit 10.7; which contains all of the terms of the Methodist License Agreement.

Exhibits

3.

We note your disclosure in the footnotes to the exhibit index that "portions of this exhibit (indicated by asterisks) are omitted in accordance with the rules of the SEC." If you intend to redact information pursuant to Item 601(b)(10)(iv) of Regulation S-K, please revise the applicable footnote to state that certain identified information has been excluded from the exhibit because it is both not material and the type of information that the registrant treats as private or confidential.

Response: The Company respectfully acknowledges the Staff’s comment and has amended the exhibit index of Revised Registration Statement to include the requested language in the applicable footnote.

Any questions regarding the contents of this letter or the Revised Registration Statement should be addressed to the undersigned at (973) 597-2476.

Very truly yours,

/s/ Steven M. Skolnick

Steven M. Skolnick

cc:

Howard Berman, Ph.D., Coya Therapeutics, Inc.

United States securities and exchange commission logo
November 29, 2022
Howard Berman, Ph.D.
Chief Executive Officer
Coya Therapeutics, Inc.
5850 San Felipe St. Suite 500
Houston, TX 77057
Re:Coya Therapeutics, Inc.
Registration Statement on Form S-1
Filed November 18, 2022
File No. 333-268482
Dear Howard Berman:
            We have reviewed your 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.
Registration Statement on Form S-1 filed November 18, 2022
COYA 201, page 76
1.We note your revised disclosure on page 77 in response to prior comment 1 that a
significant decrease in the secretion of pro-inflammatory cytokines and a significant
increase in the secretion of anti-inflammatory cytokines.  Please expand your disclosure of
the second study to discuss the data from the results to support the conclusions drawn.
Methodist License Agreement, page 85
2.We note your disclosure on page 67 that you amended the Methodist License Agreement
in September 2022.  Please revise your disclosure on page 85 accordingly and also file
such amendment as an exhibit to the registration statement as required by Item 601(b)(10)
of Regulation S-K or tell us why it is not material.

 FirstName LastNameHoward Berman, Ph.D.
 Comapany NameCoya Therapeutics, Inc.
 November 29, 2022 Page 2
 FirstName LastName
Howard Berman, Ph.D.
Coya Therapeutics, Inc.
November 29, 2022
Page 2
Exhibits
3.We note your disclosure in the footnotes to the exhibit index that "portions of this exhibit
(indicated by asterisks) are omitted in accordance with the rules of the SEC."  If you
intend to redact information pursuant to Item 601(b)(10)(iv) of Regulation S-K, please
revise the applicable footnote to state that certain identified information has been excluded
from the exhibit because it is both not material and the type of information that the
registrant treats as private or confidential.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            Refer to Rules 460 and 461 regarding requests for acceleration.  Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
            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.

CORRESP
1
filename1.htm

coya-corresp.DOCX.htm

Steven M. Skolnick

One Lowenstein Drive

Partner

Roseland, New Jersey 07068

T:          973 597 2476

F:           973 597 2477

E:           sskolnick@lowenstein.com

November 18, 2022

VIA EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

Mail Stop 3030

Washington, DC 20549

Attn:

Tara Harkins

Kevin Kuhar

Jane Park

Tim Buchmiller

Re:

Coya Therapeutics, Inc.

Amendment No. 2 to
Draft Registration Statement on Form S-1
Submitted October 28, 2022
CIK No. 0001835022

Ladies and Gentlemen:

On behalf of Coya Therapeutics, Inc. (the “Company”), we are hereby responding to the letter, dated November 4, 2022 (the “Comment Letter”), from the staff (the “Staff”) of the Division of Corporation Finance, Office of Life Sciences, of the Securities and Exchange Commission (the “Commission”),  regarding the Company’s Amendment No. 2 to the Draft Registration Statement on Form S-1, submitted on October 28, 2022 (the “Registration Statement”). In response to the Comment Letter and to update certain information in the Registration Statement, the Company is publicly filing a revised registration statement with the Commission (the “Revised Registration Statement”). For ease of reference, set forth below in bold are the comments of the Staff with respect to the Registration Statement, as reflected in the Comment Letter. The Company’s response is set forth below each comment. Capitalized terms used herein have the meanings set forth in the Registration Statement unless defined herein.

Securities and Exchange Commission

Division of Corporation Finance

November 18, 2022

Page 2

The Company has authorized us to respond to the Comment Letter as follows:

Amendment 2 to Form S-1 Draft Registration Statement

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.

Response: The Company respectfully acknowledges the Staff’s comment and has amended the Revised Registration Statement on pages 2 and 76 to include the requested disclosure.

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.

Response: The Company respectfully acknowledges the Staff’s comment and has amended the Revised Registration Statement on page 34 to include additional information regarding the counter-party to the binding term sheet.

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.

Response: The Company respectfully acknowledges the Staff’s comment and has amended the Revised Registration Statement on page 69 to include the requested disclosure.

Securities and Exchange Commission

Division of Corporation Finance

November 18, 2022

Page 3

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.

Response: The Company respectfully acknowledges the Staff’s comment and has amended the Revised Registration Statement on page 74 to include the requested disclosure.

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.

Response: The Company respectfully acknowledges the Staff’s comment and has amended the Revised Registration Statement on page 80 to include the referenced disclosure. The Company further advises the Staff that the study, for which the table appears on page 79, included a limited and unbalanced number of patients in each group and did not allow for a meaningful statistical comparison. Accordingly, no p-values are available. Disclosure has been added to page 82 to clarify the foregoing.

Any questions regarding the contents of this letter or the Revised Registration Statement should be addressed to the undersigned at (973) 597-2476.

Very truly yours,

/s/ Steven M. Skolnick

Steven M. Skolnick

cc:

Howard Berman, Ph.D., Coya Therapeutics, Inc.

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.

 FirstName LastNameHoward Berman, Ph.D.
 Comapany NameCoya Therapeutics, Inc.
 November 4, 2022 Page 2
 FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc:       Steven M. Skolnick, Esq.

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.

 FirstName LastNameHoward Berman, Ph.D.
 Comapany NameCoya Therapeutics, Inc.
 October 19, 2022 Page 2
 FirstName LastName
Howard Berman, Ph.D.
Coya Therapeutics, Inc.
October 19, 2022
Page 2
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.

 FirstName LastNameHoward Berman, Ph.D.
 Comapany NameCoya Therapeutics, Inc.
 October 19, 2022 Page 3
 FirstName LastName
Howard Berman, Ph.D.
Coya Therapeutics, Inc.
October 19, 2022
Page 3
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.

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.

 FirstName LastNameHoward Berman, Ph.D.
 Comapany NameCoya Therapeutics, Inc.
 September 15, 2022 Page 2
 FirstName LastName
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
manufacturing process is a barrier to further studies for COYA 101 with a larger number
of participants, please include a brief discussion of that, or any other material challenges,
in an appropriate location in your prospectus.

 FirstName LastNameHoward Berman, Ph.D.
 Comapany NameCoya Therapeutics, Inc.
 September 15, 2022 Page 3
 FirstName LastName
Howard Berman, Ph.D.
Coya Therapeutics, Inc.
September 15, 2022
Page 3
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.

 FirstName LastNameHoward Berman, Ph.D.
 Comapany NameCoya Therapeutics, Inc.
 September 15, 2022 Page 4
 FirstName LastName
Howard Berman, Ph.D.
Coya Therapeutics, Inc.
September 15, 2022
Page 4
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.

 FirstName LastNameHoward Berman, Ph.D.
 Comapany NameCoya Therapeutics, Inc.
 September 15, 2022 Page 5
 FirstName LastName
Howard Berman, Ph.D.
Coya Therapeutics, Inc.
September 15, 2022
Page 5
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.

 FirstName LastNameHoward Berman, Ph.D.
 Comapany NameCoya Therapeutics, Inc.
 September 15, 2022 Page 6
 FirstName LastName
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
ranging from high-single to low-double digit percentages.  Please revise your disclosure to
provide the number of tiers and a reasonable idea of the amount of the royalty rates that
does not exceed ten percentage points.

 FirstName LastNameHoward Berman, Ph.D.
 Comapany NameCoya Therapeutics, Inc.
 September 15, 2022 Page 7
 FirstName LastName
Howard Berman, Ph.D.
Coya Therapeutics, Inc.