On this page of StockholderLetter.com we present the latest annual shareholder letter from Coya Therapeutics, Inc. — ticker symbol COYA. Reading current and past COYA letters to shareholders can bring important insights into the investment thesis.

 •  5/16/2025 Letter Continued (Full PDF)
 •  5/19/2023 COYA Stockholder Letter
 •  3/28/2024 COYA Stockholder Letter
 •  More "Biotechnology" Category Stockholder Letters
 •  COYA Benford's Law Stock Score = 92

COYA Shareholder/Stockholder Letter Transcript:

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORMlO-K
(Mark One)
181
ANNUAL REPORT PURSUANT TO SECTION 13 OR IS(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2024
0
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR tS(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE
TRANSITION PERIOD FROM
TO
Commission File Number 001-41583
Coya Therapeutics, Inc.
(Exact name of Registrant as specified in its Charter)
Delaware
85-4017781
(State or other jurisdiction of
incorpor ation or organization)
(I.R.S. Employer
Identification No.)
5850 San Felipe St., Suite 500
Houston, TX
77057
(Address of principal executive offices)
(Zip Code)
Registrant' s telephone number, including area code: (800) 587-8170
Securities registered pursuant to Section IZ(b) of the Act:
T r ading
Title of each class
Common Stock, par value $0.0001 per s hare
Securities registered pursuant to Section 12(g) of the Act: None
Symbol(s)
COYA
Name of each exchange on which registered
The Nasdaq Stock Market LLC
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes 0
No 181
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Acl. Yes 0
No 181
Indicate by check mark whether the Registrant: (I) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the Registrant was required to ftle such reports), and (2) has been subject to such filing requirements for the past 90
days. Yes 181 No 0
Indicate by check mark whether the Registrant bas submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T
(  232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes 181 No 0
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated fi ler, a non-accelerated filer, smaller reporting company, or an emerging growth
company. Sec the definitions of"largc accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the
Exchange Act.
Large accelerated filer
0
Accelerated filer
0
Non-accelerated filer
181
Smaller reporting company
181
Emerging growth company
181
If an emerging growth company, indicate by check mark if the registrant has elected not to usc the extended transition period for complying with any new or revised
fmancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 0
Indicate by check mark whether the registrant has filed a report on and attestation to its management' s assessment of the effectiveness of its internal control over
financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
0
If securities arc registered pursuant to Section 12(b) of the Act, indicate by check mark whether the fmancial statements of the registrant included in the filing reflect the
correction of an error to previously issued financial statements. 0
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the
registrant's executive officers during the relevant recovery period pursuant to   240. 10D-J(b). D
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes 0
No 181
The aggregate market value of the voting and non-voting common equity held by non-affi liates of the Registrant, based on the closing price of the shares of common
stock on the Nasdaq Capital Market on June 30, 2024, was approximately $85,212,539.
The number of shares of Registrant's common stock outstanding as of March 14, 2025 was 16,724,998.

DOCUMENTS TNCORPORA TED BY REFERENCE
Portions of the registrant's proxy statement for the 2025 annual meeting of stockholders to be filed pursuant to Regulation 14A within 120 days after the registrant's
fiscal year ended De.c;ember 3 1, 2024, are incorporated by reference in Part HI of this Form 10-K.
Auditor Firm ld: 410
Auditor Name: Weaver and Tidwell, L.L.P.
Auditor Location: Austin, Texas

Table of Contents
Page
PART I
Item J.
Item 1A.
Item lB.
Item JC.
Item 2.
Item 3.
Item 4.
PARTU
Item 5.
Business
Risk Factors
Unresolved Staff Cornrnents
Cybersecurity
Properties
Legal Proceedings
Mine Safety Disclosures
33
71
71
71
71
71
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 9C.
Market for Registrant's Cornrnon Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities
[Reserved]
Management's Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
PART ill
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accounting Fees and Services
86
86
86
86
86
PART IV
Item 15.
Item 16.
Exhibits and Financial Statement Schedules
Form 10-K Summary
87
72
72
73
84
84
84
84
85
85
88

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements made under the headings "Summary," "Business," "Management's Discussion and Analysis of
Financial Condition and Results of Operations" and elsewhere in this Annual Report on Form I 0-K contain forward-looking statements
that reflect our plans, beliefs, expectations and current views with respect to, among other things, future events and financial
performance.
Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts and are
often characterized by the use of words such as "believe," "can," "could,'' "potential," "plan,'' "predict," "goals,'' "seek," "should,"
"may," "may have," "would," "estimate," "continue," "anticipate," "intend," "expect" or by discussions of strategy, plans or intentions.
Such forward-looking statements involve known and unknown risks, uncertainties, assumptions and other important factors that could
cause our actual results, performance or achievements, or industry results, to differ materially from historical results or any future results,
performance or achievements expressed, suggested or implied by such forward-looking statements. These include, but are not limited
to, statements about:









our ability to develop, obtain regulatory approval for and commercialize our product candidates;
the timing of future investigational new drug ("IND") submissions, initiation of preclinical studies and clinical trials, and
timing of expected clinical results for our product candidates;
our success in early preclinical studies, which may not be indicative of results obtained in later studies or clinical trials;
the outbreak of public health emergencies, epidemics, pandemics, which could adversely impact our business, including
our preclinical studies and any future clinical trials;
the potential benefits of our product candidates;
our ability to identify patients with the diseases treated by our product candidates, and to enroll patients in clinical trials;
the success of our efforts to expand our pipeline of product candidates and develop marketable products through the use
of our potential therapeutic modalities;
our expectations regarding collaborations and other agreements with third parties and their potential benefits;
our ability to obtain, maintain and protect our intellectual property;
our reliance upon intellectual property licensed from third parties;
impacts of increased trade tariffs, import quotas or other trade restrictions or measures taken by the United States and other
countries, including the recent and potential changes in U.S. trade policies that may be made by the Trump presidential
administration;
our ability to identity, recruit and retain key personnel;
our financial performance;
developments or projections relating to our competitors or our industry;
the impact of laws and regulations;
our expectations regarding the time during which we will be am emerging growth company under the JOBS Act; and
other factors and assumptions described in this Annual Report on Form 10-K under "Risk Factors," "Management's
Discussion and Analysis of Financial Condition and Results of Operations," and "Our Business", and elsewhere in this
Annual Report on Form 10-K.
These statements are based on our historical performance and on our current plans, estimates and projections in light of
information currently available to us, and therefore you should not place undue reliance on them. The inclusion of this forward-looking
information should not be regarded as a representation by us, the underwriters or any other person that the future plans, estimates or
expectations contemplated by us will be achieved. Forward-looking statements made in this Annual Report on Form 10-K speak only
as of the date of this Annual Report on Form 10-K, and we undertake no obligation to update them in light of new information or future
events, except as required by Jaw.
You should carefully consider the above factors, as well as the factors discussed elsewhere in this Annual Report on Form 1OK, including under "Risk Factors," before deciding to invest in our securities. The factors identified above should not be construed as
an exhaustive list of factors that could affect our future results and should be read in conjunction with the other cautionary statements
that are included in this Annual Report on Form 10-K. Furthermore, new risks and uncertainties arise from time to time, and it is
impossible for us to predict those events or how they may affect us. If any of these trends, risks or uncertainties actually occurs or
continues, our business, revenue and financial results could be harmed, the trading prices of our securities could decline and you could
lose all or part of your investment. All forward-looking statements attributable to us or persons acting on our behalf are expressly
qualified in their entirety by this cautionary statement.

PART I
ITEM 1. BUSINESS
All references in this report to "Coya," the "Company," "we," "us," or "our" mean Coya Therapeutics, Inc. unless stated
otherwise or the context otherwise indicates.
Overview
We are a clinical-stage biotechnology company focused on developing proprietary new therapies to enhance the function of
regulatory T cells ("Tregs"). Tregs are a subpopulation ofT-lymphocytes consisting of CD4+CD25high hFOXP3+ cells that suppress
inflammatory responses. Tregs were first discovered in 1995 by Dr. Shimon Sakaguchi and since their discovery multiple lines of
research have contributed to elucidate Treg biology and its role in health and disease. Tregs and their transcription factors have been
shown to be essential to maintaining cellular homeostasis by regulating autoimmune and inflammatory responses and maintaining selftolerance in mammals. Dysfunctional Tregs underlie numerous disease states, and this cellular dysfunction is driven by the chronic
inflammatory environment and high levels of ox idative stress commonly observed in certain diseases. Further, the degree of Treg
dysfunction is correlated with the severity and progression of serious and life-threatening conditions. These and other recent advances
in the understanding of Treg biology, have made this subset ofT-lymphocytes an important potential therapeutic target, which we
believe may provide new treatments for serious diseases.
Our core focus is developing therapies to target Treg dysfunction. Treg disfunction has been identified as an important
pathophysiological component ofneurodegenerative, autoimmune, and metabolic diseases, all areas where we believe new and effective
therapies are urgently needed. We believe we have expertise in three distinct potential therapeutic modalities: Treg-enhancing biologics,
Treg-derived exosomes, and autologous Treg cell therapy. Our expertise includes both ex vivo and in vivo approaches intended to restore
the suppressive and irnmunomodulatory functions of Tregs.
Our lead asset, COY A 302, is a Treg-enhancing biologic, which was developed from key learnings established in our early
work and discoveries of our autologous Treg cell therapy asset. Our autologous Treg cell therapy program has completed a Phase 1 and
Phase 2a studies in amyotrophic lateral sclerosis, or ALS. The clinical data from these initial studies has served as an important
confim1ation of the underlying immunomodulatory properties ofTregs and their potential therapeutic benefits. These studies have also
significantly expanded our own foundational knowledge of the biological activity of Tregs and key biomarkers of disease progression
and drug effect, which we believe will be critical for the design of our future clinical and preclinical studies, the selection of future
targeted diseases and the overall advancement of our development pipeline. We believe our findings have also established mechanistic
benefits of combination biologics to address Treg dysfunction as well as highlighted important advantages of scalability and cost.
COYA 302 is the combination of our proprietary low dose interleukin-2 (COYA 301, or LD IL-2) and the immunomodulatory
drug CTLA4-Ig, and we believe this combination has the potential to provide a sustained and durable effect on our first series of
indications (neurodegenerative disorders) through targeting of multiple pathways. Our research and clinical efforts have led us to believe
that combination biologics using our LD JL-2 as a backbone modality could be an effective way to treat neurodegenerative conditions
that are inherently driven by a complexity of pathways. We believe COYA 302 is the most clinically advanced of what we hope will be
a family of combination therapies that all feature our LD IL-2. Given the growing list of indications for which we are developing it, we
can now refer to COYA 302 as a "Pipeline in a Product."
Our operations have consisted of developing our clinical and preclinical product candidates and we have devoted substantially
all of our resources to developing product and technology rights, conducting research and development (which includes preclinical and
non-clinical studies of our product candidates), organizing and staffing our company, ongoing business operations and raising capital.
We have funded our operations primarily through the private and public sale of our securities. Our net losses were $14.9 million and
$8.0 million for the years ended December 31 , 2024 and 2023, respectively. As of December 31 , 2024, we had an accumulated deficit
of $40.7 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development
expenditures and general and administrative expenditures. Our ability to generate product revenue sufficient to achieve profitability will
depend heavily on the successful development and eventual commercialization of one or more of our current or future product
candidates.
We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance our product
candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval. [n addition, if we obtain
marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product
manufacturing, marketing, sales and distribution. We expect our expenses and capital requirements will increase significantly in
connection with our ongoing activities as we:

continue our ongoing and planned research and development of our product candidates;

initiate nonclinical studies and clinical trials for any additional product candidates that we may pursue;



 5/16/2025 Letter Continued (Full PDF)