Coya Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Coya Therapeutics, Inc. has filed its 2023 annual report (10-K), detailing its financial status and business operations as of December 31, 2023.</b>

AI Summary

Coya Therapeutics, Inc. (COYA) filed a Annual Report (10-K) with the SEC on March 19, 2024. Coya Therapeutics, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The filing covers the period ending December 31, 2023, with a filing date of March 19, 2024. The company's principal business address is located at 12645 Memorial Dr., Suite F1 #305, Houston, TX 77024. Coya Therapeutics, Inc. is classified under the Pharmaceutical Preparations industry (SIC code 2834). The report includes details on various financial instruments and agreements, such as convertible debt, warrants, and development agreements.

Why It Matters

For investors and stakeholders tracking Coya Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Coya Therapeutics' financial health, operational activities, and strategic developments throughout 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed information within the filing, including financial statements and risk factors, allows stakeholders to understand the company's market position, regulatory environment, and potential challenges in the pharmaceutical sector.

Risk Assessment

Risk Level: medium — Coya Therapeutics, Inc. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, lengthy development cycles, and high research and development costs, as indicated by the nature of its business and the typical risks associated with this sector.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Coya Therapeutics' current financial position and the specific challenges it faces in drug development and commercialization.

Key Numbers

• 20231231 — Fiscal Year End (Reported period)
• 20240319 — Filing Date (Date of submission)
• 0000950170-24-033161 — Accession Number (Unique identifier for the filing)
• 001-41583 — SEC File Number (Company's SEC registration number)
• 2834 — SIC Code (Pharmaceutical Preparations)

Key Players & Entities

• Coya Therapeutics, Inc. (company) — Filer name
• 0000950170-24-033161 (other) — Accession Number
• 20231231 (date) — Fiscal year end
• 20240319 (date) — Filing date
• 12645 Memorial Dr., Suite F1 #305 (address) — Business address
• Houston, TX 77024 (address) — Business address
• 2834 (other) — Standard Industrial Classification (Pharmaceutical Preparations)
• 001-41583 (other) — SEC File Number

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive government regulation, which can impact product development, manufacturing, marketing, and pricing.
• Financing and Liquidity Risks [high — financial]: The company may require additional funding to support its operations and development activities, and there is no assurance that such funding will be available on favorable terms.
• Research and Development Risks [high — operational]: Drug development is a lengthy, expensive, and uncertain process with a high rate of failure.
• Competition [medium — market]: The company faces intense competition from other pharmaceutical and biotechnology companies, including large, well-established firms.

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share COYA The Nasdaq Stock Mar
• $8.0 million — of our securities. Our net losses were $8.0 million and $12.2 million for the years ended D
• $12.2 million — s. Our net losses were $8.0 million and $12.2 million for the years ended December 31, 2023 a
• $25.9 million — 2023, we had an accumulated deficit of $25.9 million. Our primary use of cash is to fund ope
• $7.5 million — aid a non-refundable upfront payment of $7.5 million (the "DRL Upfront Payment"). Under the
• $4.2 million — development of COYA 302 as follows: (i) $4.2 million upon FDA acceptance of an Investigation
• $40.0 million — nt also calls for up to an aggregate of $40.0 million in development milestones and up to an
• $677.25 million — nt milestones and up to an aggregate of $677.25 million in sales milestones, relating to the Ne
• $26.5 m — lted in gross proceeds of approximately $26.5 million, at a price of $6.06 per share of
• $6.06 — roximately $26.5 million, at a price of $6.06 per share of common stock, before deduc
• $7.58 — of common stock at an exercise price of $7.58 per share. Such warrants have a term of

Filing Documents

• coya-20231231.htm (10-K) — 2292KB
• coya-ex3_1.htm (EX-3.1) — 67KB
• coya-ex3_2.htm (EX-3.2) — 153KB
• coya-ex4_7.htm (EX-4.7) — 40KB
• coya-ex10_18.htm (EX-10.18) — 601KB
• coya-ex31_1.htm (EX-31.1) — 23KB
• coya-ex31_2.htm (EX-31.2) — 22KB
• coya-ex32_1.htm (EX-32.1) — 15KB
• coya-ex97_1.htm (EX-97.1) — 45KB
• img260855_0.jpg (GRAPHIC) — 103KB
• img260855_1.jpg (GRAPHIC) — 71KB
• img260855_2.jpg (GRAPHIC) — 59KB
• img260855_3.jpg (GRAPHIC) — 80KB
• img260855_4.jpg (GRAPHIC) — 108KB
• img260855_5.jpg (GRAPHIC) — 23KB
• img260855_6.jpg (GRAPHIC) — 20KB
• img260855_7.jpg (GRAPHIC) — 21KB
• img260855_8.jpg (GRAPHIC) — 28KB
• img260855_9.jpg (GRAPHIC) — 95KB
• img260855_10.jpg (GRAPHIC) — 82KB
• img260855_11.jpg (GRAPHIC) — 66KB
• img260855_12.jpg (GRAPHIC) — 37KB
• img260855_13.jpg (GRAPHIC) — 56KB
• img260855_14.jpg (GRAPHIC) — 162KB
• img260855_15.jpg (GRAPHIC) — 119KB
• img24248206_0.jpg (GRAPHIC) — 10KB
• img24248206_1.jpg (GRAPHIC) — 249KB
• img24248206_2.jpg (GRAPHIC) — 10KB
• img24248206_3.jpg (GRAPHIC) — 249KB
• 0000950170-24-033161.txt (&nbsp;) — 12854KB
• coya-20231231.xsd (EX-101.SCH) — 1192KB
• coya-20231231_htm.xml (XML) — 1135KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 33 Item 1B. Unresolved Staff Comments 72 Item 1C. Cybersecurity 72 Item 2.

Properties

Properties 72 Item 3.

Legal Proceedings

Legal Proceedings 72 Item 4. Mine Safety Disclosures 72 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 73 Item 6. [Reserved] 73 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 74 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 86 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 86 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 86 Item 9A.

Controls and Procedures

Controls and Procedures 86 Item 9B. Other Information 87 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 87 PART III Item 10. Directors, Executive Officers and Corporate Governance 88 Item 11.

Executive Compensation

Executive Compensation 88 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 88 Item 13. Certain Relationships and Related Transactions, and Director Independence 88 Item 14. Principal Accounting Fees and Services 88 PART IV Item 15. Exhibits and Financial Statement Schedules 89 Item 16. Form 10-K Summary 90 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 10-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 re

BUSINESS

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 of T-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 self-tolerance in mammals. Dysfunctional Tregs underlie numerous disease states, and this cellular dysfunction is driven by the chronic inflammatory environment and high levels of oxidative 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 of T-lymphocytes an important potential therapeutic target, which we believe may provide new treatments for serious diseases. We have built a diversified product candidate pipeline that includes both ex vivo and in vivo approaches intended to restore the suppressive and immunomodulatory functions of Tregs. Our product candidate pipeline is based on our three distinct potential therapeutic modalities: Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. "Autologous" means the treatment of a patient with human cells derived from the patient itself, whereas "Allogeneic" means the treatment of a patient with human cells derived from a donor other than the patient, w

View Full Filing

View this 10-K filing on SEC EDGAR