# EDGAR Filing Document

**Accession Number:** 0001835022
**File Stem:** 0001193125-26-218198
**Filing Date:** 2026-5
**Character Count:** 21640
**Document Hash:** 9e7aa40b5c19fe2501ecb1e5ccb08736
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-218198.hdr.sgml**: 20260512

**ACCESSION NUMBER**: 0001193125-26-218198

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 10

**CONFORMED PERIOD OF REPORT**: 20260512

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260512

**DATE AS OF CHANGE**: 20260512

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Coya Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001835022
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41583
- **FILM NUMBER:** 26965896

**BUSINESS ADDRESS:**
- **STREET 1:** 12645 MEMORIAL DR., SUITE F1 #305
- **CITY:** HOUSTON
- **STATE:** TX
- **ZIP:** 77024
- **BUSINESS PHONE:** 650.739.3939

**MAIL ADDRESS:**
- **STREET 1:** 12645 MEMORIAL DR., SUITE F1 #305
- **CITY:** HOUSTON
- **STATE:** TX
- **ZIP:** 77024

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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## FORM 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** May 12, 2026<br>

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Coya Therapeutics, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-41583 | 85-4017781 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 5850 San Felipe St., Suite 500 |  |  |
| Houston**,** Texas |  | 77057 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** 800 587-8170<br>

N/A<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities registered pursuant to Section 12(b) of the Act:**

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock, par value $0.0001 per share | COYA | The Nasdaq Stock Market LLC |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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## Item 2.02 Results of Operations and Financial Condition.
On May 12, 2026, Coya Therapeutics, Inc. (the "Company") issued a press release disclosing certain information regarding its results of operations for the fiscal quarter ended March 31, 2026. A copy of the press release is furnished under Item 2.02 of this Current Report on Form 8-K as Exhibit 99.1.

The information included in this Item 2.02, and Exhibit 99.1 to this Current Report on Form 8-K, shall not be deemed "filed" for the purposes of or otherwise subject to the liabilities under Section 18 of the Securities Exchange Act of 1934 as amended (the "Exchange Act"). Unless expressly incorporated into a filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act made after the date hereof, the information contained in this Item 2.02 and Exhibit 99.1 hereto shall not be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

**Item 8.01. Other Events.**

On May 11, 2026, the U.S. Food and Drug Administration granted Fast Track Designation to COYA 302 for the treatment of Amyotrophic Lateral Sclerosis (ALS).

## Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.

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| | |
|:---|:---|
| Exhibit No. | Description |
| 99.1 | [<u>Press Release dated May 12, 2026.</u>](coya-ex99_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

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**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | **COYA THERAPEUTICS, INC.** |
| Date: | May 12, 2026 | By:  | /s/ Arun Swaminathan Ph.D. |
|  |  |  | Arun Swaminathan Ph.D.<br>Chief Executive Officer<br>(Principal Executive Officer) |

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## Exhibit 99.1

**Coya Therapeutics Reports First Quarter 2026 Financial Results and Provides a Corporate Update** 

HOUSTON, TX., May 12, 2026 (BUSINESS WIRE)-- <u>Coya Therapeutics, Inc.</u> (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance T-cell (Treg) function in patients with neurodegenerative disorders, announces its financial results for the quarter ended March 31, 2026 and provides a corporate update .

"We are off to a strong start in 2026, building on the clinical and scientific progress achieved last year," said Arun Swaminathan, Ph.D., Chief Executive Officer of Coya. "The ALSTARS trial is now in full recruitment mode, and we maintain our guidance for a 1Q 2027 topline readout. With a solid foundation and balance sheet in place we are well positioned to deliver on our priorities for 2026."

**Recent Corporate Highlights**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•FDA granted Fast Track Designation to COYA 302 for the treatment of ALS on March 11, 2026. Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Announced U.S. FDA acceptance of Investigation New Drug (IND) Application for COYA 302 for the treatment of frontotemporal dementia (FTD).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Reported results of the investigator-initiated study of low-dose IL-2 and CTLA4-Ig combination treatment demonstrating Treg enhancement and cognitive stability in FTD patients.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Announced $11.1 million private placement, led by Dr. Reddy's Laboratories, Inc. ($10 million) and Greenlight Capital ($1.1 million), an existing institutional stockholder of the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Announced publication in *Brain Communications* demonstrating regulatory T-cell dysfunction and system inflammation in frontotemporal dementia, supporting mechanistic rationale for the use of COYA 302 as a therapy in patients with frontotemporal dementia.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Announced publication in *Annals of Clinical and Translational Neurology* demonstrating correlation between longitudinal biomarker data and clinical outcomes supporting the mechanistic rationale for COYA 302 in patients with ALS.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The ALSTARS protocol was amended to remove the prior exclusion criteria for patients receiving antihypertensive medications and for those with controlled autoimmune diseases. The amended protocol was cleared through both FDA and Health Canada and is expected to allow for a broader patient population, which we believe will increase the enrollment rate.

**Upcoming Expected Catalysts for 2026**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•June 2026: Scientific presentations at upcoming 5<sup>th</sup> Annual ALS Drug Development Summit and ENCALS (European Network to Cure ALS)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•2H 2026: Targeting full enrollment of our ALSTARS Phase 2 trial.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•2H 2026: Initiate Phase 2a study evaluating COYA 302 for the treatment of FTD.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•2H 2026: Report additional single cell proteomics data from the completed ALS and AD investigator-initiated trials.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•2H 2026: Publication of COYA 303 *in vivo* data in inflammatory animal model of peripheral and CNS inflammation.

Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya, added, "The recent revision to our inclusion/exclusion criteria [for our ALSTARS protocol] has expanded the patient population to study this potential therapy for ALS. We expect that this change will also increase the recruitment rate," said Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya. "We continue to strengthen the biological foundation of our approach as we believe the investigator-initiated study findings and publications noted above highlight the role of immune dysregulation and systemic inflammation in FTD and ALS, and reinforce the promising potential of COYA 302 to modulate these pathways and impact disease progression."

**Financial Results**

As of March 31, 2026, Coya had cash and cash equivalents of $50.7 million.

Collaboration revenue was $0.3 million for each of the three months ended March 31, 2026 and 2025, and related to the Company's R&D services performance obligation under the Development and License Agreement with DRL.

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Research and development expenses decreased by $1.1 million, from $5.2 million for the three months ended March 31, 2025, to $4.1 million for the three months ended March 31, 2026. The decrease was primarily due to a $1.2 million decrease in external preclinical and clinical product candidates, reflecting the timing of preclinical activities undertaken in early 2025 to support the Company's Investigational New Drug applications for COYA 302 in ALS. The decrease was further driven by a $0.1 million decrease in sponsored research expense, partially offset by a $0.2 million increase in internal research and development expenses.

General and administrative expenses increased by $1.1 million, from $2.7 million for the three months ended March 31, 2025, compared to $3.4 million for the three months ended March 31, 2026. The increase was primarily due to a $1.1 million increase in employee compensation, which included a non-cash charge of $1.0 million related to the modification of stock options held by the Company's former Executive Chairman in connection with his resignation.

Net loss was $7.2 million for the three months ended March 31, 2026, compared to net loss of $7.3 million for the three months ended March 31, 2025.

**About Coya Therapeutics, Inc.**

Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells ("Tregs") to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases. This cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system.

Coya's investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya's therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.

For more information about Coya, please visit <u>www.coyatherapeutics.com</u> 

**About COYA 302**

COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 comprises proprietary low dose interleukin-2 (LD

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IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS and other neurodegenerative diseases. These mechanisms may have additive or synergistic effects.

Coya is currently conducting the ALSTARS Trial, a Phase 2, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of COYA 302 for the treatment of ALS (Identifier: NCT07161999).

COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency.

**Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Coya Therapeutics, Inc. (the "Company") regarding the potential benefits, effectiveness and safety of its product candidates; the significance and potential benefits associated with the FDA's Fast Track designation for COYA 302; the Company's ability to advance its product candidates through the preclinical and clinical development processes; the Company's expectations regarding, quality, timing and availability of data from the Company's clinical trials; the timing of announcements, updates and results of the Company's clinical trials and related data; the Company's future results of operations and financial position, including cash runway; and the potential therapeutic benefits and economic value of the Company's product candidates. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company's actual results to differ from current expectations are discussed in the Company's filings with the Securities and Exchange Commission (the "SEC"), including the section titled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

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**Investor Contact**<br> David Snyder, CFO<br> david@coyatherapeutics.com

**Media Contacts**<br> Russo Partners<br> David Schull<br> David.Schull@russopartnersllc.com<br> 858-717-2310

Rachelle Babb<br> rachelle.babb@russopartnersllc.com<br> 929-325-7559

Source: Coya Therapeutics, Inc.

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**COYA THERAPEUTICS, INC.** 

**CONDENSED BALANCE SHEETS**

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| | | |
|:---|:---|:---|
|  | **(unaudited)** |  |
|  | **March 31,** | **December 31,** |
|  | **2026** | **2025** |
| **Assets** |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $50724643 | $46822786 |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaids and other current assets | 2538036 | 3116232 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 53262679 | 49939018 |
| Fixed assets, net | 8420 | 11227 |
| Total assets | $53271099 | $49950245 |
| **Liabilities and Stockholders' Equity** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;Accounts payable | $948192 | $1061122 |
| &nbsp;&nbsp;Accrued expenses | 1355714 | 3612913 |
| &nbsp;&nbsp;Deferred collaboration revenue | 1242635 | 1197856 |
| &nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 3546541 | 5871891 |
| Deferred collaboration revenue | 754198 | 1050124 |
| Total liabilities | 4300739 | 6922015 |
| Stockholders' equity: |  |  |
| &nbsp;&nbsp;Series A convertible preferred stock, $0.0001 par value: 10,000,000 shares authorized, none issued or outstanding as of March 31, 2026 or December 31, 2025 | - | - |
| &nbsp;&nbsp;Common stock, $0.0001 par value; 200,000,000 shares authorized; 23,457,183 and 20,934,456 shares issued and outstanding as of March 31, 2026 or December 31, 2025, respectively | 2346 | 2094 |
| Additional paid-in capital | 118138281 | 104989413 |
| Accumulated deficit | (69170267) | (61963277) |
| &nbsp;&nbsp;Total stockholders' equity | 48970360 | 43028230 |
| Total liabilities and stockholders' equity | $53271099 | $49950245 |

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**COYA THERAPEUTICS, INC.**

**CONDENSED UNAUDITED INTERIM STATEMENTS OF OPERATIONS**

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| | | |
|:---|:---|:---|
|  | **Three Months Ended March 31,** | **Three Months Ended March 31,** |
|  | **2026** | **2025** |
| Collaboration revenue | $251147 | $257884 |
| Operating expenses: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 4096580 | 5214076 |
| &nbsp;&nbsp;&nbsp;&nbsp;In-process research and development | 10000 | - |
| &nbsp;&nbsp;&nbsp;&nbsp;General and administrative | 3781977 | 2713890 |
| &nbsp;&nbsp;&nbsp;&nbsp;Depreciation | 2807 | 6840 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 7891364 | 7934806 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Loss from operations | (7640217) | (7676922) |
| Other income: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Other income | 433227 | 370165 |
| Pre-tax loss | (7206990) | (7306757) |
| Income tax expense | - | - |
| Net loss | $(7206990) | $(7306757) |
| **Per share information:** |  |  |
| Net loss per share of common stock, basic and diluted | $(0.32) | $(0.44) |
| Weighted-average shares of common stock outstanding, basic and diluted | 22644304 | 16720511 |

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**COYA THERAPEUTICS, INC.**

**CONDENSED UNAUDITED INTERIM STATEMENTS OF CASH FLOWS** 

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| | | |
|:---|:---|:---|
|  | **Three Months Ended March 31,** | **Three Months Ended March 31,** |
|  | **2026** | **2025** |
| **Cash flows from operating activities:** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Net loss | $(7206990) | $(7306757) |
| &nbsp;&nbsp;&nbsp;&nbsp;Adjustment to reconcile net loss to net cash used in operating activities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Depreciation | 2807 | 6840 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Stock-based compensation, including the issuance of restricted stock | 2195516 | 1080082 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Acquired in-process research and development assets | 10000 | - |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Changes in operating assets and liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Collaboration receivable | - | - |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Prepaids and other current assets | 578196 | 3126042 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | (154713) | 101879 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accrued expenses | (1382199) | 421523 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Deferred collaboration revenue | (251147) | (257884) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net cash used in operating activities | (6208530) | (2828275) |
| **Cash flows from investing activities:** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Purchase of in-process research and development assets | (885000) | - |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net cash used in investing activities | (885000) | - |
| **Cash flows from financing activities:** |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Proceeds from sale of common stock, net of offering costs | 10995387 | - |
| &nbsp;&nbsp;&nbsp;&nbsp;Proceeds from the exercise of stock options | - | 19137 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net cash provided by financing activities | 10995387 | 19137 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net increase (decrease) in cash and cash equivalents | 3901857 | (2809138) |
| Cash and cash equivalents as of beginning of the period | 46822786 | 38339762 |
| Cash and cash equivalents as of end of the period | $50724643 | $35530624 |
| Supplemental disclosures of non-cash investing and financing activities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Financing costs related to the sale of common stock in accounts payable | $41783 | $- |
| &nbsp;&nbsp;&nbsp;&nbsp;In-process research and development costs in accrued expenses | $250000 | $- |

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