COYA 8-K
Coya Therapeutics, Inc. (COYA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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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.
Item 2.02 Results of Operations and Financial Condition.
On August 11, 2026, Coya Therapeutics, Inc. (the “Company”) issued a press release disclosing certain information regarding its results of operations for the fiscal quarter ended June 30, 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 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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. |
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Date: |
August 11, 2026 |
By: |
/s/ Arun Swaminathan Ph.D. |
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Arun Swaminathan Ph.D. |
Coya Therapeutics Reports Second Quarter 2026 Financial Results and Provides a Corporate Update
HOUSTON, TX., August 11, 2026 (BUSINESS WIRE)-- Coya Therapeutics, Inc. (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 June 30, 2026 and provides a corporate update.
“During the second quarter, we made notable progress advancing our lead program, COYA 302,” said Arun Swaminathan, Ph.D., Chief Executive Officer of Coya. “Enrollment in the ALSTARS Phase 2 ALS trial is proceeding as planned, and we remain on track to complete enrollment this year and report topline data in the first quarter of 2027. At the same time, we plan to initiate a Phase 2 study of COYA 302 in frontotemporal dementia (FTD) in the coming months. Together, these programs reflect our differentiated strategy of applying Treg biology to address the shared mechanisms of these neurodegenerative conditions.”
Recent Corporate Highlights
Upcoming Expected Milestones 2026:
“The progress we have made in the ALSTARS trial continues to reinforce our confidence in COYA 302 as we advance this program for people living with ALS,” said Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya. “The blinded extension phase of the ALSTARS trial is now well underway. We are grateful to the patients, families, and investigators whose partnership makes this work possible.”
Financial Results
As of June 30, 2026, Coya had cash and cash equivalents of $43.2 million, sufficient to fund operations, as currently planned, past the Phase 2 ALSTARS topline data readout and into the second half of 2027.
Collaboration revenue was $0.2 million for each of the three months ended June 30, 2026 and 2025, and related to the Company’s R&D services performance obligation under the Development and License Agreement with DRL.
Research and development expenses increased by $1.3 million from $3.7 million for the three months ended June 30, 2025 to $5.0 million for the three months ended June 30, 2026. The increase was primarily due to a $1.1 million increase in preclinical and clinical product candidate costs, reflecting primarily the advancement of the COYA 302 ALS Phase 2 clinical trial. The increase was further driven by a $0.4 million increase in internal research and development expenses, partially offset by a $0.2 million decrease in sponsored research expense.
General and administrative expenses decreased by $0.6 million from $2.9 million for the three months ended June 30, 2025 compared to $2.3 million for the three months ended June 30, 2026. The decrease was primarily due to a $0.4 million decrease in professional services and a $0.2 million decrease in employee compensation, including lower stock-based compensation.
Net loss was $6.6 million for the three months ended June 30, 2026, compared to net loss of $6.1 million for the three months ended June 30, 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 www.coyatherapeutics.com
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 IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS, FTD 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.
Investor Contact
David Snyder, CFO
[email protected]
Media Contacts
Russo Partners
David Schull
[email protected]
858-717-2310
Rachelle Babb
[email protected]
929-325-7559
Source: Coya Therapeutics, Inc.
COYA THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
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(unaudited) |
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June 30, |
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December 31, |
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2026 |
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2025 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
43,181,002 |
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$ |
46,822,786 |
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Prepaids and other current assets |
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3,876,735 |
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3,116,232 |
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Total current assets |
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47,057,737 |
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49,939,018 |
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Fixed assets, net |
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5,614 |
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11,227 |
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Other assets |
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244,727 |
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- |
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Total assets |
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$ |
47,308,078 |
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$ |
49,950,245 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ |
1,085,519 |
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$ |
1,061,122 |
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Accrued expenses |
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1,193,460 |
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3,612,913 |
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Deferred collaboration revenue |
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1,233,452 |
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1,197,856 |
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Total current liabilities |
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3,512,431 |
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5,871,891 |
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Deferred collaboration revenue |
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519,636 |
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1,050,124 |
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Total liabilities |
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4,032,067 |
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6,922,015 |
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Stockholders' equity: |
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Series A convertible preferred stock, $0.0001 par value: 10,000,000 shares authorized, none issued or outstanding as of June 30, 2026 or December 31, 2025 |
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- |
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- |
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Common stock, $0.0001 par value; 200,000,000 shares authorized; 23,457,849 and 20,934,456 shares issued and outstanding as of June 30, 2026 or December 31, 2025, respectively |
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2,346 |
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2,094 |
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Additional paid-in capital |
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119,082,192 |
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104,989,413 |
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Accumulated deficit |
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(75,808,527 |
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(61,963,277 |
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Total stockholders' equity |
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43,276,011 |
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43,028,230 |
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Total liabilities and stockholders' equity |
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$ |
47,308,078 |
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$ |
49,950,245 |
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COYA THERAPEUTICS, INC.
CONDENSED UNAUDITED INTERIM STATEMENTS OF OPERATIONS
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Three Months Ended June 30, |
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2026 |
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2025 |
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Collaboration revenue |
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$ |
243,745 |
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$ |
163,616 |
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Operating expenses: |
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Research and development |
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5,030,667 |
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3,663,103 |
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In-process research and development |
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1,656 |
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- |
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General and administrative |
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2,255,603 |
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2,908,191 |
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Depreciation |
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2,807 |
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6,840 |
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Total operating expenses |
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7,290,733 |
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6,578,134 |
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Loss from operations |
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(7,046,988 |
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(6,414,518 |
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Other income: |
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Other income |
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408,728 |
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319,541 |
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Pre-tax loss |
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(6,638,260 |
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(6,094,977 |
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Income tax expense |
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- |
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- |
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Net loss |
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$ |
(6,638,260 |
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$ |
(6,094,977 |
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Per share information: |
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Net loss per share of common stock, basic and diluted |
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$ |
(0.28 |
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$ |
(0.36 |
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Weighted-average shares of common stock outstanding, basic and diluted |
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23,457,227 |
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16,724,998 |
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COYA THERAPEUTICS, INC.
CONDENSED UNAUDITED INTERIM STATEMENTS OF CASH FLOWS
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Six Months Ended June 30, |
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2026 |
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2025 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(13,845,250 |
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$ |
(13,401,734 |
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Adjustment to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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5,614 |
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13,680 |
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Stock-based compensation, including the issuance of restricted stock |
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3,139,427 |
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2,115,795 |
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Acquired in-process research and development assets |
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11,656 |
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- |
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Changes in operating assets and liabilities: |
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Prepaids and other current assets |
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(640,062 |
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2,298,347 |
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Other assets |
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(120,441 |
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- |
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Accounts payable |
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(96,044 |
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(656,784 |
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Accrued expenses |
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(1,544,454 |
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1,450,625 |
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Deferred collaboration revenue |
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(494,892 |
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(421,500 |
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Net cash used in operating activities |
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(13,584,446 |
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(8,601,571 |
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Cash flows from investing activities: |
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Purchase of in-process research and development assets |
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(886,656 |
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- |
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Net cash used in investing activities |
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(886,656 |
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- |
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Cash flows from financing activities: |
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Proceeds from sale of common stock, net of offering costs |
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10,953,604 |
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- |
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Payment of financing costs related to the ATM Offering Program |
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(124,286 |
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- |
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Proceeds from the exercise of stock options |
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- |
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19,137 |
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Net cash provided by financing activities |
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10,829,318 |
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19,137 |
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Net decrease in cash and cash equivalents |
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(3,641,784 |
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(8,582,434 |
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Cash and cash equivalents as of beginning of the period |
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46,822,786 |
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38,339,762 |
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Cash and cash equivalents as of end of the period |
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$ |
43,181,002 |
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$ |
29,757,328 |
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Supplemental disclosures of non-cash investing and financing activities: |
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In-process research and development costs in accrued expenses |
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$ |
250,000 |
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$ |
- |
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Financing costs related to the ATM Offering Program in accounts payable |
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$ |
120,441 |
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$ |
- |
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