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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
Date of Report (Date of earliest event reported): October 5, 2026
Coya Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)
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| Delaware |
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001-41583 |
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85-4017781 |
(State or Other Jurisdiction
of Incorporation) |
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(Commission File Number) |
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(IRS Employer
Identification No.) |
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| 5850 San Felipe St., Suite 500 |
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| Houston, Texas |
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77057 |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: 800 587-8170
N/A
(Former Name or Former Address, if Changed Since Last Report)
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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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Title of each class
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Trading
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Name of each exchange
on which registered |
| Common Stock, par value $0.0001 per share |
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COYA |
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The Nasdaq Stock Market LLC |
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. ☐
On October 5, 2026, Coya Therapeutics, Inc. (the “Company”) issued a press release announcing full enrollment of the planned one hundred and twenty (120) patients in the Company’s ongoing Phase 2/3 ALSTARS Trial (NCT07161999) evaluating COYA 302, the Company’s combination of proprietary low-dose IL-2 and CTLA-4 Ig, for the treatment of amyotrophic lateral sclerosis (“ALS”). Additional participants already engaged in active screening will be allowed to enroll in the trial if deemed eligible. Topline data from the double-blind treatment phase are anticipated in early Q2 2027.
The ALSTARS Trial is a Phase 2/3, randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of COYA 302 in patients with ALS. Approximately 120 subjects will be randomized 1:1:1 to receive one of two pre-specified dosing regimens of COYA 302 or placebo during a 24-week double-blind treatment phase. Patients who complete the 24-week placebo-controlled phase enter a 24-week blinded active-treatment extension phase; patients receiving COYA 302 continue their assigned regimen, while placebo patients are re-randomized to one of the two COYA 302 dosing regimens, providing up to 48 weeks of data on COYA 302. The primary endpoint is change in disease severity over time, measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score from baseline to Week 24 compared with placebo. Study objectives include evaluation of efficacy, safety and tolerability, biological activity, and biomarker levels.
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this Current Report on Form 8-K that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: the timing of topline data from the double-blind treatment phase, expectations of 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 Current Report on Form 8-K 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.
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: October 5, 2026 |
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By: |
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/s/ Arun Swaminathan Ph.D. |
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Arun Swaminathan Ph.D.
Chief Executive Officer |
