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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): July 29, 2025
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
Symbol(s) |
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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. ☐
Item 8.01. Regulation FD Disclosure.
As previously disclosed, on June 30, 2025, Coya Therapeutics Inc. (“Coya”) submitted additional non-clinical data to support the initiation of its Investigational New Drug Application (the “IND”) for the initiation of a planned clinical study entitled “Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study with Additional 24-Week Open Label Extension (OLE) to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)” (the “Phase 2 Study”) to the U.S. Food and Drug Administration (the “FDA”).
On July 29, 2025, the FDA informed Coya that due to the FDA’s present workload and lack of resources, they are unable to meet its initial review goal date for the IND of July 30, 2025. The FDA also informed Coya that they will provide their decision on approval of the IND as soon as possible, and expect that it will be provided no later than August 29, 2025.
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: July 29, 2025 |
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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 |
