Coya Therapeutics (NASDAQ: COYA) gains $4.2M FDA IND milestone

Rhea-AI Filing Summary

Coya Therapeutics, Inc. reports receiving a $4.2 million milestone payment from its strategic partner Dr. Reddy’s Laboratories. The payment was triggered when the FDA accepted Coya’s Investigational New Drug application for a planned Phase 2 clinical study of COYA 302 in amyotrophic lateral sclerosis (ALS).

Coya is also entitled to an additional $4.2 million from Dr. Reddy’s Laboratories when the first patient is dosed in this Phase 2 ALS study, which is designed as a randomized, double-blind, placebo-controlled, multi-center trial with an open-label extension.

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Biotech and partnerships analyst

Coya secures $4.2M FDA-triggered milestone with another $4.2M tied to trial start.

Coya Therapeutics received a $4.2 million milestone from Dr. Reddy’s Laboratories after FDA acceptance of its IND for a Phase 2 ALS study of COYA 302. This reflects progress under their Development and License Agreement dated December 5, 2023.

The agreement also provides for an additional $4.2 million when the first patient is dosed in the Phase 2 trial, a randomized, double-blind, placebo-controlled, multi-center study with an open-label extension. Realization of the second payment depends on reaching that dosing milestone, so actual financial impact will track the study’s operational progress.

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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): August 29, 2025

Coya Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-41583		85-4017781
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

5850 San Felipe St., Suite 500
Houston, Texas		77057
(Address of Principal Executive Offices)		(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:

☐ 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:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		COYA		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. Other Events.

On August 29, 2025, Coya Therapeutics Inc. (“Coya”) received a $4.2 million milestone payment from its strategic partner, Dr. Reddy’s Laboratories Ltd. (“DRL”), pursuant to a Development and License Agreement, dated December 5, 2023 (the “Agreement”), as a result of the U.S. Food and Drug Administration’s (the “FDA”) acceptance of Coya’s 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”). Pursuant to the Agreement, Coya will also receive an additional $4.2 million payment from DRL upon the dosing of the first patient in the Phase 2 Study.

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.

						COYA THERAPEUTICS, INC.
Date: September 2, 2025				By:		/s/ Arun Swaminathan Ph.D.
						Arun Swaminathan Ph.D. Chief Executive Officer

FAQ

What payment did Coya Therapeutics (COYA) receive from Dr. Reddy’s Laboratories?

Coya Therapeutics received a $4.2 million milestone payment from Dr. Reddy’s Laboratories after the FDA accepted its IND for a Phase 2 ALS study of COYA 302.

Why did Coya Therapeutics receive the $4.2 million milestone payment?

The $4.2 million milestone was earned when the FDA accepted Coya’s Investigational New Drug application for a planned Phase 2 COYA 302 ALS clinical study.

Is Coya Therapeutics eligible for additional milestone payments under the DRL agreement?

Yes. Under the agreement, Coya will receive an additional $4.2 million from Dr. Reddy’s Laboratories when the first patient is dosed in the Phase 2 ALS study.

What is the design of Coya Therapeutics’ planned Phase 2 ALS study for COYA 302?

The planned Phase 2 COYA 302 ALS study is described as a randomized, double-blind, placebo-controlled, multi-center, 24-week trial with an additional 24-week open-label extension.

What agreement governs the milestone payments between Coya Therapeutics and Dr. Reddy’s Laboratories?

The milestone payments are governed by a Development and License Agreement between Coya Therapeutics and Dr. Reddy’s Laboratories dated December 5, 2023.

Which regulatory event triggered the recent milestone payment to Coya Therapeutics?

The milestone was triggered by the U.S. FDA’s acceptance of Coya’s IND for initiating the planned Phase 2 COYA 302 study in ALS.