Coya Therapeutics expects FTD trial to start in 2027

The planned Phase 2 trial of COYA 302 for frontotemporal dementia is now expected in 2027, as resources are prioritized for ALS development.

Rhea-AI Filing Summary

Coya Therapeutics, Inc. expects to begin an open-label extension of its Phase 2/3 ALSTARS trial evaluating COYA 302 for ALS in November 2026, as the first cohort completes the 48-week treatment period. Participants who complete that period may continue receiving COYA 302, allowing collection of longer-term efficacy and safety data. ALSTARS includes a 24-week double-blind treatment phase and a 24-week blinded active-treatment extension.

Coya is prioritizing resources toward ongoing ALS development and timely ALSTARS milestones. Its planned Phase 2 trial of COYA 302 for FTD, previously anticipated in the second half of 2026, is now expected in 2027. Cash runway guidance remains unchanged, with existing cash resources expected to fund operations into the second half of 2027, beyond the anticipated ALSTARS topline data readout.

0 points · 0 major

NegativeiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• None.

Negative

• Moderate point. Forward-looking: it has not happened yet and may not happen.FTD Phase 2 start now expected in 2027, after prior second-half 2026 anticipation.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Key Figures

Planned ALSTARS enrollment: Approximately 120 subjects Randomization ratio: 1:1:1 Double-blind treatment phase: 24 weeks +4 more

7 metrics

Planned ALSTARS enrollment Approximately 120 subjects ALSTARS trial

Randomization ratio 1:1:1 Two COYA 302 dosing regimens or placebo

Double-blind treatment phase 24 weeks ALSTARS trial

Blinded active-treatment extension 24 weeks ALSTARS trial

Expected open-label extension start November 2026 As the first cohort completes the 48-week treatment period

Expected FTD Phase 2 trial start 2027 Previously anticipated in the second half of 2026

Cash runway guidance Into the second half of 2027 Existing cash resources expected to fund operations beyond the anticipated ALSTARS topline data readout

Key Terms

open-label extension, Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), re-randomized, topline data readout

4 terms

open-label extension medical

"initiate an open-label extension (“OLE”) of the Phase 2/3 ALSTARS Trial"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) medical

"measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)"

re-randomized technical

"placebo patients are re-randomized to one of the two COYA 302 dosing regimens"

topline data readout medical

"beyond the anticipated ALSTARS topline data readout"

A topline data readout is the initial summary of a clinical trial’s most important results, showing whether the study met its main goals. Like a headline score after a sports game, it gives investors a quick sense of success or failure that can shift a company’s outlook, affect future funding, and move the stock while more detailed analyses and regulatory reviews follow.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Coya Therapeutics expect to start the COYA 302 open-label extension?

Coya expects to begin the extension in November 2026, as the first cohort completes the 48-week treatment period. Participants who complete that period may continue receiving COYA 302, and the extension is intended to support collection of longer-term efficacy and safety data.

When is Coya's COYA 302 trial for FTD expected to start?

The Phase 2 trial evaluating COYA 302 for FTD is now expected to start in 2027; it was previously anticipated in the second half of 2026. Coya said the timing accompanies its prioritization of resources toward ongoing ALS development and timely completion of near-term ALSTARS milestones.

How is the COYA 302 ALSTARS trial structured?

Approximately 120 subjects will be randomized 1:1:1 to one of two COYA 302 dosing regimens or placebo. The study has a 24-week double-blind treatment phase followed by a 24-week blinded active-treatment extension; placebo participants are re-randomized to a COYA 302 regimen for the extension.

What is the primary endpoint in the COYA 302 ALSTARS trial?

The primary endpoint is the change in disease severity over time, measured by the ALSFRS-R total score from baseline to Week 24 compared with placebo.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Understanding 8-K Material Events →

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Available on EDGAR 10/14/2026 - 08:30 AM EDT Accepted by SEC EDGAR 10/14/2026 - 08:30 AM EDT Learn about SEC filing dates

false 0001835022 0001835022 2026-10-14 2026-10-14

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 14, 2026

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 October 14, 2026, Coya Therapeutics, Inc. (the “Company”) issued a press release announcing plans to initiate an open-label extension (“OLE”) of the Phase 2/3 ALSTARS Trial (NCT07161999) evaluating COYA 302 for the treatment of amyotrophic lateral sclerosis (“ALS”). The Company plans to initiate the OLE in response to requests from ALSTARS investigators and study participants. The OLE will provide participants who complete the 48-week treatment period with the opportunity to continue receiving COYA 302, while enabling the collection of longer-term efficacy and safety data. The Company expects the OLE to begin in November 2026 as the first cohort completes the 48-week treatment period.

Concurrent with the anticipated initiation of the OLE, the Company expects to prioritize resources toward the ongoing clinical development of COYA 302 in ALS and assuring timely completion of important near-term milestones in the ALSTARS Trial. With this prioritization, the planned initiation of the Phase 2 clinical trial evaluating COYA 302 in frontotemporal dementia (“FTD”), previously anticipated in the second half of 2026, is now expected in 2027.

The Company’s cash runway guidance remains unchanged, with existing cash resources expected to fund operations into the second half of 2027, beyond the anticipated ALSTARS topline data readout.

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 commencement of the OLE, the commencement of the Phase 2 clinical trial evaluating COYA 302 in FTD, 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.

						COYA THERAPEUTICS, INC.
Date: October 14, 2026				By:		/s/ Arun Swaminathan Ph.D.
						Arun Swaminathan Ph.D.
						Chief Executive Officer

Filing Exhibits & Attachments

3 documents

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.1 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 18.3 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.4 KB