Coya Therapeutics Announces Completion of Patient Enrollment of an Investigator-Initiated, Open-Label Study with Low-Dose IL-2 and CTLA4-Ig Combination Treatment in Patients with Mild to Moderate Frontotemporal Dementia

Following the positive interim results in 5 patients announced earlier this year, a total of 9 patients have been enrolled as planned

The study is progressing according to protocol, and no safety issues have been reported

Study completion is anticipated in Q4 2025 with topline to follow

HOUSTON, Sept. 29, 2025 /PRNewswire/ -- Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announces completion of patient enrollment of an investigator-initiated, proof-of-concept, open-label study with low-dose IL-2 and CTLA4-Ig combination treatment in patients with Frontotemporal Dementia (FTD). The study is led by Dr. Alireza Faridar and Dr. Stanley Appel at the Houston Methodist Neurological Institute (Houston, TX) with funding from The Peggy and Gary Edwards Endowment Fund. Study patients received subcutaneously administered CTLA4-Ig, followed by a 5-day course of low-dose IL-2 every four weeks, for a total of 22 weeks of dosing and follow-up.

Following the positive interim results of 5 patients announced in April 2025, the study has enrolled an additional 4 patients for a total of 9 FTD patients. The trial is progressing according to the study protocol and no serious adverse events or discontinuations due to safety issues have been reported.  Study completion is anticipated in Q4 2025 with topline to follow. Following database lock and analysis of the data, the Company plans to release the results of the study.

"We are pleased to announce the completion of this important clinical milestone. FTD is a devastating neurodegenerative disease of high unmet need. We remain committed to developing an effective and safe treatment for this rare form of dementia," Dr. Fred Grossman, CMO commented.

About Frontotemporal Dementia
Frontotemporal dementia (FTD) refers to a group of neurodegenerative disorders characterized by altered behavior and language, with a progressive decline in executive function.¹ FTD affects an estimated 30,000 Americans.² FTD is categorized clinically into various subtypes; the main three include behavioral-variant frontotemporal dementia and two language variants, semantic dementia (also known as semantic variant primary progressive aphasia) and progressive non-fluent aphasia (also known as non-fluent variant primary progressive aphasia). FTD is a presenile dementia, meaning it can occur in younger individuals, often between the ages of 45 and 64. The average age of onset is 58, with an average survival time of 7.5 years.^1,2

References

1. Knopman et al. Development of methodology for conducting clinical trials in frontotemporal lobar degeneration. Brain 2008; 131(11): 2957-2968.
2. Rascovsky et al. Rate of progression differs in frontotemporal dementia and Alzheimer disease. Neurology 2005; 65(3): 397-403.

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

Forward-Looking Statements
This press release contains "forward-looking" statements that are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," and similar expressions are intended to identify forward-looking statements.

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SOURCE Coya Therapeutics, Inc.