Coya Therapeutics Announces the First Cohort of Patients in the ALSTARS Trial Have Begun the Blinded Active-Treatment Extension Phase

Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, announces the initiation of the blinded extension phase of the ALSTARS Trial (ClinicalTrials.gov Identifier: NCT07161999). Patients who complete the 24-week placebo-controlled double-blind phase enter the blinded extension phase of the study and continue on their regimen from the first phase; placebo patients are re-randomized to receive one of the two pre-specified dosing regimens of COYA 302 for a total of 24-weeks to provide a total of up to 48 weeks of data on COYA 302. To learn more about the study, please visit ALSTARS Trial.

Fred Grossman, DO, FAPA, President and Chief Medical Officer of Coya said, “We are very pleased with the progress of this important clinical study of COYA 302 in people with ALS that we hope may ultimately lead to a transformational new treatment. We would like to thank the patients, families, and caregivers for their ongoing support and contribution to the ALSTARS Trial.”

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.

About COYA 302

COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 comprises proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS and other neurodegenerative diseases. These mechanisms may have additive or synergistic effects.

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