HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic platforms intended to enhance Treg function, including biologics and cell therapies, today announced expansion of its exclusive worldwide rights for the development and commercialization of COYA 301, the Company’s low-dose IL-2 subcutaneous administration product candidate. Under the expanded terms of the agreement with ARScience Biotherapeutics, Inc. (ARScience Bio), Coya has been granted the rights to develop and commercialize COYA 301 as a monotherapy for the treatment of multiple autoimmune diseases. These additional rights expand on the rights provided in the original license which allowed Coya to develop and commercialize the product candidate as monotherapy for a number of neurodegenerative conditions and as a combination Treg-based therapy across multiple therapeutic areas.

“We believe that Treg dysfunction is a common characteristic in certain neurodegenerative and autoimmune diseases. The expansion of the license agreement enables our development of COYA 301 in a potentially larger group of patients suffering from progressive diseases characterized by sustained inflammation,” stated Howard Berman, Ph.D., Chief Executive Officer of Coya. “Our strategy is to develop COYA 301 both as a monotherapy and in combination with other immunomodulatory drugs (COYA 302) to potentially mitigate persistent inflammation,” Dr. Berman added.

Carlos Banado, CEO of ARScience Biotherapeutics noted, “There is not currently an approved recombinant human low-dose IL-2 for therapeutic use. The development of a low-dose IL-2 formulation, delivered via a subcutaneous injection, may provide an effective treatment in a wide range of diseases characterized by increased inflammation. We are confident that Coya Therapeutics has the expertise to develop and commercialize this asset in multiple indications and we look forward to a successful collaboration.”

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, and this cellular dysfunction may lead to a 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. Coya’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. For more information about Coya, please visit www.coyatherapeutics.com

About ARScience Biotherapeutics, Inc.

ARScience Bio team has over 20 years of experience in cytokine and immunomodulator development and manufacturing. The company has built strong partnerships with leading academic institutions and clinical groups to develop novel indications for its portfolio of products. ARScience Bio pipeline includes cytokines and immunomodulators that enhance the activity of new cell therapy treatments as well as targets for orphan diseases with affordable and improved therapeutic profiles against existing treatments. For more information about ARScience Bio, please visit www.arsciencebio.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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