Coya Therapeutics, Inc. Announces Expansion of Exclusive Worldwide Licensing Agreement with ARScience Biotherapeutics, Inc. for Development and Commercialization of COYA 301, Coya’s Low-Dose Interleukin 2 (IL-2) Product Candidate

• COYA 301 is an immunomodulatory cytokine for subcutaneous administration, intended to enhance regulatory T cell (Treg) function in vivo to treat the systemic and neuro-inflammation underlying certain autoimmune and neurodegenerative diseases.
• The original agreement provided Coya with global exclusive rights to develop and commercialize COYA 301 as a combination therapy across multiple therapeutic areas and disease conditions, and as a monotherapy for multiple neurodegenerative conditions.
• The expansion of the agreement grants Coya exclusive rights to develop and commercialize COYA 301 as monotherapy for the treatment of multiple serious autoimmune diseases.

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.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; ; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contacts

Coya Therapeutics, Inc.
Investor Contact
David Snyder

[email protected]

Hayden IR

James Carbonara

(646)-755-7412

[email protected]

Media Contact
Jessica Starman

[email protected]

ARScience Biotherapeutics, Inc.
Investor Contact
[email protected]