Coya Therapeutics, Inc. Announces an Agreement with Dr. Reddy�s Laboratories, Ltd. to License its proposed biosimilar Abatacept for the Development and Commercialization of COYA 302 for the Treatment of Neurodegenerative Diseases

• COYA 302 is an investigational combination biologic for subcutaneous administration, comprised of COYA 301 and CTLA4-Ig (Abatacept). COYA 302 has a dual mechanism of action intended to suppress the chronic and sustained inflammation underlying certain neurodegenerative diseases.
• COYA 301 is an investigational immunomodulatory cytokine for subcutaneous administration intended to enhance regulatory T cell (Treg) function in vivo, and Abatacept is a fusion protein that binds to antigen-presenting cells and downregulates T effector cells and other pro-inflammatory cells.
• As part of the development of the combination product COYA 302, Coya will source CTLA4-Ig from Dr. Reddy�s
• Under the terms of the agreement, Coya retains exclusive rights to develop and commercialize COYA 302 across multiple neurodegenerative diseases in multiple territories, including North and South America, the EU, United Kingdom, and Japan.
• Dr. Reddy’s obtains exclusive rights to commercialize COYA 302 across multiple neurodegenerative disease conditions in areas outside of Coya’s territory.
• Results from a proof-of-concept clinical study for COYA 302 evaluating pharmacodynamic, biomarker, safety, and preliminary efficacy parameters in patients with Amyotrophic Lateral Sclerosis (ALS) will be presented by Dr. Stanley Appel at the MDA Conference in Dallas, Texas on March 21, 2023.

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 a worldwide agreement with Dr. Reddy’s Laboratories Limited. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company. Under this agreement, Coya will in-license the proposed Abatacept biosimilar of Dr. Reddy’s for the development of Coya’s combination product for neurodegenerative diseases, COYA 302. It is a dual biologic intended to suppress neuroinflammation via multiple immunomodulatory pathways, for the treatment of neurodegenerative conditions.

COYA 302 is comprised of two components – COYA 301 and CTLA4-Ig. Coya will develop COYA 301. Under the terms of the Agreement, Coya has been granted an exclusive, royalty-bearing license to Dr. Reddy’s proposed biosimilar Abatacept for the development and commercialization of Coya 302 for the treatment of certain neurological diseases for sale in multiple territories including North and South America, the EU, United Kingdom, and Japan. As consideration for the license, Coya will pay a one-time non-refundable upfront fee to Dr. Reddy’s. In addition, Coya will owe tiered payments to Dr. Reddy’s based upon Coya’s achievement of certain developmental milestones. Coya will also owe royalties to Dr. Reddy’s on Net Sales of Coya 302 within its licensed territory on a tiered basis. The Agreement does not preclude Dr. Reddy’s from launching its proposed biosimilar Abatacept globally for approved indications post regulatory approval.

Coya anticipates that it will file an IND for COYA 302 in the 2H of 2023 with the goal of initiating a phase 1b/2 trial in ALS (Amyotrophic Lateral Sclerosis) soon thereafter.

The Agreement also provides for the license of Coya 301, Coya’s low dose IL-2 to Dr. Reddy’s to permit the commercialization by Dr. Reddy’s of Coya 302 in territories not otherwise granted to Coya. Coya will receive royalties on Net Sales by Dr. Reddy’s in their territories based on the same tiered structure as Coya owes Dr. Reddy’s. The Agreement also allows Dr. Reddy’s and Coya to enter into a mutually satisfactory commercial supply agreement at an appropriate time.

“This is a landmark agreement for Coya in our efforts to develop COYA 302. To partner with such a high-caliber pharmaceutical company like Dr. Reddy’s is what every emerging biotechnology company strives for, and we believe that the combined resources of both organizations strengthens our chances to bring this therapeutic modality to patients with neurodegenerative diseases if approved by regulatory authorities,” commented Howard H Berman, Ph.D., CEO of Coya Therapeutics.

Adrian Hepner, M.D., Ph.D. and CMO of Coya added, “We believe that the COYA 302 proof-of-concept clinical data in ALS patients is encouraging and sets the foundation to advance our development program. Our combination therapy approach has been designed to address the multiple pathophysiological pathways leading to chronic and sustained inflammation that drives the progression of serious neurodegenerative diseases. We plan to file an IND in the second half of this year and work closely with the regulatory authorities to initiate our clinical studies soon thereafter.”

Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s commented, “We are very happy to collaborate with Coya in this effort to advance therapies that address critical unmet needs for a variety of neuro-degenerative diseases. As a global biosimilars developer, we believe our proposed Abatacept biosimilar will be valuable in the development of this innovative combination therapy. We continue to look for ways to use our scientific capabilities and product portfolio to serve patients around the world.”

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 Dr. Reddy’s Laboratories

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.

Forward-Looking Statements

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