Enters Licensing Agreement with UNeMed Corporation (UNeMed), the Technology Transfer Office of University of Nebraska Medical Center

• Abundant evidence indicates that high levels of inflammation and decreased levels of Regulatory T cells (Tregs) lead to an increased oxidative state in PD, which play a major role in disease progression and possibly etiology

• COYA 301 is a low-dose-IL-2 (ld IL-2) formulation for subcutaneous administration, intended to enhance Treg function in vivo to treat the systemic and neuro-inflammation underlying neurodegenerative and autoimmune diseases

• This agreement grants Coya the exclusive license to patent rights and know-how (IP) related to COYA 301 and combinations for treatment of PD

• IP is based on recently published data documenting that ld IL-2 significantly expands Treg populations and protects nigrostriatal dopaminergic neurons in an animal model of PD

• The license further diversifies Coya’s Treg enhancing biologic portfolio in neurodegenerative disease and expands upon the promising clinical data recently presented in Amyotrophic Lateral Sclerosis (ALS) and Alzheimer’s Disease (AD) while opening strategic clinical partnering opportunities in PD

Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic programs intended to enhance Treg function, today announced expansion of its patent estate for COYA 301, the Company’s low-dose IL-2 (ld IL-2) subcutaneous administration product candidate. Under the terms of the agreement with UNeMed, Coya has been granted the exclusive patent rights and know-how for use of ld IL-2 and ld IL-2 combinations for PD. UNeMed will receive payments upon achievement of certain milestones and will also be eligible to receive tiered low-single digit royalty on net sales.

“We believe that Treg dysfunction is the common thread that binds together many neurodegenerative diseases. This license is based on strong preclinical animal data in PD, builds upon the highly promising clinical data observed in ALS and AD, and expands the optionality that Coya has in strategic partnering discussions to execute on future clinical trials in PD,” said Arun Swaminathan, Ph.D., Chief Business Officer.

The preclinical model published by University of Nebraska Medical Center scientists demonstrated that treatment with ld IL-2 induced a treatment-specific Treg population with overexpression of immunosuppressive Treg cell markers. Furthermore, the treatment had a potent neuroprotective effect on nigral dopaminergic neurons in affected mice. The degeneration of nigral dopaminergic neurons is considered the hallmark of PD suggesting that this interventional strategy may lead to sustained suppressive immune responses and neuroprotection in PD. The paper is titled Interleukin-2 expands neuroprotective regulatory T cells in Parkinson’s disease and can be accessed here:

“We are incredibility excited about this partnership,” UNeMed President and CEO Michael Dixon, Ph.D., said. “Coya is in a great position to develop this new therapy, and bring it to the market where it can have a significantly positive impact on healthcare.”

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’ lead 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 UNeMed Corporation

UNeMed Corporation is the technology transfer and commercialization office for the University of Nebraska Medical Center. UNeMed serves all UNMC researchers, faculty and staff who develop new biomedical technology and inventions, and strives to help bring those innovations to the marketplace. Learn more at UNeMed.com, or contact them at unemed@unmc.edu or 402-559-2468.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230620349788/en/