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    Coya Therapeutics Announces That Its Combination LD IL-2/GLP-1 RA Candidate (COYA 303) Demonstrated Potent Systemic and Brain Anti-Inflammatory Efficacy In Vivo

    11/4/25 8:00:00 AM ET
    $COYA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $COYA alert in real time by email

    COYA 303 is an investigational proprietary biologic combination of low-dose (LD)-IL-2 and GLP-1 receptor agonist (RA) for subcutaneous administration with potential for treating inflammation-driven diseases like Alzheimer's Disease, and other neurodegenerative and autoimmune diseases

    COYA 303 significantly reduced peripheral pro-inflammatory cell expansion, enhanced Regulatory T Cell function, attenuated CNS inflammation, and shifted macrophages to an anti-inflammatory phenotype, compared to controls

    COYA-303 may represent a next-generation dual immunomodulatory GLP-1–based therapy uniting the Nobel Prize–recognized science of regulatory T cells (Tregs) with the emerging immune benefits of GLP-1 receptor agonists.

    Coya Therapeutics, Inc. (NASDAQ:COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, today announced results of an in vivo animal study designed to evaluate the effects of COYA 303 (LD IL-2 and GLP-1RA investigational proprietary biologic combination) in a well-characterized in vivo lipopolysaccharide (LPS) preclinical mouse model of systemic and neurologic inflammation. Results from this completed study confirmed the interim findings previously reported by the Company.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251104427252/en/

    Representative Data for Systemic Tregs and Immunomodulation Credit: Coya Therapeutics, Inc.

    Representative Data for Systemic Tregs and Immunomodulation Credit: Coya Therapeutics, Inc.

    Dr. Fred Grossman, Coya's Chief Medical Officer, stated, "This study strengthens our multi-targeted approach developing new therapies for diseases of high unmet need. COYA 303 has shown synergistic effects reducing peripheral and central inflammation in vitro and in vivo. We believe this supports our combination approach with potential development in neurodegenerative diseases."

    Dr. Arun Swaminathan, Coya's CEO, stated, "We believe the data supports the potential of COYA-303 to improve the efficacy of GLP-1 RA in neurodegenerative diseases like Alzheimer's Disease in a synergistic manner. The anticipated readout of the Novo Nordisk EVOKE and EVOKE+ trials studying semaglutide, a GLP-1 RA in patients with mild Alzheimer's Disease will inform our strategy moving forward."

    Study Highlights:

    In this animal model, mice received daily injections of LPS for five days to induce a moderate but sustained inflammatory response representative of chronic inflammation seen in neurodegenerative disease. Animals were treated with daily injections of COYA 303 for four days, starting a day after initiation of LPS injections. The study control groups included the individual components of COYA 303, vehicle-only, and LPS-only treated animals.

    Coya intends to publish a full dataset which the Company believes demonstrates that COYA 303 significantly modulates multiple systemic and central nervous system immune parameters and shifts monocytes from a pro-inflammatory to an anti-inflammatory phenotype. Moreover, the Company believes COYA 303 has significant effects on multiple Treg-associated activation and functional markers, indicating enhanced Treg stability and suppressive capacity.

    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

    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 press release, 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 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/20251104427252/en/

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    Get the next $COYA alert in real time by email

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