Coya Therapeutics to Present Biomarker and Preliminary Efficacy Clinical Data for COYA 301 for the Treatment of Patients with Alzheimer’s Disease (AD) at the 2023 Keystone Symposia Meeting for Neurodegeneration held on May 15-19th, 2023

Rhea-AI Summary

Coya Therapeutics (NASDAQ: COYA) has announced results from a proof-of-concept study evaluating COYA 301, a low-dose interleukin-2 (IL-2) therapy for Alzheimer’s Disease (AD). Conducted by Dr. Stanley Appel and Dr. Alireza Faridar at the Houston Methodist Hospital, the study involved eight patients over four months, assessing Treg function and safety. Initial findings suggest potential enhancement of anti-inflammatory responses, crucial for tackling neuroinflammation seen in AD. The study results will be presented at the 2023 Keystone Symposia in Whistler, British Columbia, from May 15-19.

Positive

• COYA 301 aims to enhance Treg function, potentially improving AD treatment.
• Study evaluated safety, tolerability, and efficacy in a clinical setting.

Negative

• Limited sample size of eight patients may affect the reliability of results.
• The open-label design may influence bias in safety and efficacy evaluations.

- The proof-of-concept open-label study evaluated the safety and tolerability, regulatory T cell (Treg) function, blood biomarkers, and preliminary efficacy of COYA 301 in eight patients with mild-to-moderate AD. The academic study was conducted by Dr. Appel and Dr. Faridar at the Houston Methodist Hospital.

- COYA 301 is Coya’s investigational low-dose interleukin-2 (IL-2) for subcutaneous administration. COYA 301 has been designed to enhance Treg anti-inflammatory function in vivo.

- Treg dysfunction has been identified as a key driver of neuroinflammation, which is observed in AD and other neurodegenerative diseases, and may contribute to disease progression.

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, today announced the presentation of results from an academic clinical study in patients with Alzheimer’s Disease (AD) with Coya’s COYA 301, its proprietary investigational proprietary biologic. The presentation will be made at the 2023 Keystone Symposia Neurodegeneration: New Biology Guiding the Next Generation of Therapeutic Development, to be held at Whistler, British Columbia, Canada from May 15-19^th, 2023.

The proof-of-concept open-label clinical study is the first-of-its-kind evaluating low-dose IL-2 immunotherapy for the treatment of AD. Patients in the study received investigational treatment with COYA 301 for four consecutive months and were evaluated for safety and tolerability, Treg function, serum biomarkers of inflammation, and clinical functioning as measured by the Mini-Mental State Examination (MMSE) and the Clinical Dementia Rating (CDR). COYA 301 is intended to enhance anti-inflammatory regulatory T cell function in vivo and has been designed to be administered subcutaneously to minimize treatment burden for patients and caregivers.

The study was conducted at the Houston Methodist Research Institute (Houston, Texas) and led by Stanley Appel, M.D. and Alireza Faridar, M.D. Dr. Appel is chair of Coya’s Scientific Advisory Board and is former chair of the Stanley H. Appel Department of Neurology. He is the director of the Ann Kimball & John W. Johnson Center for Cellular Therapeutics, Professor of Neurology at Weill Cornell Medical College, and the Peggy and Gary Edwards Distinguished Chair for the Treatment and Research of ALS at the Houston Methodist Research Institute.

Alzheimer’s disease is a progressive neurological condition usually seen in people over the age of 65 in which the death of brain cells causes memory loss and cognitive decline. It is the most common type of dementia, accounting for around 60–80% of cases of dementia in the United States. Alzheimer’s disease affects around 5 million people in the US with estimates suggesting that this number will nearly triple by 2060.

Presentation details are:

• Title: A Regulatory T Cell Expansion Strategy to Target Inflammation in AD: Phase I feasibility trial
• Date: To Be Announced
• Conference: 2023 Keystone Symposia - Neurodegeneration: New Biology Guiding the Next Generation of Therapeutic Development (https://www.keystonesymposia.org/conferences/conference-listing/meeting?eventid=6922)

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

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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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.

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Investor Contact

David Snyder

david@coyatherapeutics.com

Hayden IR

James Carbonara

(646)-755-7412

James@haydenir.com

Media Contact

Jessica Starman

media@coyatherapeutics.com

Source: Coya Therapeutics, Inc.

FAQ

What are the key findings of the COYA 301 study?

The study indicated potential enhancement of Treg function and assessed safety and tolerability in patients with Alzheimer's Disease.

When and where will the COYA 301 study results be presented?

Results will be presented at the 2023 Keystone Symposia from May 15-19 in Whistler, British Columbia.

What is COYA 301 and its purpose?

COYA 301 is an investigational low-dose IL-2 therapy designed to enhance regulatory T cell function to combat inflammation in Alzheimer's Disease.

Who conducted the COYA 301 study?

The study was led by Dr. Stanley Appel and Dr. Alireza Faridar at Houston Methodist Hospital.

What is the significance of Treg dysfunction in Alzheimer's Disease?

Treg dysfunction is linked to neuroinflammation, which is a key factor in the progression of Alzheimer's Disease.