Coya Therapeutics, Inc. to Present Proof of Concept Clinical Data at Multiple Scientific Conferences Throughout 2023

• COYA 301 (biologic monotherapy) clinical and biomarkers data in patients with Alzheimer’s disease (AD) to be presented in 1H 2023 and 2H 2023
• COYA 302 (biologics combination therapy) clinical and biomarkers data in patients with Amyotrophic Lateral Sclerosis (ALS) to be presented in Q1 2023

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 plans for presenting proof-of-concept clinical data from two open-label academic studies conducted at Houston Methodist Hospital, under the leadership of Professor Stanley Appel, MD, the Chair of Coya’s Scientific Advisory Board.

“We believe that the proof-of-concept clinical data from COYA 301 as monotherapy, and COYA 302 (biologics combination therapy) from early academic studies in patients with AD and ALS are encouraging and support further development of our biologic investigational candidates. We will be presenting these study data at upcoming scientific conferences this year, starting in the first quarter of 2023,” stated Howard Berman, Ph.D., Chief Executive Officer of Coya. “We are committed to developing COYA 301 and COYA 302 across multiple therapeutic areas, including neurodegenerative and autoimmune diseases,” Dr. Berman added. The Company anticipates announcing more details about the presentations in the future.

COYA 301 (biologic monotherapy) clinical and biomarkers data in patients with Alzheimer’s disease (AD) to be presented in 1H 2023 and 2H 2023

The first academic study with COYA 301 provides proof-of concept data, including biological activity, serum biomarkers of inflammation, tolerability and preliminary clinical outcomes in patients with AD. Alzheimer’s disease is the most common form of dementia, affecting over 6 million people in the US. About 1 in 9 people (10.7%) age 65 and older has AD.¹

COYA 302 (biologics combination therapy) clinical and biomarkers data in patients with Amyotrophic Lateral Sclerosis (ALS) to be presented in Q1 2023

The second academic COYA 302 clinical trial evaluated the tolerability, biological activity and preliminary efficacy of COYA 302 in patients with ALS and included assessment of serum biomarkers of inflammation and oxidative stress. ALS, also known as Lou Gehrig’s disease, is a neurodegenerative life-threatening disease affecting nerve cells in the brain and spinal cord. People with ALS progressively lose the ability to speak, eat, move, and breathe. There are over 30,000 patients with ALS in the US, and about 5,000 new patients are diagnosed every year.²

References

1. Rajan KB, Weuve J, Barnes LL, McAninch EA, Wilson RS, Evans DA. Population estimate of people with clinical AD and mild cognitive impairment in the United States (2020-2060). Alzheimers Dement 2021;doi:10.1002/alz.12362.
2. National Amyotrophic Lateral Sclerosis (ALS) Registry. Centers for Disease Control and Prevention (www.cdc.gov).

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.

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/20230202005257/en/