Coya Therapeutics Strengthens its Management Team with the Appointment of Dr. Michelle Frazier as Senior Vice President of Regulatory Affairs

• Dr. Frazier brings over 20 years of strong regulatory expertise since her tenure at the FDA followed by a successful career in the pharmaceutical industry.
• Dr. Frazier spent 7 years at the FDA, where she was a team lead reviewing over 60 new molecular entities, overseeing multiple biologic license applications, including the first anti-angiogenic monoclonal antibody approved for cancer therapy. In turn, she was recognized multiple times for her leadership and excellence.
• Subsequent to FDA, Dr. Frazier has demonstrated a proven track record for overseeing and guiding successful global regulatory strategies at prestigious bio pharmaceutical companies for numerous biologic drug products leading to FDA approval of multiple biologic license applications and supplements, including Udenyca^® (pegfilgrastim-cbqv biosimilar), and Blincyto^®, the first bispecific monoclonal antibody product. As part of her career, Dr. Frazier has also provided strategic advice to multiple biotechnology companies.
• Dr. Frazier received a B.S in Microbiology from Washington State University and a Ph.D. In Cell Biology from Loyola University.

Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, today announced the appointment of Dr. Michelle Frazier, Ph.D. to Coya’s management team as Senior Vice President of Regulatory Affairs. Dr. Frazier will leverage her regulatory and CMC expertise to guide and oversee all of Coya’s regulatory submissions including the upcoming IND submission for COYA 302 for the treatment of Amyotrophic Lateral Sclerosis (ALS).

“Dr. Frazier has proven time and again that she has the expertise and ability to take biologics across the finish line to FDA approval. She has overseen the entire regulatory and submission process for biologic drugs from start to finish at multiple organizations and I am confident she will do the same for Coya. Her deep understanding of FDA requirements and practices makes her a strong addition to our growing organization,” stated Howard H. Berman, Ph.D., CEO of Coya Therapeutics.

Dr. Frazier commented: “Coya is developing highly promising multimodal Treg therapies for the treatment of neurodegenerative diseases of high unmet need. I look forward to joining the distinguished team at Coya and share both the urgency and the commitment to make these products a reality for our patients and their families, if approved by the regulatory authorities.”

Udenyca^® is a registered trademark of Coherus BioSciences.

Blincyto^® is a registered trademark of Amgen.

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 lead therapeutic programs includes Treg-enhancing biologics (COYA 300 Series product candidates) COYA 301 and COYA 302, which are 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/20230614506156/en/