Like a Kite Pharma, but developing regulatory T-cell (Treg) therapies for neurodegenerative diseases like ALS, rather than CAR-T for cancer.

Imagine an immunology pioneer like Genentech, but exclusively dedicated to developing medicines that modulate regulatory T cells for conditions like dementia and autoimmune disorders.

Think of a specialized biotech like Vertex Pharmaceuticals, but instead of targeting genetic diseases, COYA focuses on precisely tuning regulatory T cells for neurodegenerative and autoimmune conditions.

• COYA 101: An autologous regulatory T-cell product candidate for treating Amyotrophic Lateral Sclerosis.
• COYA 301: A Treg-enhancing biologic for treating Frontotemporal Dementia.
• COYA 302: A biologic combination designed to enhance Treg function and deplete T effector cells for neurodegenerative and autoimmune diseases.
• COYA 201: An allogeneic Treg exosome product candidate for neurodegenerative, autoimmune, and metabolic diseases.
• COYA 206: An antigen-directed Treg-derived exosome product candidate in discovery stage.

• Lonza Group AG (LONN.SW)
• Catalent, Inc. (CTLT)
• Emergent BioSolutions, Inc. (EBS)
• Parexel International Corporation

Arun Swaminathan, Ph.D. Chief Executive Officer

Dr. Arun Swaminathan became Coya Therapeutics' Chief Executive Officer on November 1, 2024, after joining the company as Chief Business Officer in April 2023 and being appointed to the Board in August 2024. He brings over 20 years of healthcare business executive experience with a strong focus on corporate and business development, strategy, and finance. Previously, Dr. Swaminathan co-founded and served as CEO of Lynkogen Inc., a pre-clinical stage biotech. He also held the role of Chief Business Officer for Actinium Pharmaceuticals, where he spearheaded a $452 million deal, and for Alteogen, where he led deals totaling over $6 billion. He began his career in clinical development and commercial roles at BristolMyers Squibb and Covance.

David S. Snyder, M.B.A. Chief Financial Officer and Chief Operating Officer

David S. Snyder joined Coya Therapeutics in March 2022 as Chief Financial Officer and Chief Operating Officer, bringing over 25 years of experience as CFO for public and high-growth companies. He has assisted four life science companies in preparing for public company operations. Prior to Coya, he served as CFO for DisperSol Technologies, LLC and its wholly-owned subsidiary Austhera BioSciences, Inc. His past CFO roles include Exicure, Inc. (2014-2020), Cellular Dynamics, Inc. (2008-2014), and Roche NimbleGen (2007-2008). Earlier in his career, Mr. Snyder was CFO for companies in the real estate, software, and manufacturing sectors, and worked with financial and real estate investor Sam Zell.

Howard Berman, Ph.D. Executive Chairman

Dr. Howard Berman co-founded Coya Therapeutics in 2020 and served as its Chief Executive Officer from inception until October 30, 2024, when he transitioned to his current role as Executive Chairman. He successfully guided Coya through its IPO in 2023. Dr. Berman is also the founder of Imaware, Inc., a company he successfully led through a strategic M&A acquisition in 2024. With over 25 years of leadership experience across both public and private life sciences companies, he previously held management and clinical development positions at leading global biopharmaceutical companies such as Novartis, Eli Lilly, AbbVie, and Morphosys, where he contributed to the development and launch of numerous drugs. He has raised over $100 million in venture, public, and non-dilutive funding.

Fred Grossman, Ph.D. President and Chief Medical Officer

Dr. Fred Grossman was appointed President and Chief Medical Officer of Coya Therapeutics in July 2023. He possesses extensive experience, having held executive positions at prominent pharmaceutical companies including Eli Lilly, Johnson & Johnson, Bristol Myers Squibb, Sunovion, Glenmark Pharmaceuticals, and Mesoblast Inc. At Glenmark Pharmaceuticals, he oversaw the development of the entire pipeline, encompassing generics, complex generics, and next-generation biologics. His experience also includes serving as Chief Medical Officer at Mesoblast, Inc., where he focused on developing allogeneic cellular therapies for inflammatory diseases.

1. Clinical Trial Failure and Drug Development Risk: As a clinical-stage company, Coya Therapeutics' success is heavily dependent on the successful outcome of its ongoing and planned clinical trials. Setbacks, delays, or outright failures in these trials due to lack of efficacy, safety concerns, or other issues could severely impact the company. Its product candidates, such as COYA 101, COYA 301, COYA 302, COYA 201, and COYA 206, are in various stages of development, from discovery to Phase 2a, meaning the path to commercialization is long and uncertain. The ability of these candidates to achieve applicable endpoints in clinical trials and demonstrate a favorable safety profile is critical for their advancement.
2. Regulatory Approval Risk: Even with successful clinical trial results, Coya Therapeutics must obtain regulatory approval from agencies such as the FDA to market its products. There is no guarantee that regulatory bodies will approve the company's product candidates, a fundamental hurdle for any clinical-stage biopharmaceutical company with no products approved for commercial sale. The timing and eventual outcome of these regulatory reviews are significant uncertainties.
3. Funding and Capital Risk: Developing novel therapeutics is a capital-intensive process. Coya Therapeutics has reported net losses and an accumulated deficit, indicating an ongoing need for substantial capital to fund its research and development activities and clinical trials. The company's ability to raise additional capital, potentially through equity offerings, is crucial for its continued operations and advancement of its pipeline, and failure to do so could jeopardize its business.

Addressable Markets for Coya Therapeutics' Main Products and Services

• COYA 101 (Amyotrophic Lateral Sclerosis - ALS): The global Amyotrophic Lateral Sclerosis (ALS) market was valued at approximately USD 0.79 billion in 2024 and is projected to reach USD 1.38 billion by 2035, growing at a Compound Annual Growth Rate (CAGR) of 5.2%. In North America, the ALS market is expected to hold the highest share, partly due to advanced healthcare infrastructure and increasing research and development activities. Another report indicates the global ALS market size was USD 835.8 million in 2025 and is projected to reach USD 1496.9 million by 2035. The market size for ALS in the United States was USD 800 million in 2024.
• COYA 301 (Frontotemporal Dementia - FTD): The market for Frontotemporal Dementia (FTD) across the 7 major markets (US, EU4 (Germany, Spain, Italy, and France), UK, and Japan) was valued at USD 142.8 million in 2024. This market is expected to reach USD 688.2 million by 2035, exhibiting a CAGR of 15.37% during the period 2025-2035. The United States accounted for the highest market size within the 7MM for FTD, with approximately USD 68 million in 2023. The global frontotemporal dementia market is also projected to increase from $3.25 billion in 2025 to $4.99 billion by 2030, at a CAGR of 9.0%.
• COYA 302 (Neurodegenerative and autoimmune diseases):
  • Neurodegenerative Diseases: The global neurodegenerative disease market size was estimated at USD 52.3 billion in 2024 and is projected to grow to USD 81.23 billion in 2029 with a CAGR of 9.2%. Another estimate places the global neurodegenerative disease market size at approximately USD 61.93 billion in 2024, projected to reach USD 121.30 billion by 2034. North America was the largest region in the neurodegenerative disease market in 2024.
  • Autoimmune Diseases: The global autoimmune disease therapeutics market is valued at USD 168.6 billion in 2025 and is forecast to reach USD 226.2 billion by 2035, reflecting a CAGR of 3.0%. The global Autoimmune Diseases Treatment market size was approximately $109.53 billion by the end of 2025. North America's Autoimmune Diseases Treatment market is dominant, with the United States holding a significant share.
• COYA 201 (Neurodegenerative, autoimmune, and metabolic diseases):
  • Neurodegenerative Diseases: (See COYA 302 above)
  • Autoimmune Diseases: (See COYA 302 above)
  • Metabolic Diseases: The global metabolic disorder therapeutics market was valued at USD 74.97 billion in 2024 and is projected to reach USD 157.65 billion by 2033, growing at a CAGR of 8.6%. North America holds the largest revenue share in the global metabolic disorder therapeutics market.
• COYA 206 (Antigen directed Treg-derived exosome product candidate): Null

1. Milestone Payments from COYA 302 for ALS

   A significant driver of near-term revenue growth for Coya Therapeutics is anticipated to come from milestone payments associated with its strategic partnership with Dr. Reddy's Laboratories. The FDA's acceptance of the Investigational New Drug (IND) application for COYA 302 in Amyotrophic Lateral Sclerosis (ALS) has already triggered a $4.2 million milestone payment. An additional $4.2 million milestone payment is expected upon the first patient dosing in the COYA 302 ALSTARS trial for ALS. Dr. Reddy's Laboratories holds commercialization rights for COYA 302 in the U.S., U.K., Canada, and the European Union, positioning future product sales as a long-term revenue source if approved.

2. Advancement of COYA 302 into and through Phase 2 Clinical Trials for ALS

   The progression of COYA 302 through its Phase 2 clinical trial for ALS, known as the ALSTARS trial, is a crucial revenue driver. The trial was launched in Q3 2025 and has expanded to include sites in Canada. Positive topline data from this Phase 2 study, anticipated in 2026, would significantly de-risk the asset and potentially lead to further strategic collaborations, increased investment, or more favorable terms in existing partnerships, ultimately paving the way for eventual commercialization and product revenue.

3. Progression of COYA 302 into Phase 2b Clinical Trials for Frontotemporal Dementia (FTD)

   The planned submission of an IND for a Phase 2b study of COYA 302 in patients with Frontotemporal Dementia (FTD) represents another potential revenue growth driver. The company has already secured a $5.0 million strategic investment from the Alzheimer's Drug Discovery Foundation (ADDF) to support the development of COYA 302 for FTD. Successful advancement of COYA 302 in FTD could unlock additional funding, milestone payments, or partnership opportunities, broadening Coya's therapeutic reach and future revenue streams.

Share Issuance

• Coya Therapeutics closed its initial public offering (IPO) in January 2023, issuing 3,050,000 shares of common stock and accompanying warrants for gross proceeds of approximately $15.25 million.
• In October 2024, the company issued 1,379,314 shares of common stock in a private placement to accredited investors.
• Coya Therapeutics announced an $11.1 million private placement in January 2026.

Inbound Investments

• Dr. Reddy's Laboratories Ltd. (via a subsidiary) acquired a 9.7% stake in Coya Therapeutics in March 2026.
• Coya has received milestone payments from Dr. Reddy's Laboratories Ltd. under a Development and License Agreement, specifically tied to FDA acceptance of an Investigational New Drug (IND) application for COYA 302.

Capital Expenditures

• Capital expenditures have been reported as not available ("N/A") in recent financial summaries.
• The company's primary focus for capital allocation is to advance its programs in preclinical studies into clinical trials, further discovery and candidate selection stage programs, and for general corporate purposes.