Coya Therapeutics Stock Price, News & Analysis

Coya Therapeutics, Inc. (NASDAQ: COYA) is a clinical-stage biotechnology company headquartered in Houston, Texas. The company is focused on developing proprietary treatments based on the biology and potential therapeutic advantages of regulatory T cells ("Tregs") to target systemic inflammation and neuroinflammation. According to Coya, dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, where cellular dysfunction may lead to sustained inflammation, oxidative stress, and loss of immune system homeostasis.

Coya operates in the biotechnology research and development space, concentrating on neurodegenerative disorders. Across multiple press releases, the company describes itself as a clinical-stage biotechnology company developing biologics that enhance Treg function in patients with neurodegenerative disorders. Its common stock trades on The Nasdaq Stock Market LLC under the symbol COYA, as disclosed in several Form 8-K filings.

Therapeutic Focus on Regulatory T Cells (Tregs)

Coya’s investigational product candidate pipeline is built around multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. The company states that its therapeutic platforms include:

• Treg-enhancing biologics
• Treg-derived exosomes
• Autologous Treg cell therapy

These platforms are intended to address systemic inflammation and neuroinflammation by enhancing Treg number and function and modulating inflammatory pathways. Coya’s disclosures emphasize that its programs target diseases with high unmet medical need, particularly in neurodegeneration.

Key Investigational Programs: COYA 302

A central program in Coya’s pipeline is COYA 302, repeatedly described in company communications as an investigational and proprietary biologic combination therapy. Coya states that COYA 302 has a dual immunomodulatory mechanism of action intended to:

• Enhance the anti-inflammatory function of regulatory T cells (Tregs)
• Suppress inflammation produced by activated monocytes and macrophages

COYA 302 comprises proprietary low-dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration. Coya reports that COYA 302 is being developed for the treatment of patients with amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, and in some communications also references frontotemporal dementia (FTD) as a target indication.

Coya is conducting the ALSTARS Trial, described as a Phase 2, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of COYA 302 for the treatment of ALS (ClinicalTrials.gov Identifier: NCT 07161999). Company news releases and SEC filings note that the trial is designed as a 24-week study with an additional 24-week blinded extension period in which all participants receive COYA 302, and that clinical sites are located in the United States and Canada.

COYA 302 in ALS and Frontotemporal Dementia

Coya has provided additional detail on COYA 302 in ALS-focused communications. The company states that COYA 302 is designed to enhance the number and function of Tregs while suppressing pro-inflammatory myeloid activity, which Coya identifies as key drivers of ALS progression. In its description of the ALSTARS Trial, Coya notes that eligible participants are randomized to receive one of two doses of COYA 302 or placebo during the double-blind phase, followed by an extension period in which all participants receive COYA 302.

For frontotemporal dementia (FTD), Coya has announced that the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application for COYA 302 for the treatment of FTD. In addition, Coya reported results from an investigator-initiated open-label study in patients with FTD using low-dose IL-2 and CTLA4-Ig, which are the components of COYA 302. In that study, Coya reports enhanced Treg numbers and suppressive function and cognitive stability over a 22-week treatment period, with no serious adverse events observed.

COYA 303 and Additional Pipeline Elements

Beyond COYA 302, Coya has disclosed development of COYA 303, described as an investigational proprietary biologic combination of low-dose IL-2 and a GLP-1 receptor agonist (GLP-1 RA) for subcutaneous administration. The company states that COYA 303 is being evaluated in an in vivo lipopolysaccharide (LPS) mouse model of systemic and neurologic inflammation. In its press releases, Coya reports that COYA 303 significantly reduced peripheral pro-inflammatory cell expansion, enhanced Treg function, attenuated central nervous system inflammation, and shifted macrophages to an anti-inflammatory phenotype in this model.

Coya characterizes COYA 303 as a potential next-generation dual immunomodulatory GLP-1–based therapy that unites Treg biology with the immune effects of GLP-1 receptor agonists. The company has indicated potential relevance of COYA 303 for neurodegenerative and autoimmune diseases and has referenced Alzheimer’s disease in this context.

Regulatory and Clinical Milestones

Coya’s SEC filings and news releases highlight several regulatory and clinical milestones related to COYA 302:

• Acceptance by the FDA of the IND for COYA 302 in ALS, which triggered a milestone payment from strategic partner Dr. Reddy’s Laboratories Ltd. under a Development and License Agreement.
• Subsequent dosing of the first patient in the ALSTARS Trial, which Coya reports triggered an additional milestone payment under the same agreement.
• Acceptance, without objection, of a Clinical Trial Application (CTA) by Health Canada for COYA 302 in ALS, allowing activation of Canadian clinical sites.
• FDA acceptance of an IND for COYA 302 in FTD, enabling planned clinical evaluation in that indication.

These events are documented in Coya’s Form 8-K filings and press releases, which also note that COYA 302 remains an investigational product not yet approved by the FDA or any other regulatory agency.

Financing and Public Company Status

Coya Therapeutics, Inc. is a publicly traded company with its common stock registered under Section 12(b) of the Securities Exchange Act of 1934 and listed on The Nasdaq Stock Market LLC under the symbol COYA. Multiple Form 8-K filings confirm this listing status.

The company has reported capital-raising activities, including an underwritten public offering of common stock. In an 8-K dated October 23, 2025, Coya describes entering into an Underwriting Agreement for an offering of 4,181,818 shares of common stock at a public offering price of $5.50 per share, with estimated gross proceeds of approximately $23.0 million before expenses. A related press release states that the offering was upsized and that net proceeds are intended for working capital and general corporate purposes, including funding clinical development.

Coya also reports receiving milestone payments under its Development and License Agreement with Dr. Reddy’s Laboratories Ltd. related to regulatory progress of COYA 302 in ALS. These payments are described in Form 8-K filings as tied to FDA acceptance of the IND and to dosing of the first patient in the Phase 2 study.

Corporate Governance and Shareholder Matters

As reflected in its SEC filings, Coya holds an annual meeting of stockholders at which directors are elected and auditors ratified. For example, in an 8-K dated June 26, 2025, the company reports the election of three Class III directors for three-year terms and the ratification of its independent registered public accounting firm. These disclosures illustrate Coya’s status as a U.S. public company subject to ongoing reporting and governance requirements.

Research and Scientific Communication

Coya’s news releases indicate active engagement in scientific research and communication. The company has reported:

• Publication of a study in Frontiers in Immunology linking inflammation and oxidative stress to the progression of Parkinson’s disease.
• Preclinical in vivo animal data for COYA 303 demonstrating central nervous system anti-inflammatory effects and systemic Treg-enhancing effects.
• Investigator-initiated clinical studies using low-dose IL-2 and CTLA4-Ig in Alzheimer’s disease and FTD.
• Participation in healthcare and clinical trials conferences, including events focused on Alzheimer’s disease and broader healthcare investment audiences.

These activities, as described in company communications, align with Coya’s stated focus on Treg biology, systemic inflammation, and neuroinflammation across multiple neurodegenerative indications.

Business Context and Risk Considerations

Across its press releases, Coya consistently characterizes COYA 302 and COYA 303 as investigational product candidates that are not yet approved by the FDA or other regulatory authorities. The company includes forward-looking statement disclaimers noting that development timelines, regulatory outcomes, clinical trial results, and market opportunities are subject to risks and uncertainties. Investors reviewing COYA stock and related information should consider that Coya is a clinical-stage biotechnology company whose programs are in development and subject to regulatory review and clinical validation.

FAQs about Coya Therapeutics, Inc. (COYA)

• What does Coya Therapeutics, Inc. do?
  Coya Therapeutics, Inc. is a clinical-stage biotechnology company that states it is developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (Tregs) to target systemic inflammation and neuroinflammation. Its programs address conditions such as neurodegenerative, metabolic, and autoimmune diseases where Treg dysfunction is implicated.
• Where is Coya Therapeutics headquartered?
  Coya reports in multiple press releases that it is headquartered in Houston, Texas. Its SEC filings list Houston, Texas as the location of its principal executive offices.
• On which exchange does COYA trade?
  According to Coya’s Form 8-K filings, the company’s common stock, par value $0.0001 per share, is listed on The Nasdaq Stock Market LLC under the trading symbol COYA.
• What is COYA 302?
  COYA 302 is described by Coya as an investigational and proprietary biologic combination therapy comprising proprietary low-dose interleukin-2 (LD IL-2) and CTLA-4 Ig. It is intended to enhance the anti-inflammatory function of regulatory T cells and suppress inflammation produced by activated monocytes and macrophages and is being developed for subcutaneous administration in ALS and other neurodegenerative diseases, including FTD.
• What is the ALSTARS Trial?
  The ALSTARS Trial is a Phase 2, randomized, multi-center, double-blind, placebo-controlled clinical study sponsored by Coya to evaluate the efficacy and safety of COYA 302 for the treatment of amyotrophic lateral sclerosis (ALS). Company disclosures state that the study includes sites in the United States and Canada and incorporates a 24-week blinded extension period in which all participants receive COYA 302.
• Is COYA 302 approved by the FDA?
  No. Coya explicitly states in its press releases that COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency. The company has received FDA acceptance of IND applications for COYA 302 in ALS and FTD, which allows clinical trials to proceed, but this is not the same as marketing approval.
• What is COYA 303?
  COYA 303 is described by Coya as an investigational proprietary biologic combination of low-dose IL-2 and a GLP-1 receptor agonist (GLP-1 RA) for subcutaneous administration. In an in vivo LPS mouse model, Coya reports that COYA 303 reduced peripheral pro-inflammatory cell expansion, enhanced Treg function, attenuated CNS inflammation, and shifted macrophages to an anti-inflammatory phenotype.
• Which diseases is Coya targeting with its Treg-focused therapies?
  In its communications, Coya links Treg dysfunction to neurodegenerative, metabolic, and autoimmune diseases. Specific neurodegenerative conditions mentioned in relation to its programs and studies include amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), Alzheimer’s disease, and Parkinson’s disease.
• Does Coya have any strategic partnerships?
  Yes. Coya’s Form 8-K filings describe a Development and License Agreement with Dr. Reddy’s Laboratories Ltd. and its affiliate. Under this agreement, Coya reports receiving milestone payments tied to FDA acceptance of the IND for COYA 302 in ALS and dosing of the first patient in the ALSTARS Trial.
• What type of company is Coya in terms of development stage?
  Coya repeatedly describes itself as a clinical-stage biotechnology company. This indicates that its product candidates are in clinical and preclinical development and that it does not describe any approved commercial products in the provided materials.