Coya Therapeutics Receives Clinical Trial Application (CTA) Acceptance from Health Canada to Proceed with the COYA 302 ALSTARS Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Key Terms

clinical trial application regulatory

An application submitted to a regulatory authority requesting formal permission to begin testing a new drug, medical device, or treatment in humans. Like asking for a building permit before construction, it summarizes safety data, plans for how the study will be run, and monitoring procedures; investors watch these filings closely because approval lets a program move from lab research to clinical testing, reducing uncertainty and creating value-driving milestones.

cta regulatory

A CTA (Commodity Trading Advisor) is a professional or firm that manages and advises clients on trading futures, options and other derivatives, similar to a coach who designs and runs strategies using these instruments. It matters to investors because CTAs make decisions that can affect portfolio risk and returns, and they operate under regulatory oversight, so knowing a CTA’s strategy, performance and compliance helps assess potential reward and risk.

amyotrophic lateral sclerosis medical

A progressive disease in which nerve cells that control voluntary muscles gradually fail, leading to loss of movement, speech and eventually breathing — like an electrical wiring system in the body slowly shorting out. It matters to investors because there are few effective treatments, so clinical trial results, regulatory approvals, new therapies or diagnostics can rapidly change patient care, market opportunity and company valuations.

als medical

Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that damages the nerve cells controlling muscles, gradually causing weakness, loss of movement and difficulty breathing — similar to the body’s wiring slowly failing. For investors, ALS matters because research progress, clinical trial results, regulatory approvals or setbacks can dramatically affect the value of companies developing treatments, patient-care markets and related healthcare services.

placebo-controlled medical

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

regulatory t cell medical

Regulatory T cells are a type of immune cell that act like peacekeepers, calming other immune cells to prevent excessive or misdirected attacks on the body. For investors, they matter because therapies that boost or block these cells can treat autoimmune diseases, transplant rejection, or cancer, making them a focal point for drug development and a potential driver of company value if therapies prove safe and effective.

treg medical

Treg, short for regulatory T cell, is a type of immune cell that acts like a brake on the immune system, calming or suppressing immune responses to prevent excessive inflammation or attack on the body's own tissues. For investors, therapies that boost or block Tregs can change the commercial outlook for drugs treating autoimmune diseases, organ transplant rejection or cancer, because shifting this balance can determine a treatment’s effectiveness and safety.

biologics medical

Biologics are medicines made from living cells or their components rather than from simple chemical recipes, more like a handcrafted product than a mass-produced pill. They matter to investors because they often command higher prices and longer patent protection but also carry greater manufacturing, regulatory and supply risks—so a successful biologic can boost a company’s revenue significantly, while setbacks can quickly affect its stock.

The CTA No Objection Letter from Health Canada allows for initiation of patient enrollment in the ALSTARS Trial at Canadian ALS centers.

The ALSTARS Trial is a phase 2, placebo-controlled study that includes clinical sites in the United States and Canada to evaluate the efficacy and safety of COYA 302 for the treatment of ALS

The ALSTARS Trial is underway in the United States and will now proceed in Canada

HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announces that Health Canada has accepted, without objection, the Clinical Trial Application (CTA) for COYA 302 for the treatment of amyotrophic lateral sclerosis (ALS). The CTA acceptance by Health Canada allows for activation of clinical sites in Canada, enhancing patient recruitment alongside the U.S. clinical sites.

Dr. Fred Grossman, Coya’s Chief Medical Officer, commented: “The activation of Canadian sites is an important step forward for the ALSTARS Trial that we believe will further enhance recruitment of this important study currently underway in the United States. We look forward to working with the Canadian ALS centers, with the goal of potentially delivering new, safe and effective treatments for ALS.”

About COYA 302

COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the 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 for the treatment of patients with ALS, and other neurodegenerative diseases. These mechanisms may have additive or synergistic effects.

Coya is currently conducting the ALSTARS Trial, 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).

COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency.

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. This cellular dysfunction may lead to 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.

For more information about Coya, please visit www.coyatherapeutics.com.

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Investor Contact

David Snyder, CFO

david@coyatherapeutics.com

astr partners

Matthew Beck

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917-415-1750

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Source: Coya Therapeutics, Inc.