Coya Therapeutics Presents Updated ALS Biomarker Data at the 2nd Annual Johnson Center Symposium

Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, announces that Dr. Stanley Appel, M.D., Chairman of Coya’s Scientific Advisory Board, and Dr. David Beers, Ph.D., Associate Research Professor of Neurology, Houston Methodist Hospital (HMH), will present biomarker data today as part of a presentation at the 2^nd Annual Johnson Center Symposium in Houston, TX.

The data presented highlights the strong predictive value of oxidative stress biomarker (4-HNE) levels with the rate of disease progression and survival in ALS patients from a longitudinal patient registry cohort.

Summary of Study Results

• A retrospective cohort study was conducted at HMH using longitudinal sera samples collected between January 2018 and December 2022 in 50 adult patients with confirmed sporadic ALS
• Randomly selected sera samples were assayed for 4-HNE levels by standard ELISAs and correlated with clinical outcomes and compared with 4-HNE levels from sera samples of 53 age-matched healthy controls
• Serum 4-HNE levels predictive of survival in ALS patients: 4-HNE levels significantly correlated with survival from onset of disease to death and from diagnosis to death
• Serum 4-HNE levels are elevated at diagnosis in bulbar vs. limb onset ALS: 4-HNE levels are increased in bulbar vs. limb onset ALS patients at diagnosis and parallel the shorter survival of bulbar ALS onset patients from diagnosis to death.
• ROC analysis demonstrates 100% sensitivity for 21 month survival threshold: 100% of patients that had serum levels > 8ug/ml were deceased within the subsequent 21 months, while 2/3 of patients that had serum levels < 8ug/ml were alive 21 months later.

Dr. Stanley Appel, M.D., Chairman of Coya’s SAB, commented: “The demonstration that serum levels of 4-HNE are highly correlated with ALS progression and survival highlights the potential value of this lipid peroxide as a biomarker of disease pathophysiology and as an independent monitor of clinical status.”

4-HNE Relevance in Disease Pathophysiology

Reactive oxygen species (ROS) are generated mainly as byproducts of mitochondrial respiration and are tightly controlled by multiple anti-oxidant mechanisms. In neurodegenerative diseases, such as ALS, when the antioxidant system is overwhelmed by overproduction of ROS, oxidative stress occurs. 4-HNE, an abundant and reactive oxygen species, is thought to exert neuronal toxicity ultimately through formation of toxic protein aggregates, as seen in ALS patients. Additionally, 4-HNE appears to be causally involved in multiple pathophysiologic events associated with disease pathophysiology, including motor neuron death.