#United States #Houston #ALS Research #biotechnology #Coya Therapeutics

Coya Therapeutics Reports Second Quarter Financial Results and Corporate Updates

Coya Therapeutics, a clinical-stage biotechnology firm based in Houston, Texas, recently published its financial results for the second quarter of 2025, alongside key corporate updates regarding its research initiatives. The company is concentrating on developing biological therapies that enhance regulatory T cell (Treg) functionality, particularly focusing on treating neurodegenerative disorders.

Recent Highlights

As of June 30, 2025, Coya has made significant strides on several fronts:
1. FDA Submission: The company submitted nonclinical data to the FDA to initiate a Phase 2 trial for the COYA 302 treatment in patients with Amyotrophic Lateral Sclerosis (ALS).
2. Scientific Findings: Coya published findings in Frontiers of Immunology, relating inflammation and oxidative stress to the progression of Parkinson’s Disease (PD). The study highlighted the correlation of peripheral pro-inflammatory responses, detailing their impact on PD severity.
3. Patent Achievement: A U.S. patent was granted for a stable ready-to-use liquid IL-2 formulation, which protects Coya's exclusive rights for several indications.

Upcoming Catalysts for 2025

Coya Therapeutics is poised for pivotal developments:

• - By August 29, the FDA is expected to make a decision regarding the Investigational New Drug (IND) application for COYA 302 in ALS.
• - Following the acceptance of the IND and the initiation of the COYA 302 trial, Coya anticipates receiving $8.4 million from its partner, Dr. Reddy's Laboratories (DRL).
• - The company is set to release longitudinal ALS biomarker data correlating Neurofilament Light Chain levels and oxidative stress markers with patient survival and progression.
• - Plans are in place for the release of new proteomic data from a previously completed study of low-dose Interleukin-2 in Alzheimer’s disease (AD) patients.
• - Coya will soon share top-line clinical data for ongoing trials as well as initiate new IND submissions for Frontotemporal Dementia (FTD).

Leadership Insights

Coya's CEO, Dr. Arun Swaminathan, expressed optimism regarding the upcoming FDA decision, emphasizing the growing data supporting their approach to enhancing Treg functionality in neurodegenerative diseases. CMO Dr. Fred Grossman highlighted the importance of the IND submission and the potential initiation of the Phase 2 clinical trial for ALS.

Financial Overview

As of the end of June 2025, Coya had approximately $29.8 million in cash and cash equivalents. The collaboration revenue reported for the recent quarter was significantly lower at $0.2 million compared to $3.4 million in the same period last year—primarily due to immediate revenue recognition upon executing an amended agreement. The company recorded a net loss of $6.1 million for Q2 2025, compared to a loss of $2.9 million during the same period in 2024.

Products in Development

COYA 302 is an innovative biologic therapy designed to enhance the anti-inflammatory properties of regulatory T cells while inhibiting inflammation caused by activated immune cells. This product is targeted for ALS treatment and is still in investigational stages, pending FDA approval.

COYA 303 combines components that show dual-action immunomodulation, enhancing Treg functionality while suppressing inflammatory responses from various immune cells.

Company Background

Founded in Houston, TX, Coya Therapeutics is dedicated to advancing proprietary therapies aimed at tackling systemic inflammation and neuroinflammation, particularly related to neurodegenerative, metabolic, and autoimmune conditions through restoring Treg functionality.

For updates and more information, visit Coya Therapeutics.

Forward-Looking Statements

Investors should be aware of risks associated with forward-looking statements in this report regarding business plans and potential financial performance due to ongoing developments and regulatory processes. Coya commits to keeping stakeholders informed as they navigate through this evolving landscape.