GMP Production of Exosomes Slated for Later This Year
Research Report

Coya Therapeutics Inc. (COYA:NASDAQ) is on track to start larger-scale clinical batch production of regulatory T cell-derived exosomes in Q4/25, "a key milestone in the transition toward first-in-human trials," reported D. Boral Capital Analyst Jason Kolbert in a March 27 research note. Coya develops biologics designed to enhance regulatory T cell (Treg) function.

"The progress made to date underscores the company's commitment to expanding its Treg-based therapeutic portfolio and positions the exosome platform as a potential breakthrough in the treatment of neuroinflammatory disorders," Kolbert wrote.

164% Potential Upside

Boral maintained its 12-month target price on the U.S.-based biotech, of $18 per share, noted Kolbert. In comparison, the company is trading now at about $6.81 per share. Thus the target implies a potential return for investors of 164%.

Coya is a Buy.

Manufacturing Update

Kolbert gave an update on this specific preclinical program of Coya. In it, the biotech is investigating the use of T cell-derived exosomes to treat chronic inflammation in neurodegenerative and systemic diseases, by leveraging Treg biology to modulate immune dysfunction.

Earlier this year, the first engineering batches of the exosomes were made successfully. Now production and characterization optimization is underway. Later in 2025, the program is slated to enter Good Manufacturing Practice (GMP) production, "paving the way for an initial clinical study," Kolbert wrote. The Johnson Center for Cellular Therapeutics, Hop On A Cure and Energy Transfer all support the program.

Coya holds the exclusive rights for its clinical applications.

Preclinical Efficacy Shown

Coya's Treg-derived exosome program, in chronic inflammation in neurodegenerative and systemic diseases, consistently has shown preclinical efficacy, or robust immunoregulatory properties, highlighted Kolbert. Coya has shown that the investigational treatment simultaneously suppressed T cells and maintained resilience in inflammatory environments.

Also, wrote Kolbert, "preclinical data support the potential for Treg exosomes to complement existing biologics in the company's pipeline, COYA-302." COYA-302 is the company's investigational and proprietary biologic combination therapy of interleukin-2 and CTLA4-Ig.

Well-Positioned Financially

Coya management reiterated that its upcoming manufacturing of Tred-derived exosomes "does not impact the company's financial runway," the analyst reported, given the program is funded externally.

"With a strengthened financial foundation and a robust clinical pipeline, Coya remains well-positioned to advance its neuroinflammation-targeted therapies and drive shareholder value in the year ahead," added Kolbert.

Events to Watch For

Coya expects multiple catalysts in 2025, reported Kolbert, in addition to the start of GMP manufacturing of its Treg-derived exosomes later this year.

One expected event is the company's submission of nonclinical data supporting its planned COYA-302 Phase 2b trial in amyotrophic lateral sclerosis. Another is receipt of potential milestone payments from Dr. Reddy's when the study begins.

Further, data readouts are expected from two other of Coya's preclinical trials: the one in Alzheimer's disease and the one in frontotemporal dementia.

Coya's market cap is $109 million. Its 52-week range is $4.75−10.69 per share.