Coya Therapeutics (NASDAQ: COYA) is a clinical-stage biotechnology company focused on developing therapies that enhance the function of regulatory T cells (Tregs) to treat inflammatory and neurodegenerative diseases. The company generates cash through partnership agreements rather than product sales, having received an up-front nonrefundable payment of $7.5 million in January 2024, a $4.2 million milestone payment upon FDA acceptance of an IND application for COYA 302 in August 2025, and a $4.2 million milestone payment upon dosing of the first patient in a Phase 2 ALS trial in December 2025, all under a development agreement with Dr. Reddy's Laboratories. No products are commercially approved as of the 10-K filed March 16, 2026. The lead asset, COYA 302, a combination biologic comprising COYA 301 (proprietary low-dose interleukin-2) and CTLA4-Ig, is in a Phase 2 randomized, double-blind, placebo-controlled trial for amyotrophic lateral sclerosis (the ALSTARS Trial). CEO is Arun Swaminathan, Ph.D., and Howard Berman serves as Executive Chairman.

Revenue model

Milestone-based and royalty-bearing licensing. Under the DRL Development Agreement with Dr. Reddy's Laboratories, Coya received $7.5 million upfront (January 2024), $4.2 million on FDA IND acceptance (August 2025), and $4.2 million on first patient dosing (December 2025). The agreement includes up to $40.0 million in additional development milestones and up to $677.3 million in sales milestones for defined territories, plus low-to-mid-teens royalties on net sales of COYA 302. A June 2024 amendment paid Coya a one-time $3.9 million in exchange for forgiving the first $6.0 million in royalties otherwise owed. No product revenue as of the filing date.

Products and services

COYA 302: lead investigational biologic combining COYA 301 (proprietary low-dose interleukin-2, LD IL-2) and CTLA4-Ig, designed to enhance Treg function and suppress monocyte/macrophage-driven inflammation. Currently in the ALSTARS Trial, a Phase 2 randomized, multi-center, double-blind, placebo-controlled study for ALS (NCT 07161999). Not FDA-approved as of March 16, 2026. Earlier autologous Treg cell therapy program completed Phase 1 and Phase 2a studies in ALS.

Customers and end markets

Primary commercial partner is Dr. Reddy's Laboratories (DRL), which holds development and commercialization rights for COYA 302 in defined territories under the DRL Development Agreement. End markets targeted are neurodegenerative and inflammatory diseases, with ALS as the initial clinical indication.

Value-chain role

Drug developer and licensor. Coya conducts preclinical and clinical research, holds proprietary IP on Treg-enhancing biologics, and out-licenses commercialization rights to pharmaceutical partners. It does not manufacture or sell finished drug products commercially.

Geographic exposure

U.S.-based clinical development, with rights to COYA 302 in certain territories (described as 'New Territories') licensed to Dr. Reddy's Laboratories under the DRL Development Agreement. Specific territory definitions are not detailed in the excerpts.

Source: SEC 10-K, filed 2026-03-16

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