Coya Therapeutics, Inc.

Coya Therapeutics, Inc. is a clinical-stage biotechnology company developing therapies that enhance regulatory T cell (Treg) function to treat neurodegenerative, autoimmune, and metabolic diseases. Its pipeline centers on COYA 301, COYA 302, COYA 303, and exosome-based programs, with a current focus on advancing COYA 302 in ALS and FTD through clinical studies and partnering arrangements.

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— Coya Therapeutics, Inc.
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Clinical-stage Treg therapeutics100% Drug candidates designed to enhance regulatory T cell function in disease.
Lead program: COYA 3020% Combination biologic program being advanced in ALS and FTD clinical studies.
Platform programs: COYA 301 and COYA 3030% Backbone and follow-on programs intended for combination use and new indications.
Exosome research0% Preclinical work on Treg-derived exosomes as a potential therapeutic modality.

Coya does not yet sell approved products; its near-term counterparties are clinical investigators, research...

  • Clinical trial patientsprimary

    Patients with ALS and other neurodegenerative diseases enrolled to test safety and efficacy of COYA 302.

  • Pharmaceutical licensing partnerprimary

    Dr. Reddy's holds commercialization rights in defined territories and supports development/commercialization of COYA 302.

  • Research institutionssecondary

    Academic and hospital collaborators that support preclinical validation and sponsored research on exosomes and Tregs.

  • Future physicians and payorsemerging

    Specialists and reimbursement bodies that would determine adoption and access if products are approved.

Coya is headquartered in the United States and conducts its core development work there...

  • •United States is the main operating base and clinical-development center
  • •COYA 302 rights cover the U.S., Canada, EU, and U.K. via DRL
  • •Additional territories include Japan, Mexico, and South America
  • •No product sales yet, so geography is driven by R&D and licensing
  • •Future commercialization will depend on local approvals and payor access

Coya’s strategy is to build a Treg-focused pipeline across neurodegenerative and autoimmune diseases, with COYA 302 as...

01
Advance COYA 302 clinical development in ALSshort-term

This is the company’s principal near-term value driver and the most advanced program.

02
Expand COYA 302 into adjacent neurodegenerative diseasesmedium-term

Broader indications could increase the commercial opportunity for the same platform.

03
Develop COYA 301 and COYA 303 as combination/backbone assetsmedium-term

These programs are intended to create a modular pipeline and support future combinations.

04
Use partnerships and grants to conserve capitalshort-term

The company is pre-revenue and needs external funding to extend runway and de-risk development.

Coya is a clinical-stage company with no approved products, so its value depends on successful trial outcomes,...

critical

Clinical development failure

COYA 302 and other programs are investigational and may not show efficacy or safety in later studies.

Scope
ALSTARS Phase 2 and future neurodegenerative indications
Materiality
high
high

Financing and going-concern risk

The company has recurring losses and will need substantial additional capital to continue development.

Scope
Equity raises, debt, collaborations, and strategic transactions
Materiality
high
high

Dependence on licensed intellectual property

Key programs rely on third-party licenses; termination or unfavorable terms could impair the pipeline.

Scope
Treg technology, DRL_AB, and other in-licensed assets
Materiality
high
medium

Manufacturing and supply-chain dependence

Programs depend on specialized vendors and equipment for cell therapy and exosome work.

Scope
Terumo BCT, Repligen, Malvern, Izon, ThermoFisher, Applied Biosystems
Materiality
medium
medium

Reimbursement and market-access uncertainty

Even if approved, uptake will depend on coverage, pricing, and payor acceptance.

Scope
Physician-administered specialty therapies in the U.S. and abroad
Materiality
medium
Collaboration revenue recognition
Can cause lumpy quarterly revenue and margin volatility
Accrued research and development expenses
Affects operating expenses and current liabilities
Stock-based compensation valuation
Can materially affect G&A and R&D expense
Going-concern assessment
Important for evaluating runway and capital risk

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: 28/04/2026