COYANasdaqPharmaceutical PreparationsUS GAAP · USD

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.

Kysy yhtiöstä
Liikevaihto7,9milj. USD
+123,6 %v/v
Liikevoitto (EBIT)−22,6milj. USD
−30,8 %v/v
EBIT-marginaali−283,9%
+201,5 %-yks.v/v
Nettotulos−21,2milj. USD
−42,6 %v/v
Vapaa kassavirta−10,7milj. USD
−4,4 %v/v

Tilikausi 2025 · muutos edellisvuodesta

Kehitys 2021–2025

−30−20−10010milj. USD2021: EBIT −4,9 milj. USD20212022: 0,00 milj. USD2022: EBIT −9,8 milj. USD20222023: 6,0 milj. USD2023: EBIT −7,9 milj. USD20232024: 3,6 milj. USD2024: EBIT −17 milj. USD20242025: 7,9 milj. USD2025: EBIT −23 milj. USD20257,9−23
LiikevaihtoLiikevoitto (EBIT)

Liiketoiminta

Osuus liikevaihdosta
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.

Asiakkaat

Coya does not yet sell approved products; its near-term counterparties are clinical investigators, research collaborators, and licensing partners rather than end patients. If approved, its therapies would be used by physicians treating ALS, FTD, Alzheimer’s disease, Parkinson’s disease, autoimmune disease, and potentially metabolic disease patients. The company also relies on third-party payors and reimbursement systems for eventual commercialization.

Clinical trial patients

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

Pharmaceutical licensing partner

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

Research institutions

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

Future physicians and payors

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

Strategia

Coya’s strategy is to build a Treg-focused pipeline across neurodegenerative and autoimmune diseases, with COYA 302 as the lead clinical asset. It is also trying to extend the platform through COYA 301, COYA 303, and exosome programs while using partnerships and licensing to reduce development burden and broaden reach.

Advance COYA 302 clinical development in ALSLyhyt aikaväli

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

Expand COYA 302 into adjacent neurodegenerative diseasesKeskipitkä aikaväli

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

Develop COYA 301 and COYA 303 as combination/backbone assetsKeskipitkä aikaväli

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

Use partnerships and grants to conserve capitalLyhyt aikaväli

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

Maantiede

Coya is headquartered in the United States and conducts its core development work there. Its disclosed commercial rights for COYA 302 span the U.S., Canada, the European Union, the United Kingdom, and other ex-U.S. territories through licensing arrangements, while Japan, Mexico, and South America are also referenced in its territorial structure. Because the company is pre-commercial, geography mainly affects where trials, licensing rights, and future reimbursement pathways are concentrated.

Riskit

Coya is a clinical-stage company with no approved products, so its value depends on successful trial outcomes, regulatory approvals, and eventual reimbursement. It also faces financing risk because it has ongoing losses and will need additional capital, plus execution risk from reliance on third-party licensors, manufacturers, and collaborators.

Järjestetty vakavuuden mukaan
MatalaKohtalainenKorkeaMatalaKohtalainenKorkeaVaikutus →Todennäköisyys →Clinical development failure1Dependence on licensed intellectual property2Manufacturing and supply-chain dependence4Reimbursement and market-access uncertainty5
Vaikutus on riskin vakavuus ja todennäköisyys sen toteutumisen todennäköisyys lähivuosina, molemmat arvioitu yhtiön raporttien perusteella. Numerot vastaavat listaa.
  1. Clinical development failureVaikutus: KriittinenTodennäköisyys: Kohtalainen

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

    Kohdistuu: ALSTARS Phase 2 and future neurodegenerative indications

  2. Dependence on licensed intellectual propertyVaikutus: KorkeaTodennäköisyys: Kohtalainen

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

    KohdistuuTreg technologyDRL_ABOther in-licensed assets
  3. Financing and going-concern riskVaikutus: Korkea

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

    KohdistuuEquity raisesDebtCollaborationsStrategic transactions
  4. Manufacturing and supply-chain dependenceVaikutus: KeskitasoTodennäköisyys: Kohtalainen

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

    KohdistuuTerumo BCTRepligenMalvernIzonThermoFisherApplied Biosystems
  5. Reimbursement and market-access uncertaintyVaikutus: KeskitasoTodennäköisyys: Kohtalainen

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

    Kohdistuu: Physician-administered specialty therapies in the U.S. and abroad

Kirjanpito

Harkinnanvaraiset erät
Collaboration revenue recognition

Revenue is derived from the DRL Development Agreement and includes license and service components recognized over time or upon triggering events.

Vaikutus: Can cause lumpy quarterly revenue and margin volatility

Accrued research and development expenses

Management estimates unpaid clinical, preclinical, and vendor costs at period end.

Vaikutus: Affects operating expenses and current liabilities

Stock-based compensation valuation

Fair value depends on assumptions such as volatility and discount for lack of marketability.

Vaikutus: Can materially affect G&A and R&D expense

Going-concern assessment

Persistent losses and funding needs require management to assess liquidity and disclosure.

Vaikutus: Important for evaluating runway and capital risk

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Päivitetty: 24.9.2026