Coya Therapeutics
Coya Therapeutics is a clinical-stage biotechnology company developing multi-modality regulatory T cell (Treg) therapies — biologics, exosomes, and cell therapy — for neurodegenerative, autoimmune, and metabolic diseases, with lead asset COYA 302 in Phase 2 ALS trials.
- Company typePublic
- Founded2020
- HeadquartersHouston, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Coya Therapeutics does
Coya Therapeutics is a clinical-stage biotechnology company developing regulatory T cell (Treg)-based therapeutics for neurodegenerative, autoimmune, and metabolic diseases. Founded around 2020-2021 and headquartered in Houston, Texas, the company is publicly traded on NASDAQ under ticker COYA and was established to commercialize the Treg technology platform licensed from Dr. Stanley Appel at Houston Methodist Hospital. Its pipeline addresses diseases with no approved disease-modifying therapies, with primary focus on amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and Alzheimer's disease. The senior leadership team brings over 20 years of pharmaceutical experience, and the Scientific Advisory Board is anchored by Shimon Sakaguchi (discoverer of Tregs) and Dr. Stanley Appel (pioneer of Treg therapy in ALS).
Coya Therapeutics firmographics
Firmographics- Name
- Coya Therapeutics
- Legal name
- Coya Therapeutics, Inc.
- Website
- https://coyatherapeutics.com
- Company type
- Public
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Coya Therapeutics is a clinical-stage biotechnology company developing multi-modality regulatory T cell (Treg) therapies — biologics, exosomes, and cell therapy — for neurodegenerative, autoimmune, and metabolic diseases, with lead asset COYA 302 in Phase 2 ALS trials.
- Ownership category
- akta.pro rank
Coya Therapeutics industry classification
Industry- Product category
- Biopharmaceuticals
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Gene Therapy for Rare/Monogenic Diseases (HLAAACAE)
- akta.pro secondary industry
- CAR-T & TCR-T Therapies (HLAAABAC)
Keywords
Where Coya Therapeutics is headquartered
LocationHeadquarters
- HQ city
- Houston
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Coya Therapeutics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- Collaboration / Licensing Revenue: Pre-commercial clinical-stage biotech generating collaboration revenue from strategic partners (e.g., milestone-based payments from Dr. Reddy's Laboratories tied to ALSTARS patient dosing). FY2025 collaboration revenues of $7.9 million versus $3.6 million in FY2024. No approved products; future revenue expected from out-licensing, milestone payments, and eventual product commercialization.
Go-to-market motion3 records
Distribution channels3 records
Marketing channels9 records
Coya Therapeutics product offering
Product offeringCore offering
Coya Therapeutics is a clinical-stage biotechnology company developing a multi-modality regulatory T cell (Treg) therapeutic platform intended to restore Treg function and suppress chronic neuroinflammation. Its pipeline spans investigational Treg-enhancing biologics (lead asset COYA 302, a low-dose IL-2 + CTLA-4 Ig combination in Phase 2 for ALS), Treg-derived exosomes, and autologous Treg cell therapy, targeting neurodegenerative, autoimmune, and metabolic diseases with no approved disease-modifying therapies.
Product overview
Coya Therapeutics is a clinical-stage biotechnology company developing a multi-modality Treg (regulatory T cell) therapy platform addressing neurodegenerative, autoimmune, and metabolic diseases. The portfolio is organized into three therapeutic modalities: (1) Treg-modifying biologics, led by COYA 302 (a low-dose IL-2 + CTLA-4 Ig combination currently in the Phase 2 ALSTARS trial for ALS and an FDA IND-accepted Phase 2 trial for FTD, with FDA Fast Track Designation in ALS), COYA 301 (a proprietary low-dose IL-2 in a pre-filled syringe for subcutaneous injection), and COYA 303 (an LD IL-2/GLP-1 RA combination candidate for Alzheimer's); (2) allogeneic Treg-derived exosomes, including COYA 201 (Treg-derived exosomes) and COYA 206 (tethered exosome polymer hybrids for targeted drug/cargo delivery); and (3) autologous Treg cell therapy, anchored by COYA 101 (expanded autologous Tregs for ALS, with Coya actively seeking strategic options for the asset). The platform is supported by Coya's proprietary CTreg (Cryopreservation for Tregs) manufacturing technology and TAI (Tregs Against Inflammation) and iscEXO (immunosuppressive cell Exosome) platforms.
Differentiator
Problem solved
Functional benefit
Brands
- COYA 302: Investigational Treg-enhancing biologic combination therapy (low-dose IL-2 + CTLA-4 Ig) for ALS, FTD, and other neurodegenerative diseases; lead asset in Phase 2 ALSTARS trial.
- COYA 301
- COYA 201
- COYA 206
- COYA 101
- COYA 303
Products and services
- COYA 302 Investigational combination biologic therapy pairing low-dose IL-2 with CTLA-4 Ig that synergistically enhances Treg function and depletes effector T cells and macrophages to reduce inflammation. Coya's lead asset, in the Phase 2 ALSTARS trial for ALS (NCT07161999) and an FDA IND-accepted Phase 2 trial for FTD; granted FDA Fast Track Designation in ALS.
- COYA 301 Proprietary low-dose IL-2 Treg-enhancing biologic therapy supplied in a pre-filled syringe for subcutaneous injection; plays a key role in the development, expansion, activity, and survival of Tregs. Investigational product candidate not yet approved by the FDA.
- COYA 303 Investigational combination biologic candidate pairing low-dose IL-2 with a GLP-1 receptor agonist; demonstrated potent systemic and brain anti-inflammatory efficacy in vivo in an animal study, supporting potential development for Alzheimer's and other neurodegenerative diseases.
- COYA 201 First-in-class allogeneic exosomes derived from Tregs that suppress inflammation and provide anti-inflammatory and neuroprotective effects. Investigational product candidate not yet approved by the FDA.
- COYA 206 Proprietary exosome polymer hybrid platform licensed by Coya with exclusive worldwide rights for research, development, and manufacturing, enabling exosomes to target proteins of interest while delivering drugs and/or cargo. Investigational product candidate not yet approved by the FDA.
- COYA 101 Autologous Treg cell therapy for ALS in which patient-derived dysfunctional Tregs are removed via leukapheresis, expanded ex vivo, cryopreserved, and re-infused using Coya's patent-pending CTreg™ cryopreservation technology that enables serial infusions from a single manufacturing round. Investigational product candidate; Coya is actively seeking strategic options for this asset.
Quantifiable outcome
- Phase 1 ALS trial (COYA 101) showed halting of fast decline typically seen in ALS patients following expanded autologous Treg infusions
- +4 more outcomes
Companies that use Coya Therapeutics
Customer profileSegments5 records
Ideal customer profiles3 records
Coya Therapeutics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature8 records
Coya Therapeutics partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered flagship.
- Houston Methodist Neurological InstituteflagshipResearch collaboration and clinical translation partner. Dr. Stanley Appel and his team at Houston Methodist conducted the first-in-human Phase 1 trial of expanded autologous Tregs in ALS and continue to collaborate on Treg-based therapy development; published Treg dysfunction biomarker study in FTD in Brain Communications. Source of the licensed Treg technology underlying Coya's pipeline.
- Dr. Reddy's Laboratories (development milestone partner)flagship$4.2 million milestone payment from Dr. Reddy's triggered by dosing of first ALS patients in the ALSTARS Phase 2 trial of COYA 302 (December 2025); strategic collaboration on technology transfer and commercial readiness for low-dose IL-2 manufacturing.
Scale indicators20 records
Recent moves6 records
Expansion highlights6 records
Coya Therapeutics competitors and assessment
Company assessmentDirect peers
- BrainStorm Cell Therapeutics: Clinical-stage biotech developing autologous cell therapies for neurodegenerative diseases, most notably NurOwn for ALS; directly comparable as a small-cap cell/immunology therapy developer targeting the same ALS indication as Coya's COYA 302.
- Lineage Cell Therapeutics: Clinical-stage cell therapy company developing allogeneic and transplant-compatible cell therapies for neurological and ophthalmic conditions; comparable modality (cell-based therapeutics for neurodegeneration) and similar clinical-stage profile.
- Mesoblast: Cell therapy company developing mesenchymal stem cell-based treatments for inflammatory and immune-mediated diseases; Coya's incoming CMO Fred Grossman was previously CMO at Mesoblast, and the companies share a cell-based approach to inflammatory disease.
- Helius Medical Technologies: Clinical-stage neurology company developing novel therapies for neurodegenerative conditions including ALS-related symptoms; comparable as a small-cap clinical-stage neuroscience company.
- ProQR Therapeutics: Clinical-stage biotechnology company developing RNA-based therapeutics for rare and neurodegenerative genetic diseases; comparable as a small-cap clinical-stage biotech focused on neurological indications.
- Equillium: Clinical-stage immunology biotech developing therapies that modulate immune responses in inflammatory and autoimmune diseases; comparable Treg/immunology focus for autoimmune indications in Coya's pipeline.
Broad incumbents
- Biogen: Large biotech with an established ALS franchise (Tofersen/SOD1-ALS through partnership with Ionis) and broader neuroscience pipeline; comparable as a major incumbent in neurodegenerative disease therapeutics with overlapping ALS focus.
- Ionis Pharmaceuticals: Established RNA-targeted therapeutics company with a substantial neurology pipeline including partnered ALS programs; comparable as a broader player in neurodegenerative drug development.
- Alnylam Pharmaceuticals: Commercial-stage RNAi therapeutics company with programs in rare neurological and metabolic diseases; comparable as a broader biotech pursuing innovative modalities for serious diseases including neurodegeneration.
Others
- Dr. Reddy's Laboratories: Strategic manufacturing collaborator and equity investor in Coya ($10M private placement, $4.2M milestone); provides technology transfer and scale-up manufacturing for low-dose IL-2 in support of COYA 302 commercial readiness.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Coya Therapeutics social profiles
Digital presenceCoya Therapeutics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Coya Therapeutics leadership team
Management profileNumber of profiles
Profiles9 records
Coya Therapeutics funding detail
Funding detailFunding overview
Funding rounds7 records
Investors4 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Coya Therapeutics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Coya Therapeutics
What does Coya Therapeutics do?
Coya Therapeutics is a clinical-stage biotechnology company developing a multi-modality regulatory T cell (Treg) therapeutic platform intended to restore Treg function and suppress chronic neuroinflammation. Its pipeline spans investigational Treg-enhancing biologics (lead asset COYA 302, a low-dose IL-2 + CTLA-4 Ig combination in Phase 2 for ALS), Treg-derived exosomes, and autologous Treg cell therapy, targeting neurodegenerative, autoimmune, and metabolic diseases with no approved disease-modifying therapies.
Is Coya Therapeutics a public or private company?
Coya Therapeutics is a public company. It is classified as public and is currently operating.
When was Coya Therapeutics founded?
Coya Therapeutics was founded in 2020. It employs 1 to 10 people.
Where is Coya Therapeutics based?
Coya Therapeutics is headquartered in Houston, United States, in the North America region.
How does Coya Therapeutics make money?
One revenue line is on record: collaboration / Licensing Revenue.
Who are Coya Therapeutics's main competitors?
Direct peers on record are BrainStorm Cell Therapeutics, Lineage Cell Therapeutics, Mesoblast, Helius Medical Technologies, ProQR Therapeutics and Equillium. Broad incumbents are Biogen, Ionis Pharmaceuticals and Alnylam Pharmaceuticals. Dr. Reddy's Laboratories is listed as an others.
Does Coya Therapeutics have an API?
No public API is recorded for Coya Therapeutics.
What industry is Coya Therapeutics in?
Coya Therapeutics's product category is Biopharmaceuticals. Its primary akta.pro industry code is HLAAACAE, Gene Therapy for Rare/Monogenic Diseases, with a secondary code of HLAAABAC, CAR-T & TCR-T Therapies. Its NAICS code is 541714 and its SIC code is 2836.