What Oncostellae does

Oncostellae is a clinical-stage biopharmaceutical company founded in 2013 and headquartered in Santiago de Compostela, Galicia, Spain. The company discovers and develops proprietary small-molecule drug candidates targeting high unmet medical needs in immunology and oncology, with active programs in inflammatory bowel disease (ulcerative colitis), women's health (uterine fibroids), colorectal cancer, and fibrosis. It was founded by Dr. Mabel Loza, a researcher from the University of Santiago de Compostela, and biotech entrepreneur Julio Castro, whose prior deal-making track record includes the Oryzon-Roche €525M licensing transaction (2014) and the Palobiofarma-Novartis acquisition (2015). The company operates with a lean team of 1-10 employees.

The pipeline consists of three proprietary drug candidates. The lead asset, OST-122, is an oral, gut-restricted JAK3/TYK2/ARK5 inhibitor designed to act exclusively in the gastrointestinal tract, achieving millimolar fecal concentrations while maintaining plasma levels below 1 ng/mL; it successfully completed Phase 2a proof-of-concept in 36 ulcerative colitis patients and was tolerated up to 1,200 mg in Phase 1. OST-499 is an oral, non-steroidal progesterone receptor and glucocorticoid receptor antagonist in Phase 1 for uterine fibroids and colon cancer (subsequently carved out into Oriva Therapeutics in January 2026). OST-664 is an oral ARK5 inhibitor in late discovery (~70% complete) for fibrosis. Patent applications are pending at the European Patent Office for ALK5 inhibitors and GR antagonists developed under the IO4COLON project. The central technical differentiator is the company’s GI-restricted drug delivery platform, which directly addresses FDA safety concerns regarding systemic JAK inhibitors (infections, thromboembolism, cardiac events).

Oncostellae’s business model is licensing-centric and asset-light: the company develops candidates from conception through Phase I/II and then outlicenses further development and commercialization rights to large or mid-size pharmaceutical partners in exchange for upfront payments, development milestones, and royalties. The company has no commercial products and generates no product revenue. Business development is conducted primarily through participation in international biotech partnering conferences (BIO-Europe, BIO Digital, Biospain, BIO Investor Day). Cumulative disclosed private funding totals approximately €5.65M across rounds in 2017, 2022, 2024, and 2025, supplemented by a €2.39M CDTI Seal of Excellence grant for OST-122 development in 2025-2026. The 2024 European Commission Seal of Excellence under Horizon Europe EIC Accelerator provides external validation of OST-122’s regulatory positioning.

Name

Oncostellae

Legal name

ONCOSTELLAE, S.L.

Website

https://oncostellae.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

Oncostellae is a clinical-stage Spanish biopharmaceutical company developing proprietary small-molecule drug candidates—most notably the gut-restricted JAK inhibitor OST-122—for inflammatory bowel disease, oncology, and fibrosis, and outlicensing clinical-stage assets to pharmaceutical partners.

Ownership category

akta.pro rank

Product category

Clinical-stage biopharmaceutical drug discovery

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Gastroenterology Specialty Pharmaceuticals (HLAIACAE)

akta.pro secondary industries

Immunology & Inflammation Pharmaceuticals (HLAIAAAD), Oncology & Hematology Pharmaceuticals (HLAIAAAC)

Keywords

• Clinical-stage biopharmaceutical
• Small-molecule drug discovery
• Kinase inhibitor development
• Inflammatory bowel disease therapeutics
• Drug outlicensing services

Headquarters

HQ city

Orense

HQ country

Spain

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Others

Revenue model

1. Licensing and Outlicensing: Oncostellae's business model is based on discovering new drug candidates, developing them through Phase I/II clinical trials, and then outlicensing further development and commercialization rights to established pharmaceutical companies. The company receives upfront payments, milestone payments tied to development progress, and royalty payments on future sales.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Oncostellae is a clinical-stage biopharmaceutical company that discovers and develops proprietary small-molecule drug candidates (kinase inhibitors and receptor antagonists) for inflammatory bowel disease, uterine fibroids, colon cancer and fibrosis. It advances candidates through Phase I/II clinical trials and then outlicenses further development and commercialization rights to large pharmaceutical companies in exchange for upfront, milestone and royalty payments.

Product overview

Oncostellae is a clinical-stage biopharmaceutical company pioneering the discovery and development of proprietary small-molecule drug candidates addressing high unmet medical needs in immunology and oncology. The company's product portfolio consists of three distinct drug candidates: OST-122 (lead product) is a gut-restricted JAK3/TYK2-ARK5 inhibitor in Phase IIa for inflammatory bowel disease; OST-499 is a non-steroidal PR/GR antagonist in Phase I for uterine fibroids and colon cancer; and OST-664 is an ARK5 inhibitor in discovery phase for fibrosis. Oncostellae develops clinical candidates from conception through Phase I/II, with further development and commercialization rights licensed to pharmaceutical companies.

Differentiator

Problem solved

Functional benefit

Products and services

• OST-122 Oral, non-systemic (gut-restricted) JAK3/TYK2/ARK5 inhibitor for the local treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis. Designed to act exclusively in the gastrointestinal tract, avoiding severe systemic toxicities (infections, thromboembolism, cardiac events) associated with FDA-approved systemic JAK inhibitors. Successfully completed Phase 2a proof-of-concept.
• OST-499 Oral, non-steroidal progesterone receptor (PR) and glucocorticoid receptor (GR) antagonist in Phase 1 clinical trials for the treatment of uterine fibroids, other gynecological disorders and colon cancer.
• OST-664 Oral ARK5 inhibitor in discovery phase (70% complete) for the treatment of fibrosis.

Quantifiable outcome

• Phase 2a study demonstrated excellent safety profile with minimal systemic absorption in 36 patients with moderate to severe ulcerative colitis over 4-week treatment period
• +2 more outcomes

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Six partnerships are on record, tiered minor and core.

• Oriva TherapeuticsminorStrategic or Co-development Partner · 1 January 2026Spin-off company launched by Asabys that incorporated two advanced assets from Oncostellae (ORV-362 for endometriosis and ORV-499 for uterine fibroids) as part of a women's health-focused biotech company. Oncostellae's OST-499 program became part of Oriva's pipeline.
• University of Santiago de CompostelaminorStrategic or Co-development Partner · 1 January 2021Academic institution supporting the IO4COLON project consortium, providing research infrastructure and expertise for discovery of immunotherapeutic drugs for colon cancer treatment.
• LEITAT Technology CenterminorStrategic or Co-development Partner · 1 January 2021Technology center supporting the IO4COLON project with expertise in technological development and innovation for new therapeutic product discovery.
• GalChimiacoreStrategic or Co-development Partner · 1 January 2018Galician biotech company specializing in organic synthesis and medicinal chemistry. Long-standing collaboration partner in the Neogalfarma and IO4COLON consortia, contributing research programs in prostate and breast cancer alongside Oncostellae.
• AMSLabcoreStrategic or Co-development Partner · 1 January 2018Galician biotech company providing analytical technology platform capabilities. Core consortium partner in Neogalfarma and IO4COLON projects, developing analytical methods including HPLC-MS/MS for detection of kinase inhibitors and glucocorticoid receptor antagonists.
• NanogapminorStrategic or Co-development Partner · 1 January 2016Galician biotech company specialized in nanomaterials with potential antitumor effects. Joined the Neogalfarma consortium in 2016, bringing nanotechnology capabilities to expand the portfolio of cancer treatments under development.

Scale indicators4 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Immunic Therapeutics: Clinical-stage biotech developing small molecules for chronic inflammatory and autoimmune diseases, including IMU-856 (gut-restricted, targeting S1P receptor modulator) for inflammatory bowel disease. Directly comparable to Oncostellae as both pursue gut-restricted oral therapies for IBD with similar safety-focused differentiation strategies.
• Landos Biopharma: Clinical-stage biotech developing oral gut-restricted therapeutics for IBD, including omilancor (LANCL2 agonist) and LABP-104. Comparable to Oncostellae as both pursue oral, locally-acting small molecules designed to minimize systemic exposure for UC and Crohn's disease.
• Galapagos NV: European biotech that developed and out-licensed filgotinib (JAK1 inhibitor) to Gilead for IBD and other inflammatory indications. Galapagos shares Oncostellae's combination of European roots, JAK inhibitor focus in IBD, and outlicensing business model.

Regional players

• Oryzon Genomics: Spanish clinical-stage epigenetics company whose lead asset (vafidemstat) was previously licensed to Roche in a €525M deal (2014). Closely comparable Spanish biotech with a similar small-molecule clinical-stage profile, founded around the same time as Oncostellae, and connected to co-founder Julio Castro's track record.
• Palobiofarma: Spanish biotech developing adenosine receptor modulators and other small molecules for oncology and inflammatory diseases, which was acquired by Novartis in 2015. Comparable Spanish small-molecule biotech with a similar licensing/exit pathway and connection to Oncostellae co-founder Julio Castro's network.

Broad incumbents

• AbbVie: Global biopharmaceutical company marketing upadacitinib (Rinvoq), a systemic JAK1 inhibitor approved for ulcerative colitis. Represents the established systemic JAK approach that OST-122's gut-restricted profile is designed to differentiate against, and a likely outlicensing counterparty.
• Pfizer: Global pharma that developed and markets tofacitinib (Xeljanz), the first-in-class JAK inhibitor and the asset at the center of the FDA's systemic JAK safety scrutiny. Comparable as a potential licensing partner for OST-122 given its established IBD commercial infrastructure.
• Eli Lilly: Global pharma marketing baricitinib (Olumiant), a systemic JAK inhibitor co-developed with Incyte for inflammatory and autoimmune indications. Comparable as a large-pharma reference point for JAK inhibitor class dynamics and a potential partner for Oncostellae's gut-restricted asset.

Emerging players

• Theravance Biopharma: Specialty biopharma focused on developing and commercializing small-molecule therapeutics for inflammatory and respiratory diseases. Comparable mid-sized clinical/commercial-stage biopharma with a similar outlicensing/partnering orientation in inflammatory disease.
• Dr. Falk Pharma: European specialty pharmaceutical company focused on gastroenterology and hepatology, including developing locally-acting drugs for IBD. Comparable as a European specialist GI therapeutics company and a potential regional licensing partner for OST-122.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks1 record

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/oncostellae

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds5 records

Investors8 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Oncostellae