Defined engagement models. Operational readiness.

RECARTA is approved under EU Hospital Exemption in Lithuania, with product-specific ATMP manufacturing permit No. 25. The full site GMP licence is an application in progress, not granted. KELI's active partnership focus is pharma co-development and Lithuanian clinical delivery. Gulf and Asia-Pacific market entry is planned, not an existing commercial operation.

Partnership tracks. Defined opportunities for discussion.

Pharma co-development

KELI-101 · CTA preparationRECARTA · Hospital Exemption

KELI's clinical-development MSC asset and earlier cell therapy programmes are available for co-development discussions with pharmaceutical and biotech partners. KELI-101 is manufactured in-house at LUHS. Manufacturing status →

Asset licensing

Potential out-licensing of KELI-101, RECARTA-A and KELI-102 under defined territorial or indication-specific terms, with manufacturing and regulatory responsibilities agreed for each asset.

Co-development

Joint development agreements where KELI contributes platform technology, manufacturing, and regulatory expertise while the partner contributes clinical development funding, commercial infrastructure, or indication-specific knowledge.

Technology access

Access to KELI's cell-selection, expansion and process-development expertise under a structured licence, with CMC documentation and process transfer scoped to the specific product.

Placenta-derived exosomes

Placenta-derived exosomes are preclinical. KELI welcomes early discussions on therapeutic and cosmeceutical co-development.

Market entry pathways. Current EU activity and planned regions.

RECARTA's authorisation applies in Lithuania. Expansion into the Gulf and Asia-Pacific requires separate partner, regulatory, and market-access work and is described here as planned.

Market entry planned

Gulf region

Market entry plannedRegulatory assessmentClinical delivery feasibility

Gulf market entry is planned. KELI is evaluating local regulatory requirements, clinical delivery models, and potential distribution structures. No Gulf manufacturing, product authorisation, commercial operation, or institutional partnership is represented as active.

Market entry planned

Asia-Pacific

Market entry plannedPartner assessmentRegulatory pathway

Asia-Pacific market entry is planned. KELI is assessing potential clinical and commercial partners and the relevant product-specific regulatory routes. No regional subsidiary or institutional agreement is presented as operational.

EU pathway

European clinical and hospital network

RECARTA · LithuaniaKELI-101 · in-house at LUHSFour-country trial planned

KELI-101: CTA in preparation, not submitted, not enrolling. First patient planned Q2 2027, subject to CTA approval. KELI-101 is manufactured in-house at LUHS. Manufacturing status → Four-country site activation remains subject to local requirements.

Structured pathway from inquiry to deployment.

Every KELI partnership follows a defined engagement process with clear milestones, governance structure, and decision criteria. This provides a shared basis for evaluating collaboration.

Feasibility assessment

Initial scientific and commercial evaluation. Mutual NDA. Technical due diligence on platform fit, manufacturing requirements, and regulatory pathway alignment.

Term sheet and agreement

Structured agreement defining scope, responsibilities, timelines, milestones, IP allocation, and commercial terms. Quality agreement for manufacturing partnerships.

Development execution

Joint development activities per agreed plan. Regular governance meetings. Milestone-based progress with defined go/no-go criteria.

Commercial deployment

Product launch, market access, or supply scale-up per commercial terms. Ongoing supply agreements and quality oversight.