Scientific rigor
Every development decision is grounded in validated preclinical data, reproducible manufacturing processes, and regulatory-aligned clinical design. We do not advance programs without mechanistic rationale and supporting evidence.
Built to deliver regenerative medicine at scale.
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-101: CTA in preparation, not submitted, not enrolling. First patient planned Q2 2027, subject to CTA approval.
Platform company. Not a single-asset bet.
KELI's six public programmes span chondrocyte, placental MSC, extracellular-vesicle and CRISPR-engineered MSC development.
KELI-101 is manufactured in-house at LUHS. Manufacturing and licence status.
- Lithuania
- Founded
- RECARTA in patients (Hospital Exemption)
- KELI-101 CTA in preparation
- 6
- Public programmes
- Gulf/APAC planned
- Expansion
How we operate. What drives decisions.
Operational discipline
GMP manufacturing, quality systems, and clinical operations are executed with pharmaceutical-grade discipline. Documentation, traceability, and process control are non-negotiable.
Capital efficiency
We prioritise product-specific authorisations and shared manufacturing infrastructure at LUHS. Each programme retains its own quality and regulatory requirements.
Regulatory alignment
Our development strategy is designed in collaboration with former regulatory agency members. We build for approval, not just publication.
Experienced operators. Domain-specific depth.
Our leadership team combines deep expertise in cell therapy development, GMP manufacturing, clinical operations, and regulatory affairs. Each member brings direct operational experience in bringing advanced therapies from concept through clinical validation.
Justinas Mačiulaitis, MD, PhD
Founder, CEO and Chief Scientific Officer
Orthopaedic surgeon (Gijos Klinikos) and chief researcher at LSMU's Advanced Cell Therapy Centre. 22 peer-reviewed publications on cartilage repair and mesenchymal stromal cells; inventor on KELI's patent filings. ORCID 0000-0002-1265-8657
Prof. Romaldas Mačiulaitis, MD, PhD
Chief Medical Officer
Nephrologist and professor of clinical pharmacology, LSMU. Member of EMA's Committee for Advanced Therapies (2009–2022) and CHMP (2004–2022); chair of Lithuania's Medicines Authorisation Board (2007–2017)
Neringa Kaminskienė, MPharm
Chief Quality Officer
Pharmacist; QA/QC lead for ATMP manufacturing and tissue banking; certifying person under RECARTA's Hospital Exemption permit; previously GMP licensing consultant (LS Consult) and hospital cytotoxic-preparation QC
Rūta Brilingaitė, MPharm
Qualified Person
Pharmacist; 20 years in EU GMP quality assurance, including 16 years as QA Director and Qualified Person at Santonika (sterile injectables), responsible for batch certification and hosting regulatory inspections
Dominyka Aleliūnienė, MSc
Head of Manufacturing
Biotechnologist (MSc biochemical analysis, VMU); leads ATMP production under aseptic GMP conditions at LUHS — chondrocyte manufacturing and placental MSC process development, optimisation and validation; previously GMP nucleotide production at Thermo Fisher Scientific Baltics
Ewa Zak, MPh
Head of Regulatory Affairs
25 years in clinical research; global regulatory and start-up manager (IQVIA); former Head of Clinical Operations at WPD Pharmaceuticals; led first-in-human oncology programmes, EU scientific-advice, orphan and paediatric submissions
Regulatory and scientific advisory leadership.
Our advisory board includes former EMA committee members who provide direct insight into regulatory evaluator expectations, clinical trial design, and submission strategy for advanced therapy medicinal products.
Janis Ancans, Dr.biol.
Former core member of EMA's Committee for Advanced Therapies (CAT) and its Cell Product Working Party; external expert to the Latvian State Agency of Medicines; Chief Scientist at Medrego (ATMP consultancy, Riga); contributor to ATMP classification, marketing-authorisation evaluation and guideline drafting
Dr Dirk Groenewegen, MSc, PhD
Biotech entrepreneur; founder and former CEO of Glycostem Therapeutics (allogeneic NK cell therapy); EIC Accelerator business coach; 30 years in cell and gene therapy venture building, IP and licensing
Dr Algirdas J. Lukosevicius
Doctorate in clinical pharmacology (University of Illinois Chicago); BSc Pharmacy (St. John's University). Managing Director and CEO of PHL Corporation, New York, advising life-sciences companies on fundraising and transactions. Former CEO of Overture Pharma (raised $75M acquisition funding) and of The Cadogan Group, Vienna, where he financed a $235M acquisition of a listed oncology company. Global Adviser, Pharma and Healthcare, GlobalEdgeMarkets
EU-headquartered. Market entry planned.
Manufacturing facility operated at LUHS, Kaunas
Vilnius, Lithuania
Corporate headquarters. Business development, regulatory affairs, and investor relations.
Kaunas, Lithuania
ATMP manufacturing for RECARTA under Permit No. 25 at LUHS; separate in-house GMP licence application in progress.
EU clinical network
KELI-101 trial planned across four EU countries. CTIS documents approximately 95% finalised; IMPD pending and CTA not submitted. First patient enrolment planned for Q2 2027, subject to CTA approval.
Gulf and Asia-Pacific
Market entry planned. No regional operations or commercial authorisations represented as active.
Learn more about Keli Therapeutics.
Contact our team for corporate presentations, partnership discussions, or investor materials.