i.
Authorised product
RECARTA is KELI's authorised product. KELI-101 is in CTA preparation.
Authorised product, owned manufacturing, grant-funded base.
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.
Three structural advantages over conventional biotech.
ii.
Manufacturing moat
KELI-101 is manufactured in-house at LUHS. Manufacturing and licence status.
iii.
Portfolio architecture
Six programmes across cell therapy and extracellular vesicles share manufacturing infrastructure at LUHS and regulatory expertise.
Programme pipeline
- 1. Research
- 2. Preclinical
- 3. IND-enabling
- 4. Pre-IND
- 5. CTA preparation
- 6. Phase 1b/2
- 7. Authorised (HE)
RECARTA
Hospital Exemption
Research (preceding stage)
Preclinical (preceding stage)
IND-enabling (preceding stage)
Pre-IND (preceding stage)
CTA preparation (preceding stage)
Phase 1b/2 (preceding stage)
Authorised (HE) (current stage)
RECARTA-A
Pre-IND
Research (preceding stage)
Preclinical (preceding stage)
IND-enabling (preceding stage)
Pre-IND (current stage)
CTA preparation
Phase 1b/2
Authorised (HE)
KELI-101
CTA preparation
Research (preceding stage)
Preclinical (preceding stage)
IND-enabling (preceding stage)
Pre-IND (preceding stage)
CTA preparation (current stage)
Phase 1b/2
Authorised (HE)
KELI-102
IND-enabling
Research (preceding stage)
Preclinical (preceding stage)
IND-enabling (current stage)
Pre-IND
CTA preparation
Phase 1b/2
Authorised (HE)
GE-MSC
Research
Research (current stage)
Preclinical
IND-enabling
Pre-IND
CTA preparation
Phase 1b/2
Authorised (HE)
KELI-EXO
Preclinical
Research (preceding stage)
Preclinical (current stage)
IND-enabling
Pre-IND
CTA preparation
Phase 1b/2
Authorised (HE)
| Program | Programme detail | Research | Preclinical | IND-enabling | Pre-IND | CTA preparation | Phase 1b/2 | Hospital Exemption |
|---|---|---|---|---|---|---|---|---|
| RECARTAHospital Exemption | Cartilage repair (autologous) | ✓ | ||||||
| KELI-101CTA preparation | AKI post-cardiac surgery | ✓ | ||||||
| RECARTA-APre-IND | Cartilage repair (allogeneic) | ✓ | ||||||
| KELI-102IND-enabling | Systemic inflammatory and autoimmune diseases | ✓ | ||||||
| KELI-EXOPreclinical | Placenta-derived exosomes | ✓ | ||||||
| GE-MSCResearch | Genetically engineered MSCs (CRISPR)Fibrotic and inflammatory conditions | ✓ |
Grant-funded base. Current round.
- Grant funding
- €3.5M
- €3.5M in EU and national grant funding awarded to KELI, including a €2.5M EIC Accelerator grant (2025).
- Current round
- €4.0M
- €4.0M convertible loan (€3.9M primary, €0.1M founder secondary).
- Programmes sharing infrastructure
- 6
- Shared manufacturing infrastructure at LUHS.
- KELI-101
- CTA preparation
- Manufactured in-house at LUHS.
Near-term catalysts. Defined value inflection.
Regulatory preparation, in-house manufacturing and clinical execution define the next development milestones.
2025
EIC Accelerator grant
€2.5M EIC Accelerator grant.
complete
2025
RECARTA authorisation
RECARTA is KELI's authorised product.
complete
March 2026
RECARTA clinical delivery partnership
Autologous chondrocyte therapy with Gijos Klinikos, Kaunas.
active
2026
MesAKI submission preparation
EU CTR 2026-527099-98-00 assigned. CTIS dossier approximately 95% finalised; IMPD is the remaining document. KELI-101 is manufactured in-house at LUHS.
active
Q2 2027
First MesAKI patient — planned
KELI-101: CTA in preparation, not submitted, not enrolling. First patient planned Q2 2027, subject to CTA approval.
planned
Later stage
Clinical data readout
Timing will be set by enrolment, study conduct, and the approved protocol; no Phase 2 readout date is committed.
planned
Durable advantages. Structural moats.
Manufacturing foundation
KELI manufactures in-house at LUHS.
Intellectual property
Two international patent filings (2026): PCT/EP2026/051592 and USPTO 19/632,505. Exclusive global licence from LSMU.
RECARTA authorisation
RECARTA is KELI's authorised product.
Regulatory inside track
Ex-EMA CAT/CHMP advisory leadership provides direct insight into evaluator expectations and submission strategy.
Multiple exit pathways. Optionality preserved.
KELI may consider licensing, acquisition and a future listing as contingent options, subject to programme progress and market conditions.
Licensing
Licensing may be considered as a contingent option, subject to programme progress and partner interest.
Acquisition
An acquisition may be considered as a contingent option, subject to programme progress and market conditions.
Future listing
A future listing may be considered as a contingent option, subject to programme progress, governance readiness and market conditions.
Investor materials. Available on request.
Qualified institutional investors may request access to KELI's data room. Materials include the investor summary, clinical data package, and manufacturing capability deck.
Investor Summary
Six-programme pipeline and use of proceeds.
Available on request
Clinical Data Package
KELI-101 preclinical evidence, MesAKI trial materials, and RECARTA outcomes.
Available on request
Manufacturing Capability Deck
LUHS manufacturing infrastructure and capability.
Available on request
Request data-room access
Materials are shared with qualified investors after review. We reply within five working days.
info@keli.eu
European Innovation Council
Lithuanian Business Support Agency
Agency for Science, Innovation and Technology
EU Structural Funds
Begin the diligence conversation.
KELI's investor relations team is available for introductory calls, site visits, and structured due diligence processes. Contact us directly to initiate.