Mesoblast

MESOPhase 3

Melbourne, AustraliaFounded 2004mesoblast.com

Mesoblast is a global leader in developing allogeneic (off-the-shelf) cellular medicines derived from its proprietary mesenchymal lineage cell technology platform. Its most advanced candidate, remestemcel-L, has a Biologics License Application (BLA) under priority review with the FDA for pediatric SR-aGVHD, with a PDUFA date of August 2, 2024. The company's strategic focus is on advancing its late-stage pipeline in inflammatory conditions with high unmet need while leveraging its scalable manufacturing platform.

Market Cap

$1.9B

Founded

2004

Employees

200-500

Focus

BiologicsBiosimilarsCell & Gene Therapy

MESO · Stock Price

USD 14.36+5.74 (+66.59%)

Historical price data

AI Company Overview

Technology Platform

Proprietary platform for manufacturing allogeneic, off-the-shelf mesenchymal lineage (stromal) cell therapies with immunomodulatory and anti-inflammatory properties, derived from adult bone marrow.

Pipeline Snapshot

41 drugs in pipeline, 12 in Phase 3

Drug	Indication	Stage
Remestemcel-L	Grade B Acute Graft Versus Host Disease	Phase 3
Prochymal®	Crohn's Disease	Phase 3
remestemcel-L	Grade B aGVHD	Phase 3
Rexlemestrocel-L + HA mixture + Saline	Degenerative Disc Disease	Phase 3
Infusion of one MPC expanded cord unit and one unexpanded cord unit + Infusion o...	Acute Myelogenous Leukemia	Phase 3

Funding History

Total raised: $138M

PIPE$138MSurgCenter DevelopmentSep 15, 2020

IPOUndisclosedUndisclosedDec 15, 2004

Opportunities

Near-term FDA approval for remestemcel-L in pediatric SR-aGVHD could provide first commercial revenue and validate the platform.

The large, underserved markets for chronic low back pain and advanced heart failure represent multi-billion dollar opportunities.

Successful outcomes could attract major pharmaceutical partnership deals.

Risk Factors

High regulatory risk with the pending FDA decision; potential for clinical trial failures in late-stage programs; challenges in commercializing a novel, high-cost cell therapy and securing reimbursement; ongoing need for capital leading to potential dilution.

Competitive Landscape

In SR-aGVHD, competing with off-label use of Incyte's ruxolitinib and other investigational agents, but aims to be first FDA-approved therapy. In chronic low back pain, competes with devices, surgery, and pain meds but offers a unique regenerative approach. Differentiation lies in its scalable, off-the-shelf allogeneic cell platform and late-stage pipeline.

Publications

Patents

Pipeline