Fortress Biotech (FBIO) Corporate presentation summary

Market opportunity and positioning

• Targeting the $13B global cell therapy market with a robust IP portfolio and proprietary bioreactor technology.

• Global stem cell therapy market projected to grow from $11B in 2022 to $31.5B by 2030, driven by expanding clinical applications and increased R&D investment.

• Focus on rare pediatric diseases and inflammatory conditions, with initial indications including steroid-refractory pediatric graft versus host disease, Crohn's disease, ARDS, CHF, and chronic low back pain.

• Addressing significant unmet needs in pediatric acute GVHD, where mortality rates can reach 90% and current treatment options are limited.

Technology and product highlights

• Developed a novel bioreactor (CEVA-D) that enhances the potency of mesenchymal stem cells (MSCs) via mechano-transduction, upregulating anti-inflammatory gene programs.

• CEVA-101 is an off-the-shelf, mechano-transduced MSC product with demonstrated increased efficacy at lower doses.

• Enhanced potency is evidenced by increased PGE2 and IDO production, TNFα suppression, and T cell proliferation suppression.

• Potency assays and RNA-Seq confirm upregulation of key anti-inflammatory signals and consistent expression of cell surface markers after conditioning.

Manufacturing and cost advantages

• Bioreactor process enables use of 2-5X fewer cells than conventional clinical doses, reducing cost of goods sold (COGS) by up to 75%.

• COGS per dose could be reduced from $20,000 to $4,000, based on lower dosing requirements and efficient manufacturing.

• Scalable manufacturing workflow includes injection molding, laser cutting, and automated assembly, with both 2D and 3D bioreactor models in development.

• 3D scale-up uses magnetic beads and programmable shear profiles for large-volume production without moving parts.