Fortress Biotech, Inc. · NASDAQ:FBIO
Fortress Biotech — Cellvation — Investor Presentation (May 2025)
30 slides from Fortress Biotech's investor presentation, May 2025
Slide 1: Cellvation Corporate Presentation, May 2025
A Majority-Owned Subsidiary of Fortress Biotech May 2025
Slide 2: Investment Highlights
Investment Highlights 1 Novel Bioreactor for Enhancing Potency of Cellular Therapies 7 2 Robust Global IP Portfolio In Vitro & In Vivo Proof of Targeting $13B Global Cell Concept Established in Therapy Market Multiple Cell Types 6 3 Clinical Development in Rare Enhanced Potency Based on Pediatric Di
Slide 3: Overview
Overview Novel Cellular Therapeutics for Inflammatory Conditions • Based on Research from University of Texas Health Science Center (Houston) CEVA-D (Mechano-Transduction Device) • Shear Stress Up-Regulates Anti-Inflammatory Gene Programs o Ability to use fewer, more potent cells for any cell therap
Slide 4: Global Stem Cell Market
Global Stem Cell Market Global Stem Cell Therapy Market Estimated at $11B in 2022, Expected to Reach $31.5B by 2030 Pharma with Increased Interest In Stem Cell Therapy Based on Number and Size of Biotech Deals Expanding Clinical Applications in Cardiac, Neurological and Autoimmune Disorders Increase
Slide 5: Development Pipeline
Development Pipeline CEVA-101 (Mechano-Transduced Cells) Pre-Clinical Phase 1 Phase 2 Phase 3 Market Potential Steroid-Refractory Pediatric Graft Versus $2.7B Global Host Disease Market in 2023 Crohn’s Disease $10B Global Market in 2023 Acute Respiratory Distress Syndrome $3B Global Market in 2023 C
Slide 6: CEVA-D: Enhanced Potency Reduces COGS
CEVA-D: Enhanced Potency Reduces COGS Enhanced potency based on established matrix o PGE2 production o IDO production o TNFα suppression o T cell proliferation suppression Increased potency translates into o Decreased COGS based on lower dosing requirements o Potential to expand into other indicatio
Slide 7: CEVA-101: Proprietary Cell Product, Refractory Pediatric Acute GvHD
CEVA-101: Proprietary Cell Product Initial Indication: Refractory Pediatric Acute GvHD Children with steroid-refractory acute graft versus host disease (SR-aGVHD) Treatment Options o Corticosteroids are first-line therapy for aGVHD o Only one approved treatment for disease refractory to steroids o N
Slide 8: CEVA-101: Refractory Pediatric Acute GvHD (cont.)
CEVA-101: Proprietary Cell Product Initial Indication: Refractory Pediatric Acute GvHD (cont.) Initial Clinical Design Inclusion Criteria o Male and female, ages of 2 months and 17 years o Confirmed aGVHD following BMT o Failed to respond to treatment with systemic corticosteroid therapy o Grades C
Slide 9: Proprietary Bioreactor and Novel Cells: Key Data & Technical Details
Proprietary Bioreactor and Novel Cells Key Data & Technical Details
Slide 10: CEVA-D & CEVA101: Key Publication
CEVA-D & CEVA101: Key Publication Wall Shear Stress (WSS) Stimulates Anti-Inflammatory Mediators • Promotes Signaling To Suppress TNF-α • Improves Therapeutic Efficacy of MSCs in Rat Model of TBI
Slide 11: CEVA-D: Rationale
CEVA-D: Rationale Create a biological enhancement during the manufacturing process Stem cells start out in embryologic aorta-gonad-mesonephros Subjected to shear stress that up-regulates specific gene programs Concept observed for HSCs in Daly Lab
Slide 12: Conditioned Cells More Effective at Lower Dose
CEVA-D: Conditioned Cells More Effective @ Lower Dose (published) A Suppression of TNF- α B Dosing for Equivalence of TNF- α Suppression % TNF-α Production % TNF-α Production
Slide 13: CEVA-D: Increases PGE2 Production
CEVA-D: Increases PGE2 Production 3x Increase in PGE2 Production • Cells treated for three hours in CEVA-D bioreactor • PGE2 : established marker for MSCs efficacy
Slide 14: CEVA-D: Increases PGE2 and IDO Production
CEVA-D: Increases PGE2 and IDO Production
Slide 15: Importance of PGE2 Expression
Importance of PGE2 Expression Genetically engineered MSCs expressing PGE2 better suppress microglial M1 polarization MAPCs suppress GVHD via PGE2 synthesis (Highfill et al, Blood 2009) PGE2 Production M1-type microglia 1200 9 ** 8 1000 7 p=0.05 Percent CD86+ microglia 800 6 * Sham PGE2 (pg/ml) hAF19
Slide 16: CEVA-101 vs. Static MSC
CEVA-101 vs. Static MSC Data derived using cGMP compliant WJ-derived MSCs
Slide 17: CEVA-D Cells: Potency
CEVA-D Cells: Potency *PTSG2 is COX2 RNA-Seq Demonstrates Enhanced Potency of CEVA101 Versus Static Cells **TNFAIP8 isTSG6 • Log-fold increases in key anti-inflammatory signals • Confirms published pre-clinical data with cGMP compliant cell line
Slide 18: CEVA-D Cells: Characterization
CEVA-D Cells: Characterization Consistent Expression of Key Cell Surface Markers After Mechano-Transduction o Repeated passages & differentiation often reduce anti-inflammatory potency Sample CD34 CD73 CD90 CD105 CD146 hBM-MSC 5204 (Research Grade 0.17 99.99 99.93 99.08 100 Control) [p3] RoosterBio
Slide 19: CEVA-D: Sterility & Quality Control
CEVA-D: Sterility & Quality Control Viability 14 Day Sterility Culture ▻ Release Criteria: >70.0% ▻ Release Criteria: Negative ▻ Lot Average: 90.80% ▻ Lot Average: Negative Endotoxin Testing Viable Cell Yield ▻ Release Criteria: <5.00 EU/mL ▻ Release Criteria: >80.0% ▻ Lot Average: <1.00EU
Slide 20: CEVA-D: Biology of Mechano-Transduced Cells
CEVA-D: Biology of Mechano-Transduced Cells Enhanced anti-inflammatory activity (Potency) o Broad set of gene programs up-regulated o Gain and loss of function of PGE2 confirms importance MSC Source Agnostic Reproduced under cGMP conditions, release Potency assays linked to outcomes in in vivo model
Slide 21: CEVA-D: Development Status and Intellectual Property
CEVA-D: Development Status and Intellectual Property 2D Device: functioning with defined manufacturing process 3D Device: in prototype development phase All devices and methods backed by robust IP protection o Methods & Apparatus for Conditioning Cell Populations o Issued / Allowed: Australia, China
Slide 22: CEVA-D: Scale Up
CEVA-D: Scale Up Production of Single Dose (CEVA101) Channel Dimensions: 7.50 x 8.00 x 0.04 cm o ~⅕ Clinical-scale o Seeding Density: 60k MSC / cm2 All parts designed for injection molding
Slide 23: CEVA-D: Manufacturing Work-Flow
CEVA-D: Manufacturing Work-Flow
Slide 24: CEVA-D: Production Model
CEVA-D: Production Model Quick Connects Run 8X per pump 50 million cells @ 25k/cm2 45 x 10 cm size
Slide 25: CEVA-D: Flow Loop
CEVA-D: Flow Loop 3.25” 1.5°-Female & 3.5”-Male Luer 7.5” (Pump Tubing) & 1.5’-Male Luer
Slide 26: CEVA-D: Conditioning Schedule
CEVA-D: Conditioning Schedule Conditioning Schedule o Fibronectin Coating: 12 hours ▪ 10 ug/mL o Seeding: 4 hours ▪ Can optimize for chosen cell line o Incubation: 15 hours o Flow Loop: 3 hours o TrypLE Harvest: 15 minutes
Slide 27: CEVA-D: Process for 2D Production
CEVA-D: Process for 2D Production Injection molding of casing Laser cutting of plates Laser welding Cleaning Sterilization (gamma, EtO) Packaging
Slide 28: CEVA-D: 3D Scale-Up
CEVA-D: 3D Scale-Up Rather than keeping cells still and moving fluid (2D), the opposite is done for 3D 3D cannot be accomplished with stirrer tank as beads and cells move with fluid Strategy based on use of magnetic beads with pulsatile current o Produces cell movement through the fluid o Generates
Slide 29: CEVA-D: 3D Process Rendering
CEVA-D: 3D Process Rendering Magnetic beads (depicted in green) are coated with cells Spiral current (see blue arrows) creates magnetic field Magnetic field accelerates movement of beads and produces shear stress
Slide 30: Investment Highlights
Investment Highlights 1 Novel Bioreactor for Enhancing Potency of Cellular Therapies 7 2 Robust Global IP Portfolio In Vitro & In Vivo Proof of Targeting $13B Global Cell Concept Established in Therapy Market Multiple Cell Types 6 3 Clinical Development in Rare Enhanced Potency Based on Pediatric Di