Fortress Biotech, Inc. · NASDAQ:FBIO
Fortress Biotech — Investor Presentation (February 2017)
28 slides from Fortress Biotech's investor presentation, Feb 14, 2017
Slide 1: Corporate Presentation
Proprietary Materials Corporate Presentation Lindsay A. Rosenwald , MD President and CEO Chairman of the Board February 2017
Slide 2: Forward Looking Statements
Proprietary Materials Fortress Biotech 2 This presentation may contain “forward - looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to ou
Slide 3: Fortress Biotech: Our Unique Approach
Proprietary Materials Fortress Biotech: Our Unique Approach What we do: Acquire, develop and commercialize novel biopharmaceutical products in all stages of development and across multiple therapeutic areas directly within Fortress Biotech and through our subsidiaries. Our business strategy: Build s
Slide 4: Fortress Biotech: Creating Opportunity
Proprietary Materials Fortress Biotech: Creating Opportunity Business Advantages • Unique business model and company structure • Seek out the best product candidates • Move fast to get products to market • Extensive experience in structuring deals • Take advantage of time - sensitive opportunities •
Slide 5: Experienced Leadership
Proprietary Materials Experienced Leadership 5 • Co - Portfolio Manager and Partner of Opus Point Partners • Prolific and successful investor in the life sciences industry for over 20 years previously as Chairman of Paramount BioCapital Lindsay A. Rosenwald, MD President and CEO Chairman of the Boar
Slide 6: Diversified Portfolio of Subsidiaries
Proprietary Materials Diversified Portfolio of Subsidiaries 6 Cancer: Immuno - oncology & Targeted Anti - cancer Agents CAR - T / Immuno - Oncology: Brain Cancer, Leukemia Cell Therapy: Traumatic Brain Injury Rare & Life Threatening Conditions: Amyloidisis Orphan / Rare Diseases: GNE Myopthay , Neph
Slide 7: Provide Efficient Way To Develop / Commercialize A Product
Proprietary Materials Provide Efficient Way To Develop / Commercialize A Product Fortress Biotech 7 Identify Product Candidates We seek and identify new in - licensing opportunities in all therapeutic areas and all stages of development from: • Academic centers • Corporate entities • Government heal
Slide 8: Fortress: Offer Subsidiaries Accelerated Drug Development
Proprietary Materials Fortress: Offer Subsidiaries Accelerated Drug Development Fortress Biotech 8 Scientific Affairs SUBSIDIARY 1. Expertise in each therapeutic area 2. Knowledge of the development process 3. Pooled resources 4. Cost efficient operations structure 5. Top - tier focused management t
Slide 9: Out-License Strategy Adds To Market Size
Proprietary Materials Out - License Strategy Adds To Market Size • Supports portfolio / capital needs • Provides revenue to find more assets • Monetizes pipeline Fortress Biotech 9 Country Worldwide Ex U.S. Deal Out - License Agreements
Slide 10: Hematology / Oncology Pipeline
Proprietary Materials Hematology / Oncology Pipeline Subsidiary Product Candidate Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Commercial Caelum Biosciences CAEL - 101 AL Amyloidosis Checkpoint Therapeutics Anti - PD - L1 Solid Tumor Anti - GITR Anti - CAIX CK - 101 EGFR Inhib
Slide 11: Diversified Pipeline Across Different Therapeutic Areas
Proprietary Materials Proprietary Materials Diversified Pipeline Across Different Therapeutic Areas Fortress Biotech 11 Subsidiary Product Candidate Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Commercial Cellvation CEVA101 MNCs for Pediatric TBI CEVA101 MNCs for Adult TBI CEV
Slide 12: Significant Synergies Between & Among Subsidiaries
Proprietary Materials Checkpoint Immuno - Oncology Platform Helocyte Anti - CMV Vaccine for GBM Checkpoint 1. CK - 101 Anti - EGFR 2. CK - 102 PARP Inhibitor 3. CK - 103 BET Inhibitor 4. Anti - CAIX Mustang CAR - Ts 1. MB - 101 IL13R α 2 for GBM 2. MB - 102 CD123 for AML Significant Synergies Betwee
Slide 13: Caelum Biosciences: AL Amyloidosis
Proprietary Materials Proprietary Materials Fortress Biotech 13 Focus Developing treatments toward rare and life threatening diseases that lack effective therapies Market Size 30,000 - 45,000 patients in the US and EU; 4,500 newly diagnosed patients per year AL amyloidosis is the largest of systemic
Slide 14: CAEL-101 Phase 1a/1b Organ Response Rates
Proprietary Materials CAEL - 101 Phase 1a/1b Organ Response Rates Fortress Biotech 14 Renal Response Phase 1a & 1b (n=8) Cardiac Response Phase 1a & 1b (n=8) Overall Responders Best Organ Response 8 Weeks Single Dose PHASE 1A 63% Responders 12 Weeks 4 Weekly Doses PHASE 1B 70% Responders >30% and >3
Slide 15: Checkpoint Therapeutics: Immuno-Oncology and Targeted Agents
Proprietary Materials Proprietary Materials Fortress Biotech 15 Focus Acquire and develop novel immuno - oncology and targeted cancer agents alone and in combination to treat patients with solid tumors Market Size Anti - PD - (L)1 >$30B, Anti - GITR > $1B, CK - 101 EGFR > $3B, CK - 103 BET > $500M P
Slide 16: CK-101, 3rd Generation EGFR Pre-Clinical Efficacy
Proprietary Materials CK - 101, 3rd Generation EGFR Pre - Clinical Efficacy Fortress Biotech 16 Vehicle Control CK - 101 50 mg/kg CK - 101 100 mg/kg CK - 101 200 mg/kg Afatinib 20 mg/kg IC 50 ( nM ) Cell Line A431 H1975 HCC827 Mutation EGFR Wild - Type EGFR Mutant L858R / T790M EGFR Mutant Exon 19 d
Slide 17: Mustang Bio: CAR-T Programs
Proprietary Materials Proprietary Materials Fortress Biotech 17 Focus Two lead CAR - T programs targeting IL13R α 2 and CD123, for the treatment of Glioblastoma Multiforme and AML/BPDCN, respectively Market Size In U.S., Japan and five major EU markets per year… ~30,000 newly diagnosed GBMs (maligna
Slide 18: Phase 1 Clinical Trials With MB-101 & MB-102 Are Ongoing
Proprietary Materials CD123 CARs PBS CD19R 26292 32716 Day 4 Day 12 Day 33 10 4 MAX 10 4 MIN 1010 7 MAX 10 6 MIN 10 5 MAX 10 4 MIN Phase 1 Clinical Trials With MB - 101 & MB - 102 Are Ongoing MB - 101 is Ongoing Patient Population Rel /Ref GBM – Arm 1: Resectable / Arm 2: Non - resectable Planned En
Slide 19: Cellvation: Traumatic Brain Injury
Proprietary Materials Fortress Biotech 19 Focus Develop novel biologic therapies for TBI treatment Market Size 200,000 adults / 50,000 children with TBI Product Candidate CEVA101: Autologous bone - marrow derived mononuclear cells Clinical Trials Two ongoing Phase 2 studies, one adult and one pediat
Slide 20: Structural Preservation Through Cell Therapy
Proprietary Materials Structural Preservation Through Cell Therapy CEVA101 Phase 1: Volumetric Preservation in Pediatric TBI CEVA101 Phase 1: Volumetric Preservation in Adult TBI Fortress Biotech 20 • Post - TBI MRI at Month 1 (Scan 1) versus Month 6 (Scan 2) • Preservation of Grey Matter (GM), Whit
Slide 21: Helocyte: CMV Immunotherapies
Proprietary Materials Proprietary Materials Fortress Biotech 21 Focus Develop novel immunotherapies for the prevention and treatment of CMV that can cause life - threatening disease in those with weak immune systems Market Size CDC estimates 50 - 80% infected with Cytomegalovirus (CMV) by age of 40
Slide 22: Phase Studies: Journal Publications
Proprietary Materials Phase 1 Studies: Journal Publications Phase 1b (Completed, Published in The Lancet ) Design Single - Center (City of Hope) Study in 36 Allogeneic HSCT CMV(+)Recipients Randomized (1:1) between Vaccine Arm (VA) and Observation Arm (OA) Dosing Schedule Two subcutaneous vaccinatio
Slide 23: Escala Therapeutics: ManNAc
Proprietary Materials Proprietary Materials Fortress Biotech 23 Focus Develop and commercialize bid oral treatment for GNE Myopathy and primary podocyte nephropathies. No other company has this focus. Market Size GNE Myopathy : U.S. – 400 and WW – 2000 diagnosed Nephropathy (including diabetic): ~22
Slide 24: ManNAc Clinical Data
Proprietary Materials Month -36 -30 -24 -18 -12 -6 0 6 12 QMA Total Composite (kg) 0 200 400 600 800 1000 ManNAc Clinical Data Phase 1 PK Results: ManNAc + Neu5Ac Open Label Phase 2 Study Fortress Biotech 24 • 12 subjects on ManNAc were also previously in the Natural History Study • Nearly all had e
Slide 25: Avenue Therapeutics: IV Tramadol
Proprietary Materials Proprietary Materials Fortress Biotech 25 Focus Development of IV tramadol for the treatment of post - surgical pain Market Size IV analgesics sells ~$1bn IV acetaminophen sells ~$250MM Oral tramadol prescriptions increased from 23.3MM (2008) to 43.8MM (2013) Outside U.S.: IV t
Slide 26: Survey of Anesthesiologists: Favorable View of IV Tramadol
Proprietary Materials Survey of Anesthesiologists: Favorable View of IV Tramadol Survey of 30 U.S. Anesthesiologists. Conducted through LEERINK and available upon request. Fortress Biotech 26 Patients Taking Switch To IV Tramadol Add IV Tramadol IV Morphine 40% 41% IV NSAIDS 26% 37% IV Acetaminophen
Slide 27: Journey Medical: Innovative Dermatology Products
Proprietary Materials Fortress Biotech 27 Focus Identify and rapidly commercialize innovative, differentiated dermatology products through efficient and potent sales and marketing model Product Candidates Targadox : Doxycycline -- acne Dermsorb : Hydrocortisone -- atopic dermatitis Luxamend : Wound
Slide 28: Accelerated Drug Development Model
Proprietary Materials Accelerated Drug Development Model Fortress Subsidiaries Are Creating A Pipeline of Therapies For Life - Threatening Diseases Fortress Biotech 28 Diversified Pipeline Experienced, Proven Leadership
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