Fortress Biotech, Inc. · NASDAQ:FBIO
Fortress Biotech — Investor Presentation (December 2017)
33 slides from Fortress Biotech's investor presentation, Dec 14, 2017
Slide 1: Corporate Presentation December 2017
Non - Confidential Materials Corporate Presentation December 2017
Slide 2: Forward Looking Statements
Non - Confidential Materials Forward Looking Statements 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
Slide 3: Fortress Biotech: Our Unique Approach
Non - Confidential 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:
Slide 4: Fortress Biotech: Creating Opportunity
Non - Confidential 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 opportun
Slide 5: Experienced Leadership
Non - Confidential Materials Experienced Leadership 5 • Co - Portfolio Manager and Partner of Opus Point Partners, LLC • 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
Slide 6: Subsidiaries' Relationship to Fortress
Non - Confidential Materials Subsidiaries’ Relationship to Fortress 6 Rare & Life Threatening Conditions: Amyloidosis Rare Pediatric Diseases: Menkes Disease & Other Metabolism Disorders CAR - T / Immuno - Oncology: Brain Cancer, Leukemia Immunotherapies: Cancer, Infectious Disease Orphan / Rare Dis
Slide 7: Provide Efficient Way To Develop / Commercialize A Product
Non - Confidential Materials Provide Efficient Way To Develop / Commercialize A Product 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 health organiz
Slide 8: Fortress: Offer Subsidiaries Accelerated Drug Development
Non - Confidential Materials Fortress: Offer Subsidiaries Accelerated Drug Development 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 team 6. Acc
Slide 9: Out-License Strategy Adds To Market Size
Non - Confidential Materials Out - License Strategy Adds To Market Size • Supports portfolio / capital needs • Provides revenue to find more assets • Monetizes pipeline 9 Country Worldwide Ex U.S. Deal Out - License Agreements
Slide 10: Hematology / Oncology Pipeline
Non - Confidential Materials Hematology / Oncology Pipeline Product Candidate Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Commercial Caelum Biosciences CAEL - 101 AL Amyloidosis Checkpoint Therapeutics CK - 301 Anti - PD - L1 Solid Tumor Anti - GITR Anti - CAIX CK - 101 EGFR
Slide 11: Diversified Pipeline Across Different Therapeutic Areas
Non - Confidential Materials Non - Confidential Materials Diversified Pipeline Across Different Therapeutic Areas 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 CEVA10
Slide 12: Diversified Pipeline Across Different Therapeutic Areas
Non - Confidential Materials Non - Confidential Materials Diversified Pipeline Across Different Therapeutic Areas 12 Subsidiary Product Candidate Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Commercial Avenue Therapeutics IV Tramadol Post Surgical Pain Journey Medical Corporat
Slide 13: Caelum: Focus on AL Amyloidosis
Non - Confidential Materials Non - Confidential Materials 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 am
Slide 14: CAEL-101 Phase 1a/1b Organ Response Rates
Non - Confidential Materials CAEL - 101 Phase 1a/1b Organ Response Rates 14
Slide 15: CAEL-101: 67% of Patients Achieved Cardiac Response
Non - Confidential Materials CAEL - 101 - 67% of Patients Achieved Cardiac Response 15
Slide 16: Checkpoint Therapeutics: Focus
Non - Confidential Materials Non - Confidential Materials 16 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 > $5B, CK - 103 BET > $1B Produc
Slide 17: CK-301: Pre-Clinical Activity
Non - Confidential Materials CK - 301: Pre - Clinical Activity 17 T Cell - Specific Transcription (Fold increase) 10 Poster: AACR Annual Meeting 2017 CK - 301 potency similar to competitor anti - PD - L1 antibodies in PD - 1/PD - L1 blockade bioassay (reversing T - Cell inhibition) -8 -7 -6 -5 0 2 4
Slide 18: CK-101, 3rd Generation EGFR Pre-Clinical Efficacy
Non - Confidential Materials CK - 101, 3rd Generation EGFR Pre - Clinical Efficacy 18 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 del Afatini
Slide 19: Mustang Bio: Focus on CAR-T Programs
Non - Confidential Materials Non - Confidential Materials 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 (malignant bra
Slide 20: Regression of Recurrent Multifocal Glioblastoma After IL13Rα2 CAR T Cells
Non - Confidential Materials Regression of Recurrent Multifocal Glioblastoma After Intraventricular Delivery of IL13R α 2 - Targeted CAR T Cells 20 Sagittal MRI (top) and PET (bottom) of the brain Axial MRI of the brain All metastatic tumors in the spine were completely eliminated Maximum lesion are
Slide 21: Helocyte: CMV Immunotherapies
Non - Confidential Materials Non - Confidential Materials 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 CMV
Slide 22: Phase Studies: Journal Publications
Non - Confidential 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 vac
Slide 23: Cyprium: Menkes Disease
Proprietary Materials Non - Confidential Materials 23 Focus Developing novel therapies for the treatment of rare, fatal pediatric diseases, with initial focus on Menkes disease and related copper metabolism disorders Market Size Menkes disease is a rare X - linked pediatric disease caused by gene mu
Slide 24: Aevitas: Complement-Mediated Diseases Gene Therapy
Proprietary Materials Non - Confidential Materials 24 Focus Developing treatments towards complement - mediated diseases Market Size Potential disease targets: Age - related macular degeneration (AMD) (~ 10 million patients in the U.S. per year; expected to double by year 2050 ) Paroxysmal nocturnal
Slide 25: Tamid Bio: Rare Disease Gene Therapy
Proprietary Materials Non - Confidential Materials 25 Focus Developing treatments towards rare diseases Market Size Potential disease targets: Mucopolysaccharidosis - 1 (MPS - 1 ) ( ~ 1 / 1,000,000 people ) Corneal transplant rejection ( ~ 33,000 transplants per year in U.S. , failure rate up to 5
Slide 26: Avenue Therapeutics: IV Tramadol For Post-Surgical Pain
Non - Confidential Materials Non - Confidential Materials 26 IV Tramadol For Post - Surgical Pain IV Tramadol, if approved, would be the only Schedule IV intravenous opioid in the U.S. Focus IV tramadol for the treatment of post - surgical pain Market Size IV analgesics sells ~$1bn per year in the U
Slide 27: Survey of Anesthesiologists: Favorable View of IV Tramadol
Non - Confidential Materials Survey of Anesthesiologists: Favorable View of IV Tramadol Survey of 30 U.S. Anesthesiologists. Conducted through LEERINK and available upon request. 27 Patients Taking Switch To IV Tramadol Add IV Tramadol IV Morphine 40% 41% IV NSAIDS 26% 37% IV Acetaminophen 24% 35% O
Slide 28: Journey Medical: Dermatology Products
Non - Confidential Materials 28 Focus Identify, develop and commercialize innovative, differentiated prescription dermatology products through a highly efficient and potent sales and marketing model Product Portfolio Targadox ( doxycyline tablets ) : Sever e acne Ceracade (skin emulsion) : Atopic an
Slide 29: Cellvation: Biologic Therapies for TBI
Non - Confidential Materials 29 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 pediatric Phase
Slide 30: Structural Preservation Through Cell Therapy
Non - Confidential Materials Structural Preservation Through Cell Therapy CEVA101 Phase 1: Volumetric Preservation in Pediatric TBI CEVA101 Phase 1: Volumetric Preservation in Adult TBI 30 • Post - TBI MRI at Month 1 (Scan 1) versus Month 6 (Scan 2) • Preservation of Grey Matter (GM), White Matter (
Slide 31: Synergies Between & Among Subsidiaries
Non - Confidential 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 3. MB - 103 HER2 for
Slide 32: Accelerated Drug Development Model
Non - Confidential Materials Accelerated Drug Development Model Fortress Subsidiaries Are Creating A Pipeline of Therapies For Life - Threatening Diseases 32 Diversified Pipeline Experienced, Proven Leadership
Slide 33: Non - Confidential Materials Corporate Presentation December 2017
Non - Confidential Materials Corporate Presentation December 2017
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