Fortress Biotech, Inc. · NASDAQ:FBIO
Fortress Biotech — Investor Presentation (August 2017)
29 slides from Fortress Biotech's investor presentation, Aug 9, 2017
Slide 1: Corporate Presentation August 2017
Non - Confidential Materials Corporate Presentation August 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 Cancer: Immuno - oncology & Targeted Anti - cancer Agents CAR - T / Immuno - Oncology: Brain Cancer, Leukemia Acu
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 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 EGF
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: Caelum Biosciences: CAEL-101 AL Amyloidosis
Non - Confidential Materials Non - Confidential Materials 12 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 13: CAEL Phase 1a/1b Organ Response Rates
Non - Confidential Materials CAEL - 101 Phase 1a/1b Organ Response Rates 13 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 >300 pg/ml d
Slide 14: Checkpoint Therapeutics Overview
Non - Confidential Materials Non - Confidential Materials 14 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 > $1B Produc
Slide 15: CK-101, 3rd Generation EGFR Pre-Clinical Efficacy
Non - Confidential Materials CK - 101, 3rd Generation EGFR Pre - Clinical Efficacy 15 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 16: CK-301: Pre-Clinical Activity
Non - Confidential Materials CK - 301: Pre - Clinical Activity 16 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 17: Mustang Bio Overview
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 18: Regression of Recurrent Multifocal Glioblastoma After CAR T Cells
Non - Confidential Materials Regression of Recurrent Multifocal Glioblastoma After Intraventricular Delivery of IL13R α 2 - Targeted CAR T Cells 18 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 19: Helocyte: CMV Immunotherapies
Non - Confidential Materials Non - Confidential Materials 19 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 20: 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 21: Cyprium Therapeutics: Menkes Disease
Proprietary Materials Non - Confidential Materials 21 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 22: Avenue Therapeutics: IV Tramadol For Post-Surgical Pain
Non - Confidential Materials Non - Confidential Materials 22 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 23: 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. 23 Patients Taking Switch To IV Tramadol Add IV Tramadol IV Morphine 40% 41% IV NSAIDS 26% 37% IV Acetaminophen 24% 35% O
Slide 24: Journey Medical Corporation: Dermatology
Non - Confidential Materials 24 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 25: Cellvation: CEVA101 Severe Traumatic Brain Injury
Non - Confidential Materials 25 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 26: 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 26 • Post - TBI MRI at Month 1 (Scan 1) versus Month 6 (Scan 2) • Preservation of Grey Matter (GM), White Matter (
Slide 27: 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 Synergies Between & A
Slide 28: Accelerated Drug Development Model
Non - Confidential Materials Accelerated Drug Development Model Fortress Subsidiaries Are Creating A Pipeline of Therapies For Life - Threatening Diseases 28 Diversified Pipeline Experienced, Proven Leadership
Slide 29: Non - Confidential Materials Corporate Presentation August 2017
Non - Confidential Materials Corporate Presentation August 2017
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