Fortress Biotech, Inc. · NASDAQ:FBIO
Fortress Biotech — Coronado Biosciences — Investor Presentation (November 2014)
18 slides from Fortress Biotech's investor presentation, Nov 7, 2014
Slide 1: Altamira Bio, Inc. - A wholly owned subsidiary of Coronado Biosciences
Altamira Bio, Inc. Formerly TSO Development Corp. A wholly owned subsidiary of Coronado Biosciences November 2014
Slide 2: Forward-Looking Statements
Forward - Looking Statements Statements in this presentation that are not descriptions of historical facts are forward - looking statements within the meaning of the “ safe harbor ” provisions of the Private Securities Litigation Reform Act of 1995. We have attempted to identify forward - looking st
Slide 3: Altamira's Mission
Altamira’s Mission Altamira Bio, Inc. is a biotechnology company dedicated to developing Trichuris suis Ova (TSO), a novel immune modulator, for pediatric immune - mediated conditions with autism being the lead indication 3
Slide 4: Immune-mediated Disease Prevalence versus Helminths Exposure
Immune - mediated Disease Prevalence versus Helminths Exposure 4 High Moderate Low Immune - mediated diseases more common in developed world Helminths exposure more common in the developing world
Slide 5: Hygiene Hypothesis Science
Hygiene Hypothesis Science 5 Helminth exposure encourages immune regulation Elliott & Weinstock , Ann NY Acad Sci , 2012
Slide 6: About Us
About Us 6 Science Focus » Treat immune - mediated diseases based on the science of the “Hygiene Hypothesis” Patient Focus » Pediatric immune - mediated conditions with autism being the lead indication Disease Focus » Autism Spectrum Disorder (ASD) » Atopic Dermatitis (AD) » Celiac Disease Proprieta
Slide 7: Deep Knowledge of the Biotech World
Deep Knowledge of the Biotech World 7 Lucy Lu, MD » EVP and CFO of Coronado Biosciences since 2012 » Therapeutic lead of the Autism program at Coronado » Former Senior Analyst at Citi Investment Research » Over 10 years of biotech equity research experience George Avgerinos, PhD » SVP of biologics m
Slide 8: What is TSO (Trichuris suis ova)?
What is TSO ( Trichuris suis ova)? » Oral administration with no odor or taste » No systemic phase and no direct transmission » Transient exposure in humans » Non - human parasite and cannot multiply in human host 8 Biologic comprising the microscopic eggs of the porcine whipworm CHARACTERISTICS
Slide 9: TSO History: What did we learn from the Crohn's disease experience?
TSO History 9 What did we learn from the Crohn’s disease experience? Phase II Data 4Q2013 Crohn’s disease Result Two Phase 2 studies failed Decision Investment in Crohn’s was discontinued due to competitive landscape Safety Database 500 patients Signal of activity/effect » Subset of patients with hi
Slide 10: Moving Forward
Moving Forward 10 Shift focus to immune - mediated diseases in children Phase II Data 4Q2013 Crohn’s Disease Autism (ASD) Trial Started May 2014 » Affects 1 in 68 children » Costs society $236 billion per year » No FDA approved medicine for core symptoms Atopic Dermatitis (AD) Pilot Trial to start i
Slide 11: Autism Spectrum Disorder (ASD)
Autism Spectrum Disorder (ASD) 11 Most significant unmet medical need Description A complex neurodevelopmental disorder of early childhood onset characterized by deficits in social communication and restricted interests and repetitive behaviors » Many patients also have difficult behaviors such as h
Slide 12: Is Autism an Immune Mediated Disease?
Is Autism an Immune Mediated Disease? 12 Current or Past GI Issues with Low Level Inflammation Maternal Autoimmune Diagnosis Brain Inflammation Peripheral Immune Abnormalities Abnormal Gut Microbiome * Publications available
Slide 13: TSO for Pediatric Autism
TSO for Pediatric Autism A multi - center, randomized, double - blind, placebo - controlled, crossover study designed to evaluate the safety and efficacy of TSO in pediatric ASD patients 13 16 Weeks Patients receive either TSO or placebo once every 2 weeks 4 Weeks Washout 16 weeks Opposite treatment
Slide 14: How do we maximize efficacy signal detection in the ASD trial?
How do we maximize efficacy signal detection in the ASD trial? Potential Hurdle Our Mitigation Strategies Placebo response » Select experienced sites and conduct ongoing training » Enroll patients with behavior issues Rater variability » Require same caretaker and rater for assessments » Include add
Slide 15: Atopic Dermatitis (AD)
Atopic Dermatitis (AD) 15 Large unmet need in long - term treatment of pediatric patients Description A chronic relapsing, inflammatory, pruritic disease of the skin resulted from a combination of skin barrier dysfunction and immunodeviation . Population C ommonly appears in infancy and persists int
Slide 16: Celiac Disease
Celiac Disease 16 Objective histological and serological endpoints Description An autoimmune disorder of the small intestine triggered by dietary gluten, a form of protein found in some grains Population Children to adults Treatment Gluten avoidance (Difficult for school - aged children and adolesce
Slide 17: The Future
The Future » The only helminthic therapy in clinical development » Focused on large markets with unmet need » Experienced management and board of directors 17 A company focused on pediatric immune - mediated diseases Autism (ASD) Study Started May 2014 Atopic Dermatitis Pilot Trial to start in 2015
Slide 18: Altamira Bio, Inc. - Thank You
Altamira Bio, Inc. Formerly TSO Development Corp. A wholly owned subsidiary of Coronado Biosciences THANK YOU!!!
Coronado Biosciences — Investor Presentation (November 2014) on 6ix