Fortress Biotech, Inc. · NASDAQ:FBIO
Fortress Biotech — Coronado Biosciences — Investor Presentation (April 2014)
16 slides from Fortress Biotech's investor presentation, Apr 14, 2014
Slide 1: Coronado Biosciences Investor Presentation April 2014
NASDAQ: CNDO April 2014 Lindsay A. Rosenwald, MD Chairman, President and CEO
Slide 2: 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 statements by terminology incl
Slide 3: Value Proposition
» Experienced management team and board of directors - In both drug development and business development - Dedicated to maximizing shareholder value » Business development expertise - Products and technologies acquisitions and licensing - Investment and spin - out opportunities - Creative financing
Slide 4: Key Board Members and Management
Lindsay A. Rosenwald, MD Chairman, President and CEO » P rolific and successful investor in the life sciences industry for over 20 years previously as Chairman of Paramount BioCapital » Co - Portfolio Manager and Partner of Opus Point Partners Michael S. Weiss Executive Vice - Chairman, Strategic De
Slide 5: Business Development Strategies
» Products and technologies - We intend to pursue product and technology acquisitions and licenses. » Investment opportunities - We may make controlling and non - controlling investments in companies with proprietary products and/or technologies where we believe shareholder value will be enhanced, w
Slide 6: TSO: Trichuris suis ova (CNDO-201)
» A biologic comprising the microscopic eggs of the porcine whipworm » A novel approach to treat immune - mediated diseases based on the science of the “ Hygiene Hypothesis ” » Favorable tolerability and safety profile - Non - human parasite - Transient exposure in humans - Does not multiply in huma
Slide 7: TSO Phase 2 Crohn's Disease Studies - Negative Topline Announced 4Q13
» 12 week, dose ranging study - TSO 250, 2500, 7500 or placebo - N=240 • CDAI = 220 - 350 » Outcome – Discontinued post 2 nd Interim analysis TSO Phase 2 Crohn ’ s Disease Studies - Negative Topline Announced 4Q13 7 TRUST - I TRUST - II » 12 week study - TSO 7500 or placebo - N=250 • CDAI = 220 - 45
Slide 8: Is there any reason for optimism?
» Signal of biological activity and efficacy in TRUST - I subset analysis - TSO demonstrated a non - significant improvement in approximately half of the patients with higher disease activity (CDAI>290), a pre - specified subset • 56% response rate in TSO arm versus 42% in placebo arm = 14% treatmen
Slide 9: Other TSO Positives
» Q ualified supply of OVA » Reference IND with growing safety database » Compelling epidemiological “story” » Continual anecdotal reports of efficacy in autism » Broad academic and “grass roots” interest - Reagents developed suitable for clinical development monitoring » Increased awareness of diff
Slide 10: TSO Rehabilitation
» Multiple step plan to re - gain, restore and reward investor confidence » Re - focus on pediatric indication with high unmet medical need that will drive investor value - Autism » Other indications we may be interested in - Food allergy - Eosinophilic esophagitis (EE) - Celiac disease » Will focus
Slide 11: Scientific Rationale for TSO for Autism
» Numerous threads of evidence suggest that Autism is an immune mediated disorder linked to the hygiene hypothesis (HH) - Gene – environment mismatch is likely responsible for the dramatic increase in incidence - Increase parallels that of asthma and other HH conditions » Strong evidence for GI issu
Slide 12: TSO Autism Studies
» Montefiore Medical Center/ Albert Einstein College of Medicine : double - blind, placebo - controlled, randomized cross - over study in 10 adult, high functioning autism patients - In the first 5 patients that completed the study, a separation from placebo in favor of TSO on three measures of dise
Slide 13: CNDO-109: Activated Natural Killer Cells
» NK cells represent the key component of the body ’ s innate immune surveillance system - Activation with CNDO - 109 does not require toxic cytokines or long - term culture/expansion, and does not change NK cell phenotypes - Preclinical activity demonstrated in multiple myeloma, breast cancer, pros
Slide 14: CNDO-109 Mechanism of Action
» Activated ex vivo by tumor cell lysate (CNDO - 109) » Effective from autologous or allogeneic NK cell source » Uniquely positioned in patients with “ minimal residual disease ” » Remains active after freeze/thaw CNDO - 109 Mechanism of Action 14 Trigger receptor Trigger receptor Priming receptor P
Slide 15: CNDO-109 Phase 1 Study in AML
» Phase 1 investigator sponsored open - label trial » To determine the safety of infusion of allogeneic Tumor - activated NK ( TaNK ) cells after low dose radiotherapy plus chemotherapy in high - risk relapse or refractory AML patients » Enrolled 8 AML patients - 5 in Complete Remission at time of s
Slide 16: Financials
Financials 16 Listed on NASDAQ: CNDO Market Cap as of 4/7/2014 ~$78M Shares Outstanding 44.2M Additional 2.9 M options and warrants Cash Position as of 12/31/2013 $99.5M Total Restricted Cash/Debt (03 - 31 - 2014) $14.0M
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