Fortress Biotech, Inc. · NASDAQ:FBIO
Fortress Biotech — Coronado Biosciences — Investor Presentation (December 2013)
52 slides from Fortress Biotech's investor presentation, Dec 24, 2013
Slide 1: Coronado Biosciences
Coronado BIOSCIENCES
Slide 2: Coronado Biosciences
_ >» Coronado BIOS ClE NC ES BO
Slide 3: December 2013
NASDAQ: CNDO December 2013 Lindsay A. Rosenwald, MD Chairman, President and CEO Exhibit 99.1
Slide 4: Coronado
coronado
Slide 5: Slide 5
Slide 6: Forward-Looking Statements
Forward-Looking Statements 2 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 statemen
Slide 7: Coronado
coronado
Slide 8: Slide 8
Slide 9: Value Proposition
Value Proposition 3 » 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 - C
Slide 10: Coronado
coronado
Slide 11: Slide 11
Slide 12: Key Management and Board Members
Key Management and Board Members 4 Lindsay A. Rosenwald, MD Chairman, President and CEO » Prolific and successful investor in the life sciences industry for over 20 years as Chairman of Paramount BioCapital » Co-Portfolio Manager and Partner of Opus Point Partners Lucy Lu, MD EVP & Chief Financial O
Slide 13: Coronado
coronado
Slide 14: Slide 14
Slide 15: Business Development Strategies
Business Development Strategies 5 » 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 share
Slide 16: Coronado
coronado
Slide 17: Slide 17
Slide 18: TSO: Trichuris suis ova (CNDO-201)
TSO: Trichuris suis ova (CNDO-201) 6 » Porcine whipworm ova - Represents a novel approach to treating autoimmune diseases – the “Hygiene Hypothesis” - Natural immunomodulator - regulates T-Reg cells and inflammatory cytokines » Planned and ongoing studies in multiple autoimmune indications including
Slide 19: Slide 19
Slide 20: Slide 20
Slide 21: Benefits of Trichuris suis ova (TSO)
Benefits of Trichuris suis ova (TSO) 7 » Does not multiply in human host » Colonization is self-limited in humans » No systemic phase » No direct transmission » Ova stable » Oral dosing; 1 tbsp solution taken once every 2 weeks - Clear, odorless, tasteless - Ova are Microscopic Benefits of Trichuris
Slide 22: Coronado
coronado
Slide 23: Slide 23
Slide 24: TSO Phase 2 Crohn's Disease Studies
TSO Phase 2 Crohn’s Disease Studies 8 » 12 week, dose ranging study - TSO 250, 2500, 7500 or placebo - N=240 - Crohn’s patients • CDAI = 220-350 » Outcome – Discontinued post 2 nd Interim analysis TSO Phase 2 Crohn’s Disease Studies TRUST - I TRUST - II » 12 week study - TSO 7500 or placebo - N=250
Slide 25: Coronado
coronado
Slide 26: Slide 26
Slide 27: Select TSO Trials
9 Select TSO Trials Select TSO Trials * TSO Phase 2a studies being conducted as Investigator-Initiated Studies Planned OL = Open-Label DB = Double-Blind SB= Single-Blind PC = Placebo-Controlled *expected Indication Pre-Clinical Phase 1 Phase 2a* Phase 2 Phase 3 Design Ulcerative Colitis 120 pt, DB,
Slide 28: Coronado
coronado
Slide 29: Slide 29
Slide 30: Scientific Rationale for TSO for Autism
Scientific Rationale for TSO for Autism 10 » 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
Slide 31: Coronado
coronado
Slide 32: Slide 32
Slide 33: Pilot Study of TSO in Autism
Pilot Study of TSO in Autism 11 » Ongoing double-blind, placebo-controlled, randomized cross- over study in 10 adult, high functioning autism patients at Montefiore Medical Center » In the first 5 patients that completed the study, there was a statistically significant separation from placebo in fav
Slide 34: Coronado
coronado
Slide 35: Slide 35
Slide 36: TSO Intellectual Property
TSO Intellectual Property 12 » Three issued US patents entitled ‘Use of Parasitic Biological Agents for Prevention and Control of Autoimmune Disease’ directed to compositions, methods of producing compositions, and methods of autoimmune disease with helminths – exp. 12/2018 » Five additional pending
Slide 37: Coronado
coronado
Slide 38: Slide 38
Slide 39: CNDO-109: Activated Natural Killer Cells
CNDO-109: Activated Natural Killer Cells 13 » NK cells represent the key component of the body’s innate immune surveillance system » Proof of principle established in patients with high-risk refractory or relapsed acute myeloid leukemia (AML) » Activation with CNDO-109 does not require toxic cytokin
Slide 40: CNDO-109 Mechanism of Action
CNDO-109 Mechanism of Action 14 Resting Donor NK Trigger ligand Primed Donor NK Patient’s tumor Primed Donor NK CNDO-109 » 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” » Re
Slide 41: Coronado
coronado
Slide 42: Slide 42
Slide 43: CNDO-109 Phase 1 Study in AML
15 CNDO-109 Phase 1 Study in AML 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 » Enrolle
Slide 44: Coronado
coronado
Slide 45: Slide 45
Slide 46: CNDO-109 Clinical Development
16 CNDO-109 Clinical Development CNDO-109 Clinical Development » Initiated Phase 1/2 allogeneic clinical trial for the treatment of relapsed AML » Future autologous studies in other tumor types are possible (e.g. multiple myeloma, breast, ovarian and prostate)
Slide 47: Coronado
coronado
Slide 48: Slide 48
Slide 49: CNDO-109 Intellectual Property
CNDO-109 Intellectual Property 17 » Core patent - “Method for activating natural killer cells by tumor cell preparation in vitro ” - Issued in U.S. - exp. 1/2029 - Issued in Australia – exp. 3/2026 - Pending in Europe, Canada, Japan and India » Patent pending - “Preserved Compositions of Activated N
Slide 50: Coronado
coronado
Slide 51: Slide 51
Slide 52: Financials
Financials 18 Financials Listed on NASDAQ: CNDO Market Cap as of 12/20/2013 ~$75M Shares Outstanding 35.5M - Additional 4.0 M options and warrants - Additional 3.9 M restricted shares Cash Position as of 9/30/2013 $106.3M Total Debt as of 9/30/2013 $15.0M Accounts Payable as of 9/30/2013 $1.1M Worki
Coronado Biosciences — Investor Presentation (December 2013) on 6ix