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Compositions and Methods for Treating Viral Infections * Expiration dates do not include any patent term extension CNDO 109 Intellectual Property CNDO 109 Intellectual Property 17 Financials Financials 18 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 Working Capital as of 9/30/2013 $96.9M
Hollander s study point to potential efficacy Scientific Rationale for TSO for Autism Scientific Rationale for TSO for Autism 10 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 favor of TSO on three measures of disease that reflect a core feature of autism (the restrictive interests and repetitive behavior domain) Montefiore Einstein Rigidity Scale (MERS) Repetitive Behavior Scale Revised (RBS R) Sameness Scale Social Responsiveness Scale (SRS) Repetitive Behaviors Scale TSO is well tolerated Final results are expected in mid 2014 Pilot Study of TSO in Autism Pilot Study of TSO in Autism 11 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 patents * Expiration dates do not include any patent term extension TSO Intellectual Property TSO Intellectual Property 12 Use of Parasitic Biological Agents for Disease Prevention and Control directed to the treatment of animals/man with a Th1 or Th2 mediated autoimmune disease exp. 11/2023 Production of a Viable, Storable Worm Egg Suspension directed to a process for preparation of TSO using an acid wash exp. 3/2028 Method for Characterizing the Biological Activity of Helminth Eggs, in particular Trichuris Eggs exp. 5/2029 Treatment with Helminths directed to methods of treating obesity and IBS exp. 10/2029 Compositions and Methods for Treating IBD directed to a method of treating IBD by contacting an isolated dendritic/macrophage cell with a helminth exp. ~9/2032 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 cytokines or long term culture/expansion, and does not change NK cell phenotypes Preclinical activity demonstrated in multiple myeloma, breast cancer, prostate cancer and ovarian cancer CNDO 109: Activated Natural Killer Cells CNDO 109: Activated Natural Killer Cells 13 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 CNDO 109 Mechanism of Action 14 Trigger receptor Trigger receptor Priming receptor Priming receptor Trigger receptor Priming receptor Resting Donor NK Priming signal Trigger ligand Priming Signal 1 Triggering Signal 2 Serial Killer Tumor lysis Dead Tumor cell Primed Donor NK Patient s tumor Primed Donor NK CNDO 109 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 Enrolled 8 AML patients 5 in Complete Remission at time of study entry 1 patient in partial relapse (PR) at time of study entry 3/5 experienced a longer CR than their previous CR, in addition PR patient achieved CR Kottaridis, et al ., ASH 2011 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) 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 NK Cells and Methods of Using the Same exp. 7/2030 Provisional application pending in the U.S.
Business Development Strategies Business Development Strategies 5 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 psoriasis, autism, multiple sclerosis, and ulcerative colitis Natural properties suggest strong potential for a safe profile North and South America and Japanese rights for all indications TSO: Trichuris suis ova (CNDO 201) TSO: Trichuris suis ova (CNDO 201) 6 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 suis ova (TSO) Benefits of Trichuris suis ova (TSO) 7 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 TSO Phase 2 Crohn s Disease Studies 8 TRUST I TRUST II 12 week study TSO 7500 or placebo N=250 Crohn s patients CDAI = 220 450 The randomization was stratified by disease activity as measured by CDAI Outcome Did NOT meet overall primary endpoint of response 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, PC Ulcerative Colitis (MOA) 18 pt, DB, PC Multiple Sclerosis (US) 15 pt, SB Multiple Sclerosis (EU) 50 pt, DB, PC Autism 10 pt, DB, Cross Autism 60 pt, DB, PC Psoriasis 20 pt, OL 1H2014 (*) 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 issues and immune dysregulation in Autism patients Up to 70% of the patients have current or past GI issues, and endoscopy often shows low level inflammation in these patients Abnormal cytokines, B cell and T cell subsets, and low levels of regulatory cytokines Evidence of activation of the innate immune system in the CNS Maternal autoimmune diagnosis is a recognized risk factor Anecdotal evidence and the interim data from Dr.
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, while preserving capital and strength of our balance sheet. Spin out opportunities From time to time we may spin out new companies based on current and new technologies and products that we develop, license or acquire.
Weiss Co Vice Chairman Co Portfolio Manager and Partner of Opus Point Partners, LLC (since 2009) Executive Chairman, Interim CEO and President of TG Therapeutics Chairman and CEO of Keryx Biopharmaceuticals Eric K. Rowinsky, MD Co Vice Chairman World renown oncologist, former CMO at ImClone, board of Biogen/Idec Chief Medical Officer and Head of Research and Development; Executive Vice President at Stemline Therapeutics Products and technologies We intend to pursue product and technology acquisitions and licenses.
Avgerinos, PhD Sr. VP, Biologics Operations Divisional VP, Global Process and Manufacturing Sciences, Abbvie Over 30 years experience in biopharmaceutical process development including Humira process and manufacturing Key Management and Board Members Key Management and Board Members 4 Kevin Horgan, MD Chief Medical Officer more than 25 years of academic and pharmaceutical experience SVP and Chief Medical officer at Soligenix Vice President of Clinical Immunology at Janssen Biotech Michael S.
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 Officer Senior Analyst at Citi Investment Research Over 10 years of biotech equity research experience George C.
We expressly disclaim any obligation or undertaking to update or revise any statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances after the date of this presentation. Forward Looking Statements Forward Looking Statements 2 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 solutions Two biologic product candidates in clinical stage development Focused on autoimmune diseases and cancer immunotherapy Strong proprietary position Value Proposition Value Proposition 3 Lindsay A.
Forward looking statements are based on management s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated risks include those set forth in our SEC filings including, in particular, risks relating to: our ability to attract, integrate and retain key personnel; the results of research and development activities; uncertainties relating to preclinical and clinical testing, financing and strategic agreements and relationships; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; our ability to successfully manufacture TSO in the US; dependence on third party manufacturers; and competition.
NASDAQ: CNDO December 2013 Lindsay A. Rosenwald, MD Chairman, President and CEO Exhibit 99.1 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 including anticipates, believes, can, continue, could, estimates, expects, intends, may, plans, potential, predicts, should, or will or the negative of these terms or other comparable terminology.