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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 Eric K. Rowinsky, MD Vice Chairman World renown oncologist, former CMO at ImClone, board of Biogen/Idec Over 25 years of healthcare experience Lindsay Rosenwald, MD Director and Founder A prolific and successful investor in the life sciences industry for over 20 years Financials Financials 26 Listed on NASDAQ: CNDO Market Cap as of 8/28/2013 ~$275M Shares Outstanding 33.9M Additional 5.2M options and warrants Cash Position as of 6/30/2013 $67.9M Additional $35.9M from ATM through 8/28/13 TSO Initiate Multiple Investigator Initiated Studies 2H 2013 TRUST II (Falk) Crohn s study 2nd Interim Results 4Q 2013 TRUST I (CNDO) Crohn s study Topline Results 4Q 2013 CNDO 109 Initiate Multiple Myeloma Study 2014 Anticipated Upcoming Milestones Anticipated Upcoming Milestones 27 Two biologic product candidates in clinical stage development Focused on autoimmune diseases and cancer immunotherapy Strong proprietary position Novel treatments with broad therapeutic applications addressing multi billion dollar markets Four efficacy clinical trials completed and multiple additional trials ongoing TSO: Trichuris suis ova (CNDO 201) in Crohn s Disease, Ulcerative Colitis (UC) and Multiple Sclerosis (MS) CNDO 109 : Tumor Activated NK Cells in relapsed Acute Myeloid Leukemia (AML) Experienced management team and board of directors Investment Highlights Investment Highlights 28
Weisman, MD Chairman and Chief Executive Officer Company Group Chairman, Research Development for Pharmaceuticals at JNJ President of Research Development at Centocor Over 20 years of pharmaceutical/biotechnology experience Noah D. Beerman EVP Chief Operating Officer President CEO of RXi Pharmaceuticals Over 25 years of pharmaceutical/biotechnology experience Karin Hehenberger, MD, PhD EVP of Scientific Affairs Senior positions at private and public investment firms and as an executive at Eyetech, JNJ and JDRF MD and PhD from Karolinska, postdoc at Harvard medical school Key Management and Board Members Key Management and Board Members 25 Lucy Lu, MD EVP Chief Financial Officer Senior Analyst at Citi Investment Research Over 10 years of biotech equity research experience George C.
Compositions and Methods for Treating Viral Infections * Expiration dates do not include any patent term extension CNDO 109 Intellectual Property CNDO 109 Intellectual Property 23 Potential CNDO 109 Target Indications G7 Drug Treatable Population G7 Market Sales (USD Mil) Mortality AML 43,500 $165 5 year mortality rate is 85 90% but varies by age Multiple Myeloma 44,000 $2,870 Stage III: median survival of 29 months Breast Cancer 494,000 $10,100 Stage IV: 5 year mortality rate is 76% Ovarian 57,110 $424 Overall 5 year survival rate of 45% Prostate 500,000 $4,000 Overall 5 year survival rate of +99%, but 2 leading cause of cancer deaths in men G7 = U.S., U.K., Germany, France, Italy, Spain, Japan Sources: Decision Resources 2011/2012 If Coronado establishes the efficacy of CNDO 109 activated NK cells in the treatment of AML, Coronado believes the market opportunity for CNDO 109 activated NK cell therapy is large due to the fact that many types of tumors are sensitive to killing by activated NK cells. 24 CNDO 109 Market Opportunity CNDO 109 Market Opportunity nd Harlan F.
J Neuroimmunol. 2011;233:6 13 Effect of TSO in Multiple Sclerosis Effect of TSO in Multiple Sclerosis Fleming , et.al., Multiple Sclerosis Journal 2011 14 Indication Pre Clinical Phase 1 Phase 2a* Phase 2 Phase 3 Design Crohn s Disease ~500pts, DB, PC 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 Type 1 Diabetes 36 pt, DB, PC Early Intervention Type 1 Diabetes 100 pt, DB, PC Early intervention Type 1 Diabetes 150 pt, DB, PC Prevention Psoriatic Arthritis 24 pt, DB, PC Rheumatoid Arthritis 50 pt, DB, PC 15 TSO Pipeline TSO Pipeline * TSO Phase 2a studies being conducted as Investigator Initiated Studies Planned OL = Open Label DB = Double Blind SB= Single Blind PC = Placebo Controlled 2H2013 Two phase 2 studies 2H2013 2H2013 2H2013 2H2013 2H2013 2H2013 TSO Manufacturing Process TSO Manufacturing Process Certified specific pathogen free minipigs Observation and pathogen testing Oral Inoculation with OVA from master bank Development of infection Harvest OVA from pigs Isolation and purification Processing and pathogen inactivation API Quality and pathogen testing Incubation and sterilization Formulation process Fill/finish DRUG Product Quality and microbiological testing 16 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 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 * Expiration dates do not include any patent term extension TSO Intellectual Property TSO Intellectual Property 17 Potential TSO Target Indications U.S./Japan Prevalence U.S./Japan Annual Market Sales (USD Mil) Ulcerative Colitis 669,000 $1,300 Crohn s Disease 534,000 $2,600 Multiple Sclerosis 485,000 $6,400 Sources: Decision Resources 2012 The mechanism of action of TSO should, if approved, allow it to be positioned in a variety of autoimmune disorders, including inflammatory bowel diseases and multiple sclerosis as well as other potential disorders such as rheumatoid arthritis and psoriasis. 18 TSO Market Opportunity TSO Market Opportunity 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 19 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 20 Trigger receptor Trigger receptor Priming receptor Priming receptor Trigger receptor Priming receptor Resting Donor NK Primed Donor NK Priming signal CNDO 109 Trigger ligand Patient s tumor Priming Signal 1 Triggering Signal 2 Primed Donor NK Serial Killer Tumor lysis 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 2 or 3 (CR2 or CR3) 1 patient in partial relapse (PR) 3/5 experienced a longer CR than their previous CR, in addition PR patient achieved CR 21 Kottaridis, et al ., ASH 2011 CNDO 109 Phase 1 Study in AML CNDO 109 Phase 1 Study in AML Initiated Phase 1/2 allogeneic clinical trial for the treatment of relapsed AML Once the dose is selected, plan to initiate a randomized Phase 2 trial Potential for regulatory approval with single randomized, controlled clinical trial if data are clinically meaningful and statistically persuasive Future autologous studies planned in other tumor types (including multiple myeloma, breast, ovarian and prostate) 22 CNDO 109 Clinical Development CNDO 109 Clinical Development 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.
Am J Public Health 2000 Faustman, D. Institute of Medicine Report, Women s Health Research: Progress, Pitfalls, and Promise, 2010 Epidemiological data demonstrate: Various immunological and autoimmune diseases are much less common in the developing world than the industrialized world Immigrants to the industrialized world from the developing world increasingly develop immunological disorders in relation to the length of time since arrival in the industrialized world Distribution of Autoimmune Disorders Distribution of Autoimmune Disorders and Helminths and Helminths 7 Autoimmune disorders incidence Helminths infestation incidence 8 Elliott Weinstock, Ann NY AcadSci , 2012 The Biology Supporting the Hygiene The Biology Supporting the Hygiene Hypothesis Hypothesis 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) 9 Effect of TSO in Crohn s Disease Effect of TSO in Crohn s Disease 10 75.9 62.1 79.3 72.4 Patients and Methods 29 CD patients with CDAI 220 (mean=294) Median duration of the disease : 4 yrs Baseline meds 5ASA, low dose steroids, 6 MP or Aza, washout of TNF inhibitors 2500 TSO every 3 weeks for 24 weeks Remission defined as a CDAI of 150 points Response defined as a CDAI 100 point drop from baseline Summers , et.al., GUT 2004 Effect of TSO in Ulcerative Colitis Effect of TSO in Ulcerative Colitis 11 50 40 30 20 10 0 p=0.04 16.7% 43.3% Placebo T. suis Summers , et.al., Gastroenterology 2005 Patients and Methods n = 54 UC patients with a UCDAI score 4 points Average score 8.7 8.8 Duration of disease averaged 8 years 2500 TSO every 2 weeks for 3 months Most patients refractory to previous therapy Response was defined as 4 point drop 12 week, dose ranging study Double blind, randomized, placebo controlled TSO 250, 2500, 7500 or placebo N=240 (2 nd interim) Crohn s patients CDAI = 220 350 CRP 2X ULN or Calprotectin 1X ULN Outcome Remission rates 2 nd Interim 4Q 2013 TSO Phase 2 Crohn s Disease Studies TSO Phase 2 Crohn s Disease Studies 12 TRUST I TRUST II 12 week study Double blind, randomized, placebo controlled TSO 7500 or placebo N=250 Crohn s patients CDAI = 220 450 Endoscopic evidence of inflammation Outcome Response rates Topline data 4Q 2013 Impact of Parasitic Infections on the Impact of Parasitic Infections on the Course of Multiple Sclerosis Course of Multiple Sclerosis Correale J, Farez MF.
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 Two biologic product candidates in clinical stage development Focused on autoimmune diseases and cancer immunotherapy Strong proprietary position Novel treatments with broad therapeutic applications addressing multi billion dollar markets Four efficacy clinical trials completed and multiple additional trials ongoing TSO: Trichuris suis ova (CNDO 201) in Crohn s Disease, Ulcerative Colitis (UC) and Multiple Sclerosis (MS) CNDO 109 : Tumor Activated NK Cells in relapsed Acute Myeloid Leukemia (AML) Experienced management team and board of directors Value Proposition Value Proposition 3 TSO ( Trichuris suis ova or CNDO 201) Indication Pre Clinical Phase 1 Phase 2a* Phase 2 Phase 3 Crohn s Disease Ulcerative Colitis Multiple Sclerosis Autism Psoriasis Type 1 Diabetes Psoriatic Arthritis Rheumatoid Arthritis CNDO 109 (Tumor Activated Natural Killer Cells) Acute Myeloid Leukemia Multiple Myeloma 4 Coronado Pipeline Overview Coronado Pipeline Overview 2H2013 * TSO Phase 2a studies being conducted as Investigator Initiated Studies; CNDO 109 Phase 2a AML study is a Phase 1/2 study Planned 2H2013 2H2013 2014 2H2013 Porcine whipworm ova Represents a novel approach to treating autoimmune diseases the Hygiene Hypothesis Natural immunomodulator regulates T Reg cells and inflammatory cytokines Clinical proof of principle established in Inflammatory Bowel Disease and Multiple Sclerosis Phase 2 studies ongoing in Crohn s disease Planned and ongoing studies in multiple additional autoimmune indications 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) 5 (adapted from Bach, NEJM , 2002) 6 Rapid Emergence of Autoimmune Rapid Emergence of Autoimmune and Immune Mediated Diseases and Immune Mediated Diseases There are 100 immune mediated diseases affecting 50 million Americans Second highest cause of chronic disease in United States and number one cause of morbidity in women In contrast, most of these diseases are rare in less developed countries Walsh SJ, Rau LM.
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.
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. 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.
Developing Unique Products for Autoimmune Diseases and Cancer (NASDAQ: CNDO) September 2013 Harlan F. Weisman, MD Chairman 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.