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Cooper, MD Executive Chairman Served as Chairman CEO of Indevus Pharmaceuticals, Inc. Over 25 years of pharmaceutical/biotechnology experience Eric K. Rowinsky, MD Vice Chairman World renown oncologist, former CMO at ImClone, board of Over 25 years of healthcare experience Lindsay Rosenwald, MD Director and Founder A prolific and successful investor in the life sciences industry for Research Foundation and at JNJ Diabetes Biogen/Idec over 20 years 26 Listed on NASDAQ: CNDO 12/19/2011 Market Cap as of 8/29/2012 $140M Shares Outstanding 24.4M Additional 3.4M options and warrants Cash Position as of 6/30/2012 $38.2M Additional $15M loan secured in August Financials 27 Principal $15M Interest 9.25%* Payment Terms 42 Months First 12 months, interest only Next 30 months, principal and interest Warrants 73,009 Exercise price $5.65 *The loan bears interest at a rate per annum equal to the greater of (i) 9.25% or (ii) 9.25% plus the sum of the prevailing prime rate minus 3.25% $15M Hercules Loan TSO Initiate Phase 2 Crohn s study Completed Initiate Multiple Investigator Initiated Studies 2H 2012 TRUST II (Falk) Crohn s study 2nd Interim Results Mid 2013 TRUST I (CNDO) Crohn s study Topline Results 2H 2013 CNDO 109 Initiate US Phase 1/2 study 2H 2012 28 Upcoming Milestones Upcoming Milestones 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 29 Investment Highlights Investment Highlights
Sandage, Jr., PhD President Chief Executive Officer Served as EVP CSO of Indevus Pharmaceuticals, Inc. Over 30 years of pharmaceutical/biotechnology experience Noah D. Beerman EVP Chief Operating Officer Served as President CEO of RXi Pharmaceuticals Over 25 years of pharmaceutical/biotechnology experience Karin Hehenberger, MD, PhD EVP Chief Medical Officer Served in senior management positions at Juvenile Diabetes Over 12 years of pharmaceutical/biotechnology experience Lucy Lu, MD EVP Chief Financial Officer Served Senior Analyst Citi, Lazard and First Albany Over 10 years of equity research experience Glenn L.
Compositions and Methods for Treating Viral Infections * Expiration dates do not include any patent term extension 23 CNDO 109 Intellectual Property CNDO 109 Intellectual Property 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 25 Key Management and Board Members Key Management and Board Members Bobby W.
J Neuroimmunol. 2011;233:6 Antihelminth Treatment (n=4) Antihelminth Treatment (n=4) 12 patients/group 13 Impact of Parasitic Infections on the Impact of Parasitic Infections on the Course of Multiple Sclerosis Course of Multiple Sclerosis Fleming , et.al., Multiple Sclerosis Journal 2011 14 Effect of TSO in Multiple Sclerosis TSO ( Trichuris suis ova or CNDO 201) 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, OL Multiple Sclerosis (US) 16 pt, SB Multiple Sclerosis (EU) 50 pt, DB, PC Autism 10 pt, DB, Cross Psoriasis 20 pt, OL Type 1 Diabetes (early intervention 60 pt, DB, PC Type 1 Diabetes (prevention) 150 pt, DB, PC Psoriatic Arth/RA 20 30 pt, DB, PC 15 * TSO Phase 2a studies being conducted as Investigator Initiated Studies Planned 1Q2013 4Q2012 Two phase 2 studies 4Q2012 1Q2013 2013 1Q2013 OL = Open Label DB = Double Blind, SB= Single Blind PC = Placebo Controlled TSO Pipeline TSO Pipeline 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 TSO Manufacturing Process TSO Manufacturing Process 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 17 TSO Intellectual Property TSO Intellectual Property 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 19 CNDO 109: Activated Natural Killer Cells CNDO 109: Activated Natural Killer Cells 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 20 Resting Donor NK Primed Donor NK CNDO 109 Patient s tumor Dead Tumor cell Priming Signal 1 Triggering Signal 2 Primed Donor NK Tumor lysis Priming receptor Trigger receptor Priming receptor Trigger receptor Trigger receptor Priming signal Priming receptor Trigger ligand Serial Killer CNDO 109 Mechanism of Action CNDO 109 Mechanism of Action 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 1Q 2012 Filed IND 2H 2012 Initiate Phase 1/2 allogeneic clinical trial for the treatment of relapsed AML Once the dose is selected, 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 Rapid Emergence of Autoimmune and Immune Mediated Diseases 7 Autoimmune disorders incidence Helminths infestation incidence High High High Moderate Moderate Moderate Low Low Low High High Moderate Moderate Low Low 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 Epidemiological data demonstrate: Distribution of Autoimmune Disorders Distribution of Autoimmune Disorders and Helminths and Helminths 8 Weinstock and Elliott, Inflamm Bowel Dis , Jan 2009 POOR SANITATION, IMPURE FOOD AND CROWDED LIVING CONDITIONS Helminthic and bacterial exposures Inhibits Excess Reactivity Viral, bacterial and protozoan infections Crohn s Disease, Ulcerative Colitis, Multiple Sclerosis other autoimmune diseases Elliott Weinstock, Ann NY Acad Sci , 2012 (Prevents) The Biology Supporting the Hygiene The Biology Supporting the Hygiene Hypothesis Hypothesis Excess Th1 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 9 Benefits of Trichuris suis ova (TSO) Benefits of Trichuris suis ova (TSO) 10 75.9 62.1 79.3 72.4 Patients and Methods 29 CD patients with CDAI 220 (mean=296) 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 2005 Effect of TSO in Crohn s Disease Effect of TSO in Crohn s Disease 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 Effect of TSO in Ulcerative Colitis Effect of TSO in Ulcerative Colitis 12 week, dose ranging study Double blind, randomized, placebo controlled TSO 250, 2500, 7500 or placebo N=250 (2 nd interim) Crohn s patients CDAI = 220 350 CRP 2X ULN or Calprotectin 1X ULN Outcome Remission rates 2 nd Interim Mid 2013 12 TRUST I TRUST II 12 week study Double blind, randomized, placebo controlled TSO 7500 or placebo N=220 Crohn s patients CDAI = 220 450 Endoscopic evidence of inflammation Outcome Response rates Topline data 2H 2013 TSO Phase 2 Crohn s Disease Studies TSO Phase 2 Crohn s Disease Studies 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. 2 Forward Looking Statements 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 3 Value Proposition Value Proposition : 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 Other indications** CNDO 109 (Tumor Activated Natural Killer Cells) Acute Myeloid Leukemia Multiple Myeloma, Solid Tumors 4 2H2012 4Q2012 * TSO Phase 2a studies being conducted as Investigator Initiated Studies ** Other indications include Rheumatoid Arthritis and Psoriatic Arthritis Planned 4Q2012 1Q2013 2013 1Q2013 Coronado Pipeline Overview Coronado Pipeline Overview 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 Ongoing Phase 2 studies ongoing in Crohn s disease Planned 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 5 TSO: Trichuris suis ova (CNDO 201) 6 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: 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; 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.