Bobby W. Sandage, Jr., PhD President & Chief Executive Officer. January 2012

Transcription

1 Bobby W. Sandage, Jr., PhD President & Chief Executive Officer January 2012

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 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. 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 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

3 Two biologic product candidates in clinical stage development - Focused on autoimmune diseases and cancer immunotherapy - Strong proprietary property position Novel treatment approaches with broad therapeutic applications addressing multi-billion dollar markets Completed four clinical trials - CNDO-201: Trichuris suis ova (TSO) in Crohn s Disease, Ulcerative Colitis (UC) and Multiple Sclerosis (MS) - CNDO-109: Tumor Activated NK Cells in relapsed Acute Myeloid Leukemia (AML) Recently completed binding Terms of Agreement with Falk and OvaMed propels Coronado into Phase II development Experienced management team and board of directors 3

4 CNDO-201 (TSO) Compound & Indication Preclinical Phase I Phase IIa Phase IIb Crohn s Disease Ulcerative Colitis Multiple Sclerosis CNDO-109 (Tumor Activated NK Cells) Compound & Indication Preclinical Phase I Phase IIa Phase IIb Relapsed AML Initiate P I/II 1Q 2012 Multiple Myeloma Solid Tumors 4

5 Porcine whipworm ova - Represents a novel approach to treating autoimmune diseases the Hygiene Hypothesis - Natural immunomodulator - regulates T-Cells (Th1 and Th2) and inflammatory cytokines Proof of principle established in Inflammatory Bowel Disease and Multiple Sclerosis Natural properties suggest strong potential for a safe profile - Not associated with risks of immunosuppressant drugs Oral bi-weekly administration North and South America and Japanese rights for all indications 5

6 Bach NEJM

7 Autoimmune disorders incidence Helminths infestation incidence High High Moderate Low Moderate Low 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 7

8 The developing immune system must receive stimuli from infectious agents, symbiotic bacteria or parasites in order to adequately develop regulatory T- cells. Otherwise, it will be more susceptible to autoimmune diseases resulting from insufficiently balanced T h 1 and T h 2 responses Viral, bacterial and protozoan infections Excess Th1 Crohn s Disease, Ulcerative Colitis, Multiple Sclerosis & other autoimmune diseases (Prevents) POOR SANITATION, IMPURE FOOD AND CROWDED LIVING CONDITIONS Helminthic and bacterial exposures Immune Regulation Inhibits Excess Reactivity GENETIC PREDISPOSITION (Weinstock and Elliott, Inflamm Bowel Dis, Jan 2009) 8

9 Does not multiply in human host Colonization is self-limited in humans No systemic phase No direct transmission Ova stable 9

10 Summers, et.al., GUT

11 % of Patients Achieving a Response P= P= Summers, et.al., Gastroenterology

12 Antihelminth Treatment (n=4) Antihelminth Treatment (n=4) 12 patients/group Correale J, Farez MF. J Neuroimmunol. 2011;233:6 12

13 Fleming, et.al., Multiple Sclerosis Journal

14 Binding Terms of Agreement for CNDO-201 in Crohn s - Immediately advances Coronado to Phase II status - Grants Coronado exclusive rights to Falk Preclinical Know-How and rights under Falk s patents for use in our territories - Cross License and Data Sharing (co-development) for Crohn s Contribute equally in patients to development of product in the US and Europe Collaborate with OvaMed on manufacturing issues Steering Committee to oversee development - Consideration from Coronado to Falk 1M on transfer of Preclinical Know-how 1.5M on transfer of interim (blinded) results from Falk Phase II Crohn s trial 2.5M on transfer of final results from Falk Phase II Crohn s trial (expected in 2H 2012) 1% royalties on CNDO-201 sales in the Coronado territories for all indications Anticipate signing Collaboration Agreement in 1Q

15 3Q 2011 Filed IND in September with U.S. FDA 4Q 2011 Initiated Phase I dose escalation study 2Q 2012 Initiate Phase IIb Crohn s Study in U.S. 2H 2012 Initiate Phase II Multiple Sclerosis Study in U.S. 2H 2012 Total of 18 clinical trials completed, ongoing or planned including over 1000 patients 15

16 Indication Location Completed Ongoing Planned Design # Pts Sponsor Crohn s Univ. Iowa OL, Single arm 29 INV Crohn s Germany DB, PC 212 Falk Crohn s US 2Q 2012 DB, PC 200 CNDO Ulcerative colitis Ulcerative colitis Univ. Iowa Univ. Chicago DB, PC 54 INV 2H 2012 DB, PC 120 INV/NIH OL = Open Label DB = Double-Blind PC = Placebo-Controlled INV= Investigator Initiated 16

17 Indication Location Completed Ongoing Planned Design # Pts Sponsor MS MS Univ. Wisconsin Univ. Wisconsin OL, Single arm OL, Single arm MS Copenhagen OL, Single arm 5 INV 18 INV 10 INV MS Copenhagen DB, PC 80 INV MS Berlin 1Q 2012 DB, PC 50 INV MS US 2H 2012 DB, PC 200 CNDO OL = Open Label DB = Double-Blind PC = Placebo-Controlled INV= Investigator Initiated 17

18 Indication Location Completed Ongoing Planned Design # Pts Sponsor RA Univ. Albany 2Q 2012 DB, PC 20 INV/CNDO Psoriatic Arthritis Autism Seasonal allergy Tree Nut Allergy Tree Nut Allergy Israel OL, Single arm Montefiore, NYC 2Q 2012 DB, crossover 10 INV/CNDO 10 INV Copenhagen DB, PC 100 INV Harvard Univ. Harvard Univ. OL, Single arm OL, Single arm 5 INV 10 INV OL = Open Label DB = Double-Blind PC = Placebo-Controlled INV= Investigator Initiated 18

19 The mechanism of action of CNDO-201 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. Potential CNDO-201 Target Indications U.S./Japan Prevalence U.S./Japan Annual Market Sales (USD Mil) Ulcerative Colitis 712,000 $1,100 Crohn s Disease 585,000 $2,400 Multiple Sclerosis 400,000 $5,400 Sources: Decision Resources

20 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 Proof of principle established in patients with high-risk refractory or relapsed acute myeloid leukemia (AML) Preclinical activity demonstrated in multiple myeloma, breast cancer, prostate cancer and ovarian cancer Continuing to evaluate other tumor types 20

21 Activated ex vivo by tumor cell lysate Effective from autologous or allogeneic NK cell source Resting Donor NK Priming Signal 1 Trigger receptor Priming receptor Priming signal Triggering Signal 2 CNDO-109 Uniquely positioned in patients with minimal residual disease Remains active after freeze/thaw Primed Donor NK Serial Killer Priming receptor Trigger receptor Trigger ligand Patient s tumor Tumor lysis Primed Donor NK Priming receptor Trigger receptor Dead Tumor cell 21

22 Phase I 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 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 Kottaridis, et al., ASH

23 2Q 2012 Initiate Phase I/II allogeneic clinical trial for the treatment of relapsed AML Once the dose is selected, initiate a randomized Phase II 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) 23

24 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. Potential CNDO-109 Target Indications G7 Incidence G7 Market Sales (USD Mil) Mortality AML 28,500 $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 nd leading cause of cancer deaths in men G7 = U.S., U.K., Germany, France, Italy, Spain, Japan Sources: Decision Resources

25 Bobby W. Sandage, Jr., PhD President & Chief Executive Officer Served as EVP and 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 Glenn L. Cooper, MD Executive Chairman Served as Chairman and Chief Executive Officer 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 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 One of his start-up companies, Cougar Biotechnology, was recently acquired last year for $1 billion (all cash) by Johnson and Johnson, a record for a company with only Phase II data (oncology) 25

26 Listed on NASDAQ: CNDO December 19, 2011 Market Cap as of 1/5/2012 $116M Shares Outstanding 18.5M Additional 3.0M options and warrants Cash Position as of 9/30/11 $27M 26

27 CNDO-201 Initiated Phase I dose escalation study Completed Report results from Phase I safety study 1Q 2012 Initiate Phase IIb Crohn s trial 2Q 2012 Initiate Pilot study in Rheumatoid Arthritis 2Q 2012 Initiate Phase II MS trial 2H 2012 CNDO-109 Report final Phase I data in AML Completed Complete IND-enabling CMC Completed File IND 1Q 2012 Initiate US Phase I/II Study 2Q

28 Two biologic product candidates in clinical stage development - Focused on autoimmune diseases and cancer immunotherapy - Strong proprietary property position Novel treatment approaches with broad therapeutic applications addressing multi-billion dollar markets Completed four clinical trials - CNDO-201: Trichuris suis ova (TSO) in Crohn s Disease, Ulcerative Colitis (UC) and Multiple Sclerosis (MS) - CNDO-109: Tumor Activated NK Cells in relapsed Acute Myeloid Leukemia (AML) Recently completed binding Terms of Agreement with Falk and OvaMed propels Coronado into Phase II development Experienced management team and board of directors 28