Coronado Corporate Presentation - September 2011 Rodman and Renshaw Conference

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Coronado Biosciences is engaged in the development of novel immunotherapy biologic agents. The Company's two principal pharmaceutical product candidates in clinical development are: CNDO-201, a biologic for the treatment of autoimmune diseases, such as Crohn's disease, ulcerative colitis and multiple sclerosis; and CNDO-109, a biologic that activates natural killer cells, for the treatment of acute myeloid leukemia and solid tumors.

The Company recently completed a $25.8 million round of financing and is using the proceeds to advance its pipeline, including funding Phase II double-blind, placebo controlled trial of CNDO-201 for the treatment of Crohn's Disease scheduled for initiation in early 2012 and a Phase I/II dose escalation and expansion trial of CNDO-109 for the treatment of relapsed Acute Myeloid Leukemia (AML) planned for 2012. Each of these drugs is a novel therapy that has achieved clinical proof-of-concept in indications with unmet medical needs.

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Coronado Corporate Presentation - September 2011 Rodman and Renshaw Conference

  1. 1. Coronado BiosciencesCorporate PresentationSeptember 2011<br />Bobby W. Sandage, Jr., PhD President & Chief Executive Officer<br />
  2. 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 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 include those set forth in our Registration Statement on Form 10 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; 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.<br />2<br />Forward Looking Statements<br />
  3. 3. Focused on autoimmune diseases and cancer immunotherapy<br />Two biologic product candidates in clinical stage development<br />Novel treatment approach with broad therapeutic applications addressing multi-billion dollar markets<br />Completed four clinical trials<br />CNDO-201: Trichuris suisova (TSO) in Crohn’s Disease, Ulcerative Colitis (UC) and Multiple Sclerosis (MS)<br />CNDO-109: Tumor Activated NK Cells in relapsed Acute Myeloid Leukemia (AML)<br />Strong proprietary property position<br />Experienced management team and board of directors<br />3<br />Company and Product Highlights<br />
  4. 4. CNDO-201 (TSO)<br /> Compound & Indication Preclinical Phase I Phase IIa Phase IIb<br />Crohn’s Disease<br />Coronado Biosciences Pipeline<br />Initiate P2 1Q 2012<br />Ulcerative Colitis<br />Multiple Sclerosis<br />CNDO-109 (Tumor Activated NK Cells)<br /> Compound & Indication Preclinical Phase I Phase IIa Phase IIb<br />Relapsed AML <br />Initiate P 1/2 2012 <br />Multiple Myeloma<br />Solid Tumors<br />4<br />
  5. 5. Porcine whipworm ova<br />Represents a novel approach to treating autoimmune diseases – the “Hygiene Hypothesis”<br />Natural immunomodulator - regulates T-Cells (Th1 and Th2) and inflammatory cytokines<br />Proof of principle established in inflammatory bowel disease and MS<br />Natural properties suggest strong potential for a safe profile – not associated with risks of immunosuppressant drugs<br />Oral bi-weekly administration<br />Initial indications have well established clinical trial pathways<br />North and South America and Japanese rights for all indications from OvaMed<br />5<br />CNDO-201: Trichuris suisova (TSO)<br />European rights to TSO for GI indications have been license to Dr. Falk Pharma, who has initiated a Phase II trial in Crohn’s Disease<br />
  6. 6. 6<br />Rapid Emergence of Immune-Related Diseases<br /> Bach NEJM 2002<br />
  7. 7. 7<br />Distribution of Autoimmune Disorders and Helminths<br />Autoimmune disorders incidence<br />Helminths infestation incidence<br />High<br />High<br />Moderate<br />Moderate<br />Low<br />Low<br />Epidemiological data demonstrate:<br />Various immunological and autoimmune diseases are much less common in the developing world than the industrialized world<br />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<br />
  8. 8. The Hygiene Hypothesis<br />Viral, bacterial and protozoan infections<br />Excess<br />Th1<br />Crohn’s Disease, Ulcerative Colitis, Multiple Sclerosis & other autoimmune diseases<br />GENETIC PREDISPOSITION<br />POOR SANITATION,IMPURE FOOD <br />AND CROWDED LIVING CONDITIONS<br /> 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 Th1 and Th2 responses<br />Helminthic and bacterial exposures<br />Immune Regulation<br />Inhibits<br />Excess<br />Reactivity<br />(Prevents)<br />(Weinstock and Elliott, Inflamm Bowel Dis, Jan 2009)<br />8<br />
  9. 9. <ul><li>Does not multiply in human host
  10. 10. Colonization is self-limited in humans
  11. 11. No systemic phase
  12. 12. No direct transmission
  13. 13. Ova stable</li></ul>9<br />Benefits of Trichuris suis ova (TSO)<br />
  14. 14. 10<br />Effect of TSO in Crohn’s Disease Patients<br />79.3<br />75.9<br />72.4<br />62.1<br />Summers, et.al., GUT 2005<br />
  15. 15. 11<br />Effect of TSO in Ulcerative Colitis Patients<br />% of Patients Achieving a Response<br />44.8<br />P=0.04<br />43.3<br />P=0.04<br />17.4<br />16.7<br />Summers, et.al., Gastroenterology 2005<br />
  16. 16. 2H 2011<br />File IND with U.S. FDA<br />Phase I dose escalation study<br />36 Crohn's disease patients (3 placebo and 9 treated per cohort)<br />500, 2500 and 7500 TSO single dose<br />Dose escalated every 2 weeks<br />Results- December 2011<br />1Q 2012<br />Initiate Phase II Crohn’s Study in U.S.<br />12<br />Next Steps for TSO in IBD<br />
  17. 17. The Impact of Parasitic Infections on the Course of Multiple Sclerosis<br />Antihelminth<br />Treatment<br /> (n=4)<br />Antihelminth<br />Treatment<br /> (n=4)<br />12 patients/group<br />Correale J, Farez MF. J Neuroimmunol. 2011;233:6 <br />
  18. 18. 14<br />Effect of TSO in Multiple Sclerosis Patients<br />Fleming, et.al., Multiple Sclerosis Journal 2011<br />
  19. 19. HINT 2 (open label)<br />Enrolling 18 subjects<br />2500 Trichuris suis ova every 2 weeks for 10 months<br />University of Wisconsin<br />Top-line data expected in 2H2012<br />TRIMS A (open label)<br />Enrolled 10 patients<br />2500 Trichuris suis ova every 2 weeks for 12 weeks<br />Rigshospitalet, Danish Multiple Sclerosis Research Center <br />Abstract presentation October 2011<br />TRIMS B (double-blind placebo controlled)<br />To enroll 80 patients<br />2500 Trichuris suis ova every 2 weeks for 12 months<br />Rigshospitalet, Danish Multiple Sclerosis Research Center <br />Enrollment initiation targeted for 4Q2011<br />15<br />On-going Investigator Sponsored Trials in MS<br />
  20. 20. NK cells represent the key component of the body’s innate immune surveillance system<br />Safe, effective activation of these NK cells in cancer patients remain a long sought after goal in oncology therapy <br />Membrane lysate preparation (CNDO-109) derived from a well characterized lymphoblastic leukemia cell line (CTV-1)<br />Primes NK cells without triggering NK-mediated lysing<br />Activation with CNDO-109 does not require toxic cytokines or long-term culture/expansion, and does not change NK cell phenotypes<br />Proof of principle established in patients with high-risk refractory or relapsed acute myeloid leukemia (AML)<br />Preclinical activity demonstrated in multiple myeloma, breast cancer, prostate cancer and ovarian cancer<br />Continuing to evaluate other tumor types <br />16<br />CNDO-109: Activated Natural Killer Cells<br />
  21. 21. 17<br />CNDO-109 Mechanism of Action<br />CNDO-109<br />Priming<br />signal<br />Resting<br />Donor NK<br />Primed<br />Donor NK<br />Primed<br />Donor NK<br />Priming<br />receptor<br />Trigger<br />receptor<br />Priming – Signal 1<br />Activated ex vivo by CTV-1<br />Effective from autologous or allogeneic NK cell source<br />Easier to make, more potent, and durable than cytokine (IL-2) primed NK cells<br />Uniquely positioned in patients with “minimal residual disease”<br />Remains active after freeze/thaw<br />Patient’s<br />tumor<br />Triggering – Signal 2<br />Priming<br />receptor<br />Trigger<br />receptor<br />Trigger<br />ligand<br />Tumor lysis<br />“Serial Killer”<br />Dead <br />Tumor<br />cell<br />Priming<br />receptor<br />Trigger<br />receptor<br />
  22. 22. Phase I investigator sponsored open-label trial<br />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<br />Enrolled 7 AML patients in complete remission (CR) following multiple relapses and/or high-risk<br />18<br />CNDO-109 Phase I Study in AML<br />
  23. 23. Final Phase I UK clinical trial results reported in 4Q2011<br />File IND in U.S. in early 2012<br />Initiate Phase 1/2 allogeneic clinical trial for the treatment of relapsed AML<br />Potential for regulatory approval with single randomized, controlled clinical trial if data are clinically meaningful and statistically persuasive<br />Once the dose is selected, initiate a randomized phase 2 trial<br />Future autologous studies planned in other tumor types (including multiple myeloma, breast, ovarian and prostate)<br />19<br />CNDO-109 Next Steps<br />
  24. 24. Bobby W. Sandage, Jr., PhD – President & Chief Executive Officer<br />Served as EVP and CSO of Indevus Pharmaceuticals, Inc.<br />Over 30 years of pharmaceutical/biotechnology experience<br />Glenn L. Cooper, MD – Executive Chairman<br />Served as Chairman and Chief Executive Officer of Indevus Pharmaceuticals, Inc.<br />Over 25 years of Pharmaceutical/Biotechnology experience<br />Eric K. Rowinsky, MD – Vice Chairman <br />World renown oncologist, former CMO at ImClone, board of Biogen/Idec<br />Over 25 years of Healthcare experience<br />Lindsay Rosenwald, MD – Director and Founder<br />A prolific and successful investor in the Life Sciences industry for over 20 years<br />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 2 data (oncology)<br />20<br />Key Management and Board Members<br />
  25. 25. <ul><li>Investment to-date $65M
  26. 26. Shares Outstanding 18,524,245
  27. 27. Cash Position $29M
  28. 28. Filed Form 10 to become July 15, 2011</li></ul> public reporting company<br /><ul><li>Trading on Major ExchangeDecember 2011</li></ul>21<br />Financialsas of 7/15/2011<br />
  29. 29. CNDO-201 <br />File IND submission 3Q 2011<br />Report results from Phase I safety study 4Q 2011<br />Report additional Phase 1 MS data 4Q 2011<br />Initiate Phase 2b Crohn’s trial 1Q 2012<br />CNDO-109<br />Report final Phase 1 data in AML 4Q 2011<br />Complete IND-enabling CMC 4Q 2011<br />File IND submission 1Q 2012<br />Initiate US Phase 1/2 Study 1H 2012<br />22<br />Upcoming Milestones<br />
  30. 30. Focused on autoimmune diseases and cancer immunotherapy<br />Two biologic product candidates in clinical stage development<br />Novel treatment approach with broad therapeutic applications addressing multi-billion dollar markets<br />Completed four clinical trials<br />CNDO-201: Trichuris suisova (TSO) in Crohn’s Disease, Ulcerative Colitis (UC) and Multiple Sclerosis (MS)<br />CNDO-109: Tumor Activated NK Cells in relapsed Acute Myeloid Leukemia (AML)<br />Strong proprietary property position<br />Experienced management team and board of directors<br />23<br />Investment Highlights<br />

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