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Curis, Inc. (NASDAQ: CRIS) Corporate Presentation January 2006

Curis, Inc. (NASDAQ: CRIS) Corporate Presentation January 2006. Forward Looking Statements.

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Curis, Inc. (NASDAQ: CRIS) Corporate Presentation January 2006

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  1. Curis, Inc. (NASDAQ: CRIS) Corporate PresentationJanuary 2006

  2. Forward Looking Statements This presentation contains statements about Curis’s future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks relating to: both our and our collaborators’ ability to successfully research, obtain regulatory approvals for, develop and commercialize products based upon our technologies, including with respect to our lead product candidate for the treatment of basal cell carcinoma; our ability to obtain and maintain proprietary protection for our technologies and product candidates; competitive pressures; our ability to maintain strategic collaborations, including with Genentech, Ortho Biotech and Wyeth; our ability to raise additional funds to finance our operations, including our obligations under our co-development arrangement with Genetech; and those factors described in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, and other reports that we file with SEC. The forward-looking statements included in this presentation represent our views as of the date of this presentation. We anticipate that subsequent events and developments will cause our views to change. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation.

  3. Presentation Outline Business Model Technology Overview Collaborations and Product Candidates Patents/Financials

  4. Curis Business Strategy • Research expertise allows Curis to sign high-value agreements with top-tier biotech and pharma companies for late-stage preclinical candidates • Diverse collaboration structures allow for calculated risk assumption and retained technology rights • Curis is co-developing a skin cancer product with Genentech • Co-development option on hair growth program with P&G • Portfolio approach results in product diversity (i.e., technology platform, compound type, and target indication) • Payments from collaborators lessen future dependence on capital markets • Cash milestones under top five deals total ~$750 million • Research capabilities ensure pipeline of new drug development candidates

  5. Curis Collaborative / Licensed Programs Collaborator Technology Compound Primary Indication Hh pathway Small molecule Basal cell carcinoma antagonist (topical formulation) Hh pathway Sm. mol. Antag. Other solid tumors and antibodies (systemic formulation) Hh pathway Small molecule Stroke and other agonist neurological disorders BMP pathway Protein agonist Chronic kidney disease and related disorders Undisclosed Small molecule Not disclosed pathway antagonist Undisclosed Small molecule Not disclosed pathway agonist Hh pathway Small molecule Hair growth agonist (topical delivery)

  6. I II III Curis Model: Current TargetValid Med Chem Discovery Preclinical IND Products Clinical Phases HTS Early Late Mid BCC Co-Dev’t PYY Obesity BMP-7 Kidney Hh Oncology 10 FTEs Hh Neurology 8 FTEs Hair Re- Growth (Co-Dev’t Option) 2 FTEs Cardio 12 FTEs (Genentech Discovery) SMA 8 FTEs (SMA) Stem Cell Assays 2 FTEs (Centocor)

  7. Curis Proprietary Programs Curis Program Technology Compound Primary Indication Discovery Small Spinal Muscular Screening Molecules Atrophy (1) Hh pathway Nucleic Acid Cardiovascular (local delivery) Discovery Small Not disclosed Screening Molecules Discovery Small BMP-7 Agonists (2) Screening Molecules (1) Supported by a $5.4 million grant from the Spinal Muscular Atrophy Foundation. Any compounds derived from SMA program are owned by Curis. (2) Screening efforts are partially funding by Centocor, a subsidiary of Johnson & Johnson. Curis will own any small molecule compounds discovered and Centocor will have a right to first negotiation for a further collaboration.

  8. Presentation Outline Business Model Technology Overview Collaborations and Product Candidates Patents/Financials/Summary

  9. Stem Cells are Regulated by Signaling Pathways to Build the Body’s Tissues and Organ Systems Stem Cells Progenitor Cells Specialized Cells S i g n a l i n g P a t h w a y s

  10. Mutations in Stem Cells can Lead to Proliferation of Cancer Cells Stem Cells Unregulated Signaling Pathways CANCER

  11. Pathway Antagonists can Block Cancer Growth Signaling Pathway Antagonist Stem Cells Unregulated Signaling Pathways CANCER

  12. Presentation Outline Business Model Technology Overview Collaborations and Product Candidates Patents/Financials/Summary

  13. Hedgehog Pathway Antagonist Program Basal Cell Carcinoma and other Solid Tumor Cancers Collaboration with ©2005 Curis Inc.

  14. Genentech Hh Antagonist Collaboration Established: June 2003 Deal structure: $8.5 million up-front payment, development milestones, product royalties, minimum two years R&D support, BCC co- development option in U.S. Primary indications: Topical treatment for basal cell carcinoma (co-development program with Curis) and systemic treatment of other solid tumors

  15. Phase I Trial for Basal Cell Carcinoma • The Phase I study is a double-blind, randomized, placebo-controlled study that will enroll approximately 60 patients • The primary outcomes measured in this trial will be the safety and tolerability of a multi-dose regimen of the Hedgehog antagonist • Curis and Genentech are also evaluating clinical activity of the drug candidate • Clinical activity is defined as complete eradication of the treated basal cell carcinoma lesion • The trial contains three segments including a dose-escalation segment, an expansion of the maximum dose group from the dose-escalation segment, and a biological activity segment

  16. Phase I Trial for BCC Updated • The dose-escalation segment of the trial has recently completed • Preliminary data from the dose-escalation segment suggest that the drug candidate appears to be safe and well tolerated and, while some clinical activity was observed, it was less than anticipated • Enrollment in expansion of the “maximum dose group” segment of the trial has been temporarily suspended • Patients are being enrolled in the third segment of the clinical trial, designed to examine the biologic activity of the drug candidate • Curis expects that the trial will be completed in the first half of 2006 • At the conclusion of the Phase I trial, Genentech and Curis will make a decision about whether or not to move to a Phase II trial

  17. Phase I Trial for BCC Options If the current drug candidate does not advance into Phase II clinical trials, there are several possible development scenarios including, but not limited to, the following: • Extend the duration of the treatment regimen of the existing drug candidate (as formulated) • Reformulate the current drug candidate for a new Phase I trial with a topical formulation • Use one of the additional compounds licensed to Genentech for a new Phase I trial with a topical formulation • Return the compounds to Curis for internal development • Cease the BCC program all together, but maintain the other programs for solid tumors and the undisclosed pathway

  18. Other Cancers Associated with Abnormal Expression of Hedgehog Medulloblastoma1 Small Cell Lung Cancer 2 Pancreatic Carcinoma 3,4 Stomach Cancer 4 Esophageal Cancer 4 Colorectal Cancer 5 Prostate Cancer 6,7,8 Breast Cancer 9 1 Romer et al, 2004, 2 Watkins et al, 2003, 3 Thayer et al, 2003, 4 Berman et al, 2003, 5 Qualtrough et al 2004, 6 Fan et al, 2004, 7 Karhadkar et al, 2004, 8 Sanchez et al, 2004, 9Kubo et al, 2004

  19. Certain Cancers Hedgehog Protein Angiogenesis Factors VEGF Ang-1 Ang-2 Growth Factors IGF-I BDNF NGF Abnormal Hedgehog Expression Supports Growth of Certain Cancers Adjacent Stromal Cells

  20. Angiogenesis Factors VEGF Ang-1 Ang-2 Growth Factors IGF-I BDNF NGF Curis Antagonist Technologies Block the Hedgehog Pathway Certain Cancers Small Molecules Hedgehog Protein Antibodies Adjacent Stromal Cells

  21. Genentech Hedgehog Antagonist Collaboration: Anticipated Milestones Selection of lead drug October 2005 completed development candidate for other solid tumors First IND filing Curis estimates second for other solid tumors half of 2006 (cash milestone payment) Data from BCC First half of 2006 Phase I trial

  22. Hair Growth Regulation (Hedgehog Agonist Technologies) Collaboration with ©2005 Curis Inc.

  23. Hair Growth Model Day 4 Day 4 Day 7 Stimulated Hair Follicles Replicating Hair Follicle Cells New Hair Shaft Growing Hedgehog Pathway Regulates Initiationand Maintenance of Hair Growth Source: internal Curis research

  24. Vehicle Treated Agonist Treated Small Molecule Hedgehog AgonistPromotes Hair Growth One dose, topical application, day 13 after treatment Source: internal Curis research

  25. Hair Growth R&D Agreement with P&G • Curis could receive more than $100 million in milestone payments, in addition to royalties and research support. • P&G receives a worldwide exclusive license to Curis’ Hedgehog agonist technology for dermatological indications. • At the time of IND filing, Curis will have the option to co-develop a product candidate through Phases 1 and 2 of clinical development. • Curis receives $0.5 million in an upfront payment and $2.8 million in preclinical milestones, contingent upon achievement of certain preclinical goals.

  26. Hedgehog Pathway Agonist Program Neurological and other Disorders Collaboration with ©2005 Curis Inc. ©2003 Curis Inc.

  27. Wyeth Hedgehog Agonist Collaboration Established: January 2004 Deal structure: $3 million up-front payment, development milestones of up to $170 million, product royalties, minimum two years R&D support (1) Primary indications: Stroke and other neurological disorders • – Development milestone total is based on the successful development • and regulatory approval of two products.

  28. BLUE staining denotes presence of Hedgehog Relative Level of Hedgehog mRNA 600 400 Day 0 Day 1 200 0 0 1 3 7 13 Time After Injury (days) Source: internal Curis research Hedgehog Pathway is Activated in Response to Nerve Injury

  29. Infarct Area Vehicle Small Molecule Hedgehog Agonist Reduces Infarct Size in Stroke Model Stroke Neuroprotection Model Hedgehog Agonist Source: internal Curis research

  30. Wyeth Hedgehog Agonist Collaboration: Anticipated Milestones - Market Selection of Lead : Curis estimates 2006-2007 IND candidate(cash milestone payment) Disease incidence: Approximately 700,000 patients suffer a stroke each year in U.S.1 Marketing advantage: Presently no effective therapies for treating stroke 1 American Heart Association, Heart Disease and Stroke Statistics – 2005 Update

  31. BMP Pathway Program Kidney Disease and Associated Disorders Licensed to a subsidiary of ©2005 Curis Inc.

  32. Ortho Biotech (J&J) BMP License Established: November 2002 Transitioned to Centocor in 2005 Deal structure: $3.5 million up-front payment, development milestones including $30 million on NDA approval, product royalties Primary indications: Chronic kidney disease and disorders associated with end stage renal disease

  33. The BMP-7 Pathway Promotes Kidney Function and Prevents Kidney Disease Related Disorders BMP-7 maintains kidney structure and function BMP-7 promotes skeletal mineralization BMP-7 prevents vascular calcification

  34. BMP-7 Prevents Development of MetabolicBone Disease and Vascular Calcification Chronic Kidney Disease Model Vascular Calcification Bone Formation Rate 12 **p<0.05 vs disease ** 8 *p<0.05 vs normal ***p<0.01 * 4 *** 0 Normal Disease Untreated Disease + BMP-7 Source: Lund et al, 2004 and Davies et al, 2003

  35. Ortho Biotech (J&J) BMP License: Anticipated Milestone - Market Estimated IND filing: 2007-2008 1 Disease incidence: Approximately 423,000 patients have end-stage renal disease in U.S.2 Marketing advantage: Presently no effective therapies for treating renal disease and associated complications 1 BMP development recently transferred to Centocor (a separate division of Johnson & Johnson). 2 U.S. Renal Data System, 2004 Annual Report

  36. Undisclosed Pathway Antagonist/Agonist Program Collaboration with ©2005 Curis Inc.

  37. Genentech Undisclosed Pathway Antagonist/Agonist Program Established: April 2005 Deal structure: $3 million up-front payment, development milestones of up to $140 million, product royalties, minimum two years R&D support ($6M) (1) Primary indications: Antagonist: not disclosed Agonist: not disclosed • – Development milestone total is based on the successful development • and regulatory approval of two products in each of the agonist and antagonist • programs.

  38. Curis Proprietary Programs Curis Program Technology Compound Primary Indication Discovery Small Spinal Muscular Screening Molecules Atrophy (1) Hh pathway Nucleic Acid Cardiovascular (local delivery) Discovery Small Not disclosed Screening Molecules Discovery Small BMP-7 Agonists (2) Screening Molecules (1) Supported by a $5.4 million grant from the Spinal Muscular Atrophy Foundation. Any compounds derived from SMA program are owned by Curis. (2) Screening efforts are partially funding by Centocor, a subsidiary of Johnson & Johnson. Curis will own any small molecule compounds discovered and Centocor will have a right to first negotiation for a further collaboration.

  39. Presentation Outline Business Model Technology Overview Collaborations and Product Candidates Patents/Financials

  40. Strong Intellectual Property Position • Approximately 200 US patents issued or allowed and over 100 pending in U.S. Approximately 300 foreign patents issued or allowed and 350 foreign patents pending • Compositions of matter covering signaling proteins, receptors, antibodies, small molecule agonists and antagonists, and others • Fields of medical use including renal disorders, metabolic bone diseases, neurology, oncology, cardiovascular disease, alopecia, and others • Methods of screening for small molecules, manufacture, proliferation, purification, differentiation, and others

  41. Financial Data September 30, 2005 (amounts in 000’s except per share data) Cash, cash equivalents, investments $ 42,800 Accounts receivable $ 2,000 Convertible debt $ 2,500 Other debt $ 2,800 Shareholders’ equity $ 41,500 Basic shares outstanding 48,300 Fully diluted shares outstanding 60,100 YTD loss per share $ (0.28)

  42. 2005 Achievements • Signed collaboration with P&G for hair growth • Start of Phase I trial in BCC with Genentech • Co-development deal signed with Genentech for BCC • Second development deal signed with Genentech • Extended funding granted from Genentech for solid tumor program • Development milestone achieved with Wyeth for neurological disorders; funding extension • Expansion of relationship with Centocor • Hair growth data published in Journal of Investigational Dermatology

  43. Upcoming Milestones Genentech Collaboration - Cancer Data from BCC Phase I trial 1H 2006 First IND filing for other solid tumors 2H2006 Wyeth Collaboration – Stroke Possible selection of lead candidate 2006 P&G Collaboration – Hair Growth Preclinical milestones ($2.8M) 2006+ CV, SMA and other Programs Research and discovery ongoing

  44. Curis, Inc. (NASDAQ: CRIS) Corporate Presentation January 2006

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