curis inc nasdaq cris corporate presentation january 2006
Download
Skip this Video
Download Presentation
Curis, Inc. (NASDAQ: CRIS) Corporate Presentation January 2006

Loading in 2 Seconds...

play fullscreen
1 / 44

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


  • 529 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Curis, Inc. (NASDAQ: CRIS) Corporate Presentation January 2006' - Angelica


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
forward looking statements
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.

presentation outline
Presentation Outline

Business Model

Technology Overview

Collaborations and Product Candidates

Patents/Financials

curis business strategy
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
curis collaborative licensed programs
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)

curis model current
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)

curis proprietary programs
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.

presentation outline8
Presentation Outline

Business Model

Technology Overview

Collaborations and Product Candidates

Patents/Financials/Summary

stem cells are regulated by signaling pathways to build the body s tissues and organ systems
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

mutations in stem cells can lead to proliferation of cancer cells
Mutations in Stem Cells can Lead to Proliferation of Cancer Cells

Stem

Cells

Unregulated

Signaling

Pathways

CANCER

pathway antagonists can block cancer growth
Pathway Antagonists can Block Cancer Growth

Signaling

Pathway

Antagonist

Stem

Cells

Unregulated

Signaling

Pathways

CANCER

presentation outline12
Presentation Outline

Business Model

Technology Overview

Collaborations and Product Candidates

Patents/Financials/Summary

slide13
Hedgehog Pathway Antagonist Program

Basal Cell Carcinoma and

other Solid Tumor Cancers

Collaboration with

©2005 Curis Inc.

genentech hh antagonist collaboration
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

phase i trial for basal cell carcinoma
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
phase i trial for bcc updated
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
phase i trial for bcc options
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
other cancers associated with abnormal expression of hedgehog
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

abnormal hedgehog expression supports growth of certain cancers
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

curis antagonist technologies block the hedgehog pathway
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

genentech hedgehog antagonist collaboration anticipated milestones
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

slide22
Hair Growth Regulation

(Hedgehog Agonist Technologies)

Collaboration with

©2005 Curis Inc.

hedgehog pathway regulates initiation and maintenance of hair growth
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

small molecule hedgehog agonist promotes hair growth
Vehicle Treated

Agonist Treated

Small Molecule Hedgehog AgonistPromotes Hair Growth

One dose, topical application, day 13 after treatment

Source: internal Curis research

hair growth r d agreement with p g
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.
slide26
Hedgehog Pathway Agonist Program

Neurological and other Disorders

Collaboration with

©2005 Curis Inc.

©2003 Curis Inc.

wyeth hedgehog agonist collaboration
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.
hedgehog pathway is activated in response to nerve injury
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
small molecule hedgehog agonist reduces infarct size in stroke model
Infarct

Area

Vehicle

Small Molecule Hedgehog Agonist Reduces Infarct Size in Stroke Model

Stroke Neuroprotection Model

Hedgehog Agonist

Source: internal Curis research

wyeth hedgehog agonist collaboration anticipated milestones market
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

slide31
BMP Pathway Program

Kidney Disease and Associated Disorders

Licensed to

a subsidiary of

©2005 Curis Inc.

ortho biotech j j bmp license
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

the bmp 7 pathway promotes kidney function and prevents kidney disease related disorders
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

slide34
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

ortho biotech j j bmp license anticipated milestone market
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

slide36
Undisclosed Pathway

Antagonist/Agonist Program

Collaboration with

©2005 Curis Inc.

genentech undisclosed pathway antagonist agonist program
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.
curis proprietary programs38
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.

presentation outline39
Presentation Outline

Business Model

Technology Overview

Collaborations and Product Candidates

Patents/Financials

strong intellectual property position
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
financial data
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)

2005 achievements
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
upcoming milestones
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