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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 425
FILED BY CURIS, INC.
PURSUANT TO RULE 425 UNDER THE SECURITIES ACT OF 1933
SUBJECT COMPANY: CURIS, INC.
Date of Report: April 14, 2000
The statements in this presentation that are not historical facts are forward-
looking statements that involve risks and uncertainties including, without
limitation, risks associated with the inherent uncertainty of pharmaceutical
research, product development, regulatory approval and commercialization, the
impact of competitive products, patents, patent litigation, product liability,
third party reimbursement, required stockholder approvals and other risks and
uncertainties associated with the biotechnology industry and merger transactions
generally. For additional information concerning factors that could cause actual
results to differ materially, please refer to the risk factors section of
Creative BioMolecules, Inc.'s Form 10-K for the year ended 1999 and Curis,
Inc.'s Form S-4.
INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ THE JOINT PROXY
STATEMENT/PROSPECTUS REGARDING THE BUSINESS COMBINATION TRANSACTION REFERENCED
IN THE FOREGOING INFORMATION, WHEN IT BECOMES AVAILABLE, BECAUSE IT WILL CONTAIN
IMPORTANT INFORMATION. SUCH JOINT PROXY STATEMENT/PROSPECTUS WILL BE FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION BY CURIS, INC. INVESTORS AND SECURITY
HOLDERS MAY OBTAIN A FREE COPY OF THE JOINT PROXY STATEMENT/PROSPECTUS (WHEN
AVAILABLE) AND OTHER DOCUMENTS FILED BY CURIS, INC. AT THE COMMISSION'S WEB SITE
AT WWW.SEC.GOV. THE JOINT PROXY STATEMENT/PROSPECTUS AND SUCH OTHER DOCUMENTS
MAY ALSO BE OBTAINED DIRECTLY FROM CURIS, INC., CREATIVE BIOMOLECULES, INC.,
ONTOGENY, INC. AND REPROGENESIS, INC.
Curis Introductory Slide Presentation:
[CREATIVE BIOMOLECULES, INC. LOGO] [REPROGENESIS, INC. LOGO]
[ONTOGENY, INC. LOGO]
CURIS
REGENERATIVE THERAPEUTICS FROM FUNCTIONAL GENOMICS
AND
DEVELOPMENTAL BIOLOGY
SAFE HARBOR STATEMENT
THE STATEMENTS IN THIS PRESENTATION THAT ARE NOT HISTORICAL FACTS ARE
FORWARD-LOOKING STATEMENTS THAT INVOLVE RISKS AND UNCERTAINTIES INCLUDING,
WITHOUT LIMITATION, RISKS ASSOCIATED WITH THE INHERENT UNCERTAINTY OF
PHARMACEUTICAL RESEARCH, PRODUCT DEVELOPMENT, REGULATORY APPROVAL AND
COMMERCIALIZATION, THE IMPACT OF COMPETITIVE PRODUCTS, PATENTS, PATENT
LITIGATION, PRODUCT LIABILITY, THIRD PARTY REIMBURSEMENT AND OTHER RISKS
AND UNCERTAINTIES ASSOCIATED WITH THE BIOTECHNOLOGY INDUSTRY. FOR
ADDITIONAL INFORMATION CONCERNING FACTORS THAT COULD CAUSE ACTUAL RESULTS
TO DIFFER MATERIALLY, PLEASE REFER TO THE RISK FACTORS SECTION OF CREATIVE
BIOMOLECULES, INC.'S FORM 10-K FOR THE YEAR ENDED 1999 AND CURIS, INC.'S
FORM S-4.
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INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ THE JOINT PROXY
STATEMENT/PROSPECTUS REGARDING THE BUSINESS COMBINATION TRANSACTION
REFERENCED IN THE FOREGOING INFORMATION, WHEN IT BECOMES AVAILABLE, BECAUSE
IT WILL CONTAIN IMPORTANT INFORMATION. SUCH JOINT PROXY
STATEMENT/PROSPECTUS WILL BE FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION BY CURIS, INC.
INVESTORS AND SECURITY HOLDERS MAY OBTAIN A FREE COPY OF THE JOINT PROXY
STATEMENT/PROSPECTUS (WHEN AVAILABLE) AND OTHER DOCUMENTS FILED BY CURIS,
INC. AT THE COMMISSION'S WEB SITE AT WWW.SEC.GOV. THE JOINT PROXY
STATEMENT/PROSPECTUS AND SUCH OTHER DOCUMENTS MAY ALSO BE OBTAINED DIRECTLY
FROM CURIS, INC. CREATIVE BIOMOLECULES, INC., ONTOGENY, INC. AND
REPROGENESIS, INC.
CURIS HIGHLIGHTS
- - MERGER OF CREATIVE BIOMOLECULES (CBMI), ONTOGENY AND
REPROGENESIS
FOCUS ON REGENERATIVE MEDICINE PRODUCTS AND TECHNOLOGY
- - PRODUCT PIPELINE: PRECLINICAL TO PMA/BLA
- - MULTIPLE CORPORATE PARTNERSHIPS
- - TARGET CLOSE - JUNE 2000
- - 155 EMPLOYEES AND $70M CASH AT 12/31/99
- - CONSOLIDATE IN CAMBRIDGE AREA
REGENERATIVE MEDICINE
Developing therapies to repair and/or regenerate tissue to restore function.
REGENERATIVE MEDICINE
Slide includes images of proteins, cells, biomaterials, and small molecules
applied to repair or regenerate tissue function
CURIS OPPORTUNITIES
- - REGENERATIVE MEDICINE
- - ONCOLOGY
- - FUNCTIONAL GENOMICS
- - DEVELOPMENTAL BIOLOGY
CURIS CORE STRENGTHS
- - FUNCTIONAL GENOMICS DISCOVERY PLATFORM (ONTOGENY)
Developmental Biology
Proprietary biological assays and disease models
Genomics partners
- - KEY TECHNOLOGIES FOR REGENERATIVE MEDICINE
Protein factors (Ontogeny, CBMI)
Cell therapy technologies (Ontogeny, Reprogenesis)
Biomaterials and tissue engineering (Reprogenesis)
Small Molecule Screening (Ontogeny, CBMI)
CURIS PIPELINE
Slide includes chart of products in development by stage of development
OP-1 IMPLANT(TM)
- - PRODUCT
- OP-1 Implant(TM) family of products*
- - MARKET OPPORTUNITY
- Orthopaedic Reconstruction: more than 1.5 million procedures each year
in US
- - ADVANTAGE
- Replace invasive autograft harvest
- Stimulate bone formation
- - STATUS
- Filed for approval in US, Europe and Australia
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* Partnered with Stryker Corporation
CHONDROGEL(TM):
VESICOURETERAL REFLUX
- - PRODUCT
- Cell/matrix gel
- Augmentation with autologous cartilage
- - MARKET OPPORTUNITY
- 1% children affected
- - - $200M worldwide potential
- 10,000-15,000 procedures/yr. (U.S.)
- - ADVANTAGE
- Less invasive than surgery
- - STATUS: PHASE III
Slide includes image of bladder showing administration of product.
CHONDROGEL(TM):
PHASE III CLINICAL EVALUATION
Orphan drug status
DHHS clinical trial grant
Successful Phase II
23/29 patients completely resolved at 3 months
Phase III trial
49 patients enrolled (target 60)
complete enrollment by 1H'00
BLA target 1H'02
NEO-BLADDER FUNCTIONAL ORGAN REGENERATION
Children's Hospital/Harvard
Function at 11 months - canine studies
95% of normal capacity
Maintain compliance
Unmet need - bladder augmentation
Cancer, infection, trauma
500,000 patients with deficiency
20,000 surgeries/yr. (U.S.)
Current standard - bowel transplant
High donor site morbidity
High complication rate
Marginal efficacy
Phase II IND target: 2001
AUTOLOGOUS NEO-BLADDER
Biopsy patient bladder
Expand cells and combine with matrix
Surgically attach Neo-bladder
Vascularize with omentum
Slide includes image of bladder showing administration of product.
MAINTENANCE OF CAPACITY AND COMPLIANCE IN AUGMENTED BLADDER
Canine subtotal cystectomy model at 11 months
Slide shows images of bladder and charts % compliance with time after implant
Oberpenning et al., Nature Biotech, 17, 149, 1999
VASCUGEL (TM) - Restenosis in Coronary Artery Disease
Standard care is CABG or PTCA/Stent
. 450,000 CABG procedures U.S./yr
. 565,000 PTCA U.S./yr
. 395,000 Stents U.S./yr
Restenosis and thrombosis occur in 20%-40% of cases
Prevention requires delivery of multiple agents
Endothelial cells produce known anti-restenosis agents
HSPG, Prostacyclin
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Slide shows image of blocked artery
VASCUGEL (TM) DEVELOPMENT STATUS
Vein graft applications
Human endothelial cells
Initial indications is CABG
Phase I/II IND filing planned for 2000
NIST/ATP grant provides clinical support
Endovascular applications
Human endothelial cells
Initial indication in coronary stenting
Phase I/II IND filing planned for 2001
NIST/ATP Grant provides preclinical support
Slide shows image of equipment
PRECLINICAL REDUCTION IN RESTENOSIS AND THROMBOSIS
Porcine carotid balloon injury model
Slide shows charts of restenosis and thrombosis reduction
Nugent et al., Circulation Research 84, 4, 384, 1999
BASAL CELL CARCINOMA
Slide shows image of human body with basal cell carcinoma (BCC)
Gorlin et al., 1965
BASAL CELL CARCINOMA
Most common human cancer
U.S. incidence: 700,000 -900,000/year
Lifetime risk, caucasians: 1/4-1/3
UV induced
Increased risk with sun exposure
Heritable (BCNS): many tumors, early onset
Sporadic: few tumors, later onset
BASAL CELL CARCINOMA TIMELINE
1996: Mutation associated with disease
1997: Animal model validated
1998: Therapeutic program initiated
In vitro assay created and validated
Combinatorial chemistry libraries accessed
HTS completed and hits identified
1999: Optimization
2000: IND preparation
IPF1 CONTROLS PANCREATIC FORMATION
Slide shows image of pancreas buds
Data from H. Edlund and T. Edlund
IPF1(-) MICE HAVE NO PANCREAS
Mice lacking the IPF1 gene do not develop a pancreas and die soon after
birth, presumably from uncontrolled Type 1 diabetes
Slide shows image of mice
Jonsson, Carlsson, T. Edlund and H. Edlund.
October 13, 1994. Nature, 317, 606
MATURATION FACTOR REGULATES INSULIN SECRETION
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Slide shows image chart of insulin release/maturation factor
DECAY OF ISLET GLUCOSE RESPONSE IN VITRO
Slide shows graph of days in culture/insulin release
HEDGEHOG STIMULATES HAIR GROWTH
Slide shows image of mouse skin biopsy
Hh GENERATES HAIR GROWTH IN A DOSE RELATED MANNER
HEDGEHOG ACCELERATES HAIR GROWTH
Black mice, dyed blond, injected intradermally with adenovirus +/- Shh
insert
Accelerated growth of existing hair would appear as blond hair with "dark
roots"
Instead, acceleration of hair follicle maturation results in new all black
hair in Shh-treated mice
Slide shows image of hair growth in mice
Laboratory of Dr. Ronald Crystal, Cornell University
CURIS PIPELINE
Slide includes chart of products in development by stage of development
CURIS CORPORATE PARTNERS
- - BECTON DICKINSON Type I Diabetes
- - BIOGEN Neuro
- - COMGENEX CombiChem
- - GENZYME MOLECULAR ONCOLOGY SAGE, Genomics
- - INCYTE PHARMACEUTICALS Genomics
- - OXFORD ASYMMETRY CombiChem, Medicinal Chemistry
- - PERKIN ELMER'S TROPIX High Throughput Screening
- - STRYKER Orthopaedic
CURIS ACADEMIC COLLABORATIONS
- - BARNES/WASH U
- - BOSTON CHILDREN'S
- - COLUMBIA
- - HARVARD
- - HARVARD MEDICAL
- - JOHNS HOPKINS
- - MICHIGAN
- - MIAMI PROJECT
- - MGH
- - MIT
- - NIH
- - STANFORD
- - UCSF
- - UMASS
- - VANDERBILT
- - WHITEHEAD
CURIS MANAGEMENT TEAM
- - DOROS PLATIKA, M.D. President and CEO
- Progenitor, Mass General Hospital/Harvard, Whitehead/MIT
- - LYNN BAIRD, PH.D., VP Preclinical and Regulatory
- CytoTherapeutics, Johnson & Johnson
- - GEORGE ELDRIDGE, VP Finance and CFO
- Boston Life Sciences, Kidder Peabody
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- - FRANK GENTILE, PH.D., VP Program Management
- CytoTherapeutics, ETH-Zurich
- - BRUCE LEICHER, VP and General Counsel
- Genetics Institute, BBN
- - LEE RUBIN, PH.D., VP Research
- Eisai, Athena Neurosciences
- - JAMES SIGLER, VP Manufacturing
- Genzyme Tissue Repair, United States Navy
BOARD OF DIRECTORS
- MARTYN D. GREENACRE, President and CEO, Delsys Pharmaceutical Corp.;
SmithKline Beacham
- RUTH B. KUNATH, Vulcan Northwest, Inc.
- JAMES R. MCNAB, JR., Chairman, Reprogenesis
- DOUGLAS A. MELTON, PH.D., Chair, Department of Molecular and Cellular
Biology, Harvard University; Gilead
- DOROS PLATIKA, M.D., current President and CEO, Ontogeny, Inc.;
future President and CEO, Curis, Inc.
- MICHAEL ROSENBLATT, M.D., Harvard Medical School and Interim
President, Beth Israel Deaconess Medical Center; Merck
- JAMES R. TOBIN, President and CEO, Boston Scientific; Biogen; Baxter
CURIS SUMMARY
Regenerative medicine company of the future
Potential powerhouse with:
Product under regulatory review in US, Europe and Australia
Multiple products in late-stage clinical development
Numerous early clinical and advanced pre-clinical products
Discovery engine that combines functional genomics and developmental
biology
More than 150 issued patents and 225 pending patent application worldwide
[Creative BioMolecules, Reprogenesis and Ontogeny logos]
CURIS
Regenerative Therapeutics from
Functional Genomics and
Developmental Biology
