<PAGE>
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: March 6, 2000
The statements in this press release/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.
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.
<PAGE>
PRESS RELEASE
CURIS, INC. TO BE FORMED BY THE MERGER OF THREE BOSTON BIOTECHNOLOGY COMPANIES
-- Creative BioMolecules, Ontogeny and Reprogenesis Create the
Regenerative Medicine Company of the Future --
CAMBRIDGE AND HOPKINTON, MA: February 15, 2000: Creative BioMolecules, Inc.
(NASDAQ: CBMI), Ontogeny, Inc. and Reprogenesis, Inc. announced today that they
will merge to form Curis, Inc. The combination of these companies will create a
leader in the emerging field of regenerative medicine. Following the close of
the transaction, Curis will have:
- - a product which is currently under regulatory review in the United
States, Europe and Australia;
- - multiple products in late-stage clinical development;
- - numerous early clinical and late-stage pre-clinical products; and
- - a discovery engine that combines functional genomics and developmental
biology across multiple medical indications.
These products have the potential to change the way degenerative disease, cancer
and other disorders associated with loss of function are treated.
Curis' near-term commercial opportunities will include the OP-1 Implant(TM)
family of products which are being developed by Stryker Corporation for
orthopaedic reconstruction. The first product has been submitted for marketing
approval in the United States, Europe and Australia. Additional clinical trials
are ongoing to broaden the OP-1 Implant's(TM) use in the areas of fresh
fractures, spinal fusion and periodontal disease. Curis' lead internal products
will be in the treatment of urological disorders. Chondrogel(TM), for the
treatment of vesicoureteral reflux -- a serious pediatric urological disorder --
is in a pivotal Phase III trial. Additional tissue engineered products are also
under clinical evaluation. Curis' pre-clinical pipeline will include products
that treat cardiovascular disease, stroke and skin cancer. The discovery engine
has identified product opportunities in diabetes, peripheral neuropathy and hair
growth. These product opportunities demonstrate how Curis will be a solution to
the challenge of extracting value from the data being created by the human
genome program.
<PAGE>
Under the terms of the merger, which is subject to shareholder and regulatory
approval, Creative BioMolecules' shareholders will receive three Curis shares
for every ten shares of Creative BioMolecules. Following completion of the
transaction, Creative BioMolecules' shareholders will hold approximately 43%,
Ontogeny's shareholders will hold approximately 38% and Reprogenesis'
shareholders will hold approximately 19% of Curis. Based upon the closing sales
price of Creative BioMolecules on February 14, 2000, Curis would have a market
capitalization of approximately $600 million. The merger is expected to close in
June 2000.
"Curis will be positioned to identify and successfully commercialize therapeutic
opportunities derived from the human genome program," said Doros Platika, MD,
president and chief executive officer of Ontogeny who will serve as president
and chief executive officer of Curis. "The technologies at Curis will represent
a powerful system to identify target genes that may restore function through
repair and regeneration. Curis' technology platform has already identified
protein, small molecule and stem cell product opportunities. The Company is
further backed by leading corporate partners and sustainable financial strength,
including near-term product revenue opportunities."
"By combining a powerful discovery engine with a late-stage product pipeline,
this merger is the best way to build a sustainable business that will provide
significant value to our shareholders," commented Michael M. Tarnow, president
and chief executive officer of Creative BioMolecules. "Curis' products and
product opportunities will address unmet needs in major therapeutic areas."
"Curis' late-stage work in the urology field provides the opportunity for the
Company to develop a proprietary sales and marketing organization," said Daniel
R. Omstead, Eng.ScD., president and chief executive officer of Reprogenesis.
"Curis' development pipeline will continue to add meaningful therapies which
will be pursued on a proprietary basis or in conjunction with major corporate
partners."
Regenerative medicine seeks to recreate conditions that support the growth of
cells and tissue to repair or regenerate tissue that is lost due to trauma or
degenerative disease. Combining insight gained through the study of
developmental biology with high-throughput screening capabilities and
biocompatible materials enables the development of cell therapies, orthopaedic
implants, protein and growth factor therapeutics and small molecule compounds.
These therapies are designed to treat the underlying cause of degenerative
disease by replacing lost function.
Creative BioMolecules, Inc. is a biopharmaceutical company focused on the
development of therapies for human tissue regeneration. The Company's core
technologies are based on our understanding of the role
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<PAGE>
that morphogenic proteins play in human biology. These proteins are involved in
the initiation and regulation of the cellular events responsible for the
formation of human tissues and organs. The first product resulting from Creative
BioMolecules' technology, the OP-1 Implant(TM) for orthopaedic reconstruction,
is licensed to Stryker Corporation and is under regulatory review for approval
in the United States, Europe and Australia.
Ontogeny, Inc., located in Cambridge, Massachusetts is a privately-held company
whose mission is to become the preeminent biopharmaceutical company focused on
translating developmental biology insights into regenerative medicine therapies
that will significantly improve the quality of life by activating the body's
ability to repair and regenerate, or to specifically control abnormal and
malignant growth. The Company is developing therapeutics for neurological
diseases including Parkinson's and Alzheimer's diseases, diabetes and
dermatological disorders including skin cancer and hair growth.
Reprogenesis, Inc., located in Cambridge, Massachusetts, is a privately held
biotechnology company which intends to be the leader in the development of
tissue engineered therapies to treat unmet medical needs. The Company has
proprietary technology utilizing the combination of cells and biomaterials to
restore, repair or replace lost tissue or physiological function. The Company
has a broad preclinical and clinical pipeline of products in the areas of
urology, cardiovascular biology and plastic and reconstructive surgery.
Chondrogel(TM) is its most advanced product. This product is in a Phase III
clinical trial and is used to treat vesicoureteral reflux, a congenital
urological disorder that affects 1% of all children.
####
Contact:
Karla MacDonald
Manager, Corporate Communications
Tel.: 617.912.2953
Fax: 617.912.2994
Steven L. Basta
VP, Finance and Business Development
Tel.: 617.912.2950
Fax: 617.912.2991
Creative BioMolecules, Inc.
101 Huntington Ave.
Suite 2400
Boston, MA 02199
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<PAGE>
http://www.creativebio.com
CURIS FACT SHEET
ABOUT CURIS
Curis, Inc. will be formed by leveraging the combined strengths of Creative
BioMolecules, Ontogeny and Reprogenesis to create the regenerative medicine
company of the future. Curis will combine a powerful functional genomics and
developmental biology discovery engine with a robust pipeline of near-term
commercial, late-stage clinical and earlier stage developmental opportunities.
The Company is further backed by leading corporate partners and sustainable
financial strength, including near-term product revenue opportunities.
REGENERATIVE MEDICINE
Regenerative medicine seeks to recreate conditions that support the growth of
cells and tissue to repair or regenerate tissue that is lost due to trauma or
degenerative disease. The developmental biology discovery system uses model
organisms to determine gene function, key stem cell populations and proteins
that can serve as potential therapeutic agents. Thus, for a given medical
deficiency or disease, Curis will identify the key factors and genes responsible
for proper function. Combining the insights of developmental biology with
high-throughput screening capabilities enables the identification of therapies
designed to treat the underlying cause of degenerative disease. The company will
develop cellular, protein or small molecule products to restore normal function.
This approach may well revolutionize the way many degenerative, traumatic and
congenital disorders are treated.
CURIS TECHNOLOGIES AND PRODUCT OPPORTUNITIES
Curis will utilize the following technologies to identify, develop and/or
commercialize novel products and plans to generate 1-2 INDs per year.
- - Model systems for functional genomic studies
- - Screening assays to identify antagonists and agonists of key biological
pathways
- - Proprietary transgenic models of disease
- - Cell and tissue technology for correcting structural or functional
disorders
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<PAGE>
- - Chondrogel(TM) for vesicoureteral reflux
- - Vascugel(TM) for post-coronary artery bypass graft (CABG)
restenosis
- - Pancreatic stem cells for type I diabetes
- - Bladder augmentation
Tissue engineering: Biomaterials that provide the appropriate
environment for the formation of tissue in a 3-dimensional space.
- - Guided tissue formation
- - Natural biopolymers
- - Semi-synthetic biopolymers
- - Cell and drug delivery
Proteins and peptides:
- - OP-1 Implant (TM) for orthopaedic reconstruction (partnered
with Stryker Corporation)
- - Sonic hedgehog for hair growth
- - OP-1 protein for stroke recovery
- - Hedgehog derivatives that are neuroprotective for the
treatment of neuropathies
- - Peptide to restore and maintain normal beta islet function in
type II diabetes
Small molecules that can restore normal function by inhibiting or
stimulating critical biological pathways
- - ONT-23 for the treatment of basal cell carcinoma and
medulloblastoma
- - Neurotrophic agonists
- - Inhibitors of pathways involved in colon cancer
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<PAGE>
PATENT POSITION
Curis will contain intellectual property positions in the areas of cells, growth
factors/proteins, small molecule agonists/ antagonists and tissue engineering.
The combined entities will own or have rights to more than 150 issued patents
and 225 pending patent applications worldwide.
COLLABORATIONS
Corporate collaborations include (partial list):
- - Stryker Corporation
- - Biogen, Inc.
- - Becton Dickinson
- - Incyte Pharmaceuticals Inc.
- - Oxford Asymmetry International
- - Genzyme Molecular Oncology
- - Perkin-Elmer's Tropix
- - ComGenex
Academic collaborations include (partial list):
- - Harvard University
- - Harvard Medical School
- - University of Michigan
- - Massachusetts Institute of Technology
- - Stanford University
- - University of California - San Francisco
- - National Institutes of Health
- - The Johns Hopkins University
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<PAGE>
- - University of Massachusetts
- - And numerous other American and European centers of academic excellence
FINANCES
Financial reserves of the combined entities as of December 31, 1999 were
approximately $70 million. Curis' plan is to target at least 2 years of cash and
to continue exploring product and partnership opportunities.
PERSONNEL
The combined organization consists of approximately 155 scientists, development,
manufacturing, quality and administrative staff. The scientific staff contains
researchers who are recognized to be among the best in their fields. Curis
anticipates future growth in the areas of clinical development, sales and
marketing.
BOARD OF DIRECTORS (listed alphabetically)
- - Martyn D. Greenacre, President and CEO, Delsys Pharmaceutical Corp.
- - Ruth B. Kunath, Vulcan Northwest, Inc.
- - James R. McNab, Jr., Chairman and Co-Founder, Reprogenesis; Parker
Medical Associates, LSI Capital
- - Douglas A. Melton, Ph.D., Chair, Department of Molecular and Cellular
Biology, Harvard University
- - Doros Platika, M.D., current President and CEO, Ontogeny, Inc.; future
President and CEO, Curis, Inc.
- - Michael Rosenblatt, M.D., Professor of Medicine, Harvard Medical School
and Interim President, Beth Israel Deaconess Medical Center
- - James R. Tobin, President and CEO, Boston Scientific Corporation
###
[Image]
NEWS:
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<PAGE>
On February 15, 2000, Ontogeny announced a merger with Creative BioMolecules and
Reprogenesis to form Curis, Inc. Please visit the site for the information that
is currently available. For additional information on the combined entity's
programs and technologies we invite you to browse the Ontogeny and Creative
BioMolecules web sites.
[Image] [Image]
Ontogeny, Inc., founded in August 1994, is a
privately-held biotechnology company whose
mission is to be the pre-eminent
[Image] biopharmaceutical company utilizing
developmental biology to create therapeutics
that will significantly improve the quality
of life by activating the body's ability to
repair and regenerate. Developmental biology
[Image] is the functional genomics solution to the
post-genomic drug discovery challenge.
Developmental biology is the study of how cells,
[Image] tissues and organs change as they interact
during development. Ontogeny's research is
based on the process whereby an organism
changes its size, shape and organization from
[Image] a fertilized egg to a mature individual. The
same processes and molecules that are active
during development are reactivated in adult
regenerative processes. This is an efficient
and powerful system for generating
[Image] regenerative and oncology therapeutics that
may change the way we treat degenerative
diseases, cancers and other disorders
associated with loss of function. Ontogeny is
identifying ways to rejuvenate damaged
systems by looking at the signaling processes
of cells during development and restoring
them in adults to trigger repair and
regeneration.
Ontogeny, Inc.
45 Moulton Street
Cambridge, MA 02138
tel: 617/876-0086
fax: 617/876-0866
www.ontogeny.com
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<PAGE>
The information on this web site contains forward-looking statements that
involve a number of risks and uncertainties. For this purpose, any statements
contained therein that are not statements of historical fact may be deemed to be
forward-looking statements. Without limiting the foregoing, the words
"believes", "anticipates", "plans", "expects", "intends" and similar
expressions are intended to identify forward-looking statements. The risks and
uncertainties involved include, without limitation, risks associated with the
inherent uncertainty of pharmaceutical research, product development and
commercialization, the impact of competitive products, patent, product liability
and third party reimbursement risks associated with the biotechnology industry,
and other risks and uncertainties that may be detailed from time to time in
Ontogeny's periodic reports. There are important factors that could cause actual
results to differ materially from those indicated by such forward-looking
statements. Please note that all of Ontogeny's potential products are at an
early stage of development; the results obtained in preclinical studies may not
be indicative of results that will be obtained in clinical trials; and there can
be no assurance that Ontogeny or an Ontogeny corporate partner will receive
regulatory approvals to commence or continue clinical trials of product
candidates or to market any products or that delays in the completion of
clinical trials as a result of delays in patient enrollment or other factors
will not occur.
Copyright (c) 1998
Ontogeny, Inc.
Cambridge, MA, USA
All rights reserved
Additional legal
information
[Image] [Image] [Image] [Image]
[Image] [Image] [Image] [Image]
[Image] [Image] [Image] [Image] [Image] [Image] [Image]
Last updated: February 15, 2000
Thank you for visiting the Curis, Inc. web site. On February 15, 2000 it was
announced that Curis will be formed by the merging of Creative BioMolecules,
Inc., Ontogeny, Inc. and Reprogenesis, Inc. to create the regenerative medicine
company of the future.
To view the following documents about Curis please click below.
PRESS RELEASE, February 15, 2000
FACT SHEET
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<PAGE>
PRESENTATION
To contact the individual companies:
Creative BioMolecules, Inc.
508/782-1100
www.creativebio.com
Ontogeny, Inc.
617/876-0086
www.ontogeny.com
Reprogenesis, Inc.
617/499-2928
The statements on this web site 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, regulation, 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
concerning factors that could cause actual results to differ materially, please
refer to the risk factors section of our February 15, 2000 press release and
Creative BioMolecules, Inc.'s Form 10K at www.creativebio.com for the year ended
1998.
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 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 Creative BioMolecules, Inc., Ontogeny, Inc. and
Reprogenesis, Inc.
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<PAGE>
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
CONCERNING FACTORS THAT COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY,
PLEASE REFER TO THE RISK FACTORS SECTION OF CREATIVE BIOMOLECULES, INC.'S
FORM 10K FOR THE YEAR ENDED 1998. 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 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 CREATIVE BIOMOLECULES, INC., ONTOGENY, INC. AND
REPROGENESIS, INC.
CURIS HIGHLIGHTS
- - FORMED BY THE MERGER OF CREATIVE BIOMOLECULES (CBMI), ONTOGENY
AND REPROGENESIS TO CREATE THE REGENERATIVE MEDICINE COMPANY OF
THE FUTURE
- - TARGET CLOSE DATE JUNE 2000
- - 155 EMPLOYEES
- - CASH RESERVES AS OF 12/31/99 APPROXIMATELY $70M
- - TARGET AT LEAST 2 YEARS CASH
- - CONSOLIDATE IN CAMBRIDGE AREA
BOARD OF DIRECTORS
- - MARTYN D. GREENACRE, President and CEO, Delsys Pharmaceutical Corp.
<PAGE>
- - 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
- - 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
- - JAMES R. TOBIN, President and CEO, Boston Scientific
CURIS CORE STRENGTHS
- - DEVELOPMENTAL BIOLOGY
- - FUNCTIONAL GENOMICS
- - PROPRIETARY BIOLOGICAL ASSAYS AND MODEL SYSTEMS
- - CELLULAR TECHNOLOGIES
- - TISSUE ENGINEERING
- - GROWTH FACTORS, PROTEINS AND PEPTIDES
- - SMALL MOLECULE AGONISTS AND ANTAGONISTS
CURIS CORPORATE PARTNERS
- - BECTON DICKINSON
- - BIOGEN
- - COMGENEX
- - GENZYME MOLECULAR ONCOLOGY
- - INCYTE PHARMACEUTICALS
- - OXFORD ASYMMETRY
- - PERKIN ELMER'S TROPIX
- - STRYKER BIOTECH
CURIS ACADEMIC COLLABORATIONS
- - BARNES/WASH U
- - BOSTON CHILDREN'S
- - COLUMBIA
- - HARVARD
- - HARVARD MEDICAL
- - JOHNS HOPKINS
- - MICHIGAN
- - MIAMI
- - MGH
- - MIT
- - NIH
- - STANFORD
- - UCSF
- - UMASS
- - VANDERBILT
- - WHITEHEAD
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<PAGE>
REGENERATIVE MEDICINE
Use of therapeutics to stimulate repair and/or regeneration for the restoration
of normal function.
REGENERATIVE MEDICINE
Slide includes images of proteins, cells, biomaterials, and small molecules
applied to therapy
CURIS OPPORTUNITIES
- - REGENERATIVE MEDICINE
- - ONCOLOGY
- - FUNCTIONAL GENOMICS
- - DEVELOPMENTAL BIOLOGY
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
- - THERAPEUTIC BENEFIT
- Targeted to replace an autograft procedure
- Stimulates bone formation
- - STATUS
- First product is currently under regulatory review in US, Europe and
Australia
CHONDROGEL(TM):
VESICOURETERAL REFLUX
- - PRODUCT
- Cell and matrix delivered via minimally invasive technique
- Provides augmentation with autologous cartilage
- - MARKET OPPORTUNITY
- 1% children affected with the potential of $200M worldwide
- - THERAPEUTIC BENEFIT
- Less invasive than current standard of care
- - STATUS: PHASE III
Slide includes image of bladder showing administration of product.
CHONDROGEL(TM):
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<PAGE>
PHASE III CLINICAL EVALUATION
- - ORPHAN DRUG STATUS OBTAINED
- - DHHS CLINICAL TRIAL GRANT OBTAINED
- - APPROXIMATELY 100 TOTAL PATIENTS TREATED
- - COMPARISON TO HISTORICAL CONTROL
- - PATIENT ENROLLMENT TARGET 1H'00
- - BLA TARGET 1H'02
BASAL CELL CARCINOMA
Slide shows image of human torso with basal cell carcinoma.
BASAL CELL CARCINOMA
- - MOST COMMON HUMAN CANCER
- USA Incidence: 700,000 - 900,000/year
- Lifetime risk, caucasians: 1/4 - 1/3 and increasing
- - TUMOR BEHAVIOR:
- Enlarges slowly
- Invades locally
- Metastasizes rarely
- - UV INDUCED
- - 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
HEDGEHOG STIMULATES HAIR GROWTH
Images of mouse skin biopsy.
IN VIVO HEDGEHOG TREATMENT
Images of preclinical hair growth studies.
HEDGEHOG ADENOVIRAL GENE THERAPY 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
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<PAGE>
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 late-stage pre-clinical products
- Discovery engine that combines functional genomics and developmental
biology
- - MORE THAN 150 ISSUED PATENTS AND 225 PENDING PATENT APPLICATIONS
WORLDWIDE
CURIS
REGENERATIVE THERAPEUTICS FROM FUNCTIONAL GENOMICS
AND
DEVELOPMENTAL BIOLOGY
<PAGE>
March 1, 2000 Press Release - Creative BioMolecules Reports 1999 Year-End
Results
CONTACT: Karla MacDonald
Manager, Corporate Communications
Creative BioMolecules, Inc.
(617) 912-2953
Steven L. Basta
V.P., Finance and Business Development
Creative BioMolecules, Inc.
(617) 912-2950
FOR IMMEDIATE RELEASE
---------------------
CREATIVE BIOMOLECULES REPORTS 1999 YEAR-END RESULTS
On February 15, 2000, Creative BioMolecules, Inc. announced the merger with
Ontogeny, Inc. and Reprogenesis, Inc. to Form Curis, Inc.
Hopkinton, MA, March 1, 2000--Creative BioMolecules, Inc. (Nasdaq: CBMI) today
announced financial results for the year ended December 31, 1999. The Company
reported revenues of $5,138,000 and expenses of $17,248,000 for the full year,
resulting in a net loss of $12,110,000, or $0.40 per share to common
shareholders. The comparable figures for the year ended December 31, 1998 were
revenues of $12,625,000 and expenses of $34,020,000 resulting in a net loss of
$21,395,000, or $0.66 per share. For the fourth quarter 1999, the net loss per
share was $0.10 as compared with $0.15 per share for the fourth quarter 1998.
The Company ended 1999 with approximately $21.4 million in cash and marketable
securities.
On February 15, 2000, Creative BioMolecules announced that it will merge with
Ontogeny, Inc. and Reprogenesis, Inc. to form a new public company named Curis,
Inc. The combination of these companies will create a leader in the emerging
field of regenerative medicine. Under the terms of the merger, which is subject
to shareholder and regulatory approval, Creative BioMolecules' shareholders will
receive three Curis shares for every ten shares of Creative BioMolecules.
Following completion of the transaction, Creative BioMolecules' shareholders
will hold approximately 43%, Ontogeny's shareholders will hold approximately 38%
and Reprogenesis' shareholders will hold approximately 19% of Curis. The merger
is expected to close in June 2000.
DISCUSSION OF CREATIVE BIOMOLECULES, INC.'S YEAR-END RESULTS
Revenues generated during the fourth quarter of 1999 resulted primarily from
research funding in support of the development of a therapy to treat renal
failure and from interest income. The Company's research and development
expenses during this period included costs associated with the development of
therapies to treat renal failure, stroke and other indications. The decrease in
revenues and expenses during 1999 as compared with 1998 result primarily from
the November 1998 sale of certain of the Company's OP-1 manufacturing rights and
assets to Stryker Corporation for increased royalties on commercial product
sales. During 1998, Creative BioMolecules operated a commercial-scale
manufacturing facility and received revenue from
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<PAGE>
PAGE 2
Stryker for supply of OP-1. Costs associated with the manufacturing facility
were recorded as research and development expenses.
Creative BioMolecules, Inc. is a biopharmaceutical company focused on the
development of therapies for human tissue regeneration. The Company's core
technologies are based on our understanding of the role that morphogenic
proteins play in human biology. These proteins are involved in the initiation
and regulation of the cellular events responsible for the formation of human
tissues and organs. The first product resulting from Creative BioMolecules'
technology, the OP-1 Implant(TM) for orthopaedic reconstruction, is licensed to
Stryker Corporation and has been submitted for marketing approval in the United
States, Europe and Australia. For more information on Creative BioMolecules,
please visit our web site at http://www.creativebio.com.
Curis, Inc. will be a leader in the emerging field of regenerative medicine.
Formed by the merger of three Boston area biotechnology companies, Creative
BioMolecules, Inc. (Nasdaq: CBMI), Ontogeny, Inc. and Reprogenesis, Inc., Curis
will combine insight gained through the study of developmental biology with
high-throughput screening capabilities, proteins, cells and biocompatible
materials to enable the development of new regenerative medicine therapies.
Curis' pipeline will include: 1) a product which is currently under regulatory
review in the United States, Europe and Australia; 2) multiple products in late-
stage clinical development; 3) numerous early clinical and late-stage
preclinical products; and 4) a discovery engine that combines functional
genomics and developmental biology across multiple medical indications. These
products have the potential to change the way degenerative disease, cancer and
other disorders associated with loss of function are treated. Curis will be a
publicly held company located in Cambridge, Massachusetts. For more information,
please visit the Curis web site at http://www.curisinc.com.
The statements in this press release 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 factors that could cause actual results to differ
materially, please refer to the risk factors section of Creative BioMolecules,
Inc.'s Form 10K for the year ended 1998.
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 Creative BioMolecules, Inc., Ontogeny, Inc.
and Reprogenesis, Inc.
(more)
<PAGE>
PAGE 3
CREATIVE BIOMOLECULES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
<TABLE>
<CAPTION>
Three Months Twelve Months
Ended Ended
------------------------------- ----------------------------------
12/31/99 12/31/98 12/31/99 12/31/98
----------- ------------ ------------- -------------
<S> <C> <C> <C> <C>
REVENUE:
Research and development contracts 753,700 $ 3,418,071 $ 3,159,460 $ 10,419,071
License fees and royalties 38,800 10,000 52,400 10,000
Interest 322,113 658,472 1,924,313 2,183,472
Other 0 12,391 1,777 12,391
----------- ------------ ------------- -------------
Total revenues 1,114,613 4,098,934 5,137,950 12,624,934
----------- ------------ ------------- -------------
COSTS AND EXPENSES:
Research and development 2,403,277 5,921,147 10,434,560 24,856,147
General and administrative 1,887,143 1,439,372 6,396,094 7,474,372
1999 Reorganization and 1998 sale of
manufacturing operations 255,701 1,362,249 255,701 1,362,249
Interest 46,605 68,304 161,385 327,304
----------- ------------ ------------- -------------
Total costs and expenses 4,592,726 8,791,072 17,247,740 34,020,072
----------- ------------ ------------- -------------
NET LOSS (3,478,113) (4,692,138) (12,109,790) (21,395,138)
ACCRETION AND REPURCHASE COSTS ON SERIES 0 (412,587) (2,395,559) (986,587)
1998/A PREFERRED STOCK ----------- ------------ ------------- -------------
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS ($3,478,113) ($5,104,725) ($14,505,349) ($22,381,725)
=========== ============ ============= =============
BASIC AND DILUTED LOSS PER COMMON SHARE ($0.10) ($0.15) ($0.40) ($0.66)
=========== ============ ============= =============
SHARES FOR BASIC AND DILUTED 36,226,839 34,111,389 36,665,115 33,672,105
=========== ============ ============= =============
</TABLE>
<TABLE>
<CAPTION>
BALANCE SHEET DATA
12/31/99
-----------
<S> <C>
Cash, Cash Equivalents and Marketable Securities $21,370,585
Total Assets $28,892,291
Total Stockholders' Equity $23,421,586
</TABLE>
<PAGE>
CONTACTS:
Daniel Omstead, Eng. ScD Robert Gottlieb or
President and CEO Michael Mitchell
Reprogenesis, Inc. Feinstein Kean Healthcare
(617) 499-2928 (617) 577-8110
FOR IMMEDIATE RELEASE:
- ----------------------
REPROGENESIS, INC. ACQUIRES EXCLUSIVE LICENSE TO CHILDREN'S
HOSPITAL/HARVARD/MIT ORGAN REGENERATION TECHNOLOGY AND PRODUCT
FOR BLADDER RECONSTRUCTION
- Product will be part of Curis development portfolio, new regenerative
medicine company being formed through merger of Creative BioMolecules
(NASDAQ: CBMI),
Reprogenesis and Ontogeny -
CAMBRIDGE, MA, MARCH 6, 2000 - Reprogenesis, Inc. announced today that it has
in-licensed exclusive rights to a pioneering organ regeneration technology and a
tissue engineering bladder substitute product from Children's Hospital, Boston,
a Harvard Medical School affiliate, and the Massachusetts Institute of
Technology (MIT). The product and technology will become part of the
regenerative medicine pipeline of Curis, Inc., which will be a new public
company formed through a recently announced merger (pending shareholder
approval) of Reprogenesis, Creative BioMolecules, Inc. (NASDAQ: CBMI) and
Ontogeny, Inc. Curis plans to begin clinical trials with a bladder
reconstruction product candidate in 2001.
The organ regeneration technology was developed by Anthony Atala, M.D., Director
of the Laboratory for Tissue Engineering and Cellular Therapeutics at Children's
Hospital and Harvard Medical School, and his colleagues at Harvard Medical
School. This new technology for tissue regeneration demonstrated for the first
time in a preclinical model that tissue engineering can be successfully employed
for the de novo creation of functionally and anatomically normal bladders.
Results were published in the journal Nature Biotechnology in February of 1999.
"There is a vital need for new approaches to augment bladder function. There
are more than 500,000 patients with bladder insufficiency resulting from
<PAGE>
Reprogenesis, Inc. Acquires Exclusive License
March 6, 2000
Page 2
congenital defects, trauma, or cancer," said Dr. Atala. "Current therapy is
limited to patients with end-stage bladder disease because bladder replacement
or radical repair usually involves surgically removing sections of tissue from
other parts of the body to replace diseased parts of the bladder, an invasive
and expensive treatment. Our goal is to create a new therapeutic paradigm for
bladder disease."
"The bladder replacement technology provides a great market opportunity and fits
perfectly with Reprogenesis' pipeline of minimally invasive in vivo tissue
augmentation and repair products," said Daniel R. Omstead, Eng. ScD., President
and CEO of Reprogenesis. "The product candidate and technology will become an
important part of Curis' regenerative medicine portfolio."
The organ regeneration technology and bladder reconstruction technique involves
harvesting cells from bladder biopsy specimens and seeding them onto a pre-
formed matrix to reconstruct de novo a bladder with storage function. These
tissue-engineered bladders are then transplanted into patients to form new
organs. In the preclinical model, the new bladders exhibited normal urinary
compliance function after just one month and continued to function normally
after 11 months. Curis expects to seek approval to initiate a bladder
reconstruction study in 2001.
"We are witnessing the dawn of a new era in medicine," said Doros Platika, MD,
President and CEO of Ontogeny who will serve as President and CEO of Curis, "an
era in which we unlock the capacity to repair and regenerate tissues, including
whole organs. This agreement is another step in building Curis' pipeline of
products that repair and restore function and improve quality of life."
Curis, Inc. will be a leader in the emerging field of regenerative medicine.
Formed by the merger of three Boston area biotechnology companies, Creative
BioMolecules Inc., (NASDAQ: CBMI), Ontogeny, Inc. and Reprogenesis, Inc., Curis
will combine insight gained through the study of developmental biology with
high-throughput screening capabilities, proteins, cells and biocompatible
materials to enable the development of new regenerative medicine therapies.
Curis' pipeline will include: 1) a product which is currently under regulatory
review in the United States, Europe and Australia; 2) multiple products in late-
stage clinical development; 3) numerous early clinical and advanced preclinical
products; and 4) a discovery engine that combines functional genomics and
developmental biology across multiple medical indications. These products have
the potential to change the way degenerative disease, cancer and other disorders
associated with loss of function are treated. Curis will be a publicly held
company located in
- more -
<PAGE>
Reprogenesis, Inc. Acquires Exclusive License
March 6, 2000
Page 3
Cambridge, Massachusetts. For more information, please visit the Curis
web site at http://www.Curisinc.com.
Reprogenesis, Inc. develops products for minimally invasive in vivo tissue
augmentation and repair using the Company's proprietary technology, which
presents therapeutic opportunities in a broad range of markets. The Company's
pipeline is represented by products that create structural tissue to augment or
correct anatomical defects, restore physiological function, and repair or
restore anatomical organs. The technology is initially being applied in the
areas of urology, cardiovascular biology, and plastic and reconstructive
surgery.
The statements in this press release 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 factors that could cause actual results to differ
materially, please refer to the risk factors section of Creative BioMolecules,
Inc.'s (NASDAQ: CBMI) Form 10K for the year ended 1998.
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 Creative BioMolecules, Inc., Ontogeny, Inc.
and Reprogenesis, Inc.
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