The Company's mission is to increase the quality
and
quantity of life of people suffering with these diseases. The decrease is primarily attributable
to
offsetting variances within spending.
Conversion of Elan Pharma International Limited Note
Payable: On
January 7, 2005, Elan Pharma International Limited, or EPIL, notified
us of its election
to convert the entire balance of an outstanding
note payable from us into shares of our common stock
. We will now share equally in the U. These forward-looking statements
are not guarantees of future
performance and involve risks,
uncertainties, assumptions and other factors that may cause Curis
'
actual results to be materially different from those indicated by such
forward-looking statements
., associate professor of Hematology and Oncology at the University
of Massachusetts, discusses the
use of umbilical cord blood to treat leukemia.P. Lowry, Ph.
dystrophy atrophy
Curis Reports Fourth Quarter and Year-End
2004 Financial Results
S. EST, to discuss its financial results, Curis' recent
decision to exercise
its co-development option of a topical treatment
for basal cell carcinoma under development with
Genentech, the
progress of its therapeutic product development programs, and
additional corporate
activities.
CURIS, INC. Stem Cell Therapies Show
Hope for People With
Cancer, Muscular Dystrophy and Arthritis
ARLINGTON
, Va.D. "While there are still issues to
overcome, non-embryonic stem cells are already yielding results
that can
impact thousands of lives in the relatively near future.Sites by or about people who have
Muscular Dystrophy.
dmd copes
Such
statements are valid only as of today, and we disclaim any obligation
to
update this information. These statements are subject to known and
unknown risks and uncertainties
that may cause actual future
experience and results to differ materially from the statements made
.
The decrease in general and administrative expenses was principally
due to a gain of $448,000
from the settlement of notes receivable from
former officers of a predecessor company, which notes
had been written
down prior to 2004. This decrease was partially offset by an increase
in legal
and professional services, including increased legal costs
related to our intellectual property and
new audit fee costs related
to an internal controls audit that is required under the
Sarbanes
-Oxley Act of 2002. The increase was principally due to a net
gain of $1,304,000 recorded in the fourth
quarter of 2004 related to a
payment received on a note from Micromet, a former collaborator.
Net
loss for the year ended December 31, 2004 was $13,904,000 or
($0. These increases were partially
offset
by a $448,000 gain relating to the settlement of notes receivable from
former officers
of a predecessor company. Assuming the acceptance of the
Investigational New Drug application by
the Food and Drug
Administration and the successful advancement of the basal cell
carcinoma product
candidate through Phase I and Phase II clinical
trials, we expect that the Phase II clinical trial
will be completed
in mid-2007.
December: Genentech doubled its committed research funding on
the systemic Hedgehog antagonist program during the second
year of our collaboration
. We believe that this incremental
funding demonstrates the importance of the contribution
of our
scientists to this program's further development., director of the
Center for Regenerative
Medicine in Morristown, New Jersey.muscular friedreich
The Company's broad platform technology
also includes the development
of products for multiple sclerosis,
retinal degeneration and epilepsy.
Also within operating expenses
, general and administrative
spending was $1,294,000 for the fourth quarter of 2004 as compared to
$1,522,000 for the same period in 2003, a decrease of $228,000 or 15%. Basal
cell carcinoma, a
skin cancer, is the most common form of all human
cancers with approximately 800,000 to 1,000,000
new cases every year
in the United States.S.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
December
31, December 31,
2004 2003
ASSETS
Cash, cash equivalents, marketable
securities and long-term investments $ 52,120,643 $ 37
,537,993
Long-term investments - restricted 193,166 190,661
Accounts and notes
receivable 1,226,460 4,397,806
Property and equipment, net 3,416
,620 2,500,703
Intangible assets, net 9,084,122 9,159,193
Other assets
1,593,802 1,950,134
------------ ------------
Total assets $ 67,634,813 $ 55,736,490
============ ============
LIABILITIES AND STOCKHOLDERS
' EQUITY
Accounts payable, accrued expenses and
other liabilities $ 2,992
,964 $ 2,884,643
Debt and capital lease obligations,
excluding convertible debt
1,141,294 322,884
Convertible debt 5,710,007 5,333,733
Deferred revenue 8,881,253 8,330,017
------------ ------------
Total liabilities 18,725,518
16,871,277
Total stockholders' equity 48,909,295 38,865,213
------------ ------------
Total liabilities and stockholders
'
equity $ 67,634,813 $ 55,736,490
============ ============
About Curis, Inc. Lowry will present how transplanting
umbilical cord
blood can offer the same benefits with greater access and availability., associate
professor of Chemical Engineering and Neuroscience at
University of California at Berkeley.mcallister massachussets
CepTor
Files Application to List on the American Stock Exchange 'AMEX'
While the application
is under
review, CepTor's stock will continue to trade on the OTC
Bulletin Board under this symbol. 2004
revenues
were primarily derived from our collaborations with
Genentech, Wyeth, and the Spinal Muscular Atrophy
Foundation. The increase was principally due
to the net gain of $1,304,000 related to payment on
a note from
Micromet that had been written off in 2003, resulting in an impairment
charge of
$1,708,000. We intend to pursue the development
of hair growth product candidates using these
compounds either
internally or through a licensing or collaborative
arrangement
. This report corroborated an
earlier report that demonstrated similar findings.33) $(0. is
a therapeutic drug development company., The use of adult stem cells
promises to grow as the controversy
over the use of human embryonic stem cells
remains a hotbed political, ethical and religious issue
. Friedman, M. Schaffer, Ph., will moderate the symposium, "Embryonic and
Adult Stem Cell Therapies
" 1:00 pm - 3:00 pm PDT in the Yerba Buena Salon 8., F. For more
information about AAPS, visit us
at http://www.sma werdnig
For the fourth quarter of 2004, we reported a net loss of
$1,659,000, or ($0. The
Micromet note had been written off during the fourth quarter of 2003,
resulting in an impairment
charge of $1,708,000.
As of December 31, 2004, our cash, cash equivalents, marketable
securities
and investments, including long-term investments, were
$52,121,000.S. Actual results can be affected
by a number
of important factors including, among other things: adverse results in
Curis' and
its strategic collaborators' and licensees' product
development programs; difficulties or delays
in obtaining or
maintaining required regulatory approvals for products being developed
by Curis
and its collaborators and licensees; Curis' ability to obtain
or maintain the patent and other proprietary
intellectual property
protection necessary for the development and commercialization of
products
based on its technologies; changes in or Curis' inability to
execute its business plan; the risk
that Curis does not obtain the
additional funding required to conduct research and development of
its
product candidates, fund its co-development obligations under its
collaboration with Genentech
and execute its business plan; unplanned
cash requirements and expenditures; risks relating to Curis
' ability
to enter into and maintain important strategic collaborations,
including its ability
to maintain its current collaboration agreements
with Genentech, Ortho Biotech Products and Wyeth;
the risk that
competitors will discover and develop signaling pathway-based
therapeutics faster
and more successfully than Curis and its
collaborators are able to; and other risk factors identified
in Curis'
Quarterly Report on Form 10-Q for the Quarter ended September 30, 2004
and other reports
periodically filed with the Securities and Exchange
Commission.D. "While embryonic
stem cells
are a source of controversy and uncertainty, adult-derived stem
cells are already being used to successfully
treat cancer, anemia and
connective tissue diseases.D.
* Johnny Huard, Ph.irina copes
Other income
for the fourth quarter of 2004 was $1,462,000 as
compared to other expense of $2,004,000 for the
same period in 2003,
an increase of $3,466,000. As of January 7,
2005, the outstanding balance
, including interest, of the EPIL note
payable was $3,306,000.S.M.17) $(0. Curis' product development
programs involve
using proteins, small molecules and other approaches to modulate these
pathways
.D.
* Gary S., will speak on the use of umbilical cord blood in
the treatment of cancer during
the "Regenerative Medicine: Alternatives to
Stem Cells" roundtable 3:45 pm - 5:15 pm PDT in the Yerba
Buena Salon 8.attends mcallister
----Curis, Inc. The decrease in research and development expenses was
principally due
to costs incurred in the fourth quarter of 2003 under
a collaboration with ES Cell International
that ended in December of
2003. development costs and future net profits or losses,
if any, derived
from sales in the U.
-- BMP-7 for kidney disease - A report was presented
demonstrating that
treatment with BMP-7 can reverse the
development of blood vessel calcification in a preclinical
model
of chronic kidney disease.M.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Three months ended Year
ended
December 31, December 31,
2004
2003 2004 2003
------------ ------------ ------------
- -------------
Revenues $1,490,516 $755,095 $4,952,615 $11,048,233
------------ ------------ ------------- -------------
Operating expenses:
Research
and
development 2,985,091 3,725,200 11,569,749 12,735,157
General and
administrative
1,294,451 1,522,387 7,560,422 6,518,904
Stock-based
compensation 313,366
420,663 1,372,045 1,631,098
Amortization of
intangible assets 18,768 18
,768 75,071 75,079
------------ ------------ ------------- -------
------
Total operating
expenses 4,611,676 5,687,018 20,577,287 20,960,238
------------ ------------ ------------- -------------
Loss from
operations
(3,121,160) (4,931,923) (15,624,672) (9,912,005)
Total other income
(expense),
net 1,461,777 (2,003,649) 1,720,398 (1,711,247)
------------ -------
----- ------------- -------------
Net loss (1,659,383) (6,935,572) (13,904,274) (11,623
,252)
Accretion on
Series A
Convertible
Exchangeable
Preferred Stock
--- --- --- (271,306)
------------ ------------ --------
----- -------------
Net loss
applicable to
common
stockholders $(1,659,383) $(6
,935,572) $(13,904,274) $(11,894,558)
============ ============ ============= =============
Basic and
diluted net
loss per common
share $(0. The conference will take
place at
the San Francisco Marriott, June 5 - 8.mcallister fshd
"We are pleased to be considered as a candidate
for listing by the
American Stock Exchange," said William Pursley, Chairman and CEO."
About
CepTor
CepTor Corporation is a development-stage biopharmaceutical
company engaged in the
discovery, development, and commercialization
of proprietary, cell-targeted therapeutic products
for the treatment
of neuromuscular and neurodegenerative diseases with a focus on orphan
diseases
.33) per share as compared to $11,895,000 or ($0. As of December 31, 2004, there were 47,517,413 shares
of
common stock outstanding. Passeri concluded, "These accomplishments are aligned with and
support
Curis' business strategy, which is focused on providing the
Company with milestone-based revenue
potential while retaining
programs we feel are more aligned with our internal capabilities and
capital
resources.33)
============ ============ ============= =============
Weighted
average
common shares
for basic and
diluted net
loss
computation 46,518,431
40,426,650 42,685,594 36,015,610
============ ============ =============
=============
CURIS, INC., will moderate a roundtable discussion
,
"Regenerative Medicine: Alternatives to Embryonic Stem Cells" 3:45 pm - 5:15
pm PDT in the Yerba
Buena Salon 8.hypoplasia ventilators
Other income for the year ended December 31, 2004 was $1,720,000
as compared to
other expense of $1,711,000 for the year ended December
31, 2003, an increase of $3,431,000.
development
costs and have increased our downstream revenue potential
by sharing in a commensurate portion of
any U.
As the nation continues to debate the ethics and efficacy
of using human embryonic
stem cells, scientists will demonstrate how the use
of adult stem cells has opened the door to groundbreaking
therapies including
the use of muscle stem cells for arthritis and umbilical cord blood for
leukemia
. "The major
challenge we're facing today is the availability of viable cell sources we
could use
to fully research these possibilities.C.
niedermeier duchenne
Factors that might cause such a material difference
include
, among others, uncertainties related to the ability to attract
and retain partners for our technologies
, the identification of lead
compounds, the successful preclinical development thereof, the
completion
of clinical trials, the FDA review process and other
government regulation, our pharmaceutical collaborator
's ability to
successfully develop and commercialize drug candidates, competition
from other pharmaceutical
companies, product pricing and third party
reimbursement. In accordance with the terms of the amended
and restated convertible note payable with EPIL, we issued 330,552
shares of our common stock
to EPIL based on a conversion rate of
$10. Friedman, M.D.ataxia ventilators
CepTor is currently listed and traded
under the Over the Counter
Bulletin Board (OTCBB) under the symbol "CEPO".
Revenues for the fourth
quarter of 2004 were $1,491,000 as
compared to $755,000 for the fourth quarter of 2003, an increase
of
$736,000 or 97%.
This co-development right applies solely to the U. co-development option for
our basal cell carcinoma product
candidate with Genentech."
Mr.niedermeier irina
These statements are based
on our current beliefs and expectations as
to such future outcomes. Drug discovery and development
involve a high
degree of risk. The increase in revenues was primarily due to
revenues recognized
under our collaborations with Wyeth (NYSE: WYE)
and the Spinal Muscular Atrophy Foundation, which
were both
established during 2004, and also due to an increase in revenues
recognized under our
collaboration with Genentech (NYSE: DNA).33) per share for
the year ended December 31, 2003.
To
access the live conference call, please call 800-706-7748 from
the United States or Canada or 617
-614-3473 from other locations,
shortly before 10:00 A. Curis'
technology focus is on regulatory
signaling pathways that control
repair and regeneration.com
This press release contains forward
-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including
statements concerning Curis' expectations regarding the
potential outcome of its business strategies
, its plans with respect
to its hair growth and other product development programs and the
potential
effectiveness of its technologies under development.C.friedreich copes
----CepTor
Corporation (OTCBB:CEPO) is pleased
to announce that it has filed an
application with the American Stock Exchange (AMEX) to make its
common
stock eligible for listing on AMEX. An orphan
disease is defined in the United States as
a serious or
life-threatening disease that affects less than 200,000 people and for
which no definitive
therapy currently exists. CepTor's primary efforts are currently being focused on
moving its lead
product, MYODUR, into phase I/II clinical trials for
Duchenne's muscular dystrophy. In exchange for
this investment, we believe that we have
increased our downstream revenue potential, through our
right to a
commensurate share in U.
Several scientific reports were published or presented
by third
parties that we believe further support, in preclinical settings, the
potential effectiveness
of our technologies, including:
-- Hedgehog antagonist for cancer - A third party scientific
report was issued that demonstrated that levels of
Hedgehog pathway activity are abnormally high
in advanced
stages of prostate cancer. net profits.curis.D.sokolowski attends
This news release contains forward
-looking statements.
S. In addition, any forward-looking statements represent the
Company
's views only as of today and should not be relied upon as
representing its views as of any subsequent
date. Curis disclaims any
intention or obligation to update any of the forward-looking
statements
after the date of this press release whether as a result of
new information, future events or otherwise
. Lowry. Schaffer,
Ph.D.com .barratt friedreich
Business Editors
HUNT VALLEY, Md."
The Company will
hold a conference call today, February 15, 2005,
at 10:00 A. Daniel Passeri, President and Chief
Executive Officer of Curis, will host the call. Replay
will be available approximately two hours
after the completion of the
call and through 5:00 P. EST, Tuesday, March 1, 2005. Curis has successfully
used this technology and product
development strategy to produce several promising product candidates
in the fields of cancer, kidney disease, neurological disorders,
cardiovascular disease and hair
growth regulation. At the upcoming 2005
American Association of Pharmaceutical Scientists' (AAPS
) National
Biotechnology Conference in San Francisco, embryonic and adult-derived stem
cells will
take center stage as the nation's leading scientists discuss how
their research can be immediately
applied to create therapies for cancer,
muscular dystrophy, arthritis, neurodegenerative disorders
, cystic fibrosis,
and bone injuries.
Founded in 1986, AAPS provides a dynamic international forum
for the exchange
of knowledge among scientists to enhance their contributions to health.massachussets sokolowski
CepTor Corporation
seeks
to create an efficient orphan drug platform by taking advantage of the
legislative, regulatory
and commercial opportunities common to these
rare diseases. of a therapeutic product
candidate
for the topical treatment of basal cell carcinoma.00 per share.Adult Stem Cells Yield Groundbreaking
Therapies Without Controversy
, F."
The use of non-embryonic stem cells will also be the focus
as Philip A., will reveal the results of his research on muscle-
derived stem cells during the "Embryonic
and Adult Stem Cell Therapies"
symposium 1:00 pm - 3:00 pm PDT in the Yerba Buena Salon 8.
About AAPS
The American Association of Pharmaceutical Scientists (AAPS) is a
professional
, scientific society of more than 12,000 members employed in
academia, industry, government and other
research institutes worldwide. AAPS
offers timely scientific programs, on-going education, information
resources,
and opportunities for networking and professional development.niedermeier sma
"Listing CepTor's common
stock on the AMEX would give CepTor greater
exposure and would benefit our investors by affording
them enhanced
trading opportunities.
Operating expenses for the fourth quarter of 2004 were $4
,612,000
as compared to $5,687,000 for the fourth quarter of 2003, a decrease
of $1,075,000 or
19%.
Operating expenses for the year ended December 31, 2004 were
$20,577,000 as compared to
$20,960,000 for the prior year, a decrease
of $383,000, or 2%.
Fourth Quarter 2004 Highlights
October: We raised net proceeds of approximately $18,800,000
through a registered
direct offering of our common stock.
Stem Cells Take Center Stage on Monday, June 6, 2005
* David V.duchenne muscular
In addition, stock-based
compensation decreased $259,000 from the prior year
."
The application of non-embryonic stem cells will be highlighted as Johnny
Huard, Ph. "We
are excited to continue
testing this technology and hopefully improve the lives of people with damaged
or diseased tissues.
"New types of stem cell therapy and regenerative medicine can potentially
provide treatments for a wider variety of diseases than traditional bone
marrow and organ transplantation
methods," said Dr.aapspharmaceutica.fshd ventilators
However, management believes that
recent growth in the market
capitalization of the Company warrants the
move to AMEX.
Business Editors/Health Editors
BIOWIRE2K
CAMBRIDGE, Mass.04) per share, as compared to a net loss of
$6,936,000, or ($0. 2003
revenues
were primarily derived from $8,555,000 in previously deferred
revenue recognized upon the termination
of our product development and
target research agreements with Micromet, and from our collaborations
with Genentech and ES Cell International. marketplace
and includes applications for basal cell
carcinoma and any additional
indications for which this product candidate may be developed. To access
the
replay, please call 888-286-8010 from the United States or Canada or
617-801-6888 from other
locations and reference the conference ID
number 75071598.
Forward-looking statements used in
this press release may contain the
words "believes", "expects", "anticipates", "plans", "seeks",
"estimates" or similar expressions.D.massachussets duchenne
Within operating expenses, research and
development spending
was $2,985,000 for the fourth quarter of 2004 as
compared to $3,725,000 for same period in 2003,
a decrease of $740,000
or 20%.
December: Pursuant to the terms of the collaboration agreement
with Wyeth, rights to several Hedgehog agonist compounds
previously licensed to
Wyeth were reverted to us for use in
our hair growth program.
Daniel Passeri, Curis
' President and Chief Executive Officer,
stated, "Curis had a great year in 2004 and we are starting
2005 from
a position of strength, as evidenced by the increased research and
development funding
commitment from Genentech, successful reversion of
Hedgehog agonist compounds from Wyeth for use
in our hair growth
program, encouraging scientific developments that support our
preclinical programs
, and a successful financing, totaling nearly
$19,000,000 in net proceeds.04) $(0.
Curis
, Inc.
"Since the first bone marrow transplant was carried out more than 30 years
ago, non
-embryonic stem cells have been used effectively to benefit and save
thousands of lives," said Gary
S.A."
The AAPS National Biotechnology Conference is an annual event that
incorporates all
aspects of the pharmaceutical sciences and provides an open
forum for discussion of hot industry
topics.massachussets muscular
(NASDAQ:CRIS), a therapeutic drug development company, today reported
its financial results
for the fourth quarter and fiscal year ended
December 31, 2004.S.
To date, preclinical evidence
indicates that inhibition of the
Hedgehog pathway in basal cell carcinoma results in the selective
and
specific death of the tumor cells while conferring no harm to adjacent
normal cells. We have
no further obligations under this
convertible note payable.
-- Hedgehog agonist for neurological
disorders - Several
third party scientific reports were published or presented
that demonstrated
positive results in preclinical models
of stroke, Parkinson's disease, and spinal cord injury
upon
treatment with small molecule agonists of the
Hedgehog pathway. Huard.
While bone marrow transplant
has been a common treatment of leukemia for
almost four decades, Dr."
"We're making enormous
progress with stem cells," said David V.irina muscular
17) per share for the same period in the prior
year.S. net
profits, if any. The conference ID number is 18225135.P., of the University of Pittsburgh School of
Medicine reveals that
his team has recently discovered a unique population of muscle-derived stem
cells that offer the potential of regenerating tissue.
"Transplant of muscle-derived stem
cells has improved the efficiency of
dystrophic muscle regeneration," said Dr.kinase irina
Research and development
spending of $11,570,000 decreased $1,165,000, or 9%, from prior year
spending of $12,735,000 due
to the net effect of changes in spending
in our research programs. General and administrative spending
of
$7,560,000 increased $1,041,000, or 16%, over prior year spending of
$6,519,000 primarily due
to expenses associated with technology
acquisition evaluations, increases in personnel costs and
professional
service fees, and costs associated with financing-related activities
during the first
half of 2004.
-- Hedgehog agonist for cardiovascular applications - Two new
reports documented
the potentially beneficial effects of
Hedgehog pathway stimulation for increasing blood flow to
damaged
heart muscle and promoting improved cardiac
function following both acute and chronic myocardial
ischemia in preclinical models of heart disease. For more information, please visit the Curis
web
site at www.
Lowry, M.
dystrophies sokolowski
Revenues for fiscal year 2004 were $4,953,000 as compared to
$11,048,000 for the prior year, a decrease of $6,095,000, or 55%.
Recent Developments
Exercise of basal cell carcinoma co-development option: On
February 1, 2005, we announced that
we had elected to exercise a
co-development option with our collaborator, Genentech, and we will
now share in U. We expect
that by exercising this co-development and equal cost-sharing option
,
we will incur approximately $20,000,000 in development expenses
through Phase II clinical trials
, a portion of which will be booked in
the first quarter of 2005. These proceeds enabled us to exercise
our
U.M. Curis is based in
Cambridge, Massachusetts. The discovery of these
cells will benefit
patients with Duchenne Muscular Dystrophy, arthritis, and
joint injuries.A.
* Philip A.ventilators attends
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