Renovis Reports Fourth Quarter and Full Year 2004 Financial
Results
* REN-1654: In 2004 we enrolled patients in two Phase II trials with
REN
-1654, our orally available, small molecule for neuropathic pain.
* REN-850: In 2004 we completed
preclinical studies needed for filing an
Investigational New Drug (IND) application with the
U.
Conference Call and Webcast Information
Corey S. Our research and development
programs focus on major medical
needs in the areas of neuroprotection, pain and neuroinflammatory
diseases. Our
forward-looking statements do not reflect the potential impact of any future
acquisitions
, mergers, dispositions, joint ventures or investments we may
make.40) $(1.poe@eurorscg.
Business
Editors/Health Editors
CAMBRIDGE, Mass. Alnylam will apply RNAi technology
toward the discovery
of short interfering RNAs (siRNAs), the molecules
that induce RNA interference, to restore protein
function in CF. The company's global headquarters are in
Cambridge, Massachusetts. company Aerovance
Inc.ischemic narelle
com.
Condensed Balance Sheets
(in thousands)
December 31, December 31,
2004 2003
(1)
(1)
Assets:
Cash and cash equivalents $5,580 $1,752
Short-term investments 81,379 39,685
Prepaids and other
current assets 1,831 2,314
Total current assets 88
,790 43,751
Property and equipment, net 6,022
5,619
Other long-term assets 1,313 3,181
$96,125 $52,551
Liabilities and stockholders
' equity
(net capital deficiency):
Current liabilities $10,310
$6,165
Long-term liabilities 3,039 1,672
Convertible preferred stock -- 123,266
Stockholders
' equity
(net capital deficiency) 82,776 (78,552)
$96,125 $52,551
(1) Derived from audited
financial statements at that date. We hope a potential therapeutic will result
from this groundbreaking
technology to treat the cause of the
disease," said Robert J., president and CEO of Alnylam
Pharmaceuticals
. "We turned
to Quintiles because of the good experience we had working with them before,
as well
as their flexibility, which allows them to work with an emerging
biotech like us just as they would
with a major pharmaceutical company.guillain narelle
6 million, respectively, compared to $0 and $4.9 million compared
to $85. Basic and diluted net loss per share attributable to
common stockholders for the year ended
December 31, 2004 was $1. Food and Drug
Administration to advance REN-850 into the clinic.
REN-850 is an orally
available, small molecule for multiple sclerosis and other autoimmune
diseases. To access the call by live webcast, please log on to
the Investor Relations section
of our website at http://www.
(2) The pro forma basic and diluted loss per share amounts give
effect to
the automatic conversion of our outstanding convertible preferred
stock
into common stock as of the original date of issuance of the
preferred stock. "We are very
pleased to collaborate with Alnylam,
a leader in the discovery and development of RNAi therapeutics
, to
focus on CF. CFFT
supports and governs activities related to cystic fibrosis (CF) drug
discovery
through drug development and clinical evaluation.alnylam.
Actual results may differ materially from
those indicated by these
forward-looking statements as a result of various important factors,
including
risks related to: our approach to discover and develop novel
drugs, which is unproven and may never
lead to marketable products;
our ability to obtain additional funding to support our business
activities;
our dependence on third parties for development,
manufacture, marketing, sales and distribution of
our products; the
successful development of products, all of which are in early stages
of development;
obtaining regulatory approval for products;
competition from others using technology similar to ours
and others
developing products for similar uses; obtaining, maintaining and
protecting intellectual
property utilized by our products; and our
short operating history; as well as those risks more fully
discussed
in the "Certain Factors That May Affect Future Results" section of our
most recent Form
10-Q filed with the Securities and Exchange
Commission. Emerging U."
Quintiles also
is conducting EDC studies for Aerovance in the treatment of
cystic fibrosis, asthma and eczema.
In addition to these investigational
products, Aerovance has several preclinical programs in respiratory
disease.kayla softley
, Renovis,
Inc. Various important factors could cause actual results or
events to differ
materially from the forward-looking statements that we make,
including risks related to: our heavy
dependence on the success of CEROVIVE
(NXY-059), which is still under development; our dependence
on our strategic
collaboration with AstraZeneca; AstraZeneca's success in obtaining regulatory
approval
to market CEROVIVE (NXY-059); our ability to successfully develop
other product candidates, such
as REN-1654 and REN-850; obtaining, maintaining
and protecting the intellectual property incorporated
into our product
candidates; and our ability to obtain additional funding to support our
business
activities.
Since many diseases are caused by the inappropriate activity of
specific genes, the
ability to silence and regulate such genes
selectively through RNAi could provide a means to treat
a wide range
of human diseases.
Quintiles began using EDC in 1999
and has seen the
acceptance of EDC accelerate since then, with more than 60
EDC trials put into production in 2005
.
About Quintiles Global Data Management
Quintiles Global Data Management delivers
consistent, accurate data
through flexible and cost-effective solutions for customers.hie benefactors
Goodman
, PhD, President and Chief Executive Officer.
Eastern Standard Time.43) $(0. Doyle
Emily Poe
(650) 266-1407 (212) 845-4266
emily.
"The
opportunity to harness RNAi to treat CF represents an
important strategy in the application of our
technology for
discovering novel medicines and making a difference in patients'
lives," said John
Maraganore, Ph.K. Quintiles looks forward to bringing
Aerovance our expertise managing electronic
patient data.benefactors camryn
We
recently announced that enrollment has been completed in a Phase II
trial with REN-1654 in post-herpetic neuralgia and currently expect to
announce top-line
results from this trial by the end of the first
quarter of 2005.
We expect to initiate
IND-enabling studies with molecules from both
programs in 2005. Our most advanced product
candidate is
CEROVIVE (NXY-059), an intravenous drug for acute ischemic stroke that is in
Phase
III clinical trials with our exclusive licensee, AstraZeneca AB.org
About RNA Interference (RNAi
)
RNA interference, or RNAi, is a naturally occurring mechanism
within cells for selectively
silencing and regulating specific genes. Alnylam is developing a
pipeline of RNAi products using
Direct RNAi(TM) to treat ocular,
central nervous system, and respiratory diseases and Systemic RNAi
(TM)
to treat a broad range of diseases, including oncology, metabolic, and
auto immune diseases
. "As the leader in outsourced
EDC services, we are seeing greater appreciation for the potential
savings in
time and expense, as well as the ability to provide better access to data
throughout
the length of the study.
Aerovance was spun off from Bayer Pharmaceuticals' biotechnology unit in
August 2004.This category is for personal sites of people who have Cerebral Palsy.
cortical dewees
5 million, and
$30. Basic and diluted net loss per
share in the fourth quarter was $0. Defects in this protein
lead to thick, sticky mucus
that clogs the lungs and digestive system. CFFT and Alnylam aim to determine
whether this protein
can be redirected to the cell surface by using a potential RNAi
therapeutic
to silence specific genes., of Berkeley, Calif.menard ischemic
(Nasdaq: RNVS), a biopharmaceutical company focused
on the discovery and
development of drugs to treat neurological diseases and disorders, today
announced
financial results for the fourth quarter and full year ended
December 31, 2004.
For the
year ending December 31, 2005, the Company presently anticipates:
* Total contract revenue
from existing agreements of approximately $2. A
playback of the call and archive of the webcast
will be available through
February 24, 2005.com.70) $(7. Beall, Ph."
About the Cystic
Fibrosis Foundation and CFFT
The mission of the Cystic Fibrosis Foundation is to assure the
development
of the means to cure and control CF and to improve the
quality of life for those with the disease
.
Quintiles is using EDC in a trial being conducted in the United Kingdom
for Aerovance, Inc
.
About Quintiles
Quintiles is the global leader in pharmaceutical services, improving
healthcare worldwide by providing innovative, quality professional expertise,
market intelligence
and partnering solutions to meet the dynamic needs of the
pharmaceutical, biotechnology and healthcare
industries.benefactors guillain
By comparison, in 2003 we did not commence
any clinical trials until late in the third
quarter.43 compared with $9.64 for the same period last year.93 for the same period in 2003. The proforma
basic and diluted net loss per
share for the year ended December 31, 2003 excludes the deemed dividend
and
write-off of acquired in-process research and development."
* Cerovive(R) (NXY-059
): During 2004, Cerovive advanced through two
interim data analyses and in December we announced
that enrollment was
completed ahead of schedule in SAINT I, one of the two pivotal Phase III
trials with the IV drug in acute ischemic stroke patients. We also began our early-stage collaboration
with
Genentech in the areas of anti-angiogenesis and nerve growth during 2004
and
look forward to completing more key experiments in this program
during 2005.renovis.37)
Pro forma basic and
diluted net loss per
share excluding
write-off
of IPR+D of
$17,305 and deemed
Dividend of $43,393 (1)
$ (2. Noonan/Russo
John C.Quintiles Data Management to Conduct
200th EDC Trial
today announced that it has reached a significant
milestone in data management
-- the 200th clinical trial using Electronic Data
Capture (EDC). The company's two
lead products
are AER001, an IL4/13 receptor antagonist for severe asthma and
eczema currently in Phase 2 studies
, and AER002 a recombinant protein for CF
and COPD currently in Phase 2 studies.hie ischemic
7 million, respectively
, compared to $7. The expenses of preclinical development activities with
REN-850 and REN-214 also
contributed to the increase in research and
development spending during 2004.2 million and $6.
Net loss for the fourth quarter of 2004 was $10.40 in the fourth
quarter of 2003. We expect to
announce top-line results from SAINT I in coordination with AstraZeneca
during the
second quarter of 2005.hypoxic encephalopathy
4 million during the same periods in 2003.3 million in 2003, which included a
deemed dividend of $43. Enrollment of patients in the SAINT II and
CHANT clinical trials
is progressing consistent with AstraZeneca's
announced intention to file for regulatory approval
of Cerovive(R)
(NXY-059) in 2006.D.84) $(87. We believe applying our technology to
this
disease represents an outstanding opportunity for Alnylam and
look forward to bringing the potential
fruits of this collaboration to
patients.naudikah micah
0 million and $8. The
increase in annual expenses reflects
investments in protecting intellectual
property with patent protection of important discoveries made
in our
preclinical drug development programs. REN-850 entered the clinic earlier this week when
we
initiated a Phase Ia study in healthy volunteers.com
Alnylam Forward Looking Statement
Various statements in this release concerning our future
expectations, plans, prospects and
future operating results constitute
forward-looking statements for the purposes of the safe harbor
provisions under The Private Securities Litigation Reform Act of 1995.micah mikolaj
5 million for the
corresponding
periods in 2003.7
million and $20.4 million associated with the issuance of preferred
stock in
August 2003 and a one-time, non-cash charge of $17.3 million for the
write-off of acquired in-process
research and development (IPR+D) related to
an asset acquisition. "Looking ahead, 2005
holds
the potential to be a watershed year for the company with a number of
important clinical milestones
and continued advancement of our preclinical
programs. Enrollment is continuing in the second Phase
II trial
with REN-1654 in sciatica patients and we currently expect to announce
results
from this trial by the end of the third quarter of 2005. Goodman, Ph. Actual results or events could
differ materially
from the plans, intentions and expectations disclosed in the forward-looking
statements
we make.
Condensed Statements of Operations
(All amounts in thousands, except share
and per share amounts)
(Unaudited)
Three Months
Ended Years Ended
December 31, December
31,
2004 2003 2004 2003
Contract
revenue $656 $-- $2,625 $4,500
Operating expenses:
Research and development 8,541 7,698 30,733 20,449
General and administrative
1,994 2,207 8,270 6,637
Amortization of employee
stock-based
compensation 1,036 1,216 4,646 1,860
Acquired in-process research
and development -- -- -- 17,305
Total operating
expenses 11,571 11,121 43,649 46,251
Loss from operations
(10,915) (11,121) (41,024) (41,751)
Other income (expense) 334
30 1,083 (121)
Net loss (10,581) (11,091) (39,941)
(41,872)
Deemed dividend upon issuance
of Series E convertible
preferred
stock -- -- -- (43,393)
Net loss attributable to
common stockholders $(10,581) $(11,091) $(39,941) $(85,265)
Basic and
diluted net loss
per share $(0.Cystic Fibrosis Foundation Therapeutics and
Alnylam Initiate Collaboration to Discover RNAi Therapeutic to Treat Cystic Fibrosis
The CF
Foundation
provides support to fund CFFT's operations, specifically
the Therapeutics Development Program.cff
. Services include
capturing, analyzing and reporting patient-related data traditionally, by
paper
and fax, or electronically, by EDC and PDA, and then integrating data
into a clean, compatible and
fully CDISC-compliant database to facilitate
regulatory submission and acceptance.com.menard hypoxic
Revenue
for the quarter and year ended December 31, 2004 was $656,000 and
$2. In addition to the
product
development expenses we incurred in 2004 we also made investments in
research facilities, personnel
, and laboratory equipment and supplies, which
were needed to pursue earlier stage research efforts
in our programs focused
on neuroprotection and pain.6 million compared to
$11.
For additional
information about the company, please visit
http://www.43) $(9.
Cystic fibrosis is a genetic
disease affecting approximately
30,000 children and adults in the United States., president and CEO
of the CF
Foundation and CFFT.kristi microcephaly
General and administrative expenses for the quarter and year
ended
December 31, 2004 were $2. The Company intends to update financial guidance for 2005 when
it
releases results for each quarter or upon the announcement of material
corporate events.
About Renovis
Renovis is a biopharmaceutical company developing drugs to treat
neurological
diseases and disorders.renovis. All statements, other than statements of
historical facts, included
in this press release regarding our strategy,
future operations, future financial position, future
revenues, projected
costs, prospects, plans and objectives of management are forward-looking
statements
.
Contacts:
INVESTORS: MEDIA:
Renovis, Inc. and
BETHESDA, Md. If so, the goal will be to
develop this potential RNAi therapeutic as a treatment for
CF
patients. In addition, any forward-looking statements represent our
views only as of today
and should not be relied upon as representing
our views as of any subsequent date., which is studying
a drug candidate
for chronic obstructive pulmonary disease.
hie narelle
3 million, respectively, compared
to $2. Pro forma basic and diluted net loss per
share for the year ended December 31, 2004 was
$1.
* Preclinical programs: Our scientists made important progress in 2004 in
our three
ongoing preclinical programs.
* REN-213: During 2004, we completed several Phase II clinical
studies
with REN-213, an IV drug candidate for acute pain.m. (Nasdaq: ALNY), a leading
RNAi
therapeutics company, announced today that they have initiated a
collaborative program to discover
Direct RNAi(TM) therapeutics for the
treatment of cystic fibrosis (CF).
"Existing drugs for cystic
fibrosis focus on the symptoms and
complications of the disease, such as preventing infections, reducing
the quantity and thickness of secretions in the lungs, and improving
breathing and digestion.
D. For more information about CF,
the CF Foundation or CFFT, call (800) FIGHT CF or visit www.
Growing
from its foundation as the world's first company focused on
RNAi therapeutics, the company's leadership
in the field of RNAi is
supported by its preeminent founders and advisors and its strengths in
fundamental
patents, technology, and know-how that underlie the
commercialization of RNAi therapeutics. Quintiles
Global Data Management has
more than 1,000 employees in 10 offices around the world.naudikah softley
6 million during
the same periods in 2003. In August, AstraZeneca initiated the
CHANT (Cerebral Hemorrhage
and NXY-Treatment) trial to assess the safety
and tolerability of Cerovive(R) (NXY-059) in
patients with acute
intracerebral hemorrhage.S.6
million; and
* Total operating
expenses of $45 million to $50 million.93)
Shares used to compute
basic and diluted
net
loss per share 24,370,671 1,179,521 21,670,435 969,692
Pro
forma basic and
diluted net loss
per share $(0.----March 16,
2005
--
Cystic Fibrosis Foundation Therapeutics to Provide $1. In most patients,
potentially functional
CFTR protein is made but does not reach the
cell surface.
RESEARCH TRIANGLE PARK, N.
For more information visit
the company's Web site at http://www.cortical encephalopathy
In our oral cytoprotection and
VR1 programs we have identified a number of promising lead candidates.
RENOVIS
, INC. The median
life expectancy has improved from early childhood to the mid-30s
today, but many
individuals battle lung disease for years.palsy encephalopathy
All revenue in 2004 resulted from our
collaboration with
Genentech in the areas of neurological disorders and
anti-angiogenesis. To access the playback of
the call, dial 888-286-8010, (in
the United States), or 617-801-6888 (internationally), reservation
number
67829792. We are
independently developing REN-1654, an oral drug for neuropathic pain
in Phase
II clinical trials and REN-850, an oral drug for multiple sclerosis in Phase I
clinical
trials. We may not actually achieve these plans, intentions or
expectations and Renovis cautions
investors not to place undue reliance on our
forward-looking statements.12)
Shares used
to compute
pro forma basic and
diluted net loss
per share (2) 24
,370,671 17,388,084 23,481,249 11,561,881
(1) Non-GAAP pro forma information is provided
to facilitate comparison
with 2004 results.5 million in up front and
milestone-driven
funding for the discovery effort, along with
introductions to world-class CF academic researchers
and access to
critical research resources. "The ability to collaborate with a strong foundation,
such as the CF Foundation and its affiliate, CFFT, allows us to
address this unmet medical need
.
About Alnylam Pharmaceuticals, Inc., Quintiles
Transnational Corp.
"This achievement
is important for Quintiles as well as the pharmaceutical
and biotechnology industries because it
indicates the increasing recognition
of the tangible benefits of EDC," said Paula Brown Stafford
, Executive Vice
President, Global Data Management, Quintiles.
"We are thrilled to work again
with Aerovance, an emerging
biopharmaceutical company that is conducting important research into
serious
respiratory and inflammatory diseases. Quintiles has 16,000
specialized employees and
offices in 50 countries.microcephaly narelle
Research and development expenses for the quarter and year ended December
31, 2004 were $8.
At December 31, 2004, Renovis had $87.0 million in cash, cash equivalents
and short-term investments.
2004 Highlights
"Renovis achieved a number of important
objectives in 2004," said Corey S. Doyle, Vice
President of Finance and CFO, will review fourth quarter
and full year results
via webcast and conference call on Thursday, February 17, 2005 at 4:30 p. CFFT
is expected to provide Alnylam with $1. studying COPD drug in U.
ischemic amerongen
All revenue in 2003 resulted
from milestone payments that
we received from our exclusive licensee, AstraZeneca AB, when Cerovive
(R)
(NXY-059) entered Phase III clinical trials. The increase in
research and development expenses
reflects investments in the clinical
development of REN-1654 in neuropathic pain and REN-213 in acute
post-operative pain. Pro forma basic and diluted net loss per share in the fourth
quarter was
$0.84 compared to
$87.12
for the same period in 2003.
2005 Financial Guidance
Financial projections involve a high level of uncertainty due, among many
factors, to the variability
involved in predicting clinical trial enrollment
rates and results, requirements of early stage research
programs, and the
potential for Renovis to enter into new licensing agreements or strategic
collaborations
.64) $(1.5 Million
Cystic Fibrosis Foundation Therapeutics, Inc. A defective gene
causes
the body to produce an abnormally thick, sticky mucus that
obstructs the lungs, leading to life-threatening
lung infections, and
obstructs the pancreas, causing difficulty absorbing food. For additional information
, please visit
www.S."
About Aerovance
Aerovance is a privately held biopharmaceutical
company focused
exclusively on the development and commercialization of biologics for severe
respiratory
and inflammatory diseases such as asthma, cystic fibrosis (CF),
chronic obstructive pulmonary disease
(COPD) and eczema.amerongen micah
SOUTH SAN FRANCISCO, Calif. Additionally, we added administrative
resources
in 2004 to support the expansion of our clinical and preclinical
activities, and to accommodate increased
reporting and regulatory requirements
associated with operating as a public company following our
initial public
offering in February 2004.1 million for the same period last year.70 in 2004 compared
to $2. Accordingly, we ended all efforts
to commercialize REN-213 and decided not to advance
REN-214, a nasal
formulation of the drug in preclinical studies, into the clinic., President
and CEO, and John C. We do not assume any obligation to update any forward-looking
statements.
(CFFT), the drug
discovery and development affiliate of the Cystic Fibrosis Foundation
(CFF), and
Alnylam Pharmaceuticals, Inc.C.hypoxic cerebral
43 in 2004 compared to $0.
Net loss attributable to common stockholders
for the year ended December 31,
2004 was $39. As previously
announced, the data from these
studies did not support continued
investment in the program by Renovis.
CEROVIVE
(NXY-059) is a registered trademark of the AstraZeneca group of
companies. All other product names
and marks are or may be trademarks or
registered trademarks used to identify products or services
of their
respective owners. These and other risks are described in greater detail in
the "Risk
Factors" section of our Quarterly Report on Form 10-Q, which was
filed with the Securities and Exchange
Commission on November 15, 2004.
RENOVIS, INC.D. We do not assume any obligation
to
update any forward-looking statements.freebyrd menard
CFFT is the non-profit
drug discovery and development affiliate
of the CF Foundation.hypoxic menard
This guidance
does not include the impact of FAS123R, "Accounting for
Stock-Based
Compensation," which the Company is required to adopt in the third
quarter
of 2005.
Safe Harbor Statement
This press release contains forward-looking statements
within the meaning
of the Private Securities Litigation Reform Act of 1995 that involve
substantial
risks and uncertainties.com
"
This genetic disease is marked by defects in a protein, known
as
the Cystic Fibrosis Transmembrane conductance Regulator (CFTR)
protein, required for proper
transport of salt and water across the
cell membrane. The discovery of RNAi has been heralded by
many as
a major breakthrough, and the journal Science named RNAi the top
scientific achievement
of 2002, as well as one of the top 10
scientific advances of 2003.
Alnylam is a biopharmaceutical
company seeking to develop and
commercialize novel therapeutics based on RNA interference, or RNAi
.
"Quintiles Data Management has developed an elegant clinical EDC program
for us," said Richard
Fuller, Chief Operating Officer, Aerovance.quintiles.narelle mikolaj
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