Sirtris Pharmaceuticals, Inc. (NASDAQ: SIRT), a biopharmaceutical
company focused on discovering and developing small molecule drugs
to treat diseases of aging such as Type 2 Diabetes, announced today
that it reported its consolidated financial results for the quarter
and year ended December 31, 2007, and also commented on certain
other recent corporate accomplishments and plans. "We achieved
important milestones in sirtuin drug discovery and development last
year and anticipate further progress this year," said Christoph
Westphal, M.D., Ph.D., Chief Executive Officer and Vice Chair of
Sirtris Pharmaceuticals, Inc. "In particular, we have continued to
advance our new chemical entity (NCE) program consisting of SIRT1
activators that are chemically distinct from, and significantly
more potent than our initial clinical candidate, SRT501, a
proprietary formulation of resveratrol. We expect the first of
these NCEs to enter into the clinic in the first half of 2008.
SRT501 showed initial positive results in a Phase 1b study in
patients with Type 2 Diabetes and is currently in: (i) a second
Phase 1b study in patients with Type 2 Diabetes; (ii) a Phase 2a
study in patients with Type 2 Diabetes and; (iii) a Phase 1b study
in patients with MELAS, a mitochondrial disease and a potential
orphan drug opportunity for Sirtris.� Recent Accomplishments and
2008 Plans -- Clinical progress: � -- Our first new chemical entity
(NCE), which is structurally unrelated to and more potent than
SRT501, is expected to enter the clinic in the first half of 2008.
We have shown, in vivo, that our NCEs lower glucose and improve
insulin sensitivity and therefore have the potential to be orally
available frontline therapy for Type 2 Diabetes. -- In January
2008, we announced positive Phase 1b clinical trial results with
SRT501 in patients with Type 2 Diabetes. SRT501, which targets the
SIRT1 enzyme, was found to be safe and well-tolerated. On the last
day of this 28 day study, there was a trend towards lowering of
fasting plasma glucose and a significant lowering of glucose levels
at the two-hour time point in an oral glucose tolerance test. � --
Results of NCE SIRT1 activator preclinical studies: � -- We
published NCE data for the first time in the scientific journal
Nature in November 2007. We showed that in both diet-induced obese
and genetically obese mouse models of Type 2 Diabetes, our NCEs
improve insulin sensitivity, lower plasma glucose levels and
increase the function of mitochondria (the powerhouses of all
cells). In another well-established preclinical model of Type 2
Diabetes and insulin resistance (Zucker fa/fa rats), these SIRT1
activators improved whole-body glucose homeostasis and insulin
sensitivity in adipose tissue, skeletal muscle and liver. These
rodent models of diabetes are considered to be highly predictive of
efficacy in humans. � -- In December 2007, we presented data
showing that one of our SIRT1 activator NCEs lowers plasma glucose
and improves insulin sensitivity in a pre-clinical model of Type 2
Diabetes better than sitagliptin, a DPP-4 inhibitor. In contrast to
DPP-4 inhibitors, which lower glucose, SIRT1 activation appears to
both lower glucose and improve insulin sensitivity in various
preclinical models. SIRT1 activation also does not cause weight
gain, a side-effect associated with certain other diabetes drugs. �
-- Expansion into other therapeutic disease areas: Our first Phase
1b study with SRT501 in an oncology indication is scheduled to
begin in mid-2008. This month we announced that we are initiating
preclinical studies with SRT501 and certain NCEs in collaboration
with the National Cancer Insitute. � -- Sirtuin platform expansion
beyond SIRT1: SIRT3 is our next target of interest for a metabolic
disease. We have in-licensed SIRT3 screening technology from the
lab of Professor Eric Verdin, M.D. Associate Director and Senior
Investigator at the Gladstone Institute of Virology and Immunology
and a Professor of Medicine at the University of California, San
Francisco (UCSF). � -- Partnering: We may consider pursuing a
strategic partnership in the next 12-18 months. � -- Scientific
Advisory Board: In February, we announced that Leonard Guarente,
PhD, Novartis Professor of Biology at the Massachusetts Institute
of Technology, signed a new, exclusive consulting agreement with
us. We believe that we now have the most significant key opinion
leaders in the sirtuin field on our Scientific Advisory Board.
Fourth Quarter and Full Year 2007 Financial Results (Unaudited) As
of December 31, 2007, Sirtris had cash, cash equivalents and
short-term investments of $118.1 million compared to $50.0 million
on December 31, 2006. This is just above the top-end of our
financial guidance estimate provided at the conclusion of the
second quarter of $115.0 - 118.0 million. Net loss for the fourth
quarter of 2007 was $9.1 million, or $0.32 per share, as compared
to $4.4 million, or $4.60 per share, for the fourth quarter of
2006. Net loss includes stock-based compensation of $307,000 and
$259,000 for the quarters ended December 31, 2007 and 2006,
respectively. Net loss for the year ended December 31, 2007 was
$31.1 million, or $1.74 per share, as compared to $17.0 million, or
$18.48 per share, for the year ended December 31, 2006. Net loss
includes stock-based compensation of $2.9 million and $758,000 for
the years ended December 31, 2007 and 2006, respectively. Research
and development expense for the fourth quarter of 2007 was
$8.3�million compared to $3.6�million for the fourth quarter of
2006. For the year ended December 31, 2007, research and
development expense was $29.0�million compared to $14.2�million for
the prior year. The increase in both periods is due primarily to
increases in external clinical trial costs, preclinical studies
costs, formulation expense for our product candidates, sponsored
research costs, allocated occupancy and information technology
costs, and personnel costs related principally to increases in
research and development headcount. General and administrative
expense for the fourth quarter of 2007 was $2.0�million compared to
$1.1�million for the fourth quarter of 2006. For the year ended
December 31, 2007, general and administrative expense was
$6.2�million compared to $4.3�million for the prior year. The
increase in both periods is due primarily to increases in
professional fees associated with being a public company,
stock-based compensation expense, personnel costs, and allocated
occupancy and information technology costs. 2008 Financial Guidance
Based on current operating plans, we expect to end 2008 with cash,
cash equivalents and short-term investments of between $70.0 and
$75.0 million. We expect our net loss for 2008, excluding
stock-based compensation, to be in the range of $44.0 and $47.0
million. Stock-based compensation is projected to be in the range
of $3.5 to $4.5 million in 2008. Conference Call Information
Management will provide an update on the Company, discuss year-end
results, and provide financial guidance for calendar 2008 via
conference call on Monday, February 25, 2008 at 4:30 p.m. EST. To
access the call, please dial 800-289-0572 (domestic) or
913-981-5543 (international) five minutes prior to the start time
and provide the passcode 9183492. A replay of the call will be
available from 6:00 p.m. EST on February 25, 2008 until March 11,
2008. To access the replay, please dial 888-203-1112 (domestic) or
719-457-0820 (international), and provide the passcode 9183492. A
live audio webcast of the call also will be available on the
"Investors" section of the Company's website,
www.sirtrispharma.com. An archived webcast will be available on the
Sirtris website approximately one hour after the call and will be
archived for 14 days. About Sirtris Pharmaceuticals Sirtris
Pharmaceuticals is a biopharmaceutical company focused on
discovering and developing proprietary, orally available, small
molecule drugs with the potential to treat diseases associated with
aging, including metabolic diseases such as Type 2 Diabetes. Our
drug candidates are designed to mimic certain beneficial health
effects of calorie restriction, without requiring a change in
eating habits, by activation of sirtuins, a recently discovered
class of enzymes that the Company believes control the aging
process. The Company's headquarters are in Cambridge,
Massachusetts. This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements include, but are not limited
to, the potential therapeutic effects of SIRT1 activators for
diseases of aging, such as Type 2 Diabetes, cancer, and other
disorders; the potential effects of SIRT3 activators for metabolic
diseases; the progress and potential results of pre-clinical and
clinical studies of SRT501 and novel chemical entities; the
initiation of additional clinical trials to test the potential
therapeutic effects of SIRT1 activators; the possibility of a
strategic partnership within the next 12-18 months; and the
potential of sirtuin activators to receive regulatory approval.
These forward-looking statements about future expectations, plans
and prospects of Sirtris Pharmaceuticals involve significant risks,
uncertainties and assumptions, including risks related to the lack
of results that would provide a basis for predicting whether any of
the Company's product candidates will be safe or effective, or
receive regulatory approval, the possibility that results of
pre-clinical studies are not necessarily predictive of clinical
trial results, the Company's potential inability to initiate and
complete pre-clinical studies and clinical trials for its product
candidates, the fact that none of the Company's product candidates
has received regulatory approvals, the potential inability of the
Company to gain market acceptance of the Company's product
candidates, and those other risks factors that can be found in the
Company's filings with the Securities and Exchange Commission.
Actual results may differ materially from those Sirtris
Pharmaceuticals contemplated by these forward-looking statements.
Sirtris Pharmaceuticals does not undertake to update any of these
forward-looking statements to reflect a change in its views or
events or circumstances that occur after the date of this release.
Sirtris Pharmaceuticals, Inc. (A development-stage company)
Unaudited Selected Consolidated Balance Sheet Information (in
thousands) � � December December 31, 2007 31, 2006 Cash and cash
equivalents $ 23,062 $ 7,513 Short-term investments 95,024 42,497
Working capital 111,734 47,338 Total assets 125,215 52,086 Notes
payable, net of current portion and discount 6,711 9,425
Stockholders� equity (deficit) � � 110,516 � � (27,634 ) Sirtris
Pharmaceuticals, Inc. (A development-stage company) Unaudited
Condensed Consolidated Statements of Operations Information �(in
thousands, except share and per share amounts) � � � � Three Months
Ended December 31, Year Ended December 31, 2007 2006 2007 2006 �
Revenue $ � $ � $ � $ � Operating expenses: Research and
development (1) 8,286 3,647 29,035 14,242 General and
administrative (1) � 2,022 � � � 1,074 � � � 6,157 � � � 4,340 �
Total operating expenses 10,308 4,721 35,192 18,582 Loss from
operations (10,308 ) (4,721 ) (35,192 ) (18,582 ) Interest income
1,590 701 5,495 2,447 Interest expense � (334 ) � � (359 ) � �
(1,393 ) � � (878 ) Net loss $ (9,052 ) � $ (4,379 ) � $ (31,090 )
� $ (17,013 ) Net loss per share - basic and diluted $ (0.32 ) $
(4.60 ) $ (1.74 ) $ (18.48 ) Weighted average number of common
shares used in net loss per basic and diluted 28,576,159 955,834
17,919,388 924,694 � � (1) Amounts include stock-based compensation
expense, as follows: Research and development $ 120 $ 183 $ 2,334 $
557 General and administrative 187 76 601 201
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