Sierra Natl BK Tehachapi Calif (MM) (NASDAQ:SIRT)
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Sirtris Pharmaceuticals, Inc. (NASDAQ: SIRT), a biopharmaceutical
company focused on discovering and developing small molecule drugs to
treat diseases of aging, announced today that it reported its
consolidated financial results for the quarter ended June 30, 2007 and
also commented on certain other recent corporate accomplishments.
"We have made important advances in sirtuin drug discovery this year,
and anticipate further progress," said Christoph Westphal, M.D., Ph.D.,
Chief Executive Officer of Sirtris Pharmaceuticals, Inc. "In particular,
we have continued to advance our development pipeline. Our initial
clinical candidate, SRT501, is in two Phase 1b studies in patients with
Type 2 Diabetes, and we plan to announce results of the first of these
two studies in the second half of 2007. We recently announced initiation
of a Phase 1b study of SRT501 in MELAS, a mitochondrial disease and a
potential orphan drug opportunity for Sirtris. We also strengthened and
advanced our new chemical entity program, consisting of SIRT1 activators
that are chemically distinct from and significantly more potent than
SRT501, in multiple pre-clinical models of metabolic disease and Type 2
Diabetes.”
Recent Accomplishments
-- Completed initial public offering resulting in $62.5 million in net
proceeds to the Company.
-- Presented Phase 1a safety and pharmacokinetic data at the 6th Annual
Metabolic Diseases Drug Discovery and Development World Summit on July
17,2007. In order to evaluate dose, safety, tolerability and
pharmacokinetics, SRT501 at doses of 0.3-5.0 grams was administered
orally, once daily to 85 healthy male volunteers in separate study
groups for seven days. SRT501 was found to be safe and well tolerated,
no serious adverse events were reported, and pharmacokinetics were
linear at days one and seven.
-- Presented additional data in preclinical models of Type 2 Diabetes
with SRT501 and several new chemical entities (NCEs) that are
significantly more potent that SRT501, demonstrating glucose lowering
and improved insulin sensitivity in the diet induced obesity (DIO)
model, the ob/ob model and the Zucker fa/fa model.
-- Initiated a Phase 1b study with SRT501 in patients with Mitochondrial
Encephalopathy, Lactic Acidosis, and Stroke-like episodes (MELAS). A
total of 30 patients (15 in treatment group, 15 control) will be dosed
once daily for three months; primary endpoints are safety and
pharmacokinetics.
Second Quarter 2007 Financial Results (Unaudited)
Net loss for the quarter ended June 30, 2007 was $6.6 million, or $0.51
per share, as compared to $3.8 million, or $4.66 per share, for the
quarter ended June 30, 2006.
Research and development expense for the second quarter of 2007 was
$6.2 million compared to $3.2 million for the second quarter of 2006.
The increase is due primarily to increases in external chemistry and
biology costs, personnel costs related principally to increases in
research and development headcount, allocated occupancy and information
technology costs, and stock-based compensation expense.
General and administrative expense for the second quarter was
$1.3 million compared to $1.1 million for the second quarter of 2006.
The increase is due primarily to increases in accounting fees associated
with being a public company and stock-based compensation expense.
As of June 30, 2007, Sirtris had cash, cash equivalents and short-term
investments of $136.0 million compared to $50.0 million on December 31,
2006. The Company expects to end the year with between $115.0 and $118.0
million in cash, cash equivalents and short-term investments.
Conference Call Information
Management will provide an update on the Company and discuss second
quarter results via conference call on Monday, August 13, 2007, at 4:30
p.m. EDT. 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 2478956. A replay of the call will be available
from 6:00 p.m. EDT on August 13, 2007 until August 24, 2007. To access
the replay, please dial 888-203-1112 (domestic) or 719-457-0820
(international), and provide the passcode 2478956.
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
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 multiple neurodegenerative diseases and
other types of disorders, the progress and results of pre-clinical
studies of SIRT1 activators, and the potential of sirtuin modulators 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)
Selected Consolidated Balance Sheet Information
(Unaudited)
June 30,
December 31,
2007
2006
(in thousands)
Cash and cash equivalents
$
74,005
$
7,513
Short-term investments
61,945
42,497
Working capital
130,921
47,338
Total assets
142,419
52,086
Notes payable, net of current portion and discount
7,992
9,4425
Stockholders’ equity (deficit)
127,383
(27,634)
Sirtris Pharmaceuticals, Inc.
(A development-stage company)
Selected Consolidated Statements of Operations Information
(in thousands, except share and per share amounts)
(Unaudited)
Three months ended June 30, 2007
Six months ended June 30, 2007
2007
2006
2007
2006
Revenue
$
—
$
—
$
—
$
—
Operating expenses:
Research and development (1)
6,175
3,204
11,295
6,359
General and administrative (1)
1,312
1,053
2,551
2,196
Total operating expenses
7,487
4,257
13,846
8,555
Loss from operations
(7,487
)
(4,257
)
(13,846
)
(8,555
)
Interest income
1,288
662
2,188
1,029
Interest expense
(404
)
(224
)
(728
)
(224
)
Net loss
$
(6,603
)
$
(3,819
)
$
(12,386
)
$
(7,750
)
Net loss per share - basic and diluted
$
(0.51
)
$
(4.66
)
$
(1.75
)
$
(9.76
)
Weighted average number of common shares used in net loss per basic
and diluted
12,928,107
822,809
7,113,201
797,789
(1) Amounts include stock-based compensation expense, as follows:
Research and development
$
887
$
121
$
1,067
$
241
General and administrative
126
37
220
59