Sirtris Pharmaceuticals Reports Second Quarter 2007 Financial Results; Significant Progress Toward 2007 Goals
13 August 2007 - 10:00PM
Business Wire
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
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