Neurobiological Technologies, Inc. Reports First Quarter Fiscal Year 2009 Financial Results
November 06 2008 - 6:30AM
PR Newswire (US)
EMERYVILLE, Calif., Nov. 6 /PRNewswire-FirstCall/ --
Neurobiological Technologies, Inc. (NTI(R)) (NASDAQ:NTII) today
announced its financial results for the quarter ended September 30,
2008, the first quarter of the company's fiscal year ending June
30, 2009. Revenue for the three months ended September 30, 2008 was
$3.6 million, compared to $3.9 million for the three months ended
September 30, 2007. Operating expenses were $6.8 million for the
first quarter of fiscal 2009 compared to $7.1 million for the same
period in the prior year. Within the company's operating expenses,
research and development was $5.5 million for each of the first
quarters of fiscal 2009 and 2008, and general and administrative
decreased to $1.3 million for the first quarter of fiscal 2009
compared to $1.7 million for the first quarter of fiscal 2008. The
company's operating loss was $3.2 million for both periods. Net
loss was $2.8 million for the three months ended September 30, 2008
compared to $0.9 million for the three months ended September 30,
2007. The increased net loss for the fiscal 2009 quarter was
primarily due to a non-cash gain of $2.9 million recorded in the
fiscal 2008 period as a result of fair-value accounting for a
financial instrument. Net loss per share was $0.10 for the three
months ended September 30, 2008 compared to $0.19 for the three
months ended September 30, 2007. As of September 30, 2008, the
company had $28.2 million in cash and short-term investments. The
company also held $10.3 million in auction rate securities, which
are classified as long-term investments. "Our clinical team is
making important progress on the development of Viprinex(TM) for
acute ischemic stroke as we start our new fiscal year. This
dedicated group is preparing for the upcoming interim analysis
while simultaneously accelerating trial enrollment for the
subsequent final analysis of this pivotal trial," said Paul E.
Freiman, president and chief executive officer. "The Viprinex
studies have recently surpassed a total of 600 patients enrolled
(out of a target of 650 patients), the first 500 of which will be
considered for the upcoming interim analysis, which we expect to
complete by January 2009. The interim futility review will
constitute a major go/no-go decision for the Viprinex program,
since it is the first efficacy assessment ever by our independent
Data Safety Monitoring Board (DSMB). For the trial to pass
futility, Viprinex must demonstrate predetermined efficacy
criteria. If we pass the interim evaluation, the clinical data will
remain blinded until the final analysis of the trial, which we
expect to complete by mid-2009." NTI also announced that it has
amended its stockholder rights plan, originally adopted by the
Board of Directors in 2005, to increase the percentage of the
company's common stock that can be acquired by a shareholder from
15 to 20% before rights are triggered under the plan. Conference
Call Information NTI will webcast its quarterly financial results
and host a conference call today at 10:30 a.m. (ET), 7:30 a.m.
(PT). Dial-in number (800) 309-1245 (U.S. and Canada) and
719-457-2080 (International). The webcast can be accessed by going
to http://investor.shareholder.com/ntii/events.cfm . A playback of
the conference call will be available from 1:30 p.m. (ET) today
through midnight (ET) on November 13, 2008. Replay number: (888)
203-1112 (U.S. and Canada) / (719) 457-0820 (international). Replay
access code: 8094663. About Neurobiological Technologies, Inc.
Neurobiological Technologies, Inc., (NASDAQ:NTII) is a
biopharmaceutical company focused on developing novel,
first-in-class agents for central nervous system conditions and
other serious unmet medical needs. The Company's most advanced
product candidate, Viprinex(TM) (ancrod), is in Phase 3 clinical
testing as a novel investigational drug for the treatment of acute
ischemic stroke. Viprinex has multiple mechanisms of action and is
specifically designed to extend the time period that patients can
be treated after the onset of a stroke. Acute ischemic stroke is
one of the most prevalent, debilitating and costly diseases in the
world for which there are few acceptable treatment options. NTI
also has early-stage development programs for Alzheimer's and
Huntington's diseases and rights to receive payments on an approved
drug for Alzheimer's disease and an investigational drug in Phase 3
trials for brain swelling. NOTE: Except for the historical
information contained herein, the matters discussed in this press
release are forward-looking statements that involve risks and
uncertainties, including uncertainties regarding the development of
Viprinex for acute ischemic stroke, delays or other problems with
our clinical trials, the outcome of the interim analysis, the time
and costs for obtaining approval for Viprinex, and levels of future
expenditures and capital resources needed to fund operations, as
well as other risks detailed from time to time in our filings with
the Securities and Exchange Commission, including our Annual Report
on Form 10-K, as updated periodically in Quarterly Reports on Form
10-Q and Current Reports on Form 8-K. Actual results may differ
materially from those projected. These forward-looking statements
represent our judgment as of the date of the release and we
undertake no obligation to update these forward-looking statements.
- FINANCIAL TABLES TO FOLLOW - CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) (in thousands, except per share data) Three
months ended September 30, 2008 2007 REVENUES Royalty $2,078 $1,981
Technology sale and collaboration services 1,487 1,919 Total
revenues 3,565 3,900 EXPENSES Research and development 5,452 5,460
General and administrative 1,331 1,659 Total expenses 6,783 7,119
Operating loss (3,218) (3,219) Interest income 249 28 Gain on sale
of long-term investments 170 -- Interest expense, including
non-cash amortization of $588 discount on notes for the three
months ended September 30, 2007 -- (633) Non-cash gain on decrease
in fair value of warrants 37 2,902 NET LOSS $(2,762) $(922) BASIC
AND DILUTED NET LOSS PER SHARE $(0.10) $(0.19) Shares used in basic
and diluted net loss per share calculation 26,924 4,772 SELECTED
CONSOLIDATED BALANCE SHEET DATA (in thousands) September 30, June
30, 2008 2008 Unaudited Note 1 Cash and cash equivalents $26,122
$27,941 Short-term investments 2,059 2,039 Long-term investments
10,274 11,850 Total assets 39,338 43,187 Current liabilities 10,067
9,042 Total liabilities 22,101 22,901 Stockholders' equity 17,237
20,286 Note 1: Information as of June 30, 2008 has been derived
from the audited financial statements at that date. DATASOURCE:
Neurobiological Technologies, Inc. CONTACT: Matthew M. Loar, CFO of
Neurobiological Technologies, Inc., +1-510-595-6000 Web site:
http://www.ntii.com/
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