09.04.2008 21:30:00
|
Northfield Laboratories Inc. Reports Fiscal 2008 Third Quarter Financial Results
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today financial
results for the third fiscal quarter ended February 29, 2008.
For the third fiscal quarter, Northfield reported a net loss of $4.8
million, or $0.18 cents per share, compared with a net loss of $6.1
million, or $0.23 cents per share for the corresponding period last
year. At the close of the quarter, the company reported shareholder’s
equity of $32.3 million and $27.1 million in cash and marketable
securities.
Activities of the Quarter
Northfield continues to focus on the preparation of a Biologics
License Application (BLA) for PolyHeme for submission to FDA. We
expect to submit the BLA this summer, most likely sometime in the
third calendar quarter. We also plan to submit a request for priority
review of our BLA, as we believe PolyHeme satisfies the stated
criteria for priority review based on its potential to address an
unmet medical need.
Ernest E. Moore, M.D, the lead investigator for the Phase III study,
and the Publications Committee for the PolyHeme Study Group prepared
and submitted a manuscript on the study results to a peer-reviewed
journal.
Northfield participated in a recent Endpoint Initiative Meeting in
Dallas hosted by the National Trauma Institute. There were invited
participants from the military, FDA, NIH, academia, and industry. The
goals of this meeting were to define clinically relevant endpoints in
trauma research, and to identify strategies to facilitate awareness
and acceptance of these endpoints in planning for future research and
clinical trials.
Recent and Upcoming Events
Northfield will be presenting an overview of the clinical development
of PolyHeme at the FDA/NIH sponsored Public Workshop on
Hemoglobin-Based Oxygen Carriers being held on the NIH campus April
29-30.
Investor Outreach
Northfield presented at the BIO CEO and Investor Conference in
February.
We continue our outreach to institutional investors through one-on-one
meetings.
Conference Call and Webcast Information
Northfield will host a conference call to discuss third quarter
financial results on Thursday, April 10, 2008 at 11:00 a.m.ET/10:00 a.m.
CT. To access the conference call, investors may dial 866.770.7146 and
enter the passcode 362290007. A replay of the call will be available for
two weeks by dialing 888.286.8010 and entering the passcode 28304075.
The webcast is being distributed through the Thomson StreetEvents
Network to both institutional and individual investors. Individual
investors may listen to the call at http://www.fulldisclosure.com,
Thomson/CCBN’s individual investor portal,
powered by StreetEvents. Institutional investors may access the call via
Thomson’s password-protected event management
site, StreetEvents (http://www.streetevents.com).
Interested investors may also access the live webcast through the Company’s
website, located at www.northfieldlabs.com.
About Northfield Laboratories
Northfield Laboratories Inc. is a leader in developing an
oxygen-carrying red blood cell substitute for the treatment of
life-threatening blood loss, when an oxygen-carrying fluid is required
and red blood cells are not available. PolyHeme®
is a solution of chemically modified human hemoglobin that requires no
cross matching and is therefore compatible with all blood types. It has
a shelf life in excess of 12 months. For further information, visit www.northfieldlabs.com. Forward Looking Statement This press release may contain forward-looking statements concerning,
among other things, Northfield’s future
business plans and strategies and clinical and regulatory developments
affecting our PolyHeme red blood cell substitute product. These
forward-looking statements are identified by the use of such terms as "intends,” "expects,” "plans,” "estimates,” "anticipates,” "should,” "believes”
and similar terms. These forward-looking statements involve inherent
risks and uncertainties. Our actual results may therefore differ
materially from those predicted by the forward-looking statements
because of various factors and possible events, including the
possibility that since the full data from our Phase III clinical trial
have not been submitted to, or reviewed by, FDA, they may not be
sufficient to demonstrate the safety or effectiveness of PolyHeme, our
ability to successfully file a Biologics License Application, our
ability to be granted priority review of our Biologics License
Application, our ability to obtain FDA approval to market PolyHeme
commercially, our need to obtain additional capital to finance our
ongoing business operations and the construction of an expanded
commercial-scale manufacturing facility, our ability to obtain adequate
supplies of raw materials and to manufacture PolyHeme in commercial
quantities, our ability to market PolyHeme successfully, the possibility
that competitors will develop products that will render PolyHeme
obsolete or non-competitive, our ability to protect our intellectual
property rights, the outcome of certain governmental inquiries and
purported class action lawsuit as described in our most recently filed
annual report on Form 10-K and quarterly report on Form 10-Q, the
possibility that we may be subject to product liability claims and other
legal actions, our dependency on a limited number of key personnel, the
uncertainty of third party reimbursement for our product and other risks
and uncertainties described from time to time in our periodic reports
filed with the Securities and Exchange Commission, including our most
recently filed annual report on Form 10-K and annual report on Form 10-Q. These forward-looking statements speak only as of the date of this
press release. We do not undertake any obligation to update or
publicly release any revisions to forward-looking statements to reflect
events, circumstances or changes in expectations after the time such
statement is made. All subsequent written and oral forward-looking
statements attributable to Northfield or any person acting on our behalf
are qualified by this cautionary statement.
TABLES TO FOLLOW
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Balance Sheets
February 29, 2008 and May 31, 2007
(In thousands)
Feb 29,
May 31,
2008
2007
Assets
(unaudited)
Current assets:
Cash
$
16,526
$
23,224
Restricted Cash
589
530
Short-term marketable securities
9,963
16,934
Prepaid expenses
328
673
Other current assets
0
213
Total current assets
27,406
41,574
Plant and equipment, net
8,283
8,525
Other assets
20
20
Total assets
$
35,709
$
50,119
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable
$
1,763
$
3,573
Accrued expenses
188
101
Accrued compensation and benefits
843
566
Government grant liability
589
530
Total current liabilities
3,383
4,770
Other liabilities
14
7
Total liabilities
3,397
4,777
Shareholders' equity:
Capital stock
269
269
Additional paid-in capital
246,508
244,881
Deficit accumulated during the development stage
-214,465
-199,808
Total shareholders' equity
32,312
45,342
Total liabilities and
shareholders' equity
$
35,709
$
50,119
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Operations
Nine months ended February 29, 2008 and February 29, 2007
(In thousands except per share data)
Nine Months Ended
Feb 29,
Feb 29,
2008
2007
(unaudited)
(unaudited)
Revenues - license income
$
-
$
-
Costs and expenses:
Research and development
3,669
4,476
General and administrative
1,481
2,270
5,150
6,746
Other income and expense:
Interest income
319
634
Interest expense
-
-
319
634
Cumulative effect of change in
accounting principle
Net loss
$
-4,831
$
-6,112
Net loss per basic share
$
-0.18
$
-0.23
Shares used in calculation of per share data
26,958
26,911
Der finanzen.at Ratgeber für Aktien!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
JETZT DEVISEN-CFDS MIT BIS ZU HEBEL 30 HANDELN
Handeln Sie Devisen-CFDs mit kleinen Spreads. Mit nur 100 € können Sie mit der Wirkung von 3.000 Euro Kapital handeln.
82% der Kleinanlegerkonten verlieren Geld beim CFD-Handel mit diesem Anbieter. Sie sollten überlegen, ob Sie es sich leisten können, das hohe Risiko einzugehen, Ihr Geld zu verlieren.
Nachrichten zu Northfield Laboratories Inc.mehr Nachrichten
Keine Nachrichten verfügbar. |
Analysen zu Northfield Laboratories Inc.mehr Analysen
Indizes in diesem Artikel
NASDAQ Comp. | 19 278,90 | -1,03% |