Northfield Laboratories Inc. Reports Fiscal 2008 Fourth Quarter and Year-End Financial Results
14 Agosto 2008 - 5:45PM
Business Wire
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that it
has filed its Annual Report on Form 10K, letter from the Chairman,
and final Proxy Statement with the Securities Exchange Commission.
These items are available on the Company�s website at
www.northfieldlabs.com. For the fiscal year, Northfield reported a
net loss of $20.4 million, or $.76 per share, compared with a net
loss of $27.7 million, or $1.03 per share, for the prior fiscal
year. The Company reported shareholders� equity of $27.0 million,
with $20.7 million in cash and marketable securities. Northfield
reported a loss of $5.8 million, or $0.21 cents per share, for the
fiscal fourth quarter, compared with a loss of $6.4 million, or
$0.24 cents per share, for the corresponding period last year.
Highlights of the Fiscal Year Northfield continues to prepare its
Biologics License Application for PolyHeme�, the Company�s human
hemoglobin-based oxygen carrier for the treatment of
life-threatening hemoglobin levels when blood is not available.
Based on the current activities described in the 10K, the Company
anticipates submitting the final BLA with a request for priority
review in the fourth calendar quarter of 2008. The data from
Northfield�s multicenter Phase III trial with PolyHeme were
presented at the American College of Surgeons, and the presentation
formed the basis for a paper which has been submitted to a
peer-reviewed journal for publication. The study results were
presented at a plenary session at the XI International Symposium on
Blood Substitutes in Beijing. Northfield participated in the
FDA/NIH public workshop Hemoglobin-Based Oxygen Carriers: Current
Status and Future Directions. Northfield participated in meetings
related to the advancement of trauma care, including the Endpoint
Initiatives in Trauma meeting hosted by the National Trauma
Institute and the Decision Gate in Progress Review at Fort Detrick.
Northfield supported its clinical investigators in the final phase
of public disclosure required under CFR 50.24, the regulation under
which the Phase III study was conducted. Annual Meeting of
Stockholders Northfield will hold its 2008 annual meeting of
stockholders on Thursday, October 2, 2008, at 10:00 a.m., local
time, at the Deer Path Inn, Lake Forest, Illinois. The entire
meeting, including the official proceedings, the annual business
update, and the question and answer session will be broadcast live
on the Internet. Details will be provided approximately two weeks
before the meeting date. About Northfield Laboratories and
PolyHeme� Northfield Laboratories Inc. is a leader in developing an
oxygen-carrying red blood cell substitute for the treatment of
life-threatening hemoglobin levels, when an oxygen-carrying fluid
is required and red blood cells are not available. Northfield�s
product, PolyHeme(R), is under clinical investigation as an
oxygen-carrying red blood cell substitute. It is a solution of
chemically modified human hemoglobin that requires no cross
matching and is therefore compatible with all blood types.
PolyHeme� has a shelf life in excess of 12 months. For further
information, visit http://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 our potential inability to regain compliance with
applicable Nasdaq listing standards, 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 a purported class
action lawsuit as described in our most recently filed annual
report on Form 10-K, 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. 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.
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