Northfield Laboratories Inc. Reports Fiscal 2009 Third Quarter Financial Results
09 Abril 2009 - 3:30PM
Business Wire
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today
financial results for the third fiscal quarter ended February 28,
2009.
For the third fiscal quarter, Northfield reported a net loss of
$6.3 million, or $0.23 per share, compared with a net loss of $4.8
million, or $0.18 per share, for the corresponding period last
year. At the close of the quarter, Northfield reported
shareholders� equity of $10.8 million, with $4.7 million in cash
and marketable securities. As a development stage company,
Northfield does not generate revenues.
Recent and Upcoming
Events
- Northfield announced that its
BLA for PolyHeme was accepted for filing and that FDA has
designated the submission for Priority Review, with a review goal
date of April 30, 2009.
- The manuscript describing the
results of our Multicenter Phase III trial, entitled Human
Polymerized Hemoglobin for the Treatment of Hemorrhagic Shock when
Blood Is Unavailable: The USA Multicenter Trial, was published in
the January 2009 print edition of the Journal of the American
College of Surgeons.
- Northfield implemented a number
of measures to reduce its cash burn in order to preserve cash for
ongoing operations, including eliminating positions at its
manufacturing facility in Mount Prospect, Illinois, and reducing
hours for remaining staff. In addition, the Company is closing the
corporate offices and relocating staff to the owned Mount Prospect
facility.
- Northfield announced it had
completed a registered direct offering to a single institutional
investor, representing gross proceeds of approximately $1.4
million.
- Northfield announced that
researchers from the University of Colorado at Denver/ Denver
Health Medical Center, Bonfils Blood Center in Denver, and
University of Texas Southwestern Medical Center at Dallas had
demonstrated that the use of PolyHeme� significantly reduces
metastases and primary tumor growth in a mouse model of pancreatic
cancer. The authors suggest that the use of PolyHeme in lieu of red
blood cells may prolong survival in patients with pancreatic cancer
who require transfusions. The research was presented at the Society
of Surgical Oncology 62nd Annual Cancer Symposium in Phoenix,
Arizona.
NOTE: There will be no conference call as the Company
anticipates hosting a call upon receiving notification of the
status of its BLA from FDA.
About Northfield
Laboratories
Northfield Laboratories is a leader in developing a
hemoglobin-based oxygen-carrying red blood cell substitute. The
initial indication we are seeking for our investigational product
PolyHeme is the treatment of life-threatening red blood cell 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 an extended 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 the possibility that FDA may not meet the
required time periods for the review of our BLA under�applicable
laws, regulations and guidances, our potential inability to obtain
FDA approval to market PolyHeme commercially based on our BLA, our
potential inability to maintain compliance with applicable Nasdaq
listing standards, our need to obtain additional capital to finance
our ongoing business operations and the construction of an expanded
commercial-scale manufacturing facility, our potential inability to
obtain adequate supplies of raw materials and to manufacture
PolyHeme in commercial quantities, our potential inability to
market PolyHeme successfully, the possibility that competitors will
develop products that will render PolyHeme obsolete or
non-competitive, our potential inability to protect our
intellectual property rights, the outcome of a purported class
action lawsuit as described in our most recently filed 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 quarterly 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 FOLLOW�
� � � NORTHFIELD LABORATORIES INC. (a company in the development
stage) � � � Balance Sheets February 28, 2009 and May 31, 2008 (In
thousands) � Feb 28, May 31, 2009 2008 Assets (unaudited) Current
assets: Cash $ 2,894 $ 12,747 Restricted cash 77 301 Short-term
marketable securities 1,744 7,980 Prepaid expenses 308 696 Other
current assets 834 - Total current assets 5,857 21,724 � Plant and
equipment, net 8,438 8,241 Other assets 20 20 Total assets $ 14,315
$ 29,985 � Liabilities and Shareholders' Equity Current
liabilities: Accounts payable $ 1,768 $ 1,917 Accrued expenses 165
112 Government grant liability 77 301 Accrued compensation and
benefits 757 658 Other current liabilities 730 - Total current
liabilities 3,497 2,988 � Other liabilities 11 14 Total liabilities
3,508 3,002 � Shareholders' equity: Capital stock 270 270
Additional paid-in capital 248,519 246,929
Deficit accumulated during the
development stage
-237,982 -220,216 Total shareholders' equity 10,807 26,983 �
Total liabilities and
shareholders' equity
$ 14,315 $ 29,985 � � � � � NORTHFIELD LABORATORIES INC. (a company
in the development stage) � Statements of Operations Three months
ended February 28, 2009 and February 29, 2008 (In thousands except
per share data) � Three Months Ended Feb 28, Feb 29, 2009 2008
(unaudited) (unaudited) � Revenues - license income $ - $ - � Costs
and expenses: Research and development 4,746 3,669 General and
administrative 1,517 1,481 6,263 5,150 � Other income and expense:
Interest income 12 319 Interest expense - - �
Cumulative effect of change in
accounting principle
- - � Net loss $ -6,251 $ -4,831 � Net loss per basic share $ -0.23
$ -0.18 �
Shares used in calculation of per
share data
27,009 26,959
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