Northfield labs (NASDAQ:NFLD)
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Northfield Laboratories Inc. (Nasdaq: NFLD) announced today financial
results for the second fiscal quarter ended November 30, 2008.
For the second fiscal quarter, Northfield reported a net loss of $5.6
million, or $0.21 per share, compared with a net loss of $5.0 million,
or $0.19 per share, for the corresponding period last year. At the close
of the quarter, Northfield reported shareholders’ equity of $16.5
million, with $10.1 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.
Northfield announced the manuscript 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. The paper appeared in the on-line version in November 2008.
Northfield’s Chairman and CEO Steven A. Gould, M.D., presented at the
Rodman and Renshaw 10th Annual Healthcare Conference in New
York in November.
Dr. Gould has also accepted the invitation of BIO to present at the
upcoming BIO CEO & Investor conference in New York.
Conference Call
Northfield will host its second quarter 2009 earnings conference call
with the financial community on Monday, January 12, 2009 at 11:00 a.m.
Eastern Time (10 a.m. Central Time).
This call is being webcast by Thomson Reuters and can be accessed at
Northfield’s Web site at http://www.northfieldlabs.com.
A replay will be available in the same location for two weeks following
the call.
The webcast is also 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,
the Thomson Reuters 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).
Investors may also dial 866.783.2139 and enter the passcode 97752406. A
replay of the call will be available for two weeks by dialing
888.286.8010 and entering the passcode 34016526.
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 regain 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.
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Balance Sheets
November 30, 2008 and May 31, 2008
(In thousands)
Nov 31,
May 31,
2008
2008
Assets
(unaudited)
Current assets:
Cash
$5,030
$12,747
Restricted cash
77
301
Short-term marketable securities
4,998
7,980
Prepaid expenses
466
696
Other current assets
306
-
Total current assets
10,877
21,724
Plant and equipment, net
8,436
8,241
Other assets
20
20
Total assets
$19,333
$29,985
Liabilities and Shareholders’ Equity
Current liabilities:
Accounts payable
$1,655
$1,917
Accrued expenses
72
112
Government grant liability
77
301
Accrued compensation and benefits
710
658
Other current liabilities
306
-
Total current liabilities
2,820
2,988
Other liabilities
15
14
Total liabilities
2,835
3,002
Shareholders’ equity:
Capital stock
270
270
Additional paid-in capital
247,960
246,929
Deficit accumulated during the development stage
-231,732
-220,216
Total shareholders’ equity
16,498
26,983
Total liabilities and shareholders’ equity
$19,333
$29,985
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Operations
Three months ended November 30, 2008 and November 30, 2007
(In thousands except per share data)
Three Months Ended
Nov 30,
Nov 30,
2008
2007
(unaudited)
(unaudited)
Revenues - license income
$
-
$
-
Costs and expenses:
Research and development
4,271
3,940
General and administrative
1,377
1,482
5,648
5,422
Other income and expense:
Interest income
54
401
Interest expense
-
-
Cumulative effect of change in accounting principle
-
-
Net loss
$
-5,594
$
-5,021
Net loss per basic share
$
-0.21
$
-0.19
Shares used in calculation of per share data
26,959
26,938