09.01.2008 22:48:00
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Correcting and Replacing Northfield Laboratories Inc. Reports Fiscal 2008 Second Quarter Financial Results
Second table, header should read: Three months ended November 30, 2007
and November 30, 2006 (sted Six months ended November 30, 2007 and
November 30, 2006).
The corrected release reads:
NORTHFIELD LABORATORIES INC. REPORTS FISCAL 2008 SECOND QUARTER
FINANCIAL RESULTS
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today financial
results for the second fiscal quarter ended November 30, 2007.
For the second fiscal quarter, Northfield reported a net loss of $5.0
million, or $0.19 cents per share, compared with a net loss of $7.6
million, or $0.28 cents per share for the corresponding period last
year. At the close of the quarter, the company reported shareholder’s
equity of $36.7 million and $31.4 million in cash and marketable
securities.
Activities of the Quarter
Northfield’s key focus in 2008 is preparing
a Biologics License Application (BLA) for PolyHeme for submission to
FDA. Our goal is to submit our BLA during the first half of calendar
2008. 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.
An independent panel of experts has reviewed the cardiac data on all
patients enrolled in the Phase III trial. The panel is still working
on its final analysis, interpretation, and report.
Recent and Upcoming Events Scientific Presentations
Dr. Ernest E. Moore, lead investigator for Northfield’s
Phase III study with PolyHeme, delivered a presentation entitled "Postinjury
Resuscitation with Human Polymerized Hemoglobin: The USA Multicenter
Trial” at the 93rd
Annual Clinical Congress of the American College of Surgeons on
October 10, 2007, in New Orleans.
Dr. Steven A. Gould was a key speaker and presented the study results
at a plenary session at the XI International Symposium on Blood
Substitutes in Beijing in October.
Northfield will be presenting an overview of its clinical development
at the FDA/NIH sponsored Public Workshop on the Safety of
Hemoglobin-Based Oxygen Carriers in April.
Investor Outreach
Northfield presented at the Thomas Weisel Partners Healthcare
Conference and the UBS Global Life Sciences Conference in September,
and at the BIO Investor Conference in October.
Northfield will be presenting at the BIO CEO and Investor Conference
in February.
Conference Call and Webcast Information
Northfield will host a conference call to discuss second quarter
financial results on Thursday, January 10, 2008 at 11:00 a.m. ET/10:00
a.m. CT. To access the conference call, investors may dial 800.591.6923.
The participant passcode is 76350137. A replay of the call will be
available after 1:00 p.m. on January 10 through January 24, 2008, at
888.286.8010. The replay passcode number is 62876164.
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. 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, the availability of 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, 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.
TABLES TO FOLLOW
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Balance Sheets
November 30, 2007 and May 31, 2007
(In thousands)
Nov 30,
May 31,
2007
2007
Assets
(unaudited)
Current assets:
Cash
$
19,511
$
23,224
Restricted Cash
1,685
530
Short-term marketable securities
10,188
16,934
Prepaid expenses
604
673
Other current assets
65
213
Total current assets
32,053
41,574
Plant and equipment, net
8,413
8,525
Other assets
20
20
Total assets
$
40,486
$
50,119
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable
$
1,313
$
3,573
Accrued expenses
123
101
Accrued compensation and benefits
661
566
Government grant liability
1,685
530
Total current liabilities
3,782
4,770
Other liabilities
12
7
Total liabilities
3,794
4,777
Shareholders' equity:
Capital stock
270
269
Additional paid-in capital
246,056
244,881
Deficit accumulated during the development stage
-209,634
-199,808
Total shareholders' equity
36,692
45,342
Total liabilities and shareholders' equity
$
40,486
$
50,119
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Operations
Three months ended November 30, 2007 and November 30, 2006
(In thousands except per share data)
Three Months Ended
Nov 30,
Nov 30,
2007
2006
(unaudited)
(unaudited)
Revenues - license income
$
-
$
-
Costs and expenses:
Research and development
3,940
5,625
General and administrative
1,482
2,701
5,422
8,326
Other income and expense:
Interest income
401
723
Interest expense
-
-
401
723
Cumulative effect of change in accounting principle
Net loss
$
-5,021
$
-7,603
Net loss per basic share
$
-0.19
$
-0.28
Shares used in calculation of per share data
26,938
26,800
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