CORRECTING and REPLACING Northfield Laboratories Inc. Reports Fiscal 2008 Third Quarter...
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CORRECTING and REPLACING Northfield Laboratories Inc. Reports Fiscal 2008 Third Quarter Financial Results
EVANSTON, Ill.--(Business Wire)--
Third full paragraph of release, under Conference Call and Webcast
Information should be replaced with the following:
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 36290007. A replay of the call
will be available for two weeks by dialing 888.286.8010 and entering
the passcode 28304075.
The corrected release reads:
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 36290007. 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(R) 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
-0-
*T
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 -214,465 -199,808
stage
Total shareholders' equity 32,312 45,342
Total liabilities and
shareholders' equity $ 35,709 $ 50,119
*T
-0-
*T
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
*T
Northfield Laboratories Inc.
Sophia H. Twaddell, 847-864-3500
Vice President, Corporate Communications
stwaddell@northfieldlabs.com
or
Fleishman-Hillard
Tom Laughran, 312-751-3519
laughrant@fleishman.com
Copyright Business Wire 2008
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