NFLD Northfield Laboratories Inc. (MM)

Northfield Laboratories Inc. (NASDAQ:NFLD) announced today financial results for the first fiscal quarter ended August 31, 2008. For the first fiscal quarter, Northfield reported a net loss of $5.9 million, or $.22 per share, compared with a net loss of $4.8 million, or $.18 per share, for the corresponding period last year. At the close of the quarter, Northfield reported shareholders� equity of $21.7 million, with $15.3 million in cash and marketable securities. As a development stage company, Northfield does not generate revenues. Recent and Upcoming Events At its annual meeting of shareholders on October 2, 2008, Northfield affirmed its intention to submit a 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, during the fourth calendar quarter of 2008. Northfield will also seek Priority Review designation for its application. Northfield announced at the annual meeting that the manuscript entitled Human Polymerized Hemoglobin for the Treatment of Hemorrhagic Shock when Blood Is Unavailable: The USA Multicenter Trial has been accepted for publication in the Journal of the American College of Surgeons. The paper will appear in the January 2009 print edition and will be available earlier on-line. Northfield�s Chairman and CEO Steven A. Gould, M.D., will be presenting at the Rodman and Renshaw 10th Annual Healthcare Conference in November. Northfield will not host a conference call this quarter since the annual meeting was webcast one week ago. 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 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 TO FOLLOW NORTHFIELD LABORATORIES INC. (a company in the development stage) � � � � � � Balance Sheets August 31, 2008 and May 31, 2008 (In thousands) � Aug 31, May 31, 2008 2008 Assets (unaudited) Current assets: Cash $7,330 $12,747 Restricted Cash 220 301 Short-term marketable securities 7,993 7,980 Prepaid expenses 631 696 Total current assets 16,174 21,724 � Plant and equipment, net 8,192 8,241 Other assets 20 20 Total assets $24,386 $29,985 � � Liabilities and Shareholders' Equity Current liabilities: Accounts payable $1,561 $1,917 Accrued expenses 84 112 Government grant liability 220 301 Accrued compensation and benefits 801 658 Total current liabilities 2,666 2,988 � Other liabilities 15 14 Total liabilities 2,681 3,002 � Shareholders' equity: Capital stock 270 270 Additional paid-in capital 247,573 246,929 Deficit accumulated during the development stage -226,138 -220,216 � Total shareholders' equity 21,705 26,983 � Total liabilities and shareholders' equity $24,386 $29,985 � � � � NORTHFIELD LABORATORIES INC. (a company in the development stage) � Statements of Operations Three months ended August 31, 2008 and August 31, 2007 (In thousands except per share data) � Three Months Ended Aug 31, Aug 31, 2008 2007 (unaudited) (unaudited) � Revenues - license income $- $- � Costs and expenses: Research and development 4,382 3,777 General and administrative 1,622 1,510 6,004 5,287 � � Other income and expense: Interest income 82 482 Interest expense - - 82 482 � Cumulative effect of change in accounting principle � � Net loss $-5,922 $-4,805 � Net loss per basic share $-0.22 $-0.18 � Shares used in calculation of per share data 26,958 26,915