09.04.2008 21:30:00

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 362290007. 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® 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 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 stage -214,465 -199,808   Total shareholders' equity 32,312 45,342   Total liabilities and shareholders' equity $ 35,709 $ 50,119 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
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