(Source: Business Wire)
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today financial results for the third fiscal quarter ended February 28, 2009.
For the third fiscal quarter, Northfield reported a net loss of $6.3 million, or $0.23 per share, compared with a net loss of $4.8 million, or $0.18 per share, for the corresponding period last year. At the close of the quarter, Northfield reported shareholders' equity of $10.8 million, with $4.7 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.
The manuscript describing the results of our Multicenter Phase III trial, 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.
Northfield implemented a number of measures to reduce its cash burn in order to preserve cash for ongoing operations, including eliminating positions at its manufacturing facility in Mount Prospect, Illinois, and reducing hours for remaining staff. In addition, the Company is closing the corporate offices and relocating staff to the owned Mount Prospect facility.
Northfield announced it had completed a registered direct offering to a single institutional investor, representing gross proceeds of approximately $1.4 million.
Northfield announced that researchers from the University of Colorado at Denver/ Denver Health Medical Center, Bonfils Blood Center in Denver, and University of Texas Southwestern Medical Center at Dallas had demonstrated that the use of PolyHeme® significantly reduces metastases and primary tumor growth in a mouse model of pancreatic cancer. The authors suggest that the use of PolyHeme in lieu of red blood cells may prolong survival in patients with pancreatic cancer who require transfusions. The research was presented at the Society of Surgical Oncology 62nd Annual Cancer Symposium in Phoenix, Arizona.
NOTE: There will be no conference call as the Company anticipates hosting a call upon receiving notification of the status of its BLA from FDA.
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 underapplicable laws, regulations and guidances, our potential inability to obtain FDA approval to market PolyHeme commercially based on our BLA, our potential inability to maintain 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.
TABLES FOLLOW
NORTHFIELD LABORATORIES INC. (a company in the development stage) Balance Sheets February 28, 2009 and May 31, 2008 (In thousands) Feb 28, May 31, 2009 2008 Assets (unaudited) Current assets: Cash $ 2,894 $ 12,747 Restricted cash 77 301 Short-term marketable securities 1,744 7,980 Prepaid expenses 308 696 Other current assets 834 - Total current assets 5,857 21,724 Plant and equipment, net 8,438 8,241 Other assets 20 20 Total assets $ 14,315 $ 29,985 Liabilities and Shareholders' Equity Current liabilities: Accounts payable $ 1,768 $ 1,917 Accrued expenses 165 112 Government grant liability 77 301 Accrued compensation and benefits 757 658 Other current liabilities 730 - Total current liabilities 3,497 2,988 Other liabilities 11 14 Total liabilities 3,508 3,002 Shareholders' equity: Capital stock 270 270 Additional paid-in capital 248,519 246,929 Deficit accumulated during the development stage -237,982 -220,216 Total shareholders' equity 10,807 26,983 Total liabilities and shareholders' equity $ 14,315 $ 29,985 NORTHFIELD LABORATORIES INC. (a company in the development stage) Statements of Operations Three months ended February 28, 2009 and February 29, 2008 (In thousands except per share data) Three Months Ended Feb 28, Feb 29, 2009 2008 (unaudited) (unaudited) Revenues - license income $ - $ - Costs and expenses: Research and development 4,746 3,669 General and administrative 1,517 1,481 6,263 5,150 Other income and expense: Interest income 12 319 Interest expense - - Cumulative effect of change in accounting principle - - Net loss $ -6,251 $ -4,831 Net loss per basic share $ -0.23 $ -0.18 Shares used in calculation of per share data 27,009 26,959 -------------------------------------------------------------------------------
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