EVANSTON, Ill., April 15 /PRNewswire-FirstCall/ -- Northfield Laboratories
Inc. (Nasdaq: NFLD), a leading developer of an oxygen-carrying blood
substitute for trauma and elective surgery situations, reported a loss as
anticipated of $0.18 per basic share for its third fiscal quarter ended
February 28, 2002. As a developmental-stage company, Northfield has no
revenues.
For the third quarter, Northfield reported a loss of $2.6 million, or
$0.18 cents per basic share compared with a loss of $2.6 million, or $0.18
cents per basic share, in the year earlier period. For the latest nine
months, net loss was $7.9 million, or $0.56 cents per basic share compared
with a loss of $7.4 million, or $0.52 cents per basic share, in the first nine
months of months of fiscal 2001. At the close of the quarter, the company
reported shareholder's equity of $22.2 million, with $20.7 million in cash and
marketable securities.
Update on Discussions with FDA
"We have had a number of discussions, both face-to-face meetings and
telephone conferences with the Center for Biologics Evaluation and Research of
the U.S. Food & Drug Administration, to clarify our understanding of the
comments received from them in regard to our Biologics License Application
(BLA)," said Richard DeWoskin, chief executive officer. "As a result of these
discussions, we are making good progress in developing appropriate responses
to these comments. We will continue to move forward in our discussions with
CBER and we remain optimistic that we will adequately address their questions
and achieve consensus on the approval of PolyHeme for use in urgent blood loss
situations."
Published Article Demonstrates Effectiveness of PolyHeme in Trauma
Settings
In the April 4, 2002, edition of The New England Journal of Medicine,
Cothren, Moore, et. al describe the successful use of PolyHeme in a case of
life-threatening hemorrhage. Dr. Steven A. Gould, M.D., president of
Northfield Laboratories added, "This article demonstrates the life-sustaining
capability of PolyHeme in the setting of life threatening blood loss when
blood cannot be used. In addition to our trauma experience we continue to
receive frequent requests for use of PolyHeme on an emergent, compassionate
basis as life-saving therapy in situations where blood is unavailable or
cannot be used. Our cumulative data will further enhance the overall strength
of our request for regulatory approval for use of PolyHeme in life-threatening
settings."
Operations
In addition to the discussions with CBER, DeWoskin provided an update on
the ongoing operations of the company. "We remain confident about our long-
term prospects," he said. "We believe our cash position is adequate given our
current expense rate. The results from our clinical trial data remain as
promising as ever and our current focus is on obtaining FDA approval for
PolyHeme. Although we anticipate additional clinical trials in the future to
expand the indications for which PolyHeme may be marketed, we do not expect to
initiate these studies until we reach an understanding with CBER regarding the
status of our BLA."
Upcoming Events
Northfield will be participating in two upcoming meetings. On May 9,
2002, the company will present at the Health Care 2002, Deutsche Banc Alex.
Brown Healthcare Conference in Baltimore. On May 30-31, 2002, Northfield will
present at the AABB Symposium, Oxygen Therapeutics and Transfusion
Alternatives Conference in Washington, D.C.
About the Company
Northfield Laboratories, founded in 1985, is a leading developer of an
oxygen-carrying blood substitute. Its product, PolyHeme, is the only blood
substitute undergoing clinical trials that has been tested at large enough
dosages to be considered a substitute for acute blood loss in trauma and
surgical settings. As a result of the process used to manufacture the blood
substitute, essentially a solution of polymerized hemoglobin, PolyHeme has a
longer shelf life than blood, requires no cross matching and does not transmit
disease.
Statements in this release that are not strictly historical are "forward-
looking" statements that are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Forward-looking
statements involve known and unknown risks, which may cause the company's
actual results in the future to differ materially from expected results.
Northfield cautions that the FDA approval process for PolyHeme continues to be
subject to significant risks and uncertainties. The FDA could refuse to
accept Northfield's BLA in its current form. If Northfield's BLA is accepted,
the FDA could deny its approval for the commercial sale of PolyHeme or could
require additional clinical tests as a condition to its approval. If FDA
approval for the commercial sale of PolyHeme is granted, the indication uses
for which PolyHeme may be marketed could be significantly limited by the FDA.
Other risks may include: competition from other blood substitute products;
the company's ability to obtain regulatory approval to market PolyHeme
commercially; the company's and/or its representative's ability to
successfully market and sell PolyHeme; the company's ability to manufacture
PolyHeme in sufficient quantities; the company's ability to obtain an adequate
supply of raw materials; the company's ability to maintain intellectual
property protection for its proprietary product and to defend its existing
intellectual property rights from challenges by third parties; the
availability of capital to finance planned growth; and the extent to which the
hospitals and physicians using PolyHeme are able to obtain third-party
reimbursement, as described in the company's filing with the Securities and
Exchange Commission.
Visit the Northfield website at: http://www.northfieldlabs.com
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Operations
Three months and nine months ended February 28, 2002 and February 28, 2001
(In thousands except per share data)
Three months ended Nine months ended
Feb 28, Feb 28, Feb 28, Feb 28,
2002 2001 2002 2001
(unaudited)(unaudited) (unaudited)(unaudited)
Revenues - license income $ - $ - $ - $ -
Costs and expenses:
Research and development 2,176 2,489 6,735 6,964
General and administrative 583 620 1,951 2,047
2,759 3,109 8,686 9,011
Other income and expense:
Interest income 168 505 739 1,646
Interest expense - - - -
168 505 739 1,646
Net loss $(2,591) $(2,604) $(7,947) $(7,365)
Net loss per basic share $(0.18) $(0.18) $(0.56) $(0.52)
Shares used in calculation
of per share data 14,266 14,263 14,266 14,253
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Balance Sheets
February 28, 2002 (unaudited) and May 31, 2001
(In thousands)
Feb 28, May 31,
2002 2001
Assets
Current assets:
Cash $15,708 $6,436
Short-term marketable securities 4,997 22,263
Prepaid expenses 172 378
Other current assets 52 455
Total current assets 20,929 29,532
Plant and equipment, net 2,345 2,847
Other assets 73 123
Total assets $23,347 $32,502
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $484 $1,773
Accrued expenses 172 154
Accrued compensation and benefits 315 261
Total current liabilities 971 2,188
Other liabilities 175 166
Total liabilities 1,146 2,354
Shareholders' equity:
Capital Stock 143 143
Additional paid-in capital 117,503 117,503
Deficit accumulated during
the development stage (95,445) (87,498)
Total shareholders' equity 22,201 30,148
Total liabilities and shareholders' equity $23,347 $32,502
SOURCE Northfield Laboratories Inc.
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Related links:
http://www.northfieldlabs.com
CONTACT:
Richard DeWoskin, Chief Executive Officer of
Northfield Laboratories, +1-847-864-3500, or Investors, Bill
Schmidle, +1-312-640-6753, Media, Cindy Martin, +1-312-640-6741,
both of FRB Weber Shandwick
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