EVANSTON, Ill., Oct. 16 /PRNewswire/ -- 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, for
its fiscal 2002 first quarter ended August 31, 2001. As a development stage
company, Northfield has no revenues.
Financial Performance
For the first quarter, Northfield reported a loss of $3.2 million, or
$0.22 cents per basic share, compared with a loss of $2.5 million, or $0.18
cents per basic share, in the year-earlier period.
At the close of the quarter, the company reported shareholders' equity of
$27.0 million, with $26.1 million in cash and marketable securities.
"The first quarter marked a milestone in Northfield's history with the
submission of our Biologics License Application (BLA) to the FDA for PolyHeme
-- the first submission ever for an oxygen-carrying blood substitute for human
use. We're extremely proud of this achievement," said Richard DeWoskin,
chairman and chief executive officer. "We are equally proud of our unrivaled
trauma data, demonstrating the life-sustaining benefits of PolyHeme in urgent,
massive blood loss situations."
On August 31, 2001, Northfield webcast its annual business update, giving
shareholders, prospective investors and the media an overview of its
technology and PolyHeme's compelling clinical benefits, including
substantially increased survival rates, as well as some insight into the
regulatory process. The annual business update was extremely well received by
its audience with participation up more than 30 percent from a year ago. At
Northfield's annual meeting, all of the company's directors were re-elected to
one-year terms by more than 90 percent shareholder support, and the
ratification of its independent auditors, KPMG LLP, was approved.
Subsequent to the close of the quarter, Dr. Steven A. Gould, president,
presented a scientific paper titled, "The Life-Sustaining Capacity of PolyHeme
in Massive Blood Loss Situations When Blood May be Unavailable," at the
American College of Surgeons annual meeting on October 11, which was favorably
received by the scientific and medical communities.
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 .
Statements of Operations
Northfield Laboratories Inc.
(a company in the development stage)
Statements of Operations
Three months ended August 31, 2001 and August 31, 2000
(In thousands except per share data)
Three months ended
August 31, August 31,
2001 2000
(unaudited) (unaudited)
Revenues - license income $ --- $ ---
Costs and expenses:
Research and development 2,649 2,238
General and administrative 843 870
3,492 3,108
Other income and expense:
Interest income 301 590
Interest expense --- ---
301 590
Net loss $(3,191) $(2,518)
Net loss per basic share $(0.22) $(0.18)
Shares used in calculation of
per share data 14,266 14,242
Balance Sheet
Northfield Laboratories Inc.
(a company in the development stage)
Balance Sheets
August 31, 2001 and May 31, 2001
(In thousands)
August 31, May 31,
Assets 2001 2001
(unaudited)
Current assets:
Cash $4,491 $6,436
Short-term marketable securities 21,583 22,263
Prepaid expenses 270 378
Other current assets 146 455
Total current assets 26,490 29,532
Plant and equipment, net 2,695 2,847
Other assets 122 123
Total assets $29,307 $32,502
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $1,076 $1,773
Accrued expenses 462 154
Accrued compensation and benefits 641 261
Total current liabilities 2,179 2,188
Other liabilities 171 166
Total liabilities 2,350 2,354
Shareholders' equity:
Capital stock 143 143
Additional paid-in capital 117,503 117,503
Deficit accumulated during the (90,689) (87,498)
development stage
Total shareholders' equity 26,957 30,148
Total liabilities and
shareholders' equity $29,307 $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 General Info.,
Leslie Hunziker, +1-312-640-6760, Analysts, Bill Schmidle,
+1-312-640-6753, Media, Cindy Martin, +1-312-640-6741, all of FRB
Weber Shandwick
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