EVANSTON, Ill., Jan. 12 /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 second fiscal quarter ended November 30, 2000. As a development-stage
company, Northfield has no revenues.
During the quarter, the company continued clinical studies for its blood
substitute, PolyHeme(R), as an oxygen-carrying alternative for the treatment
of acute blood loss. Northfield's trauma trial involves high dosage and rapid
infusion of PolyHeme in situations that are life threatening and where massive
blood loss has occurred. The company strongly believes that this application
addresses the greatest worldwide clinical need and has the best commercial
prospects in the blood substitute market. Northfield is the only company in
its field in clinical trials with an oxygen-carrying blood substitute being
rapidly infused at high dosage -- as much as 20 units, or twice the blood
volume of an average adult.
Compassionate Use of PolyHeme Increases
Northfield has conducted trials in three settings: urgent and elective
use, as discussed, and a compassionate use of the product to provide
life-saving therapy to patients when blood cannot be used. This compassionate
use is done on a case-by-case basis in consultation with the FDA under the
provisions of an emergency investigational new drug application. "Northfield,
for a number of years, has made PolyHeme available for appropriate
compassionate use," said President Steven A. Gould, M.D. "Our primary
objective from the outset has been to develop a product that saves lives.
This is an area where we differentiate ourselves from our competitors.
PolyHeme offers a life-saving benefit in urgent circumstances when blood is
not available or acceptable."
Compassionate-use requests for PolyHeme have increased recently due to
typical blood shortages during the holidays, reduced competitor capability in
this area as well as various other circumstances. "We appear to be the only
sponsor willing to offer a product for compassionate use currently. Yet,
despite the tremendous logistical effort this entails for Northfield, it's
important to us because we strongly believe in the overwhelming benefit it
provides," said Gould.
Financial Performance
For the second quarter, Northfield reported a loss of $2.2 million, or
$0.16 cents per basic share compared with a loss of $2.3 million, or
$0.16 cents per basic share, in the year-earlier period.
For the latest six months, net loss was $4.8 million, or $0.33 cents per
basic share compared with a loss of $4.3 million, or $0.31 cents per basic
share, in the first six months of fiscal 2000.
At the close of the quarter, the company reported shareholders' equity of
$37.1 million, with $33.3 million in cash and marketable securities.
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.
Northfield Laboratories was founded in 1985. The company is headquartered
in Evanston, Illinois, and its stock is traded on the Nasdaq National Market
System under the symbol NFLD.
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. These risks include, among others: 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.
For more information on Northfield Laboratories Inc. via facsimile at no
cost, simply dial 1-800-PRO-INFO and enter the company code NFLD.
Visit the Northfield website at: http://www.northfieldlabs.com .
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Operations
Three months and six months ended November 30, 2000 and November 30, 1999
(In thousands except per share data)
Three months ended Six months ended
Nov 30, Nov 30, Nov 30, Nov 30,
2000 1999 2000 1999
(unaudited) (unaudited) (unaudited)
(unaudited)
Revenues
-- license income $ - $ - $ - $ -
Costs and expenses:
Research and
development 2,237 2,362 4,474 4,487
General and
administrative 558 524 1,428 1,008
2,795 2,886 5,902 5,495
Other income and expense:
Interest income 551 579 1,141 1,149
Interest expense - - - -
551 579 1,141 1,149
Net loss $(2,244) $(2,307) $(4,761) $(4,346)
Net loss per
basic share $(0.16) $(0.16) $(0.33) $(0.31)
Shares used in
calculation of
per share data 14,242 14,240 14,242 14,240
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Balance Sheets
November 30, 2000 (unaudited) and May 31, 2000
(In thousands)
Nov 30, May 31,
2000 2000
Assets
Current assets:
Cash $9,559 $15,154
Short-term marketable securities 23,771 23,129
Prepaid expenses 273 409
Other current assets 532 506
Total current assets 34,135 39,198
Plant and equipment, net 2,809 2,456
Other assets 123 74
Total assets $37,067 $41,728
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $1,214 $1,061
Accrued expenses 92 174
Accrued compensation and benefits 267 251
Total current liabilities 1,573 1,486
Other liabilities 161 148
Total liabilities $1,734 $1,634
Shareholders' equity:
Capital Stock 142 142
Additional paid-in capital 117,276 117,276
Deficit accumulated during the (82,085) (77,324)
development stage
Total shareholders' equity 35,333 40,094
Total liabilities and
shareholders' equity $37,067 $41,728
SOURCE Northfield Laboratories Inc.
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Related links:
http://www.northfieldlabs.com
CONTACT:
Richard DeWoskin, Chief Executive Officer of
Northfield Laboratories, 847-864-3500, or General Information,
Leslie Hunziker of The Financial Relations Board, 312-640-6760
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