EVANSTON, Ill., April 18 /PRNewswire/ -- Northfield Laboratories Inc.
(Nasdaq: NFLD), a leading developer of an oxygen-carrying blood substitute for
trauma and elective surgery situations, today reported a loss, as anticipated,
for its third fiscal quarter and nine months ended February 29, 2000. As a
development-stage company, Northfield has no revenues.
The company reported continued favorable results in clinical studies for
its blood substitute, PolyHeme(R), as an oxygen-carrying alternative for the
treatment of urgent acute blood loss. Both its elective surgery trial and
trauma trial involve 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.
Analysis of Trauma Trial Data Confirms Objective
Over the last few months, Northfield has been analyzing data from its
trials and is currently considering its regulatory position based on its
findings. "We're pleased with the results from these trials, which
demonstrate potential benefit in urgent, acute blood loss settings, including
trauma, emergency surgery and unexpected, life-threatening blood loss during
elective surgical procedures," said Richard DeWoskin, chairman and chief
executive officer. Management has said that clinical trials may continue
throughout the regulatory review process, once initiated. Northfield's trauma
data indicate that PolyHeme could increase survival in life-threatening
hemorrhage when blood may be unavailable.
Elective Surgery Studies Continue; Additional Trials Being Considered
While the use of the product in its elective surgery trial is the same as
for trauma -- high dose, rapid infusion for acute blood loss -- the endpoint
for Northfield's trial is the elimination of the use of banked blood. This
trial is producing very important results; however, due to its complex
protocol, patient accrual is progressing slowly, as previously reported. As a
result, management is considering instituting additional elective surgery
trials with different protocols for the same indication to more broadly and
rapidly confirm PolyHeme's capability as an alternative to blood in critical
care situations.
Expanded Market Opportunities Under Review
Northfield is alone in focusing on urgent, life-threatening blood loss
indications involving high doses and rapid infusion rates. However, other
companies in the field are developing and testing blood substitutes in stable,
elective patient settings for indications allowing low dosage and slow
infusion. Northfield believes the targeting of PolyHeme to this application
would be straightforward, having already achieved success at high doses and
rapid infusion rates, and is reviewing the market opportunity and clinical
benefit of expanding a new, albeit narrow market for PolyHeme.
Internal Manufacturing Plans Initiated, Partnership Discussions Continue
To prepare for commercialization, Northfield has expanded manufacturing
capacity of PolyHeme from 4,000 units annually to 10,000 units. Management
has stated that it is still in discussion with several potential
manufacturing, marketing / distribution, and source supply partners, and has
not ruled out entering into an alliance sometime in the future when it would
be most beneficial to both parties.
Financial Performance
For the third quarter, Northfield reported a loss of $2.5 million, or
$0.17 cents per basic share compared with a loss of $1.7 million, or
$0.12 cents per basic share, in the year-earlier period.
For the nine months, the net loss was $6.8 million, or $0.48 cents per
basic share, versus $5.1 million, or $0.36 cents per basic share, last year.
Continued increases in research and development expenses result from increases
associated with conducting clinical trials and producing PolyHeme for use in
the company's clinical trials.
At the close of the quarter, the company reported shareholders' equity of
$42.4 million, with $40.7 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 nine months ended February 29, 2000 and February 28, 1999
(In thousands except per share data)
Three months ended Nine months ended
Feb. 29, Feb. 28, Feb. 29, Feb. 28,
2000 1999 2000 1999
(unaudited) (unaudited)
Revenues - license income $-- $-- $-- $--
Costs and expenses:
Research and development 2,365 1,700 6,851 5,383
General and administrative 658 597 1,666 1,748
3,023 2,297 8,517 7,131
Other income and expense:
Interest income 559 606 1,707 1,995
Interest expense -- -- -- --
559 606 1,707 1,995
Net loss $(2,464) $(1,691) $(6,810) $(5,136)
Net loss per
basic share $(0.17) $(0.12) $(0.48) $(0.36)
Shares used in
calculation of per
share data 14,240 14,115 14,240 14,106
Northfield Laboratories Inc.
(a company in the development stage)
Balance Sheets
February 29, 2000 (unaudited) and May 31, 1999
(In thousands)
February 29, May 31,
Assets 2000 1999
Current assets:
Cash $29,586 $25,856
Short-term marketable securities 11,065 21,706
Prepaid expenses 107 302
Other current assets 330 268
Total current assets 41,088 48,132
Plant and equipment, net 2,759 2,756
Other assets 75 75
Total assets $43,922 $50,963
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $971 $1,325
Accrued expenses 113 121
Accrued compensation and benefits 259 221
Total current liabilities 1,343 1,667
Other liabilities 141 125
Total liabilities 1,484 1,792
Shareholders' equity:
Capital stock 142 142
Additional paid-in capital 117,262 117,186
Deficit accumulated during the (74,966) (68,157)
development stage
Total shareholders' equity 42,438 49,171
Total liabilities and
shareholders' equity $43,922 $50,963
SOURCE Northfield Laboratories Inc.
 back to top
Related links:
http://www.northfieldlabs.com
CONTACT:
Richard DeWoskin, Chief Executive Officer of
Northfield Laboratories Inc., 847-864-3500; or General, Michael
Rosenbaum, or Analysts-Investors, Leslie Loyet, both of The
Financial Relations Board, 312-266-7800
|
