Northfield Laboratories Inc. Reports Second Quarter Fiscal Year 2006 Financial Results
January 09 2006 - 5:41PM
PR Newswire (US)
EVANSTON, Ill., Jan. 9 /PRNewswire-FirstCall/ -- Northfield
Laboratories Inc. (NASDAQ:NFLD) announced today financial results
for the second quarter of fiscal 2006, which ended November 30,
2005. Northfield reported a loss of $6.3 million or $ 0.23 cents
per share for the second quarter, compared with a loss of $4.9
million or $0.23 cents per share for the corresponding period last
year. As expected, increases in operating expenses were incurred to
conduct, expand, and support our pivotal Phase III trial. At the
close of the quarter, the Company reported shareholders' equity of
$83.9 million, with $86.1 million in cash and marketable
securities. As a development stage company, Northfield does not
generate revenues. Clinical Trial * Enrollment continues in the
Company's pivotal Phase III study designed to evaluate the safety
and efficacy of PolyHeme(R), Northfield's human hemoglobin-based
oxygen-carrying resuscitative fluid, when administered to patients
in hemorrhagic shock following traumatic injury. The primary
endpoint is survival at 30 days. 30 Level I trauma centers
throughout the United States are currently enrolling patients in
the trial, which has a target enrollment of 720 patients. Two
additional sites have received Institutional Review Board approval
and are expected to begin enrolling. * As of December 31, 2005,
approximately 580 patients had been enrolled in the study,
representing approximately 80% of the planned enrollment. * During
the quarter, the Independent Data Monitoring Committee (IDMC)
recommended that the Company's pivotal Phase III trial with
PolyHeme(R) continue without modification following the fourth
planned interim analysis of the study data. The IDMC reviewed
blinded data on mortality in the first 500 patients enrolled in the
study. This is the first time a hemoglobin-based oxygen-carrying
resuscitative fluid has successfully passed this patient evaluation
milestone in the high-risk trauma population. Other Recent and
Upcoming Events * The Company was notified it would receive $3.5
million in the 2006 Defense Appropriations budget. Senator Richard
Durbin of Illinois, the Assistant Democratic Leader and a member of
the Senate Appropriations Committee, secured the funding. He
visited Northfield's Mt. Prospect manufacturing facility to make
the announcement. * The Company issued a request for proposal (RFP)
for the planned expansion of its manufacturing capacity in Mt.
Prospect, IL. * The Company participated in a number of
institutional investor conferences during the quarter, including:
the UBS Global Life Sciences conference in New York in September;
the BIO Investor Forum in San Francisco in October; the Rodman and
Renshaw Techvest 7th Annual Healthcare Conference in New York in
November, and the SG Cowen EU Healthcare Conference in Barcelona,
also in November. * The Company will be presenting at the BIO CEO
and Investor Conference in New York in February and at the 25th
Annual SG Cowen Healthcare Conference in Boston in March. The
presentations will be webcast; details will be available one week
prior to the date. Conference Call and Webcast Information
Northfield will host a conference call to discuss first quarter
financial results on Tuesday, January 10, 2006 at 11:00 a.m.
ET/10:00 a.m. CT. To access the conference call, investors may dial
1-866-202-4683. The participant passcode is 53166350. A replay of
the call will be available after 1:00 p.m. on January 10 through
January 24, 2005, at 1-888-286-8010. The replay passcode number is
74579270. The webcast is being distributed through the Thomson
StreetEvents Network to both institutional and individual
investors. Individual investors may listen to the call at
http://www.fulldisclosure.com/, Thomson/CCBN's individual investor
portal, powered by StreetEvents. Institutional investors may access
the call via Thomson's password-protected event management site,
StreetEvents (http://www.streetevents.com/). Interested investors
may also access the live webcast through the Company's Web site,
located at http://www.northfieldlabs.com/. About Northfield
Laboratories Northfield Laboratories Inc. is a leader in developing
an oxygen-carrying resuscitative fluid for the treatment of urgent,
large volume blood loss in trauma and resultant surgical settings.
PolyHeme(R) is a solution of chemically modified human hemoglobin
that requires no cross matching and is therefore compatible with
all blood types. It has a shelf life of over 12 months. Enrollment
is currently underway in a pivotal Phase III trial of PolyHeme(R)
beginning in the pre-hospital setting. For further information,
visit http://www.northfieldlabs.com/. 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(R) 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 our ability to
obtain FDA approval to market PolyHeme commercially, the
availability of capital to finance our clinical trials and ongoing
business operations, our ability to obtain adequate supplies of raw
materials and to manufacture PolyHeme in commercial quantities, our
ability to market PolyHeme successfully, the possibility that
competitors will develop products that will render PolyHeme
obsolete or non-competitive, our ability to protect our
intellectual property rights, 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 quarterly report on Form 10-Q and annual report
on Form 10-K. 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. NORTHFIELD LABORATORIES INC. (a company in
the development stage) Balance Sheets November 30, 2005 and May 31,
2005 (In thousands) Nov 30, May 31, 2005 2005 Assets (unaudited)
Current assets: Cash $43,630 $6,800 Short-term marketable
securities 42,489 91,330 Prepaid expenses 536 827 Other current
assets 105 140 Total current assets 86,760 99,097 Plant and
equipment, net 948 835 Other assets 69 69 Total assets $87,777
$100,001 Liabilities and Shareholders' Equity Current liabilities:
Accounts payable $2,426 $3,325 Accrued expenses 107 111 Accrued
compensation and benefits 1,098 540 Total current liabilities 3,631
3,976 Other liabilities 237 252 Total liabilities 3,868 4,228
Shareholders' equity: Capital stock 267 267 Additional paid-in
capital 241,092 240,972 Deficit accumulated during the (157,411)
(145,361) development stage Deferred compensation (39) (105) Total
shareholders' equity 83,909 95,773 Total liabilities and
shareholders' equity $87,777 $100,001 NORTHFIELD LABORATORIES INC.
(a company in the development stage) Statements of Operations Three
and six months ended November 30, 2005 and November 30, 2004 (In
thousands except per share data) Three Months Ended Six months
Ended Nov 30, Nov 30, Nov 30, Nov 30, 2005 2004 2005 2004
(unaudited) (unaudited) (unaudited) (unaudited) Revenues - license
income $ - $ - $ - $ - Costs and expenses: Research and development
5,573 4,177 10,667 8,216 General and administrative 1,460 910 2,849
1,859 7,033 5,087 13,516 10,075 Other income and expense: Interest
income 764 156 1,466 276 Interest expense - - - - 764 156 1,466 276
Cumulative effect of change in accounting principle 0 Net loss $
(6,269) $ (4,931) $ (12,050) $ (9,799) Net loss per basic share $
(0.23) $ 0 $ (0.45) $ (0.46) Shares used in calculation of per
share data 26,759 21,440 26,755 21,422 FOR FURTHER INFORMATION
CONTACT: Sophia H. Twaddell Sharon L. Weinstein Vice President,
Director, Investor Relations Corporate Communications Noonan Russo
(847) 864-3500 (212) 845-4271 DATASOURCE: Northfield Laboratories
Inc. CONTACT: Sophia H. Twaddell, Vice President, Corporate
Communications, of Northfield Laboratories Inc., +1-847-864-3500, ;
or Sharon L. Weinstein, Director, Investor Relations, of Noonan
Russo, +1-212-845-4271, , for Northfield Laboratories Inc. Web
site: http://www.northfieldlabs.com/ http://www.fulldisclosure.com/
http://www.streetevents.com/
Copyright
Northfield labs (NASDAQ:NFLD)
Historical Stock Chart
From Jun 2024 to Jul 2024
Northfield labs (NASDAQ:NFLD)
Historical Stock Chart
From Jul 2023 to Jul 2024