EVANSTON, Ill., Jan. 9 /PRNewswire-FirstCall/ -- Northfield Laboratories Inc. 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
