Northfield Laboratories Inc. Reports Third Quarter 2005 Financial Results
EVANSTON, Ill. - PRNewswire-FirstCall - April 11
EVANSTON, Ill., April 11 /PRNewswire-FirstCall/ -- Northfield Laboratories Inc. (NASDAQ:NFLD) announced today financial results for the third quarter of fiscal 2005, which ended February 28, 2005.
Northfield reported a loss of $4.8 million, or $ 0.21 cents per basic and diluted share for the third quarter, compared with a loss of $3.5 million or $0.20 cents per basic and diluted share for the corresponding period last year. As expected, significant increases in operating expenses were incurred to conduct, expand, report, and support our pivotal Phase III trial.
At the close of the quarter, the Company reported shareholders' equity of $101.4 million, with $102.3 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. Seventeen Level I trauma centers throughout the United States are currently enrolling patients in the trial, which has a target enrollment of 720 patients. Five additional sites have full institutional review board (IRB) approval and are slated to begin enrollment. Multiple others are actively engaged in community outreach at this time. * The Company announced earlier today that the Independent Data Monitoring Committee (IDMC) recommended that the Phase III trial continue without modification following the third interim analysis of blinded data from the trial. * The Company also announced today that the IDMC concluded that no adjustment in the sample size of the study is required following a blinded power analysis based on a comparison between the mortality rate predicted in the protocol and the observed mortality rate in the trial to date. Therefore, trial enrollment remains at a total of 720 patients. Other Recent and Upcoming Events * The Company raised $77.6 million in gross proceeds from a public offering that closed on February 9, 2005. * Laurel A. Omert, M.D. joined the Company as Chief Medical Officer in mid-January. * The Company participated in the SG Cowen Health Care Conference in Boston in March, and is slated to present in May at the Rodman and Renshaw Techvest Global Healthcare Conference in Paris, and at the UBS Specialty Pharmaceuticals Conference in New York. Conference Call and Web Cast Information
Northfield will hold a conference call to discuss third quarter financial results on Tuesday, April 12, 2005 at 11:00 a.m. ET/10:00 a.m. CT. To access the conference call, please dial 1.800.510.0146. The participant passcode is 25564697. A replay of the call will be available after 1:00 p.m. To access the replay dial 1.888.286.8010 and key in the passcode number 57222456. The replay will be available until April 26, 2005.
The call will also be available via live Web cast through Northfield's website, located at northfieldlabs.com. Institutional investors may access the call via CCBN's password-protected event management site, StreetEvents (http://www.streetevents.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 northfieldlabs.com .
This press release contains forward-looking statements concerning, among other things, Northfield's future business plans and strategies and clinical and regulatory developments affecting our PolyHeme(R) blood 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.
FOR FURTHER INFORMATION CONTACT:
Steven A. Gould, M.D. Sharon L. Weinstein
Chairman and Chief Executive Officer Noonan Russo
(847) 864-3500 (212) 845-4271
sharon.weinstein@eurorscg.com
Sophia H. Twaddell
Vice President, Corporate Communications
(847) 864-3500
stwaddell@northfieldlabs.com
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Balance Sheets
February 28, 2005 and May 31, 2004
(In thousands)
Feb 28 May 31,
2005 2004
Assets (unaudited)
Current assets:
Cash $14,291 $39,043
Short-term marketable securities 87,997 3,444
Prepaid expenses 353 615
Other current assets 80 1
Total current assets 102,721 43,103
Plant and equipment, net 730 1,006
Other assets 70 70
Total assets $103,521 $44,179
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $1,449 $1,838
Accrued expenses 52 117
Accrued compensation and benefits 366 419
Total current liabilities 1,867 2,374
Other liabilities 251 253
Total liabilities 2,118 2,627
Shareholders' equity:
Capital stock 267 214
Additional paid-in capital 240,959 166,534
Deficit accumulated during the (139,685) (125,040)
development stage
Deferred compensation (138) (156)
Total shareholders' equity 101,403 41,552
Total liabilities and
shareholders' equity $103,521 $44,179
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Operations
Three and nine months ended February 28, 2005
and February 29, 2004
(In thousands except per share data)
Three Months Ended Nine Months Ended
Feb 28, Feb 29, Feb 28, Feb 29,
2005 2004 2005 2004
(unaudited) (unaudited) (unaudited) (unaudited)
Revenues - license
income $ -- $ -- $ -- $ --
Costs and expenses:
Research and
development 3,818 2,630 12,033 7,387
General and
administrative 1,311 883 3,170 2,587
5,129 3,513 15,203 9,974
Other income and
expense:
Interest income 281 29 557 77
Interest expense -- -- -- --
281 29 557 77
Cumulative effect of
change in
accounting principle 75
Net loss $(4,848) $(3,484) $(14,646) $(9,972)
Net loss per share -
basic and diluted $(0.21) $(0.20) $(0.67) $(0.62)
Shares used in
calculation of
per share data 22,658 17,093 21,830 16,070
Northfield Laboratories Inc.
Web Site: northfieldlabs.com |
