-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RRsZMNYFy/Mtv++3wKU1cVoV2R+OZMuDoXFamTHXAjfwRTZiBQD+lqxIOIJ0IiR1 ICU3fE3dhwf4z2dqfHBaHA== 0000950137-04-008467.txt : 20041012 0000950137-04-008467.hdr.sgml : 20041012 20041012170317 ACCESSION NUMBER: 0000950137-04-008467 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20040831 FILED AS OF DATE: 20041012 DATE AS OF CHANGE: 20041012 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NORTHFIELD LABORATORIES INC /DE/ CENTRAL INDEX KEY: 0000920947 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 363378733 STATE OF INCORPORATION: DE FISCAL YEAR END: 0531 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-24050 FILM NUMBER: 041075332 BUSINESS ADDRESS: STREET 1: 1560 SHERMAN AVE STREET 2: SUITE 1000 CITY: EVANSTON STATE: IL ZIP: 60201-4800 BUSINESS PHONE: 8478643500 MAIL ADDRESS: STREET 1: 1560 SHERMAN AVE STE 1000 STREET 2: 37TH FLOOR CITY: EVANSTON STATE: IL ZIP: 60201-4800 10-Q 1 c88632e10vq.txt QUARTERLY REPORT ================================================================================ SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED AUGUST 31, 2004 OR [ ] TRANSITION REPORT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _______________TO _______________ COMMISSION FILE NUMBER 0-24050 NORTHFIELD LABORATORIES INC. (Exact name of registrant as specified in its charter) DELAWARE 36-3378733 (State or other jurisdiction (I.R.S. Employer of incorporation or organization) Identification Number) 1560 SHERMAN AVENUE, SUITE 1000, EVANSTON, ILLINOIS 60201-4800 (Address of principal executive offices) (Zip Code) REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (847) 864-3500 FORMER NAME, FORMER ADDRESS AND FORMER FISCAL YEAR, IF CHANGED SINCE LAST REPORT: NOT APPLICABLE INDICATE BY CHECK MARK WHETHER THE REGISTRANT (1) HAS FILED ALL REPORTS REQUIRED TO BE FILED BY SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 DURING THE PRECEDING 12 MONTHS (OR FOR SUCH SHORTER PERIOD THAT THE REGISTRANT WAS REQUIRED TO FILE SUCH REPORTS), AND (2) HAS BEEN SUBJECT TO SUCH FILING REQUIREMENTS FOR THE PAST 90 DAYS. YES [X] NO [ ] APPLICABLE ONLY TO ISSUER INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PRECEDING FIVE YEARS: INDICATE BY CHECK MARK WHETHER THE REGISTRANT IS AN ACCELERATED FILER (AS DEFINED IN RULE 12b-2 OF THE EXCHANGE ACT). YES [X] NO [ ] AS OF AUGUST 31, 2004, REGISTRANT HAD 21,404,439 SHARES OF COMMON STOCK OUTSTANDING ================================================================================ CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION This Quarterly Report contains forward-looking statements concerning, among other things, our prospects, clinical and regulatory developments affecting our potential product and our business strategies. 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 risks and uncertainties. Actual results may differ materially from those predicted by the forward-looking statements because of various factors and possible events, including those discussed under "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission. Because these forward-looking statements involve risks and uncertainties, actual results may differ significantly from those predicted in these forward-looking statements. You should not place undue weight on these statements. These statements speak only as of the date of this document or, in the case of any document incorporated by reference, the date of that document. All subsequent written and oral forward-looking statements attributable to Northfield or any person acting on our behalf are qualified by the cautionary statements in this section and in our Annual Report. We will have no obligation to revise these forward-looking statements. REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM The Board of Directors Northfield Laboratories Inc.: We have reviewed the balance sheet of Northfield Laboratories Inc. (a company in the development stage) as of August 31, 2004, and the related statements of operations and cash flows for the three-month periods ended August 31, 2004 and August 31, 2003, and for the period from June 19, 1985 (inception) through August 31, 2004. We have also reviewed the statements of shareholders' equity (deficit) for the three-month period ended August 31, 2004 and for the period from June 19, 1985 (inception) through August 31, 2004. These financial statements are the responsibility of the Company's management. We conducted our review in accordance with standards of the Public Company Accounting Oversight Board (United States). A review of interim financial information consists principally of applying analytical procedures to financial data and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with the standards of the Public Company Oversight Board (United States), the objective of which is the expression of an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion. Based on our review, we are not aware of any material modifications that should be made to the financial statements referred to above for them to be in conformity with accounting principles generally accepted in the United States of America. We have previously audited, in accordance with standards of the Public Company Accounting Oversight Board (United States), the balance sheet of Northfield Laboratories Inc. as of May 31, 2004, and the related statements of operations, shareholders' equity (deficit), and cash flows for the year then ended and for the period from June 19, 1985 (inception) through May 31, 2004 (not presented herein); and in our report dated July 12, 2004, we expressed an unqualified opinion on those financial statements. In our opinion, the information set forth in the accompanying balance sheet as of May 31, 2004 and in the accompanying statement of shareholders' equity (deficit) is fairly stated, in all material respects, in relation to the statements from which it has been derived. As discussed in note 4 to the financial statements, the Company adopted Statement of Financial Accounting Standards No. 143, "Accounting for Asset Retirement Obligations", as of June 1, 2003. /s/ KPMG LLP Chicago, Illinois October 5, 2004 NORTHFIELD LABORATORIES INC. (a company in the development stage) Balance Sheets August 31, 2004 and May 31, 2004
AUGUST 31, MAY 31, 2004 2004 ----------------- ------------------ (unaudited) ASSETS Current assets: Cash $ 25,896,005 39,042,884 Marketable securities 11,017,894 3,443,825 Prepaid expenses 593,389 614,664 Other current assets 24,242 1,082 ------------------ ------------- Total current assets 37,531,530 43,102,455 Property, plant, and equipment 14,582,119 14,521,555 Accumulated depreciation (13,674,294) (13,515,061) ------------------ ------------- Net 907,825 1,006,494 ------------------ ------------- Other assets 70,136 70,389 ------------------ ------------- $ 38,509,491 44,179,338 ================== ============= LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,036,746 1,837,651 Accrued expenses 56,152 117,007 Accrued compensation and benefits 416,528 418,813 ------------------ ------------- Total current liabilities 1,509,426 2,373,471 Other liabilities 251,802 252,756 ------------------ ------------- Total liabilities 1,761,228 2,626,227 ------------------ ------------- Shareholders' equity: Preferred stock, $.01 par value. Authorized 5,000,000 shares; none issued and outstanding - - Common stock, $.01 par value. Authorized 30,000,000 shares; issued and outstanding 21,404,439 at August 31, 2004 and 21,398,439 at May 31, 2004 214,044 213,984 Additional paid-in capital 166,572,522 166,534,302 Deficit accumulated during the development stage (129,906,524) (125,039,555) Deferred compensation (131,779) (155,620) ------------------ ------------- Total shareholders' equity 36,748,263 41,553,111 ------------------ ------------- $ 38,509,491 44,179,338 ================== =============
See accompanying notes to financial statements and accountants' review report. NORTHFIELD LABORATORIES INC. (a company in the development stage) Statements of Operations Three months ended August 31, 2004 and 2003 and for the period from June 19, 1985 (inception) through August 31, 2004
CUMULATIVE FROM THREE MONTHS ENDED AUGUST 31, JUNE 19, 1985 ------------------------------ THROUGH 2004 2003 AUGUST 31, 2004 ----------- ---------- --------------- (unaudited) (unaudited) (unaudited) Revenues - license income $ -- -- 3,000,000 Costs and expenses: Research and development 4,038,436 2,199,352 111,054,491 General and administrative 948,725 682,528 45,402,708 ----------- ---------- ------------ 4,987,161 2,881,880 156,457,199 Other income and expense: Interest income 120,192 23,426 23,708,830 Interest expense -- -- 83,234 ----------- ---------- ------------ $ 120,192 23,426 23,625,596 ----------- ---------- ------------ Net loss before cumulative effect of change in accounting principle (4,866,969) (2,858,454) (129,831,603) ----------- ---------- ------------ Cumulative effect of change in accounting principle -- 74,921 74,921 ----------- ---------- ------------ Net loss $(4,866,969) (2,933,375) (129,906,524) =========== ========== ============ Net loss per share - basic and diluted $ (0.23) (0.20) (12.50) =========== ========== ============ Shares used in calculation of per share data - basic and diluted 21,404,374 14,965,409 10,388,638 =========== ========== ============
See accompanying notes to financial statements and accountants' review report. NORTHFIELD LABORATORIES INC. (a company in the development stage) Statements of Shareholders' Equity (Deficit) Three months ended August 31, 2004 and for the period from June 19, 1985 (inception) through August 31, 2004
PREFERRED STOCK COMMON STOCK --------------------------- --------------------------- NUMBER AGGREGATE NUMBER AGGREGATE OF SHARES AMOUNT OF SHARES AMOUNT ------------ ------------ ------------ ------------ Issuance of common stock on August 27, 1985 $ -- $ -- 3,500,000 $ 35,000 Issuance of Series A convertible preferred stock at $4.00 per share on August 27, 1985 (net of costs of issuance of $79,150) -- -- -- -- Net loss -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1986 -- -- 3,500,000 35,000 Net loss -- -- -- -- Deferred compensation relating to grant of stock options -- -- -- -- Amortization of deferred compensation -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1987 -- -- 3,500,000 35,000 Issuance of Series B convertible preferred stock at $35.68 per share on August 14, 1987 (net of costs of issuance of $75,450) -- -- -- -- Net loss -- -- -- -- Amortization of deferred compensation -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1988 -- -- 3,500,000 35,000 Issuance of common stock at $24.21 per share on June 7, 1988 (net of costs of issuance of $246,000) -- -- 413,020 4,130 Conversion of Series A convertible preferred stock to common stock on June 7, 1988 -- -- 1,250,000 12,500 Conversion of Series B convertible preferred stock to common stock on June 7, 1988 -- -- 1,003,165 10,032 Exercise of stock options at $2.00 per share -- -- 47,115 471 Issuance of common stock at $28.49 per share on March 6, 1989 (net of costs of issuance of $21,395) -- -- 175,525 1,755 Issuance of common stock at $28.49 per share on March 30, 1989 (net of costs of issuance of $10,697) -- -- 87,760 878 Sale of options at $28.29 per share to purchase common stock at $.20 per share on March 30, 1989 (net of costs of issuance of $4,162) -- -- -- -- Net loss -- -- -- -- Deferred compensation relating to grant of stock options -- -- -- -- Amortization of deferred compensation -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1989 -- -- 6,476,585 64,766 Net loss -- -- -- -- Deferred compensation relating to grant of stock options -- -- -- -- Amortization of deferred compensation -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1990 -- -- 6,476,585 64,766 Net loss -- -- -- -- Amortization of deferred compensation -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1991 -- -- 6,476,585 64,766 Exercise of stock warrants at $5.60 per share -- -- 90,000 900 Net loss -- -- -- -- Amortization of deferred compensation -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1992 -- -- 6,566,585 65,666 Exercise of stock warrants at $7.14 per share -- -- 15,000 150 Issuance of common stock at $15.19 per share on April 19, 1993 (net of costs of issuance of $20,724) -- -- 374,370 3,744 Net loss -- -- -- -- Amortization of deferred compensation -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1993 -- -- 6,955,955 69,560 Net loss -- -- -- -- Issuance of common stock at $6.50 per share on May 26, 1994 (net of costs of issuance of $2,061,149) -- -- 2,500,000 25,000 Cancellation of stock options -- -- -- -- Amortization of deferred compensation -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1994 -- -- 9,455,955 94,560 Net loss -- -- -- -- Issuance of common stock at $6.50 per share on June 20, 1994 (net of issuance costs of $172,500) -- -- 375,000 3,750 Exercise of stock options at $7.14 per share -- -- 10,000 100 Exercise of stock options at $2.00 per share -- -- 187,570 1,875 Cancellation of stock options -- -- -- -- Amortization of deferred compensation -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1995 -- $ -- 10,028,525 $ 100,285
See accompanying notes to financial statements and accountants' review report.
SERIES A CONVERTIBLE SERIES B CONVERTIBLE DEFICIT TOTAL PREFERRED STOCK PREFERRED STOCK ACCUMULATED SHARE- -------------------------- ---------------------------- ADDITIONAL DURING THE DEFERRED HOLDERS' NUMBER AGGREGATE NUMBER AGGREGATE PAID-IN DEVELOPMENT COMPEN- EQUITY OF SHARES AMOUNT OF SHARES AMOUNT CAPITAL STAGE SATION (DEFICIT) ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ -- $ -- -- $ -- $ (28,000) $ -- $ -- $ 7,000 250,000 250,000 -- -- 670,850 -- -- 920,850 -- -- -- -- -- (607,688) -- (607,688) ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ 250,000 250,000 -- -- 642,850 (607,688) -- 320,162 -- -- -- -- -- (2,429,953) -- (2,429,953) -- -- -- -- 2,340,000 -- (2,340,000) -- -- -- -- -- -- -- 720,000 720,000 ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ 250,000 250,000 -- -- 2,982,850 (3,037,641) (1,620,000) (1,389,791) -- -- 200,633 200,633 6,882,502 -- -- 7,083,135 -- -- -- -- -- (3,057,254) -- (3,057,254) -- -- -- -- -- -- 566,136 566,136 ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ 250,000 250,000 200,633 200,633 9,865,352 (6,094,895) (1,053,864) 3,202,226 -- -- -- -- 9,749,870 -- -- 9,754,000 (250,000) (250,000) -- -- 237,500 -- -- -- -- -- (200,633) (200,633) 190,601 -- -- -- -- -- -- -- 93,759 -- -- 94,230 -- -- -- -- 4,976,855 -- -- 4,978,610 -- -- -- -- 2,488,356 -- -- 2,489,234 -- -- -- -- 7,443,118 -- -- 7,443,118 -- -- -- -- -- (791,206) -- (791,206) -- -- -- -- 683,040 -- (683,040) -- -- -- -- -- -- -- 800,729 800,729 ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ -- -- -- -- 35,728,451 (6,886,101) (936,175) 27,970,941 -- -- -- -- -- (3,490,394) -- (3,490,394) -- -- -- -- 699,163 -- (699,163) -- -- -- -- -- -- -- 546,278 546,278 ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ -- -- -- -- 36,427,614 (10,376,495) (1,089,060) 25,026,825 -- -- -- -- -- (5,579,872) -- (5,579,872) -- -- -- -- -- -- 435,296 435,296 ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ -- -- -- -- 36,427,614 (15,956,367) (653,764) 19,882,249 -- -- -- -- 503,100 -- -- 504,000 -- -- -- -- -- (7,006,495) -- (7,006,495) -- -- -- -- -- -- 254,025 254,025 ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ -- -- -- -- 36,930,714 (22,962,862) (399,739) 13,633,779 -- -- -- -- 106,890 -- -- 107,040 -- -- -- -- 5,663,710 -- -- 5,667,454 -- -- -- -- -- (8,066,609) -- (8,066,609) -- -- -- -- -- -- 254,025 254,025 ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ -- -- -- -- 42,701,314 (31,029,471) (145,714) 11,595,689 -- -- -- -- -- (7,363,810) -- (7,363,810) -- -- -- -- 14,163,851 -- -- 14,188,851 -- -- -- -- (85,400) -- 85,400 -- -- -- -- -- -- -- 267 267 ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ -- -- -- -- 56,779,765 (38,393,281) (60,047) 18,420,997 -- -- -- -- -- (7,439,013) -- (7,439,013) -- -- -- -- 2,261,250 -- -- 2,265,000 -- -- -- -- 71,300 -- -- 71,400 -- -- -- -- 373,264 -- -- 375,139 -- -- -- -- (106,750) -- 106,750 -- -- -- -- -- -- -- (67,892) (67,892) ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ -- $ -- -- $ -- $ 59,378,829 $(45,832,294) $ (21,189) $ 13,625,631
NORTHFIELD LABORATORIES INC. (a company in the development stage) Statements of Shareholders' Equity (Deficit) Three months ended August 31, 2004 and for the period from June 19, 1985(inception) through August 31, 2004
PREFERRED STOCK COMMON STOCK --------------------------- --------------------------- NUMBER AGGREGATE NUMBER AGGREGATE OF SHARES AMOUNT OF SHARES AMOUNT ------------ ------------ ------------ ------------ Net loss -- $ -- -- $ -- Issuance of common stock at $17.75 per share on August 9, 1995 (net of issuance costs of $3,565,125) -- -- 2,925,000 29,250 Issuance of common stock at $17.75 per share on September 11, 1995 (net of issuance costs of $423,238) -- -- 438,750 4,388 Exercise of stock options at $2.00 per share -- -- 182,380 1,824 Exercise of stock options at $6.38 per share -- -- 1,500 15 Exercise of stock options at $7.14 per share -- -- 10,000 100 Cancellation of stock options -- -- -- -- Amortization of deferred compensation -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1996 -- -- 13,586,155 135,862 Net loss -- -- -- -- Exercise of stock options at $0.20 per share -- -- 263,285 2,633 Exercise of stock options at $2.00 per share -- -- 232,935 2,329 Exercise of stock options at $7.14 per share -- -- 10,000 100 Amortization of deferred compensation -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1997 -- -- 14,092,375 140,924 Net loss -- -- -- -- Exercise of stock options at $7.14 per share -- -- 5,000 50 Amortization of deferred compensation -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 1998 -- -- 14,097,375 140,974 Net loss -- -- -- -- Non-cash compensation -- -- -- -- Exercise of stock options at $7.14 per share -- -- 17,500 175 Exercise of stock warrants at $8.00 per share -- -- 125,000 1,250 ------------ ------------ ------------ ------------ Balance at May 31, 1999 -- -- 14,239,875 142,399 Net loss -- -- -- -- Non-cash compensation -- -- -- -- Exercise of stock options at $13.38 per share -- -- 2,500 25 ------------ ------------ ------------ ------------ Balance at May 31, 2000 -- -- 14,242,375 142,424 Net loss -- -- -- -- Non-cash compensation -- -- -- -- Exercise of stock options at $6.38 per share -- -- 6,000 60 Exercise of stock options at $10.81 per share -- -- 17,500 175 ------------ ------------ ------------ ------------ Balance at May 31, 2001 -- -- 14,265,875 142,659 Net loss -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 2002 -- -- 14,265,875 142,659 Net loss -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 2003 -- -- 14,265,875 142,659 Issuance of common stock at $5.60 per share on July 28, 2003 (net of costs of issuance of $909,229) -- -- 1,892,857 18,928 Issuance of common stock to directors at $6.08 per share on October 30, 2003 -- -- 12,335 123 Deferred compensation related to stock grants -- -- 25,500 255 Amortization of deferred compensation -- -- -- -- Issuance of common stock at $5.80 per share on January 29, 2004 (net of costs of issuance of $1,126,104) -- -- 2,585,965 25,860 Issuance of common stock at $5.80 per share on February 18, 2004 (net of costs of issuance of $116,423) -- -- 237,008 2,370 Issuance of common stock at $5.80 per share on April 15, 2004 (net of costs of issuance of $192,242) -- -- 409,483 4,095 Issuance of common stock at $12.00 per share on May 18, 2004 (net of costs of issuance of $1,716,831.36) -- -- 1,954,416 19,544 Exercise of stock options at $6.38 per share -- -- 15,000 150 Net loss -- -- -- -- ------------ ------------ ------------ ------------ Balance at May 31, 2004 21,398,439 213,984 Exercise of stock options at $6.38 per share -- -- 6,000 60 Amortization of deferred compensation -- -- -- -- Net loss -- -- -- -- ------------ ------------ ------------ ------------ Balance at August 31, 2004 (unaudited) $ 21,404,439 $ 214,044
See accompanying notes to financial statements and accountants' review report.
SERIES A CONVERTIBLE SERIES B CONVERTIBLE DEFICIT TOTAL PREFERRED STOCK PREFERRED STOCK ACCUMULATED SHARE- - --------------------------- --------------------------- ADDITIONAL DURING THE DEFERRED HOLDERS' NUMBER AGGREGATE NUMBER AGGREGATE PAID-IN DEVELOPMENT COMPEN- EQUITY OF SHARES AMOUNT OF SHARES AMOUNT CAPITAL STAGE SATION (DEFICIT) - ------------ ------------ ------------ ------------ ------------ ------------- ------------ ------------ -- $ -- -- $ -- $ -- $ (4,778,875) $ -- $ (4,778,875) -- -- -- -- 48,324,374 -- -- 48,353,624 -- -- -- -- 7,360,187 -- -- 7,364,575 -- -- -- -- 362,937 -- -- 364,761 -- -- -- -- 9,555 -- -- 9,570 -- -- -- -- 71,300 -- -- 71,400 -- -- -- -- (80,062) -- 80,062 -- -- -- -- -- -- -- (62,726) (62,726) - ------------ ------------ ------------ ------------ ------------ ------------- ------------ ------------ -- -- -- -- 115,427,120 (50,611,169) (3,853) 64,947,960 -- -- -- -- -- (4,245,693) -- (4,245,693) -- -- -- -- 50,025 -- -- 52,658 -- -- -- -- 463,540 -- -- 465,869 -- -- -- -- 71,300 -- -- 71,400 -- -- -- -- -- -- 2,569 2,569 - ------------ ------------ ------------ ------------ ------------ ------------- ------------ ------------ -- -- -- -- 116,011,985 (54,856,862) (1,284) 61,294,763 -- -- -- -- -- (5,883,378) -- (5,883,378) -- -- -- -- 35,650 -- -- 35,700 -- -- -- -- -- -- 1,284 1,284 - ------------ ------------ ------------ ------------ ------------ ------------- ------------ ------------ -- -- -- -- 116,047,635 (60,740,240) -- 55,448,369 -- -- -- -- -- (7,416,333) -- (7,416,333) -- -- -- 14,354 -- -- 14,354 -- -- -- -- 124,775 -- -- 124,950 -- -- -- -- 998,750 -- -- 1,000,000 - ------------ ------------ ------------ ------------ ------------ ------------- ------------ ------------ -- -- -- -- 117,185,514 (68,156,573) -- 49,171,340 -- -- -- -- -- (9,167,070) -- (9,167,070) -- -- -- -- 57,112 -- -- 57,112 -- -- -- -- 33,425 -- -- 33,450 - ------------ ------------ ------------ ------------ ------------ ------------- ------------ ------------ -- -- -- -- 117,276,051 (77,323,643) -- 40,094,832 -- -- -- -- -- (10,174,609) -- (10,174,609) -- -- -- -- -- -- -- -- -- -- -- -- 38,220 -- -- 38,280 -- -- -- -- 189,000 -- -- 189,175 - ------------ ------------ ------------ ------------ ------------ ------------- ------------ ------------ -- -- -- -- 117,503,271 (87,498,252) -- 30,147,678 -- -- -- -- -- (10,717,360) -- (10,717,360) - ------------ ------------ ------------ ------------ ------------ ------------- ------------ ------------ -- -- -- -- 117,503,271 (98,215,612) -- 19,430,318 -- -- -- -- -- (12,250,145) -- (12,250,145) - ------------ ------------ ------------ ------------ ------------ ------------- ------------ ------------ -- -- -- -- 117,503,271 (110,465,757) -- 7,180,173 -- -- -- -- 9,671,843 -- -- 9,690,771 -- -- -- -- 74,877 -- -- 75,000 -- -- -- -- 190,995 -- (191,250) -- -- -- -- -- -- -- 35,630 35,630 -- -- -- -- 13,846,633 -- -- 13,872,493 -- -- -- -- 1,255,853 -- -- 1,258,223 -- -- -- -- 2,178,664 -- -- 2,182,759 -- -- -- -- 21,716,616 -- -- 21,736,160 -- -- -- -- 95,550 -- -- 95,700 -- -- -- -- -- (14,573,798) -- (14,573,798) - ------------ ------------ ------------ ------------ ------------ ------------- ------------ ------------ -- -- 166,534,302 (125,039,555) (155,620) 41,553,111 -- -- -- -- 38,220 -- -- 38,280 -- -- -- -- -- -- 23,841 23,841 -- -- -- -- -- (4,866,969) -- (4,866,969) - ------------ ------------ ------------ ------------ ------------ ------------- ------------ ------------ -- $ -- -- $ -- $166,572,522 $(129,906,524) $ (131,779) $ 36,748,263
NORTHFIELD LABORATORIES INC. (a company in the development stage) Statements of Cash Flows Three months ended August 31, 2004 and 2003 and for the period from June 19, 1985 (inception) through August 31, 2004
CUMULATIVE FROM THREE MONTHS ENDED AUGUST 31, JUNE 19, 1985 ----------------------------- THROUGH 2004 2003 AUGUST 31, 2004 ------------ ------------ --------------- (unaudited) (unaudited) (unaudited) Cash flows from operating activities: Net loss $ (4,866,969) (2,933,375) (129,906,524) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 167,977 169,962 17,932,933 Non-cash compensation 23,841 -- 3,687,194 Loss on sale of equipment -- -- 66,359 Changes in assets and liabilities: Prepaid expenses 21,275 70,787 (802,600) Other current assets (23,160) -- (1,920,493) Other assets -- (17,800) 6,851 Accounts payable (800,905) (971,368) 1,036,746 Accrued expenses (60,855) (31,529) 56,152 Accrued compensation and benefits (2,285) (41,864) 416,528 Other liabilities (954) 93,188 251,802 ------------ ------------ ------------ Net cash used in operating activities (5,542,035) (3,661,999) (109,175,052) ------------ ------------ ------------ Cash flows from investing activities: Purchase of property, plant, equipment, and capitalized engineering costs (60,564) (7,821) (18,822,867) Proceeds from sale of land and equipment -- -- 1,863,023 Proceeds from matured marketable securities 3,090,000 2,000,000 414,627,352 Proceeds from sale of marketable securities -- -- 7,141,656 Purchase of marketable securities (10,672,560) -- (432,736,967) ------------ ------------ ------------ Net cash provided by (used in) investing activities (7,643,124) 1,992,179 (27,927,803) ------------ ------------ ------------ Cash flows from financing activities: Proceeds from issuance of common stock 38,280 10,600,000 156,684,599 Payment of common stock issuance costs -- (909,229) (9,132,842) Proceeds from issuance of preferred stock -- -- 6,644,953 Proceeds from sale of stock options to purchase common shares -- -- 7,443,118 Proceeds from issuance of notes payable -- -- 1,500,000 Repayment of notes payable -- -- (140,968) ------------ ------------ ------------ Net cash provided by financing activities 38,280 9,690,771 162,998,860 ------------ ------------ ------------ Net (decrease) increase in cash (13,146,879) 8,020,951 25,896,005 Cash at beginning of period 39,042,884 4,897,962 -- ------------ ------------ ------------ Cash at end of period $ 25,896,005 12,918,913 25,896,005 ============ ============ ============
See accompanying notes to financial statements and accountants' review report. NORTHFIELD LABORATORIES INC. (A COMPANY IN THE DEVELOPMENT STAGE) NOTES TO FINANCIAL STATEMENTS AUGUST 31, 2004 (1) BASIS OF PRESENTATION The interim financial statements presented are unaudited but, in the opinion of management, have been prepared in conformity with accounting principles generally accepted in the United States of America applied on a basis consistent with those of the annual financial statements. Such interim financial statements reflect all adjustments (consisting of normal recurring accruals) necessary for a fair presentation of the financial position and the results of operations for the interim periods presented. The results of operations for the interim periods presented are not necessarily indicative of the results to be expected for the year ending May 31, 2005. The interim financial statements should be read in connection with the audited financial statements for the year ended May 31, 2004. (2) USE OF ESTIMATES Management of the Company has made a number of estimates and assumptions relating to the reporting of assets and liabilities and the disclosure of contingent assets and liabilities to prepare these financial statements in conformity with accounting principles generally accepted in the United States of America. Actual results could differ from those estimates. (3) COMPUTATION OF NET LOSS PER SHARE Basic earnings per share is based on the weighted average number of shares outstanding and excludes the dilutive effect of unexercised common stock equivalents. Diluted earnings per share is based on the weighted average number of shares outstanding and includes the dilutive effect of unexercised common stock equivalents. Because the Company reported a net loss for all periods presented, basic and diluted per share amounts are the same. Of the total options outstanding as of August 31, 2004, the Company has 1,058,500 options in-the-money and 191,000 options out-of-the money, 153,760 warrants that were in-the-money, and 58,632 warrants that were out-of-the money that were excluded from the net loss per share calculation. (4) ASSET RETIREMENT OBLIGATIONS The Company adopted Statement of Financial Accounting Standards, SFAS No. 143 - "Accounting for Asset Retirement Obligations" as of June 1, 2003. The cumulative effect of the change in accounting principle upon implementation was to recognize a net asset of $17,800, an increase in liabilities of $92,721 and an increase in net loss of $74,921, or $0.01 per share. The obligation relates to the restoration of a leased manufacturing facility to its original condition. A liability of $100,000 had been recorded in a prior period. The Company's asset retirement obligations are included in other liabilities. The balances and changes thereto are summarized below:
Quarter Ended August 31, 2004 - -------------------------------------------------------------------------- (unaudited) Obligation at May 31, 2004 $210,066 Accretion 4,726 -------- Obligation at August 31, 2004 $214,792 ==========================================================================
If the change in accounting had been applied retroactively, the Company's pro forma net loss for the three months ended August 31, 2003 would have been $2,858,454, with a $0.01 decrease in loss per share. (5) STOCK OPTIONS The Company accounts for its fixed plan stock options under the intrinsic value method of accounting prescribed by Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees", and related interpretations in accounting for options granted to directors, officers, and key employees under the plans. As such, compensation expense is recorded on the date of grant and amortized over the period of service only if the current market value of the underlying stock exceeded the exercise price. No stock-based employee compensation cost is reflected in net loss, as each option granted under these plans had an exercise price equal to the market value of the underlying common stock on the date of grant. The following table illustrates the effect on net loss if the Company had applied the fair value recognition provisions of the Statement of Financial Accounting Standards (SFAS) 123, "Accounting for Stock Based Compensation", to the measurement of stock-based employee compensation, including a straight-line recognition of compensation costs over the related vesting periods for fixed awards:
Three Months Ended August 31, August 31, 2004 2003 ----------- ------------ (unaudited) (unaudited) Net loss as reported $(4,866,969) (2,933,375) Add: Stock based compensation expense included in statements of operations 23,841 -- Deduct: Total stock based compensation expense determined under the fair value method for all awards, net of related tax effects (269,613) (120,206) ----------- ------------ (5,112,741) (3,053,581) =========== ============ Basic and diluted loss per share: As reported (0.23) (0.20) Pro forma (0.24) (0.20) =========== ============
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. Since Northfield's incorporation in 1985, we have devoted substantially all of our efforts and resources to the research, development and clinical testing of our potential product, PolyHeme(R). We have incurred operating losses during each year of our operations since inception and expect to incur substantial additional operating losses for the next several years. From Northfield's inception through August 31, 2004, we have incurred operating losses totaling $129,907,000. We will be required to complete our pivotal Phase III prehospital trial and obtain FDA regulatory approval before PolyHeme can be sold commercially. The FDA regulatory process is subject to significant risks and uncertainties, including those described under "Risk Factors" in our annual report on Form 10-K filed with the Securities and Exchange Commission. We therefore cannot at this time reasonably estimate the timing of any future revenues from the commercial sale of PolyHeme. The costs incurred by Northfield to date and during each period presented below in connection with our development of PolyHeme are described in the Statements of Operations in our financial statements. Our success will depend on several factors, including our ability to obtain FDA regulatory approval of PolyHeme and our manufacturing facilities, obtain sufficient quantities of blood to manufacture PolyHeme in commercial quantities, manufacture and distribute PolyHeme in a cost-effective manner, enforce our patent positions and raise sufficient capital to fund these activities. We have experienced significant delays in the development and clinical testing of PolyHeme. We cannot ensure that we will be able to achieve these goals or that we will be able to realize product revenues or profitability on a sustained basis or at all. RESULTS OF OPERATIONS We reported no revenues for either of the three-month periods ended August 31, 2004 or 2003. From Northfield's inception through August 31, 2004, we have reported total revenues of $3,000,000, all of which were derived from licensing fees. OPERATING EXPENSES Operating expenses for our first fiscal quarter ended August 31, 2004 totaled $4,987,000, an increase of $2,105,000 from the $2,882,000 reported in the first quarter of fiscal 2004. Measured on a percentage basis, fiscal 2005 operating expenses exceeded fiscal 2004 expenses by 73.0%. As expected, significant increases in operating expenses were incurred to conduct, expand, report and support our pivotal phase III prehospital trial. Research and development expense during the first quarter of fiscal 2005 totaled $4,038,000, an increase of $1,839,000, or 83.6%, from the $2,199,000 reported in the first quarter of fiscal 2004. Our pivotal phase III prehospital trial is enrolling patients and we continue to actively pursue additional Level I trauma sites to participate. As of August 31, 2004, 16 sites had full Institutional Review Board approval and 13 of the sites were enrolling patients. Work continues to achieve our goal of having 20 sites enrolling by December 31, 2004. Included in the first quarter of fiscal 2005 research and development expense was an increase of $454,000 for hospital charges and an increase of $738,000 from the first quarter of fiscal 2004 for data accumulation, data monitoring and analysis. We anticipate that these expenses will continue to grow consistent with the rate of patient enrollment and site initiation. Also included in the first quarter research and development expenses were increased expenses to manufacture PolyHeme, increased use of science consultants to prepare for the reporting to FDA and an increase in executive compensation for two officers hired during fiscal 2004. General and administrative expenses in the first quarter of fiscal 2005 totaled $949,000, which is an increase of $266,000, or 38.9%, from the general and administrative expenses reported in the first quarter of fiscal 2004 of $683,000. The increased expenses this year fall into three principal areas: (i) professional services increased by $126,000 for legal and accounting, lobbying and expenses related to our annual report to shareholders. (ii) increased filing fees charged based on our capitalization and (iii) expenses related to original market research on the commercial sale of PolyHeme. Lobbying efforts have been successful in securing a $1.4 million federal appropriation as part of the 2005 Defense Appropriations Bill. We anticipate modest increases in general and administrative expenses over the balance of fiscal 2005. Our new Internet Web site was launched in September 2004 and an expansion of business development activities is planned. Successfully completing our pivotal phase III prehospital trial remains our primary focus. INTEREST INCOME Interest income for the three-month period ended August 31, 2004 totaled $120,000, an increase of $97,000 from the $23,000 in interest income reported in the three-month period ended August 31, 2003. Following three successful fund raising efforts in fiscal 2004, Northfield started the fiscal year 2005 with $42,487,000 in available cash and marketable securities. This compares to available cash and marketable securities at the beginning of fiscal 2004 of $6,890,000. The significant increase in cash balances and a modest increase in available short-term interest rates caused interest income to increase. We continue to invest our funds only in high grade, short-term instruments. Over the balance of fiscal year 2005, we anticipate interest income will exceed the $108,000 earned in fiscal 2004 by more than $200,000. NET LOSS The net loss for the three-month period ended August 31, 2004 totaled $4,867,000, or $0.23 per share, compared to a net loss of $2,933,000, or $0.20 per share, for the first quarter ended August 31, 2003. In dollar terms the loss increased by 65.9%, but on a per share basis the additional 6,439,000 shares outstanding in the current year mitigated the loss per share increase to 15.0%. LIQUIDITY AND CAPITAL RESOURCES From Northfield's inception through August 31, 2004, we have used cash in operating activities and for the purchase of property, plant, equipment and engineering services in the amount of $127,998,000. For the first fiscal quarters ended August 31, 2004 and 2003, these cash expenditures totaled $5,603,000 and $3,670,000, respectively. The first fiscal quarter 2005 increase in cash utilization is due primarily to expenses related to our pivotal Phase III prehospital trial. We have financed our research and development and other activities to date through the public and private sale of equity securities and, to a more limited extent, through the license of product rights. As of August 31, 2004, we had cash and marketable securities totaling $36,914.000. We believe our existing capital resources will be adequate to satisfy our operating capital requirements, including our Phase III clinical trial, and maintain our existing manufacturing plant and office facilities for approximately the next 15 to 21 months. Thereafter, we will require substantial additional funding to continue our operations. We may issue additional equity or debt securities or enter into collaborative arrangements with strategic partners, which could provide us with additional funding or absorb expenses we would otherwise be required to pay. We are also pursuing potential sources of additional government funding. Any one or a combination of these sources may be utilized to raise additional capital. We believe our ability to raise additional capital or enter into a collaborative arrangement with a strategic partner will depend primarily on the results of our clinical trial, as well as general conditions in the business and financial markets. An inability to raise sufficient levels of capital could materially delay or prevent the commercialization of PolyHeme, even if approved by FDA. Our capital requirements may vary materially from those now anticipated because of the timing and results of our clinical testing of PolyHeme, the establishment of relationships with strategic partners, changes in the scale, timing or cost of our commercial manufacturing facility, competitive and technological advances, the FDA regulatory process, changes in our marketing and distribution strategy and other factors. CRITICAL ACCOUNTING POLICIES The preparation of financial statements requires management to make estimates and assumptions that affect amounts reported therein. We believe the following critical accounting policy reflects our more significant judgments and estimates used in the preparation of our financial statements. NET DEFERRED TAX ASSETS VALUATION We record our net deferred tax assets in the amount that we expect to realize based on projected future taxable income. In assessing the appropriateness of our valuation, assumptions and estimates are required, such as Northfield's ability to generate future taxable income. In the event we were to determine that it was more likely than not we would be able to realize our deferred tax assets in the future in excess of their carrying value, an adjustment to recognize the deferred tax assets would increase income in the period such determination was made. As of August 31, 2004, we have recorded a 100% percent valuation allowance against our net deferred tax assets. CONTRACTUAL OBLIGATIONS The following table reflects a summary of our contractual cash obligations as of August 31, 2004:
LESS THAN 4-5 CONTRACTUAL CASH OBLIGATIONS TOTAL ONE YEAR 1-3 YEARS YEARS - -------------------------------------- ------------- ----------- ---------- ---------- Lease Obligations(1)........................... $ 3,039,093 $ 856,593 $1,172,075 $1,010,425 Other Obligations.............................. 861,181 672,848 188,333 -- ------------- ----------- ---------- ---------- Total Contractual Cash Obligations............. $ 3,900,274 $ 1,529,441 $1,360,408 $1,010,425 ============= =========== ========== ==========
- ---------- (1) The lease for our Evanston headquarters is cancelable with six months notice combined with a termination payment equal to six months base rent. At August 31, 2004, this penalty would have amounted to $152,625. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK. We currently do not have any foreign currency exchange risk. We invest our cash and cash equivalents in government securities, certificates of deposit and money market funds. These investments are subject to interest rate risk. However, due to the nature of our short-term investments, we believe that the financial market risk exposure is not material. A one percentage point decrease on our cash and marketable securities of $36.9 million at August 31, 2004 would decrease interest income by $369,000 on an annual basis. ITEM 4. CONTROLS AND PROCEDURES. Based on their evaluation as of the end of the period covered by this report, our Chief Executive Officer and Senior Vice President and Chief Financial Officer have concluded that Northfield's disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, are effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission's rules and forms. There were no changes in our internal control over financial reporting that occurred during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. PART II. OTHER INFORMATION Item 6. Exhibits a) Exhibit 15 - Acknowledgment of Independent Registered Public Accounting Firm Regarding Accountants' Review Report Exhibit 31.1 - Certification of Steven A. Gould, M.D., pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 Exhibit 31.2 - Certification of Jack J. Kogut, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 Exhibit 32.1 - Certification of Steven A. Gould, M.D., pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 Exhibit 32.2 - Certification of Jack J. Kogut, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Company in the capacities indicated on October 11, 2004. SIGNATURE TITLE /s/ Steven A. Gould, M.D. Chairman of the Board and Chief - ------------------------- Executive Officer (Principal Steven A. Gould, M.D. Executive Officer) /s/ Jack J. Kogut Sr. Vice President and Chief - ------------------------- Financial Officer Jack J. Kogut EX-15 2 c88632exv15.txt ACKNOWLEDGEMENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM REGARDING ACCOUNTANTS' REVIEW REPORT EXHIBIT 15 ACKNOWLEDGEMENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM REGARDING ACCOUNTANTS' REVIEW REPORT The Board of Directors Northfield Laboratories Inc.: With respect to registration statements (Nos. 333-15877, 333-51681, 333-79579, 333-102672 and 333-110110) on Form S-8 and the registration statements (No. 333-106615 and 333-115459) on Form S-3 of Northfield Laboratories Inc., we acknowledge our awareness of the use therein of our report dated October 5, 2004 related to our review of interim financial information. Pursuant to Rule 436(C) under the Securities Act of 1933, such report is not considered to be a part of a registration statement prepared or certified by an accountant or a report prepared or certified by an accountant within the meaning of sections 7 and 11 of the Act. Very truly yours, /s/ KPMG LLP Chicago, Illinois October 11, 2004 EX-31.1 3 c88632exv31w1.txt CERTIFICATION EXHIBIT 31.1 CERTIFICATION I, Steven A. Gould, M.D., Chief Executive Officer, certify that: 1. I have reviewed this report on Form 10-Q of Northfield Laboratories Inc. (the "Registrant"); 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report; 4. The Registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the Registrant and have: a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; b. Evaluated the effectiveness of the Registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and c. Disclosed in this report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Registrant's internal control over financial reporting; and 5. The Registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant's auditors and the audit committee of Registrant's Board of Directors (or persons performing the equivalent functions): a. all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant's ability to record, process, summarize and report financial information; and b. any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal control over financial reporting. Date: October 11, 2004 /s/ Steven A. Gould, M.D. --------------------------- Steven A. Gould, M.D. Chief Executive Officer EX-31.2 4 c88632exv31w2.txt CERTIFICATION EXHIBIT 31.2 CERTIFICATION I, Jack J. Kogut, Chief Financial Officer, certify that: 1. I have reviewed this report on Form 10-Q of Northfield Laboratories Inc. (the "Registrant"); 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report; 4. The Registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the Registrant and have: a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; b. Evaluated the effectiveness of the Registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and c. Disclosed in this report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Registrant's internal control over financial reporting; and 5. The Registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant's auditors and the audit committee of Registrant's Board of Directors (or persons performing the equivalent functions): a. all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant's ability to record, process, summarize and report financial information; and b. any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal control over financial reporting. Date: October 11, 2004 /s/ Jack J. Kogut --------------------------- Jack J. Kogut Chief Financial Officer EX-32.1 5 c88632exv32w1.txt CERTIFICATION EXHIBIT 32.1 CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Quarterly Report of Northfield Laboratories Inc. on Form 10-Q for the period ended August 31, 2004 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, Steven A. Gould, M.D., Chief Executive Officer of Northfield Laboratories Inc., certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 that: (1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Northfield Laboratories Inc. Date: October 11, 2004 /s/ Steven A. Gould, M.D. - ---------------------------- Steven A. Gould, M.D. Chief Executive Officer EX-32.2 6 c88632exv32w2.txt CERTIFICATION EXHIBIT 32.2 CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Quarterly Report of Northfield Laboratories Inc. on Form 10-Q for the period ended August 31, 2004 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, Jack J. Kogut, Chief Financial Officer of Northfield Laboratories Inc., certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 that: (1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Northfield Laboratories Inc. Date: October 11, 2004 /s/ Jack J. Kogut - -------------------------------- Jack J. Kogut Chief Financial Officer -----END PRIVACY-ENHANCED MESSAGE-----