Northfield Laboratories Inc., bleeds

Northfield released its financial results for the fourth fiscal quarter and year-ended May 31, 2007, informing shareholders that it lost 24 cents a share in the 4th quarter and $1.03 for fiscal 2007. Plans are in place for 2008 . . .

"Our singular focus in FY08 is the successful submission of a Biologics License Application for PolyHeme® with a request for priority review," said Steven A. Gould, M.D., Chairman and Chief Executive Officer. "We have already submitted a detailed summary of the pivotal Phase III trial data to FDA, which was followed by a pre-BLA meeting. Given our strong belief in PolyHeme's ability to address a critical unmet medical need and its potential to save lives, we are committed to making our product available for patients with urgent, life-threatening blood loss when blood is not available."

Northfield's press release included summary coverage of topics listed below (and others):

Highlights of the Year and Upcoming Events
Commercialization Activities
Financial
Investor Outreach
Annual Meeting of Stockholders

I am looking forward to the day when Rambus Inc. provides its shareholders with a date for its annual meeting and shares similar information . . .

Northfield Laboratories Inc. lost 23 cents per share

Northfield Laboratories Inc. lost $6.1million, or 23 cents a share, as compared to a year-ago quarter's loss of $6.4 million, or 24 cents a share. Northfield is re-analyzing its Phase III trial for its blood substitute product known as PolyHeme.

Northfield taking shots, will it need a transfusion?

Adam Feuerstein, who has a self-proclaimed "obsession with blood substitutes", writes for TheStreet.com and is no fan of Polyheme, Northfield Laboratories hoped for blood substitute. He believes, despite Northfield's hopes and protestations to the contrary, that Polyheme will not receive FDA approval killed more than the current regimen of treatment of blood or saline and blood in tandem. While it plays out he opines:

In the meantime, Northfield will file Polyheme with the FDA and make its case for approval. There's nothing wrong with that. As an investor, however, it's better to sit on the sideline than get involved.

Say Nay To Northfield

There certainly is no doubt that before long Northfield will require FDA approval for Polyheme or a transfusion of cash . . .

Earlier in the week (1/9/07) Northfield announced financial results for the second quarter of fiscal 2007, which ended November 30, 2006.

Net loss of $7.6 million, or $0.28 cents per share, for the second quarter compared with a net loss of $6.3 million, or $0.23 cents per share, for the corresponding period last year.

Shareholders' equity of $56.2 million, with $51.6 million in cash and marketable securities.

Northfield Laboratories Inc. bled

The share price of Northfield plummeted more than 50% following Northfield's preliminary report of top-line data from its Phase III trial assessing the safety and efficacy of PolyHeme(R), its human hemoglobin based oxygen-carrying red blood cell substitute.

Northfield and its contract research organization agree there were some errors in the data - some of the deaths were study patients not per protocol - and will unlock the database, correct the errors, verify the database and then re-lock the database.

In short, the data as reported to date reveals that more deaths occurred when PolyHeme was administered than in the control group - thus PolyHeme is not a superior treatment and the number of death was large enough that PolyHeme also failed the non inferior barrier as well.

Whether the corrected and verified database will reverse the preliminary results enough (or at all) to warrant FDA approval PolyHeme remains an unknown. Northfield remains publicly optimistic and expects to release additional safety date within 4-6 weeks.

Genetic Engineering News

Reuters

Northfield Laboratories Inc. - Update - Phase III

Conference call and webcast today, Tuesday, December 19, 2006, at 5:00 p.m. ET.

Steven A Gould, M.D., Northfield’s Chairman and CEO, will host the call and provide an update on the company’s pivotal Phase III clinical trial.

To access the call, investors may dial 866.831.6270 and enter the passcode 34502416. International investors may dial 617.213.8858 and enter the same passcode.

Investors may also access a live webcast of the call at www.northfieldlabs.com.

A replay will be available and will be archived until January 2, 2007. The replay number is 888-286-8010, passcode 17196716.

Northfield Laboratories - PR machine

Earlier this week Northfield Laboratories took a hit when Morgan Joseph decided to initiate coverage with a "sell" and a $6.00 target.

Today Northfield announces that Steven A. Gould, M.D., Chairman and Chief Executive Officer, will be presenting at the BMO Focus on Healthcare 2006 Conference on Wednesday, December 6, 2006, at 2:30 p.m. ET.

Positive press. Coincidence or public relations department on their game? Whatever, Rambus Inc. should be taking notes.

Northfield Laboratories is a sell?

That is what Morgan Joseph is telling its fans.

Morgan Joseph commenced coverage of Northfield Laboratories with a Sell rating aimed at $6.

StreetInsider.com reports that Morgan Joseph commenced coverage of Northfield Laboratories (Nasdaq: NFLD) with a Sell rating aimed at $6.

Analyst Eugene Trogan said, "PolyHeme Phase III data is likely to be mired by safety concerns, making FDA approval highly unlikely, in our opinion. Questions over PolyHeme's safety have created a climate in which the FDA will feel hard-pressed, in our view, to approve PolyHeme unless the product demonstrates stellar results, a scenario we consider to be highly unlikely. The most well-known risk is hemoglobin's vasoconstrictive effects, among others, some of which include cardiac and gastroinstestinal toxicity, inflammation, and oxidative stress."

Northfield Laboratories which closed yesterday (11/27/06) at $15.64 and opened this morning at $14.90, must be thrilled that Morgan Joseph joined the party.