said Wednesday that it expects to run out of money in eight weeks, adding that it must raise $19 million to keep operating through October.
The announcement is the latest in a series of regulatory and financial setbacks for Biopure's effort to develop a blood substitute known as Hemopure. Despite vigorous cost-cutting, Biopure was down to $6.3 million in cash and cash equivalents as of Oct. 31, the end of its recent fiscal year.
Given its financial condition, the Cambridge, Mass.-based company said it expects its auditor, Ernst & Young, to append a "going-concern" rider to the year-end audit.
Biopure's stock lost 5 cents, or 12.2%, to 36 cents. The stock has traded above $1 only four days since May 3.
Biopure had hoped to secure FDA approval for Hemopure for use in patients undergoing elective orthopedic surgery. By mid-2003, the company indicated it could receive FDA approval by late 2003 or early 2004. But the Food and Drug Administration asked enough questions about safety and demanded enough additional tests to thwart that timetable.
Subsequently, Biopure began talking to the FDA about seeking Hemopure's approval for people who had suffered a heart attack. But such an application will require a new preclinical study on top of current animal studies.
The company also is in midstage human testing in Europe of Hemopure for people who have undergone the arterial plaque-clearing process called angioplasty. Enrollment in a midstage clinical test in South Africa for Hemopure in patients with unstable trauma has been delayed until early next year because of what the company said are "site procedures" at the hospital hosting the research.
Biopure also said it has submitted final reports for only one of three animal studies that the FDA had requested last year regarding the orthopedic surgery application. The final reports for the other two studies "are being compiled by the study investigators," Biopure said.
The company added that thanks to a research agreement, the U.S. Naval Research Center is working on an application to the FDA for testing Biopure in an out-of-hospital trauma setting for people who have suffered an acute blood loss. The Navy is conducting a preclinical animal study.
Biopure also reported that it lost $9.4 million, or 16 cents a share, on revenue of $1.77 million for the three months ended Oct. 31, the fourth quarter of its last fiscal year. This compares with a loss of $13 million, or 16 cents a share, on revenue of $1.15 million, for the same period in 2003.
Most of the recent revenue came from military contracts and from sales of Oxyglobin, the company's blood substitute for anemic dogs. But Oxyglobin sales are declining as Biopure cuts costs and devotes most of its money and effort to gaining FDA approval of Hemopure.