said Wednesday that it had $4 million in cash on hand as of July 31, enough to keep the company operating into September, but the developer of an artificial blood substitute said it will need to raise another $10 million to stay in business through March 2005.
Cambridge, Mass.-based Biopure provided the financial update as it released third-quarter results. It lost $9.4 million, or 19 cents a share, on revenue of $333,000 for the three months ended July 31. That compares with a loss of $11.3 million, or 28 cents a share, on revenue of $885,000 for the same period last year.
Biopure trimmed its loss because it has been cutting costs -- laying off employees and reducing sales and production of its only commercial product, a blood substitute for treating anemic dogs called Oxyglobin -- as it focuses on trying to win Food and Drug Administration approval for its human blood substitute, Hemopure. Revenue has declined because the cost-cutting efforts are forcing it to limit sales of Oxyglobin.
Biopure said it must raise the extra $10 million to help finance new tests of Hemopure in treating certain heart patients and in continuing the preparation of tests of Hemopure in a trauma setting. The money also will be used to finance additional FDA-mandated tests and to finance the answering of agency questions about Biopure's original application that Hemopure be approved for acutely anemic patients undergoing elective orthopedic surgery.
Last year, the FDA raised many questions about the orthopedic surgery application, which triggered delays in the agency's review of Hemopure. The FDA presented a number of safety questions, forcing Biopure to conduct more animal tests and provide more data. All of this led to the deflating of Biopure's stock, which reached a 52-week high of $9.03 last August but now trades at 65 cents.
"The company continues to evaluate the most expeditious path to regulatory approval for Hemopure," the company said as it announced its financial results.
Biopure said Wednesday that a defense appropriations bill recently signed into law by President Bush contains $7 million in funding for the Navy to continue research on Hemopure for civilian and military trauma uses. Biopure said the Navy is responsible for designing and seeking FDA acceptance of a proposed clinical trial of using Hemopure for trauma patients.
Biopure also recently began a clinical test of Hemopure in South Africa for treating trauma patients in a hospital setting. Hemopure has been approved for use in South Africa, but it has not been offered there for sale yet. Biopure added that a European clinical trial of Hemopure continues to enroll patients who are undergoing the arterial-plaque clearing procedure known as angioplasty.