A Medical Device Daily

Oxygen therapeutic developer Biopure (Cambridge) reported that its board has approved a reverse 1-for-6 stock split of its outstanding Class A common stock, effective May 27. The move, it said, follows the approval by company stockholders at its annual meeting on April 6 for a reverse stock split in the range of 1:2 to 1:6.

The company said the split is intended to broaden its investor base and assist in regaining compliance with the Nasdaq’s $1 minimum bid price listing. It will, Biopure said, increase its share price and decrease the number of shares, warrants and options outstanding.

The company reported having nearly 146.16 million shares of Class A common stock outstanding at the end of trading May 19. The total number of shares outstanding when the market opens on May 27 should be somewhat less than 24.36 million if no warrants are exercised in the interim, Biopure said. The stock is expected to trade for 20 trading days thereafter under the ticker symbol BPURD before reverting to BPUR.

Biopure said it would not issue fractional shares following the reverse split. Stockholders entitled to fractional shares will receive a cash payment equal to the fractional share multiplied by the closing price of its common stock on May 26, multiplied by six.

The company also reported financials for the second fiscal quarter ended April 30. It reported a net loss of $6.6 million, or 5 cents per share, compared to a net loss of $12 million, or 25 cents per share, in the year-earlier period.

Total fiscal 2Q05 revenues were $620,000, including $315,000 from past congressional appropriations administered by the U.S. Army and $305,000 from sales of the company’s veterinary product Oxyglobin. Revenues for the same period last year were $893,000, “almost entirely from Oxyglobin sales,” it said.

Army payments reimburse it “for certain trauma development expenses” for Hemopure, its oxygen therapeutic under development for human use, it said.

The company said it is now preparing to sell Hemopure in South Africa “but does not expect these activities or the resulting revenues to have a material effect on FY05 results.”

As of April 30, Biopure had $20.7 million in cash on hand, which it said “will fund operations into March 2006” under its current plan. In South Africa, it has submitted a Phase II clinical trial protocol to that country’s Medicines Control Council for review and designed to assess the safety and efficacy of low doses of Hemopure, administered perioperatively to improve wound healing in patients with peripheral vascular disease who are undergoing lower limb amputation.

In Europe, it said, “the pilot Phase II safety and feasibility trial of Hemopure in elective coronary angioplasty patients has completed and the process of verifying, locking, unblinding and analyzing the data has begun

It said that in the U.S. it to provide information to the FDA to support the Navy’s trauma development program and as a prerequisite to filing an investigation new drug (IND) application to initiate an ischemia trial in the U.S. It added that it would submit further responses, including safety and risk-benefit analyses, additional preclinical data from animal models of coronary occlusion and the European Phase II human clinical trial data “in the next few weeks.”

It also reported the results of a pre-clinical study of Hemopure in an animal model of cardiac ischemia in the April issue of the American Journal of Physiology — Heart and Circulatory Physiology, titled “A novel hemoglobin-based blood substitute protects against myocardial reperfusion injury.”

The schedule for the 10th International Symposium on Blood Substitutes in Providence, Rhode Island, June 13 to 15, will include, it said, several “Hemopure-related” presentations.