MannKind expects FDA Afrezza meeting Aug. 10

MannKind says it will meet with FDA about new trials of inhaled insulin Afrezza on Aug. 10

Associated Press

VALENCIA, Calif. (AP) -- MannKind Corp. said it expects to meet with regulators next week about proposed late-stage trials for its inhaled insulin drug Afrezza, but its lack of details worried some investors.Analysts said Wall Street may have been hoping for more specifics about the development of Afrezza, and added that MannKind is low on cash. Late Thursday the company reported its cash, cash equivalents and marketable securities at June 30 totaled $25.3 million, down from $70.4 million at Dec. 31.In a conference call late Thursday to discuss quarterly results, President and Chief Operating Officer Hakan Edstrom said the company will meet with Food and Drug Administration officials on Wednesday.The FDA told MannKind in January that it would need to run additional clinical trials to get marketing approval for Afrezza. The company and the agency have been discussing the design and goals of those trials. MannKind first asked the FDA to approve Afrezza in March 2009, and was asked to provide more data.Rodman & Renshaw analyst Michael Higgins said investors were expecting more particulars about MannKind's discussions with the FDA."The company expects to start enrolling Type 1 diabetes patients right after meeting with the FDA next week to discuss both trials," he said. "While fewer details were provided about the trial design with the Type 2 patients, we look forward to gaining greater clarity on this program after that meeting,"Robert W. Baird & Co. analyst Thomas Russo said the new Afrezza studies may not be complete until early 2013, which is several months later than he expected. Both Russo and Higgins said MannKind has enough cash to last until early 2012, and Russo said the company has not announced its plans for raising more money. He said that if the company sells more stock, it could dilute existing shares significantly because of MannKind's low stock price. Shares are down 68 percent in the year to date.The company also reported its second-quarter results late Thursday. MannKind said it lost $44.5 million compared to $42.3 million a year ago. On a per-share basis its loss remained at 37 cents. MannKind, which has no products on the market, reported no revenue in the latest quarter, down from $93,000 in the second quarter of 2010.Analysts expected a loss of 30 cents per share, according to FactSet.Shares of MannKind gave up 11 cents to $2.60 in midday trading. The stock has traded between $2.60 and $10.05 in the last year.

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