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MannKind's CEO Discusses Q1 2012 Results - Earnings Call Transcript

Stocks in this article: MNKD

Our cash burn increased from $20.1 million spend in the fourth quarter of 2011 to $33.1 million in the first quarter of 2012, reflecting the acceleration of our spending in 2012 as we enroll the planned clinical trials and approached commercialization. With our cash in hand and amount remaining available under the credit facility from Al, we believe we will be able to fund our operations into the fourth quarter of 2012. We continue to pursue additional funding opportunities to extend our cash runway, but I cannot comment further until we have something definitive to announce.

With that, I would like to now turn the call over to Hakan. Hakan?

Hakan S. Edstrom

Thank you, Matt. Good afternoon. The focus of the organization during the first quarter certainly have been on the clinical trial programs, and all of our clinical trials are progressing satisfactorily. Our 2 trials, the 171 and 175, are well underway. We've opened all the planned sites in the U.S., Russia and Ukraine, and they are actively bringing in patients to the studies.

As early in the month, we had screened approximately 75% of the planned patients in both trials. We have experienced higher-than-expected screen failure rates, that is patients that are evaluated but participation in the studies do not meet the protocol requirements for inclusion.

To address this shortfall of patients, we have initiated more sites in the U.S. using our own monitoring staff. We've also contracted with a CRO to start up a number of additional sites. And in addition, to help our sites identify potential patients, we are working with a vendor who will identify and refer additional patients to our study sites. We expect these measures to help expedite the screening and enrollment process.

As you will remember, we previously stated that we had hoped to complete enrollment in both the 171 and 175 clinical trials by the end of this quarter. While we have not yet given up on this timeline, it is foreseeable that the studies will not be fully enrolled until next quarter with last patient, last visit taking place sometime early in 2013.

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