The Bottom Line: They made progress but slowly ... patients enrollment in Athena continues with FDA approval to expand the scope of the ATHENA clinical program , continued qualification for BARDA, a spatter of commercial registration in Australia, Contained SG&A expenses … still too slow in recognizing product revenue – hopefully the 2nd half will be better. Regulatory approvals … are still too slow. Cash be ... problematic as they proceed through the 2nd half?
The Puregraft® was a good deal as it drew away focus to the current focus. CYTX is adjusting 2013 revenue target to $14 M in combined product and cash contract revenue – could that be considered … guidance? The restructured term loan resulted in net proceeds, deferred payment and lesser quarterly payments – prolonging their capacity to BARDA payments and any … partnering collaborations which precludes any run to the capital markets – they still need to cut expense!
CYTX … expects the Athena program to begin enrolling in Q4/13 at up to 10 centers, immediately following the full enrollment of ATHENA. Athena II is important to determining the optimal cell dose for heart failure. In addition to strengthening the clinical data on the utility of ADRCs for heart failure, CYTX believes having this additional data on a 2nd dose will maximize the chance of a pivotal trial. Full enrollment of ATHENA II is anticipated during the first half of 2014 and is not expected to delay the initiation of the U.S. pivotal trial planned for 2015.
The ADVANCE trial has enrolled 23 patients. As part of a comprehensive evaluation of CYTX’s global cardiovascular strategy, resource utilization and development priorities, they have decided to … discontinue enrollment … in the ADVANCE trial once it has achieved the 2013 target enrollment goal of 25 patie