Cytori Therapeutics (CYTX)

Cytori Therapeutics is an emerging biotech company seeking to leverage 1) proprietary adipose-derived stem and regenerative cells- (ADRCs) based Habeo cell therapy as a potential treatment in various disorders; and 2) generic liposomal doxorubicin (ATI-0918) that potentially could be the first generic launched in Europe. ATI-0918 is bioequivalent to Johnson and Johnson’s Caelyx (The U. S. brand name: Doxil). CYTX is scheduled to conduct a stability test in 1Q18 and possibly submit to EMA for approval between 4Q18 and 2Q19 with potential approval in 2020. CYTX is also seeking a commercial partner for ATI-0918 in Europe. Although the recent STAR pivotal study that evaluated Habeo cell therapy in scleroderma did not met its primary endpoint, outcomes of the diffuse disease subset are encouraging. Despite the scenario that additional Phase III studies might be needed, several other opportunities remain for Habeo cell therapy. Possibilities include scleroderma in Europe and stress urinary incontinence in Japan. Further, Habeo cell therapy operation in Japan could be a meaningful revenue source going forward, while BARDA contract for thermal burn and radiation (with potential value up to $106MM) could also be an important asset.