Cytori Therapeutics Inc (NASDAQ:CYTX) Shares Rocked by Preliminary Phase 3 Results

Cytori Therapeutics Inc (NASDAQ:CYTX)

Cytori Therapeutics Inc (NASDAQ:CYTX) shares lost over 56% after the biotech firm announced disappointing preliminary data from its STAR trial of HabeoTM Cell Therapy in patients with scleroderma. Investors fled the stock in heavy volumes – over thirteen times the daily average.

NASDAQ:CYTX Cytori
Daily Candle Graph $CYTX

San Diego, CA-based Cytori Therapeutics Inc (NASDAQ:CYTX) STAR Trial is a randomized, double blind, placebo-controlled, multi-site Phase III clinical trial. It has a total enrollment of over 80 patients with impaired hand function from scleroderma. The trial, taking place at 20 sites, was designed to evaluate the one-year safety and efficacy of a single administration of Cytori Cell Therapy: HABEO™ in patients with scleroderma affecting the hands.

In the combined study population, the primary endpoint, specifically mean improvement in the Cochin Hand Function Score, did not show statistical difference between treated patients and those receiving placebo at 24 weeks and 48 weeks as determined by both analysis of covariance and mixed model repeated measure analysis. The Raynaud’s Condition Score, a secondary endpoint, improved in both the treatment and placebo group but was not statistically different between the Habeo treated and placebo groups.

Marc H. Hedrick, MD, President and Chief Executive Officer of Cytori Therapeutics Inc (NASDAQ:CYTX) stated “We are disappointed that the study missed the primary and secondary endpoints. However, we are very encouraged by the trends toward improved hand function and scleroderma-related health status in patients with diffuse cutaneous scleroderma.”

The market took the newshard. Last Friday shares of CYTX closed at $1.11 but after news of the Phase 3 data release, shares gapped down to open at $0.50. Even before today’s collapse, Cytori Therapeutics Inc (NASDAQ:CYTX) was having a rough ride YTD the shares were down over 26%, and were down for the year over 45%.

While losses have been normal every year for CYTX shareholders, they have been shrinking. In 2012 the per share loss was (-$8.25) but by 2016 the company had managed to shrink the annual loss to (-$1.28). Sale may be the more worrisome indicator. In 2012 the company posted $14.5 million in sales and that figure shrank to $11.4 million in 2016.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.