If 2017 wasn't already bad enough for holders of Cytori Therapeutics (NASDAQ:CYTX) stock, things got worse on Monday and the bloodletting is continuing on Tuesday, making CYTX one of the worst performing stocks on the NASDAQ exchange this week.
Shares were already halved once this year and that has happened again following the San Diego-based developer of regenerative and oncologic therapies releasing top-line, preliminary data from its pivotal STAR trial of Habeo Cell Therapy in patients with scleroderma.
Despite the company finding some positives in the numbers, the bottom line was the trial didn't meet its primary or secondary endpoints of a statistically significant improvement in hand function and scleroderma-associated functional disability.
There currently is no cure for scleroderma, an autoimmune condition of unknown cause characterized by chronic hardening and tightening of the skin and connective tissue. According to the American College of Rheumatology, about 75,000 to 100,000 Americans suffer from the disease.
The randomized, double blind, placebo-controlled STAR phase 3 trial enrolled 88 patients with scleroderma across 20 sites looking to improve hand function through injections of Cytori's Habeo Cell Therapy. Clinical change was measured through the patient-reported Cochin Hand Function Score at 24 and 48 weeks, investigator assessment at 48 weeks and other industry metrics.
Cytori wants to analyze the data more before determining the next steps in Habeo development, noting meaningful improvements in a specific subset of the patient population. There were 51 patients enrolled with diffuse cutaneous scleroderma, a more severe form of the disease.
These patients showed "clinically important differences" in the Cochin Hand Function Score and the Health Assessment Questionnaire-Disability Index (HAQ-DI), a measure of functional disability and an important secondary endpoint in the trial.
The diffuse version of the disease is known for having the highest mortality rate among all rheumatic diseases. Cytori signaled that Habeo therapy could have a place for these patients that have no other treatment options.
Investors aren't buying into possibilities for the future, instead selling heavily into the failed trial news. Entering the week at $1.11, shares were demolished by 56.7% to $0.48 cents on Monday and are down another 8.4% in morning trading on Tuesday to $0.44, as the company could now be staring at possible NASDAQ listing requirement violations in a month for market capitalization and bid price if things don't rebound.
