Greenwich LifeSciences shares fell more than 15% in early morning trading Tuesday after White Diamond Research said trial data suggest the biotech’s main asset is a failure.
All peer reviewed publications of Greenwich’s Phase 2 trial results for its drug GP2, a vaccine to prevent the recurrence of breast cancer following surgery, show a lack of statistical significance, said White Diamond in a report Tuesday.
Greenwich claims GP2 works, citing trials that show patients reaching ‘‘statistically significant peak immunity’’ after six months of treatment with the drug. The company’s website says that the safety and efficacy of the GP2 immunotherapy have been tested in four clinical trials, where 146 patients have received treatment to date.
White Diamond is doubtful of Greenwich’s statements, saying the company manipulated data and published trial results in an ‘‘obscure poster presentation’’ plagued by ‘‘numerous red flags, such as false statements and the unexplained exclusion of patients from the data.’’
Greenwich shares were down nearly 17% at $10.52 each as of 9:35 a.m. Tuesday in New York. White Diamond sees them worth just $3 apiece.
The short seller said that GP2’s Phase 3 study is struggling to enroll patients, estimating that if the trial is not redesigned, it will probably take between 12 and 20 years for the final vaccine data results to be finished.
Investors ‘‘have to fully realize their ROI [return on investment] prospects’’ given the very long duration of the study and ‘‘low probability of success,’’ said White Diamond, who believes the company’s CEO and his team are using the biotech ‘‘as a vehicle to enrich themselves.’’