Shares of Zynerba Pharmaceuticals (ZYNE 0.29%) gained 356% in the first six months of the year, according to data provided by S&P Global Market Intelligence. The clinical-stage pharmaceutical has emerged from obscurity thanks in part to the craze surrounding everything and anything related to marijuana.
Its lead and only drug candidate, Zygel, is a cannabidiol (CBD) gel aimed at treating seizures and behavioral symptoms associated with neuropsychiatric disorders including fragile X syndrome and autism spectrum disorder. Despite the surging stock price, the company is valued at just $300 million today.
Investors appear to be anticipating a few milestones for Zynerba. Results from a phase 3 trial for Zygel in fragile X syndrome are expected before the end of 2019. If the clinical trial achieves success, then a new drug application (NDA) would be filed in the first half of 2020.
The company also expects phase 2 data from a study evaluating Zygel's potential to treat development and epileptic encephalopathies in Q3 2019. Meanwhile, results from two phase 2 trials evaluating the drug candidate's potential to treat behavioral symptoms in autism spectrum disorder and 22q11.2 deletion syndrome are expected in the first half of 2020.
Zynerba exited March with $68 million in cash, and reported an operating loss of $9.5 million in Q1 2019, which suggests it should have enough cash on hand to reach its near-term milestones. Whether or not the clinical trials deliver successful outcomes is another matter, but a relatively lowly market cap of just $300 million suggests Wall Street isn't getting too excited just yet.