What happened
Shares of Zynerba Pharmaceuticals (ZYNE) 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.
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So what
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.
Now what
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.
