On August 1st, Zynerba Pharmaceuticals (NASDAQ:ZYNE) came out with the company's financial results for the second quarter of 2017. As Zynerba is a clinical stage pharmaceutical company without any commercialized products (and therefore without any revenue), the focus of their earnings release falls on two things; cash (to gauge how long the company has before they may need to raise capital) and updates on the company's clinical trials. That said, here are 7 things (not in any particular order) that current and prospective investors in Zynerba should pay attention to from the company's recent earnings release and pipeline update:
At the end of the second quarter (June 30th) of 2017, Zynerba had $70.2 million in cash and cash equivalents. The company believes that this cash position is sufficient to develop five Phase-3 ready programs, initiate at least one phase 3 program (assuming support from the FDA to move forward) and fund operations and capital requirements into 2019.
In the second quarter of 2017, research and development expenses were $5.7 million, including 0.6 million of non-cash, stock based compensation. General and administrative expenses for Q2'17 were $2.6 million, including stock-based compensation expense of $0.8 million.
Net loss in Q2'17 was $8.3 million, or $0.64 per basic and diluted share.
Zynerba completed dosing in their Phase 2 STAR 1 clinical trial of ZYN002 Cannabidiol (CBD) Gel in adult epilepsy patients. A total of 188 patients were randomized and dosed with either 195 mg or 390 mg of CBD in ZYN002 4.2% gel or placebo daily for 12 weeks. The primary endpoint of the trial is the median reduction in seizure frequency per 28-day period compared to baseline. Top line data from this trial is expected soon.
The company also completed dosing in their Phase 2 STOP Clinical Trial for ZYN002 CBD Gel in adult osteoarthritis patients. A total of 320 patients were randomized into one of three dosing groups, receiving either 250 mg or 500 mg of CBD in ZYN002 4.2% gel or placebo daily for 12 weeks. The primary endpoint of this trial is the change from baseline in the weekly mean of the 24-hour average worst pain score at week 12. Results are expected later this month.
Zynerba has completed enrollment in their FAB-C Exploratory Phase 2 Clinical Trial of ZYN002 CBD Gel in pediatric Fragile X Syndrome patients, enrolling 20 patients. The objective of the study is to assess changes in anxiety, depression and mood versus baseline. The U.S. FDA has granted an orphan-drug designation to ZYN002 CBD gel for the treatment of Fragile X syndrome.
The company has initiated a Phase 1 study to assess the safety, tolerability and pharmacokinetics of ZYN001, a patented, pro-drug of THC delivered via a patch. Several formulations and patch wear times will be assessed in up to 48 healthy subjects.
On this news, shares of Zynerba finished Tuesday's trading session higher by 6.81%. Year-to-date, Zynerba shares have fallen more than 3%.
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