Reported final results from a Phase 1 Single Rising Dose trial: These results confirmed initial findings that ZYN002 CBD gel was safe and well tolerated in healthy volunteers and patients with epilepsy across a wide range of doses.
Anticipated 2016 Clinical Milestones
ZYN002, synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery
Zynerba plans to initiate additional Phase 2 trials in osteoarthritis (OA) and Fragile X syndrome (FXS) in the second half of 2016.
ZYN001, pro-drug of THC that enables transdermal delivery via patch
In the second half of 2016, Zynerba expects to initiate Phase 1 studies to evaluate the PK profile and tolerability of ZYN001 in healthy volunteers.
Second Quarter 2016 Financial Results
As of June 30, 2016, cash and cash equivalents were $32.1 million, compared to $36.8 million as of March 31, 2016.
Research and development expenses for the second quarter of 2016 were $4.8 million, including stock-based compensation of $0.4 million. General and administrative expenses for the second quarter of 2016 were $1.5 million, including stock-based compensation expense of $0.4 million. Net loss for the second quarter of 2016 was $6.2 million with basic and diluted net loss per share of $0.70.
Financial Outlook
Based on current operating plans, the Company expects that its existing cash and cash equivalents will fund its research and development programs and operations through 2017, which will include Phase 2 top line results for the five indications being evaluated for ZYN002 and ZYN001.
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