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Zynerba Pharmaceuticals Reports Third Quarter 2016 Financial Results and Operational Highlights
“The third quarter was marked by significant advancement of our lead development candidate, ZYN002 CBD gel,” said
Highlights from the Third Quarter 2016 & Recent Developments
Began Dosing of First Patients in STAR 1 Clinical Trial for the Treatment of Adult Epilepsy
- In August, Zynerba began dosing patients in STAR 1 (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy), a randomized, multi-center, multi-dose Phase 2 clinical trial that will evaluate 97.5 mg or 195 mg of CBD in ZYN002 4.2% gel or placebo every 12 hours in approximately 180 adult refractory epilepsy patients with focal seizures. The primary endpoint will assess the median percentage change in seizure frequency over the 12-week treatment period versus baseline. Safety and tolerability will also be assessed.
Initiated STAR 2 Open-Label Extension for the Treatment of Adult Epilepsy
- In November, Zynerba initiated an open-label clinical trial in adult epilepsy patients with refractory focal seizures who complete the STAR 1 study. Patients will receive treatment with ZYN002 for up to 52-weeks. The open-label clinical trial is designed to support long-term safety and tolerability of ZYN002 CBD gel.
Launched Phase 2 STOP Clinical Trial for the Treatment of Osteoarthritis (OA)
- In September, Zynerba initiated the STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis) trial, a multi-center, placebo-controlled, Phase 2 clinical trial that will evaluate 125 mg or 250 mg of CBD in ZYN002 4.2% gel or placebo twice daily in approximately 300 patients with knee pain due to OA. The primary endpoint is the change from baseline in the weekly mean of the 24-hour average worst pain score.
- In October, the Company announced that it is working with
LTS Lohmann Therapie-Systeme AG, a market leader in transdermal therapeutic solutions, to optimize the formulation of ZYN001 into a state of the art drug-adhesive matrix transdermal patch. ZYN001 is a patent-protected pro-drug of THC being developed for the treatment of fibromyalgia and peripheral neuropathic pain.
Upcoming Events in the Fourth Quarter of 2016
- At the
American Society of Epilepsymeeting to be held in Houston, TX, from December 2-6, Zynerba will present two posters highlighting safety and tolerability and cognitive and mood effects for ZYN002.
- Zynerba will host a Clinical Research Day on
December 15th in New York Cityfeaturing distinguished experts who will discuss the role of cannabinoid-based treatments in epilepsy, osteoarthritis and Fragile X syndrome.
Upcoming Clinical Milestones
ZYN002 CBD Gel
- Zynerba plans to initiate a third Phase 2 clinical trial of ZYN002 in patients with Fragile X syndrome (FXS) by year-end 2016.
- Top line results of three Phase 2 clinical trials in refractory epilepsy, OA and FXS are expected in the first half of 2017.
ZYN001 pro-drug of THC Patch
- Zynerba expects to initiate Phase 1 clinical trials to evaluate the pharmacokinetic profile and tolerability of ZYN001 in healthy volunteers in the first half of 2017.
- Phase 2 clinical trials in the treatment of fibromyalgia and peripheral neuropathic pain are planned to begin in the second half of 2017.
Third Quarter 2016 Financial Results
Research and development expenses for the third quarter of 2016 were
Management believes that the Company’s available funds, including proceeds from the sale of common stock received through
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the
|ZYNERBA PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three months ended||Nine months ended|
|September 30, 2016||September 30, 2015||September 30, 2016||September 30, 2015|
|Research and development||4,504,097||2,271,968||11,880,264||4,136,659|
|General and administrative||1,493,461||1,922,755||4,649,948||3,208,003|
|Total operating expenses||5,997,558||4,194,723||16,530,212||7,344,662|
|Loss from operations||(5,997,558||)||(3,995,316||)||(16,522,962||)||(7,115,037||)|
|Other income (expense):|
|Foreign exchange loss||(6,270||)||-||(49,668||)|
|Total other income (expense)||16,477||1,572||3,575||2,948|
|Loss before income taxes||(5,981,081||)||(3,993,744||)||(16,519,387||)||(7,112,089||)|
|Income tax benefit||-||-||(27,543||)||-|
|Net loss per share - basic and diluted||$||(0.67||)||$||(0.66||)||$||(1.86||)||$||(2.37||)|
|Basic and diluted weighted average shares outstanding||8,912,508||6,045,211||8,865,854||2,998,480|
|Non-cash stock-based compensation included above:|
|Research and development||$||292,385||$||297,169||$||916,036||$||297,169|
|General and administrative||513,019||539,655||1,465,906||539,655|
|ZYNERBA PHARAMCEUTICALS, INC.|
|CONSOLIDATED BALANCE SHEETS|
|September 30, 2016||December 31, 2015|
|Cash and cash equivalents||$||31,780,773||$||41,513,060|
|Incentive and tax receivables||2,281,205||356,718|
|Prepaid expenses and other current assets||1,464,564||1,545,917|
|Total current assets||35,526,542||43,415,695|
|Property and equipment, net||304,141||227,646|
|Liabilities and Stockholders' Equity|
|Deferred grant revenue||370,575||841,225|
|Total current liabilities||4,947,105||3,937,617|
|Deferred grant revenue, long-term||463,400||—|
|Additional paid-in capital||69,946,049||62,276,779|
|Total stockholders' equity||30,883,778||39,705,924|
|Total liabilities and stockholders' equity||$||36,294,283||$||43,643,541|
Jim Fickenscher, CFO and VP, Corporate Development Zynerba Pharmaceuticals484.581.7483 Fickenscherj@zynerba.com Kimberly Minarovich Argot Partners212.600.1902 email@example.com Media Contact Eliza Schleifstein Argot Partners973.361.1546 firstname.lastname@example.org