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Zynerba Pharmaceuticals Reports Third Quarter 2018 Financial Results and Operational Highlights
“The momentum we established in the first half of 2018 continued through the third quarter,” said
Third Quarter 2018 and Recent Highlights
ZYN002 in Fragile X Syndrome (FXS)
Initiated CONNECT-FX, a Pivotal Clinical Trial of ZYN002 in FXS
Enrollment is progressing in CONNECT-FX (Clinical study of Cannabidiol (CBD) in Children and Adolescents with Fragile X), a pivotal, multi-national, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of ZYN002 in three to 17-year old FXS patients with full mutation of the FMR1 gene. The primary endpoint is the change from baseline to the end of the treatment period in the Aberrant Behavior Checklist-Community FXS Specific (ABC-CFXS) Social Avoidance subscale. Top line data are expected in the second half of 2019; there are currently no approved products indicated for FXS.
Presented New Data at the 16th
Zynerba presented new data demonstrating that treatment with ZYN002 improved core behavioral symptoms of FXS with statistical significance versus baseline across multiple measures of efficacy at week 12, and these improvements were sustained through 38 weeks of treatment. For example, significant improvements vs. baseline in social avoidance as measured by the ABC-CFXS were demonstrated at 12 weeks (58%; p=0.0040) and 38 weeks (75%; p=0.0013) of treatment with ZYN002.
Poster Accepted for Presentation at the 57th Annual Meeting of the
The poster presentation is on
ZYN002 in Developmental and Epileptic Encephalopathies (DEE)
Enrollment Nearing Completion in the Phase 2 BELIEVE 1 Clinical Trial in DEE; Topline Results Expected in 2019
Enrollment is progressing in BELIEVE 1 (Open Label Study to Assess the Safety and Efficacy of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Developmental and Epileptic Encephalopathy). This is a six-month multi-dose Phase 2 clinical trial evaluating the efficacy and safety of ZYN002 in approximately 50 children and adolescents with DEE, a category of epilepsy syndromes that involve significant developmental impairment or regression of developmental progress, and are highly resistant to treatment. The Company expects to complete enrollment by year-end 2018.
ZYN002 in Focal Epilepsy
STAR-2 Long-Term Data Accepted for Poster Presentation at the 2018 Annual Meeting of the
The poster presentation is on
The Company improved its capital structure through a completed follow-on offering, resulting in net proceeds of $29.9 million after deducting underwriting discounts and commissions and offering expenses.
Third Quarter 2018 Financial Results
The Company’s cash and cash equivalent position as of
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company’s ability to obtain additional funding to support its clinical development programs; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; clinical results for the Company’s product candidates may not be replicated or continue to occur in additional trials and may not otherwise support further development in a specified indication or at all; actions or advice of the
|ZYNERBA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
|Three months ended September 30,||Nine months ended September 30,|
|Research and development||$||4,859,902||$||5,753,764||$||22,368,881||$||16,978,016|
|General and administrative||3,125,780||2,795,839||9,982,743||7,640,489|
|Total operating expenses||7,985,682||8,549,603||32,351,624||24,618,505|
|Loss from operations||(7,985,682||)||(8,549,603||)||(32,351,624||)||(24,618,505||)|
|Other income (expense):|
|Foreign exchange (loss) gain||(99,897||)||76,468||(409,010||)||361,450|
|Total other income (expense)||178,317||238,398||230,692||724,800|
|Net loss per share - basic and diluted||$||(0.47||)||$||(0.63||)||$||(2.21||)||$||(1.87||)|
|Basic and diluted weighted average shares outstanding||16,587,353||13,098,914||14,531,272||12,743,332|
|Non-cash stock-based compensation included above:|
|Research and development||$||743,153||$||591,898||$||2,267,783||$||1,722,456|
|General and administrative||841,077||1,130,745||2,759,330||2,544,260|
|ZYNERBA PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
|September 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||66,177,376||$||62,510,277|
|Incentive and tax receivables||3,095,195||3,983,604|
|Prepaid expenses and other current assets||3,413,029||1,733,701|
|Total current assets||72,685,600||68,227,582|
|Property and equipment, net||248,741||164,527|
|Liabilities and Stockholders' Equity|
|Deferred grant revenue||171,975||171,975|
|Total current liabilities||9,141,067||7,442,721|
|Deferred grant revenue, long-term||—||662,000|
|Additional paid-in capital||173,877,449||138,916,900|
|Total stockholders' equity||63,793,274||60,949,588|
|Total liabilities and stockholders' equity||$||72,934,341||$||69,054,309|
Source: Zynerba Pharmaceuticals, Inc.