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Zynerba Pharmaceuticals Reports Second Quarter 2018 Financial Results and Operational Highlights
“Our strong clinical and corporate momentum continued over the past few months, including initiating CONNECT-FX, a pivotal study in Fragile X syndrome, and the BELIEVE 1 study in developmental and epileptic encephalopathies,” said
Second Quarter 2018 and Recent Highlights
ZYN002 in Fragile X Syndrome (FXS)
Initiated CONNECT-FX, a Pivotal Clinical Trial of ZYN002 in FXS; Enrollment is Ongoing with Topline Results Expected in the Second Half of 2019
The Company initiated and is currently enrolling patients 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 study will enroll approximately 200 male and female patients from approximately 20 clinical sites in the U.S., Australia, and
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, after 12 weeks of treatment with ZYN002, patients achieved a statistically significant mean improvement of 58% (n=12; p=0.0040) vs. baseline in the social avoidance subscale of the ABC-CFXS assessment. After 38 weeks of treatment with ZYN002, patients achieved a statistically significant mean improvement of 75% (n=9; p=0.0013) vs. baseline as measured by the same assessment. ZYN002 was well tolerated and no clinically meaningful negative trends in vital signs, ECG, or clinical safety laboratories, including liver function tests (LFTs), were observed.
ZYN002 in Developmental and Epileptic Encephalopathies (DEE)
Enrollment Ongoing in the Phase 2 BELIEVE 1 Clinical Trial in DEE; Topline Results Expected in 2019
Zynerba initiated 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), a six-month multi-dose Phase 2 clinical trial evaluating the efficacy and safety of ZYN002 in approximately 50 children and adolescents with DEE. The primary efficacy assessment is change in seizure frequency. DEE is a group of epilepsy syndromes that involve significant developmental impairment or regression of developmental progress, and are highly resistant to treatment. The category includes a number of syndromes, including Doose, Dravet, Lennox-Gastaut, and West, among others.
ZYN002 in Focal Epilepsy
Presented Clinical Data from the STAR 2 Open Label Study of ZYN002 in Patients with Refractory Focal Seizures at the 2018
Adult refractory focal seizure patients administering transdermal ZYN002 in STAR 1 and STAR 2 showed continued reductions in focal seizures compared to baseline through 12 months of treatment. ZYN002 was well tolerated. These data continue to suggest the potential for ZYN002 in the treatment of epilepsy, and provide insight into the design of the upcoming double blind, placebo controlled Phase 2b study, which the Company expects to initiate in the second half of 2018.
Corporate
Strengthened Balance Sheet with Successful Follow-On Offering Raising
The Company closed a follow-on offering on
Second Quarter 2018 Financial Results
As of
Financial Outlook
The Company’s cash and cash equivalent position as of
Conference call information
Zynerba management will host a live conference call and webcast today at 8:30 am Eastern Time to provide a corporate update. The call can be accessed by dialing (866) 573-0180 (U.S. and
About
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 (unaudited) |
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Three months ended June 30, | Six months ended June 30, | ||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | $ | 8,533,466 | $ | 5,732,797 | $ | 17,508,979 | $ | 11,224,252 | |||||||||
General and administrative | 3,436,340 | 2,632,857 | 6,856,963 | 4,844,650 | |||||||||||||
Total operating expenses | 11,969,806 | 8,365,654 | 24,365,942 | 16,068,902 | |||||||||||||
Loss from operations | (11,969,806 | ) | (8,365,654 | ) | (24,365,942 | ) | (16,068,902 | ) | |||||||||
Other income (expense): | |||||||||||||||||
Interest income | 186,304 | 124,535 | 361,488 | 201,420 | |||||||||||||
Foreign exchange (loss) gain | (223,731 | ) | (82,360 | ) | (309,113 | ) | 284,982 | ||||||||||
Total other income (expense) | (37,427 | ) | 42,175 | 52,375 | 486,402 | ||||||||||||
Net loss | $ | (12,007,233 | ) | $ | (8,323,479 | ) | $ | (24,313,567 | ) | $ | (15,582,500 | ) | |||||
Net loss per share - basic and diluted | $ | (0.89 | ) | $ | (0.64 | ) | $ | (1.80 | ) | $ | (1.24 | ) | |||||
Basic and diluted weighted average shares outstanding | 13,504,485 | 13,052,294 | 13,486,191 | 12,562,594 | |||||||||||||
Non-cash stock-based compensation included above: | |||||||||||||||||
Research and development | $ | 776,386 | $ | 588,713 | $ | 1,524,630 | $ | 1,130,558 | |||||||||
General and administrative | 979,473 | 766,661 | 1,918,253 | 1,413,515 | |||||||||||||
Total | $ | 1,755,859 | $ | 1,355,374 | $ | 3,442,883 | $ | 2,544,073 | |||||||||
ZYNERBA PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS (unaudited) |
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June 30, 2018 | December 31, 2017 | ||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 43,115,051 | $ | 62,510,277 | |||||
Incentive and tax receivables | 3,961,748 | 3,983,604 | |||||||
Prepaid expenses and other current assets | 1,962,291 | 1,733,701 | |||||||
Total current assets | 49,039,090 | 68,227,582 | |||||||
Property and equipment, net | 273,784 | 164,527 | |||||||
Incentive and tax receivables | 2,056,498 | — | |||||||
Other assets | 834,174 | 662,200 | |||||||
Total assets | $ | 52,203,546 | $ | 69,054,309 | |||||
Liabilities and Stockholders' Equity | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 6,379,750 | $ | 3,355,255 | |||||
Accrued expenses | 4,910,918 | 3,915,491 | |||||||
Deferred grant revenue | — | 171,975 | |||||||
Total current liabilities | 11,290,668 | 7,442,721 | |||||||
Deferred grant revenue, long-term | 833,974 | 662,000 | |||||||
Total liabilities | 12,124,642 | 8,104,721 | |||||||
Stockholders' equity: | |||||||||
Common stock | 13,561 | 13,554 | |||||||
Additional paid-in capital | 142,359,776 | 138,916,900 | |||||||
Accumulated deficit | (102,294,433 | ) | (77,980,866 | ) | |||||
Total stockholders' equity | 40,078,904 | 60,949,588 | |||||||
Total liabilities and stockholders' equity | $ | 52,203,546 | $ | 69,054,309 | |||||
Investor Contacts
484.581.7483
fickenscherj@zynerba.com
484.581.7489
robertsw@zynerba.com
Source: Zynerba Pharmaceuticals, Inc.