Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in
innovative pharmaceutically-produced transdermal cannabinoid
therapies for rare and near-rare neuropsychiatric disorders, today
reported financial results for the third quarter
ended September 30, 2018 and provided an overview of recent
operational highlights.
“The momentum we established in the first half of
2018 continued through the third quarter,” said Armando Anido,
Chairman and Chief Executive Officer of Zynerba. “We began
enrolling patients into CONNECT-FX, our pivotal study in Fragile X
syndrome and we expect to complete enrollment in BELIEVE-1, our
Phase 2 study in developmental and epileptic encephalopathies,
before year end. With our third quarter 2018 follow-on offering, we
are well capitalized and expect our current cash to take us through
the presentation of top line data for both of these studies.”
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 NFXF International Fragile X
Conference from the Ongoing Open Label FAB-C Phase 2 Study of
ZYN002
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 American College of Neuropsychopharmacology (ACNP)
The poster presentation is on Wednesday, December 12, 2018 in
poster session III from 5:30 PM to 7:30 PM EST. The meeting will be
at the Diplomat Beach Resort in Hollywood, Florida from December 9
through 12, 2018.
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 American Epilepsy Society (AES)
The poster presentation is on Sunday, December 2, 2018 in poster
session 2 from 12:00 PM to 2:00 PM EST. The meeting will be at the
Ernest N. Morial Convention Center in New Orleans, LA from
November 30 to December 4, 2018. The poster will highlight efficacy
and safety data from adult patients with refractory focal epilepsy
receiving treatment with ZYN002 for up to 18 months. These data
contribute to the design of the upcoming double blind,
placebo-controlled Phase 2b study, which the Company expects to
initiate in the fourth quarter of 2018.
Corporate
Completed Successful $30 Million Follow-on Offering
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
As of September 30, 2018, cash and cash equivalents were $66.2
million, compared to $62.5 million as of December 31, 2017.
Research and development expenses for the third quarter of 2018
were $4.9 million, including stock-based compensation of $0.7
million. General and administrative expenses for the third quarter
of 2018 were $3.1 million, including stock-based compensation
expense of $0.8 million. Net loss for the third quarter of 2018 was
$7.8 million with basic and diluted net loss per share of
$(0.47).
Financial OutlookThe Company’s cash and cash
equivalent position as of September 30, 2018 was $66.2 million,
which management believes is sufficient to fund operations and
capital requirements into the first half of 2020.
About Zynerba Pharmaceuticals, Inc. Zynerba
Pharmaceuticals is the leader in pharmaceutically-produced
transdermal cannabinoid therapies for rare and near-rare
neuropsychiatric disorders. We are committed to improving the lives
of patients and their families living with severe, chronic health
conditions including Fragile X syndrome and refractory epilepsies.
Learn more at www.zynerba.com and follow us on Twitter at
@ZynerbaPharma
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 U.S. Food
and Drug Administration and foreign regulatory agencies may affect
the design, initiation, timing, continuation and/or progress of
clinical trials or result in the need for additional clinical
trials; the Company’s ability to obtain and maintain regulatory
approval for its product candidates, and the labeling under any
such approval; the Company’s reliance on third parties to assist in
conducting pre-clinical and clinical trials for its product
candidates; delays, interruptions or failures in the manufacture
and supply of the Company’s product candidates the Company’s
ability to commercialize its product candidates; the size and
growth potential of the markets for the Company’s product
candidates, and the Company’s ability to service those markets; the
Company’s ability to develop sales and marketing capabilities,
whether alone or with potential future collaborators; the rate and
degree of market acceptance of the Company’s product candidates;
and the Company’s expectations regarding its ability to obtain and
adequately maintain sufficient intellectual property protection for
its product candidates. This list is not exhaustive and these and
other risks are described in the Company’s periodic reports,
including the annual report on Form 10-K, quarterly reports on Form
10-Q and current reports on Form 8-K, filed with or furnished to
the Securities and Exchange Commission and available
at www.sec.gov. Any forward-looking statements that the
Company makes in this press release speak only as of the date of
this press release. The Company assumes no obligation to update
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
|
|
ZYNERBA PHARMACEUTICALS,
INC.CONSOLIDATED STATEMENTS OF
OPERATIONS(unaudited) |
|
|
|
|
|
|
|
|
|
Three months ended September
30, |
|
Nine months ended September
30, |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
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): |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
278,214 |
|
|
|
161,930 |
|
|
|
639,702 |
|
|
|
363,350 |
|
|
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 |
|
$ |
(7,807,365 |
) |
|
$ |
(8,311,205 |
) |
|
$ |
(32,120,932 |
) |
|
$ |
(23,893,705 |
) |
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
Total |
|
$ |
1,584,230 |
|
|
$ |
1,722,643 |
|
|
$ |
5,027,113 |
|
|
$ |
4,266,716 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ZYNERBA PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE
SHEETS(unaudited) |
|
|
|
|
|
|
|
|
|
September 30, 2018 |
|
December 31, 2017 |
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
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 |
|
|
Other
assets |
|
|
— |
|
|
|
662,200 |
|
|
Total
assets |
|
$ |
72,934,341 |
|
|
$ |
69,054,309 |
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
|
$ |
3,553,350 |
|
|
$ |
3,355,255 |
|
|
Accrued
expenses |
|
|
5,415,742 |
|
|
|
3,915,491 |
|
|
Deferred
grant revenue |
|
|
171,975 |
|
|
|
171,975 |
|
|
Total
current liabilities |
|
|
9,141,067 |
|
|
|
7,442,721 |
|
|
Deferred
grant revenue, long-term |
|
|
— |
|
|
|
662,000 |
|
|
Total
liabilities |
|
|
9,141,067 |
|
|
|
8,104,721 |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
Common
stock |
|
|
17,623 |
|
|
|
13,554 |
|
|
Additional paid-in capital |
|
|
173,877,449 |
|
|
|
138,916,900 |
|
|
Accumulated deficit |
|
|
(110,101,798 |
) |
|
|
(77,980,866 |
) |
|
Total
stockholders' equity |
|
|
63,793,274 |
|
|
|
60,949,588 |
|
|
Total
liabilities and stockholders' equity |
|
$ |
72,934,341 |
|
|
$ |
69,054,309 |
|
|
|
|
|
|
|
|
Investor Contacts
Jim Fickenscher, CFO and VP Corporate DevelopmentZynerba
Pharmaceuticals484.581.7483fickenscherj@zynerba.com
Will Roberts, VP Investor Relations and Corporate
CommunicationsZynerba
Pharmaceuticals484.581.7489robertsw@zynerba.com
Zynerba Pharmaceuticals (NASDAQ:ZYNE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Zynerba Pharmaceuticals (NASDAQ:ZYNE)
Historical Stock Chart
From Apr 2023 to Apr 2024