Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage
specialty pharmaceutical company dedicated to developing and
commercializing innovative transdermal synthetic cannabinoid
treatments, today reported financial results for the first quarter
ended March 31, 2017 and provided an overview of recent operational
highlights.
“This quarter, we were very pleased to have surpassed target
enrollment in both the STAR 1 and STOP trials for ZYN002 in adult
epilepsy and adult osteoarthritis patients, respectively, which we
believe indicates strong patient and physician interest in these
indications for ZYN002,” said Armando Anido, Chairman and Chief
Executive Officer. “We are swiftly advancing our Phase 2 programs
for ZYN002 and expect to announce top-line results for the STAR 1
trial first and then the STOP trial in the July/August timeframe,
followed by top-line results from the FAB-C study in pediatric
Fragile X syndrome patients later in the third quarter. We have
also made important progress toward initiating our Phase 1 program
for ZYN001, a pro-drug THC patch, which we expect to start by the
end of the second quarter of 2017. Momentum across our pipeline
continues to build and we remain poised for a transformational
2017.”
First Quarter 2017 and Recent Highlights
Exceeded Target Enrollment of Phase 2 STAR 1 Clinical Trial for
ZYN002 CBD Gel in Adult Epilepsy Patients
A total of 188 patients have been randomized in the Phase 2 STAR
1 double-blind, placebo-controlled clinical trial in adult patients
with refractory epilepsy, exceeding the 180-patient enrollment
target. Following randomization, patients are dosed with either 195
mg or 390 mg of CBD in ZYN002 4.2% gel or placebo daily for 12
weeks. The primary endpoint of the trial is the median reduction in
seizure frequency per 28-day period compared to baseline. The
company expects to report top-line data from this trial in
July/August 2017.
Enrollment Continues in Phase 2 STAR 2 Open-Label Extension
Clinical Trial for ZYN002 CBD Gel in Adult Epilepsy Patients
Patients who complete the STAR 1 trial may elect to enroll into
the STAR 2 trial, designed to evaluate long-term safety and
tolerability of ZYN002 CBD gel across a range of doses. In the
open-label extension study, patients receive a high or low-dose of
ZYN002 (390 mg or 195 mg of CBD in ZYN002 4.2% gel, respectively)
for up to 52 weeks. Of the 151 patients who have completed the STAR
1 trial through May 8, 2017,147 have enrolled into STAR 2.
Exceeded Target Enrollment of Phase 2 STOP Clinical Trial for
ZYN002 CBD Gel in Adult Osteoarthritis Patients
Dosing is ongoing in the randomized, double-blind,
placebo-controlled Phase 2 STOP trial in osteoarthritis of the
knee. We have exceeded the initial target enrollment of 300
patients with 320 patients randomized into one of three dosing
groups. Patients are receiving either 250 mg or 500 mg of CBD in
ZYN002 4.2% gel or placebo daily for 12 weeks. The primary
endpoint of the trial is the change from baseline in the weekly
mean of the 24-hour average worst pain score at week 12. Top-line
results are expected to be released after the STAR 1 Trial results
in July/August 2017.FAB-C Exploratory Phase 2 Clinical Trial of
ZYN002 CBD Gel in Pediatric Fragile X Syndrome Patients Remains on
Track for Top-line Data in 3Q 2017The Phase 2 exploratory FAB-C
clinical trial is designed to evaluate the safety and efficacy of
ZYN002 CBD gel in pediatric patients with Fragile X syndrome (FXS).
The primary objective is to assess intra-patient changes in
anxiety, depression and mood (as measured by the ADAMS scale)
versus baseline. The company is targeting enrollment of 16 patients
and expects to announce top-line data from the trial in the third
quarter of 2017.
Initiation of Phase 1 Programs for ZYN001 On Track for 1H
2017
By the end of the first half of this year, the company expects
to initiate Phase 1 trials of ZYN001, a patent-protected, pro-drug
of THC that enables transdermal delivery via a patch. The Phase 1
program will evaluate the safety and tolerability of ZYN001 through
single and multiple rising dose trials in normal subjects and
patients with fibromyalgia. Pending successful Phase 1 results, a
Phase 2 program for ZYN001 in fibromyalgia and neuropathic pain is
planned to start in the second half of 2017.
Strengthened Senior Management Team
In March 2017, Ken Jones, CPA was named Corporate Controller of
Zynerba. Mr. Jones brings over 30 years of experience in
financial reporting, accounting and tax functions across multiple
industries, including a combined 16 years serving as Corporate
Controller at Vitae Pharmaceuticals and UbiquiTel, Inc.
In April 2017, Ray Mannion joined Zynerba as Vice President,
Manufacturing. Mr. Mannion has spent over 35 years in international
manufacturing, operations and engineering in the pharmaceutical,
medical devices and electrical connection systems industries with
Teva Pharmaceuticals, NuPathe, Puricore, Kensey Nash Corporation,
AMP Incorporated and others.
In May 2017, Will Roberts was appointed Vice President, Investor
Relations and Corporate Communications at Zynerba. Mr. Roberts
is an experienced pharmaceutical executive with 25 years of broad
communications and scientific research experience with companies
including Adaptimmune Therapeutics, ViroPharma Incorporated and
MedImmune, Inc.
Strengthened Balance Sheet with Successful Follow-On Offering
Raising $58 Million in Gross ProceedsIn the first quarter of 2017,
the company completed a follow-on offering, selling 3,220,000
shares of our common stock at an offering price of $18.00 per
share, resulting in gross proceeds of $58.0 million. Net proceeds
received after deducting underwriting and commissions and offering
expenses were $54.2 million, which Zynerba intends to use for the
clinical development of ZYN002 and ZYN001, general research and
development, and general corporate purposes.
First Quarter 2017 Financial Results
As of March 31, 2017, cash and cash equivalents were $77.5
million, compared to $31.0 million as of December 31, 2016.
Research and development expenses for the first quarter of 2017
were $5.5 million, including stock-based compensation of $0.5
million. General and administrative expenses for the first quarter
of 2017 were $2.2 million, including stock-based compensation
expense of $0.6 million. Net loss for the first quarter of 2017 was
$7.3 million with basic and diluted net loss per share of $0.60.
Financial Outlook
The company believes that the current cash position of $77.5
million is sufficient to develop five Phase 3-ready programs and,
assuming support from the FDA to move forward, initiate at least
one Phase 3 program and fund operations and capital requirements
into 2019.
About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage
specialty pharmaceutical company focused on developing and
commercializing proprietary next-generation synthetic cannabinoid
therapeutics formulated for transdermal delivery. Zynerba is
developing therapeutic candidates based on proprietary transdermal
technologies that, if successfully developed, may allow sustained,
consistent and controlled delivery of therapeutic levels of two
cannabinoids: cannabidiol (CBD), a non-psychoactive cannabinoid,
and tetrahydrocannabinol (THC). Transdermal delivery has the
potential to reduce adverse effects associated with oral dosing.
ZYN002, the Company’s CBD gel, is the first and only synthetic CBD
formulated as a patent-protected permeation-enhanced gel. In March
2017, the Company completed enrollment in the Phase 2 STAR 1
(Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy)
clinical trial of ZYN002 CBD gel in refractory epilepsy patients
with focal seizures, the most common form of epilepsy in adults.
Also in March 2017, the Phase 2 STOP (Synthetic Transdermal
Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis)
clinical trial in patients with knee pain due to osteoarthritis was
fully enrolled. In December 2016, the Company initiated the
exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety
and Behavioral Challenges with CBD) clinical trial in children with
Fragile X syndrome (FXS). Zynerba is also developing ZYN001, which
utilizes a synthetically manufactured pro-drug of THC. A Phase 1
clinical study for ZYN001 is planned to begin by the end of the
first half of 2017. Learn more at www.zynerba.com and follow the
Company 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. For example, there can be no guarantee that the
Company will obtain approval for ZYN002 or ZYN001 from the U.S.
Food and Drug Administration (FDA) or foreign regulatory
authorities; even if ZYN002 or ZYN001 are approved, the Company may
not be able to obtain the label claims that it is seeking from the
FDA. In addition, the Company’s cash and cash equivalents may not
be sufficient to support its operating plan for as long as
anticipated. 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 success, cost and timing of
the Company’s product development activities, studies and clinical
trials; the success of competing products that are or become
available; 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 |
|
|
|
|
March 31, 2017 |
|
March 31, 2016 |
Revenue |
|
|
|
$ |
— |
|
|
$ |
7,250 |
|
Operating expenses: |
|
|
|
|
|
Research
and development |
|
|
|
|
5,491,455 |
|
|
|
2,568,989 |
|
General
and administrative |
|
|
|
|
2,211,793 |
|
|
|
1,680,130 |
|
Total
operating expenses |
|
|
|
|
7,703,248 |
|
|
|
4,249,119 |
|
Loss from
operations |
|
|
|
|
(7,703,248 |
) |
|
|
(4,241,869 |
) |
Other
income (expense): |
|
|
|
|
|
Interest
income |
|
|
|
|
76,885 |
|
|
|
12,377 |
|
Foreign
exchange gain (loss) |
|
|
|
|
367,342 |
|
|
|
(23,148 |
) |
Total
other income (expense) |
|
|
|
|
444,227 |
|
|
|
(10,771 |
) |
Loss
before income taxes |
|
|
|
|
(7,259,021 |
) |
|
|
(4,252,640 |
) |
Income
tax expense |
|
|
|
|
— |
|
|
|
28,734 |
|
Net
loss |
|
|
|
$ |
(7,259,021 |
) |
|
$ |
(4,281,374 |
) |
|
|
|
|
|
|
Net loss per share -
basic and diluted |
|
|
|
$ |
(0.60 |
) |
|
$ |
(0.49 |
) |
|
|
|
|
|
|
Basic and
diluted weighted average shares outstanding |
|
12,067,453 |
|
|
|
8,823,951 |
|
|
|
|
|
|
|
Non-cash stock-based
compensation included above: |
|
|
|
|
|
Research
and development |
|
|
|
$ |
541,845 |
|
|
$ |
248,732 |
|
General
and administrative |
|
|
|
|
646,854 |
|
|
|
515,067 |
|
Total |
|
|
|
$ |
1,188,699 |
|
|
$ |
763,799 |
|
ZYNERBA PHARMACEUTICALS, INC. |
CONSOLIDATED BALANCE SHEETS |
(Unaudited) |
|
|
|
|
|
|
|
|
|
March 31, 2017 |
|
December 31, 2016 |
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
|
$ |
77,493,189 |
|
|
$ |
30,965,791 |
|
Incentive
and tax receivables |
|
|
|
3,867,811 |
|
|
|
3,613,943 |
|
Prepaid
expenses and other current assets |
|
|
|
2,002,966 |
|
|
|
1,830,958 |
|
Total
current assets |
|
|
|
83,363,966 |
|
|
|
36,410,692 |
|
Property
and equipment, net |
|
|
|
198,197 |
|
|
|
143,382 |
|
Incentive and tax receivables |
|
|
|
1,141,533 |
|
|
|
— |
|
Other
assets |
|
|
|
200 |
|
|
|
200 |
|
Total
assets |
|
|
$ |
84,703,896 |
|
|
$ |
36,554,274 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
|
|
$ |
996,866 |
|
|
$ |
1,848,084 |
|
Accrued
expenses |
|
|
|
5,110,490 |
|
|
|
4,284,907 |
|
Deferred
grant revenue |
|
|
|
833,975 |
|
|
|
833,975 |
|
Total
current liabilities |
|
|
|
6,941,331 |
|
|
|
6,966,966 |
|
Stockholders' equity: |
|
|
|
|
|
Common
stock |
|
|
|
13,215 |
|
|
|
9,995 |
|
Additional paid-in capital |
|
|
|
130,976,933 |
|
|
|
75,545,875 |
|
Accumulated deficit |
|
|
|
(53,227,583 |
) |
|
|
(45,968,562 |
) |
Total
stockholders' equity |
|
|
|
77,762,565 |
|
|
|
29,587,308 |
|
Total
liabilities and stockholders' equity |
|
|
$ |
84,703,896 |
|
|
$ |
36,554,274 |
|
|
|
|
|
|
|
Investor Contacts
Jim Fickenscher, CFO and VP Corporate Development
Zynerba Pharmaceuticals
484.581.7483
fickenscherj@zynerba.com
Will Roberts, VP Investor Relations and Corporate Communications
Zynerba Pharmaceuticals
484.581.7489
robertsw@zynerba.com
Kimberly Minarovich
Argot Partners
212.600.1902
kimberly@argotpartners.com
Media Contact
Eliza Schleifstein
Argot Partners
973.361.1546
eliza@argotpartners.com
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