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 first quarter ended March 31,
2022, and provided an overview of recent operational highlights and
a pipeline update.
“We are excited by the opportunities ahead for Zygel in FXS and
other rare and near-rare neuropsychiatric indications, and have
made meaningful progress since the beginning of this year,” said
Armando Anido, Chairman and Chief Executive Officer of Zynerba.
“Specifically, during the first quarter of 2022, we continued to
enroll patients in our Phase 3 pivotal trial in patients with FXS,
completed enrollment in our Phase 2 trial in patients with 22q11.2
deletion syndrome and advanced toward submission of an
Investigational New Drug application for a Phase 3 trial in
patients with ASD that we expect to initiate in the second half of
2022.”
Operational Highlights and Pipeline Update
Zygel in Fragile X Syndrome (FXS)
- The Company continues to expect
topline results from RECONNECT, a confirmatory pivotal Phase 3
trial of Zygel in patients with FXS, in the second half of 2023.
The Company believes that the results from RECONNECT, if positive,
will be sufficient to support the submission of a New Drug
Application (NDA) for Zygel in patients with FXS.
- During the first quarter of 2022,
Zynerba received orphan drug designation for cannabidiol, the
active ingredient in Zygel, for the treatment of FXS from the
European Commission. As previously announced, the Company believes,
based on the scientific advice of the European Medicines Agency,
that the successful completion of the current development program
for Zygel in FXS will satisfy the requirements of a marketing
authorization application in the European Union.
- Presented data at the 2022 Society
of Biological Psychiatry (SOBP) Annual Meeting in April and the
2022 International Society for Autism Research (INSAR) Annual
Meeting in May demonstrating that in the long-term safety and
efficacy study of Zygel in children and adolescents with FXS,
improvement was seen in Social Avoidance in the full population,
with the greatest improvement in patients with complete methylation
of the FMR1 gene. Patients with complete methylation, who match the
primary efficacy population in the ongoing confirmatory trial,
RECONNECT, achieved and maintained meaningful change in Social
Avoidance, supporting design enhancements for RECONNECT. (Poster
and Presentation)
Zygel in 22q11.2 Deletion Syndrome (22q)
- In the first quarter of 2022, the
Company completed enrollment for the 14-week open-label Phase 2
INSPIRE trial in children and adolescents with genetically
confirmed 22q. The Company continues to expect topline data from
INSPIRE mid-year 2022. A total of 20 patients have been enrolled in
the INSPIRE trial.
- The Company plans to move forward in
22q as an orphan indication pending results from the INSPIRE trial,
and subsequent discussion with the U.S. Food and Drug
Administration (FDA) on the regulatory path forward. The Company
has previously received orphan drug designation from the FDA for
cannabidiol, the active ingredient in Zygel, for the treatment of
22q.
Zygel in Autism Spectrum Disorder (ASD)
- The Company is finalizing the Phase
3 study protocol and will submit an Investigational New Drug
application to the FDA prior to commencing the pivotal program. The
Company expects to initiate the first of two Phase 3 trials in
patients with ASD in the second half of 2022.
- As previously announced, earlier
discussions with the FDA included agreement on utilizing the
irritability subscale of the Aberrant Behavior Checklist –
Community (ABC-C) as the primary endpoint to support an indication
for the treatment of irritability in ASD. This is the same primary
endpoint utilized in the pivotal trials for the two existing FDA
approved treatments for ASD.
First Quarter 2022 Financial Results
Research and development expenses were $5.1 million for the
first quarter of 2022, including stock-based compensation of $0.5
million. General and administrative expenses were $3.8 million in
the first quarter of 2022, including stock-based compensation
expense of $0.6 million. Net loss for the first quarter of 2022 was
$8.5 million, with basic and diluted loss per share of $(0.21).
Financial Outlook
As of March 31, 2022, cash and cash equivalents were $69.7
million, compared to $67.8 million as of December 31, 2021. On May
11, 2021, the Company entered into a Controlled Equity OfferingSM
Sales Agreement, or the 2021 Sales Agreement”, with Cantor
Fitzgerald & Co., Canaccord Genuity, LLC, H.C. Wainwright &
Co. LLC and Ladenburg Thalmann & Co. Inc., as sales agents,
pursuant to which the Company may sell, from time to time, up to
$75.0 million of its common stock. In the first quarter of 2022,
the Company sold and issued 857,060 shares of its common stock
under the 2021 Sales Agreement in the open market resulting in
gross proceeds of $1.8 million and net proceeds of $1.6 million,
after deducting commissions and offering expenses. From April 1,
2022 through May 13, 2022, the Company sold and issued 297,362
shares of its common stock under the 2021 Sales Agreement in the
open market resulting in gross proceeds and net proceeds of $0.6
million, after deducting commissions and offering expenses.
During the three months ended March 31, 2022, the Company
received a payment of $8.0 million from the Australian Tax Office
for research and development incentives for the years ended
December 31, 2018, 2019 and 2020.
Management believes that the Company’s cash and cash equivalents
are sufficient to fund operations and capital requirements into the
second half of 2023.
About Zygel
Zygel is the first and only pharmaceutically-manufactured
cannabidiol formulated as a patent-protected permeation-enhanced
clear gel, designed to provide controlled drug delivery into the
bloodstream transdermally (i.e. through the skin). Recent studies
suggest that cannabidiol may modulate the endocannabinoid system
and improve certain behavioral symptoms associated with
neuropsychiatric conditions. Zygel is an investigational drug
product in development for the potential treatment of behavioral
symptoms associated with Fragile X syndrome (FXS), autism spectrum
disorder (ASD), and 22q11.2 deletion syndrome (22q). The Company
has received orphan drug designation for cannabidiol, the active
ingredient in Zygel, from the FDA and the European Commission in
the treatment of FXS and by the FDA for the treatment of 22q.
Additionally, Zygel has been designated a Fast Track development
program for treatment of behavioral symptoms of FXS.
About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals is the leader in innovative
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,
autism spectrum disorder, and 22q11.2 deletion syndrome. 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 expectations, projections and
estimates regarding expenses, future revenue, capital requirements,
incentive and other tax credit eligibility, collectability and
timing, and availability of and the need for additional financing;
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; the Company’s expectations regarding its ability to
obtain and adequately maintain sufficient intellectual property
protection for its product candidates; and the extent to which
health epidemics and other outbreaks of communicable diseases,
including COVID-19, could disrupt our operations or adversely
affect our business and financial conditions. 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, |
|
|
|
2022 |
|
|
|
2021 |
|
|
Operating
expenses: |
|
|
|
|
Research and development |
$ |
5,146,605 |
|
|
$ |
4,609,010 |
|
|
General and administrative |
|
3,757,310 |
|
|
|
3,275,797 |
|
|
Total operating expenses |
|
8,903,915 |
|
|
|
7,884,807 |
|
|
Loss from operations |
|
(8,903,915 |
) |
|
|
(7,884,807 |
) |
|
Other income
(expense): |
|
|
|
|
Interest income |
|
96,044 |
|
|
|
5,633 |
|
|
Foreign exchange gain (loss) |
|
317,252 |
|
|
|
(82,454 |
) |
|
Total other income (expense) |
|
413,296 |
|
|
|
(76,821 |
) |
|
Net loss |
$ |
(8,490,619 |
) |
|
$ |
(7,961,628 |
) |
|
|
|
|
|
|
Net loss per
share - basic and diluted |
$ |
(0.21 |
) |
|
$ |
(0.20 |
) |
|
|
|
|
|
|
Basic and
diluted weighted average shares outstanding |
|
40,304,484 |
|
|
|
40,065,715 |
|
|
|
|
|
|
|
Non-cash
stock-based compensation included above: |
|
|
|
|
Research and development |
$ |
529,496 |
|
|
$ |
619,391 |
|
|
General and administrative |
|
630,986 |
|
|
|
645,446 |
|
|
Total |
$ |
1,160,482 |
|
|
$ |
1,264,837 |
|
|
|
|
|
|
|
ZYNERBA PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE SHEETS
|
(unaudited) |
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
|
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
$ |
69,697,865 |
|
|
$ |
67,808,000 |
|
|
Incentive and tax receivables |
|
1,602,831 |
|
|
|
9,580,468 |
|
|
Prepaid expenses and other current assets |
|
1,930,380 |
|
|
|
2,831,392 |
|
|
Total current assets |
|
73,231,076 |
|
|
|
80,219,860 |
|
|
Property and
equipment, net |
|
376,745 |
|
|
|
385,833 |
|
|
Incentive
and tax receivables |
|
264,206 |
|
|
|
— |
|
|
Right-of-use
assets |
|
509,002 |
|
|
|
565,814 |
|
|
Total assets |
$ |
74,381,029 |
|
|
$ |
81,171,507 |
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
$ |
1,603,834 |
|
|
$ |
1,798,813 |
|
|
Accrued expenses |
|
7,103,959 |
|
|
|
7,896,598 |
|
|
Lease liabilities |
|
210,512 |
|
|
|
209,068 |
|
|
Total current liabilities |
|
8,918,305 |
|
|
|
9,904,479 |
|
|
Lease
liabilities, long-term |
|
295,754 |
|
|
|
353,694 |
|
|
Total liabilities |
|
9,214,059 |
|
|
|
10,258,173 |
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
Common stock |
|
43,324 |
|
|
|
41,218 |
|
|
Additional paid-in capital |
|
313,095,744 |
|
|
|
310,353,595 |
|
|
Accumulated deficit |
|
(247,972,098 |
) |
|
|
(239,481,479 |
) |
|
Total stockholders' equity |
|
65,166,970 |
|
|
|
70,913,334 |
|
|
Total liabilities and stockholders' equity |
$ |
74,381,029 |
|
|
$ |
81,171,507 |
|
|
|
|
|
|
|
Zynerba Contacts
Jim Fickenscher, CFO and VP Corporate DevelopmentZynerba
Pharmaceuticals484.581.7483fickenscherj@zynerba.com
Peter VozzoICR WestwickeOffice: 443.213.0505Cell:
443.377.4767Peter.Vozzo@Westwicke.com
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