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 fourth quarter and full year
ended December 31, 2021, and provided an overview of recent
operational highlights and a pipeline update.
“In 2022, we look to build on last year’s progress as we
continue to enroll patients in our confirmatory pivotal Phase 3
trial in Fragile X syndrome, initiate a Phase 3 program in autism
spectrum disorder and report topline results in our Phase 2 trial
in 22q11.2 deletion syndrome,” said Armando Anido, Chairman and
Chief Executive Officer of Zynerba. “We are committed to achieving
our goal of bringing the first pharmaceutical product indicated for
the treatment of behavioral symptoms of Fragile X syndrome to
market, as well as advancing Zygel in other rare and near rare
neuropsychiatric indications.”
Operational Highlights and Pipeline Update
Zygel in Fragile X Syndrome (FXS)
- In February 2022, the European
Commission granted orphan drug designation to cannabidiol, the
active ingredient in Zygel, for the treatment of FXS. 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.
- 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.
Zygel in 22q11.2 Deletion Syndrome (22q)
- In February 2022, the Company
announced completion of 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 FDA on the regulatory path
forward. The Company has previously received orphan drug
designation for Zygel in 22q from the FDA.
Zygel in Autism Spectrum Disorder (ASD)
- The Company expects to initiate the
first of two Phase 3 trials in patients with ASD in the second half
of 2022. The Company is finalizing the Phase 3 study protocol and
will submit an Investigational New Drug application to the U.S.
Food and Drug Administration (FDA) prior to commencing the pivotal
program.
- 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.
Corporate
- In February 2022, Albert P. Parker
was appointed Chief Legal Officer and Corporate Secretary. Mr.
Parker is an accomplished legal and business executive with over 25
years of pharmaceutical, biotech and healthcare experience. He
assumed the duties of Suzanne Hanlon, who retired from her position
at the end of February 2022.
Fourth Quarter and Full Year 2021 Financial
Results
Research and development expenses were $5.0 million for the
fourth quarter of 2021, including stock-based compensation of $0.4
million. General and administrative expenses were $3.8 million in
the fourth quarter of 2021, including stock-based compensation
expense of $0.7 million. The net loss for the fourth quarter of
2021 was $8.8 million, with basic and diluted loss per share of
$(0.22).
Research and development expenses were $21.4 million for full
year 2021, including stock-based compensation of $2.8 million.
General and administrative expenses were $15.3 million for full
year 2021, including stock-based compensation of $3.0 million. The
net loss for the full year 2021 was $37.3 million, with basic and
diluted net loss per share of $(0.95).
Financial Outlook
As of December 31, 2021, cash and cash equivalents were $67.8
million, compared to $59.2 million as of December 31, 2020.
Management believes that the Company’s cash and cash equivalents as
of December 31, 2021 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). Zygel has been
granted orphan drug designation by 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 December 31, |
|
Year ended December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
5,022,360 |
|
|
$ |
5,616,412 |
|
|
$ |
21,424,489 |
|
|
$ |
35,654,994 |
|
General and administrative |
|
|
3,814,077 |
|
|
|
4,573,114 |
|
|
|
15,345,901 |
|
|
|
16,407,548 |
|
Total operating expenses |
|
|
8,836,437 |
|
|
|
10,189,526 |
|
|
|
36,770,390 |
|
|
|
52,062,542 |
|
Loss from operations |
|
|
(8,836,437 |
) |
|
|
(10,189,526 |
) |
|
|
(36,770,390 |
) |
|
|
(52,062,542 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
4,433 |
|
|
|
4,926 |
|
|
|
21,047 |
|
|
|
243,992 |
|
Foreign exchange gain (loss) |
|
|
16,938 |
|
|
|
566,890 |
|
|
|
(559,681 |
) |
|
|
481,719 |
|
Total other expense |
|
|
21,371 |
|
|
|
571,816 |
|
|
|
(538,634 |
) |
|
|
725,711 |
|
Net loss |
|
$ |
(8,815,066 |
) |
|
$ |
(9,617,710 |
) |
|
$ |
(37,309,024 |
) |
|
$ |
(51,336,831 |
) |
|
|
|
|
|
|
|
|
|
Net loss per
share - basic and diluted |
|
$ |
(0.22 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.95 |
) |
|
$ |
(1.90 |
) |
|
|
|
|
|
|
|
|
|
Basic and
diluted weighted average shares outstanding |
|
|
40,227,715 |
|
|
|
29,299,233 |
|
|
|
39,259,495 |
|
|
|
27,022,931 |
|
|
|
|
|
|
|
|
|
|
Non-cash
stock-based compensation included above: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
384,304 |
|
|
$ |
604,603 |
|
|
$ |
2,827,971 |
|
|
$ |
2,194,888 |
|
General and administrative |
|
|
657,097 |
|
|
|
639,514 |
|
|
|
2,982,609 |
|
|
|
2,982,639 |
|
Total |
|
$ |
1,041,401 |
|
|
$ |
1,244,117 |
|
|
$ |
5,810,580 |
|
|
$ |
5,177,527 |
|
|
|
|
|
|
|
|
|
|
ZYNERBA PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE SHEETS
|
|
December 31, 2021 |
|
December 31, 2020 |
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
67,808,000 |
|
|
$ |
59,157,187 |
|
Incentive and tax receivables |
|
|
9,580,468 |
|
|
|
9,042,586 |
|
Prepaid expenses and other current assets |
|
|
2,831,392 |
|
|
|
5,166,401 |
|
Total current assets |
|
|
80,219,860 |
|
|
|
73,366,174 |
|
Property and
equipment, net |
|
|
385,833 |
|
|
|
585,403 |
|
Right-of-use
assets |
|
|
565,814 |
|
|
|
105,199 |
|
Total assets |
|
$ |
81,171,507 |
|
|
$ |
74,056,776 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
|
$ |
1,798,813 |
|
|
$ |
2,522,716 |
|
Accrued expenses |
|
|
7,896,598 |
|
|
|
11,280,843 |
|
Lease liabilities |
|
|
209,068 |
|
|
|
109,689 |
|
Total current liabilities |
|
|
9,904,479 |
|
|
|
13,913,248 |
|
Lease
liabilities, long-term |
|
|
353,694 |
|
|
|
— |
|
Total liabilities |
|
|
10,258,173 |
|
|
|
13,913,248 |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
Common stock |
|
|
41,218 |
|
|
|
29,975 |
|
Additional paid-in capital |
|
|
310,353,595 |
|
|
|
262,286,008 |
|
Accumulated deficit |
|
|
(239,481,479 |
) |
|
|
(202,172,455 |
) |
Total stockholders' equity |
|
|
70,913,334 |
|
|
|
60,143,528 |
|
Total liabilities and stockholders' equity |
|
$ |
81,171,507 |
|
|
$ |
74,056,776 |
|
|
|
|
|
|
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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