Zynerba Pharmaceuticals Reports Third Quarter 2021 Financial Results and Operational Highlights
November 15 2021 - 7:00AM
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, 2021, and provided an overview of recent operational highlights
and a pipeline update.
“We remain focused on enrolling patients into our confirmatory
pivotal Phase 3 RECONNECT trial in children and adolescents with
Fragile X Syndrome,” said Armando Anido, Chairman and Chief
Executive Officer of Zynerba. “If the results from RECONNECT are
positive, Zygel has the potential to become the first FDA approved
treatment option for the significant unmet medical need that
affects FXS patients and their families.”
Third Quarter 2021 and Recent Highlights and Zygel
Pipeline Update
Zygel in Fragile X Syndrome (FXS)
- Zynerba initiated a pivotal,
multinational randomized, double-blind, placebo-controlled,
multiple-center, efficacy and safety (RECONNECT) Phase 3 trial
during the third quarter of 2021. The RECONNECT trial is designed
to evaluate the efficacy and safety of Zygel (cannabidiol
formulated in a transdermal gel) in children and adolescents with
FXS. The trial is planned to confirm the positive results observed
in a population of responders in the Company’s CONNECT-FX trial.
(Press Release)
- RECONNECT is an 18-week trial that
is expected to enroll approximately 200 children and adolescents,
aged three through 17 years, at approximately 25 clinical sites in
the United States, Australia, the UK and Ireland. Approximately 160
of the patients enrolled will have complete (100%) methylation of
their FMR1 gene and approximately 40 patients will have partial
methylation of their FMR1 gene. Patients will be randomized 1:1 to
either Zygel or placebo. Randomization will be stratified by
gender, methylation status and weight.
- The primary endpoint for the trial
will be the change from baseline to the end of the treatment period
in the Aberrant Behavior Checklist-Community FXS Specific
(ABC-CFXS) Social Avoidance subscale in patients who have complete
methylation of their FMR1 gene. The ABC-CFXS Social Avoidance
subscale is the same primary endpoint used in the CONNECT-FX trial.
The Company believes that the results from RECONNECT, if positive,
will be sufficient to support the submission of a New Drug
Application for Zygel in patients with FXS.
- Presented data at the American
Academy of Child and Adolescent Psychiatry (AACAP) Annual Meeting
demonstrating that more patients on Zygel attained and maintained
clinically meaningful improvement in social avoidance as compared
to placebo-treated patients during the double-blind treatment phase
of CONNECT-FX. In addition, patients who received blinded Zygel in
CONNECT-FX continued to improve on open-label Zygel with
approximately two-thirds of patients achieving sustained meaningful
improvement in social avoidance at 16 weeks and 24 weeks on
Zygel.
- Presented data at the 2021 National
Organization for Rare Disorders (NORD) Rare Diseases and Orphan
Products Breakthrough Summit describing the design of the Phase 3
RECONNECT trial of Zygel in children and adolescents with FXS based
on learnings from CONNECT-FX.
Zygel in Autism Spectrum Disorder (ASD)
- Presented data at The Society for
the Study of Behavioural Phenotypes (SSBP) Conference 2021
demonstrating that through 38 weeks of treatment, the Phase 2
BRIGHT trial suggests initial evidence of a positive benefit-risk
profile for Zygel when administered in addition to stable standard
of care in children and adolescents with moderate-to-severe ASD.
Furthermore, in patients who completed the 38-week treatment period
in BRIGHT, statistically significant improvements compared to
baseline were sustained in all efficacy measures of ASD compared to
baseline. (Press Release)
Zygel in 22q11.2 Deletion Syndrome (22q)
- The Company
continues to screen patients for the 14-week open-label Phase 2
INSPIRE trial in children and adolescents with genetically
confirmed 22q.
Zygel in Developmental and Epileptic Encephalopathies
(DEE)
- Published results
from the Company’s open-label Phase 2 BELIEVE study in the Journal
of the American Medical Association (JAMA) Network Open. The
article describes the positive results from BELIEVE, the first
trial of a non-oral formulation of cannabidiol in children and
adolescents with DEEs, and concludes that Zygel was safe, well
tolerated, and was associated with reductions in focal impaired
awareness seizures (FIAS) and tonic-clonic seizure (TCS) frequency
and disease burden. (Press Release)
Zynerba will provide an update on its development path forward
in ASD, 22q and DEE by the end of 2021.
Corporate
- In November 2021,
Stephen O’Quinn, Pharm.D. was appointed as the Vice President,
Medical Affairs. Dr. O’Quinn is a senior pharmaceutical executive
with more than 30 years of experience in clinical development,
medical affairs and commercialization of medicines in multiple
therapy areas, including neurology and psychiatry. Dr. O’Quinn
spent over 20 years with GlaxoSmithKline in senior leadership
roles. He most recently served as a consultant to pharmaceutical
clients, including Zynerba Pharmaceuticals, supporting clinical
development and medical affairs activities. Dr. O’Quinn earned a
Doctor of Pharmacy, with highest honors, from the University of
North Carolina at Chapel Hill. He completed a post-doctoral
fellowship in Cardiovascular Pharmacotherapy with the UNC School of
Pharmacy and Division of Cardiology. He also completed marketing
and executive leadership training at The Wharton School of the
University of Pennsylvania.
Third Quarter 2021 Financial Results
Research and development expenses were $6.3 million for the
third quarter of 2021, including stock-based compensation of $0.8
million. General and administrative expenses were $3.9 million in
the third quarter of 2021, including stock-based compensation
expense of $0.8 million. The net loss for the third quarter of 2021
was $10.6 million, with basic and diluted loss per share of
$(0.26).
Financial Outlook
As of September 30, 2021, cash and cash equivalents were $75.6
million, compared to $59.2 million as of December 31, 2020.
Management believes that the Company’s cash and cash equivalents as
of September 30, 2021 are sufficient to fund operations and
capital requirements well into the first half of 2024.
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, 22q11.2 deletion syndrome, and a
heterogeneous group of rare and ultra-rare epilepsies known as
developmental and epileptic encephalopathies. 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; the timing and outcome of
current and future legal proceedings; 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 September 30, |
|
Nine months ended September 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
$ |
6,341,171 |
|
|
$ |
5,805,948 |
|
|
$ |
16,402,129 |
|
|
$ |
30,038,582 |
|
|
General and administrative |
|
3,869,481 |
|
|
|
3,425,831 |
|
|
|
11,531,824 |
|
|
|
11,834,434 |
|
|
Total operating expenses |
|
10,210,652 |
|
|
|
9,231,779 |
|
|
|
27,933,953 |
|
|
|
41,873,016 |
|
|
Loss from operations |
|
(10,210,652 |
) |
|
|
(9,231,779 |
) |
|
|
(27,933,953 |
) |
|
|
(41,873,016 |
) |
|
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest income |
|
5,038 |
|
|
|
10,781 |
|
|
|
16,614 |
|
|
|
239,066 |
|
|
Foreign exchange (loss) gain |
|
(376,637 |
) |
|
|
172,467 |
|
|
|
(576,619 |
) |
|
|
(85,171 |
) |
|
Total other expense |
|
(371,599 |
) |
|
|
183,248 |
|
|
|
(560,005 |
) |
|
|
153,895 |
|
|
Net loss |
$ |
(10,582,251 |
) |
|
$ |
(9,048,531 |
) |
|
$ |
(28,493,958 |
) |
|
$ |
(41,719,121 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per
share - basic and diluted |
$ |
(0.26 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.73 |
) |
|
$ |
(1.59 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and
diluted weighted average shares outstanding |
|
40,092,128 |
|
|
|
29,243,375 |
|
|
|
38,933,209 |
|
|
|
26,258,626 |
|
|
|
|
|
|
|
|
|
|
|
Non-cash
stock-based compensation included above: |
|
|
|
|
|
|
|
|
Research and development |
$ |
818,390 |
|
|
$ |
544,909 |
|
|
$ |
2,443,667 |
|
|
$ |
1,590,285 |
|
|
General and administrative |
|
751,603 |
|
|
|
717,716 |
|
|
|
2,325,512 |
|
|
|
2,343,125 |
|
|
Total |
$ |
1,569,993 |
|
|
$ |
1,262,625 |
|
|
$ |
4,769,179 |
|
|
$ |
3,933,410 |
|
|
|
|
|
|
|
|
|
|
|
ZYNERBA PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE SHEETS
|
(unaudited) |
|
|
|
|
September 30, 2021 |
|
December 31, 2020 |
|
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
$ |
75,642,498 |
|
|
$ |
59,157,187 |
|
|
Incentive and tax receivables |
|
8,535,607 |
|
|
|
9,042,586 |
|
|
Prepaid expenses and other current assets |
|
3,880,014 |
|
|
|
5,166,401 |
|
|
Total current assets |
|
88,058,119 |
|
|
|
73,366,174 |
|
|
Property and
equipment, net |
|
447,728 |
|
|
|
585,403 |
|
|
Incentive
and tax receivables |
|
868,083 |
|
|
|
— |
|
|
Right-of-use
assets |
|
622,240 |
|
|
|
105,199 |
|
|
Total assets |
$ |
89,996,170 |
|
|
$ |
74,056,776 |
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
$ |
2,636,350 |
|
|
$ |
2,522,716 |
|
|
Accrued expenses |
|
8,053,949 |
|
|
|
11,280,843 |
|
|
Lease liabilities |
|
207,635 |
|
|
|
109,689 |
|
|
Total current liabilities |
|
10,897,934 |
|
|
|
13,913,248 |
|
|
Lease
liabilities, long-term |
|
411,237 |
|
|
|
— |
|
|
Total liabilities |
|
11,309,171 |
|
|
|
13,913,248 |
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
Common stock |
|
41,282 |
|
|
|
29,975 |
|
|
Additional paid-in capital |
|
309,312,130 |
|
|
|
262,286,008 |
|
|
Accumulated deficit |
|
(230,666,413 |
) |
|
|
(202,172,455 |
) |
|
Total stockholders' equity |
|
78,686,999 |
|
|
|
60,143,528 |
|
|
Total liabilities and stockholders' equity |
$ |
89,996,170 |
|
|
$ |
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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