Zynerba Pharmaceuticals Reports Second Quarter 2021 Financial Results and Operational Highlights
August 09 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 second quarter ended June 30,
2021, and provided an overview of recent operational highlights and
a pipeline update.
“We continue to make progress across our portfolio, particularly
in FXS in which our confirmatory pivotal Phase 3 trial, RECONNECT,
is expected to start in the third quarter of 2021,” said Armando
Anido, Chairman and Chief Executive Officer of Zynerba. “Following
a positive meeting with the FDA on our development program in
autism spectrum disorder (ASD), we are evaluating and prioritizing
our development options for ASD, 22q and developmental and
epileptic encephalopathies and we expect to provide guidance on the
path forward in each of these indications by the end of 2021.”
Second Quarter 2021 and Recent Highlights and Zygel
Pipeline Update
Zygel in Fragile X Syndrome (FXS)
- Zynerba expects to initiate
RECONNECT (A Randomized,
Double-Blind, Placebo-Controlled,
Multiple-Center,
Efficacy and Safety Study of
ZYN002 Administered as a Transdermal Gel to Children and
Adolescents with Fragile X Syndrome), a pivotal, multi-national
confirmatory Phase 3 trial of Zygel in children and adolescents
with FXS, in the third quarter of 2021. The trial is designed to
confirm the positive results observed in a population of responders
in the Company’s previously conducted CONNECT-FX trial. (Press
release)
- The RECONNECT trial will be an
18-week trial which will enroll approximately 200 children and
adolescents of which approximately 160 patients will have complete
(100%) methylation of their FMR1 gene and approximately 40 patients
will have partial methylation of their FMR1 gene. The primary
endpoint for the trial will be the change in the Aberrant Behavior
Checklist-Community FXS Specific (ABC-CFXS) Social Avoidance
subscale in patients who have complete methylation of their FMR1
gene. All patients, including the cohort of partially methylated
patients, will be included in a key secondary endpoint analysis.
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 International
Society for Pharmacoeconomic and Outcomes Research (ISPOR) Virtual
2021 Conference demonstrating the ABC-CFXS subscales capture
behaviors that are impactful and understandable to caregivers of
children with FXS and are fit for purpose for measuring clinical
trial endpoints in FXS. (Press release)
Zygel in Autism Spectrum Disorder (ASD)
- In the first half of 2021, Zynerba
discussed data supporting the potential efficacy of Zygel in ASD,
including the results of the Phase 2 BRIGHT trial, with the U.S.
Food and Drug Administration (FDA) to determine the regulatory path
forward. The guidance from 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 previously completed BRIGHT open label
Phase 2 trial.
- Presented data at the 2021 American
Society of Clinical Psychopharmacology (ASCP) Annual Meeting
demonstrating that Zygel may provide important clinical promise
across a spectrum of endpoints, including, behavior, seizure
reduction and sleep in children with ASD, children with
developmental epileptic encephalopathies (DEE) with comorbid ASD,
and children with FXS with comorbid ASD. These previously disclosed
data are from two open-label Phase 2 trials and one double-blind
placebo-controlled trial when added to standard of care in children
and adolescents. (Press release)
Zygel in 22q11.2 Deletion Syndrome (22q)
- Despite constantly
changing COVID-19-related restrictions in Australia, the Company
has resumed screening of patients for the 14-week open label Phase
2 INSPIRE trial in children and adolescents with genetically
confirmed 22q. Once enrollment is complete, a timeframe for
disclosing topline results of the trial will be provided.
Zygel in Developmental and Epileptic Encephalopathies
(DEE)
- Zynerba is
conducting an observational trial that will help finalize target
syndrome selection in one or more DEE syndromes in 2021. Due to the
heterogeneity of patients who fall under the DEE umbrella, the FDA
suggested the company pursue individual syndromes rather than
considering DEE as a single disorder or condition (Press
release).
- Presented data at
the Associated Professional Sleep Societies SLEEP 2021 Annual
Meeting demonstrating in an open-label Phase 2 trial with patients
with DEE, treatment with Zygel was associated with improved sleep
in children with clinically significant sleep disorders at
baseline. Furthermore, the children with both DEE and ASD appeared
to show more wide-ranging benefits on sleep compared to those with
DEE alone. The Company believes that because epilepsy and sleep
disorders have a bidirectional relationship and co-occur in
individuals with ASD, improvements in sleep may result in better
seizure control and behavior in these medically fragile children
with DEE. (Press release)
Second Quarter 2021 Financial Results
Research and development expenses were $5.5 million for the
second quarter of 2021, including stock-based compensation of $1.0
million. General and administrative expenses were $4.4 million in
the second quarter of 2021, including stock-based compensation
expense of $0.9 million. The net loss for the second quarter of
2021 was $10.0 million, with basic and diluted loss per share of
$(0.25).
Financial Outlook
As of June 30, 2021, cash and cash equivalents were $85.8
million, compared to $59.2 million as of December 31, 2020.
Management believes that the Company’s cash and cash equivalents as
of June 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 June 30, |
|
Six months ended June 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
$ |
5,451,948 |
|
|
$ |
17,349,841 |
|
|
$ |
10,060,958 |
|
|
$ |
24,232,634 |
|
|
General and administrative |
|
4,386,546 |
|
|
|
4,492,034 |
|
|
|
7,662,343 |
|
|
|
8,408,603 |
|
|
Total operating expenses |
|
9,838,494 |
|
|
|
21,841,875 |
|
|
|
17,723,301 |
|
|
|
32,641,237 |
|
|
Loss from operations |
|
(9,838,494 |
) |
|
|
(21,841,875 |
) |
|
|
(17,723,301 |
) |
|
|
(32,641,237 |
) |
|
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest income |
|
5,943 |
|
|
|
26,601 |
|
|
|
11,576 |
|
|
|
228,285 |
|
|
Foreign exchange (loss) gain |
|
(117,528 |
) |
|
|
1,482,513 |
|
|
|
(199,982 |
) |
|
|
(257,638 |
) |
|
Total other expense |
|
(111,585 |
) |
|
|
1,509,114 |
|
|
|
(188,406 |
) |
|
|
(29,353 |
) |
|
Net loss |
$ |
(9,950,079 |
) |
|
$ |
(20,332,761 |
) |
|
$ |
(17,911,707 |
) |
|
$ |
(32,670,590 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per
share - basic and diluted |
$ |
(0.25 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.47 |
) |
|
$ |
(1.32 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and
diluted weighted average shares outstanding |
|
40,065,715 |
|
|
|
26,100,264 |
|
|
|
38,344,145 |
|
|
|
24,749,851 |
|
|
|
|
|
|
|
|
|
|
|
Non-cash
stock-based compensation included above: |
|
|
|
|
|
|
|
|
Research and development |
$ |
1,005,886 |
|
|
$ |
534,900 |
|
|
$ |
1,625,277 |
|
|
$ |
1,045,376 |
|
|
General and administrative |
|
928,463 |
|
|
|
812,533 |
|
|
|
1,573,909 |
|
|
|
1,625,409 |
|
|
Total |
$ |
1,934,349 |
|
|
$ |
1,347,433 |
|
|
$ |
3,199,186 |
|
|
$ |
2,670,785 |
|
|
|
|
|
|
|
|
|
|
|
ZYNERBA PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE SHEETS
|
(unaudited) |
|
|
|
|
June 30, 2021 |
|
December 31, 2020 |
|
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
$ |
85,780,711 |
|
|
$ |
59,157,187 |
|
|
Incentive and tax receivables |
|
8,906,379 |
|
|
|
9,042,586 |
|
|
Prepaid expenses and other current assets |
|
1,767,989 |
|
|
|
5,166,401 |
|
|
Total current assets |
|
96,455,079 |
|
|
|
73,366,174 |
|
|
Property and
equipment, net |
|
509,623 |
|
|
|
585,403 |
|
|
Incentive
and tax receivables |
|
552,922 |
|
|
|
— |
|
|
Right-of-use
assets |
|
678,280 |
|
|
|
105,199 |
|
|
Total assets |
$ |
98,195,904 |
|
|
$ |
74,056,776 |
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
$ |
1,819,761 |
|
|
$ |
2,522,716 |
|
|
Accrued expenses |
|
8,002,290 |
|
|
|
11,280,843 |
|
|
Lease liabilities |
|
206,211 |
|
|
|
109,689 |
|
|
Total current liabilities |
|
10,028,262 |
|
|
|
13,913,248 |
|
|
Lease
liabilities, long-term |
|
468,385 |
|
|
|
— |
|
|
Total liabilities |
|
10,496,647 |
|
|
|
13,913,248 |
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
Common stock |
|
41,252 |
|
|
|
29,975 |
|
|
Additional paid-in capital |
|
307,742,167 |
|
|
|
262,286,008 |
|
|
Accumulated deficit |
|
(220,084,162 |
) |
|
|
(202,172,455 |
) |
|
Total stockholders' equity |
|
87,699,257 |
|
|
|
60,143,528 |
|
|
Total liabilities and stockholders' equity |
$ |
98,195,904 |
|
|
$ |
74,056,776 |
|
|
|
|
|
|
|
Zynerba Contacts
Jim Fickenscher, CFO and VP Corporate DevelopmentZynerba
Pharmaceuticals484.581.7483fickenscherj@zynerba.com
Peter VozzoWestwicke/ICROffice: 443.213.0505Cell:
443.377.4767Peter.Vozzo@Westwicke.com
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