Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in
innovative pharmaceutically-produced transdermal cannabinoid
therapies for orphan neuropsychiatric disorders, today reported
financial results for the third quarter ended September 30, 2022,
and provided an overview of recent operational highlights and a
pipeline update.
“Enrollment in our confirmatory pivotal Phase 3 RECONNECT trial
continues, and we expect topline results in the second half of
2023,” said Armando Anido, Chairman and Chief Executive Officer of
Zynerba. “With a cash runway into the first quarter of 2024, we
remain well-positioned on achieving our goal of bringing Zygel to
market as the first FDA approved treatment option for the
significant unmet medical need that affects FXS patients and their
families.”
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.
- In October 2022 the Company
announced that the U.S. Patent and Trademark Office (USPTO) issued
a patent titled “Treatment of Fragile X Syndrome With Cannabidiol,”
which includes claims directed to methods of treating Fragile X
syndrome with cannabidiol. This new patent, which expires in 2038,
is part of an expanding international intellectual property
portfolio covering the Company’s transdermal cannabidiol product
candidate, Zygel. (Press Release)
Zygel in 22q11.2 Deletion Syndrome (22q)
- Based on the positive Phase 2
INSPIRE trial data announced in June 2022 (Press Release), the
Company requested and has been granted an initial meeting with the
U.S. Food and Drug Administration (FDA) before the end of 2022 to
obtain feedback on the Phase 2 data and regulatory pathway for
Zygel in patients with 22q. The Company currently plans to initiate
a Phase 3 program in children and adolescents with 22q following
topline results from RECONNECT.
- In November 2022, the Company
announced that the USPTO issued a patent titled “Treatment of
22q11.2 Deletion Syndrome With Cannabidiol,” which includes claims
directed to methods of treating one or more behavioral symptoms of
22q with cannabidiol, and expires in 2040. (Press Release)
- The Company presented data at The
Society for the Study of Behavioural Phenotypes (SSBP) 24th
International Research Symposium in September 2022 and the 2022
National Organization for Rare Disorders (NORD) Rare Diseases and
Orphan Products Breakthrough Summit in October 2022 from the first
14-week treatment period of the Phase 2 INSPIRE trial. These data
suggest a positive risk-benefit profile for Zygel in improving
anxiety-related and behavioral symptoms in children and adolescents
with 22q. Statistically significant improvements from baseline were
seen in the Pediatric Anxiety Rating Scale (PARS-R), the total
score and all five subscales of the Anxiety, Depression and Mood
Scale (ADAMS) and all five subscales of the Aberrant Behavior
Checklist – Community (ABC-C). In addition, the majority of
patients showed clinically meaningful improvements as demonstrated
by the Clinical Global Impression – Improvement (CGI-I). Zygel was
shown to be well tolerated, and the safety profile was consistent
with previously released data from other Zygel clinical trials.
(Posters).
Third Quarter 2022 Financial Results
Research and development expenses were $5.0 million for the
third quarter of 2022, including stock-based compensation of $0.5
million. General and administrative expenses were $3.5 million in
the third quarter of 2022, including stock-based compensation
expense of $0.6 million. Net loss for the third quarter of 2022 was
$8.7 million, with basic and diluted loss per share of $(0.20).
Financial Outlook
As of September 30, 2022, cash and cash equivalents were $55.9
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 (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 third quarter of 2022,
the Company sold and issued 2,579,346 shares of its common stock
under the 2021 Sales Agreement in the open market resulting in
gross proceeds of $3.2 million and net proceeds of $3.0 million,
after deducting commissions and offering expenses.
On July 21, 2022, the Company entered into a Purchase Agreement
and registration rights agreement for up to $20 million with
Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional
investor. In the third quarter of 2022, the Company sold and issued
200,000 shares of its common stock under the 2022 Purchase
Agreement with LPC in the open market resulting in gross proceeds
of $0.2 million and net proceeds of $0.1 million, after deducting
offering expenses.
Management believes that the Company’s cash and cash equivalents
are sufficient to fund operations and capital requirements into the
first quarter of 2024. Top-line results from the Company’s
confirmatory pivotal Phase 3 RECONNECT trial of Zygel in patients
with FXS are expected in 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), 22q11.2 deletion
syndrome (22q) and autism spectrum disorder (ASD). 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 from 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,
22q11.2 deletion syndrome and autism spectrum disorder. 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 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; and the extent to which
inflation or global instability, including political instability,
may disrupt our business operations or our financial condition.
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, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
5,039,228 |
|
|
$ |
6,341,171 |
|
|
$ |
15,632,150 |
|
|
$ |
16,402,129 |
|
|
General and administrative |
|
|
3,453,648 |
|
|
|
3,869,481 |
|
|
|
10,933,411 |
|
|
|
11,531,824 |
|
|
Total operating expenses |
|
|
8,492,876 |
|
|
|
10,210,652 |
|
|
|
26,565,561 |
|
|
|
27,933,953 |
|
|
Loss from operations |
|
|
(8,492,876 |
) |
|
|
(10,210,652 |
) |
|
|
(26,565,561 |
) |
|
|
(27,933,953 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
251,855 |
|
|
|
5,038 |
|
|
|
439,590 |
|
|
|
16,614 |
|
|
Foreign exchange loss |
|
|
(435,128 |
) |
|
|
(376,637 |
) |
|
|
(893,803 |
) |
|
|
(576,619 |
) |
|
Total other income (expense) |
|
|
(183,273 |
) |
|
|
(371,599 |
) |
|
|
(454,213 |
) |
|
|
(560,005 |
) |
|
Net loss |
|
$ |
(8,676,149 |
) |
|
$ |
(10,582,251 |
) |
|
$ |
(27,019,774 |
) |
|
$ |
(28,493,958 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted |
|
$ |
(0.20 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.73 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average shares outstanding |
|
|
43,746,878 |
|
|
|
40,092,128 |
|
|
|
41,831,998 |
|
|
|
38,933,209 |
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash stock-based compensation included above: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
482,306 |
|
|
$ |
818,390 |
|
|
$ |
1,500,447 |
|
|
$ |
2,443,667 |
|
|
General and administrative |
|
|
558,794 |
|
|
|
751,603 |
|
|
|
1,809,678 |
|
|
|
2,325,512 |
|
|
Total |
|
$ |
1,041,100 |
|
|
$ |
1,569,993 |
|
|
$ |
3,310,125 |
|
|
$ |
4,769,179 |
|
|
|
|
|
|
|
|
|
|
|
|
ZYNERBA PHARMACEUTICALS,
INC.CONSOLIDATED BALANCE SHEETS
|
|
(unaudited) |
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
55,934,491 |
|
|
$ |
67,808,000 |
|
|
Incentive and tax receivables |
|
|
1,378,738 |
|
|
|
9,580,468 |
|
|
Prepaid expenses and other current assets |
|
|
3,487,626 |
|
|
|
2,831,392 |
|
|
Total current assets |
|
|
60,800,855 |
|
|
|
80,219,860 |
|
|
Property and equipment, net |
|
|
419,863 |
|
|
|
385,833 |
|
|
Incentive and tax receivables |
|
|
751,815 |
|
|
|
— |
|
|
Right-of-use assets |
|
|
394,205 |
|
|
|
565,814 |
|
|
Total assets |
|
$ |
62,366,738 |
|
|
$ |
81,171,507 |
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
1,619,697 |
|
|
$ |
1,798,813 |
|
|
Accrued expenses |
|
|
7,598,187 |
|
|
|
7,896,598 |
|
|
Lease liabilities |
|
|
213,428 |
|
|
|
209,068 |
|
|
Total current liabilities |
|
|
9,431,312 |
|
|
|
9,904,479 |
|
|
Lease liabilities, long-term |
|
|
178,672 |
|
|
|
353,694 |
|
|
Total liabilities |
|
|
9,609,984 |
|
|
|
10,258,173 |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
Common stock |
|
|
47,063 |
|
|
|
41,218 |
|
|
Additional paid-in capital |
|
|
319,210,944 |
|
|
|
310,353,595 |
|
|
Accumulated deficit |
|
|
(266,501,253 |
) |
|
|
(239,481,479 |
) |
|
Total stockholders' equity |
|
|
52,756,754 |
|
|
|
70,913,334 |
|
|
Total liabilities and stockholders' equity |
|
$ |
62,366,738 |
|
|
$ |
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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