Zosano Pharma Reports Second Quarter 2020 Financial Results and Provides Corporate Update
August 06 2020 - 8:00AM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced financial results for
the second quarter ended June 30, 2020, as well as recent business
highlights.
“Zosano is on the cusp of potentially
accomplishing what few biotech companies have the privilege of
doing, namely becoming a commercial organization with an approved
product designed to help address a significant treatment gap,” said
Steven Lo, president and CEO of Zosano. “If approved, we believe
Qtrypta’s novel drug delivery approach for the acute treatment of
migraine has the potential to address patients’ needs for an
effective, fast and durable therapy. Additionally, if approved,
Qtrypta’s simple administration as a patch may be preferred by
patients whose migraine is associated with nausea, which makes it
challenging for them to take oral medications. We are now focused
on executing on pre-commercial activities in preparation for
Qtrypta’s possible approval later this year and potential
subsequent launch in 2021.”
Business Highlights
- Received U.S. Food and Drug Administration (FDA) acceptance of
the 505(b)(2) NDA filing for Qtrypta™ for the acute treatment of
migraine
- Presented new post-hoc analyses of Qtrypta’s clinical trial
data comparing key efficacy results from the pivotal ZOTRIP study
and the open-label long-term safety study at the American Headache
Society’s Virtual Annual Scientific Meeting° Analyses suggest
that Qtrypta’s efficacy results and favorable tolerability results
across approximately 6,000 migraine episodes treated in the
long-term safety study were consistent with the statistically
significant results and tolerability results noted in the pivotal
study
- Completed a blinded market research study conducted with
high-volume physicians and payors, including 100 physician
specialists and five national payors representing over 100 million
covered lives, which found that:° 79% of the physicians
strongly agree there remains an unmet need in the treatment of
migraine in the acute setting, even in patients that respond to
preventive therapy° 70% of the physicians would offer
their patients a non-oral triptan that has fast and complete pain
relief that is sustained and well-tolerated
Financial Results for the Second Quarter
Ended June 30, 2020Zosano reported a net loss for the
second quarter of 2020 of $7.9 million, or $0.14 per share on a
basic and diluted basis, compared with a net loss of $9.4 million,
or $0.55 per share on a basic and diluted basis, for the same
quarter in 2019.
Research and development expenses for the second
quarter of 2020 were $4.9 million, compared with $6.6 million for
the same quarter in 2019. The decrease was mainly due to lower
clinical trial costs resulting from the completion of the Qtrypta
long-term safety study in 2019.
General and administrative expenses for each of
the second quarters of 2020 and 2019 were $2.8 million.
As of June 30, 2020, cash and cash equivalents
were $10.5 million as compared with $6.3 million as of December 31,
2019.
About Qtrypta™ (M207)Qtrypta is
Zosano’s proprietary investigational formulation of zolmitriptan
delivered utilizing its proprietary transdermal microneedle system
(the “System”) in development for the acute treatment of migraine.
The System consists of titanium microneedles coated with drug, and
in the case of Qtrypta™, the formulation is zolmitriptan. The
drug-coated microneedles are designed to penetrate the stratum
corneum, where the investigational drug dissolves and easily enters
into the bloodstream. In February 2017, the Company announced
statistically significant results from the ZOTRIP pivotal study, in
which the 3.8 mg dose of Qtrypta™ met both co-primary endpoints,
achieving pain freedom and most bothersome symptom freedom at 2
hours.
About MigraineMigraine is a
highly prevalent neurological disease impacting 12% of the US
population and 1 in 4 households. Patients impacted by migraine
experience significant disability, with 90% unable to function
normally. Migraine attacks are estimated to lead to lost
productivity costs as high as $36 billion annually in the United
States, including both direct and indirect costs. Zosano believes
that there is a significant need for new acute treatment options
since 74% of migraine patients experience inadequate treatment
response.
About Zosano PharmaZosano
Pharma Corporation is a clinical-stage biopharmaceutical company
focused on developing products where rapid administration of
approved molecules with established safety and efficacy profiles
may provide substantial benefit to patients, in markets where
patients remain underserved by existing therapies. The company’s
transdermal microneedle system technology consists of titanium
microneedles coated with drug that are designed to enable rapid
systemic administration of therapeutics to patients. Zosano’s lead
product candidate is Qtrypta™ (M207), which is a proprietary
formulation of zolmitriptan delivered via its transdermal
microneedle system technology, as an acute treatment for migraine.
The company anticipates that many of its current and future
development programs may enable the company to utilize a regulatory
pathway that has the potential to streamline clinical development
and accelerate the path towards commercialization. Learn more at
www.zosanopharma.com.
Forward-Looking StatementsThis
press release contains forward-looking statements regarding the
preparation for potential approval and launch of Qtrypta and other
future events and expectations events and expectations described in
this press release. Readers are urged to consider statements that
include the words "may," "will," "would," "could," "should,"
"might," "believes," "estimates," "projects," "potential,"
"expects," "plans," "anticipates," "intends," "continues,"
"forecast," "designed," "goal," "unaudited," "approximately" or the
negative of those words or other comparable words to be uncertain
and forward-looking. These statements are subject to risks and
uncertainties that are difficult to predict, and actual outcomes
may differ materially. These include risks and uncertainties,
without limitation, associated with the company’s ability to obtain
additional cash resources to continue operations for the remainder
of 2020, the process of discovering, developing and commercializing
products that are safe and effective for use as human therapeutics,
risks inherent in the effort to build a business around such
products and other risks and uncertainties described under the
heading "Risk Factors" in the company's most recent annual report
on Form 10-K and quarterly reports on Form 10-Q. Although Zosano
believes that the expectations reflected in these forward-looking
statements are reasonable, Zosano cannot in any way guarantee that
the future results, level of activity, performance or events and
circumstances reflected in forward-looking statements will be
achieved or occur. All forward-looking statements are based on
information currently available to Zosano and Zosano assumes no
obligation to update any such forward-looking statements.
Zosano Contact:Christine
MatthewsChief Financial Officer(510) 745-1200
PR Contacts:Sylvia Wheeler or
Alexandra Santosswheeler@wheelhouselsa.com or
asantos@wheelhouselsa.com
ZOSANO PHARMA
CORPORATIONCONDENSED BALANCE
SHEETS(in thousands, except par value and share
amounts)
|
June 30, 2020 |
|
December 31, 2019 |
|
(unaudited) |
|
|
ASSETS |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
10,547 |
|
|
$ |
6,316 |
|
Prepaid expenses and other current assets |
699 |
|
|
497 |
|
Total current assets |
11,246 |
|
|
6,813 |
|
Restricted cash |
455 |
|
|
455 |
|
Property and equipment, net |
30,712 |
|
|
24,636 |
|
Operating lease right-of-use assets |
5,296 |
|
|
5,763 |
|
Other long-term assets |
3 |
|
|
3 |
|
Total assets |
$ |
47,712 |
|
|
$ |
37,670 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
4,809 |
|
|
$ |
4,356 |
|
Accrued compensation |
2,754 |
|
|
2,015 |
|
Build-to-suit obligation, current portion |
3,085 |
|
|
4,554 |
|
Operating lease liabilities, current portion |
1,228 |
|
|
1,140 |
|
Paycheck Protection Program loan, current portion |
725 |
|
|
— |
|
Other accrued liabilities |
3,945 |
|
|
4,172 |
|
Total current liabilities |
16,546 |
|
|
16,237 |
|
Build-to-suit obligation, long-term portion, net of debt issuance
costs and discount |
6,509 |
|
|
6,095 |
|
Operating lease liabilities, long-term portion |
5,297 |
|
|
5,931 |
|
Paycheck Protection Program loan, long-term portion |
888 |
|
|
— |
|
Other liabilities |
8 |
|
|
15 |
|
Total liabilities |
29,248 |
|
|
28,278 |
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.0001 par value; 5,000,000 shares authorized;
none issued and outstanding as of June 30, 2020 and
December 31, 2019 |
— |
|
|
— |
|
Common stock, $0.0001 par value; 250,000,000 shares authorized;
57,245,251 and 23,503,214 shares issued and outstanding as of June
30, 2020 and December 31, 2019, respectively |
6 |
|
|
2 |
|
Additional paid-in capital |
333,863 |
|
|
308,211 |
|
Accumulated deficit |
(315,405 |
) |
|
(298,821 |
) |
Total stockholders’ equity |
18,464 |
|
|
9,392 |
|
Total liabilities and stockholders’ equity |
$ |
47,712 |
|
|
$ |
37,670 |
|
|
|
|
|
|
|
|
|
ZOSANO PHARMA
CORPORATIONCONDENSED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(in thousands, except share and
per share amounts)(unaudited)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
Revenue |
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
4,932 |
|
|
6,640 |
|
|
10,446 |
|
|
13,256 |
|
General and administrative |
2,766 |
|
|
2,767 |
|
|
5,848 |
|
|
5,638 |
|
Total operating expenses |
7,698 |
|
|
9,407 |
|
|
16,294 |
|
|
18,894 |
|
Loss from operations |
(7,698 |
) |
|
(9,407 |
) |
|
(16,294 |
) |
|
(18,894 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
5 |
|
|
82 |
|
|
15 |
|
|
162 |
|
Interest expense |
(190 |
) |
|
(35 |
) |
|
(396 |
) |
|
(76 |
) |
Other income (expense), net |
(12 |
) |
|
— |
|
|
91 |
|
|
22 |
|
Loss before provision for income taxes |
(7,895 |
) |
|
(9,360 |
) |
|
(16,584 |
) |
|
(18,786 |
) |
Provision for income taxes |
— |
|
|
— |
|
|
— |
|
|
— |
|
Net loss |
$ |
(7,895 |
) |
|
$ |
(9,360 |
) |
|
$ |
(16,584 |
) |
|
$ |
(18,786 |
) |
Unrealized gain (loss) on marketable securities, net of tax |
— |
|
|
(1 |
) |
|
|
|
5 |
|
Comprehensive loss |
$ |
(7,895 |
) |
|
$ |
(9,361 |
) |
|
$ |
(16,584 |
) |
|
$ |
(18,781 |
) |
|
|
|
|
|
|
|
|
Net loss per common share – basic and diluted |
$ |
(0.14 |
) |
|
$ |
(0.55 |
) |
|
$ |
(0.36 |
) |
|
$ |
(1.30 |
) |
Weighted-average shares used in computing net loss per common share
– basic and diluted |
54,927,408 |
|
|
16,868,643 |
|
|
45,596,713 |
|
|
14,434,365 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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