Zosano Pharma Reports First Quarter 2020 Financial Results and Provides Corporate Update
May 14 2020 - 05:05PM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced financial results for
the first quarter ended March 31, 2020, as well as recent business
highlights.
"This quarter was marked by a momentous milestone for the
company with the FDA acceptance for filing of our New Drug
Application (NDA) for Qtrypta™, a potential new treatment for
patients with migraine utilizing our microneedle patch technology,”
said Steven Lo, president and CEO of Zosano. “In preparation for
our upcoming Prescription Drug User Fee Act (PDUFA) goal date of
October 20 of this year, we have been scaling up our pre-commercial
activities, including key components such as targeting and market
access. We believe Qtrypta, if approved, will provide patients an
attractive option for their migraine treatment, given its potential
to provide rapid and sustained headache relief, in addition to the
favorable safety results demonstrated in clinical studies. We are
looking forward to the opportunity to help patients with this
debilitating disease.”
Recent Business Highlights
- Received U.S. Food and Drug Administration (FDA) filing
acceptance of the 505(b)(2) NDA filing for Qtrypta™ for the acute
treatment of migraine
- Appointed Christine Matthews, previously the company’s interim
chief financial officer, to the position of chief financial
officer
- 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 that 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 a
non-oral triptan that has fast and complete pain relief that is
sustained and well-tolerated
Financial Results for the First Quarter Ended March 31,
2020Zosano reported a net loss for the first quarter of
2020 of $8.7 million, or $0.24 per share on a basic and diluted
basis, compared with a net loss of $9.4 million, or $0.79 per share
on a basic and diluted basis, for the same quarter in 2019.
Research and development expenses for the first quarter of 2020
were $5.5 million, compared with $6.6 million for the same quarter
in 2019. The $1.1 million decrease was primarily attributable to
lower clinical trial costs due to the completion of the Qtrypta
long-term safety study in 2019.
General and administrative expenses for the first quarter of
2020 were $3.1 million, compared with $2.9 million for the same
quarter in 2019. The increase of $0.2 million was mainly due to
costs related to intellectual property matters.
As of March 31, 2020, cash and cash equivalents were $18.6
million, compared with $6.3 million as of December 31,
2019.
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 intracutaneous 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 intracutaneous microneedle system technology, as
a potential 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 would 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, the potential benefits of
Qtrypta for patients and other future 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)
|
March 31, 2020 |
|
December 31, 2019 |
|
(unaudited) |
|
|
ASSETS |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
18,557 |
|
|
$ |
6,316 |
|
Prepaid expenses and other current assets |
623 |
|
|
497 |
|
Total current assets |
19,180 |
|
|
6,813 |
|
Restricted cash |
455 |
|
|
455 |
|
Property and equipment, net |
30,164 |
|
|
24,636 |
|
Operating lease right-of-use
assets |
5,533 |
|
|
5,763 |
|
Other long-term assets |
3 |
|
|
3 |
|
Total assets |
$ |
55,335 |
|
|
$ |
37,670 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
3,263 |
|
|
$ |
4,356 |
|
Accrued compensation |
2,553 |
|
|
2,015 |
|
Build-to-suit obligation, current portion |
4,665 |
|
|
4,554 |
|
Operating lease liabilities, current portion |
1,184 |
|
|
1,140 |
|
Other accrued liabilities |
8,943 |
|
|
4,172 |
|
Total current liabilities |
20,608 |
|
|
16,237 |
|
Build-to-suit obligation,
long-term portion, net of debt issuance costs and discount |
5,129 |
|
|
6,095 |
|
Operating lease liabilities,
long-term portion |
5,618 |
|
|
5,931 |
|
Other liabilities |
10 |
|
|
15 |
|
Total liabilities |
31,365 |
|
|
28,278 |
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.0001 par value; 5,000,000 shares authorized;
none issued and outstanding as of March 31, 2020 and
December 31, 2019 |
— |
|
|
— |
|
Common stock, $0.0001 par value; 250,000,000 shares authorized;
54,361,635 and 23,503,214 shares issued and outstanding as of March
31, 2020 and December 31, 2019, respectively |
5 |
|
|
2 |
|
Additional paid-in capital |
331,475 |
|
|
308,211 |
|
Accumulated deficit |
(307,510 |
) |
|
(298,821 |
) |
Total stockholders’ equity |
23,970 |
|
|
9,392 |
|
Total liabilities and stockholders’ equity |
$ |
55,335 |
|
|
$ |
37,670 |
|
ZOSANO PHARMA
CORPORATIONCONDENSED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(in thousands, except share and
per share amounts)(unaudited)
|
Three Months Ended March 31, |
|
2020 |
|
2019 |
|
|
|
|
Revenue |
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
Research and development |
5,514 |
|
|
6,616 |
|
General and administrative |
3,082 |
|
|
2,871 |
|
Total operating expenses |
8,596 |
|
|
9,487 |
|
Loss from operations |
(8,596 |
) |
|
(9,487 |
) |
Other income (expense): |
|
|
|
Interest income |
10 |
|
|
80 |
|
Interest expense |
(206 |
) |
|
(41 |
) |
Other income, net |
103 |
|
|
22 |
|
Loss before provision for income
taxes |
(8,689 |
) |
|
(9,426 |
) |
Provision for income taxes |
— |
|
|
— |
|
Net loss |
$ |
(8,689 |
) |
|
$ |
(9,426 |
) |
Unrealized gain on marketable
securities, net of tax |
— |
|
|
6 |
|
Comprehensive loss |
$ |
(8,689 |
) |
|
$ |
(9,420 |
) |
|
|
|
|
Net loss per common share – basic
and diluted |
$ |
(0.24 |
) |
|
$ |
(0.79 |
) |
Weighted-average shares used in
computing net loss per common share – basic and diluted |
36,266,018 |
|
|
11,973,039 |
|
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