Zosano Pharma Reports First Quarter 2021 Financial Results
May 12 2021 - 4:05PM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced financial results for
the first quarter ended March 31, 2021, as well as business
highlights.
“We have gained clarity from the FDA on the resubmission plan
for the QtryptaTM NDA, and the full weight of our organization is
focused on this endeavor,” said Steven Lo, president and chief
executive officer of Zosano. “The pharmacokinetic study required
for resubmission of our Qtrypta NDA is expected to begin in June
with data available in the third quarter. Pending receipt of
positive data from this healthy volunteer study, we anticipate
resubmitting the NDA for Qtrypta by the end of this year. If
approved, we believe that Qtrypta would represent a significant
advancement in the acute treatment of migraine, a disease that
impacts one in four U.S. households.”
Select Business Highlights
- Received feedback from the U.S. Food and Drug Administration on
the protocol for the pharmacokinetic (“PK”) study required to
support the resubmission of the Qtrypta™ (zolmitriptan transdermal
microneedle system) 505(b)(2) New Drug Application (“NDA”)
- Established an agreement with Worldwide Clinical Trials to
conduct the Qtrypta PK study, which is expected to involve 48
healthy volunteers to generate comparative pharmacokinetic and
safety data
- Presented a post-hoc retrospective analysis of data from the
ZOTRIP trial at the January 2021 Annual Headache Cooperative of the
Pacific Winter Conference that suggested that Qtrypta conferred
therapeutic benefit at 30 minutes consistent with recently
published criteria for early onset of action, and that those
patients who were pain free at 30 minutes were still pain free at 2
hours
Financial Results for the First Quarter Ended March 31,
2021The company reported a net loss for the first quarter
of 2021 of $8.1 million, or $0.08 per share on a basic and diluted
basis, compared with a net loss of $8.7 million, or $0.24 per share
on a basic and diluted basis, for the same quarter in 2020.
In the first quarter of 2021, we recognized service revenue and
cost of service revenue on agreements with three pharmaceutical
companies in which we provide research and development services to
determine the feasibility of using our transdermal microneedle
system technology in connection with their pharmaceutical
agents.
Research and development expenses for the first quarter of 2021
were $5.3 million, compared with $5.5 million for the same quarter
in 2020. The decrease of $0.2 million was primarily due to lower
employee and temporary employee expenses and lower clinical trial
costs partially offset by higher production and manufacturing costs
due to the scale up and technology transfer to our commercial
manufacturing organizations and additional depreciation
expense.
General and administrative expenses for the first quarter of
2021 were $2.8 million, compared with $3.1 million for the same
quarter in 2020. The decrease of $0.3 million was primarily due to
lower professional service fees.
As of March 31, 2021, cash and cash equivalents were $26.9
million, compared with $35.3 million as of December 31, 2020.
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
designed to be delivered via its transdermal microneedle system
technology, as an acute treatment for migraine. Learn more at
www.zosanopharma.com.
Forward-Looking StatementsThis press release
contains forward-looking statements. All statements other than
statements of historical facts contained herein are forward-looking
statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, statements regarding the company’s plans for and
the anticipated timing with respect to the commencement of the PK
study and the availability of data from the study, the expected
timing of the resubmission of the company’s Qtrypta NDA to the FDA,
the potential benefits and availability 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," "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, 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 Contacts:Christine MatthewsChief
Financial Officer510-745-1200
Zosano PR:Sylvia Wheeler or Alexandra
Santosswheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
ZOSANO PHARMA
CORPORATIONBALANCE SHEETS(in
thousands, except par value and share amounts)
|
March 31,2021 |
|
December 31,2020 |
|
(unaudited) |
|
|
ASSETS |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
26,882 |
|
|
$ |
35,263 |
|
Prepaid expenses and other current assets |
1,591 |
|
|
453 |
|
Total current assets |
28,473 |
|
|
35,716 |
|
Restricted cash |
455 |
|
|
455 |
|
Property and equipment, net |
32,128 |
|
|
30,909 |
|
Operating lease right-of-use
assets |
4,651 |
|
|
4,928 |
|
Other long-term assets |
3 |
|
|
3 |
|
Total assets |
$ |
65,710 |
|
|
$ |
72,011 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,661 |
|
|
$ |
1,884 |
|
Accrued compensation |
2,703 |
|
|
2,294 |
|
Build-to-suit obligation, current portion, net of debt issuance
costs and discount |
4,697 |
|
|
4,779 |
|
Operating lease liabilities, current portion |
1,434 |
|
|
1,378 |
|
Paycheck Protection Program loan, current portion |
1,422 |
|
|
809 |
|
Other accrued liabilities |
1,491 |
|
|
3,367 |
|
Total current liabilities |
14,408 |
|
|
14,511 |
|
Build-to-suit obligation,
long-term portion, net of debt issuance costs and discount |
3,426 |
|
|
4,359 |
|
Operating lease liabilities,
long-term portion |
4,304 |
|
|
4,687 |
|
Paycheck Protection Program loan,
long-term portion |
204 |
|
|
812 |
|
Other long-term liabilities |
217 |
|
|
127 |
|
Total liabilities |
22,559 |
|
|
24,496 |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.0001 par value; 5,000,000 shares authorized;
none issued and outstanding as of March 31, 2021 and
December 31, 2020, respectively |
— |
|
|
— |
|
Common stock, $0.0001 par value; 250,000,000 shares authorized as
of March 31, 2021 and December 31, 2020, respectively;
106,372,820 and 102,066,218 shares issued and outstanding as of
March 31, 2021 and December 31, 2020, respectively |
11 |
|
|
10 |
|
Additional paid-in capital |
383,472 |
|
|
379,695 |
|
Accumulated deficit |
(340,332 |
) |
|
(332,190 |
) |
Total stockholders’ equity |
43,151 |
|
|
47,515 |
|
Total liabilities and stockholders’ equity |
$ |
65,710 |
|
|
$ |
72,011 |
|
|
|
|
|
|
|
|
|
ZOSANO PHARMA
CORPORATIONSTATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(in thousands, except per share
amounts)(unaudited)
|
Three Months Ended March 31, |
|
2021 |
|
2020 |
|
|
|
|
Service revenue |
$ |
258 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
Cost of service revenue |
162 |
|
|
— |
|
Research and development |
5,330 |
|
|
5,514 |
|
General and administrative |
2,814 |
|
|
3,082 |
|
Total operating expenses |
8,306 |
|
|
8,596 |
|
Loss from operations |
(8,048 |
) |
|
(8,596 |
) |
Other income (expense): |
|
|
|
Interest income |
1 |
|
|
10 |
|
Interest expense |
(97 |
) |
|
(206 |
) |
Other income (expense), net |
2 |
|
|
103 |
|
Loss before provision for income
taxes |
(8,142 |
) |
|
(8,689 |
) |
Provision for income taxes |
— |
|
|
— |
|
Net loss and comprehensive
loss |
$ |
(8,142 |
) |
|
$ |
(8,689 |
) |
|
|
|
|
Net loss per common share – basic
and diluted |
$ |
(0.08 |
) |
|
$ |
(0.24 |
) |
Weighted-average common shares
used in computing net loss per common share – basic and
diluted |
104,356 |
|
|
36,266 |
|
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