Zosano Pharma Reports Third Quarter 2020 Financial Results
November 13 2020 - 4:05PM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced financial results for
the third quarter ended September 30, 2020, as well as recent
business updates.
“Our priority focus is obtaining resolution regarding the NDA
for Qtrypta™,” said Steven Lo, President and CEO of Zosano. “We
plan on having a Type A meeting with the FDA as soon as possible
and look forward to clarification on next steps and the possibility
of resubmitting our NDA. We continue to believe in the promise that
Qtrypta holds as an attractive alternative for patients suffering
from migraine. Separately during the quarter, we executed a
feasibility study agreement with Mitsubishi Tanabe Pharma
Corporation that reinforces the potential of our transdermal
microneedle system technology.”
Recent Business Updates
- Entered into a feasibility study agreement with Mitsubishi
Tanabe Pharma Corporation. Under the agreement, Zosano plans to
evaluate the feasibility of formulating a pharmaceutical agent
being developed by Mitsubishi Tanabe Pharma Corporation for
administration with its proprietary transdermal microneedle system
technology
- Partnered with EVERSANA, a leading provider of commercial
services to the life science industry, to commercialize and
distribute Qtrypta™, if approved, in the United States
- Received a complete response letter (CRL) from the U.S.
Food and Drug Administration (FDA) in connection with the
Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2)
New Drug Application (NDA)
- To conserve resources, decided to end enrollment of new
subjects into the placebo-controlled Phase 2/3 clinical trial
evaluating the potential of C213 as an acute treatment for cluster
headache as of December 31, 2020; subjects enrolled prior to that
time will continue to be evaluated
Financial Results for the Third Quarter Ended September
30, 2020
Zosano reported a net loss for the third quarter of 2020 of $8.7
million, or $0.11 per share on a basic and diluted basis, compared
with a net loss of $9.9 million, or $0.55 per share on a basic and
diluted basis, for the same quarter in 2019.
Research and development expenses for the third quarter of 2020
were $5.8 million, compared with $6.5 million for the same quarter
in 2019. The decrease of $0.7 million was primarily attributable to
lower clinical trial costs of $0.8 million due to the
completion of Zosano’s long-term safety study in 2019, a decrease
of $0.2 million in compensation costs due to reduced headcount
and a $0.3 million decrease in travel and general business expenses
due to COVID-19. These decreases were partially offset by an
increase of $0.3 million associated with the scale up and
technology transfer to Zosano’s contract manufacturers and an
increase in depreciation expense of $0.3 million related to
assets placed into service at its contract manufacturers.
General and administrative expenses for the third quarter of
2020 were $2.7 million, compared with $3.1 million in 2019. The
decrease of $0.4 million was primarily attributable to a $0.4
million decrease in professional services costs related to
strategic and pre-commercial activities and a $0.2 million decrease
in compensation costs related to lower headcount. These decreases
were partially offset by a $0.2 million increase in legal and
professional services costs related to corporate and intellectual
property matters and audit fees.
As of September 30, 2020, cash and cash equivalents were $43.6
million as 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 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 or connect through LinkedIn at
https://www.linkedin.com/company/zosano-pharma, Twitter at
https://twitter.com/ZosanoPharma and Instagram at
https://www.instagram.com/zosanopharma/.
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, the company’s plan to have a Type A meeting with
the FDA and the company’s expectations with respect to the meeting
with the FDA, the company’s plan to evaluate the feasibility of
formulating a pharmaceutical agent being developed by Mitsubishi
Tanabe Pharma Corporation for administration, with the company’s
proprietary transdermal microneedle system technology and the
company’s plan with respect to the placebo-controlled Phase 2/3
clinical trial evaluating the potential of C213 as an acute
treatment for cluster headache. Such forward-looking statements
involve known and unknown risks, uncertainties, and other important
factors that may cause the company’s actual results, performance,
or achievements to be materially different from any future results,
performance, or achievements expressed or implied by the
forward-looking statements. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to the company’s business in general, see the most
recent Annual Report on Form 10-K and Quarterly Reports on Form
10-Q filed with the Securities and Exchange Commission. The company
does not plan to publicly update or revise any forward-looking
statements contained in this press release, whether as a result of
any new information, future events, changed circumstances or
otherwise, except as required by law.
Zosano Contacts: Christine Matthews Chief
Financial Officer 510-745-1200
Zosano PR: Sylvia
Wheeler or Alexandra Santos
swheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
ZOSANO PHARMA
CORPORATIONCONDENSED BALANCE
SHEETS(in thousands, except par value and share
amounts)
|
|
September 30, 2020 |
|
December 31, 2019 |
|
|
(unaudited) |
|
|
ASSETS |
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
43,554 |
|
|
$ |
6,316 |
|
Prepaid expenses and other current assets |
|
615 |
|
|
497 |
|
Total current assets |
|
44,169 |
|
|
6,813 |
|
Restricted cash |
|
455 |
|
|
455 |
|
Property and equipment,
net |
|
30,621 |
|
|
24,636 |
|
Operating lease right-of-use
assets |
|
5,204 |
|
|
5,763 |
|
Other long-term assets |
|
3 |
|
|
3 |
|
Total assets |
|
$ |
80,452 |
|
|
$ |
37,670 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
1,972 |
|
|
$ |
4,356 |
|
Accrued compensation |
|
1,982 |
|
|
2,015 |
|
Build-to-suit obligation, current portion |
|
4,293 |
|
|
4,554 |
|
Operating lease liabilities, current portion |
|
1,332 |
|
|
1,140 |
|
Paycheck Protection Program loan, current portion |
|
201 |
|
|
— |
|
Other accrued liabilities |
|
3,394 |
|
|
4,172 |
|
Total current liabilities |
|
13,174 |
|
|
16,237 |
|
Build-to-suit obligation,
long-term portion, net of debt issuance costs and discount |
|
5,447 |
|
|
6,095 |
|
Operating lease liabilities,
long-term portion |
|
5,058 |
|
|
5,931 |
|
Paycheck Protection Program
loan, long-term portion |
|
1,416 |
|
|
— |
|
Other liabilities |
|
113 |
|
|
15 |
|
Total liabilities |
|
25,208 |
|
|
28,278 |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
Preferred stock, $0.0001 par value; 5,000,000 shares authorized;
none issued and outstanding as of September 30, 2020 and
December 31, 2019 |
|
— |
|
|
— |
|
Common stock, $0.0001 par value; 250,000,000 shares authorized;
102,066,218 and 23,503,214 shares issued and outstanding as of
September 30, 2020 and December 31, 2019, respectively |
|
10 |
|
|
2 |
|
Additional paid-in capital |
|
379,326 |
|
|
308,211 |
|
Accumulated deficit |
|
(324,092 |
) |
|
(298,821 |
) |
Total stockholders’ equity |
|
55,244 |
|
|
9,392 |
|
Total liabilities and stockholders’ equity |
|
$ |
80,452 |
|
|
$ |
37,670 |
|
ZOSANO PHARMA
CORPORATIONCONDENSED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(in thousands, except share and
per share amounts)(unaudited)
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
5,824 |
|
|
6,486 |
|
|
16,270 |
|
|
19,742 |
|
General and administrative |
|
2,704 |
|
|
3,071 |
|
|
8,552 |
|
|
8,709 |
|
Total operating expenses |
|
8,528 |
|
|
9,557 |
|
|
24,822 |
|
|
28,451 |
|
Loss from operations |
|
(8,528 |
) |
|
(9,557 |
) |
|
(24,822 |
) |
|
(28,451 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
2 |
|
|
41 |
|
|
17 |
|
|
203 |
|
Interest expense |
|
(165 |
) |
|
(281 |
) |
|
(561 |
) |
|
(357 |
) |
Other income (expense), net |
|
4 |
|
|
(66 |
) |
|
95 |
|
|
(44 |
) |
Loss before provision for
income taxes |
|
(8,687 |
) |
|
(9,863 |
) |
|
(25,271 |
) |
|
(28,649 |
) |
Provision for income
taxes |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Net loss |
|
$ |
(8,687 |
) |
|
$ |
(9,863 |
) |
|
$ |
(25,271 |
) |
|
$ |
(28,649 |
) |
Unrealized gain on marketable
securities, net of tax |
|
— |
|
|
— |
|
|
— |
|
|
5 |
|
Comprehensive loss |
|
$ |
(8,687 |
) |
|
$ |
(9,863 |
) |
|
$ |
(25,271 |
) |
|
$ |
(28,644 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share –
basic and diluted |
|
$ |
(0.11 |
) |
|
$ |
(0.55 |
) |
|
$ |
(0.45 |
) |
|
$ |
(1.84 |
) |
Weighted-average shares used
in computing net loss per common share – basic and diluted |
|
77,883,158 |
|
|
17,832,092 |
|
|
56,437,417 |
|
|
15,579,387 |
|
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