Zosano Pharma Reports Third Quarter 2016 Financial Results
10 11월 2016 - 6:20AM
Zosano Pharma Corporation (NASDAQ:ZSAN), an emerging central
nervous system company focused on providing rapid symptom relief to
patients using the Company's proprietary intracutaneous delivery
system, today announced financial results for the third quarter
ended September 30, 2016.
“I'm extremely pleased with progress achieved during the period
across clinical and corporate development fronts. The announcement
of the first subject dosing in the Zotrip trial for the acute
treatment of migraine was, of course, a key milestone and we remain
on track to report results during the first quarter of 2017.
Additionally, we improved our balance sheet by executing a private
placement and strengthened the leadership team with the appointment
of Georgia Erbez as Chief Business Officer,” commented Konstantinos
Alataris, PhD, President and Chief Executive Officer of Zosano
Pharma. Ms. Erbez, who continues to serve as Zosano's Interim Chief
Financial Officer, has provided financial and strategic advisory
services as a consultant to multiple biotechnology companies and
has extensive experience in senior management roles in the
healthcare sector.
In July, Zosano announced the dosing of its first subject in its
registration-enabling pivotal efficacy trial (the Zotrip trial), of
its M207 patch, formerly known as ZP-Triptan, for the acute
treatment of migraine. The results from Zotrip are expected to be
reported in the first quarter of 2017. Furthermore, Zosano has
confirmed with the U.S. Food & Drug Administration (FDA) that a
single, positive, pivotal efficacy study, in addition to a one-year
safety study, will be sufficient to file for registration under the
505(b)(2) pathway.
In August, Zosano announced the completion of a private
placement that generated aggregate gross proceeds of approximately
$7.5 million.
Financial Results for the Third Quarter Ended September
30, 2016
- Zosano reported a net loss for the third quarter of 2016 of
$7.4 million, or $0.52 per share on a basic and diluted basis,
compared with a net loss of $8.6 million, or $0.72 per share on a
basic and diluted basis, for the same quarter in 2015.
- Research and development expenses for the third quarter of 2016
were $5.1 million, compared with $6.6 million for the same quarter
in 2015. The decision to suspend development of product candidates,
Daily B104, Weekly B206 and D107, resulted in a decrease primarily
related to production costs for the manufacturing of clinical trial
material for those products. The decrease was offset by an increase
related to M207 CRO costs.
- General and administrative expenses for the third quarter of
2016 were $2.0 million, compared with $1.7 million for the same
quarter in 2015. The increase in expenses was primarily due to an
increase in stock-based compensation, legal and consulting
costs.
- As of September 30, 2016, we had cash, cash equivalents and
marketable securities of $23.1 million, debt of $14.0 million, and
16.8 million common shares outstanding.
About Zosano Pharma
Zosano Pharma Corporation is an emerging CNS company focusing on
providing rapid symptom relief to patients using known therapeutics
and altering their delivery profile using the Company’s proprietary
intracutaneous delivery system. The Company’s goal is to make
intracutaneous drug delivery a standard of care for delivering
drugs requiring fast onset of action. Zosano Pharma has developed
its proprietary intracutaneous delivery system to administer
proprietary formulations of existing drugs through the skin for the
treatment of a variety of indications. The Company believes
that its intracutaneous delivery system offers rapid and consistent
drug delivery combined with ease of use. The Company is focused on
developing products that deliver established molecules with known
safety and efficacy profiles for markets where patients remain
underserved by existing therapies. Zosano Pharma 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 Statements
This press release contains forward-looking statements regarding
the timing of expected clinical development milestones, sufficiency
of our capital resources and need for future funding and other
future events and expectations. 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 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 our
2015 Annual Report on Form 10-K, as filed with the Securities
Exchange Commission on March 29, 2016. Although we believe that the
expectations reflected in these forward-looking statements are
reasonable, we 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 PHARMA CORPORATION AND
SUBSIDIARIES |
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(unaudited;
in thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
License fees revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
170 |
|
Collaborative development support
services |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
143 |
|
Total revenue |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
313 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
5,124 |
|
|
|
6,627 |
|
|
|
15,044 |
|
|
|
14,701 |
|
General and administrative |
|
|
2,010 |
|
|
|
1,719 |
|
|
|
6,137 |
|
|
|
4,797 |
|
Total operating expenses |
|
|
7,134 |
|
|
|
8,346 |
|
|
|
21,181 |
|
|
|
19,498 |
|
Loss from operations |
|
|
(7,134 |
) |
|
|
(8,346 |
) |
|
|
(21,181 |
) |
|
|
(19,185 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(314 |
) |
|
|
(314 |
) |
|
|
(951 |
) |
|
|
(1,247 |
) |
Other income |
|
|
- |
|
|
|
41 |
|
|
|
49 |
|
|
|
49 |
|
Warrant revaluation income |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
48 |
|
Loss on debt extinguishment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(446 |
) |
Net loss |
|
|
(7,448 |
) |
|
|
(8,619 |
) |
|
|
(22,083 |
) |
|
|
(20,781 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share ̶ basic and
diluted |
|
$ |
(0.52 |
) |
|
$ |
(0.72 |
) |
|
$ |
(1.73 |
) |
|
$ |
(1.85 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing net
loss per common share ̶ basic and diluted |
|
|
14,259 |
|
|
|
11,961 |
|
|
|
12,752 |
|
|
|
11,230 |
|
|
ZOSANO PHARMA CORPORATION AND
SUBSIDIARIES |
SELECTED
CONSOLIDATED BALANCE SHEETS DATA |
(in
thousands) |
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
(unaudited) |
|
|
Cash, cash equivalents and marketable
securities |
|
$ |
23,056 |
|
|
$ |
36,933 |
|
Total current assets |
|
|
23,497 |
|
|
|
37,271 |
|
Total assets |
|
|
30,027 |
|
|
|
45,337 |
|
Secured promissory notes, current |
|
|
5,931 |
|
|
|
3,360 |
|
Long-term debt |
|
|
8,095 |
|
|
|
11,910 |
|
Total liabilities |
|
|
18,019 |
|
|
|
18,835 |
|
Stockholders’ equity |
|
|
12,008 |
|
|
|
26,502 |
|
|
|
|
|
|
|
|
|
|
Zosano Contact:
Georgia Erbez
Chief Business Officer and
Interim Chief Financial Officer
510-745-1200
Investor Contact:
Jamien Jones
Blueprint Life Science Group
415-375-3340 x 5
jjones@bplifescience.com
Zosano Pharma (NASDAQ:ZSAN)
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