Zosano Pharma Corporation (NASDAQ:ZSAN), a CNS-focused company with
a lead product, M207, that recently established a differentiated
safety and efficacy profile in a pivotal trial as an acute
treatment for migraine, today reported financial results for the
first quarter ended March 31, 2017. In addition, John P. Walker,
Chairman of the company’s Board of Directors, has been named
Interim Chief Executive Officer to replace Konstantinos
Alataris who has resigned as CEO and director of the company.
Georgia Erbez, our Chief Business Officer and Interim Chief
Financial Officer, has assumed full responsibility for both
functions.
“The first quarter saw our lead product candidate meet both
co-primary endpoints in ZOTRIP, our pivotal efficacy study of M207
as an acute treatment for migraine. In addition, the company
completed a follow-on offering that resulted in $29.3 million in
gross proceeds earmarked for advancing M207 towards FDA approval.
These two important accomplishments are a result of the commitment
and capabilities of Zosano’s management team and gives me great
confidence in our ability to continue to meet the strategic
milestones established by the company.”
“The pivotal study results importantly validate our technology
platform, and, if approved by the FDA, point to M207’s positioning
as an acute treatment for migraine sufferers that is differentiated
from what is currently available. I look forward to working
with the team at Zosano and to bringing this exciting new drug to
market,” commented John P. Walker, Interim Chief Executive
Officer.
"On behalf of the Board of Directors, I want to thank
Konstantinos Alataris for his efforts and commitment to the
company over the past two years. We wish him well in his future
endeavors,” added Walker.
Pivotal Study Results / Status
In February, the Company announced statistically significant
results from the ZOTRIP trial, which demonstrated that the 3.8mg
dose of M207 met both co-primary endpoints, achieving pain freedom
and most bothersome symptom freedom at 2 hours. The 3.8mg dose
achieved a p value of <0.05 in the secondary endpoints of
pain freedom at 45 minutes and 1 hour, and showed durability of
effect on pain freedom to 24 and 48 hours. These results
demonstrated that M207 not only provided fast onset but also a
durability of effect, up to 2 days and hence freedom from
recurrence of migraine. Additionally, M207 demonstrated a similar
safety profile as other triptans and no Serious Adverse Events
(SAEs) were reported in the trial.
The FDA has indicated that a single, positive, pivotal efficacy
study, in addition to a safety study of M207, will be sufficient to
file for approval under a 505(b)(2) pathway. The Company plans to
initiate the safety study in the second half of 2017.
Financial Results for the First Quarter Ended March 31,
2017
- Zosano reported a net loss for the first quarter of 2017 of
$7.0 million, or $0.34 per share on a basic and diluted basis,
compared with a net loss of $8.1 million, or $0.68 per share on a
basic and diluted basis, for the same quarter in 2016.
- Research and development (R&D) expenses for the first
quarter of 2017 were $4.6 million, compared with $5.6 million for
the same quarter in 2016. The decrease was primarily driven by
decreased costs for the M207 efficacy study upon completion of the
pivotal efficacy trial and by the workforce reduction costs
associated with our strategic realignment in the first quarter of
2016.
- General and administrative (G&A) expenses for the first
quarter of 2017 were $2.1 million, compared with $2.2 million for
the same quarter in 2016. G&A expenses were essentially
consistent and were primarily composed of personnel, consulting
costs, and stock compensation expense.
- As of March 31, 2017, we had cash and cash equivalents of $37.3
million, and debt of $11.2 million. As of March 31, 2017, we had
approximately 39.2 million common shares outstanding. In March,
Zosano announced the completion of a public offering of common
stock that generated aggregate gross proceeds of approximately
$29.3 million. The financing provides funding for the continued
advancement of M207 towards an NDA submission.
About John P. Walker
Walker brings to Zosano more than 40 years of experience as
a Board Chairman, Chief Executive Officer and interim CEO at life
science companies. In these roles, he has been involved with
Vitaphore, which was sold to Union Carbide Chemicals and Plastics;
Arris/Axys, which was sold to Celera Genomics; Centaur, which was
sold to Renovis; Signal Pharmaceuticals, which was sold to Celgene;
Kai Pharmaceuticals, which was sold to Amgen; Guava Technologies,
which was sold to Millipore; and iPierian, which was sold to
Bristol Myers Squibb as well as in the mergers of Novacea and
Transcept and of Renovis and Evotec.
He is currently serving as Executive Chairman of Vizuri Life
Sciences LLC and has been a director on the Boards of other life
science companies, including Geron, Evotec and Affymax. In
addition, he currently serves on the Board of Directors of the
Lucille Packard Children’s Hospital at Stanford University and
Random Acts of Flowers, a non-profit that repurposes flowers for
ill patients. He began his early business career at American
Hospital Supply Corporation where he became President of the
Hospital Company.
About Migraine
Migraine is the leading cause of disability among neurological
disorders in the United States according to the American Migraine
Foundation. Migraine symptoms can include moderate to severe
headache pain combined with nausea and vomiting, or abnormal
sensitivity to light and sound. According to the Migraine
Research Foundation, migraine affects 30 million men, women
and children in the United States. Most migraines last between four
and 24 hours, but some last as long as three days. According to
published studies, 63% of migraine patients experience between one
and four migraines per month. According to Decision Resources,
prescription drug sales for migraine in the top seven countries
were estimated to be $3.3 billion in 2015, and are expected to grow
to $4.4 billion in 2020. Triptans, a family of tryptamine-based
drugs first sold in the 1990s, account for almost 75% of
anti-migraine therapies prescribed at office visits.
About M207
M207 is our proprietary formulation of zolmitriptan coated onto
our patented intracutaneous microneedle patch, which is then
applied with our proprietary applicator to ensure uniform and
consistent application. In February 2017, the Company announced
statistically significant results from the ZOTRIP trial, which
demonstrated that the 3.8mg dose of M207 met both co-primary
endpoints, achieving pain freedom and most bothersome symptom
freedom at 2 hours. In a Phase 1 trial, M207 demonstrated
markedly faster absorption kinetics compared to oral zolmitriptan.
The Company presented these results at the 2016 annual meeting of
the American Headache Society.
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 the
Company’s most recent annual report on Form 10-K.. 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
SUBSIDIARY |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(unaudited; in thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
Revenue |
$ |
- |
|
|
$ |
- |
|
Operating
expenses: |
|
|
|
Research
and development |
|
4,626 |
|
|
|
5,622 |
|
General
and administrative |
|
2,122 |
|
|
|
2,176 |
|
Total
operating expenses |
|
6,748 |
|
|
|
7,798 |
|
Loss from
operations |
|
(6,748 |
) |
|
|
(7,798 |
) |
Other
expense: |
|
|
|
Interest
expense, net |
|
(247 |
) |
|
|
(316 |
) |
Other
expense, net |
|
(2 |
) |
|
|
(1 |
) |
Loss
before provision for income taxes |
|
(6,997 |
) |
|
|
(8,115 |
) |
Provision
for income taxes |
|
- |
|
|
|
- |
|
Net loss |
|
(6,997 |
) |
|
|
(8,115 |
) |
|
|
|
|
Net loss per common
share ̶ basic and diluted |
$ |
(0.34 |
) |
|
$ |
(0.68 |
) |
|
|
|
|
Weighted-average shares
used in computing net loss per common share ̶
basic and diluted |
|
20,335 |
|
|
|
11,967 |
|
ZOSANO PHARMA CORPORATION AND
SUBSIDIARY |
SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS
DATA |
(in thousands) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
(unaudited) |
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
37,341 |
|
$ |
15,003 |
Total current
assets |
|
|
38,103 |
|
|
15,276 |
Total assets |
|
|
43,182 |
|
|
20,906 |
Secured promissory
note |
|
|
11,155 |
|
|
12,542 |
Total liabilities |
|
|
14,659 |
|
|
16,421 |
Stockholders’
equity |
|
|
28,523 |
|
|
4,485 |
Zosano Contact:
Georgia Erbez
Chief Business Officer and
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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