Zosano Pharma Reports Second Quarter 2017 Financial Results and Operational Update
August 10 2017 - 4:01PM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical stage
biopharmaceutical company focused on providing systemic
administration of therapeutics to patients using our proprietary
Adhesive Dermally-Applied Microarray (ADAM) technology, today
announced financial results for the second quarter ended June 30,
2017. In addition, the Company’s Board of Directors has appointed
John Walker, Zosano’s current Chairman and Interim CEO, as the
permanent CEO, effective immediately. Mr. Walker will also
remain Chairman of the Board.
“It is with great pleasure that I accept the role of permanent
CEO. I believe the company has a great deal of promise,
and our lead asset, M207, has demonstrated that it can be a
significant addition to the treatment options available to migraine
sufferers, if approved by the FDA,” commented John P. Walker,
Chairman and Chief Executive Officer. “Zosano continues to
execute on its operating plan, and is progressing towards
initiating our long-term safety study as previously announced. In
the second quarter, we received from the U.S. Food and Drug
Administration (FDA) confirmation of our previously announced study
design and requirements to advance M207 towards an NDA filing. In
addition, we participated in the American Headache Society meeting
in Boston as a late-breaking oral presentation. We continue
to prioritize increased awareness of M207 in the physician
community, and plan additional conference presentations and
publications in the second half of 2017.”
Recent Business Highlights and Clinical
Update
- In June 2017, Zosano held its end of Phase 2 meetings with the
FDA, where the FDA confirmed the previously announced design of the
Long-term Safety Study as sufficient to support an NDA filing for
M207, that the recently completed single, positive efficacy study
is sufficient for NDA filing for M207, and the FDA concurred that
the development strategy, which conforms to relevant regulatory
guidelines, appears adequate for registration of M207.
- June 2017, Zosano presented additional data from its pivotal
Phase 2/3 ZOTRIP study evaluating M207 as an acute treatment for
migraine during the 59th Annual Scientific Meeting of the American
Headache Society in Boston, Massachusetts. The 3.8mg dose achieved
significance in the secondary endpoints of pain freedom at 45
minutes and 1 hour and showed durability of effect on sustained
pain freedom at 24 and 48 hours.
- In July, Zosano announced the publication of positive phase 1
data of zolmitriptan delivery in Future Medicine’s Pain Management
Journal.
- Additionally, in July we strengthened our focus on
manufacturing leadership by promoting Hayley Lewis to Senior Vice
President of Operations. In addition to Quality, Regulatory
and FDA communications, her role has expanded to include the
additional responsibility of overseeing commercial scale process
development and manufacturing.
Financial Results for the Second Quarter Ended June 30,
2017
- Zosano reported a net loss for the second quarter of 2017 of
$6.7 million, or $0.17 per share on a basic and diluted basis,
compared with a net loss of $6.6 million, or $0.54 per share on a
basic and diluted basis, for the same quarter in 2016.
- Research and development (R&D) expenses for the second
quarter of 2017 were $4.4 million, compared with $4.3 million for
the same quarter in 2016. Increased costs in the second quarter of
2017 for labor, medical affairs, and the M207 long-term safety
study were largely offset by decreased costs for the M207 efficacy
study upon completion of the pivotal efficacy trial.
- General and administrative (G&A) expenses for the second
quarter of 2017 were $2.2 million, compared with $2.0 million for
the same quarter in 2016. G&A expenses for the second quarter
of 2017 were up slightly, due primarily to severance costs paid to
former executives.
- As of June 30, 2017, we had cash and cash equivalents of $21.2
million, short-term investments in marketable securities of $7.1
million, and debt of $9.6 million. As of June 30, 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 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 delivered
utilizing Zosano's proprietary Adhesive Dermally-Applied
Microarray, or ADAM technology. Zosano's ADAM technology
consists of titanium microprojections coated with drug, and in the
case of M207, our formulation of zolmitriptan. Our ADAM
technology delivers drug by abrading the stratum corneum and
allowing drug to be absorbed into the microcapillary system of the
skin. 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.
About Zosano Pharma
Zosano Pharma Corporation is a clinical stage biopharmaceutical
company focused on providing systemic administration of
therapeutics to patients using our proprietary Adhesive
Dermally-Applied Microarray, or ADAM technology. The Company
recently announced positive results from our ZOTRIP study that
evaluated M207, which is our proprietary formulation of
zolmitriptan delivered via our ADAM technology, as an acute
treatment for migraine. Zosano is focused on developing
products where rapid administration of established molecules with
known safety and efficacy profiles provides an increased benefit to
patients, for markets where patients remain underserved by existing
therapies. 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 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 June 30, |
|
|
Six Months Ended June 30, |
|
|
|
|
2017 |
|
|
|
|
2016 |
|
|
|
|
2017 |
|
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
$ |
- |
|
|
|
$ |
- |
|
|
|
$ |
- |
|
|
|
$ |
- |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
|
4,363 |
|
|
|
|
4,298 |
|
|
|
|
8,989 |
|
|
|
|
9,920 |
|
General
and administrative |
|
|
|
2,188 |
|
|
|
|
1,951 |
|
|
|
|
4,310 |
|
|
|
|
4,127 |
|
Total
operating expenses |
|
|
|
6,551 |
|
|
|
|
6,249 |
|
|
|
|
13,299 |
|
|
|
|
14,047 |
|
Loss from
operations |
|
|
|
(6,551 |
) |
|
|
|
(6,249 |
) |
|
|
|
(13,299 |
) |
|
|
|
(14,047 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense, net |
|
|
|
(207 |
) |
|
|
|
(321 |
) |
|
|
|
(454 |
) |
|
|
|
(637 |
) |
Other
income, net |
|
|
|
12 |
|
|
|
|
50 |
|
|
|
|
10 |
|
|
|
|
49 |
|
Net loss |
|
|
$ |
(6,746 |
) |
|
|
$ |
(6,520 |
) |
|
|
$ |
(13,743 |
) |
|
|
$ |
(14,635 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share ̶ basic and diluted |
|
|
$ |
(0.17 |
) |
|
|
$ |
(0.54 |
) |
|
|
$ |
(0.46 |
) |
|
|
$ |
(1.22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
used in computing net loss per common share ̶ basic and
diluted |
|
|
|
39,200 |
|
|
|
|
12,012 |
|
|
|
|
29,820 |
|
|
|
|
11,989 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ZOSANO PHARMA CORPORATION AND
SUBSIDIARY |
SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS
DATA |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
(unaudited) |
|
|
|
Cash, cash equivalents
and marketable securities |
|
|
$ |
28,225 |
|
|
$ |
15,003 |
Total current
assets |
|
|
|
29,391 |
|
|
|
15,276 |
Total assets |
|
|
|
34,644 |
|
|
|
20,906 |
Secured promissory
note |
|
|
|
9,634 |
|
|
|
12,542 |
Total liabilities |
|
|
|
12,687 |
|
|
|
16,421 |
Stockholders’
equity |
|
|
|
21,957 |
|
|
|
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
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