Zosano Pharma Reports Third Quarter 2018 Financial Results and Operational Update
November 14 2018 - 4:05PM
Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the
“Company”), a clinical-stage biopharmaceutical company, today
announced financial results for the third quarter ended September
30, 2018.
“The Company has continued to execute upon our
stated milestones throughout 2018. We recently completed our
registration batches; reached an important milestone in our
long-term safety study as 150 patients completed 6 months of
therapy; secured a capital equipment lease line and contracted with
a leading organization to manufacture M207. This manufacturing
arrangement provides production capacity for the commercial launch
of M207 and frees up our in house manufacturing capacity for
research and the production of clinical trial material as we seek
to expand our portfolio of proprietary programs,” stated John
Walker, chairman and chief executive officer.
“Aditionally, Greg Kitchener joined us as Chief
Financial Officer in October 2018. He brings to Zosano an enviable
track record in capital formation, and solid experience in business
and in building strong financial organizations. In concert with
Greg and the rest of the team, we will continue to focus our
attention on the execution needed to advance M207. By the end of
the first quarter of 2019, we anticipate completing the final data
set in our long-term safety study, with 50 subjects completing
their 12 month visit, and in the third quarter of 2019, we expect
to complete stability testing for our GMP manufacturing lots,
leading to the filing of the NDA in the fourth quarter of next
year.”
Recent Business Highlights and Clinical
Update
- In September 2018, Dr. Stewart Tepper presented M207 data, when
used for the treatment of difficult to treat migraines at the 17th
Biennial Migraine Trust International Symposium (MTIS).
- In September 2018, Zosano presented a phase 3 safety study
update for ADAM technology for the delivery of zolmitriptan at the
5th Annual Transdermal and Intradermal Drug Delivery Systems
Conference.
- In September 2018, Zosano announced completion and release of
registration batches of M207.
- In September 2018, Zosano entered into a financing partnership
with Trinity Capital investments that provides a capital equipment
leasing line of up to $14.0 million.
- In October 2018, Zosano entered into a long-term manufacturing
and supply agreement with Patheon, a leading global contract
development and manufacturing organization.
- In October 2018, Zosano appointed Greg Kitchener as Chief
Financial Officer.
- In October 2018, Zosano hosted a key opinion leader meeting on
new treatments for Migraine. A replay is accessible via the link
here.
- In October 2018, Zosano announced more than 150 evaluable
subjects have completed their six month visit in the M207-ADAM
study and more than 4,000 migraines treated since study
initiation.
Financial Results for the Third Quarter Ended September
30, 2018
- Zosano reported a net loss of $8.2 million, or $0.68 per share
on a basic and diluted basis, and $25.2 million, or $2.93 per share
on a basic and diluted basis, for the three and nine months ended
September 30, 2018, respectively, compared to a net loss of $7.9
million, or $0.20 per share on a basic and diluted basis, and $21.6
million, or $0.66 per share on a basic and diluted basis, for the
same periods in 2017.
- Research and development expenses were $5.9 million and $18.2
million for the three and nine months ended September 30, 2018,
respectively, compared to $5.7 million and $14.7 million for the
same periods in 2017. The increase in research and development
expenses was primarily attributable to an increase in clinical
trial costs related to the M207-ADAM study and to completion of the
registration batches.
- General and administrative (G&A) expenses were $2.4 million
and $6.9 million for the three and nine months ended September 30,
2018, respectively, compared to $2.0 million and $6.3 million for
the same periods in 2017. The increase in general and
administrative expenses was due to an increase in software
implementation costs as well as an increase in payroll and stock
compensation costs.
- As of September 30, 2018, Zosano had cash, cash equivalents and
marketable securities of $29.5 million, debt of $4.6 million and
approximately 12 million shares of common stock outstanding.
Conference Call The Company will host a
conference call with the investment community today, November 14th,
at 4:30 p.m. Eastern Time. The dial-in numbers for the conference
call are (844) 379-5311 (U.S.) or (209) 905-5963 (international).
The conference ID number is 3144819. To access the live webcast,
please visit the Investor Relations page of the Zosano Pharma
website at http://ir.zosanopharma.com/events.cfm. Please allow
extra time prior to the call to visit the site and download any
necessary software to listen to the live broadcast.
For interested individuals unable to join the live call, an
archived webcast will be available on the Company's website at
http://ir.zosanopharma.com/events.cfm approximately three hours
after the call and available through December 14, 2018.
About M207M207 is Zosano’s proprietary
formulation of zolmitriptan delivered utilizing its proprietary
ADAM technology. Zosano's ADAM technology consists of titanium
microprojections (microneedles) coated with drug, and in the case
of M207, its formulation of zolmitriptan. The drug-coated
microneedles penetrate into the epidermis and dermis, where the
drug is dissolved and enters into the bloodstream. In February
2017, the Company announced statistically significant results from
the ZOTRIP pivotal study, 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 November 2017, the
Company announced the initiation of its long-term safety study
evaluating M207 and expects to file a New Drug Application for M207
in the fourth quarter of 2019.
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 expected timing of a New
Drug Application for M207, the expected timing of the final data
set in the Company’s long-term safety study, and the expected
timing of stability testing for GMP manufacturing lots. 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, without
limitation, risks and uncertainties associated with the process of
discovering, developing and commercializing products that are safe
and effective for use as human therapeutics, risks and
uncertainties relating to the Company’s depence on third parties
for the development and commercialization of M207, risks and
uncertainties of the regulatory approval process, risks and
uncertainties 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 filed with the Securities and Exchange Commission (the
“SEC”) on March 12, 2018 and in the Company’s most recent quarterly
report on Form 10-Q filed with the SEC on November 14, 2018.
Although Zosano believes that the expectations reflected in these
forward-looking statements are reasonable, it 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. Zosano assumes no obligation to update
any forward-looking statements contained in this press release,
whether as a result of any new information, future events, changed
circumstances, or otherwise.
Zosano Contact: Greg Kitchener Chief Financial
Officer 510-745-1200
Media Contact:Sara ZelkovicLifeSci Public
Relationssara@lifescipublicrelations.com646-876-4933
|
ZOSANO PHARMA CORPORATION |
CONDENSED STATEMENTS OF
OPERATIONS |
(unaudited; in thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
5,899 |
|
|
|
5,683 |
|
|
|
18,238 |
|
|
|
14,672 |
|
General
and administrative |
|
|
2,353 |
|
|
|
2,036 |
|
|
|
6,887 |
|
|
|
6,346 |
|
Total
operating expenses |
|
|
8,252 |
|
|
|
7,719 |
|
|
|
25,125 |
|
|
|
21,018 |
|
Loss from
operations |
|
|
(8,252 |
) |
|
|
(7,719 |
) |
|
|
(25,125 |
) |
|
|
(21,018 |
) |
Other
income (expenses): |
|
|
|
|
|
|
|
|
Interest
income (expense), net |
|
|
74 |
|
|
|
(154 |
) |
|
|
(99 |
) |
|
|
(608 |
) |
Other
income, net |
|
|
9 |
|
|
|
- |
|
|
|
13 |
|
|
|
10 |
|
Net loss |
|
$ |
(8,169 |
) |
|
$ |
(7,873 |
) |
|
$ |
(25,211 |
) |
|
$ |
(21,616 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common
share ̶ basic and diluted |
|
$ |
(0.68 |
) |
|
$ |
(0.20 |
) |
|
$ |
(2.93 |
) |
|
$ |
(0.66 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares
used in computing net loss per common share ̶ basic and
diluted |
|
|
11,973 |
|
|
|
39,228 |
|
|
|
8,603 |
|
|
|
32,991 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ZOSANO PHARMA CORPORATION |
SELECTED CONDENSED BALANCE SHEETS
DATA |
(unaudited; in thousands) |
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2018 |
|
2017 |
|
|
(unaudited) |
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
29,476 |
|
$ |
11,651 |
Total current
assets |
|
|
30,545 |
|
|
13,393 |
Total assets |
|
|
38,855 |
|
|
18,000 |
Secured promissory
note |
|
|
- |
|
|
6,687 |
Equipment line of
credit |
|
|
4,601 |
|
|
- |
Total liabilities |
|
|
10,355 |
|
|
10,952 |
Stockholders’
equity |
|
|
28,500 |
|
|
7,048 |
|
|
|
|
|
|
|
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