Sunesis Pharmaceuticals Reports Second Quarter 2017 Financial Results and Recent Highlights
27 July 2017 - 9:00PM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the second quarter ended June 30, 2017. Loss
from operations for the three months ended June 30, 2017 was $8.6
million. As of June 30, 2017, cash, cash equivalents and marketable
securities totaled $22.7 million.
“We have made tangible progress under our
revised operating plan to focus primarily on our non-covalent BTK
inhibitor, SNS-062. With the first patient being dosed, the
recent initiation of our Phase 1b/2 study in patients with relapsed
chronic lymphocytic leukemia (CLL) and other B-cell malignancies
marks an important milestone for the company,” said Daniel Swisher,
Chief Executive Officer of Sunesis. “SNS-062 is designed to
overcome the leading resistance pathway to ibrutinib, the
predominant standard of care for the treatment of CLL. As a
reversible, non-covalent BTK inhibitor, SNS-062 has the potential
to establish proof of concept through the treatment and evaluation
of resistant B-cell malignancy patients from this ongoing Phase
1b/2 study.”
Mr. Swisher added, “As we work toward this goal,
we will maintain a streamlined operation and a focused investment
plan with current cash resources lasting into second quarter of
2018.”
Recent Highlights
- First Patient Dosed in Phase 1b/2 Study Evaluating Oral
Non-Covalent BTK-inhibitor SNS-062 in Adults with Chronic
Lymphocytic Leukemia (CLL) and other B-Cell Malignancies.
In July, Sunesis announced that the first patient was dosed at the
Dana-Farber Cancer Institute in the Phase 1b/2 dose-escalation and
cohort-expansion study evaluating the safety, pharmacokinetics,
pharmacodynamics, and antitumor activity of its oral, reversible,
non-covalent BTK-inhibitor, SNS-062, in adults with CLL, small
lymphocytic leukemia, Waldenstrom’s macroglobulemia and mantle cell
lymphoma. The Phase 1b/2 trial is an open-label,
sequential-group study that will enroll up to 124 subjects and is
being conducted at five leading sites in the United States.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $22.7
million as of June 30, 2017, as compared to $42.6 million as of
December 31, 2016. The decrease of $19.9 million was
primarily due to $20.5 million of net cash used in operating
activities and a debt restructuring payment of $7.6 million,
partially offset by $8.2 million primarily from sales of common
stock through the company’s at the market facility. The Company
expects that its current cash resources are sufficient to fund the
company into the second quarter of 2018.
- Revenue for the three and six months ended June 30, 2017 was
nil and $0.7 million, as compared to $0.6 million and $1.3 million
for the same periods in 2016. Revenue in each period was
primarily due to deferred revenue recognized related to the Royalty
Agreement with Royalty Pharma.
- Research and development expense was $4.9 million and $11.1
million for the three and six months ended June 30, 2017 as
compared to $6.6 million and $12.8 million for the same periods in
2016. The decrease of $1.7 million between each of the
comparable periods from last year was primarily related to reduced
spending on the vosaroxin program.
- General and administrative expense was $3.7 million and $7.6
million for the three and six months ended June 30, 2017, as
compared to $4.0 million and $8.3 million for the same periods in
2016. The decreases of $0.3 million and $0.7 million between
the comparable periods in 2016 were primarily due to reduced
personnel and commercial expenses.
- Interest expense was $0.3 million and $0.8 million for the
three and six months ended June 30, 2017, as compared to
$0.5 million and $0.8 million for the same periods in 2016.
- Net other income was $0.1 million and $0.2 million for the
three and six months ended June 30, 2017, as compared to nil and
$0.1 million for the same periods in 2016. The other income was
primarily comprised of interest income from the short-term
investments.
- Cash used in operating activities was $20.5 million for the six
months ended June 30, 2017, as compared to $20.1 million for
the same period in 2016. Net cash used in the 2017 period resulted
primarily from the net loss of $18.7 million and changes in
operating assets and liabilities of $3.9 million, partially offset
by net adjustments for non-cash items of $2.1 million.
- Sunesis reported loss from operations of $8.6 million and $18.1
million for the three and six months ended June 30, 2017, as
compared to $10.0 million and $19.9 million for the same periods in
2016. Net loss was $8.8 million and $18.7 million for the
three and six months ended June 30, 2017, as compared to $10.4
million and $20.5 million for the same periods in 2016.
Conference Call Information
Sunesis will host a conference today at 2:00
p.m. Eastern Time. The call can be accessed by dialing (844)
296-7720 (U.S. and Canada) or (574) 990-1148 (international)
and entering passcode 51914278. To access the live audio webcast,
or the subsequent archived recording, visit the “Investors and
Media – Calendar of Events” section of the Sunesis website
at www.sunesis.com. The webcast will be recorded and available
for replay on the company’s website for two weeks.
About Sunesis
Pharmaceuticals
Sunesis is a biopharmaceutical company focused
on the development and commercialization of new oncology
therapeutics for the treatment of solid and hematologic cancers.
Sunesis has built an experienced cancer drug development
organization committed to improving the lives of people with
cancer. The company is focused on advancing its novel
kinase-inhibitor pipeline, with an emphasis on establishing proof
of concept with its oral non-covalent BTK-inhibitor, SNS-062, in
ibrutinib-resistant chronic lymphocytic leukemia. Sunesis also is
supporting investigator-led studies of vosaroxin in acute myeloid
leukemia.
For additional information on Sunesis, please
visit www.sunesis.com.
SUNESIS and the logos are trademarks
of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking
statements, including statements related to the continued
development of SNS-062, including the timing of our Phase 1b/2
trial of SNS-062 and the therapeutic potential of SNS-062, further
development of its kinase inhibitor pipeline, business development
alternatives for vosaroxin, and the sufficiency of Sunesis’ cash
and funding into June 2018. Words such as “continue,”
“expect,” “goal,” “look forward,” “promising,” “will” and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon Sunesis' current
expectations. Forward-looking statements involve risks and
uncertainties. Sunesis' actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, the risk related
to the timing or conduct of Sunesis' clinical trials, including
SNS-062 Phase 1b/2 trial, the risk that Sunesis' clinical studies
for SNS-062, vosaroxin or other product candidate may not
demonstrate safety or efficacy or lead to regulatory approval, the
risk that data to date and trends may not be predictive of future
data or results, risks related to the timing or conduct of Sunesis'
clinical trials, that Sunesis' development activities for SNS-062
or vosaroxin could be otherwise halted or significantly delayed for
various reasons, that Sunesis may not be able to receive regulatory
approval of SNS-062 or vosaroxin in the U.S. or Europe,
and risks related to Sunesis' ability to raise the capital that it
believes to be accessible and is required to fully finance the
development and commercialization of SNS-062, vosaroxin and other
product candidates. These and other risk factors are discussed
under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on
Form 10-Q for the quarter ended June 30, 2017 and Sunesis'
other filings with the Securities and Exchange
Commission. Sunesis expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein reflect any change in
Sunesis' expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are
based.
SUNESIS PHARMACEUTICALS, INC. |
|
|
CONSOLIDATED BALANCE SHEETS |
|
|
(In thousands) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
(Unaudited) |
|
|
(1) |
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash
equivalents |
$ |
11,672 |
|
|
$ |
8,056 |
|
|
|
Marketable
securities |
|
11,011 |
|
|
|
34,532 |
|
|
|
Prepaids and other
current assets |
|
840 |
|
|
|
643 |
|
|
|
Total current
assets |
|
23,523 |
|
|
|
43,231 |
|
|
|
Property and equipment,
net |
|
25 |
|
|
|
3 |
|
|
|
Deposits and other
assets |
|
1,371 |
|
|
|
|
|
Total assets |
$ |
24,919 |
|
|
$ |
43,234 |
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
$ |
2,277 |
|
|
$ |
1,871 |
|
|
|
Accrued clinical
expense |
|
809 |
|
|
|
1,434 |
|
|
|
Accrued
compensation |
|
1,172 |
|
|
|
2,000 |
|
|
|
Other accrued
liabilities |
|
1,065 |
|
|
|
1,691 |
|
|
|
Current portion of
deferred revenue |
|
- |
|
|
|
610 |
|
|
|
Current portion of
notes payable |
|
1,667 |
|
|
|
3,333 |
|
|
|
Total current
liabilities |
|
6,990 |
|
|
|
10,939 |
|
|
|
Non-current portion of
notes payable |
|
5,424 |
|
|
|
11,102 |
|
|
|
Other accrued
liabilities |
|
32 |
|
|
|
169 |
|
|
|
Commitments |
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
Preferred stock |
|
18,808 |
|
|
|
18,808 |
|
|
|
Common stock |
|
2 |
|
|
|
2 |
|
|
|
Additional paid-in
capital |
|
609,744 |
|
|
|
599,632 |
|
|
|
Accumulated other
comprehensive income (loss) |
|
(9 |
) |
|
|
(22 |
) |
|
|
Accumulated
deficit |
|
(616,072 |
) |
|
|
(597,396 |
) |
|
|
Total stockholders’
equity |
|
12,473 |
|
|
|
21,024 |
|
|
|
Total
liabilities and stockholders’ equity |
|
24,919 |
|
|
|
43,234 |
|
|
|
|
|
|
|
|
|
Note 1: The consolidated balance sheet as of December 31,
2016 has been derived from the audited financial statements as of
that date included in the Company's Annual Report on Form 10-K for
the year ended December 31, 2016. |
|
|
|
|
|
|
|
|
|
SUNESIS PHARMACEUTICALS, INC. |
|
|
|
CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
|
|
AND COMPREHENSIVE
LOSS |
|
|
|
(In thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June
30, |
|
Six months ended June
30, |
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Note 2) |
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
License and other
revenue |
$ |
- |
|
|
$ |
610 |
|
|
$ |
669 |
|
|
$ |
1,250 |
|
|
|
Total
revenues |
|
- |
|
|
|
610 |
|
|
|
669 |
|
|
|
1,250 |
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
4,941 |
|
|
|
6,606 |
|
|
|
11,103 |
|
|
|
12,815 |
|
|
|
|
General and
administrative |
|
3,671 |
|
|
|
3,997 |
|
|
|
7,613 |
|
|
|
8,292 |
|
|
|
Total
operating expenses |
|
8,612 |
|
|
|
10,603 |
|
|
|
18,716 |
|
|
|
21,107 |
|
|
|
Loss from
operations |
|
(8,612 |
) |
|
|
(9,993 |
) |
|
|
(18,047 |
) |
|
|
(19,857 |
) |
|
|
Interest
expense |
|
(344 |
) |
|
|
(476 |
) |
|
|
(828 |
) |
|
|
(774 |
) |
|
|
Other
income (expense), net |
|
114 |
|
|
|
23 |
|
|
|
199 |
|
|
|
99 |
|
|
|
Net loss |
|
|
(8,842 |
) |
|
|
(10,446 |
) |
|
|
(18,676 |
) |
|
|
(20,532 |
) |
|
|
Unrealized gain (loss) on available-for-sale securities |
|
9 |
|
|
|
(1 |
) |
|
|
13 |
|
|
|
12 |
|
|
|
Comprehensive loss |
$ |
(8,833 |
) |
|
$ |
(10,447 |
) |
|
$ |
(18,663 |
) |
|
$ |
(20,520 |
) |
|
|
Basic and diluted loss per common share: |
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(8,842 |
) |
|
$ |
(10,446 |
) |
|
$ |
(18,676 |
) |
|
$ |
(20,532 |
) |
|
|
|
Shares
used in computing basic and diluted loss per common share |
|
21,521 |
|
|
|
14,493 |
|
|
|
21,276 |
|
|
|
14,468 |
|
|
|
Basic and
diluted loss per common share |
$ |
(0.41 |
) |
|
$ |
(0.72 |
) |
|
$ |
(0.88 |
) |
|
$ |
(1.44 |
) |
|
|
Investor and Media Inquiries:
Maeve Conneighton
Argot Partners
212-600-1902
Dan Swisher
Sunesis Pharmaceuticals Inc.
650-266-3715
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