Sunesis Pharmaceuticals Reports First Quarter 2017 Financial Results and Recent Highlights
08 May 2017 - 9:00PM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the first quarter ended March 31, 2017. Loss
from operations for the three months ended March 31, 2017 was $9.4
million. As of March 31, 2017, cash, cash equivalents and
marketable securities totaled $35.2 million.
“Following recent regulatory developments, our
reversible non-covalent BTK inhibitor, SNS-062, is the central
focus of our development efforts and resources,” said Daniel
Swisher, President and Chief Executive Officer of Sunesis. “Data
from SNS-062’s preclinical and healthy volunteer studies suggest a
unique drug profile for this next-generation BTK inhibitor and the
potential to overcome the key resistance mechanism of
ibrutinib. SNS-062 has the potential to address this
increasingly well-defined and prevalent unmet need in CLL and other
B-cell malignancy patients with C481S mutations, and we look
forward to dosing the first patient in our Phase 1B/2 study this
quarter.”
Mr. Swisher continued, “With regard to
vosaroxin, we plan to continue to advance its development through
investigator-sponsored group trials, and will carefully assess
business development alternatives to support any future
registration-directed studies. We expect that our current
cash resources are sufficient to fund the company into June
2018.”
First Quarter 2017 and Recent
Highlights
- Announced Withdrawal of Marketing Authorization
Application (MAA) for Vosaroxin in Europe and Shifted Primary
Development Focus to Non-Covalent Reversible BTK Inhibitor
SNS-062. On May 1st, Sunesis announced the withdrawal of
its European Marketing Authorization Application (MAA) for
vosaroxin as a treatment for relapsed/refractory acute myeloid
leukemia (AML) in patients aged 60 years and older. The decision
followed recent interactions with the European Medicine Agency’s
Committee for Medicinal Products for Human Use (CHMP), during
which the Company made an assessment based on feedback from its
rapporteurs and input from its regulatory consultants that the
committee was likely to formally adopt a negative opinion and a
withdrawal of its application was the best option at this time. The
Company also announced its plans to reduce its investment in its
AML program and shift an increasing portion of resources to the
Company’s kinase inhibitor pipeline, with an emphasis on timely
prosecution of SNS-062.
- Progress Toward Initiation of
a Phase 1b/2 Trial of
Non-Covalent Reversible BTK Inhibitor SNS-062 in
Patients with B-Cell Malignancies.
Sunesis continues to make progress toward the initiation of
treatment in a Phase 1b/2 Trial evaluating its unique, proprietary,
non-covalent reversible BTK-inhibitor SNS-062 in patients with
B-cell malignancies. The Company has activated multiple clinical
sites across the U.S., including at U.C. Irvine Cancer Center and
The Ohio State University Comprehensive Cancer Center. These
sites are beginning to actively identify patients. An additional
three top U.S. centers, Dana-Faber Cancer Institute, MD Anderson
Cancer Center and Weill Cornell Cancer Center, expected to be
initiated this quarter. Sunesis expects to announce the
dosing of the first patient this quarter.
- Announced Poster Presentation on BTK Inhibitor SNS-062
at the AACR Annual Meeting. In March, Sunesis announced a
poster presentation at the American Association for Cancer Research
2017 Annual Meeting. The poster, titled “SNS-062 demonstrates
efficacy in chronic lymphocytic leukemia in vitro and inhibits
C481S mutated Bruton tyrosine kinase” detailed results from The
Ohio State University-sponsored preclinical study, conducted in
collaboration with Sunesis, that examined the potency of SNS-062
versus ibrutinib and acalabrutinib, specifically relating to the
C481S mutation.
- Announced Progress in
Ongoing Investigator-Sponsored Studies Evaluating Vosaroxin in
Patients with Acute Myeloid Leukemia (AML). Sunesis
announced today that the Vanderbilt University sponsored VITAL
(Vosaroxin and Infusional
Cytarabine for Frontline Treatment
of Acute
Myeloid Leukemia) study of vosaroxin in
combination with cytarabine in patients with previously untreated
AML has progressed from Stage 1 to Stage 2. The single-arm,
open-label trial enrolled 17 patients in Stage 1 and, following a
one-time interim analysis by the Data Safety Monitoring Board of
responses exceeding a pre-defined efficacy threshold, is now
proceeding to enrollment in Stage 2. In this stage, the trial
will enroll at least 24 additional patients. The study is
being expanded to four additional sites including Yale University,
UCLA, Medical University of South Carolina and University of
Alabama. Sunesis also announced today that vosaroxin has been
selected as a treatment arm in the Phase 2/3 BIG-1
(Backbone
InterGroup-1) trial. BIG-1
is an open label, multicenter phase 2/3 study with multiple
randomization phases at different stages of AML treatment that is
designed to improve overall survival in younger patients (18 to 60
years). The vosaroxin portion of the trial, which is expected
to begin dosing imminently, will enroll up to 200 patients with
favorable or intermediate risk AML, who will receive consolidation
therapy of intermediate dose cytarabine with vosaroxin. The
study is being conducted at multiple French centers, led by the
University Hospital of Angers under the direction of Professor
Norbert Ifrah, and the University Institute of Hematology at the
Hôpital Saint-Louis under the direction of Professor Hervé
Dombret.
- Announced Organizational Updates. In March,
Sunesis announced two management additions: Judy Fox Ph.D. to the
position of Chief Scientific Officer and Pietro Taverna, Ph.D. to
Executive Director, Translational Medicine. In April, Eric
Bjerkholt resigned from his position of Chief Financial Officer.
Dan Swisher, our Chief Executive Officer, has assumed the CFO
responsibilities on an interim basis.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $35.2
million as of March 31, 2017, as compared to $42.6 million as of
December 31, 2016. The decrease of $7.4 million was
primarily due to $9.7 million of net cash used in operating
activities offset by $2.2 million 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 June 2018.
- Revenue for the three months ended March 31, 2017 was $0.7
million, as compared to $0.6 million for the same period on 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 $6.2 million for the three
months ended March 31, 2017 and for the same period in 2016,
primarily relating to the vosaroxin development program in each
period.
- General and administrative expense was $3.9 million for the
three months ended March 31, 2017 as compared to $4.3 million for
the same period in 2016. The decrease of $0.4 million in
2016 was primarily due to decrease in personnel expenses and
commercial expenses.
- Interest expense was $0.5 million for the three months ended
March 31, 2017 as compared to $0.3 million and for the same
period in 2016. The increase in the 2017 period was primarily due
to the increase in the notes payable.
- Net other income was $0.1 million for the three months ended
March 31, 2017 and for the same period in 2016. The other income
was primarily comprised of interest income from the short-term
investments.
- Cash used in operating activities was $9.7 million for the
three months ended March 31, 2017, as compared to
$10.7 million for the same period in 2016. Net cash used in
the 2017 period resulted primarily from the net loss of $9.8
million and changes in operating assets and liabilities of $0.9
million, partially offset by net adjustments for non-cash items of
$1.0 million.
- Sunesis reported loss from operations of $9.4 million for the
three months ended March 31, 2017, as compared to $9.9 million for
the same period in 2016. Net loss was $9.8 million for the three
months ended March 31, 2017, as compared to $10.1 million for the
same period 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 13018661. 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 potential treatment of solid and hematologic
cancers. Sunesis has built a highly-experienced cancer drug
development organization committed to improving the lives of people
with cancer. Currently, the company is focused on advancing its
novel kinase-inhibitor pipeline, which includes its proprietary
reversible non-covalent BTK-inhibitor, SNS-062.
For additional information on Sunesis, please
visit http://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 and commercialization of vosaroxin, the timing of our
Phase 1b/2 trial of SNS-062, and the sufficiency of Sunesis’ cash
and funding into June 2018. Words such as “advance,” “continue,”
“expect,” “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 that Sunesis may not be able to receive regulatory approval of
vosaroxin in the U.S. or Europe, that Sunesis' development
activities for SNS-062 or vosaroxin could be otherwise halted or
significantly delayed for various reasons, risks related to
Sunesis' need for substantial additional funding to complete the
development and commercialization of vosaroxin and other product
candidates, including SNS-062, the risk that Sunesis' clinical
studies for vosaroxin or other product candidates, including
SNS-062 or its pipeline of kinase inhibitors, 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, 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 March 31, 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 to 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) |
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2017 |
|
|
|
2016 |
|
|
(Unaudited) |
|
|
(1) |
|
|
|
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash
equivalents |
$ |
11,470 |
|
|
$ |
8,056 |
|
Marketable
securities |
|
23,706 |
|
|
|
34,532 |
|
Prepaids and other
current assets |
|
714 |
|
|
|
643 |
|
Total current
assets |
|
35,890 |
|
|
|
43,231 |
|
Property and equipment,
net |
|
1 |
|
|
|
3 |
|
Total assets |
$ |
35,891 |
|
|
$ |
43,234 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
2,647 |
|
|
$ |
1,871 |
|
Accrued clinical
expense |
|
1,351 |
|
|
|
1,434 |
|
Accrued
compensation |
|
1,055 |
|
|
|
2,000 |
|
Other accrued
liabilities |
|
1,782 |
|
|
|
1,691 |
|
Current portion of
deferred revenue |
|
- |
|
|
|
610 |
|
Current portion of
notes payable |
|
4,583 |
|
|
|
3,333 |
|
Total current
liabilities |
|
11,418 |
|
|
|
10,939 |
|
|
|
|
|
|
|
|
|
Non-current portion of
notes payable |
|
9,930 |
|
|
|
11,102 |
|
Other accrued
liabilities |
|
226 |
|
|
|
169 |
|
Commitments |
|
|
|
Stockholders’
equity: |
|
|
|
Preferred stock |
|
18,808 |
|
|
|
18,808 |
|
Common stock |
|
2 |
|
|
|
2 |
|
Additional paid-in
capital |
|
602,755 |
|
|
|
599,632 |
|
Accumulated other
comprehensive income (loss) |
|
(18 |
) |
|
|
(22 |
) |
Accumulated
deficit |
|
(607,230 |
) |
|
|
(597,396 |
) |
Total stockholders’
equity |
|
14,317 |
|
|
|
21,024 |
|
Total
liabilities and stockholders’ equity |
|
35,891 |
|
|
|
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 March
31, |
|
|
2017 |
|
|
|
2016 |
|
|
(Unaudited) |
|
(Unaudited) |
Revenue: |
|
|
|
License
and other revenue |
$ |
669 |
|
|
$ |
640 |
|
Total revenues |
|
669 |
|
|
|
640 |
|
|
|
|
|
Operating
expenses: |
|
|
|
Research
and development |
|
6,162 |
|
|
|
6,209 |
|
General
and administrative |
|
3,942 |
|
|
|
4,295 |
|
Total operating
expenses |
|
10,104 |
|
|
|
10,504 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(9,435 |
) |
|
|
(9,864 |
) |
|
|
|
|
|
|
|
|
Interest expense |
|
(484 |
) |
|
|
(298 |
) |
Other income (expense),
net |
|
85 |
|
|
|
76 |
|
Net loss |
|
(9,834 |
) |
|
|
(10,086 |
) |
Unrealized gain (loss) on available-for-sale securities |
|
4 |
|
|
|
13 |
|
Comprehensive loss |
$ |
(9,830 |
) |
|
$ |
(10,073 |
) |
|
|
|
|
|
|
|
|
Basic
and diluted loss per common share: |
|
|
|
Net
loss |
$ |
(9,834 |
) |
|
$ |
(10,086 |
) |
Shares
used in computing basic and diluted loss per common share |
|
21,029 |
|
|
|
14,443 |
|
Basic and diluted loss
per common share |
$ |
(0.47 |
) |
|
$ |
(0.70 |
) |
Investor and Media Inquiries:
Maeve Conneighton
Argot Partners
212-600-1902
Dan Swisher
Sunesis Pharmaceuticals Inc.
650-266-3715
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