Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2015 Financial Results and Recent Highlights
March 10 2016 - 6:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the fourth quarter and year ended December
31, 2015. Loss from operations for the three months and year ended
December 31, 2015 was $11.3 million and $39.3 million,
respectively. As of December 31, 2015, cash, cash equivalents and
marketable securities totaled $46.4 million.
“In the fourth quarter, we achieved a top 2015
corporate milestone with the submission and validation of our
Marketing Authorization Application in Europe for vosaroxin to
treat relapsed/refractory AML,” said Daniel Swisher, Chief
Executive Officer of Sunesis. “We are committed to bringing
this important new therapy to a patient population with so few
options. We will be providing updates later this year on the
progress in Europe and in other major regions, including North
America.”
Mr. Swisher added: “Another key milestone for
Sunesis is the progress of our pipeline of kinase inhibitors
representing targeted new approaches to the treatment of cancer.
Soon, we expect to initiate clinical development of SNS-062, our
differentiated non-covalent BTK inhibitor with a European Phase 1A
clinical trial in healthy volunteers, followed by a Phase 1B/2 in
B-cell malignancy patients later this year. We also look
forward to seeing data from the ongoing multi-arm combination study
for the Takeda-partnered pan-RAF inhibitor, TAK-580, and to
advancing our PDK-1 inhibitor, SNS-229, through IND-enabling
toxicology studies to an IND.”
Fourth Quarter 2015 and Recent Highlights
- Submission of Marketing Authorization Application for
Vosaroxin for the Treatment of Acute Myeloid Leukemia (AML) in
Europe. In December 2015, Sunesis submitted a Marketing
Authorization Application (MAA) with the European Medicines
Agency (EMA) for Vosaroxin for the treatment of
relapsed/refractory AML in patients aged 60 years and older.
The application was validated by the EMA on December 31, 2015,
confirming that the submission was complete and initiating the
Centralized Review process by the EMA’s Committee for
Medicinal Products for Human Use (CHMP). The MAA, if
authorized, provides a marketing license valid in all 28 EU member
states.
- Presentation of Results from MD Anderson Sponsored
Trial in AML and Washington University Sponsored Phase 1/2 Trial of
Vosaroxin in MDS at ASH Annual Meeting. In December 2015,
Sunesis presented results from an ongoing Phase 1B/2 University of
Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in
combination with decitabine in older patients with previously
untreated acute myeloid leukemia (AML) and high-risk myelodyplastic
syndrome (MDS), as well as results from a Washington
University-sponsored Phase 1 trial of vosaroxin plus azacitidine in
patients with myelodysplastic syndrome, at the 57th American
Society of Hematology Annual Meeting in Orlando, Florida.
The oral presentation, titled “Phase I/II Study of Vosaroxin and
Decitabine in Newly Diagnosed Older Patients (pts) with Acute
Myeloid Leukemia (AML) and High Risk Myelodyplastic Syndrome (MDS)”
and the poster “A Phase I Study of Vosaroxin plus Azacitidine for
Patients with Myelodysplastic Syndrome,” are available on the
Sunesis website at www.sunesis.com.
- Partnership with Clinigen Group to Initiate
Compassionate Use Program for Patients with AML. In
December 2015, Sunesis initiated a global Compassionate Use Program
for vosaroxin. The program is available to eligible patients
diagnosed with relapsed or refractory acute myeloid leukemia (AML)
and is being managed by Clinigen Group's Idis Managed Access
division.
- First Patient Treated in Indiana University Study of
Vosaroxin and Cytarabine in Adults Age 60 Years and Older With
Previously Untreated AML. In December 2015, the first
patient was treated in an investigator-sponsored study of vosaroxin
and cytarabine in adult patients age 60 years and older with
previously untreated acute myeloid leukemia (AML). The trial is
being conducted at the Melvin and Bren Simon Cancer
Center at Indiana University under the direction
of Seyed Hamid Sayar, M.D., Assistant Professor of Clinical
Medicine.
- European Patent Covering Vosaroxin Combination Use in
AML and Other Hematological Malignancies. In November
2015, the European Patent Office (EPO) granted European Patent No.
2 049 109 B1, claiming certain combined uses of vosaroxin and
cytarabine, at doses of 10-120 mg/m2 and 5-1500 mg/m2,
respectively, for the treatment of acute myelogenous leukemia and
acute myeloblastic leukemia. The patent further provides for
combinations of vosaroxin and cytarabine with other therapies, such
as radiation, or other chemotherapeutics, including anti-cancer
agents, in hematologic disorders, whether administered
simultaneously or sequentially. Sunesis is proceeding to validate
this patent in multiple EPO member states. The resulting national
patents would expire in the third quarter of 2027, but could be
eligible for supplementary patent term in EPO member states beyond
this date. Related patent applications are pending in several
countries, including the United
States and Japan.
- Poster Presentation of VALOR Responder Survival
Analysis at the Chemotherapy Foundation Symposium. In
November, Sunesis presented results from a responder survival
analysis of the VALOR trial at the 2015 Chemotherapy Foundation
Symposium (CFS) in New York City. The analysis examined the impact
of complete remission status on overall survival. Results showed
that CR status was the strongest independent predictor of overall
survival in patients enrolled in the study, regardless of study
arm, with median survival for patients in CR lasting more than 12
months longer than patients without a CR. Furthermore, the
addition of vosaroxin to cytarabine demonstrated a two-fold
increase in CR rate by day 60. The poster presentation, titled
“Impact of Complete Remission on Overall Survival in Patients with
Refractory/Relapsed Acute Myeloid Leukemia Treated with Vosaroxin
Plus Cytarabine or Placebo Plus Cytarabine: Responder Analysis for
the Phase 3 VALOR Trial,” is available at
www.sunesis.com.
- Presentations at the 2015 AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer
Therapeutics. In November 2015, two poster
presentations from the company’s proprietary kinase inhibitor
programs were presented at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics. The
presentations included preclinical data from the company’s
selective PDK1 inhibitors SNS-229 and SNS-510, as well as the
company’s potent noncovalent second-generation BTK inhibitor,
SNS-062.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $46.4
million as of December 31, 2015, as compared to $43.0 million as of
December 31, 2014. The increase of $3.4 million was primarily due
to net proceeds of $43.8 million from the sale of common and
preferred shares and from the exercise of warrants, stock options
and stock purchase rights, partially offset by $38.7 million of net
cash used in operating activities and $1.7 million of principal
payments against notes payable. This capital is expected to be
sufficient to fund operations through the first quarter of
2017.
- Revenues for the three months and year ended December 31,
2015 were $0.7 million and $3.1 million, as compared
to $0.9 million and $5.7 million for the same
periods in 2014. Revenue in each period was primarily due to
deferred revenue recognized related to the royalty agreement
with Royalty Pharma.
- Research and development expenses were $7.6
million and $23.7 million for the three months and
year ended December 31, 2015, from $6.0
million and $27.7 million for the same periods in
2014, primarily relating to the vosaroxin development program in
each year. The decrease of $4.0 million in 2015 was primarily due
to a decrease of $5.4 million in clinical trial expenses, partially
offset by increases of $0.9 million in personnel costs (including
an increase of $0.5 million in stock-based compensation
expense), and $0.5 million in other outside services and consulting
costs.
- General and administrative expenses for the three months and
year ended December 31, 2015 were $4.4
million and $18.7 million, as compared to $6.1
million and $23.1 million in 2014. The decrease of
$4.5 million in 2015 was due to a decrease of $4.5 million in
professional services and personnel costs.
- Interest expense was $0.2 million and $0.9
million for the three months and year ended December 31,
2015 as compared to $0.3 million and $1.7
million for the same periods in 2014. The decreases in 2015 were
due to the reduced principal balance outstanding on notes payable
to the Lenders under the Loan Agreement.
- Net other income was nil and $3.6 million for
the three months and year ended December 31, 2015, as compared
to $10.1 million and $3.8 million for the same
periods in 2014. The 2014 and 2015 amounts were primarily comprised
of non-cash credits for the revaluation of warrants issued in an
underwritten offering in 2010.
- Cash used in operations was $38.7 million for the
year ended December 31, 2015, as compared to $43.2
million for the same period in 2014.
- Sunesis reported loss from operations of $11.3
million and $39.3 million for the three months and
year ended December 31, 2015, as compared to $11.2
million and $45.0 million for the same periods in
2014. Net loss was $11.6 million and $36.7
million for the three months and year ended December 31,
2015, as compared to $1.3 million and $43.0
million for the same periods in 2014.
Conference Call Information
Sunesis will host an update conference call
today, March 10th at 11:00 a.m. Eastern Time. The call can be
accessed by dialing (877) 771-6242 (U.S. and Canada) or (440)
996-5676 (international) and entering passcode 49218884. 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 QINPREZO™ (vosaroxin)
QINPREZO™ (vosaroxin) is an anti-cancer
quinolone derivative (AQD), a class of compounds that has not been
used previously for the treatment of cancer. Preclinical data
demonstrate that vosaroxin both intercalates DNA and inhibits
topoisomerase II, resulting in replication-dependent,
site-selective DNA damage, G2 arrest and apoptosis. Both
the U.S. Food and Drug Administration (FDA)
and European Commission have granted orphan drug
designation to vosaroxin for the treatment of AML. Additionally,
vosaroxin has been granted fast track designation by
the FDA for the potential treatment of relapsed or
refractory AML in combination with cytarabine. Vosaroxin is an
investigational drug that has not been approved for use in any
jurisdiction.
The trademark name QINPREZO is conditionally
accepted by the FDA and the EMA as the proprietary name
for the vosaroxin drug product candidate.
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 and is currently pursuing regulatory approval
in Europe for its lead product candidate, vosaroxin, for
the treatment of relapsed or refractory acute myeloid leukemia in
patients aged 60 and older. In addition, the company is advancing
its kinase-inhibitor pipeline of novel targeted therapies into the
clinic.
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 Sunesis' estimated
timelines for regulatory interactions and regulatory progress,
including the anticipated progress and potential approval of
vosaroxin by the EMA, clinical development of SNS-062; Sunesis'
overall strategy in Europe and other major regions and plans to
gain marketing approval of vosaroxin in the U.S., the design,
conduct and results of clinical trials, including the expected
progress in its kinase inhibitor pipeline, and potential
advancements of SNS-229 to an IND, the need for and the role of
vosaroxin as a potential new treatment option, , and the
sufficiency of Sunesis' cash resources. Words such as
"expect," “look forward,” "potential," "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
vosaroxin could be otherwise halted or significantly delayed for
various reasons, the risk that Sunesis' clinical studies for
vosaroxin or other product candidates, including 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
conduct of Sunesis' clinical trials, risks related to Sunesis' need
for substantial additional funding to complete the development and
commercialization of vosaroxin and other product candidates, 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 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 September 30, 2015, Sunesis' Annual
Report on Form 10-K for the year ended December 31, 2015, when
available, 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) |
|
|
|
|
|
December 31, |
|
|
2015 |
|
|
|
2014 |
|
ASSETS |
(Unaudited) |
|
(Note 1) |
Current assets: |
|
|
|
Cash and cash
equivalents |
$ |
25,387 |
|
|
$ |
22,186 |
|
Marketable
securities |
|
21,043 |
|
|
|
20,795 |
|
Prepaids and other
current assets |
|
558 |
|
|
|
1,223 |
|
Total current
assets |
|
46,988 |
|
|
|
44,204 |
|
Property and equipment,
net |
|
14 |
|
|
|
42 |
|
Deposits and other
assets |
|
- |
|
|
|
- |
|
Total assets |
$ |
47,002 |
|
|
$ |
44,246 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
2,453 |
|
|
$ |
3,177 |
|
Accrued clinical
expense |
|
1,954 |
|
|
|
3,112 |
|
Accrued
compensation |
|
1,606 |
|
|
|
2,287 |
|
Other accrued
liabilities |
|
2,711 |
|
|
|
3,087 |
|
Current portion of
deferred revenue |
|
2,441 |
|
|
|
3,418 |
|
Current portion of
notes payable |
|
7,834 |
|
|
|
9,257 |
|
Warrant liability |
|
- |
|
|
|
3,543 |
|
Total current
liabilities |
|
18,999 |
|
|
|
27,881 |
|
Non-current portion of
deferred revenue |
|
610 |
|
|
|
2,563 |
|
Non-current portion of
notes payable |
|
- |
|
|
|
- |
|
Commitments |
|
|
|
Stockholders’ equity
(deficit): |
|
|
|
Convertible preferred
stock |
|
16,459 |
|
|
|
- |
|
Common stock |
|
9 |
|
|
|
7 |
|
Additional paid-in
capital |
|
570,309 |
|
|
|
536,499 |
|
Accumulated other
comprehensive loss |
|
(11 |
) |
|
|
(7 |
) |
Accumulated
deficit |
|
(559,373 |
) |
|
|
(522,697 |
) |
Total stockholders’
equity (deficit) |
|
27,393 |
|
|
|
13,802 |
|
Total liabilities and
stockholders’ equity (deficit) |
$ |
47,002 |
|
|
$ |
44,246 |
|
|
|
|
|
Note
1: The consolidated balance sheet as of December 31, 2014 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, 2014. |
SUNESIS
PHARMACEUTICALS, INC. |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
AND
COMPREHENSIVE LOSS |
(In thousands,
except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
Three months ended December
31, |
|
Year ended December
31, |
|
|
|
2015 |
|
|
|
2014 |
|
|
|
2015 |
|
|
|
2014 |
|
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Note 2) |
Revenue: |
|
|
|
|
|
|
|
|
License and other
revenue |
$ |
670 |
|
|
$ |
896 |
|
|
$ |
3,061 |
|
|
$ |
5,734 |
|
Total
revenues |
|
670 |
|
|
|
896 |
|
|
|
3,061 |
|
|
|
5,734 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
|
7,628 |
|
|
|
5,968 |
|
|
|
23,701 |
|
|
|
27,665 |
|
General and
administrative |
|
4,382 |
|
|
|
6,082 |
|
|
|
18,662 |
|
|
|
23,112 |
|
Total
operating expenses |
|
12,010 |
|
|
|
12,050 |
|
|
|
42,363 |
|
|
|
50,777 |
|
Loss from
operations |
|
(11,340 |
) |
|
|
(11,154 |
) |
|
|
(39,302 |
) |
|
|
(45,043 |
) |
Interest
expense |
|
(234 |
) |
|
|
(311 |
) |
|
|
(939 |
) |
|
|
(1,719 |
) |
Other
income (expense), net |
|
(4 |
) |
|
|
10,142 |
|
|
|
3,565 |
|
|
|
3,760 |
|
Net
loss |
|
|
(11,578 |
) |
|
|
(1,323 |
) |
|
|
(36,676 |
) |
|
|
(43,002 |
) |
Unrealized gain (loss) on available-for-sale securities |
|
(9 |
) |
|
|
2 |
|
|
|
(4 |
) |
|
|
(4 |
) |
Comprehensive loss |
$ |
(11,587 |
) |
|
$ |
(1,321 |
) |
|
$ |
(36,680 |
) |
|
$ |
(43,006 |
) |
Basic and diluted loss per common share: |
|
|
|
|
|
|
|
Net
loss: |
|
|
|
|
|
|
|
|
Basic |
$ |
(11,578 |
) |
|
$ |
(1,323 |
) |
|
$ |
(36,676 |
) |
|
$ |
(43,002 |
) |
Diluted |
$ |
(11,578 |
) |
|
$ |
(1,323 |
) |
|
$ |
(36,676 |
) |
|
$ |
(46,894 |
) |
Shares used in computing net loss per common share: |
|
|
|
|
|
|
|
Basic |
|
76,683 |
|
|
|
63,041 |
|
|
|
72,933 |
|
|
|
60,057 |
|
Diluted |
|
76,683 |
|
|
|
63,041 |
|
|
|
72,933 |
|
|
|
60,510 |
|
Net loss
per common share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.15 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.50 |
) |
|
$ |
(0.72 |
) |
Diluted |
$ |
(0.15 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.50 |
) |
|
$ |
(0.76 |
) |
|
|
|
|
|
|
|
|
|
Note 2:
The consolidated statement of operations and comprehensive loss for
the year ended December 31, 2014 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,
2014. |
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
Sunesis Pharmaceuticals (NASDAQ:SNSS)
Historical Stock Chart
From Sep 2024 to Oct 2024
Sunesis Pharmaceuticals (NASDAQ:SNSS)
Historical Stock Chart
From Oct 2023 to Oct 2024