Sunesis Pharmaceuticals Reports Third Quarter 2015 Financial Results and Recent Highlights
05 November 2015 - 11:00PM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the third quarter ended September 30, 2015.
Loss from operations for the three and nine months ended September
30, 2015 was $8.6 million and $28.0 million, respectively. As of
September 30, 2015, cash, cash equivalents and marketable
securities totaled $30.5 million.
"We continue to work diligently to complete and submit an MAA by
year end for approval of vosaroxin in Europe as a treatment for
AML," said Daniel Swisher, Chief Executive Officer of Sunesis. "We
believe the European market opportunity is significant, and remain
encouraged by the strong support from within the international AML
investigator community to bring this important new therapy to a
patient population that has seen little improvement in treatment
standards in the last 40 years. While this effort remains our
central priority, we are also carefully evaluating and refining our
plans to gain marketing approval in the U.S., and working toward
key milestones with our kinase inhibitor pipeline, including data
at the upcoming AACR-NCI-EORTC Conference followed by an upcoming
CTA filing and Phase 1 study for SNS-062 in Europe."
Third Quarter 2015 Highlights
- Received European regulatory guidance regarding
potential marketing authorization application for Vosaroxin in AML
and Announced Expected Submission of MAA Filing before Year
End. In July 2015, Sunesis announced that, following
pre-submission advisory meetings to discuss the potential
submission of a Marketing Authorization Application (MAA) for
vosaroxin in Europe, the company is proceeding with an MAA filing.
The MAA will focus on the indication of relapsed/refractory acute
myeloid leukemia (AML) in patients age 60 years and older, a
population with the greatest medical need and for whom the greatest
benefit was observed in the vosaroxin/cytarabine treatment arm of
VALOR, the company's pivotal Phase 3 study of vosaroxin in adult
patients with relapsed or refractory AML. In October, the company
confirmed that it intends to submit an MAA for vosaroxin by the end
of 2015.
- Announced Poster Presentation of VALOR Responder
Survival Analysis at the Chemotherapy Foundation
Symposium. Yesterday, Sunesis announced that results from
a responder survival analysis of the VALOR trial were presented in
a poster presentation 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 CR benefit conveyed by
vosaroxin was consistently beneficial across all pre-specified
subgroups, including in patients with the high unmet medical need,
such as those over 60 years of age and those with refractory or
relapsed disease. 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," will be available at www.sunesis.com
following the conclusion of the symposium.
- Announced Presentations at the Upcoming AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics. Sunesis recently announced that two poster
presentations from the company's proprietary kinase inhibitor
programs will be presented at the upcoming AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics, taking place November 5-9 in Boston, Massachusetts.
The presentations on November 8th will include 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.
- Announced Oral Presentation of VALOR Analysis at the
77th Annual Meeting of the Japanese Society of Hematology.
In October, Sunesis announced that data from an
analysis of the company's VALOR trial, evaluating vosaroxin in
older patients with AML, were presented at the AML Clinical Trial
Oral Session of the 77th Annual Meeting of the Japanese Society of
Hematology (JSH) in Kanazawa, Japan. The data presented at JSH,
which show a compelling survival benefit, durable responses and
tolerability profile in patients age 60 years and older, were first
presented at the European Hematology Association Congress in June
2015.
- Announced Publication of Vosaroxin Phase 3 VALOR Trial
Results in The Lancet Oncology. In August, Sunesis
announced that results from the company's Phase 3 VALOR trial were
published in The Lancet Oncology. The article, titled "Vosaroxin
plus cytarabine versus placebo plus cytarabine in patients with
first relapsed or refractory acute myeloid leukemia (VALOR): a
randomised, controlled, double-blind, multinational, phase 3 study"
is available online and appeared in the September 2015 print issue
of The Lancet Oncology. The published results describe how
although overall survival (OS) did not reach a significant
difference based on the primary unstratified log-rank analysis of
the endpoint, vosaroxin plus cytarabine, based on other
prespecified analyses did show an overall survival benefit in
relapsed/refractory AML, with the greatest benefit observed in
patients older than 60 years, a population with limited treatment
options.
- Received feedback from FDA regarding NDA filing for
Vosaroxin in AML. In July 2015, Sunesis announced that,
following a recent meeting with the U.S. Food and Drug
Administration (FDA), the FDA recommended that the company provide
additional clinical evidence to support a future NDA submission.
The company is currently evaluating and refining its plan to gain
marketing approval in the U.S. based on this feedback.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $30.5
million as of September 30, 2015, as compared to $43.0 million as
of December 31, 2014. The decrease of $12.5 million was primarily
due to $29.5 million of net cash used in operating activities and
$1.6 million of principal payments against notes payable, partially
offset by $18.6 million raised from the sale of common stock
through the company's at-the-market facility with Cantor Fitzgerald
& Co. and from option exercises. This capital is expected to be
sufficient to fund the company to the middle of 2016.
- Revenue for the three and nine months ended September 30, 2015
was $0.7 million and $2.4 million as compared to $0.9 million and
$4.8 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 expense was $5.3 million and $16.1
million for the three and nine months ended September 30, 2015 as
compared to $6.9 million and $21.7 million for the same periods in
2014. The decreases between the comparable three and nine month
periods were primarily due to reductions in clinical trial
expenses, consulting and other outside services costs in each case.
- General and administrative expense was $4.0 million and $14.3
million for the three and nine months ended September 30, 2015 as
compared to $7.2 million and $17.0 million for the same periods in
2014. The decreases between the comparable three and nine month
periods were primarily due to decreases in outside services and
personnel costs.
- Interest expense was $0.2 million and $0.7 million for the
three and nine months ended September 30, 2015 as compared to $0.4
million and $1.4 million for the same periods in 2014. The
decreases in the 2015 periods were due to the reduced principal
balance outstanding on notes payable.
- Net other income was $1.8 million and $3.6 million for the
three and nine months ended September 30, 2015 as compared to net
other expense of $1.6 million and $6.4 million for the same periods
in 2014. The amounts for each period were primarily comprised of
non-cash credits or charges for the revaluation of warrants issued
in 2010, which expired in October 2015.
- Cash used in operations was $29.5 million for the nine months
ended September 30, 2015 as compared to $34.2 million for the same
period in 2014. Net cash used in the 2015 period resulted primarily
from the net loss of $25.1 million and changes in operating assets
and liabilities of $5.6 million, partially offset by net
adjustments for non-cash items of $1.2 million.
- Sunesis reported loss from operations of $8.6 million and $28.0
million for the three and nine months ended September 30, 2015 as
compared to $13.3 million and $33.9 million for the same periods in
2014. Net loss was $7.0 million and $25.1 million for the three and
nine months ended September 30, 2015 as compared to $15.3 million
and $41.7 million for the same periods in 2014.
Conference Call Information
Sunesis will host an update conference call today, November 5th
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 65529984. 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 QINPREZOâ„¢ (vosaroxin)
QINPREZOâ„¢ (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 advancing its lead product candidate, vosaroxin, in
multiple indications to improve the lives of people with
cancer.
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 submission of the MAA for vosaroxin with the EMA, CTA
filing for SNS-062 in Europe and plans to gain marketing approval
of vosaroxin in the U.S., Sunesis' overall strategy, the design,
conduct and results of clinical trials, including the expected
progress in its kinase inhibitor pipeline, the need for and the
role of vosaroxin as a potential new treatment option, and Sunesis'
clinical development of vosaroxin, including the analysis of the
results from the VALOR clinical trial, the commercial potential of
vosaroxin in Europe and the U.S., and the sufficiency of
Sunesis' cash resources. Words such as "believe," "expect,"
"intends," "plan," "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 submit timely the MAA to the EMA, the
risk that Sunesis' clinical studies for vosaroxin may not lead to
regulatory approval 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 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 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. 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, 2015. 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) |
|
|
September 30, |
December 31, |
|
2015 |
2014 |
ASSETS |
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash and cash equivalents |
$ 16,801 |
$ 22,186 |
Marketable securities |
13,702 |
20,795 |
Prepaids and other current assets |
796 |
1,223 |
Total current assets |
31,299 |
44,204 |
Property and equipment, net |
17 |
42 |
Total assets |
$ 31,316 |
$ 44,246 |
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 1,790 |
$ 3,177 |
Accrued clinical expense |
1,909 |
3,112 |
Accrued compensation |
1,491 |
2,287 |
Other accrued liabilities |
2,652 |
3,087 |
Current portion of deferred revenue |
2,441 |
3,418 |
Current portion of notes payable |
5,861 |
9,257 |
Warrant liability |
-- |
3,543 |
Total current liabilities |
16,144 |
27,881 |
Non-current portion of deferred revenue |
1,221 |
2,563 |
Non-current portion of notes payable |
1,893 |
-- |
Commitments |
|
|
Stockholders' equity: |
|
|
Common stock |
8 |
7 |
Additional paid-in capital |
559,847 |
536,499 |
Accumulated other comprehensive loss |
(2) |
(7) |
Accumulated deficit |
(547,795) |
(522,697) |
Total stockholders' equity |
12,058 |
13,802 |
Total liabilities and stockholders'
equity |
$ 31,316 |
$ 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 September 30, |
Nine months ended
September 30, |
|
2015 |
2014 |
2015 |
2014 |
|
(Unaudited) |
(Unaudited) |
|
|
Revenue: |
|
|
|
|
License and other revenue |
$ 683 |
$ 854 |
$ 2,391 |
$ 4,838 |
Total revenues |
683 |
854 |
2,391 |
4,838 |
Operating expenses: |
|
|
|
|
Research and development |
5,259 |
6,939 |
16,073 |
21,697 |
General and administrative |
3,994 |
7,226 |
14,280 |
17,030 |
Total operating expenses |
9,253 |
14,165 |
30,353 |
38,727 |
Loss from operations |
(8,570) |
(13,311) |
(27,962) |
(33,889) |
Interest expense |
(233) |
(391) |
(705) |
(1,408) |
Other income (expense), net |
1,782 |
(1,623) |
3,569 |
(6,382) |
Net loss |
(7,021) |
(15,325) |
(25,098) |
(41,679) |
Unrealized gain (loss) on available-for-sale
securities |
3 |
(2) |
5 |
(6) |
Comprehensive loss |
$ (7,018) |
$ (15,327) |
$ (25,093) |
$ (41,685) |
Basic and diluted loss per common
share: |
|
|
|
Net loss |
$ (7,021) |
$ (15,325) |
$ (25,098) |
$ (41,679) |
Shares used in computing basic and
diluted loss per common share |
74,776 |
60,549 |
71,670 |
59,052 |
Basic and diluted loss per common
share |
$ (0.09) |
$ (0.25) |
$ (0.35) |
$ (0.71) |
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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