Phase 1b/2 Data From MD
Anderson Sponsored Study of Vosaroxin in AML and High-Risk MDS to
be Presented at the AACR Annual Meeting 2014
Sunesis to Host Conference Call Today at 11:00AM Eastern
Time
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the fourth quarter and year ended December
31, 2013. Loss from operations for the three months and year ended
December 31, 2013 was $7.6 million and $31.8 million, respectively.
As of December 31, 2013, cash, cash equivalents and marketable
securities totaled $39.3 million. On March 4, 2014, Sunesis closed
an underwritten public offering for net proceeds of approximately
$40.0 million.
Sunesis also announced today that updated data from the ongoing
Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored
study of vosaroxin in combination with decitabine in older patients
with previously untreated acute myeloid leukemia (AML) and
high-risk myelodysplastic syndrome (MDS) will be presented at the
American Association for Cancer Research Annual Meeting 2014 (AACR)
on April 8 in San Diego, California. The abstract (#CT307), which
includes preliminary results, can be found on the AACR website.
"Vosaroxin is one of the most advanced and promising therapies
in development for AML today, and with a transformative year ahead,
we will look to realize its ability to change the global standard
of care in this disease," said Daniel Swisher, Chief Executive
Officer of Sunesis. "This goal centers on the unblinding of VALOR,
expected in the third quarter of 2014, and will be supported by
data from investigator- and company-sponsored trials, beginning
with the MD Anderson-sponsored Phase 1b/2 study presentation at
AACR in April. A positive VALOR data readout will begin Sunesis'
transition from a development-stage to a commercial-ready
company."
Mr. Swisher added: "Beyond our lead program, 2014 has and will
continue to be an important year for the development of our
pipeline. We recently announced the licensing of two exciting new
programs - a differentiated BTK inhibitor and a novel PDK1
inhibitor program. Together with vosaroxin and MLN2480, a pan-RAF
inhibitor being developed with Millennium, these assets provide the
foundation for creating a leading oncology franchise."
Fourth Quarter 2013 and Recent Highlights
- Continued strong execution of VALOR trial.
Based on a recent evaluation of survival events, the unblinding of
the pivotal, Phase 3 VALOR trial of vosaroxin plus cytarabine in
first relapsed or refractory AML is now expected in the third
quarter of 2014, after reaching 562 events and locking the final
study database.
- Initiated additional investigator sponsored
studies. In December 2013, Sunesis announced the
initiation of a Phase 1/2 investigator-sponsored trial of vosaroxin
in combination with azacitidine in patients with MDS. The trial is
being conducted at the Washington University School of Medicine
under the direction of Meagan A. Jacoby, M.D., Ph.D., Instructor of
Medicine, Division of Oncology.
In October 2013, Sunesis announced the initiation of a Phase 1/2
investigator-sponsored trial of vosaroxin in adult patients with
previously treated intermediate-2 or high-risk MDS. The trial is
being conducted at Weill Cornell Medical College and New
York-Presbyterian Hospital under the direction of Gail J. Roboz,
M.D., Associate Professor of Medicine and Director of the Leukemia
Program.
- Secured additional granted patents for vosaroxin
program. In the second half of 2013, the Japan Patent
Office (JPO) granted Sunesis a patent relating to the IND
formulation of vosaroxin, and the JPO and the Australian
intellectual property office (IP Australia) each granted the
company a patent relating to certain uses of vosaroxin for
treatment of AML. In addition, the US Patent and Trademark Office
granted Sunesis a patent relating to certain methods of use of
vosaroxin for treating AML, and a further patent relating to
certain compositions of vosaroxin.
- Appointed Chief Commercial Officer. In
February 2014, Sunesis announced the appointment of Joseph I.
DePinto to the newly created position of Executive Vice
President and Chief Commercial Officer. Mr. DePinto brings over two
decades of experience in global commercial operations, including
the leadership of the commercial, marketing and strategic
development efforts behind a number of prominent oncology products.
- Expanded oncology franchise through global licensing
agreements with Biogen and Takeda/Millennium. In January
2014, Sunesis announced that it expanded its oncology franchise
through separate global licensing agreements for two preclinical
kinase inhibitor programs. The first agreement, with Biogen Idec,
is for global commercial rights to SNS-062, a potent and selective
non-covalently binding oral inhibitor of BTK (Bruton's tyrosine
kinase). BTK is a mediator of B-cell receptor signaling integral to
the pathogenesis of B-cell malignancies. Sunesis anticipates filing
an investigational new drug (IND) application for SNS-062 with the
U.S. Food and Drug Administration (FDA) in approximately one year
to begin human clinical trials.
The second agreement, with Millennium: The Takeda Oncology
Company, is for global commercial rights to several potential
first-in class, pre-clinical inhibitors of the novel target PDK1
(phosphoinositide-dependent kinase-1). PDK1 is a key kinase and
mediator of PI3K/AKT signaling, a pathway involved in cell growth,
proliferation, differentiation, motility and survival. Sunesis
anticipates selecting a lead PDK1 development candidate this year
to take into IND-enabling studies.
Financial Highlights
- Cash and investments totaled $39.3 million as of December 31,
2013, as compared to $71.2 million as of December 31, 2012. The
decrease of $31.9 million was primarily due to $37.4 million of net
cash used in operating activities and $7.2 million of principal
payments against notes payable, partially offset by net proceeds of
$12.0 million from sales of common stock through the at-the-market
facility with Cantor Fitzgerald & Co. (Cantor) and $0.6 million
from the exercise of warrants, stock options and stock purchase
rights. As of December 31, 2013, outstanding debt totaled $18.0
million.
- On March 4, 2014, Sunesis completed a $43.0 million
underwritten offering of 4,650,000 shares of common stock together
with two warrants to purchase one share of the company's common
stock for each share sold. The public offering price of each share
of common stock and two accompanying warrants was $9.25. Net
proceeds from the sale were approximately $40.0 million, after
deducting the underwriting discount and estimated offering
expenses.
The warrants may only be gross exercised for cash following
unblinding of the VALOR trial. The per share exercise price of the
first warrant (Series A warrants) is $8.50 and the second warrant
(Series B warrants) is $12.00. The Series A warrants are
exercisable until the later of 30 days after VALOR unblinding (but
no later than March 4, 2016) or December 4, 2014. The Series B
warrants are exercisable until the later of 30 days following the
PDUFA date for vosaroxin (but no later than March 4, 2016) or
September 4, 2015. Assuming the warrants are exercised in full, the
warrants could result in additional net proceeds to Sunesis of up
to $95.3 million.
- Revenues for the three months and year ended December 31, 2013
were $2.0 million and $8.0 million, as compared to $2.0 million and
$3.8 million for the same periods in 2012. Revenue in both years
was due to deferred revenue recognized under the royalty agreement
with Royalty Pharma.
- Research and development expenses decreased to $6.9 million and
$28.9 million for the three months and year ended December 31,
2013, from $7.6 million and $29.2 million for the same periods in
2012. The decreases in 2013 were primarily due to lower drug
manufacturing and other outside services and consulting costs.
- General and administrative expenses for the three months and
year ended December 31, 2013 were $2.7 million and $10.8 million,
as compared to $2.5 million and $9.2 million in 2012. The increases
in 2013 were primarily due to higher professional services and
personnel costs.
- Interest expense was $0.6 million and $2.9 million for the
three months and year ended December 31, 2013 as compared to $0.8
million and $1.9 million for the same periods in 2012. The increase
for the full year 2013 was due to the draw-down in September 2012
of the $15.0 million second tranche of the October 2011 loan
facility.
- Net other income was $1.0 million and $0.1 million for the
three months and year ended December 31, 2013 as compared to net
other income of $4.9 million and net other expense of $7.5 million
for the same periods in 2012. The amounts for each period were
primarily comprised of non-cash charges or credits for the
revaluation of warrants issued in an underwritten offering in 2010.
- Cash used in operations was $9.7 million and $37.4 million for
the three months and year ended December 31, 2013, as compared to
$9.3 million and $10.6 million for the same periods in 2012. Net
cash used in 2013 resulted primarily from the net loss of $34.6
million and changes in operating assets and liabilities of $7.1
million, including $8.0 million related to recognition of deferred
revenue under the royalty agreement with Royalty Pharma, partially
offset by net adjustments for non-cash items of $4.3 million,
including expenses of $3.9 million related to stock-based
compensation.
- Sunesis reported loss from operations of $7.6 million and $31.8
million for the three months and year ended December 31, 2013, as
compared to $8.1 million and $34.6 million for the same periods in
2012. Net loss was $7.2 million and $34.6 million for the three
months and year ended December 31, 2013, as compared to $4.1
million and $44.0 million for the same periods in 2012.
AACR Poster Information
A poster, titled "Phase I/II study of vosaroxin and decitabine
in older patients with acute myeloid leukemia (AML) and high risk
myelodysplastic syndrome (MDS)," will be presented at the San Diego
Convention Center, Hall A-E, Poster Section 38, during the Phase
II/III Clinical Trials Poster Session on Tuesday, April 8, 2014
from 8:00 a.m. to 12:00 p.m. Pacific Time (Poster #7).
Conference Call Information
Sunesis will host an update conference call today, March 6th at
11:00 a.m. Eastern Time. The call can be accessed by dialing (800)
591-6942 (U.S. and Canada) or (617) 614-4909 (international), and
entering passcode 15910310. 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 VALOR
VALOR is a Phase 3, randomized, double-blind,
placebo-controlled, pivotal trial in patients with first relapsed
or refractory AML. The trial enrolled 712 patients at more than 100
leading sites in the U.S., Canada, Europe, Australia, New Zealand
and South Korea. Patients were randomized in a ratio of 1:1 to
receive either vosaroxin on days one and four in combination with
cytarabine daily for five days, or placebo in combination with
cytarabine. The trial's primary endpoint is overall survival. For
more information on the VALOR trial, please visit
www.valortrial.com.
About Vosaroxin
Vosaroxin is a first-in-class anti-cancer quinolone derivative
(AQD), a class of compounds that has not been used previously for
the treatment of cancer. Vosaroxin both intercalates DNA and
inhibits topoisomerase II, resulting in replication-dependent,
site-selective DNA damage, G2 arrest and apoptosis. Both the 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.
About AML
AML is a rapidly progressing cancer of the blood characterized
by the uncontrolled proliferation of immature blast cells in the
bone marrow. The American Cancer Society estimates there will be
approximately 18,860 new cases of AML and approximately 10,460
deaths from AML in the U.S. in 2014. Additionally, it is estimated
that the prevalence of AML across major global markets (U.S.,
France, Germany, Italy, Spain, United Kingdom and Japan) is over
50,000. AML is generally a disease of older adults, and the median
age of a patient diagnosed with AML is about 67 years. AML patients
with relapsed or refractory disease and newly diagnosed AML
patients over 60 years of age with poor prognostic risk factors
typically die within one year, resulting in an acute need for new
treatment options for these patients.
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 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's overall strategy, the
design, conduct, progress, timing and results of the VALOR trial
and Sunesis' other clinical trials, the sufficiency of Sunesis'
financial resources and the commercial potential for vosaroxin.
Words such as "anticipate," "approximately," "assume," "believe,"
"could," "potential," "promising," "realize," "well beyond," 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, risks related to
Sunesis' need for substantial additional funding to complete the
development and commercialization of vosaroxin, risks related to
whether outstanding warrants will be exercised in the future, 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, the risk that raising funds
through lending arrangements may restrict our operations or produce
other adverse results, the risk that Sunesis' development
activities for vosaroxin could be otherwise halted or significantly
delayed for various reasons, the risk that Sunesis' clinical
studies for vosaroxin 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, the risk that
Sunesis' nonclinical studies and clinical studies may not satisfy
the requirements of the FDA, European Commission or other
regulatory agencies, risks related to the conduct of Sunesis'
clinical trials, risks related to the manufacturing of vosaroxin
and supply of the active pharmaceutical ingredients required for
the conduct of Sunesis' clinical trials, the risk of third party
opposition to granted patents related to vosaroxin, and the risk
that Sunesis' proprietary rights may not adequately protect
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 September 30, 2013, Sunesis' Annual Report on
Form 10-K for the year ended December 31, 2013, 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, |
December 31, |
|
2013 |
2012 |
ASSETS |
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash and cash equivalents |
$ 15,121 |
$ 14,940 |
Marketable securities |
24,172 |
56,287 |
Prepaids and other current
assets |
1,199 |
1,705 |
Total current assets |
40,492 |
72,932 |
Property and equipment, net |
23 |
43 |
Deposits and other assets |
10 |
42 |
Total assets |
$ 40,525 |
$ 73,017 |
|
|
|
LIABILITIES AND
STOCKHOLDERS' (DEFICIT) EQUITY |
|
Current liabilities: |
|
|
Accounts payable |
$ 953 |
$ 78 |
Accrued clinical expense |
4,750 |
5,449 |
Accrued compensation |
1,719 |
1,465 |
Other accrued liabilities |
1,645 |
2,113 |
Current portion of deferred
revenue |
7,956 |
7,956 |
Current portion of notes
payable |
9,018 |
6,610 |
Warrant liability |
7,931 |
8,070 |
Total current liabilities |
33,972 |
31,741 |
|
|
|
Non-current portion of deferred revenue |
3,712 |
11,668 |
Non-current portion of notes payable |
9,025 |
17,651 |
|
|
|
Commitments |
|
|
|
|
|
Stockholders' (deficit) equity: |
|
|
Common stock |
5 |
5 |
Additional paid-in capital |
473,509 |
457,011 |
Accumulated other comprehensive (loss)
income |
(3) |
38 |
Accumulated deficit |
(479,695) |
(445,097) |
Total stockholders' (deficit)
equity |
(6,184) |
11,957 |
Total liabilities and stockholders' (deficit)
equity |
$ 40,525 |
$ 73,017 |
|
|
|
|
|
|
Note 1: The consolidated
balance sheet as of December 31, 2012 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, 2012. |
|
SUNESIS
PHARMACEUTICALS, INC. |
CONSOLIDATED STATEMENTS
OF OPERATIONS |
AND COMPREHENSIVE
(LOSS) INCOME |
(In thousands, except
per share amounts) |
|
|
|
|
|
|
Three months
ended December 31, |
Year ended
December 31, |
|
2013 |
2012 |
2013 |
2012 |
|
(Unaudited) |
(Unaudited) |
Revenue: |
|
|
|
|
License and other revenue |
$ 1,989 |
$ 1,989 |
$ 7,956 |
$ 3,754 |
Total revenues |
1,989 |
1,989 |
7,956 |
3,754 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
6,883 |
7,589 |
28,891 |
29,185 |
General and administrative |
2,698 |
2,473 |
10,838 |
9,175 |
Total operating expenses |
9,581 |
10,062 |
39,729 |
38,360 |
|
|
|
|
|
Loss from operations |
(7,592) |
(8,073) |
(31,773) |
(34,606) |
|
|
|
|
|
Interest expense |
(623) |
(839) |
(2,917) |
(1,855) |
Other income (expense), net |
1,038 |
4,860 |
92 |
(7,490) |
Net loss |
(7,177) |
(4,052) |
(34,598) |
(43,951) |
Unrealized (loss) gain on available-for-sale
securities |
(12) |
41 |
(41) |
19 |
Comprehensive loss |
$ (7,189) |
$ (4,011) |
$ (34,639) |
$ (43,932) |
|
|
|
|
|
Basic and diluted loss per share: |
|
|
|
|
|
|
|
|
|
Net loss: |
|
|
|
|
Basic |
$ (7,177) |
$ (4,052) |
$ (34,598) |
$ (43,951) |
Diluted |
(8,257) |
(10,352) |
(34,598) |
(43,951) |
|
|
|
|
|
Shares used in computing net loss per
share: |
|
|
|
|
Basic |
54,060 |
51,412 |
52,249 |
48,146 |
Diluted |
55,573 |
52,848 |
52,249 |
48,146 |
|
|
|
|
|
Net loss per share: |
|
|
|
|
Basic |
$ (0.13) |
$ (0.08) |
$ (0.66) |
$ (0.91) |
Diluted |
$ (0.15) |
$ (0.20) |
$ (0.66) |
$ (0.91) |
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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