Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the second quarter ended June 30, 2016. Loss
from operations for the three months ended June 30, 2016 was $10.0
million. As of June 30, 2016, cash, cash equivalents and marketable
securities totaled $33.1 million.
“During the second quarter, we strengthened the
foundation of our oncology pipeline through the advancement of our
vosaroxin program and lead proprietary BTK kinase inhibitor,
SNS-062. Achievement of upcoming milestones from both these
programs we believe will unlock significant value for the company,”
said Daniel Swisher, Chief Executive Officer of Sunesis
“We are progressing our regulatory efforts to
bring vosaroxin to market in Europe as a treatment for
relapsed/refractory AML, and in parallel are maintaining an active
dialogue with potential European collaborators toward the goal of
supporting a market launch in 2017.” Mr. Swisher continued:
“As for SNS-062, our differentiated, non-covalent BTK-inhibitor, we
look forward to presenting results from our Phase 1A dose
escalation study in healthy volunteers at the upcoming
International Conference on New Concepts in B-Cell Malignancies in
September. We are actively finalizing our protocol with
investigator input to begin a Phase 1B/2 study in patients with
B-cell malignancies around year-end.”
Second Quarter 2016 and Recent Highlights
- Presentation of Updated Results from MD Anderson
Sponsored Trial in AML and high-risk MDS at EHA Annual
Meeting. In June 2016, 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) were presented at
the 21st Congress of the European Hematology
Association (EHA) in Copenhagen, Denmark. At the
optimized induction dose of 70 mg/m2 of vosaroxin (n=41), the
combination of vosaroxin and decitabine demonstrated a compelling
CR/CRp/CRi rate of 76% and a median overall survival of 16.1
months. The oral presentation, titled “Phase I/ll study of
vosaroxin and decitabine in newly diagnosed older patients with
acute myeloid leukemia and high-risk myelodysplastic syndrome,” is
available on the Sunesis website at www.sunesis.com.
- Presentation of Results Evaluating the
Value of Complete Remission Prior to HCT in Patients with
AML at ASCO Annual Meeting. In June 2016, Sunesis
presented results from a study conducted by the Center for
International Blood and Marrow Transplant Research (CIBMTR) at
the Medical College of Wisconsin demonstrating the
significant value of achieving complete remission prior to
allogeneic hematopoietic cell transplantation (HCT) in patients
with acute myeloid leukemia (AML) at the 2016 American Society of
Clinical Oncology. The study was funded jointly by Sunesis and
CIBMTR. The poster presentation, titled “Allogeneic
transplantation for advanced myelogenous leukemia: The value of
complete remission,” is available on the Sunesis website at
www.sunesis.com.
- Strengthened Executive Management Team and Board of
Directors. In June 2016, Sunesis announced the
appointment of Linda Neuman, M.D., as Vice President, Clinical
Development. In March 2016, Sunesis announced the appointment
of Geoffrey Parker to the Sunesis Board of
Directors.
- Supported First-Ever AML Awareness Month. In
May 2016, Sunesis announced its support for the first-ever AML
Awareness Month, which was held in June with AML spokesperson and
sportscaster Craig Sager. The company provided an educational grant
to support the sponsor of the campaign, CancerCare.
- First Subject Dosed in Phase 1A Healthy Volunteer Study
Evaluating Oral Non-Covalent BTK-inhibitor SNS-062. In
March 2016, the first patient was dosed in a Phase 1A, randomized,
double-blind, placebo-controlled dose-ranging study to investigate
the safety, pharmacokinetics and pharmacodynamics of its oral,
next-generation, non-covalently binding BTK-inhibitor, SNS-062, in
healthy subjects.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $33.1
million as of June 30, 2016, as compared to $46.4 million as of
December 31, 2015. The decrease of $13.3 million was primarily due
to $20.1 million of net cash used in operating activities and $8.0
million of principal and final payments against notes payable,
partially offset by $14.8 million raised from debt financing. This
capital is expected to be sufficient to fund operations to the
middle of 2017.
- Revenue for the three and six months ended June 30, 2016 was
$0.6 million and $1.2 million as compared to $0.9 million and $1.7
million for the same periods in 2015. The decrease between the
periods was primarily due to the increase in estimated performance
period through which the remaining balance of deferred revenue will
be amortized.
- Research and development expense was $6.6 million and $12.8
million for the three and six months ended June 30, 2016 as
compared to $6.3 million and $10.8 million for the same periods in
2015. The increase of $0.3 million and $2.0 million between the
comparable three- and six-month periods, respectively, was
primarily related to medical scientific affairs
activities.
- General and administrative expense was $4.0 million and $8.3
million for the three and six months ended June 30, 2016 as
compared to $5.2 million and $10.3 million for the same periods in
2015. The decrease of $1.2 million and $2.0 million between
the comparable three- and six-month periods, respectively, was
primarily due to decrease in outside services costs.
- Interest expense was $0.5 million and $0.8 million for the
three and six months ended June 30, 2016 as compared to
$0.2 million and $0.5 million for the same periods in
2015.
- Net other income was nil and $0.1 million for the three and six
months ended June 30, 2016 as compared to net other income of $1.9
million and $1.8 million for the same period in 2015. The increases
in 2015 periods were primarily comprised of non-cash credits or
charges for the revaluation of warrants issued in the October 2010
underwritten offering.
- Cash used in operating activities was $20.1 million for the six
months ended June 30, 2016, as compared to $19.8 million
for the same period in 2015. Net cash used in the 2016 period
resulted primarily from the net loss of $20.5 million and changes
in operating assets and liabilities of $2.5 million, including the
payment of a final fee of $1.2 million under the Oxford Loan
Agreement, partially offset by net adjustments for non-cash items
of $2.9 million. Net cash used in the 2015 period resulted
primarily from the net loss of $18.1 million and changes in
operating assets and liabilities of $3.4 million, partially offset
by net adjustments for non-cash items of $1.7 million.
- Sunesis reported loss from operations of $10.0 million and
$19.9 million for the three and six months ended June 30, 2016 as
compared to $10.6 million and $19.4 million for the same periods in
2015. Net loss was $10.4 million and $20.5 million for
the three and six months ended June 30, 2016, as compared
to $8.9 million and $18.0 million for the same periods in
2015.
Conference Call Information
Sunesis will host an update conference call
today, July 29th 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 48017419. 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.
Vosaroxin’s Marketing Authorization Application
for relapsed refractory AML is currently under review by the
European Medicines Agency, and a regulatory decision regarding
approval is expected in 2017.
The trademark name QINPREZO is conditionally
accepted by the FDA and the EMA as the proprietary name for the
vosaroxin drug product candidate.
About SNS-062
SNS-062 is a novel, second-generation BTK
inhibitor, a class of kinase inhibitors that selectively inhibits
the enzyme Bruton's tyrosine kinase (BTK). This target
mediates signaling through the B-cell receptor, which is critical
for adhesion, migration, proliferation and survival of normal and
malignant B-lineage lymphoid cells. Unlike other drugs in its
class, SNS-062 has a distinct kinase selectivity profile and binds
non-covalently to the BTK enzyme, potentially providing an
opportunity to address the leading resistance mechanism, a mutation
in the enzyme’s binding site required for covalent binding. In
preclinical studies, SNS-062 demonstrated potent activity against
Cys-481S mutated B-cell malignancies, and is currently being
studied in healthy subjects in a Phase 1A, randomized,
double-blind, placebo-controlled dose-ranging study to investigate
the drug’s safety, pharmacokinetics, and pharmacodynamics. With a
successful study outcome, SNS-062 is expected to proceed to a Phase
1B/2 study in patients with B-cell malignancies around year end
2016.
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 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, as well as
advancing its novel kinase-inhibitor pipeline, which includes its
proprietary 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 Sunesis' corporate
objectives, including the anticipated progress and potential
approval of vosaroxin by the EMA, timing of potential market launch
in Europe for vosaroxin, and further clinical development of
vosaroxin and SNS-062. Words such as “believe,” “goal,” “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' Annual Report on Form 10-K for
the year ended December 31, 2015, Sunesis’ Quarterly Report on
Form 10-Q for the quarter ended June 30, 2016, 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) |
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2016 |
|
|
|
2015 |
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash
equivalents |
$ |
9,447 |
|
|
$ |
26,886 |
|
Marketable
securities |
|
23,674 |
|
|
|
19,544 |
|
Prepaids and other
current assets |
|
831 |
|
|
|
558 |
|
Total current
assets |
|
33,952 |
|
|
|
46,988 |
|
Property and equipment,
net |
|
8 |
|
|
|
14 |
|
Total assets |
$ |
33,960 |
|
|
$ |
47,002 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
2,759 |
|
|
$ |
2,453 |
|
Accrued clinical
expense |
|
2,006 |
|
|
|
1,954 |
|
Accrued
compensation |
|
1,113 |
|
|
|
1,606 |
|
Other accrued
liabilities |
|
1,858 |
|
|
|
2,711 |
|
Current portion of
deferred revenue |
|
1,831 |
|
|
|
2,441 |
|
Current portion of
notes payable |
|
833 |
|
|
|
7,834 |
|
Total current
liabilities |
|
10,400 |
|
|
|
18,999 |
|
|
|
|
|
|
|
|
|
Non-current portion of
deferred revenue |
|
- |
|
|
|
610 |
|
|
|
|
|
|
|
Non-current other
accrued liabilities |
|
56 |
|
|
|
Non-current portion of
notes payable |
|
13,444 |
|
|
|
- |
|
|
|
|
|
Commitments |
|
|
|
Stockholders’
equity: |
|
|
|
Preferred stock |
|
16,459 |
|
|
|
16,459 |
|
Common stock |
|
9 |
|
|
|
9 |
|
Additional paid-in
capital |
|
573,496 |
|
|
|
570,309 |
|
Accumulated other
comprehensive income (loss) |
|
1 |
|
|
|
(11 |
) |
Accumulated
deficit |
|
(579,905 |
) |
|
|
(559,373 |
) |
Total stockholders’
equity |
|
10,060 |
|
|
|
27,393 |
|
Total liabilities and
stockholders’ equity |
$ |
33,960 |
|
|
$ |
47,002 |
|
|
|
|
|
Note
1: The consolidated balance sheet as of December 31, 2015 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, 2015. |
|
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, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Note 2) |
Revenue: |
|
|
|
|
|
|
|
|
License and other
revenue |
$ |
610 |
|
|
$ |
854 |
|
|
$ |
1,250 |
|
|
$ |
1,708 |
|
Total
revenues |
|
610 |
|
|
|
854 |
|
|
|
1,250 |
|
|
|
1,708 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
6,606 |
|
|
|
6,302 |
|
|
|
12,815 |
|
|
|
10,814 |
|
|
General and administrative |
|
3,997 |
|
|
|
5,175 |
|
|
|
8,292 |
|
|
|
10,286 |
|
Total
operating expenses |
|
10,603 |
|
|
|
11,477 |
|
|
|
21,107 |
|
|
|
21,100 |
|
Loss from
operations |
|
(9,993 |
) |
|
|
(10,623 |
) |
|
|
(19,857 |
) |
|
|
(19,392 |
) |
Interest
expense |
|
(476 |
) |
|
|
(233 |
) |
|
|
(774 |
) |
|
|
(472 |
) |
Other
income (expense), net |
|
23 |
|
|
|
1,907 |
|
|
|
99 |
|
|
|
1,787 |
|
Net loss |
|
(10,446 |
) |
|
|
(8,949 |
) |
|
|
(20,532 |
) |
|
|
(18,077 |
) |
Unrealized gain (loss) on available-for-sale securities |
|
(1 |
) |
|
|
- |
|
|
|
12 |
|
|
|
2 |
|
Comprehensive loss |
$ |
(10,447 |
) |
|
$ |
(8,949 |
) |
|
$ |
(20,520 |
) |
|
$ |
(18,075 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share: |
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
Basic |
$ |
(10,446 |
) |
|
$ |
(8,949 |
) |
|
$ |
(20,532 |
) |
|
$ |
(18,077 |
) |
|
Diluted |
$ |
(10,446 |
) |
|
$ |
(10,816 |
) |
|
$ |
(20,532 |
) |
|
$ |
(18,077 |
) |
|
Shares
used in computing basic and diluted loss per common share |
|
|
|
|
|
|
|
|
Basic |
|
86,960 |
|
|
|
72,513 |
|
|
|
86,810 |
|
|
|
70,090 |
|
|
Diluted |
|
86,960 |
|
|
|
72,525 |
|
|
|
86,810 |
|
|
|
70,090 |
|
Basic and
diluted loss per common share |
|
|
|
|
|
|
|
|
Basic |
$ |
(0.12 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.26 |
) |
|
Diluted |
$ |
(0.12 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 2:
The consolidated statement of operations and comprehensive loss for
the year ended December 31, 2015 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,
2015. |
|
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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