Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2014 Financial Results and Recent Highlights
March 12 2015 - 7:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the fourth quarter and year ended December
31, 2014. Loss from operations for the three months and year ended
December 31, 2014 was $11.2 million and $45.0 million,
respectively. As of December 31, 2014, cash, cash equivalents and
marketable securities totaled $43.0 million.
"The fourth quarter of 2014 was a focal period for Sunesis and
vosaroxin, with unblinding of our Phase 3 VALOR trial in October
and the presentation in December of the full results at the late
breaking abstract forum of ASH," said Daniel Swisher, Chief
Executive Officer of Sunesis. "AML remains a challenging disease,
with a striking absence of new therapeutic treatment options. In
this context, we are engaged in active dialogue with regulators in
Europe and the U.S. We remain on track to file an MAA in Europe in
the second half of 2015, and look forward to providing clarity on
our path forward in the U.S. around mid-year."
Mr. Swisher continued: "In addition to VALOR, we are continuing
to make progress across our pipeline, including in our investigator
sponsored trials of vosaroxin and our kinase-inhibitor
programs."
Fourth Quarter 2014 and Recent Highlights
- Announced results from pivotal Phase 3 VALOR trial of
vosaroxin and cytarabine in patients with first relapsed or
refractory acute myeloid leukemia, and late breaking presentation
at ASH Annual Meeting. In October 2014, Sunesis announced
top-line results from the Phase 3 VALOR trial of vosaroxin and
cytarabine in patients with first relapsed or refractory acute
myeloid leukemia (AML) and, in December, the presentation of full
results in a late-breaking oral presentation at the American
Society of Hematology (ASH) Annual Meeting. The randomized,
double-blind, placebo-controlled Phase 3 VALOR trial enrolled 711
adult patients with first relapsed or refractory AML at 124 leading
sites in 15 countries. Patients were stratified for age, geographic
region and disease status and randomized one to one to receive
either vosaroxin and cytarabine or placebo and cytarabine. Patients
treated with vosaroxin achieved increased overall survival compared
to those treated with placebo (7.5 months vs 6.1 months, HR=0.87),
the primary endpoint, but this difference did not achieve
statistical significance (p=0.06). The complete remission (CR)
rate, the sole secondary efficacy endpoint in the trial, did
demonstrate a significant difference for the vosaroxin combination
arm (30.1% vs 16.3%, p < 0.0001). In a pre-planned analysis
accounting for the stratification factors at randomization, a
significant improvement in overall survival was demonstrated
(HR=0.83, p=0.02). The pre-planned analysis of all treatment strata
included the following poor-prognosis patient categories: over 60
years old (7.1 months vs 5.0 months, HR=0.75, p=0.003, n=451),
refractory disease (6.7 months vs 5.0 months, HR=0.87, p=0.23,
n=301), and early relapsed disease (6.7 months vs 5.2 months,
HR=0.77, p=0.04, n=256). Outcomes in patients under 60 years old or
with late relapsed disease were comparable between treatment arms,
with no improvement in overall survival. Across all strata, the CR
and Composite CR (CR+CRp+CRi) rates were higher in the vosaroxin
combination arm. Given the complexity of interpreting the impact of
transplantation therapy, a predefined analysis of overall survival
censoring for hematopoietic stem cell transplantation was planned.
In this analysis, patients receiving the vosaroxin combination had
a median overall survival of 6.7 months versus 5.3 months for
patients receiving placebo and cytarabine (HR=0.81, p=0.02). Grade
3 or higher non-hematologic adverse events that were more common in
the vosaroxin combination arm were gastrointestinal and
infection-related toxicities, consistent with those observed in
previous company trials. The rate of serious adverse events was
55.5% in the vosaroxin combination arm compared to 35.7% in the
placebo and cytarabine arm. All-cause mortality was comparable
between the treatment arms (7.9% vs 6.6% for 30-day and 19.7% vs
19.4% for 60-day).
- Announced presentation of positive updated results from
ongoing MD Anderson-sponsored trial of vosaroxin in AML and
high-risk MDS at ASH Annual Meeting. In December
2014, Sunesis announced the presentation of updated results from
the ongoing MD Anderson-sponsored trial of vosaroxin in AML and
high-risk myelodysplastic syndrome (MDS) at the ASH Annual Meeting.
The Phase 1b/2 trial is expected to enroll up to a total of
approximately 70 patients. Patients in the ongoing trial are being
followed for response, leukemia-free survival, overall survival and
safety. At the time of presentation, 41 patients (38 AML, 3
high-risk MDS) with a median age of 70 years (range, 41-78) were
enrolled; 97% were older than 60 years and 51% were older than 70
years. Of the 37 patients evaluable for response, 22 patients (59%)
achieved complete response (CR), 5 patients (14%) achieved CR with
incomplete platelet recovery (CRp), and 1 patient (3%) achieved CR
with incomplete peripheral blood count recovery (CRi), for an
overall response rate of 76%. Preliminary median overall survival
was 8.3 months. Median duration of response for patients achieving
CR/CRp/CRi has not been reached. Patients have received a median of
2 (1 - 7) treatment cycles with median number of cycles to response
being 1 (1 - 4). Six patients (16%) have proceeded to allogeneic
stem cell transplant (ASCT) and 6 patients have relapsed. Four-week
and eight-week mortality were 0% and 14%, respectively. Infection
related toxicities were the most common Grade ≥3 adverse events.
Grade ≥3 mucositis was observed in 11 patients (30%).
- Announced submission of Letter of Intent to file a
Marketing Authorization Application (MAA) for vosaroxin in relapsed
or refractory AML with the European Medicines Agency
(EMA). In November 2014, Sunesis announced that it
had submitted a letter of intent describing its intention to file
an Marketing Authorization Application (MAA) with the European
Medicines Agency (EMA) seeking marketing authorization of vosaroxin
plus cytarabine for the treatment of relapsed or refractory
AML. The letter of intent initiates the process for the
assignment of a Rapporteur and Co-Rapporteur, who are two appointed
members of the Committee for Human Medicinal Products
(CHMP). The CHMP is the committee responsible for preparing
the EMA's opinions on questions concerning human medicines. The
Rapporteur and Co-Rapporteur will assess the MAA and provide the
CHMP with the result of their analysis, which will be the basis of
the conclusions of the CHMP. Sunesis expects to file its MAA
in the second half of 2015.
- Announced publication of REVEAL-1 trial results in the
British Journal of Haematology. In November 2014,
Sunesis announced the publication of results from the company's
Response Evaluation of Vosaroxin in Elderly AML (REVEAL-1) trial, a
Phase 2 trial of single agent vosaroxin in previously untreated,
poor-risk elderly AML patients who are unlikely to benefit from
standard induction chemotherapy, in the November 17, 2014 Online
Version of Record of the British Journal of Haematology. The
article, titled "REVEAL-1, a phase 2 dose regimen optimization
study of vosaroxin in older poor-risk patients with previously
untreated acute myeloid leukemia," is available online at
http://onlinelibrary.wiley.com/doi/10.1111/bjh.13214/abstract.
- Announced publication of Vosaroxin Phase 1b/2 AML trial
results in Haematologica. In November 2014, Sunesis
announced the online publication of results from the company's
Phase 1b/2 study of vosaroxin in combination with cytarabine in
patients with relapsed or refractory AML in the November 7, 2014
Ahead of Print issue of Haematologica. The article, titled "A Phase
1b/2 study of combination vosaroxin and cytarabine in patients with
relapsed or refractory acute myeloid leukemia," is available online
at http://www.haematologica.org/content/early/recent.
- Announced presentations of preclinical and clinical
results on MLN2480 at the 26th EORTC-NCI-AACR Symposium on
Molecular Targets and Cancer Therapeutics. In November
2014, Sunesis announced the presentation of preclinical and
clinical results on MLN2480, an oral, investigative agent for
pan-Raf kinase inhibition, at the 26th EORTC-NCI-AACR Symposium.
The results were presented by Millennium Pharmaceuticals, Inc.
("Millennium"), a wholly owned subsidiary of Takeda Pharmaceutical
Company Limited. MLN2480 is being developed by Millennium through
an exclusive license from Sunesis, which includes an option for
co-development by Sunesis. The presentations included data
from a Phase 1, multicenter, open-label, dose escalation study
designed to evaluate the safety, tolerability and maximum tolerated
dose of single agent MLN2480. Based on results from this study,
Millennium has initiated a multiarm, open-label Phase 1B Study of
MLN2480 in combination with MLN0128, an oral mTORC 1/2 inhibitor;
alisertib, an oral aurora A kinase inhibitor; or paclitaxel, in
adult patients with advanced nonhematologic malignancies.
- Announces completion of Investigational New Drug (IND)
application-enabling toxicology studies for
SNS-062.Sunesis announced today that it has completed
preclinical toxicology studies of SNS-062, a non-covalently binding
inhibitor of BTK with a distinct binding site and favorable
pharmacokinetic profile. Based on results from these studies,
the company plans to file an IND application for SNS-062 with the
FDA.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $43.0
million as of December 31, 2014, as compared to $39.3 million as of
December 31, 2013. The increase of $3.7 million was primarily due
to net proceeds of $40.0 million from the March 2014 underwritten
offering, $14.3 million from sales of common stock through the
company's at-the-market facility with Cantor Fitzgerald & Co.,
and $2.0 million from the exercise of warrants, stock options and
stock purchase rights, partially offset by $43.2 million of net
cash used in operating activities and $9.4 million of principal
payments against notes payable. As of December 31, 2014,
outstanding debt totaled $9.3 million.
- In February 2015, the loan and security agreement with Oxford
Finance LLC, Silicon Valley Bank and Horizon Technology Finance
Corporation was amended to provide for an interest-only payment
period beginning March 1, 2015 through February 1, 2016, such that
the eight remaining principal payments will be deferred and
re-amortized over the period from March 1, 2016 to October 1, 2016.
The final payment was increased from 3.75% to 4.65% of the total
amount drawn under the facility, and will become due on the new
maturity date of October 1, 2016, or such earlier date specified in
the loan and security agreement.
- Revenues for the three months and year ended December 31, 2014
were $0.9 million and $5.7 million, as compared to $2.0 million and
$8.0 million for the same periods in 2013. Revenue in each period
was primarily due to deferred revenue recognized related to the
royalty agreement with Royalty Pharma.
- Research and development expenses decreased to $6.0 million and
$27.7 million for the three months and year ended December 31,
2014, from $6.9 million and $28.9 million for the same periods in
2013. The decreases in 2014 were primarily due to a decrease in
clinical trial expenses related to the VALOR trial, partially
offset by increases in personnel, drug manufacturing and other
outside services costs, including those related to the company's
kinase inhibitor programs.
- General and administrative expenses for the three months and
year ended December 31, 2014 were $6.1 million and $23.1 million,
as compared to $2.7 million and $10.8 million in 2013. The
increases in 2014 were primarily due to higher professional
services and personnel costs.
- Interest expense was $0.3 million and $1.7 million for the
three months and year ended December 31, 2014 as compared to $0.6
million and $2.9 million for the same periods in 2013. The
decreases in 2014 were due to the reduced principal balance
outstanding on notes payable.
- Net other income was $10.1 million and $3.8 million for the
three months and year ended December 31, 2014, as compared to $1.0
million and $0.1 million for the same periods in 2013. The 2014
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 $9.0 million and $43.2 million for
the three months and year ended December 31, 2014, as compared to
$9.7 million and $37.4 million for the same periods in 2013.
- Sunesis reported loss from operations of $11.2 million and
$45.0 million for the three months and year ended December 31,
2014, as compared to $7.6 million and $31.8 million for the same
periods in 2013. Net loss was $1.3 million and $43.0 million for
the three months and year ended December 31, 2014, as compared to
$7.2 million and $34.6 million for the same periods in 2013.
Conference Call Information
Sunesis will host an update conference call today, March 12th at
11:00 a.m. Eastern Time. The call can be accessed by dialing (877)
415-3181 (U.S. and Canada) or (857) 244-7324 (international), and
entering passcode 78358079. 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 QINPREZO
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
QINPREZO for the treatment of AML. Additionally, QINPREZO has been
granted fast track designation by the FDA for the potential
treatment of relapsed or refractory AML in combination with
cytarabine. QINPREZO 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 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 estimated that there were
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 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' overall strategy, the
design, conduct, progress, timing and results of Sunesis' clinical
trials, the preliminary analysis, assessment and conclusions of the
results of the VALOR trial, the commercial potential of vosaroxin,
and the sufficiency of Sunesis' cash resources and the use of the
proceeds under the loan facility with Oxford Finance LLC, Horizon
Technology Finance Corporation and Silicon Valley Bank. Words such
as "believe," "continue," "expect," "look forward," "on track,"
"potential," "seek," "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, risks related to Sunesis' need for
substantial additional funding to complete the development and
commercialization of QINPREZO, 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 QINPREZO,
the risk that Sunesis' development activities for QINPREZO could be
otherwise halted or significantly delayed for various reasons, the
risk that Sunesis' clinical studies for QINPREZO 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, and the risk that Sunesis' clinical studies for vosaroxin
may not lead to regulatory approval. 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,
2014, Sunesis' Annual Report on Form 10-K for the year ended
December 31, 2014, 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, |
|
2014 |
2013 |
ASSETS |
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash and cash equivalents |
$ 22,186 |
$ 15,121 |
Marketable securities |
20,795 |
24,172 |
Prepaids and other current assets |
1,223 |
1,199 |
Total current assets |
44,204 |
40,492 |
Property and equipment, net |
42 |
23 |
Deposits and other assets |
-- |
10 |
Total assets |
$ 44,246 |
$ 40,525 |
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT) |
|
Current liabilities: |
|
|
Accounts payable |
$ 3,177 |
$ 953 |
Accrued clinical expense |
3,112 |
4,750 |
Accrued compensation |
2,287 |
1,719 |
Other accrued liabilities |
3,087 |
1,645 |
Current portion of deferred revenue |
3,418 |
7,956 |
Current portion of notes payable |
9,257 |
9,018 |
Warrant liability |
3,543 |
7,931 |
Total current liabilities |
27,881 |
33,972 |
Non-current portion of deferred revenue |
2,563 |
3,712 |
Non-current portion of notes payable |
-- |
9,025 |
Commitments |
|
|
Stockholders' equity (deficit): |
|
|
Common stock |
7 |
5 |
Additional paid-in capital |
536,499 |
473,509 |
Accumulated other comprehensive loss |
(7) |
(3) |
Accumulated deficit |
(522,697) |
(479,695) |
Total stockholders' equity (deficit) |
13,802 |
(6,184) |
Total liabilities and stockholders' equity
(deficit) |
$ 44,246 |
$ 40,525 |
|
|
|
Note 1: The consolidated
balance sheet as of December 31, 2013 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, 2013. |
|
|
|
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, |
|
2014 |
2013 |
2014 |
2013 |
|
(Unaudited) |
(Unaudited) |
(Unaudited) |
(Note 2) |
Revenue: |
|
|
|
|
License and other revenue |
$ 896 |
$ 1,989 |
$ 5,734 |
$ 7,956 |
Total revenues |
896 |
1,989 |
5,734 |
7,956 |
Operating expenses: |
|
|
|
|
Research and development |
5,968 |
6,883 |
27,665 |
28,891 |
General and administrative |
6,082 |
2,698 |
23,112 |
10,838 |
Total operating expenses |
12,050 |
9,581 |
50,777 |
39,729 |
Loss from operations |
(11,154) |
(7,592) |
(45,043) |
(31,773) |
Interest expense |
(311) |
(623) |
(1,719) |
(2,917) |
Other income (expense), net |
10,142 |
1,038 |
3,760 |
92 |
Net loss |
(1,323) |
(7,177) |
(43,002) |
(34,598) |
Unrealized gain (loss) on available-for-sale
securities |
2 |
(12) |
(4) |
(41) |
Comprehensive loss |
$ (1,321) |
$ (7,189) |
$ (43,006) |
$ (34,639) |
Basic and diluted loss per common
share: |
|
|
|
Net loss: |
|
|
|
|
Basic |
$ (1,323) |
$ (7,177) |
$ (43,002) |
$ (34,598) |
Diluted |
$ (1,323) |
$ (8,257) |
$ (46,894) |
$ (34,598) |
Shares used in computing net loss per common
share: |
|
|
|
|
Basic |
63,041 |
54,060 |
60,057 |
52,249 |
Diluted |
63,041 |
55,573 |
61,510 |
52,249 |
Net loss per common share: |
|
|
|
|
Basic |
$ (0.02) |
$ (0.13) |
$ (0.72) |
$ (0.66) |
Diluted |
$ (0.02) |
$ (0.15) |
$ (0.76) |
$ (0.66) |
|
|
|
|
|
Note 2: The consolidated
statement of operations and comprehensive loss for the year ended
December 31, 2013 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, 2013. |
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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