Sunesis Pharmaceuticals Reports First Quarter 2015 Financial Results and Recent Highlights
05 May 2015 - 9:00PM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the first quarter ended March 31, 2015. Loss
from operations for the three months ended March 31, 2015 was $8.8
million. As of March 31, 2015, cash, cash equivalents and
marketable securities totaled $39.8 million.
"Sunesis is committed to improving treatment outcomes of acute
myeloid leukemia patients," said Daniel Swisher, Chief Executive
Officer of Sunesis. "Working toward this goal, we remain in an
active dialogue with the FDA to determine a regulatory path forward
in the United States and look forward to gaining further clarity
around mid-2015 with the hope that we can proceed to a rolling NDA
submission in the second half of the year. In Europe, we have been
assigned a Rapporteur and a Co-Rapporteur who are two appointed
members of the EMA's Committee of Human Medicinal Products, and we
plan to meet with the Rapporteurs in mid-2015 to discuss our MAA
filing. In addition, we continue to see progress with vosaroxin in
our investigator sponsored trials and with our kinase-inhibitor
programs, including the planned submission of an IND for our
differentiated BTK inhibitor, SNS-062."
Additional First Quarter 2015 Highlights
- Announced completion of Investigational New Drug (IND)
application-enabling toxicology studies for SNS-062. In
March, Sunesis announced that it 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 this year.
- Amended Loan and Security Agreement to defer principal
for one year. In February, Sunesis executed an amendment
to its loan and security agreement with Oxford Finance LLC, Silicon
Valley Bank, and Horizon Technology Finance Corporation. The
amendment created an interest-only period from March 1, 2015
through February 1, 2016 on the remainder of Sunesis' loan balance,
deferring the remaining principal payments and providing additional
financial flexibility to execute the company's corporate strategy.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $39.8
million as of March 31, 2015, as compared to $43.0 million as of
December 31, 2014. The decrease of $3.2 million was primarily due
to $11.6 million of net cash used in operating activities and $1.6
million of principal payments against notes payable, partially
offset by $10.0 million raised from sales of common stock through
the company's at-the-market facility with Cantor Fitzgerald &
Co. A further $7.5 million was raised in April through this
facility, resulting in a pro-forma March 31 cash balance of $47.3
million. This capital is expected to be sufficient to fund the
company to the middle of 2016.
- Revenue for the three months ended March 31, 2015 was $0.9
million, as compared to $2.0 million for the same period 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 $4.5 million for the three
months ended March 31, 2015 as compared to $7.6 million for the
same period in 2014. The decrease between the periods was primarily
due to reductions of $2.1 million in clinical trial expenses and
$0.7 million in other outside services and consulting costs.
- General and administrative expense was $5.1 million for the
three months ended March 31, 2015 as compared to $3.4 million for
the same period in 2014. The increase between the periods was
primarily due to increases of $1.2 million in expenses related
primarily to commercial planning and medical affairs and
$0.5 million related to non-cash stock-based compensation.
- Interest expense was $0.2 million for the three months ended
March 31, 2015 as compared to $0.5 million for the same period in
2014. The decrease in 2015 was due to the reduced principal balance
outstanding on notes payable.
- Net other expense was $0.1 million for the three months ended
March 31, 2015 as compared to $5.1 million for the same period in
2014. The amounts for each period were primarily comprised of
non-cash charges for the revaluation of warrants issued in 2010.
- Cash used in operations was $11.6 million for the three months
ended March 31, 2015 as compared to $11.4 million for the same
period in 2014. Net cash used in the 2015 period resulted primarily
from the net loss of $9.1 million and changes in operating assets
and liabilities of $4.6 million, partially offset by net
adjustments for non-cash items of $2.1 million.
- Sunesis reported loss from operations of $8.8 million for the
three months ended March 31, 2015 as compared to $9.0 million for
the same period in 2014. Net loss was $9.1 million for the three
months ended March 31, 2015 as compared to $14.6 million for the
same period in 2014.
Conference Call Information
Sunesis will host an update conference call today, May 5th 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 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 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 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 that there will
be approximately 20,830 new cases of AML and approximately 10,460
deaths from AML in the U.S. in 2015. 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
75,000. 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, clinical
development of our product candidates, planned meetings with the
FDA and EMA to discuss the regulatory path forward for vosaroxin,
subsequent NDA and MAA submissions, plans to file an IND
application for SNS-062 with the FDA, 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 "determine," "estimate," "hope," "remain,"
"expect," "look forward," "potential," "plan," "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' 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,
risks related to the conduct of Sunesis' clinical trials, the risk
that Sunesis' clinical studies for vosaroxin may not lead to
regulatory approval, 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' Annual Report on Form 10-K
for the year ended December 31, 2014 and Sunesis' other filings
with the Securities and Exchange Commission, including Sunesis'
Quarterly Report on Form 10-Q for the quarter ended March 31, 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) |
|
|
|
|
March 31, |
December 31, |
|
2015 |
2014 |
ASSETS |
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash and cash equivalents |
$ 18,784 |
$ 22,186 |
Marketable securities |
21,009 |
20,795 |
Prepaids and other current
assets |
1,478 |
1,223 |
Total current assets |
41,271 |
44,204 |
Property and equipment, net |
31 |
42 |
Total assets |
$ 41,302 |
$ 44,246 |
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
Current liabilities: |
|
|
Accounts payable |
$ 2,121 |
$ 3,177 |
Accrued clinical expense |
2,225 |
3,112 |
Accrued compensation |
1,029 |
2,287 |
Other accrued liabilities |
2,781 |
3,087 |
Current portion of deferred
revenue |
3,418 |
3,418 |
Current portion of notes
payable |
713 |
9,257 |
Warrant liability |
3,632 |
3,543 |
Total current liabilities |
15,919 |
27,881 |
|
|
|
Non-current portion of deferred revenue |
1,709 |
2,563 |
Non-current portion of notes payable |
6,881 |
-- |
|
|
|
Commitments |
|
|
Stockholders' equity: |
|
|
Common stock |
7 |
7 |
Additional paid-in capital |
548,616 |
536,499 |
Accumulated other comprehensive loss |
(5) |
(7) |
Accumulated deficit |
(531,825) |
(522,697) |
Total stockholders' equity |
16,793 |
13,802 |
Total liabilities and stockholders'
equity |
$ 41,302 |
$ 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 March 31, |
|
2015 |
2014 |
|
(Unaudited) |
(Unaudited) |
Revenue: |
|
|
License and other revenue |
$ 854 |
$ 1,995 |
Total revenues |
854 |
1,995 |
|
|
|
Operating expenses: |
|
|
Research and development |
4,512 |
7,552 |
General and administrative |
5,111 |
3,417 |
Total operating expenses |
9,623 |
10,969 |
|
|
|
Loss from operations |
(8,769) |
(8,974) |
|
|
|
Interest expense |
(239) |
(547) |
Other income (expense), net |
(120) |
(5,052) |
Net loss |
(9,128) |
(14,573) |
Unrealized gain (loss) on available-for-sale
securities |
2 |
7 |
Comprehensive loss |
$ (9,126) |
$ (14,566) |
|
|
|
Basic and diluted loss per common share: |
|
|
Net loss |
$ (9,128) |
$ (14,573) |
Shares used in computing basic and
diluted loss per common share |
67,641 |
56,313 |
|
|
|
Basic and diluted loss per common share |
$ (0.13) |
$ (0.26) |
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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