Sunesis Pharmaceuticals Reports Second Quarter 2015 Financial Results and Recent Highlights
"We remain committed to moving vosaroxin forward as an important new therapy for patients with AML, and to realizing the value of this product candidate for all our constituents," said
Second Quarter 2015 Highlights
Received European regulatory guidance regarding potential marketing authorization application for Vosaroxin in AML. 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.
Received feedback from
FDAregarding 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 FDArecommended 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.
Announced presentation of new data at EHA 2015 from predefined subgroup of patients age 60 years and older enrolled in VALOR. In
June 2015, Sunesis announced the presentation of results from predefined subgroups of patients age 60 years and older enrolled in VALOR. The results were presented at the 20th Congressof the European Society of Hematologyin Vienna, Austria. The poster, titled "Improved survival in patients ≥60 with first relapsed/refractory acute myeloid leukemia treated with vosaroxin plus cytarabine vs placebo plus cytarabine: results from the Phase 3 VALOR study," as well as an additional poster presented at the meeting, titled "Allogeneic transplant in patients ≥60 years of age with first relapsed or refractory acute myeloid leukemia after treatment with vosaroxin or placebo plus cytarabine: results from VALOR," are available on the Sunesis website as www.sunesis.com.
Announced presentation of VALOR trial subgroup analysis at
ASCO2015. In May 2015, Sunesis announced the presentation of results from a post hoc subgroup analysis of patients age 60 years and older who underwent allogeneic hematopoietic cell transplant (HCT) in the VALOR trial. The poster, titled "Allogeneic hematopoietic cell transplant (HCT) in patients (pts) ≥ 60 years of age with first relapsed or refractory acute myeloid leukemia (R/R AML) after treatment with vosaroxin plus cytarabine (pla/cyt): results from VALOR", is available on the Sunesis website at www.sunesis.com.
Cash, cash equivalents and marketable securities totaled
$39.6 millionas of June 30, 2015, as compared to $43.0 millionas of December 31, 2014. The decrease of $3.4 millionwas primarily due to $19.8 millionof net cash used in operating activities and $1.6 millionof principal payments against notes payable, partially offset by $18.0 millionraised from the sale of common stock through the company's at-the-market facility with Cantor Fitzgerald & Co.and from option exercises. A further $0.4 millionwas raised in July through this facility, resulting in a pro-forma June 30, 2015cash balance of $40.0 million. This capital is expected to be sufficient to fund the company to the middle of 2016.
Revenue for the three and six months ended
June 30, 2015was $0.9 millionand $1.7 millionas compared to $2.0 millionand $4.0 millionfor 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
$6.3 millionand $10.8 millionfor the three and six months ended June 30, 2015as compared to $7.2 millionand $14.8 millionfor the same periods in 2014. The decreases between the comparable three and six month periods were primarily due to reductions in clinical trial expenses in each case.
General and administrative expense was
$5.2 millionand $10.3 millionfor the three and six months ended June 30, 2015as compared to $6.4 millionand $9.8 millionfor the same periods in 2014. The decrease between the comparable three month periods was primarily due to decreases in personnel costs and outside services costs. The increase between the comparable six month periods was primarily due to an increase in outside services costs.
Interest expense was
$0.2 millionand $0.5 millionfor the three and six months ended June 30, 2015as compared to $0.5 millionand $1.0 millionfor 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
$1.9 millionand $1.8 millionfor the three and six months ended June 30, 2015as compared to $0.3 millionof net other income and $4.8 millionof net other expense 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.
Cash used in operations was
$19.8 millionfor the six months ended June 30, 2015as compared to $21.6 millionfor the same period in 2014. Net cash used in the 2015 period resulted primarily from the net loss of $18.1 millionand 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
$10.6 millionand $19.4 millionfor the three and six months ended June 30, 2015as compared to $11.6 millionand $20.6 millionfor the same periods in 2014. Net loss was $8.9 millionand $18.1 millionfor the three and six months ended June 30, 2015as compared to $11.8 millionand $26.4 millionfor the same periods in 2014.
About QINPREZO™ (vosaroxin)
QINPREZO™ (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.
For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including statements related to Sunesis' overall strategy, the design, conduct and results of Sunesis' clinical trials, including the analysis, assessment and conclusions of the results of the VALOR trial, the commercial potential of vosaroxin, and the need for and the role of vosaroxin as a new treatment options, Sunesis' plans to gain marketing approval of vosaroxin in the U.S. and
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED BALANCE SHEETS|
|June 30,||December 31,|
|Cash and cash equivalents||$ 20,302||$ 22,186|
|Prepaids and other current assets||1,165||1,223|
|Total current assets||40,721||44,204|
|Property and equipment, net||19||42|
|Total assets||$ 40,740||$ 44,246|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable||$ 2,282||$ 3,177|
|Accrued clinical expense||2,249||3,112|
|Other accrued liabilities||4,072||3,087|
|Current portion of deferred revenue||3,418||3,418|
|Current portion of notes payable||3,253||9,257|
|Total current liabilities||18,284||27,881|
|Non-current portion of deferred revenue||854||2,563|
|Non-current portion of notes payable||4,421||--|
|Additional paid-in capital||557,953||536,499|
|Accumulated other comprehensive loss||(5)||(7)|
|Total stockholders' equity||17,181||13,802|
|Total liabilities and stockholders' equity||$ 40,740||$ 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||Six months ended|
|June 30,||June 30,|
|License and other revenue||$ 854||$ 1,989||$ 1,708||$ 3,984|
|Research and development||6,302||7,206||10,814||14,758|
|General and administrative||5,175||6,387||10,286||9,804|
|Total operating expenses||11,477||13,593||21,100||24,562|
|Loss from operations||(10,623)||(11,604)||(19,392)||(20,578)|
|Other income (expense), net||1,907||293||1,787||(4,759)|
|Unrealized gain (loss) on available-for-sale securities||--||(11)||2||(4)|
|Comprehensive loss||$ (8,949)||$ (11,792)||$ (18,075)||$ (26,358)|
|Basic and diluted loss per common share:|
|Basic||$ (8,949)||$ (11,781)||$ (18,077)||$ (26,354)|
|Diluted||$ (10,816)||$ (12,114)||$ (18,077)||$ (26,354)|
|Shares used in computing net loss per common share:|
|Net loss per common share:|
|Basic||$ (0.12)||$ (0.20)||$ (0.26)||$ (0.45)|
|Diluted||$ (0.15)||$ (0.20)||$ (0.26)||$ (0.45)|
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717