Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2013 Financial Results and Recent Highlights
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
Sunesis also announced today that updated data from the ongoing Phase 1b/2
"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
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 Medicineunder the direction of Meagan A. Jacoby, M.D., Ph.D., Instructor of Medicine, Division of Oncology.
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 Collegeand New York-Presbyterian Hospitalunder 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.
Cash and investments totaled
$39.3 millionas of December 31, 2013, as compared to $71.2 millionas of December 31, 2012. The decrease of $31.9 millionwas primarily due to $37.4 millionof net cash used in operating activities and $7.2 millionof principal payments against notes payable, partially offset by net proceeds of $12.0 millionfrom sales of common stock through the at-the-market facility with Cantor Fitzgerald & Co.(Cantor) and $0.6 millionfrom the exercise of warrants, stock options and stock purchase rights. As of December 31, 2013, outstanding debt totaled $18.0 million.
March 4, 2014, Sunesis completed a $43.0 millionunderwritten 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
$8.50and 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, 2013were $2.0 millionand $8.0 million, as compared to $2.0 millionand $3.8 millionfor 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 millionand $28.9 millionfor the three months and year ended December 31, 2013, from $7.6 millionand $29.2 millionfor 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, 2013were $2.7 millionand $10.8 million, as compared to $2.5 millionand $9.2 millionin 2012. The increases in 2013 were primarily due to higher professional services and personnel costs.
Interest expense was
$0.6 millionand $2.9 millionfor the three months and year ended December 31, 2013as compared to $0.8 millionand $1.9 millionfor the same periods in 2012. The increase for the full year 2013 was due to the draw-down in September 2012of the $15.0 millionsecond tranche of the October 2011loan facility.
Net other income was
$1.0 millionand $0.1 millionfor the three months and year ended December 31, 2013as compared to net other income of $4.9 millionand net other expense of $7.5 millionfor 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 millionand $37.4 millionfor the three months and year ended December 31, 2013, as compared to $9.3 millionand $10.6 millionfor the same periods in 2012. Net cash used in 2013 resulted primarily from the net loss of $34.6 millionand changes in operating assets and liabilities of $7.1 million, including $8.0 millionrelated 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 millionrelated to stock-based compensation.
Sunesis reported loss from operations of
$7.6 millionand $31.8 millionfor the three months and year ended December 31, 2013, as compared to $8.1 millionand $34.6 millionfor the same periods in 2012. Net loss was $7.2 millionand $34.6 millionfor the three months and year ended December 31, 2013, as compared to $4.1 millionand $44.0 millionfor 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
Conference Call Information
Sunesis will host an update conference call today,
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.,
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
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow.
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
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
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED BALANCE SHEETS|
|December 31,||December 31,|
|Cash and cash equivalents||$ 15,121||$ 14,940|
|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|
|Accounts payable||$ 953||$ 78|
|Accrued clinical expense||4,750||5,449|
|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|
|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|
|Stockholders' (deficit) equity:|
|Additional paid-in capital||473,509||457,011|
|Accumulated other comprehensive (loss) income||(3)||38|
|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
|License and other revenue||$ 1,989||$ 1,989||$ 7,956||$ 3,754|
|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)|
|Other income (expense), net||1,038||4,860||92||(7,490)|
|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:|
|Basic||$ (7,177)||$ (4,052)||$ (34,598)||$ (43,951)|
|Shares used in computing net loss per share:|
|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 Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717