Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2012 Financial Results and Recent Highlights
"Last year was a transformational year for Sunesis, one which brought us several steps closer to realizing vosaroxin's potential as a new treatment standard in AML," said
Mr. Swisher added: "While VALOR moves towards completion, we continue to support the important progress in the NCRI-sponsored LI-1 Phase 2/3 trial and in our kinase inhibitor collaborations with
- Continued strong execution of VALOR trial. Enrollment and execution of the VALOR trial remains on track, with 563 patients enrolled as of yesterday. Enrollment is currently ongoing at more than 100 leading sites in the U.S.,
Canada, Europe, South Korea, Australia and New Zealand. Targetenrollment of 675 patients is expected to be complete by the end of 2013, with unblinding expected in the first half of 2014 after reaching 562 events and locking the final study database.
- Continued progress of LI-1 trial. Enrollment in the Less Intensive 1 (LI-1) trial, a Phase 2/3 randomized, controlled trial evaluating novel treatment regimens, including two treatment arms containing vosaroxin, in newly diagnosed elderly acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients, has reached 62 vosaroxin-treated patients as of
March 5, 2013. LI-1 is being conducted by the United Kingdom's National Cancer Research Instituteunder the direction of Professor Alan K. Burnett, Head of Haematology at Cardiff University.
- Received new U.S. patent in collaboration with Takeda/Millennium. In
October 2012, Sunesis and Millennium were granted a composition of matter patent in the U.S. covering the MLN2480 pan-Raf inhibitor currently in clinical development. This patent is expected to expire in 2031.
2013 Key Milestones
Completion of enrollment. Sunesis remains on track to complete full enrollment of the VALOR trial in 2013.
Interim safety analysis. Sunesis expects a planned interim safety analysis of VALOR by the trial's independent Data and Safety Monitoring Board to occur in
- First interim analyses. Sunesis anticipates the first two planned interim assessments of the LI-1 trial in 2013 following enrollment of 50 evaluable patients in the respective treatment arms containing vosaroxin. Various treatment options will be evaluated in a randomized Phase 2/3 design with primary endpoints of overall survival, complete remission rate and duration of response. Treatment arms that exhibit promising results are expected to continue enrolling up to a total of 200 patients per arm.
Initiation of investigator sponsored trials. Sunesis is evaluating additional indications and trials for vosaroxin, and expects to support the initiation of additional investigator sponsored trials in MDS and AML at leading centers in 2013.
- Expansion of the intellectual property estate. Sunesis expects to secure additional patents in 2013, with the goal of supporting its global vosaroxin patent estate and intellectual property strategy. The company's multi-layered patent portfolio currently supports market exclusivity for vosaroxin to 2030 in the U.S., and beyond 2025 in multiple geographies internationally.
Kinase Inhibitor Program
Continued progress with partnered kinase inhibitor programs. Sunesis currently has partnered kinase inhibitor programs in oncology with
Millennium Pharmaceuticalsand immunology with Biogen Idec.
- Cash and investments totaled
$71.2 millionas of December 31, 2012, as compared to $44.1 millionas of December 31, 2011. The increase of $27.1 millionwas primarily due to the receipt of $25.0 millionunder a royalty agreement with Royalty Pharma; the draw-down of the second tranche of $15.0 millionfrom the 2011 venture loan facility; net proceeds from sales of common stock under controlled equity offering agreements of $17.6 million; and proceeds from the exercise of warrants, stock options and stock purchase rights of $1.9 million, partially offset by other net operating cash outflows. As of September 30, 2012, outstanding debt totaled $25.0 million.
- Revenues for the three months and year ended
December 31, 2012were $2.0 millionand $3.8 million, as compared to nil and $5.0 millionfor the same periods in 2011. Revenue in 2012 was comprised of $1.5 millionreceived from Biogen Idecin June 2012for the advancement of pre-clinical work and $2.3 millionof deferred revenue recognized related to the royalty agreement.
- Research and development expenses increased to
$7.6 millionand $29.2 millionfor the three months and year ended December 31, 2012, as compared to $6.3 millionand $22.6 millionfor the same periods in 2011. The increases in 2012 were primarily due to an increase in clinical and other expenses related to the VALOR trial.
- General and administrative expenses for the three months and year ended
December 31, 2012were $2.5 millionand $9.2 million, as compared to $2.2 millionand $8.3 millionfor the same periods in 2011. The increases in 2012 were primarily due to higher non-cash stock-based compensation expenses and other personnel-related costs.
- Interest expense was
$0.8 millionand $1.9 million for the three months and year ended December 31, 2012as compared to $0.3 millionand $0.3 millionfor the same periods in 2011. The increases in 2012 were due to the timing of the first and second tranche draw-downs under the 2011 venture loan facility.
- Other income, net was
$4.9 millionfor the three months ended December 31, 2012as compared to $4,000for the same period in 2011. Other expense, net was $7.5 millionfor the year ended December 31, 2012, as compared to other income, net of $6.0 millionfor the same period in 2011. The amounts for each period were primarily comprised of non-cash charges and credits pertaining to the revaluation of warrants issued in the underwritten offering completed in October 2010.
- Cash used in operations was
$9.3 millionand $10.6 millionfor the three months and year ended December 31, 2012, as compared to $7.3 millionand $22.8 millionfor the same periods in 2011. Net cash used in 2012 resulted primarily from the net loss of $44.0 million, partially offset by net adjustments for non-cash items of $7.5 million for the revaluation of warrants issued in the 2010 Offering and $2.7 million for stock-based compensation, and changes in operating assets and liabilities of $22.7 million, including a net increase in deferred revenue of $19.6 millionrelated to the receipt of the $25.0 millionpayment from Royalty Pharma, and an increase of $3.1 millionin accrued clinical expenses related to the VALOR trial.
- Sunesis reported loss from operations of
$8.1 millionand $34.6 millionfor the three months and year ended December 31, 2012, as compared to $8.5 millionand $25.9 millionfor the same periods in 2011. Net loss was $4.1 millionand $44.0 millionfor the three months and year ended December 31, 2012, as compared to $8.7 millionand $20.1 millionfor the same periods in 2011.
Conference Call Information
Sunesis will host an update conference call today,
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial's target enrollment is 675 patients at more than 100 leading sites in the U.S.,
Vosaroxin is a first-in-class anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow.
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logos are trademarks of
This press release contains forward-looking statements, including statements related to: (i) Sunesis' overall strategy, (ii) the design, conduct, progress, timing and results of the VALOR trial and Sunesis' other clinical programs discussed in this release, (iii) the sufficiency of Sunesis' financial resources, (iv) the progress of the kinase collaboration programs and (v) the sufficiency of Sunesis' intellectual property estate and the patent exclusivity period for vosaroxin and the MLN2480 pan-Raf inhibitor in
|SUNESIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|December 31,||December 31,|
|Cash and cash equivalents||$ 14,940||$ 9,311|
|Prepaids and other current assets||1,705||1,550|
|Total current assets||72,932||45,665|
|Property and equipment, net||43||74|
|Deposits and other assets||42||130|
|Total assets||$ 73,017||$ 45,869|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable||$ 78||$ 658|
|Accrued clinical expense||5,449||2,370|
|Other accrued liabilities||2,113||1,805|
|Current portion of deferred revenue||7,956||--|
|Current portion of notes payable||6,610||--|
|Total current liabilities||31,741||8,383|
|Non-current portion of deferred revenue||11,668||--|
|Non-current portion of notes payable||17,651||9,453|
|Non-current portion of deferred rent||--||13|
|Additional paid-in capital||457,011||429,142|
|Accumulated other comprehensive income (loss)||38||19|
|Total stockholders' equity||11,957||28,020|
|Total liabilities and stockholders' equity||$ 73,017||$ 45,869|
|Note 1: The condensed consolidated balance sheet as of December 31, 2011 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, 2011.|
|SUNESIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)|
|(In thousands, except per share amounts)|
Three months ended
|License and other revenue||$ 1,989||$ --||$ 3,754||$ 5,000|
|Research and development||7,589||6,326||29,185||22,563|
|General and administrative||2,473||2,159||9,175||8,303|
|Total operating expenses||10,062||8,485||38,360||30,866|
|Loss from operations||(8,073)||(8,485)||(34,606)||(25,866)|
|Other income (expense), net||4,860||4||(7,490)||5,984|
|Unrealized gain (loss) on available-for-sale securities||41||(1)||19||34|
|Comprehensive loss||$ (4,011)||$ (8,741)||$ (43,932)||$ (20,107)|
|Basic and diluted loss per common share:|
|Shares used in computing net loss per common share:|
|Net loss per common share:|
|Basic||$ (0.08)||$ (0.19)||$ (0.91)||$ (0.43)|
|Diluted||$ (0.20)||$ (0.19)||$ (0.91)||$ (0.43)|
|Note 2: The consolidated statement of operations and comprehensive income (loss) for the year ended December 31, 2011 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, 2011.|
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717