SOUTH SAN FRANCISCO, Calif., Nov. 4 SunesisPharmaceuticals, Inc. (Nasdaq: SNSS) today reported financial results for thethird quarter ending September 30, 2008.
Total revenue for the third quarter of 2008 was $0.5 million, with a netloss of $7.1 million. As of September 30, 2008, cash, cash equivalents andmarketable securities totaled $18.3 million, and debt totaled $1.6 million.
"In the third quarter of this year, we continued to make significantprogress moving voreloxin forward in the clinic," said Dan Swisher, ChiefExecutive Officer of Sunesis. "Enrollment in each of our ongoing ovarian andacute myeloid leukemia (AML) studies is strong, and we look forward topresenting new results from the AML studies at ASH in December."
-- Exceeded the pre-specified protocol requirement of at least 9 completeremissions (CR) or complete remissions without full platelet recovery (CRp) inthe first 30 evaluable patients for continuing the REVEAL-1 study. REVEAL-1is a Phase 2 clinical trial of single-agent voreloxin in previously untreatedelderly patients with AML.
-- Presented updated interim data from an ongoing Phase 2 clinical trialof single-agent voreloxin in platinum-resistant ovarian cancer patients at the12th Biennial Meeting International Gynecologic Cancer Society. These datashow encouraging durable anti-tumor activity in the 48 mg/m2 cohort, asmeasured by partial and complete responses, and preliminary progression-freesurvival. Voreloxin has generally been well tolerated at dose levels of 48mg/m2 dosed every three weeks and 60 mg/m2 dosed every four weeks. Enrollmentcontinues in the 75 mg/m2 cohort dosed every four weeks and the company is ontrack to complete enrollment of this cohort by the end of 2008.
-- Presented voreloxin mechanism of action data at the 20th EORTC-NCI-AACRSymposium on Molecular Targets and Cancer Therapeutics. Through its provenmechanism of action (topoisomerase II inhibition and DNA intercalation) anddistinct chemical structure, voreloxin selectively and potently drivesdividing cells into apoptosis, evades several common drug resistance pathwaysand may have advantages over other topoisomerase II inhibitors. Also at thissymposium, the company presented preliminary results from its ongoing Phase 1clinical trial of SNS-314, a pan-Aurora kinase inhibitor, in patients withadvanced solid tumors.
-- Completed dose escalation of the Phase 1 trial of SNS-032, thecompany's inhibitor of cyclin dependent kinases 2, 7 and 9. Results from thistrial will be reported at the 50th American Society of Hematology AnnualMeeting in December.
-- Received a milestone payment of $500,000 and a $375,000 convertiblenote from SARcode Corporation as a result of their initiation of a Phase 1clinical trial of SAR1118, a small molecule LFA-1 product candidate for T-cellmediated ophthalmic diseases.
-- Collaboration and license revenue for the three months ended September30, 2008 decreased to $0.5 million compared to $1.8 million for the sameperiod in 2007. The decrease was primarily due to the conclusion of theresearch phase of the kinase inhibitor collaboration with Biogen Idec in June2008.
-- Research and development expense decreased by $4.1 million, or 47percent, to $4.7 million for the three months ended September 30, 2008, from$8.8 million for the same period in 2007. This decrease is primarily due tothe termination of substantially all discovery research activities in June2008.
-- General and administrative expense for the third quarter of 2008 was$2.8 million compared to $3.4 million for the same period in 2007. Thisdecrease is primarily due to a decrease in personnel and office-relatedexpenses.
-- The company reported a net loss of $7.1 million for the quarter endedSeptember 30, 2008, compared to a reported net loss of $10.8 million for thesame period in 2007.
-- Cash used in operating activities was $28.5 million for the nine monthsended September 30, 2008, compared to $27.3 million for the same nine-monthperiod in 2007.
Conference Call Information
Sunesis management will host a conference call to review third quarterprogress and to provide a general business update on Tuesday, November 4, 2008,at 11:00 a.m. EST / 8:00 a.m. PST. Individual and institutional investors canaccess the call via 1-877-627-6566 (U.S. and Canada) or +1-719-325-4901(international). To access the live audio webcast or the subsequent archivedrecording, visit the "Investors and Media - Calendar of Events" section of theSunesis website at www.sunesis.com. The webcast will be recorded andavailable for replay on the company's website until November 18, 2008.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development andcommercialization of new oncology therapeutics for the treatment of solid andhematologic cancers. Sunesis has built a highly experienced cancer drugdevelopment organization committed to advancing its lead product candidate,voreloxin, in multiple indications to improve the lives of people with cancer.For additional information on Sunesis Pharmaceuticals, please visithttp://www.sunesis.com.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including withoutlimitation statements related to the potential safety and efficacy andcommercial potential of voreloxin, planned additional clinical testing anddevelopment efforts, the timing of clinical trial enrollment and theanticipated announcement of clinical results. Words such as "look forward,""will," "encouraging," "on track" and similar expressions are intended toidentify forward-looking statements. These forward-looking statements arebased upon Sunesis' current expectations. Forward-looking statements involverisks and uncertainties. Sunesis' actual results and the timing of eventscould differ materially from those anticipated in such forward-lookingstatements as a result of these risks and uncertainties, which include,without limitation, risks related to Sunesis' need for additional funding, therisk that Sunesis' drug development activities could be halted significantlyor delayed for various reasons, the risk that Sunesis' clinical trials forvoreloxin, SNS-032 and SNS-314 may not demonstrate safety or efficacy or leadto regulatory approval, the risk that preliminary data and trends may not bepredictive of future data or results, the risk that Sunesis' preclinicalstudies and clinical trials may not satisfy the requirements of the FDA orother regulatory agencies, risks related to the conduct of Sunesis' clinicaltrials, including the pace of enrollment, risks related to the manufacturingof Sunesis' product candidates and the risk that Sunesis' proprietary rightsmay not adequately protect the company's product candidates. These and otherrisk factors are discussed under "Risk Factors" and elsewhere in Sunesis'annual report on Form 10-K for the year ended December 31, 2007, its quarterlyreport on Form 10-Q for the quarter ended June 30, 2008 and other filingswith the Securities and Exchange Commission. Sunesis expressly disclaims anyobligation or undertaking to release publicly any updates or revisions to anyforward-looking statements contained herein to reflect any change in thecompany's expectations with regard thereto or any change in events, conditionsor circumstances on which any such statements are based.SUNESIS PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS September 30, December 31, 2008 2007 ASSETS (Unaudited) (Note 1) Current assets: Cash and cash equivalents $8,484,014 $11,726,126 Marketable securities 9,782,214 35,957,933 Prepaids and other current assets 616,182 945,583 Total current assets 18,882,410 48,629,642 Property and equipment, net 931,075 4,238,498 Assets held-for-sale 1,182,864 - Deposits and other assets 377,798 377,798 Total assets $21,374,147 $53,245,938 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and other accrued liabilities $3,997,919 $4,515,426 Accrued compensation 1,189,334 2,225,868 Deferred revenue 39,583 1,227,031 Current portion of equipment financing 1,560,967 953,940 Total current liabilities 6,787,803 8,922,265 Non-current portion of equipment financing - 1,352,684 Deferred rent liabilities 1,536,572 1,576,734 Total liabilities 8,324,375 11,851,683 Commitments Stockholders' equity: Common stock 3,440 3,437 Additional paid-in capital 322,314,385 320,579,240 Deferred stock-based compensation - (251,601) Accumulated other comprehensive (loss) income (3,475) 69,262 Accumulated deficit (309,264,578) (279,006,083) Total stockholders' equity 13,049,772 41,394,255 Total liabilities and stockholders' equity $21,374,147 $53,245,938 Note 1: The consolidated balance sheet at December 31, 2007 has been derived from the audited financial statements at that date included in the Company's Form 10-K for the fiscal year ended December 31, 2007. SUNESIS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS Three months ended Nine months ended September 30, September 30, 2008 2007 2008 2007 (Unaudited) (Unaudited) Revenue: Collaboration revenue $10,417 $1,830,274 $4,904,840 $7,366,805 License revenue 500,000 - 500,000 250,000 Total revenues 510,417 1,830,274 5,404,840 7,616,805 Operating expenses: Research and development 4,662,556 8,787,118 21,668,055 27,792,058 General and administrative 2,827,797 3,408,693 9,328,987 10,749,034 Restructuring charges 192,225 1,217,848 5,389,745 1,217,848 Total operating expenses 7,682,578 13,413,659 36,386,787 39,758,940 Loss from operations (7,172,161) (11,583,385) (30,981,947) (32,142,135) Interest income 138,668 796,731 868,465 2,310,285 Interest expense (40,278) (55,903) (154,084) (152,254) Other income, net 8,599 232 9,071 1,159 Net loss $(7,065,172) $(10,842,325) $(30,258,495) $(29,982,945) Basic and diluted loss per share $(0.21) $(0.32) $(0.88) $(0.95) Shares used in computing basic and diluted loss per share 34,401,519 34,315,961 34,381,335 31,667,511 Contacts: Media Contact: Sunesis Pharmaceuticals, Inc. Invigorate Communications Eric Bjerkholt Monique Greer 650-266-3717 415-946-1075
SOURCE Sunesis Pharmaceuticals, Inc.