SOUTH SAN FRANCISCO, Calif., Nov. 14 /PRNewswire-FirstCall/ -- Sunesis Pharmaceuticals, Inc. , a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule therapeutics, today reported financial results for the quarter ended September 30, 2005. Revenue for the third quarter was $3.3 million, with a net loss of $5.6 million. As of September 30, 2005, cash, cash equivalents and marketable securities totaled $55.0 million and debt totaled $2.5 million.
Quarter Highlights * The company completed enrollment of the first Phase I clinical trial of SNS-595, Sunesis’ lead novel cytotoxic anticancer drug. The trial is an open-label, multi-center, dose-escalation study designed to examine the safety, tolerability and pharmacokinetics of SNS-595. The results of this trial will be presented at the upcoming European Organization for Research and Treatment of Cancer (“EORTC”) conference on November 17, 2005. * On August 29, 2005, Sunesis announced the selection of SNS-314 as the lead development candidate from the company’s internal efforts to discover novel Aurora kinase inhibitors. SNS-314 has shown promising activity and pharmaceutical properties in animal models. Sunesis plans to file an Investigational New Drug (IND) application for this compound in 2006. * On September 30, 2005, the company completed an initial public offering (“IPO”) of common stock with gross proceeds of $42.0 million. Financial Highlights * Revenue from research collaborations totaled $3.3 million and $11.9 million for the three-month and nine-month periods ended September 30, 2005, respectively, compared to $2.8 million and $6.3 million for the three-month and nine-month periods ended September 30, 2004, respectively. This increase in revenue is primarily due to the signing of the kinase collaboration with Biogen Idec in August 2004. * Research and development (R&D) expense was $6.9 million and $28.3 million for the three-month and nine-month periods ended September 30, 2005, respectively. R&D expense for the three-month and nine-month periods ended September 30, 2004, was $5.6 million and $17.5 million, respectively. The $10.8 million increase in R&D expenses between the nine-month periods ended September 30, 2004 and September 30, 2005 is primarily due to an $8.9 million expense related to the in-licensing of SNS-032 and related intellectual property from Bristol-Myers Squibb in April 2005, of which $8.0 million represents a non-cash licensing fee, and a $2.8 million increase in expense related to the development of SNS-314, our Aurora kinase inhibitor. * General and administrative (G&A) expense for the third quarter was $2.1 million, compared to $1.8 million for the prior year. For the nine- month period ended September 30, 2005, these expenses were $6.1 million, compared to $5.5 million for the nine-month period ended September 30, 2004. The increase is G&A expense is primarily due to an increase in non-cash stock compensation expense. * Sunesis reported a net loss of $5.6 million for the third quarter and $22.2 million for the nine-month period ended September 30, 2005, compared to a reported loss of $4.5 million and $16.5 million, respectively, for the three-month and nine-month periods ended September 30, 2004. The loss applicable to common shareholders was $93.7 million for the third quarter, including a $88.1 million non-cash deemed dividend related to the conversion of preferred stock into common stock in conjunction with the IPO. This non-cash deemed dividend results from the redistribution of pre-IPO ownership which occurred in conjunction with the company’s IPO. Company Milestones
Sunesis anticipates the following milestones in its development programs to occur over the next four months:
* Report results from a Phase I clinical trial of SNS-595 in patients with advanced solid tumors at the EORTC conference on November 17. * Initiate a multi-center open-label Phase I clinical trial of SNS-595 in patients with acute leukemias. * Initiate a multi-center, open-label Phase II second-line clinical trial of SNS-595 in patients with non-small cell lung cancer. * Initiate a multi-center, open-label Phase II second-line clinical trial of SNS-595 in patients with small cell lung cancer. * Initiate a multi-center, open-label Phase I/II clinical trial of SNS- 032, our inhibitor of CDK 2, 7 and 9, in patients with advanced solid tumors. Conference Call Information
Sunesis’ management will host a conference call to review the results of the quarter on Monday, November 14 at 1:30 pm PST. Individual and institutional investors can access the call via (800) 310-6649 (domestic) or (719) 457-2693 (international). To access the live audio broadcast or the subsequent archived recording, visit the “Investors and Media - Calendar of Events” section of the Sunesis website at http://www.sunesis.com. Please log on to Sunesis’ website several minutes prior to the start of the presentation to ensure adequate time for any software download that may be necessary.
About Sunesis Pharmaceuticals
Sunesis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule therapeutics for oncology and other serious diseases. Sunesis has built a broad product candidate portfolio through internal discovery and in-licensing of novel cancer therapeutics. Sunesis is advancing its product candidates through in-house research and development efforts and strategic collaborations with leading pharmaceutical and biopharmaceutical companies. For additional information on Sunesis Pharmaceuticals, please visit http://www.sunesis.com.
Safe Harbor Statement
This press release contains forward-looking statements that involve substantial risks and uncertainties. Sunesis may not actually achieve the plans, intentions or expectations contained in such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations contained in such forward-looking statements. Sunesis does not assume any obligation to update any such forward-looking statements. Sunesis Pharmaceuticals, Inc Statements of Operations Three months ended Nine months ended September 30, September 30, 2005 2004 2005 2004 (unaudited) (unaudited) Revenue: Collaboration revenue $1,685,537 $1,574,669 $5,028,923 $4,302,942 Collaboration revenue from related party 1,637,499 1,205,657 6,880,943 1,991,731 Grant and fellowship revenue 21,942 38,914 89,347 135,505 Total revenues 3,344,978 2,819,240 11,999,213 6,430,178 Operating expenses: Research and development 6,870,942 5,604,924 28,263,850 17,504,300 General and administrative 2,067,215 1,779,898 6,056,145 5,477,888 Total operating expenses 8,938,157 7,384,822 34,319,995 22,982,188 Loss from operations (5,593,179) (4,565,582) (22,320,782) (16,552,010) Interest income 178,515 111,400 574,204 316,102 Interest expense (229,450) (88,755) (445,975) (299,494) Other income (expense), net 2,094 726 8,300 733 Net loss (5,642,020) (4,542,211) (22,184,253) (16,534,669) Convertible preferred stock dividends (88,092,302) - (88,092,302) - Loss applicable to common stockholders $(93,734,322) $(4,542,211) $(110,276,555) $(16,534,669) Basic and diluted net loss per share applicable to common stockholders $(45.12) $(3.51) $(67.58) $(12.89) Shares used in computing basic and diluted loss per share applicable to common stockholders 2,077,245 1,294,835 1,631,700 1,283,179 Sunesis Pharmaceuticals, Inc. Condensed Balance Sheet September 30, December 31, 2005 2004 (Unaudited) Current assets: Cash and cash equivalents $45,212,955 $7,587,512 Marketable securities 9,777,438 29,224,509 Other current assets 1,803,917 1,839,259 Total current assets 56,794,310 38,651,280 Note and interest receivable from officers and employees - 85,350 Property and equipment, net 3,982,635 3,989,357 Deposits and other assets 300,000 300,000 Total assets 61,076,945 43,025,987 Current liabilities: Short-term liabilities 9,642,547 9,653,051 Current portion of equipment financing 1,138,076 1,291,363 Total current liabilities 10,780,623 10,944,414 Other long term liabilities 5,742,446 8,874,093 Borrowings under debt facility with related party - 3,200,000 Non current portion of equipment financing 1,351,785 1,238,430 Commitments Convertible preferred stock - 108,812,619 Stockholders’ equity (deficit): Common stock 2,146 139 Additional paid-in capital and other 246,893,143 3,372,935 Accumulated deficit (203,693,198) (93,416,643) Total stockholders’ equity (deficit) 43,202,091 (90,043,569) Total liabilities, convertible preferred stock and stockholders’ equity(deficit) 61,076,945 43,025,987
Sunesis Pharmaceuticals, Inc.
CONTACT: investors, Eric Bjerkholt, CFO of Sunesis Pharmaceuticals, Inc.,+1-650-266-3717; or media, Karen L. Bergman, +1-650-575-1509, or MichelleCorral, +1-415-794-8662, both of BCC Partners, for Sunesis Pharmaceuticals,Inc.
Web site: http://www.sunesis.com/
