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8-K Filing
Viracta Therapeutics (VIRX) 8-KResults of Operations and Financial Condition
Filed: 14 Nov 05, 12:00am
Exhibit 99.1
For Immediate Release
South San Francisco, CA, November 14, 2005 – Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS), 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.
• 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.
• 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 an $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.
• 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 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 www.sunesis.com.
2
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.
CONTACTS:
Investors |
| Media |
Eric Bjerkholt, CFO |
| Karen L. Bergman or |
Sunesis Pharmaceuticals, Inc. |
| Michelle Corral |
650-266-3717 |
| BCC Partners |
|
| 650-575-1509 or 415-794-8662 |
3
Sunesis Pharmaceuticals, Inc.
Condensed Statement of Operations
|
| Three months ended September 30, |
| Nine months ended 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 |
|
See accompanying notes.
4
Sunesis Pharmaceuticals, Inc.
|
| September 30, |
| December 31, |
| ||
|
| (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 |
| ||
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