-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, JVkg02+ZTrReM8s0wsE5KV8KPRz7pfswBINCD+mZTD0I60Ch2IhMuoguP7/t+AEq u4Z26plWaPXQzM9SkCmxTA== 0001144204-07-057486.txt : 20071101 0001144204-07-057486.hdr.sgml : 20071101 20071101085847 ACCESSION NUMBER: 0001144204-07-057486 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071101 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071101 DATE AS OF CHANGE: 20071101 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SUNESIS PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001061027 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943295878 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51531 FILM NUMBER: 071204777 BUSINESS ADDRESS: STREET 1: 341 OYSTER POINT BOULEVARD CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 650-266-3500 MAIL ADDRESS: STREET 1: 341 OYSTER POINT BOULEVARD CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 FORMER COMPANY: FORMER CONFORMED NAME: MOSAIC PHARMACEUTICALS INC DATE OF NAME CHANGE: 19980709 8-K 1 v092044_8k.htm
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
 
FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 1, 2007
 
SUNESIS PHARMACEUTICALS, INC.
 
(Exact Name of Registrant as Specified in its Charter)
 
Delaware
(State or Other Jurisdiction
of Incorporation)
000-51531
(Commission
File Number)
94-3295878
(IRS Employer
Identification No.)
 
341 Oyster Point Boulevard
South San Francisco, California
 
94080
(Address of Principal Executive Offices)
 
(Zip Code)
     
 
Registrant’s telephone number, including area code: (650) 266-3500
 
Not Applicable
(Former Name or Former Address, if Changed Since Last Report.)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

 
Item 2.02. Results of Operations & Financial Condition.
 
On November 1, 2007, Sunesis Pharmaceuticals, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2007. A copy of the press release is attached hereto as Exhibit 99.1
 
Item 9.01. Financial Statements and Exhibits.
 
Press release issued by Sunesis Pharmaceuticals, Inc., dated November 1, 2007.

* * * * * * * * *
 
2

 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
     
 
SUNESIS PHARMACEUTICALS, INC.
 
 
 
 
 
 
Date: November 1, 2007 By:    /s/ VALERIE L. PIERCE
 
Valerie L. Pierce
Senior Vice President, General Counsel and
Corporate Secretary
   
 

 
EXHIBIT INDEX
 
Exhibit No.  Description
   
99.1 Press release issued by Sunesis Pharmaceuticals, Inc., dated November 1, 2007.

 

 

 


EX-99.1 2 v092044_ex99-1.htm Unassociated Document

For Immediate Release

Sunesis Pharmaceuticals Reports Third Quarter 2007 Financial Results

South San Francisco, CA, November 1, 2007 - 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, 2007. Total revenues for the third quarter were $1.8 million, with a net loss of $10.8 million, including a restructuring charge of $1.2 million. As of September 30, 2007, cash, cash equivalents and marketable securities totaled $55.0 million.

Recent Highlights

SNS-595
 
·
In October, at the recent AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, Sunesis presented preliminary results from the company’s ongoing Phase 2 clinical trial of SNS-595, a replication-dependent DNA-damaging agent, in patients with platinum-resistant ovarian cancer.
 
o
Administered as a single agent, SNS-595 demonstrated anti-tumor activity, with 88 percent (15 of 17) of evaluable patients having best responses of stable disease or better, including two partial responses. Based on these results, SNS-595 has achieved the pre-specified criterion (two or more responses) for proceeding to Stage 2 of this trial.
 
·
Data from non-clinical studies of SNS-595 were also presented at the AACR-NCI-EORTC International Conference.
 
o
In vivo studies of SNS-595 in combinations with carboplatin, cisplatin, and gemcitabine in solid tumor xenografts demonstrate potent anti-tumor activity. Results from these non-clinical studies support the evaluation of SNS-595 in combination with platinum compounds or anti-metabolites for the treatment of solid tumor malignancies.
 
·
In October, Sunesis completed enrollment of approximately 70 patients in the company’s Phase 1 clinical trial of single-agent SNS-595 in patients with acute myeloid leukemia (AML). Sunesis will present data from this study at the upcoming American Society of Hematology (ASH) meeting being held December 8-11, 2007 in Atlanta, GA. In collaboration with advisors, Sunesis is continuing to outline a development strategy for the registration of SNS-595 for the treatment of AML.
 

 
 
·
In September, Sunesis also announced the initiation of a Phase 1b clinical trial of SNS-595 in combination with cytarabine in patients with relapsed and/or refractory acute leukemias. The trial is designed to evaluate the safety, tolerability and initial indications of anti-cancer activity of escalating doses of SNS-595 when administered with a fixed dose of cytarabine.

SNS-032
 
·
Data from non-clinical studies of SNS-032 was presented at the AACR-NCI-EORTC International Conference.
 
o
SNS-032, a cyclin-dependent kinase (CDK) inhibitor demonstrated potent anti-tumor activity in xenograft models of acute leukemia and multiple myeloma after intermittent, well tolerated dosing schedules. This activity was consistent with modulation of CDK7 and CDK9 inhibition and supports investigation of SNS-032 in B-cell malignancies such as chronic lymphocytic leukemia and multiple myeloma.

SNS-314
 
·
In September, Sunesis presented non-clinical combination data on SNS-314, an Aurora kinase inhibitor, at the 14th European Cancer Conference (ECCO 14).
 
o
The cytotoxic activity of SNS-314 was shown to be additive in vitro when administered in combination with gemcitabine, docetaxel and vincristine..
 
o
SNS-314 in combination with docetaxel resulted in significant anti-tumor activity in vivo at doses and schedules where neither compound showed single-agent activity.
 
·
In September, Sunesis announced the commencement of patient dosing in a Phase 1 clinical trial of SNS-314. The dose-escalating clinical trial will examine safety, tolerability and preliminary anti-tumor activity in patients with advanced solid malignancies.

Other
 
·
In August, Sunesis announced a reorganization, including a reduction in its workforce by approximately 25 percent, to focus its resources on generating definitive data from its lead programs, while streamlining operations and extending the company’s financial resources beyond 2008.

Financial Highlights
¨
Revenue from research collaborations totaled $1.8 million for the quarter ended September 30, 2007, compared to $1.9 million for the quarter ended September 30, 2006. This slight decrease in collaboration revenue was primarily due to lower amortization of license fees in the 2007 quarter.
¨
Research and development (R&D) expense was $8.8 million for the third quarter of 2007, compared to $8.6 million for the third quarter of 2006. This change is due to increased expenses related to the development of SNS-595, partially offset by reduced spending on SNS-314 and certain research programs.
¨
General and administrative (G&A) expense for the third quarter of 2007 was $3.4 million, compared to $3.0 million for the third quarter of 2006. The increase in G&A expense was due primarily to higher average salaries, non-cash stock-based compensation expense, patent prosecution costs and certain costs related to being a publicly traded company.
 

 
¨
In the quarter ended September 30, 2007, Sunesis recorded a $1.2 million restructuring charge related to the reorganization and a reduction in force.
¨
Sunesis reported a net loss of $10.8 million for the third quarter of 2007, compared to a reported net loss of $8.7 million for the third quarter of 2006.
¨
Cash used in operating activities was $27.3 million for the nine months ended September 30, 2007, compared to $19.0 million for the same nine-month period in 2006.
¨
In the third quarter of 2007, Sunesis recorded non-cash stock compensation expense of $0.7 million.

Conference Call Information
Sunesis’ management will host a conference call to review the results of the quarter and to provide an update on the company’s business on Thursday, November 1, 2007 at 10:30 am EDT. Individual and institutional investors can access the call via (888) 297-0358 (U.S. and Canada) or (719) 325-2215 (international). To access the live audio webcast 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 including without limitation statements related to the potential efficacy of SNS-595, SNS-032 and SNS-314, planned additional clinical testing and development efforts and the anticipated timing of the commencement and completion of clinical trials and the announcement of clinical results. Words such as “support,” “will,” “possible,” “optimistic,” “expects” 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, the risk that Sunesis' drug discovery and development activities could be halted significantly or delayed for various reasons, the risk that Sunesis' clinical trials for SNS-595, SNS-032 and SNS-314 may not demonstrate safety or efficacy or lead to regulatory approval, risks related to the conduct of Sunesis' clinical trials and manufacturing of SNS-595, SNS-032 and SNS-314 and risks related to Sunesis’ need for additional funding. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' annual report on Form 10-K for the year ended December 31, 2006 and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
 
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
 


Sunesis Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
 
   
Three months ended
September 30,
 
Nine months ended
September 30,
 
   
2007
 
2006
 
2007
 
2006
 
   
(Unaudited)
 
(Unaudited)
 
Revenue:
                 
Collaboration revenue
 
$
80,776
 
$
237,046
 
$
1,539,110
 
$
6,124,418
 
Collaboration revenue from related party
   
1,749,498
   
1,712,045
   
5,827,695
   
5,591,890
 
License revenue
   
   
   
250,000
   
 
Grant and fellowship revenue
   
   
   
   
37,901
 
Total revenues
   
1,830,274
   
1,949,091
   
7,616,805
   
11,754,209
 
                           
Operating expenses:
                         
Research and development
   
8,787,118
   
8,583,298
   
27,792,058
   
27,146,773
 
General and administrative
   
3,408,693
   
3,047,583
   
10,749,034
   
8,882,784
 
Restructuring charges
   
1,217,848
   
   
1,217,848
   
 
Total operating expenses
   
13,413,659
   
11,630,881
   
39,758,940
   
36,029,557
 
                           
Loss from operations
   
(11,583,385
)
 
(9,681,790
)
 
(32,142,135
)
 
(24,275,348
)
                           
Interest income
   
796,731
   
992,261
   
2,310,285
   
2,495,965
 
Interest expense
   
(55,903
)
 
(45,970
)
 
(152,254
)
 
(433,625
)
Other income, net
   
232
   
1,856
   
1,159
   
5,749
 
Net loss
 
$
(10,842,325
)
$
(8,733,643
)
$
(29,982,945
)
$
(22,207,259
)
                           
Basic and diluted loss per share
 
$
(0.32
)
$
(0.30
)
$
(0.95
)
$
(0.82
)
                           
Shares used in computing basic and diluted loss per share
   
34,315,961
   
29,333,909
   
31,667,511
   
27,209,536
 


 
Sunesis Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
 
   
September 30,
 
December 31,
 
   
2007
 
2006
 
ASSETS
 
(Unaudited)
 
(Note 1)
 
           
Current assets:
         
Cash and cash equivalents
 
$
12,411,761
 
$
6,075,449
 
Marketable securities
   
42,567,612
   
57,029,199
 
Prepaids and other current assets
   
1,189,608
   
1,082,817
 
Total current assets
   
56,168,981
   
64,187,465
 
               
Property and equipment, net
   
4,470,776
   
4,728,929
 
Deposits and other assets
   
359,974
   
359,974
 
Total assets
 
$
60,999,731
 
$
69,276,368
 
               
LIABILITIES AND STOCKHOLDERS' EQUITY
             
               
Current liabilities:
             
Accounts payable
 
$
556,039
 
$
2,477,656
 
Accrued compensation
   
2,189,961
   
2,323,742
 
Other accrued liabilities
   
3,348,309
   
961,766
 
Current portion of deferred revenue
   
1,702,031
   
2,260,478
 
Current portion of equipment financing
   
939,664
   
885,273
 
Total current liabilities
   
8,736,004
   
8,908,915
 
               
Non current portion of deferred revenue
   
-
   
1,143,159
 
Non current portion of equipment financing
   
1,323,960
   
955,695
 
Deferred rent and other non-current liabilities
   
1,581,226
   
1,464,902
 
Total liabilities
   
11,641,190
   
12,472,671
 
               
Commitments
             
               
Stockholders' equity:
             
Common stock
   
3,432
   
2,944
 
Additional paid-in capital
   
319,938,390
   
298,073,896
 
Deferred stock compensation
   
(387,736
)
 
(1,006,604
)
Accumulated other comprehensive income (loss)
   
32,563
   
(21,376
)
Accumulated deficit
   
(270,228,108
)
 
(240,245,163
)
Total stockholders' equity
   
49,358,541
   
56,803,697
 
               
Total liabilities and stockholders' equity
 
$
60,999,731
 
$
69,276,368
 
 
Note 1:
The condensed balance sheet at December 31, 2006 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, 2006.

# # #


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