-----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, OfU2r3ximcCq8zViYm94lwNH4irKNnDhzmzI77S7+JQmLlVCa1iIo11wwlkmnyJ9 IIuu5xmWAeFWkEd7ioe39w== 0001144204-08-026796.txt : 20080508 0001144204-08-026796.hdr.sgml : 20080508 20080508090238 ACCESSION NUMBER: 0001144204-08-026796 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080508 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080508 DATE AS OF CHANGE: 20080508 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SUNESIS PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001061027 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943295878 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51531 FILM NUMBER: 08812116 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 v113156_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): May 8, 2008

SUNESIS PHARMACEUTICALS, INC.
 
(Exact Name of Registrant as Specified in its Charter)

Delaware
000-51531
94-3295878
(State or Other Jurisdiction
(Commission
(IRS Employer
of Incorporation)
File Number)
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 May 8, 2008, Sunesis Pharmaceuticals, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2008. 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 May 8, 2008.


* * * * * * * * *

 
 

 

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: May 8, 2008
By:   /s/ ERIC H. BJERKHOLT
 
Eric H. Bjerkholt
 
Senior Vice President, Corporate Development and Finance and Chief Financial Officer
 
 
 

 
 
EXHIBIT INDEX

Exhibit No.
Description

99.1
Press release issued by Sunesis Pharmaceuticals, Inc., dated May 8, 2008.

 
 

 
EX-99.1 2 v113156_ex99-1.htm Unassociated Document

For Immediate Release

Sunesis Pharmaceuticals Reports First Quarter 2008 Financial Results

South San Francisco, CA, May 8, 2008 - 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 March 31, 2008.

Total revenue for the first quarter of 2008 was $2.3 million, with a net loss of $9.6 million. As of March 31, 2008, cash, cash equivalents and marketable securities totaled $36.8 million, and debt totaled $2.1 million.

Recent Highlights

¨
In March, Sunesis presented positive interim results from the company’s ongoing Phase 2 clinical trial of SNS-595 in platinum-resistant ovarian cancer patients. As of March 10, 2008, these data show that 31 out of 35 women treated with SNS-595, and evaluable for best response using GOG-RECIST criteria, achieved disease control, including five investigator-reported objective responses (one of which is unconfirmed). SNS-595 was generally well tolerated. These data were presented at the 39th Annual Meeting on Women’s Cancer hosted by the Society of Gynecologic Oncologists.

¨
Earlier in the year, based on the safety profile and indications of activity observed at a dose of 48mg/m2 in Sunesis’ Phase 2 clinical trial of SNS-595 in platinum-resistant ovarian cancer patients, as well as advice received from clinical investigators, Sunesis amended the protocol to increase the dose to 60mg/m2 given every 28 days. At the 60mg/m2 dose the company has enrolled more than 30 patients to date. Reports thus far indicate that SNS-595 is generally well tolerated at the higher dose with a low incidence of febrile neutropenia. Therefore, later this month Sunesis plans to submit an amendment to the protocol to increase the dose intensity by 25 percent to 75mg/ m2 given every 28 days. Sunesis expects to enroll approximately 30 patients at this new dose level by the end of this year.

¨
In April, Sunesis presented data on all three of its clinical-stage product candidates, SNS-595, SNS-032 and SNS-314, at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California.
   
 
¨
Results from multiple nonclinical, translational research studies of SNS-595 presented by Sunesis researchers provide further insights into the compound’s mechanism of action and activity in certain types of cancers. SNS-595 acts by site-selective DNA intercalation and topoisomerase II poisoning resulting in apoptosis, or cell death. SNS-595's targeted DNA-topoisomerase II interactions and selectivity for proliferating cells may contribute to the broad therapeutic window observed to date in patients treated with SNS-595. SNS-595 is not a P-glycoprotein substrate and its activity is independent of the p53 family, suggesting that SNS-595 may be able to overcome these common drug resistance mechanisms. A Phase 2 single agent clinical trial of SNS-595 in ovarian cancer and a Phase 1b clinical trial of SNS-595 in combination with cytarabine in relapsed/refractory AML are ongoing.
 

 
 
¨
SNS-032, a potent and selective inhibitor of cyclin-dependent kinases 2, 7 and 9, is being evaluated in a Phase 1 clinical trial in patients with relapsed/refractory chronic lymphocytic leukemia or multiple myeloma. An oral presentation by Suzanne Trudel, MSc, M.D., Assistant Professor, Princess Margaret Hospital, University Health Network in Toronto, Canada, focused on the results from studies of SNS-032 demonstrating broad, mechanism-based activity in human myeloma cell lines and primary multiple myeloma cell cultures both as a single agent and in combination with either bortezomib (Velcade®) or lenalidomide (Revlimid®). A poster presentation by William Plunkett, Ph.D., Professor and Chief, Section of Molecular and Cellular Oncology at The University of Texas MD Anderson Cancer Center showed that SNS-032 blocks the transcription of key oncoproteins associated with mantle cell lymphoma.

 
¨
SNS-314 is a potent and selective pan-Aurora kinase inhibitor being studied in a Phase 1 dose-escalating clinical trial in patients with advanced solid tumors. Nonclinical research presented at the AACR Annual Meeting demonstrate that SNS-314 inhibits tumor growth in human xenograft models of colorectal, prostate, non-small cell lung and AML. Biomarker analyses of these nonclinical studies confirm SNS-314’s targeted, sustained activity and favorable pharmacokinetics.
 
¨
In March and April, Sunesis filed three patent applications related to its next generation fragment-based drug discovery. This technology combines the advantages of fragment assembly with high-throughput screening to generate diverse, novel starting points for medicinal chemistry. This proprietary technology platform can be applied to large proteins or protein complexes, significantly expanding the types of targets that the company can address, while reducing the time and manpower required for lead identification. To date, this approach has been applied successfully to several new drug targets, including anaplastic lymphoma kinase (ALK). Pilot screens against other targets, including protein:protein systems, are underway.

¨
Sunesis received a preclinical milestone payment in February from Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) under the companies’ drug discovery collaboration. The milestone payment was triggered by J&JPRD’s selection of a compound targeting the Cathepsin S enzyme as a development candidate emerging from the research collaboration.
 
2

 
Financial Highlights

¨
Collaboration revenue totaled $2.3 million for both the three months ended March 31, 2008 and the three months ended March 31, 2007.
 
¨
Research and development (R&D) expense was $8.7 million for the first quarter of 2008 compared to $9.3 million for the same period in 2007. The quarter-over-quarter decrease in R&D expense resulted primarily from a decrease in expense related to the SNS-314 and kinase inhibitor programs, partially offset by higher expense for the development of SNS-032 and SNS-595 due to increased clinical trial activities.
 
¨
General and administrative (G&A) expense for the first quarter of 2008 was comparable to the same period last year. G&A expense was $3.3 million for both the 2008 and 2007 periods.
 
¨
In the first quarter ended March 31, 2008, Sunesis recorded an additional $0.3 million real estate-related, non-cash, restructuring charge in conjunction with the company’s reorganization and reduction in force in 2007.
 
¨
Sunesis reported a net loss of $9.6 million for the quarter ended March 31, 2008 compared to a reported net loss of $9.4 million for the three-month period ended March 31, 2007.

¨
In the first quarter of 2008, 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 first quarter today at 11:00 a.m. EDT. Individual and institutional investors can access the call via (877) 440-5786 (U.S. and Canada) or (719) 325-4929 (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. The webcast will be recorded and available for replay on the company’s website until May 22, 2008.

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 further information on Sunesis Pharmaceuticals, please visit http://www.sunesis.com.

# # #
 
3

 
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc. All other trademarks, trade names and service marks appearing in this press release are the property of their respective owners.
 
Safe Harbor Statement
 
This press release contains forward-looking statements including without limitation statements related to the potential safety and efficacy and commercial potential of SNS-595, SNS-032 and SNS-314, planned additional clinical testing and development efforts, the timing of protocol amendments, the announcement of clinical results and the significance of new patent applications, the company’s ability to obtain patents on the underlying technology and the key benefits of the underlying technology. Words such as “support,” “will,” “plans,” “indicate,” “possible,” “optimistic,” “may,” “suggests,” “expects,” “designed” 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, the risk that preliminary data and trends may not be predictive of future data or results, the risk that Sunesis’ preclinical studies and clinical trials may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials and manufacturing of SNS-595, SNS-032 and SNS-314, risks related to Sunesis’ need for additional funding and the risk that Sunesis’ proprietary rights may not adequately protect the company’s technologies and product candidates. 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, 2007 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

4


Sunesis Pharmaceuticals, Inc.
Consolidated Statements of Operations
 
     
Three months ended
March 31,
 
 
 
2008
 
2007
 
   
(unaudited)
 
Revenue:
         
Collaboration revenue
 
$
537,500
 
$
229,167
 
Collaboration revenue from related party
   
1,765,683
   
2,037,099
 
License revenue
   
   
250,000
 
Total revenues
   
2,303,183
   
2,516,266
 
               
Operating expenses:
             
Research and development
   
8,742,895
   
9,307,478
 
General and administrative
   
3,266,129
   
3,296,147
 
Restructuring charges
   
320,774
   
 
Total operating expenses
   
12,329,798
   
12,603,625
 
               
Loss from operations
   
(10,026,615
)
 
(10,087,359
)
               
Interest income
   
460,412
   
769,626
 
Interest expense
   
(59,373
)
 
(52,043
)
Other income, net
   
671
   
739
 
Net loss
 
$
(9,624,905
)
$
(9,369,037
)
               
Basic and diluted loss per share
 
$
(0.28
)
$
(0.32
)
               
Shares used in computing basic and diluted loss per share
   
34,364,896
   
29,457,247
 

5

 
Sunesis Pharmaceuticals, Inc.
Consolidated Balance Sheets

   
March 31
 
December 31
 
   
2008
 
2007
 
ASSETS
 
(unaudited)
 
(Note 1)
 
           
Current assets:
         
Cash and cash equivalents
 
$
6,235,762
 
$
11,726,126
 
Marketable securities
   
30,581,908
   
35,957,933
 
Prepaids and other current assets
   
1,463,390
   
945,583
 
Total current assets
   
38,281,060
   
48,629,642
 
               
Property and equipment, net
   
3,971,051
   
4,238,498
 
Deposits and other assets
   
377,798
   
377,798
 
Total assets
 
$
42,629,909
 
$
53,245,938
 
               
LIABILITIES AND STOCKHOLDERS' EQUITY
             
               
Current liabilities:
             
Accounts payable and other accrued liabilities
 
$
4,475,117
 
$
4,515,426
 
Accrued compensation
   
1,405,065
   
2,225,868
 
Current portion of deferred revenue
   
752,032
   
1,227,031
 
Current portion of equipment financing
   
885,286
   
953,940
 
Total current liabilities
   
7,517,500
   
8,922,265
 
               
Non current portion of equipment financing
   
1,164,819
   
1,352,684
 
Deferred rent liabilities
   
1,472,418
   
1,576,734
 
Total liabilities
   
10,154,737
   
11,851,683
 
               
Commitments
             
               
Stockholders' equity:
             
Common stock
   
3,437
   
3,437
 
Additional paid-in capital
   
321,116,162
   
320,579,240
 
Deferred stock-based compensation
   
(134,619
)
 
(251,601
)
Accumulated other comprehensive income
   
121,180
   
69,262
 
Accumulated deficit
   
(288,630,988
)
 
(279,006,083
)
Total stockholders' equity
   
32,475,172
   
41,394,255
 
               
Total liabilities and stockholders' equity
 
$
42,629,909
 
$
53,245,938
 
 
# # #
 
6



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-----END PRIVACY-ENHANCED MESSAGE-----