-----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, Wb0boQhWtK4RHXI80nfQfxNSroNVS6mpp74kkWB7jK5L5u+JIDsoKNZVDSL26xzI Nx9ekRFCdJr6pbjOJMS2DA== 0001144204-08-033687.txt : 20080604 0001144204-08-033687.hdr.sgml : 20080604 20080604172314 ACCESSION NUMBER: 0001144204-08-033687 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080602 ITEM INFORMATION: Cost Associated with Exit or Disposal Activities ITEM INFORMATION: Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080604 DATE AS OF CHANGE: 20080604 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: 08881325 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 v116608_8k.htm
SECURITIES AND EXCHANGE COMMISSION
 
Washington, D. C.  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):  June 2, 2008
 
SUNESIS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
(State or other jurisdiction of incorporation)
 
000-51531
94-3295878
(Commission File No.)
(IRS Employer Identification No.)
 
341 Oyster Point Boulevard
South San Francisco, California 94080
(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (650) 266-3500
 
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:
 
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 2.05. Costs Associated with Exit or Disposal Activities.
 
On June 2, 2008, the Compensation Committee of the Board of Directors of Sunesis Pharmaceuticals, Inc. committed to a restructuring plan that will result in an immediate reduction of approximately 60% of Sunesis’ workforce, including the winding down of its research activities. Employees directly affected by the restructuring plan have received notification and will be provided with severance payments, outplacement assistance and the ability to extend the exercisability of their outstanding options until the later of (a) the existing expiration date of such options and (b) June 30, 2009. Sunesis announced that the restructuring plan was undertaken to focus on the advanced clinical development of Sunesis’ lead oncology product candidate, voreloxin (formerly SNS-595). The restructuring is intended to reduce Sunesis’ operating expenses. Sunesis expects to complete the restructuring plan by August 29, 2008.
 
As a result of the restructuring plan, Sunesis estimates that it will record a one-time restructuring charge of approximately $10.7 million in the second quarter of 2008. Approximately $8.0 million of this charge is related to the closing of Sunesis’ research facility. Approximately $2.5 million of this charge represents cash payments over the next twelve months for severance and other personnel-related expenses and approximately $0.4 million of this charge represents potential cash payments for real estate commission in connection with the sublease of Sunesis’ research facility. The majority of the severance payments will be paid out during the third quarter of 2008. The severance-related charge that Sunesis expects to incur in connection with the restructuring is subject to a number of assumptions, and actual results may materially differ. Sunesis may also incur other material charges not currently contemplated due to events that may occur as a result of, or associated with, the restructuring plan.
 
This current report contains “forward-looking” statements, including but not limited to statements with respect to the expected timing for completion of the restructuring plan; estimated restructuring charges to be incurred by Sunesis in the second quarter; anticipated benefits of the restructuring; potential safety and efficacy and commercial potential of voreloxin (formerly SNS-595); planned additional clinical testing and development efforts for Sunesis’ programs; the timing of enrollment in the ongoing Phase 2 clinical trial for voreloxin; the timing of announcements of clinical results for Sunesis’ programs; Sunesis’ plans to monetize its extensive fragment-based drug discovery capabilities and/or intellectual property portfolio; the advancement of compounds with Sunesis’ collaboration partners to clinical trials in 2008; the anticipated costs incurred by Sunesis in connection with the restructuring; and Sunesis’ anticipated burn rate for the second half of 2008. Any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. 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 or those of its partners, including enrollment and reporting of results, could be halted significantly or delayed for various reasons; the risk that Sunesis’ clinical trials for voreloxin or its other programs 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; the risk that Sunesis may not be able to monetize its fragment-based drug discovery capabilities and/or intellectual property portfolio; the risk that Sunesis’ restructuring costs may be greater than anticipated; the risk that Sunesis’ workforce reduction and any future workforce and expense reductions may have an adverse impact on Sunesis’ internal programs, Sunesis’ ability to hire and retain key personnel and may be distracting to management; and risks related to Sunesis’ need for additional funding and other risks detailed from time to time in Sunesis’ SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2007, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2008, and other periodic filings with the SEC. Sunesis does not undertake any obligation to update forward-looking statements.
 
 
 

 
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

In connection with the restructuring, Daniel C. Adelman, M.D., Senior Vice President, Development and Chief Medical Officer, will be leaving the company on June 6, 2008, and Robert S. McDowell, Ph.D., Vice President, Research, will be leaving the company on August 4, 2008. Dr. Adelman is entitled to receive nine months of his base salary, continued health benefits for up to nine months (which may be terminated earlier upon coverage by Dr. Adelman by a new employer) as well as the acceleration of twelve months of vesting on each of his outstanding stock option grants, as provided under his existing Executive Severance Benefits Agreement with Sunesis, dated August 8, 2005, which was filed as Exhibit 10.9 to Amendment No. 4 to Sunesis’ Registration Statement on Form S-1 (SEC File No. 333-121646), which was filed with the SEC on September 1, 2005. Dr. McDowell is entitled to receive six months of his base salary, continued health benefits for up to six months (which may be terminated earlier upon coverage by Dr. McDowell by a new employer) as well as the acceleration of twelve months of vesting on each of his outstanding stock option grants, as provided under his Executive Severance Benefits Agreement with Sunesis, dated August 4, 2005, which was filed as Exhibit 10.54 to Sunesis’ Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the SEC on March 17, 2008. These agreements were recently updated, along with the executive severance benefits agreements of all of Sunesis’ executives, to conform to modifications in the governing tax laws; the benefits under these agreements were not materially modified.

Each of Drs. Adelman and McDowell will also be afforded the opportunity to extend the exercisability of their stock options as described under Item 2.05 above and have until July 1, 2008 to accept this benefit.

Upon execution of a general release in favor of Sunesis, each of Drs. Adelman and McDowell will receive the benefits described above. In addition, assuming Dr. McDowell executes such a release, he will receive a cash bonus for his performance during the first half of 2008 of approximately $33,000.


Item 9.01. Financial Statements and Exhibits.
 
(d) Exhibits.
 
Exhibit No.
 
Exhibit Title
99.1
 
Press release, dated as of June 3, 2008, entitled “Sunesis Pharmaceuticals Focuses Resources on Development of Voreloxin (SNS-595).”

 
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.
 
 
 
 
Dated: June 4, 2008
 
 
By:
/s/ Eric H. Bjerkholt
 
 
 
Eric H. Bjerkholt
 
 
Senior Vice President, Corporate Development and Finance, Chief Financial Officer
 
 
 

 

EXHIBIT INDEX
 
 
Exhibit No.
 
Exhibit Title
99.1
 
Press release, dated as of June 3, 2008, entitled “Sunesis Pharmaceuticals Focuses Resources on Development of Voreloxin (SNS-595).”


 
 

 
EX-99.1 2 v116608_ex99-1.htm


For Immediate Release

Sunesis Pharmaceuticals Focuses Resources on Development of
Voreloxin (Formerly SNS-595)

Development Leadership Team in Place to Advance Voreloxin to Late-Stage Trials

Strategic Realignment Includes Workforce Reduction to Streamline Operations

South San Francisco, CA June 3, 2008 - Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced a corporate realignment to focus on the development of the company’s lead oncology product candidate, voreloxin (formerly SNS-595). In conjunction with this strategic restructuring, Sunesis expanded the company’s late-stage development leadership team and announced a workforce reduction of approximately 60 percent, including the winding down of its research activities. These changes are intended to concentrate the company’s financial and human resources on the strongest path to potential near-term value creation for the company’s stockholders. 

“Based on the promising clinical data achieved to date, we have made a strategic decision to focus the organization on generating critical clinical data by advancing our lead compound, voreloxin, into late-stage trials in the acute myeloid leukemia and ovarian cancer indications,” said Daniel Swisher, Sunesis’ Chief Executive Officer. “Late-stage development requires increased focus of our resources. We are also expanding and strengthening our development team with the additions of Drs. Steve Ketchum and Mary Bolton. Their extensive product development and regulatory expertise and track records of successful FDA submissions in a breadth of therapeutic areas will support our plan to advance voreloxin through late-stage trials.”

Steven B. Ketchum, Ph.D., has been appointed as Senior Vice President, Research and Development and Mary G. Bolton, M.D., Ph.D., as Vice President, Clinical Development. In addition, Judith A. Fox, Ph.D., has been promoted to Vice President, Product and Preclinical Development and Glenn C. Michelson, M.D., has been promoted to Vice President, Clinical Strategy.

To date, voreloxin has demonstrated objective responses in both solid and hematologic tumors and has been consistently well tolerated in multiple clinical trials. Sunesis is currently conducting Phase 2 clinical trials of voreloxin as a single agent for the treatment of platinum-resistant ovarian cancer and previously untreated acute myeloid leukemia (AML), as well as a Phase 1b clinical trial of voreloxin in combination with cytarabine in relapsed/refractory AML. Data recently reported at the 44th ASCO Annual Meeting in the Phase 2 ovarian cancer trial demonstrated that 48 percent of platinum-resistant ovarian cancer patients treated at a dose of 48 mg/m2 once every 21 days achieved disease control, defined as stable disease for 90 days or more or a complete or partial response. Preliminary median progression-free survival in this group of patients was 13 weeks at this dose; twenty-three patients at this dose remained on study as of May 12, 2008. Later this month, at the European Hematology Association Congress, Sunesis will report updated data on voreloxin’s activity alone, and interim data on voreloxin’s activity in combination with cytarabine for the treatment of AML.

 
 

 
Sunesis continues ongoing trials in its earlier-stage clinical programs, including the Phase 1 dose-escalation study of its cyclin-dependent kinase inhibitor, SNS-032, and its pan-Aurora kinase inhibitor, SNS-314, and expects to report data from these clinical trials this year. The company plans to seek a development partner to support advanced clinical trials of SNS-314. Future development of SNS-032 will depend on achieving positive results from the ongoing trial.

With the closing of its internal discovery research activities, Sunesis will also explore opportunities to monetize the company’s extensive fragment-based drug discovery capabilities, its preclinical programs and/or its intellectual property portfolio through a potential spin out or strategic alliance.

Sunesis will continue to benefit from any down-stream milestones or royalties based on future progress made in compounds emerging from its existing drug discovery collaborations with Biogen Idec Inc., Johnson & Johnson Pharmaceutical Research and Development LLC, Merck & Co., Inc. and SARcode Corporation. Sunesis anticipates that one or more of these compounds may advance to clinical trials within the next twelve months.

With this restructuring, Sunesis is reducing its workforce by approximately 60 employees. In addition, executive team members Daniel C. Adelman, M.D., Senior Vice President, Development and Chief Medical Officer, William L. Schary, Ph.D., Vice President, Regulatory Affairs and Quality Assurance, Robert S. McDowell, Ph.D., Vice President, Research and Jennifer A. Troia, SPHR, Vice President, Human Resources and Corporate Operations, will be leaving the company. Employees affected by the restructuring will be eligible for a severance package that includes severance pay, continuation of benefits and professional outplacement services. A one-time charge of approximately $10.7 million is expected to be incurred in the second quarter of 2008. Approximately $8.0 million of this charge is related to the closing of the company’s research facility. Approximately $2.5 million of the restructuring charge represents cash payments over the next twelve months for severance and other personnel related expenses.

“The decision to undertake this workforce reduction is a difficult one. I deeply appreciate all of the past contributions made on behalf of Sunesis by the talented and committed employees affected by this realignment. I am confident that the ongoing team will build upon their legacy as we aggressively advance voreloxin through late-stage clinical studies,” said Mr. Swisher.

 
 

 
Actions taken today will allow the company to direct most of its resources into the late-stage development of voreloxin. Sunesis expects this realignment of personnel and programs to reduce annual operating expenses by more than $15 million, thus enabling increased investment into such development. Current burn rate guidance for the second half of 2008 is in the range of $12-15 million, including payment of severance and other restructuring charges.

About Voreloxin (formerly SNS-595)
Sunesis’ lead compound, voreloxin (formerly SNS-595), is a novel naphthyridine analog, structurally related to quinolones, a class of compounds which has not been used previously for the treatment of cancer.  Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, irreversible G2 arrest and rapid apoptosis. Voreloxin is currently being evaluated in a Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients, in a Phase 1b clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML, and as a single agent in a Phase 2 clinical trial in platinum-resistant ovarian cancer. In clinical trials conducted to date, voreloxin has been generally well tolerated and has shown objective responses in both solid and hematologic tumor types.

About Sunesis Pharmaceuticals
Sunesis is a clinical-stage biopharmaceutical company focused on the development of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development 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 visit http://www.sunesis.com.


SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
 
 
 

 
Safe Harbor Statement
 
This press release contains forward-looking statements including without limitation statements related to the expected timing for completion of the restructuring plan; estimated restructuring charges to be incurred by Sunesis in the second quarter; anticipated benefits of the restructuring; potential safety and efficacy and commercial potential of voreloxin (formerly SNS-595); planned additional clinical testing and development efforts for the company’s programs; the timing of enrollment in the ongoing Phase 2 clinical trial for voreloxin; the timing of announcements of clinical results for the company’s programs; the company’s plans to monetize the company’s extensive fragment-based drug discovery capabilities and/or intellectual property portfolio; the advancement of compounds with the company’s collaboration partners to clinical trials in 2008; the anticipated costs incurred by the company in connection with the restructuring; and the company’s anticipated burn rate for the second half of 2008.  Words such as “promising,” “supports,” “optimistic,” “look forward,” “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 or those of its partners, including enrollment and reporting of results, could be halted significantly or delayed for various reasons; the risk that Sunesis’ clinical trials for voreloxin or its other programs 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; the risk that Sunesis may not be able to monetize its fragment-based drug discovery capabilities and/or intellectual property portfolio; the risk that Sunesis’ restructuring costs may be greater than anticipated; the risk that Sunesis’ workforce reduction and any future workforce and expense reductions may have an adverse impact on Sunesis’ internal programs, Sunesis’ ability to hire and retain key personnel and may be distracting to management; 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, 2007, Sunesis’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2008 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.

# # #


Investors
Media
Eric Bjerkholt
Karen L. Bergman or
SVP, Corp. Development & Finance
Michelle Corral
Sunesis Pharmaceuticals, Inc.
BCC Partners
650-266-3717
650-575-1509 or 415-794-8662

 
 

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