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Table of Contents

 
 
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): April 27, 2006 (April 17, 2006)
 
CYTOKINETICS, INCORPORATED
(Exact name of registrant as specified in its charter)
         
DELAWARE
 
  000-50633    94-3291317 
(State or other jurisdiction of   (Commission File Number)   (IRS Employer
incorporation)       Identification No.)
280 East Grand Avenue
South San Francisco, California 94080

(Address of principal executive offices, including zip code)
650-624-3000
(Registrant’s telephone number, including area code)
(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))
 
 

 


TABLE OF CONTENTS

ITEM 2.02. RESULTS FROM OPERATIONS AND FINANCIAL CONDITION.
ITEM 8.01. OTHER EVENTS.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1
EXHIBIT 99.2


Table of Contents

ITEM 2.02. RESULTS FROM OPERATIONS AND FINANCIAL CONDITION.
     On April 27, 2006, Cytokinetics, Incorporated (the “Company”) issued a press release announcing its results for the quarter ended March 31, 2006. A copy of this press release is being filed with this Current Report on Form 8-K, is attached hereto as Exhibit 99.1, and is hereby incorporated by reference into this Item 2.02.
ITEM 8.01. OTHER EVENTS.
     On April 17, 2006, the Company issued a press release announcing the initiation of a Phase I/II clinical trial of its second kinesin spindle protein inhibitor, SB-743921, in patients with non-Hodgkin’s lymphoma (“NHL”). The Company is conducting this clinical trial within the framework contemplated by the September 2005 amendment to the collaboration and License Agreement between the Company and GlaxoSmithKline that provides for the Company to conduct clinical trials in certain hematological cancers, including NHL. A copy of this press release is being filed with this Current Report on Form 8-K, is attached hereto as Exhibit 99.2, and is hereby incorporated by reference into this Item 8.01.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
The following Exhibits are filed as part of this Current Report on Form 8-K:
     
Exhibit No.   Description
 
   
99.1
  Press Release, dated April 27, 2006.
99.2
  Press Release, dated April 17, 2006.

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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.
         
  CYTOKINETICS, INCORPORATED
 
 
  By:   /s/ James H. Sabry    
    James H. Sabry   
    Chief Executive Officer   
 
Date: April 27, 2006

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Table of Contents

EXHIBIT INDEX
     
Exhibit No.   Description
 
   
99.1
  Press Release, dated April 27, 2006.
99.2
  Press Release, dated April 17, 2006.

4

exv99w1
 

Exhibit 99.1
     
Cytokinetics, Incorporated
  Burns McClellan, Inc.
Sharon Surrey-Barbari
  Clay Kramer (investors)
SVP, Finance and CFO
  Justin Jackson (media)
(650) 624-3000
  (212) 213-0006
CYTOKINETICS, INCORPORATED REPORTS
FIRST QUARTER 2006 FINANCIAL RESULTS
Company Provides Update on Clinical Development Programs
SOUTH SAN FRANCISCO, CA, April 27, 2006 – Cytokinetics, Incorporated (Nasdaq: CYTK), for the first quarter of 2006, reported revenues from research and development collaborations of $1.4 million. Net loss for the first quarter of 2006 was $12.5 million, or $0.36 per share. As of March 31, 2006, cash, cash equivalents, restricted cash and marketable securities totaled $105.8 million.
“In the first quarter of 2006, Cytokinetics continued to advance both its oncology and cardiovascular programs towards important proof-of-concept validation in human clinical trials, while gaining further insight into the potential clinical role of each of our our drug candidates. In March, we reported additional clinical trial data for ispinesib in patients with platinum-sensitive non-small cell lung cancer, in connection with our strategic alliance with GlaxoSmithKline. In our cardiology program, our Phase I clinical trial with CK-1827452 for the potential treatment of patients with heart failure is progressing as expected, and we look forward to sharing top-line data from this trial in the next few months,” stated James H. Sabry, M.D., Ph.D., Chief Executive Officer. “We are pleased with the clinical progress of our novel cytoskeletal-based drug discovery approaches for the potential treatment of cancer and heart failure.”
Company Highlights:
    In March of 2006, Cytokinetics announced that in a Phase II clinical trial, conducted by GlaxoSmithKline (GSK), and designed to evaluate the safety and efficacy of ispinesib in the second-line treatment of patients with either platinum-sensitive or platinum-refractory non-small cell lung cancer, ispinesib did not satisfy the criteria for advancement to Stage 2 in the platinum-sensitive treatment arm. This clinical trial was designed to require a minimum of 1 confirmed partial or complete response out of 20 evaluable patients in a treatment arm in order to proceed to Stage 2 in that treatment arm. The clinical trial’s primary endpoint was response rate as determined using the RECIST criteria. The best overall response in the platinum-sensitive treatment arm of this clinical trial was disease stabilization observed in 10 of 20 evaluable patients. In the overall patient population, median time to disease progression was 6 weeks for the 20 evaluable patients; in the 10 patients whose best response was stable disease, the median time to progression was 17 weeks.
 
    GSK continued to enroll patients in Stage 2 of a Phase II clinical trial evaluating ispinesib as second- or third-line treatment for patients with locally advanced or metastatic breast cancer. Investigators presented data from Stage 1 of this clinical trial at the San Antonio Breast Cancer Symposium in December 2005.
 
    GSK continued to treat patients in a Phase II clinical trial evaluating ispinesib as second-line treatment for patients with advanced ovarian cancer.
 
    GSK also continued to treat patients in two dose-escalating Phase Ib clinical trials, each designed to evaluate the safety, tolerability and pharmacokinetics of ispinesib in combination with a leading anti-cancer therapeutic, one in combination with carboplatin and the second in combination with capecitabine.
 
    The National Cancer Institute (NCI), in collaboration with GSK, continued to sponsor five Phase II clinical trials evaluating the potential efficacy of ispinesib in the treatment of patients with colorectal, hepatocellular, head and neck, hormone-refractory prostate cancer and melanoma.
 
    The NCI also continued patient enrollment in two Phase I clinical trials designed to evaluate the safety, tolerability and pharmacokinetics of ispinesib on an alternative dosing schedule. One clinical trial is enrolling patients with advanced solid tumors who have failed to respond to all standard therapies, and the second clinical trial is enrolling patients with acute leukemia, chronic myelogenous leukemia or advanced myelodysplastic syndromes.
 
    GSK continued to enroll patients in a dose-escalating Phase I clinical trial of SB-743921, our second KSP inhibitor. This clinical trial is designed to evaluate the safety, tolerability and pharmacokinetics of SB-743921 in advanced cancer patients.
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Cytokinetics Q1 Financials Press Release
April 27, 2006
Page 2
    In April of 2006, Cytokinetics announced the initiation of a Phase I/II clinical trial of SB-743921, in patients with non-Hodgkin’s Lymphoma (NHL), in connection with an expanded development program for SB-743921. This Phase I/II clinical trial is an open-label, non-randomized clinical trial designed to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of SB-743921, administered as a one-hour infusion on days 1 and 15 of a 28-day schedule, first without and then with the administration of granulocyte colony stimulating factor (GCSF) in patients with NHL. This clinical trial is designed to allow us to assess the potential efficacy of the maximum tolerated dose (MTD) of SB-743921 administered on this dosing schedule in patients with NHL.
 
    Cytokinetics continued to dose-escalate CK-1827452, a novel small molecule cardiac myosin activator for the treatment of acute heart failure, through several cohorts in a Phase I clinical trial designed to determine the maximum tolerated dose and plasma concentration of this drug candidate in healthy volunteers. The clinical trial is a double-blind, randomized, placebo-controlled, dose-escalation clinical trial being conducted to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CK-1827452 in normal healthy volunteers.
 
    In January of 2006, Cytokinetics sold $33.0 million of its common stock in a registered direct offering pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission. Under the terms of the transaction, Cytokinetics sold 5.0 million shares of common stock at a price of $6.60 per share to a select group of institutional investors. Net proceeds from the offering were approximately $32.0 million after all offering expenses.
Financials:
Revenues from research and development collaborations for the first quarter of 2006 were $1.4 million, compared to $2.6 million for the same period in 2005. Revenues for the first quarter of both 2006 and 2005 were largely derived from our research collaboration with GSK. Revenues from the first quarter of 2005 also included $0.3 million in payments from our research collaboration with AstraZeneca. The decline in collaborative research revenues in 2006, when compared to the same period in 2005, was primarily due to reductions in full time equivalent and patent reimbursement revenue of $0.9 million by GSK and a reduction in collaboration revenue from AstraZeneca in 2006.
Total research and development (R&D) expenses for the first quarter of 2006 were $11.3 million, compared to $10.5 million for the same period in 2005. The increase in R&D expenses over the prior year was primarily due to increased spending related to the advancement of our cardiovascular and early research programs, partially offset by decreased spending on proprietary technologies. In the first quarter of 2006, the stock-based compensation expense related to the adoption of the Statement of Financial Accounting Standards (SFAS) No. 123R, Share-Based Payment was offset by lower salary expense.
Total general and administrative (G&A) expenses for the first quarter of 2006 were $3.6 million, compared to $3.1 million for the same period in 2005. The increase in 2006 G&A expenses was primarily due to the recording of employee stock-based compensation charges related to SFAS No. 123R.
The net loss for the first quarter of 2006 was $12.5 million, or $0.36 per share, compared to a net loss of $10.5 million, or $0.37 per share for the same period in 2005.
Company Milestones for 2006
Oncology
Ispinesib (SB-715992)
    Additional data are anticipated from GSK’s Phase II clinical trial of second- or third-line therapy in patients with locally advanced or metastatic breast cancer in the second half of 2006.
 
    Data are anticipated from GSK’s Phase II clinical trial of second-line therapy in patients with ovarian cancer in the second or third quarter of 2006.
 
    Interim data from GSK’s Phase Ib clinical trial evaluating ispinesib in combination with carboplatin will be presented at the American Society of Clinical Oncology (ASCO) conference in June of 2006.
 
    Additional data are anticipated from GSK’s Phase Ib clinical trial evaluating ispinesib in combination with capecitabine, in the second half of 2006.
 
    Interim data from the NCI’s Phase II clinical trials in the second-line therapy of patients with metastatic colorectal cancer will be presented at the ASCO conference in June of 2006.

 


 

Cytokinetics Q1 Financials Press Release
April 27, 2006
Page 3
    Initiation of the NCI’s Phase II clinical trial in patients with renal cell cancer is anticipated in the second half of 2006.
 
    Interim data from the NCI’s Phase I clinical trial evaluating an alternative dosing schedule in patients with advanced solid tumors will be presented at the ASCO conference in June of 2006.
SB-743921
    Interim data from GSK’s Phase I clinical trial in advanced solid tumor patients will be presented at the ASCO conference in June of 2006.
GSK-923295
    A regulatory filing is anticipated by GSK in late 2006 to allow initiation of first time in human clinical trials in the first half of 2007.
The clinical trial milestones for the oncology program described above are based on information provided by GSK or the NCI. The occurrence of these events is outside of our control.
Cardiovascular
CK-1827452, intravenous formulation
    Top-line data are anticipated from our Phase I clinical trial in healthy volunteers in the second quarter of 2006.
 
    Initiation of our Phase II clinical trials program is expected in the second half of 2006.
CK-1827452, oral formulation
    Initiation of our Phase I oral bioavailability clinical trial is expected in the second half of 2006.
Conference Call and Webcast Information
Members of the Cytokinetics management team will review first quarter results via webcast and conference call today at 4:30 PM Eastern Time. To access the live webcast, please log-on in the Investor Relations section of Cytokinetics’ website at www.cytokinetics.com. Investors, members of the news media and the general public may also access the live conference call dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (International) and typing in the passcode 7704837. The webcast will be available via Cytokinetics’ website through May 27, 2006. The audiocast will be available via telephone from April 27, 2006 at 5:30 PM Eastern Time until May 4, 2006 by dialing 800-642-1687 (United States and Canada) or 706-645-9291 (International) and typing in the passcode 7704837.
About Cytokinetics
Cytokinetics is a biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs that specifically target the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Cytokinetics’ focus on the cytoskeleton enables it to develop novel and potentially safer and more effective classes of drugs directed at treatments for cancer, cardiovascular disease and other diseases. Cytokinetics has developed a cell biology driven approach and proprietary technologies to evaluate the function of many interacting proteins in the complex environment of the intact human cell. Cytokinetics employs its PUMA™ system and Cytometrix™ technologies to enable early identification and automated prioritization of compounds that are highly selective for their intended protein targets without other cellular effects, and may therefore be less likely to give rise to clinical side effects. Cytokinetics and GlaxoSmithKline (GSK) have entered into a strategic alliance to discover, develop and commercialize small molecule therapeutics targeting human mitotic kinesins for applications in the treatment of cancer and other diseases. Ispinesib (SB-715992), SB-743921 and GSK-923295 are being developed under the strategic alliance with GSK. GSK is conducting Phase II and Ib clinical trials for ispinesib and a Phase I clinical trial for SB-743921. Cytokinetics is conducting a Phase I/II clinical trial for SB-743921. Cytokinetics’ unpartnered cardiovascular disease program is the second program to leverage the company’s expertise in cytoskeletal pharmacology. Cytokinetics is conducting a Phase I clinical trial with CK-1827452, a novel small molecule cardiac myosin activator, for the intravenous treatment of heart failure and has also selected CK-1827452 as a potential drug candidate for the treatment of chronic heart failure via oral administration. Additional information about Cytokinetics can be obtained at www.cytokinetics.com.

 


 

Cytokinetics Q1 Financials Press Release
April 27, 2006
Page 4
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, statements relating to the expected initiation, timing, scope and results of Cytokinetics’ and its partners’ clinical development and research programs, including statements regarding Cytokinetics’ milestones for 2006, anticipated dates of release of data from clinical trials, upcoming presentations of clinical trial results, initiation of clinical trials, the potential benefits of our drug candidates and potential drug candidates and the enabling capabilities of our proprietary technologies. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to decisions by GSK or the NCI to postpone or discontinue development efforts for one or more compounds, difficulties or delays in patient enrollment for clinical trials, unexpected adverse side effects or inadequate therapeutic efficacy of our drug candidates, and other potential difficulties or delays in development, testing, regulatory approval, production and marketing of Cytokinetics’ drug candidates that could slow or prevent clinical development, product approval or market acceptance (including the risks relating to uncertainty of patent protection for Cytokinetics’ intellectual property or trade secrets, Cytokinetics’ ability to obtain additional financing if necessary and unanticipated research and development and other costs), the conduct of activities and continued funding under Cytokinetics’ collaborations and the implementation and maintenance of procedures, policies, resources and infrastructure relating to compliance with new or changing laws, regulations and practices. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.
###

 


 

Cytokinetics Q1 Financials Press Release
April 27, 2006
Page 5
Condensed Statement of Operations
(in thousands, except per share data)
(unaudited)
                 
    Three Months Ended  
    March 31,     March 31,  
    2006     2005  
 
               
Revenues:
               
Research and development revenues
  $ 720     $ 1,872  
License revenues
    700       700  
 
           
 
               
Total revenues
    1,420       2,572  
 
           
 
               
Operating Expenses:
               
Research and development
    11,266       10,537  
General and administrative
    3,622       3,143  
 
           
 
               
Total operating expenses
    14,888       13,680  
 
           
 
               
Operating loss:
    (13,468 )     (11,108 )
 
               
Interest and other income
    1,128       712  
Interest and other expense
    (124 )     (134 )
 
           
 
               
Net loss
  $ (12,464 )   $ (10,530 )
 
           
 
               
Net loss per common share — basic and diluted
  $ (0.36 )   $ (0.37 )
 
               
Weighted average shares used in computing net loss per common share — basic and diluted
    34,247,403       28,381,656  

 


 

Cytokinetics Q1 Financials Press Release
April 27, 2006
Page 6
Condensed Balance Sheet Data
(in thousands)
(unaudited)
                 
    March 31,     December 31,  
    2006     2005  
 
               
Assets
               
 
               
Cash and cash equivalents
  $ 73,111     $ 13,515  
 
               
Short term investments
    28,150       62,697  
 
               
Other current assets
    1,846       2,652  
 
           
 
               
Total current assets
    103,107       78,864  
 
               
Property and equipment, net
    5,949       6,178  
 
               
Restricted investments
    4,546       5,172  
 
               
Other assets
    1,066       1,247  
 
           
 
               
Total assets
  $ 114,668     $ 91,461  
 
           
 
               
Liabilities and stockholders’ equity
               
 
               
Current liabilities
  $ 9,685     $ 11,264  
 
               
Long-term obligations
    5,933       6,636  
 
               
Stockholder’s equity
    99,050       73,561  
 
           
 
               
Total liabilities and stockholders’ equity
  $ 114,668     $ 91,461  
 
           

 

exv99w2
 

Exhibit 99.2
     
Contacts:
   
 
   
Cytokinetics, Incorporated
  Burns McClellan, Inc.
Robert I. Blum
  Clay Kramer (investors)
President
  Justin Jackson (media)
(650) 624-3000
  (212) 213-0006
CYTOKINETICS ANNOUNCES THE INITIATION OF
PHASE I/II CLINICAL TRIAL FOR SB-743921
Second Drug Candidate Enters Expanded Development Program
Under Strategic Alliance with GlaxoSmithKline
South San Francisco, CA, April 17, 2006 Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the initiation of a Phase I/II clinical trial of its second Kinesin Spindle Protein (KSP) inhibitor, SB-743921, in patients with non-Hodgkin’s lymphoma (NHL). Cytokinetics is conducting this clinical trial in order to expand the development activities for SB-743921, based on a recently amended agreement with GlaxoSmithKline (GSK). SB-743921 is the second drug candidate in clinical development arising from a strategic collaboration between Cytokinetics and GSK to discover, develop and commercialize novel small molecule therapeutics targeting human mitotic kinesins for applications in the treatment of cancer and other diseases. GSK has initiated a broad Phase II clinical trial program for the lead drug candidate from this program, the KSP inhibitor ispinesib (SB-715992), and is evaluating SB-743921 in an ongoing Phase I trial in patients with advanced solid tumors.
This Phase I/II clinical trial is an open-label, non-randomized study to investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of SB-743921, administered as a one-hour infusion on days 1 and 15 of a 28 day schedule, in patients with non-Hodgkin’s lymphoma. The objective of the Phase I portion of the clinical trial is to identify the maximum tolerated dose (MTD) of SB-743921 on this schedule, in patients with either Hodgkin’s or non-Hodgkin’s lymphoma, first without prophylactic administration of granulocyte colony stimulating factor (GCSF). If the dose-limiting toxicity determining this first MTD is neutropenia, a second MTD will be determined with SB-743921 given with prophylactic administration of GCSF. Following review of the Phase I data from this clinical trial, the optimal dose and regimen of SB-743921 (i.e., without or with prophylactic administration of GCSF) will be determined for Phase II. In Phase II, 70 NHL patients, with either aggressive or indolent disease, are planned to be treated with the objective of evaluating frequency and duration of disease response in these patients.
“We are excited about the initiation of this clinical trial in patients with non-Hodgkin’s lymphoma,” stated stated Dr. Andrew A. Wolff, Cytokinetics’ Senior Vice President of Clinical Research and Development and Chief Medical Officer. “The advancement of SB-743921 into this additional Phase I/II clinical trial represents a significant step forward and is consistent with the vision of our alliance with GSK to broadly explore the role of inhibitors of KSP such as SB-743921.”
About SB-743921
In September of 2005, Cytokinetics and GSK announced an amendment to their original agreement to support further expansion of the development activities for SB-743921. Under the terms of the amendment, Cytokinetics is responsible for leading and funding development activities to explore the potential application of SB-743921 for the treatment of non-Hodgkin’s lymphoma, Hodgkin’s lymphoma and multiple myeloma, subject to the option for GSK to resume responsibility for development and commercialization activities for SB-743921 for these indications during a defined period. Cytokinetics’ development activities will be conducted in parallel with GSK’s conduct of development activities for SB-743921 in other indications and for ispinesib.
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Cytokinetics SB-743921 NHL Clinical Trial Initiation
Page 2
In May of 2005, Cytokinetics and GSK presented interim data from an ongoing open-label, non-randomized, dose-finding Phase I clinical trial in patients with advanced solid tumors at the American Society of Clinical Oncologists (ASCO) annual meeting. Based on the interim analysis, it was determined that SB-743921 appeared to have an acceptable tolerability profile on a once every 21 day schedule. The dose-limiting toxicities reported at that time were prolonged neutropenia, febrile neutropenia (with or without infection), elevated transaminases, hyperbilirubinemia and hyponatremia. Neurotoxicities, mucositis, thrombocytopenia, alopecia and nausea/vomiting requiring pre-medication had not been observed. That trial is still ongoing at this time. SB-743921 is structurally distinct from ispinesib, Cytokinetics’ most advanced drug candidate under the strategic alliance with GSK.
Background on Cytokinetics and GlaxoSmithKline Strategic Alliance
In June 2001, Cytokinetics and GSK announced that the two companies had entered into a broad strategic collaboration to discover, develop and commercialize novel small molecule therapeutics targeting mitotic kinesins for applications in the treatment of cancer and other diseases. Under the original terms of the agreement, GSK committed funding of approximately $50 million over the minimum 5-year research term, including a $14 million upfront cash payment and a $14 million purchase of Cytokinetics preferred stock. In addition, GSK could make milestone payments to Cytokinetics of up to an aggregate of $30-50 million per target for products directed to each mitotic kinesin target. GSK is responsible for worldwide development and commercialization of products arising from the collaboration. Cytokinetics will receive royalties from the sale of any resulting products. In addition, Cytokinetics retains a product-by-product option to co-fund certain development activities, thereby increasing its royalty and affording co-promotion rights in North America. During the collaboration, targets may revert to Cytokinetics for independent research and development, with GSK retaining an option to resume joint activities. In September 2005, Cytokinetics and GSK announced an amendment to their original agreement to support further expansion of the development activities for SB-743921. Based on Cytokinetics’ expanded role under the amendment in the development of SB-743921, Cytokinetics may receive additional pre-commercialization payments from GSK based on the achievement of certain milestones for SB-743921 for the additional indications described above and increased royalties from GSK on net sales of products containing SB-743921 under certain scenarios.
About Ispinesib
Ispinesib is a novel small molecule inhibitor of Kinesin Spindle Protein (KSP), a mitotic kinesin protein essential for proper cell division. Ispinesib is the first drug candidate in clinical development that has arisen from a broad strategic collaboration between Cytokinetics and GlaxoSmithKline (GSK) to discover, develop and commercialize novel small molecule therapeutics targeting human mitotic kinesins for applications in the treatment of cancer and other diseases. GSK is conducting a broad clinical trials program for ispinesib designed to study the drug candidate in multiple tumor types, combination regimens and dosing schedules. GSK is currently evaluating ispinesib in two Phase II clinical trials being conducted in patients with each of non-small cell lung, ovarian, and breast cancers and three Phase Ib clinical trials designed to evaluate ispinesib in combination with each of docetaxel, carboplatin, and capecitabine. Interim data from the ongoing breast cancer clinical trial and the platinum-refractory and the platinum-sensitive treatment arms of the non-small cell lung cancer clinical trial were announced recently. In the Phase II clinical trial enrolling patients with advanced breast cancer, the best overall responses observed with ispinesib administered as monotherapy have been partial responses in three of thirty-three evaluable patients to date. Interim data from this ongoing breast cancer trial were presented in December 2005 at the San Antonio Breast Cancer Symposium in San Antonio, Texas. In the platinum-refractory treatment arm of a Phase II clinical trial enrolling patients with non-small cell lung cancer, the best overall response observed with ispinesib administered as monotherapy has been disease stabilization in 25% of evaluable patients (N=20) with a median time to progression (TTP) of 12 weeks (overall median TTP was six weeks). . In the platinum-sensitive treatment arm of this Phase II clinical trial, the best overall response observed with ispinesib administered as monotherapy has been disease stabilization in 50% of evaluable patients (N=20) with a median time to progression (TTP) of 17 weeks (overall median TTP was six weeks). In addition to the ongoing studies being conducted by GSK, the National Cancer Institute (NCI) continues to enroll patients in five other Phase II clinical trials evaluating ispinesib in other tumor types, including melanoma, head and neck, hepatocellular, colorectal and prostate cancers. In addition, the NCI plans to conduct one additional Phase II clinical trial in patients with renal cell carcinoma. The NCI is also conducting two other Phase I clinical trials evaluating an alternative schedule of ispinesib in leukemia and advanced solid tumors.

 


 

Cytokinetics SB-743921 NHL Clinical Trial Initiation
Page 3
About Cytokinetics
Cytokinetics is a leading biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs that specifically target the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Cytokinetics’ focus on the cytoskeleton enables it to develop novel and potentially safer and more effective classes of drugs directed at treatments for cancer, cardiovascular disease and other diseases. Cytokinetics has developed a cell biology driven approach and proprietary technologies to evaluate the function of many interacting proteins in the complex environment of the intact human cell. Cytokinetics employs the PUMA™ system and Cytometrix™ technologies to enable early identification and automated prioritization of compounds that are highly selective for their intended protein targets without other cellular effects, and may therefore be less likely to give rise to clinical side effects. Cytokinetics and GlaxoSmithKline (GSK) have entered into a strategic alliance to discover, develop and commercialize small molecule therapeutics targeting human mitotic kinesins for applications in the treatment of cancer and other diseases. GSK is conducting Phase II and Ib clinical trials for ispinesib (SB-715992) and a Phase I clinical trial for SB-743921. Ispinesib, SB-743921 and GSK-923295 are being developed under the strategic alliance with GSK. Cytokinetics’ unpartnered heart failure program is the second program to leverage the company’s expertise in cytoskeletal pharmacology. Cytokinetics recently initiated a Phase I clinical trial with CK-1827452, a novel small molecule cardiac myosin activator, for the intravenous treatment of heart failure and also selected CK-1827452 as a potential drug candidate for the treatment of chronic heart failure via oral administration. Additional information about Cytokinetics can be obtained at www.cytokinetics.com.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 and it is the Company’s intent that such statements be protected by the safe harbor created thereby. Examples of such statements include, but are not limited to, statements relating to the future initiation and expected focus of clinical trials by the National Cancer Institute, statements relating to the potential clinical trials under the amendment of our strategic collaboration with GlaxoSmithKline, and statements relating to the potential benefits of the Company’s drug candidate and potential drug candidates and of our proprietary technologies.. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company’s drug candidates that could slow or prevent product approval or market acceptance (including the risk that uncertainty of patent protection for the Company’s intellectual property or trade secrets, the Company’s ability to obtain additional financing if necessary and unanticipated research and development and other costs). For further information regarding these and other risks related to the Company’s business, investors should consult the Company’s filings with the Securities and Exchange Commission. Cytokinetics does not undertake any obligation to update forward-looking statements.
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