e8vk
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)
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DELAWARE
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000-50633
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94-3291317 |
(State or other jurisdiction of
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(Commission File Number)
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(IRS Employer |
incorporation)
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Identification No.) |
280 East Grand Avenue
South San Francisco, California 94080
(Address of principal executive offices, including zip code)
650-624-3000
(Registrants 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.
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-Hodgkins 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:
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Exhibit No. |
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Description |
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99.1
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Press Release, dated April 27, 2006. |
99.2
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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.
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CYTOKINETICS, INCORPORATED
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By: |
/s/ James H. Sabry
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James H. Sabry |
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Chief Executive Officer |
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Date: April 27, 2006
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1
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Press Release, dated April 27, 2006. |
99.2
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Press Release, dated April 17, 2006. |
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exv99w1
Exhibit 99.1
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Cytokinetics, Incorporated
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Burns McClellan, Inc. |
Sharon Surrey-Barbari
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Clay Kramer (investors) |
SVP, Finance and CFO
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Justin Jackson (media) |
(650) 624-3000
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(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:
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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 trials
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. |
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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. |
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GSK continued to treat patients in a Phase II clinical trial evaluating ispinesib as
second-line treatment for patients with advanced ovarian cancer. |
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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. |
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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. |
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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. |
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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
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In April of 2006, Cytokinetics announced the initiation of a Phase I/II clinical trial of
SB-743921, in patients with non-Hodgkins 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. |
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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. |
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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)
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Additional data are anticipated from GSKs 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. |
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Data are anticipated from GSKs Phase II clinical trial of second-line therapy in
patients with ovarian cancer in the second or third quarter of 2006. |
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Interim data from GSKs 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. |
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Additional data are anticipated from GSKs Phase Ib clinical trial evaluating ispinesib
in combination with capecitabine, in the second half of 2006. |
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Interim data from the NCIs 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
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Initiation of the NCIs Phase II clinical trial in patients with renal cell cancer is
anticipated in the second half of 2006. |
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Interim data from the NCIs 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
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Interim data from GSKs Phase I clinical trial in advanced solid tumor patients will be
presented at the ASCO conference in June of 2006. |
GSK-923295
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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
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Top-line data are anticipated from our Phase I clinical trial in healthy volunteers in the second quarter of 2006. |
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Initiation of our Phase II clinical trials program is expected in the second half of 2006. |
CK-1827452, oral formulation
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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 companys
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 managements 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.
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Cytokinetics Q1 Financials Press Release
April 27, 2006
Page 5
Condensed Statement of Operations
(in thousands, except per share data)
(unaudited)
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Three Months Ended |
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March 31, |
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March 31, |
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2006 |
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2005 |
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Revenues: |
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Research and development revenues |
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$ |
720 |
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$ |
1,872 |
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License revenues |
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700 |
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700 |
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Total revenues |
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1,420 |
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2,572 |
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Operating Expenses: |
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Research and development |
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11,266 |
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10,537 |
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General and administrative |
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3,622 |
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3,143 |
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Total operating expenses |
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14,888 |
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13,680 |
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Operating loss: |
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(13,468 |
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(11,108 |
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Interest and other income |
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1,128 |
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712 |
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Interest and other expense |
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(124 |
) |
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(134 |
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Net loss |
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$ |
(12,464 |
) |
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$ |
(10,530 |
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Net loss per common share basic and diluted |
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$ |
(0.36 |
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$ |
(0.37 |
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Weighted average shares used in computing net loss per
common share basic and diluted |
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34,247,403 |
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28,381,656 |
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Cytokinetics Q1 Financials Press Release
April 27, 2006
Page 6
Condensed Balance Sheet Data
(in thousands)
(unaudited)
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March 31, |
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December 31, |
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2006 |
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2005 |
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Assets |
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Cash and cash equivalents |
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$ |
73,111 |
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$ |
13,515 |
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Short term investments |
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28,150 |
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62,697 |
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Other current assets |
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1,846 |
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2,652 |
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Total current assets |
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103,107 |
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78,864 |
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Property and equipment, net |
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5,949 |
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6,178 |
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Restricted investments |
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4,546 |
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5,172 |
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Other assets |
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1,066 |
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1,247 |
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Total assets |
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$ |
114,668 |
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$ |
91,461 |
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Liabilities and stockholders equity |
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Current liabilities |
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$ |
9,685 |
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$ |
11,264 |
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Long-term obligations |
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5,933 |
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6,636 |
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Stockholders equity |
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|
99,050 |
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|
73,561 |
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Total liabilities and stockholders equity |
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$ |
114,668 |
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$ |
91,461 |
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exv99w2
Exhibit 99.2
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Contacts: |
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Cytokinetics, Incorporated
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Burns McClellan, Inc. |
Robert I. Blum
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Clay Kramer (investors) |
President
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Justin Jackson (media) |
(650) 624-3000
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(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-Hodgkins 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-Hodgkins 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 Hodgkins or non-Hodgkins 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-Hodgkins
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-Hodgkins lymphoma, Hodgkins
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 GSKs conduct of
development activities for SB-743921 in other indications and for ispinesib.
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Cytokinetics SB-743921 NHL Clinical Trial Initiation
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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
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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
companys 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 Companys 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 Companys drug candidate and potential drug candidates and of our proprietary technologies..
Such statements are based on managements 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 Companys drug candidates that could
slow or prevent product approval or market acceptance (including the risk that uncertainty of
patent protection for the Companys intellectual property or trade secrets, the Companys 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 Companys business,
investors should consult the Companys filings with the Securities and Exchange Commission.
Cytokinetics does not undertake any obligation to update forward-looking statements.
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