paul.nowak wrote: Matt, thanks for the comments. I made an error on the version of Plone. It's 2.5 Plone running on Zope 2.9x.
In regards to the additional products, we have a skin installed and we have a product that we had custom developed for us that connects to a PostgreSQL database. We've looked at slow PostgreSQL queries causing problems and have not been able to find an issue. We've also tested for the case where the PostgreSQL server is down and have not been able to create an issue. We therefor...
SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- 04/26/07 -- Cytokinetics, Incorporated (NASDAQ: CYTK) reported revenues from research and development collaborations of
$3.2 million for the first quarter of 2007. Net loss for the first quarter
of 2007 was $11.7 million, or $0.25 per share. As of March 31, 2007, cash,
cash equivalents, restricted cash and marketable securities totaled $175.7
million.
"Cytokinetics began 2007 in a strong position both financially and
operationally with the execution of our strategic collaboration with Amgen,
and the initiation of our first Phase IIa clinical trial of
CK-1827452 in stable heart failure patients," stated Robert I. Blum,
Cytokinetics' President and Chief Executive Officer. "The collaboration
with Amgen reflects the two companies' shared enthusiasm for the potential
of CK-1827452 as a novel treatment for heart failure and for the innovative
science that drives our cardiac myosin discovery research activities.
During the quarter, we also continued to advance our oncology program as
both ispinesib and our second KSP inhibitor, SB-743921, progressed in Phase
II and Phase I clinical trials, respectively."
Company Highlights
Cardiovascular
-- Earlier this month, Cytokinetics announced the initiation of a Phase
II clinical trials program evaluating CK-1827452, a novel cardiac
myosin activator for the potential treatment of patients with either
acutely decompensated or chronic heart failure. The first study in this
program is a Phase IIa multi-center, double-blind, randomized,
placebo-controlled, dose-escalation study designed to evaluate the
safety, tolerability, pharmacokinetics and pharmacodynamic profile of
an intravenous formulation of CK-1827452 in patients with stable heart
failure. In addition to the primary objective of evaluating the safety
and tolerability of CK-1827452 in stable heart failure patients, a
secondary objective of the trial is to establish a relationship between
plasma concentration and the pharmacodynamic effects for CK-1827452 and
to determine the pharmacokinetics of the drug candidate in this
population.
Cytokinetics also recently initiated an additional Phase I clinical
trial with
CK-1827452 in the United Kingdom. This clinical trial is a
single-center,
open-label, sequential, parallel group study designed to evaluate the
potential for certain drug-drug interactions with
CK-1827452. The trial is designed to evaluate the effects of
ketoconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of
CK-1827452 in sixteen healthy male volunteers.
The
CK-1827452 clinical trials program is planned to include Phase I and
Phase II trials designed to evaluate the safety and efficacy of
CK-1827452 in a diversity of patients, including those with stable
heart failure, ischemic cardiomyopathy, impaired renal function,
acutely decompensated heart failure, and patients with chronic heart
failure at increased risk for death or hospital admission for heart
failure.
-- In January, Cytokinetics announced a strategic collaboration with
Amgen to discover, develop and commercialize novel small-molecule
therapeutics that activate cardiac muscle contractility for potential
applications in the treatment of heart failure. In addition, Amgen
obtained an option to participate in the future development and
commercialization of CK-1827452 and other drug candidates arising from
the collaboration. The collaboration is worldwide, excluding Japan.
Under the agreement, Cytokinetics received $75.0 million, comprised of
a non-refundable up-front license and technology access fee of $42.0
million and the purchase by Amgen of 3,484,806 shares of Cytokinetics
common stock at $9.47 per share for an aggregate purchase price of
approximately $33.0 million.
Joint research activities are planned to focus on identifying and
characterizing activators of cardiac myosin as back-up and follow-on
potential drug candidates to
CK-1827452. During the initial two-year research term, in addition to
performing research at its own expense under the collaboration,
Cytokinetics will continue to conduct all development activities for
CK-1827452, at its own expense, subject to Amgen's option and according
to an agreed development plan. Amgen's option is exercisable during a
defined period, the ending of which is dependent upon the satisfaction
of certain conditions, including
CK-1827452 being developed to meet pre-defined criteria in Phase IIa
clinical trials. To exercise its option, Amgen would pay a
non-refundable exercise fee of $50.0 million and thereafter would be
responsible for development and commercialization of CK-1827452 and
related compounds, subject to Cytokinetics' development and commercial
participation rights. In addition, Cytokinetics may be eligible to
receive pre-commercialization and commercialization milestone payments
of up to $600 million on
CK-1827452 and other products arising from the research, as well as
royalties that potentially escalate based on increasing levels of
annual net sales of products that may be developed in connection with
the collaboration. Cytokinetics also has the opportunity to earn
increased royalties by participating in Phase III development costs.
In that case, Cytokinetics could co-promote products in North America
and would be expected to play a significant role in the agreed
commercial activities in institutional care settings, at Amgen's
expense. If Amgen elects not to exercise its option on CK-1827452,
Cytokinetics may then proceed to independently develop CK-1827452 and
the research collaboration would terminate.
Oncology
-- GlaxoSmithKline (GSK) continued to treat a patient in a Phase II
clinical trial evaluating ispinesib, our novel kinesin spindle protein
(KSP) inhibitor, as a second-line treatment for patients with advanced
ovarian cancer.
-- The National Cancer Institute (NCI) has concluded enrollment, but
continues to treat patients in a Phase II clinical trial evaluating
ispinesib as monotherapy in patients with advanced renal cell cancer.
In addition, the NCI continues to treat patients in a Phase I clinical
trial designed to evaluate the safety, tolerability and
pharmacokinetics of ispinesib in adult patients with relapsed or
refractory acute leukemias, chronic myelogenous leukemia in blast
crisis or advanced myelodysplastic syndromes, and a Phase I clinical
trial to evaluate ispinesib as monotherapy in pediatric patients with
relapsed or refractory solid tumors.
-- Cytokinetics continued to enroll patients in a Phase I/II clinical
trial of SB-743921, evaluating patients with non-Hodgkin's lymphoma
(NHL), in connection with an expanded development program for
SB-743921. This trial is an open-label, non-randomized clinical trial
designed to investigate the safety, tolerability, pharmacokinetics and
pharmacodynamic profile of SB-743921, administered as a one-hour
infusion on days 1 and 15 of a 28-day schedule.
-- Earlier this month, at the Annual Meeting of the American
Association of Cancer Research (AACR), posters were presented
containing preclinical data relating to ispinesib, GSK-923295 and
Cytokinetics' cell-based drug discovery program.
Financials
Revenues from research and development collaborations for the first quarter
of 2007 were $3.2 million, compared to $1.4 million in the first quarter of
2006. Revenues for the first quarter of 2007 were largely derived from our
research collaboration with Amgen and revenues for the first quarter of
2006 were largely derived from our collaboration with GSK. The increase in
collaborative research revenues for the first quarter of 2007, as compared
to the same period in 2006, was primarily due to the recognition of license
revenue of $3.1 million from Amgen.
Total research and development (R&D) expenses for the first quarter of 2007
were $12.5 million, compared to $11.3 million for the first quarter of
2006. The increase in R&D expenses in the first quarter of 2007, over the
same period in 2006, was primarily due to increased spending related to
clinical and preclinical outsourcing costs, along with increased personnel
expenses including charges for stock-based compensation.
Total general and administrative (G&A) expenses for the first quarter of
2007 were $4.5 million, compared to $3.6 million in the first quarter of
2006. The increase in G&A expenses in the first quarter of 2007, over the
same period in 2006, was primarily due to increased spending for accounting
and legal fees, and personnel expenses, including charges for stock-based
compensation.
The net loss for the three months ended March 31, 2007 was $11.7 million,
or $0.25 per share, compared to a net loss for the same period in 2006 of
$12.5 million, or $0.36 per share.
Updated Company Milestones
Cardiovascular
CK-1827452:
-- In the second half of 2007, Cytokinetics plans to initiate
additional Phase I and Phase II clinical trials.
Oncology
Ispinesib:
-- In the first half of 2007, data are anticipated to be available from
GSK's Phase II clinical trial evaluating ispinesib as second- or
third-line therapy in patients with advanced breast cancer.
-- In the first half of 2007, data are anticipated to be available from
Stage 1 of the NCI's Phase II clinical trial in patients with
hormone-refractory prostate cancer and from Stage 1 of the NCI's Phase
II clinical trial in patients with hepatocellular cancer.
-- In June 2007, at the Annual Meeting of the American Society of
Clinical Oncology (ASCO), interim data are anticipated to be available
from the NCI's Phase II clinical trial designed to evaluate the safety
and efficacy of ispinesib as second-line treatment for patients with
renal cell cancer.
-- In the second half of 2007, Cytokinetics plans to initiate a Phase
I/II monotherapy clinical trial evaluating ispinesib in the first-line
treatment of patients with locally advanced or metastatic breast
cancer.
-- In the second half of 2007, data are anticipated to be available
from GSK's Phase II clinical trial evaluating ispinesib as second-line
therapy in patients with ovarian cancer and GSK's Phase Ib clinical
trial evaluating ispinesib in combination with capecitabine.
-- In 2007, data are anticipated to be available from the NCI's Phase I
clinical trial of adult patients with relapsed or refractory acute
leukemias, chronic myelogenous leukemia in blast crisis or advanced
myelodysplastic syndromes, and from Stage 1 of the NCI's Phase II
clinical trial in patients with melanoma.
SB-743921:
-- In June 2007, at the ASCO Meeting, interim Phase I data are
anticipated to be available from our ongoing Phase I/II clinical trial
in patients with NHL. In the second half of 2007, we anticipate
additional Phase I data from this same trial.
GSK-923295:
-- In 2007, the initiation of a GSK-sponsored Phase I clinical trial is
anticipated.
The anticipated dates of clinical trial initiations and the availability of
data from the clinical trials being conducted by GSK or the NCI are based
on information provided by GSK or the NCI. The occurrence of these events
is outside of our control.
Annual Stockholders' Meeting
Cytokinetics' Annual Stockholders' Meeting will be held at the Embassy
Suites Hotel located at 250 Gateway Boulevard in South San Francisco,
California at 10:00 AM on May 24, 2007.
Conference Call and Webcast Information
Members of the Cytokinetics management team will review first quarter 2007
results via webcast and conference call today at 4:30 p.m. Eastern Time.
To access the live webcast, please log-on in the Investor Center section of
Cytokinetics' website at www.cytokinetics.com. Investors, members of the
news media and the general public may access the call by dialing either
(866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078
(International) and typing in the passcode 6334721.
An archived replay of the webcast will be available via Cytokinetics'
website until May 24, 2007. The replay will also be available via
telephone by dialing (800) 642-1687 (United States and Canada) or
(706) 645-9291 (International) and typing in the passcode 6334721 from
April 26, 2007 at 5:30 p.m. Eastern Time until May 24, 2007.
About Cytokinetics
Cytokinetics is a biopharmaceutical company focused on the discovery,
development and commercialization of novel small molecule drugs that may
address areas of significant unmet clinical needs. Cytokinetics'
development efforts are directed to advancing multiple drug candidates
through clinical trials to demonstrate proof-of-concept in humans,
specifically in the areas of heart failure and cancer. Cytokinetics'
cardiovascular disease program is focused on cardiac myosin, a motor
protein essential to cardiac muscle contraction. Cytokinetics' lead
compound, CK-1827452, a novel small molecule cardiac myosin activator,
recently entered Phase II clinical trials for the treatment of heart
failure. Under a strategic alliance established in 2006, Cytokinetics and
Amgen plan to conduct research with activators of cardiac myosin in order
to identify potential treatments for patients with heart failure. Amgen has
obtained an option for the joint development and commercialization of
CK-1827452 exercisable during a defined period, the ending of which is
dependent on Cytokinetics' conduct of further clinical trials of
CK-1827452. Cytokinetics' cancer program is focused on mitotic kinesins, a
family of motor proteins essential to cell division. Cytokinetics is
developing two novel drug candidates that have arisen from this program,
ispinesib and SB-743921, each a novel inhibitor of kinesin spindle protein
(KSP), a mitotic kinesin. Ispinesib has been the subject of a broad
clinical trials program comprised of nine Phase II clinical trials as well
as six Phase I or Ib clinical trials. Cytokinetics plans to conduct
additional clinical trials with ispinesib and is conducting a Phase I/II
trial of SB-743921 in non-Hodgkin's lymphoma. Under a strategic alliance
established in 2001, Cytokinetics and GlaxoSmithKline (GSK) are conducting
research and development activities focused on the potential treatment of
cancer. GSK has obtained an option for the joint development and
commercialization of ispinesib and SB-743921, exercisable during a defined
period. Cytokinetics and GSK are conducting collaborative research
activities directed to the mitotic kinesin centromere-associated protein E
(CENP-E). GSK-923295, a CENP-E inhibitor, is being developed under the
strategic alliance by GSK. GSK is expected to begin clinical trials with
GSK-923295 in 2007. All of these drug candidates have arisen from
Cytokinetics' research activities and are directed towards 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 and
cardiovascular disease. 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 (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, conduct, timing, scope and results of Cytokinetics'
and its partners' research and development programs, including initiation
of clinical trials, future presentations concerning Cytokinetics and its
strategic partners' research and development programs and anticipated dates
of availability of data from clinical trials; the potential benefits of
Cytokinetics' drug candidates and potential drug candidates and the
enabling capabilities of Cytokinetics' biological focus; and potential
milestone payments and other payments and funding under Cytokinetics'
collaboration with Amgen and Cytokinetics' and Amgen's expected roles in
commercializing drug candidates or drugs under that collaboration. Such
statements are based on management's current expectations, but actual
results may differ materially due to various risks and uncertainties,
including, but not limited to, potential decisions by GSK or the NCI to
postpone or discontinue development efforts for GSK-923295 or ispinesib,
respectively; potential difficulties or delays in the development, testing,
regulatory approval, production and marketing of Cytokinetics' drug
candidates that could slow or prevent clinical development, product
approval or market acceptance, including risks that current and past
results of clinical trials or preclinical studies may not be indicative of
future clinical trials results, patient enrollment for clinical trials may
be difficult or delayed, Cytokinetics' drug candidates may have unexpected
adverse side effects or inadequate therapeutic efficacy, and Cytokinetics
may be unable to obtain and maintain patent or trade secret protection for
its intellectual property; Cytokinetics may incur unanticipated research
and development and other costs or be unable to obtain additional
financing if necessary; standards of care may change or others may
introduce products or alternative therapies for the treatment of
indications Cytokinetics' drug candidates and potential drug candidates
currently or potentially target; and risks and uncertainties relating to
the timing and receipt of funds under our collaborations. For further
information regarding these and other risks related to Cytokinetics'
business, investors should consult Cytokinetics' filings with the
Securities and Exchange Commission.
Condensed Statement of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months Ended
March 31, March 31,
2007 2006
------------- -------------
Revenues:
Research and development $ 147 $ 720
License revenues 3,058 700
------------- -------------
Total revenues 3,205 1,420
------------- -------------
Operating Expenses:
Research and development 12,486 11,266
General and administrative 4,483 3,622
------------- -------------
Total operating expenses 16,969 14,888
------------- -------------
Operating loss: (13,764) (13,468)
Interest and other income 2,241 1,128
Interest and other expense (169) (124)
------------- -------------
Net loss $ (11,692) $ (12,464)
============= =============
Net loss per common share - basic and
diluted $ (0.25) $ (0.36)
Weighted average shares used in computing
net loss per common share - basic and
diluted 46,761,354 34,247,403
Condensed Balance Sheet Data
(in thousands)
(unaudited)
March 31, December 31,
2007 2006
-------------- --------------
Assets
Cash and cash equivalents $ 104,048 $ 39,387
Short term investments 65,499 70,155
Other current assets 2,113 44,079
-------------- --------------
Total current assets 171,660 153,621
Property and equipment, net 8,667 9,202
Restricted investments 6,125 6,034
Other assets 543 659
-------------- --------------
Total assets $ 186,995 $ 169,516
============== ==============
Liabilities and stockholders' equity
Current liabilities $ 23,850 $ 26,393
Long-term obligations 41,196 36,810
Stockholder's equity 121,949 106,313
-------------- --------------
Total liabilities and stockholders' equity $ 186,995 $ 169,516
============== ==============
Cytokinetics, Incorporated
Christopher S. Keenan (Investors)
Director, Investor Relations
(650) 624-3000
Cytokinetics, Incorporated
Scott R. Jordan (Media)
Director, Corporate Development
(650) 624-3000