Cytokinetics, Incorporated Reports First Quarter 2013 Financial Results
(Thomson Reuters ONE) -
Company Elaborates on Key Progress in Cardiac and Skeletal Muscle Programs
SOUTH SAN FRANCISCO, CA, April 30, 2013 - Cytokinetics, Incorporated (Nasdaq:
CYTK) reported total research and development revenues of $0.8 million for the
first quarter of 2013. The net loss for the first quarter was $12.6 million, or
$0.09 per basic and diluted share, compared to a net loss of $9.9 million, or
$0.13 per basic and diluted share, for the same period in 2012. As of March
31, 2013, cash, cash equivalents and investments totaled $61.6 million.
"In the first quarter, we progressed through important milestones in both of our
later-stage clinical development programs," stated Robert I. Blum, Cytokinetics'
President and Chief Executive Officer. "We recently announced the completion of
enrollment in ATOMIC-AHF, our Phase IIb trial evaluating an intravenous form of
omecamtiv mecarbil in acute heart failure patients, and the initiation of dosing
in COSMIC-HF, our Phase II trial evaluating oral forms of omecamtiv mecarbil in
outpatients with heart failure. In addition, during the last quarter, BENEFIT-
ALS, our Phase IIb clinical trial evaluating tirasemtiv in patients with ALS,
exceeded 200 patients enrolled, and we initiated Phase I dosing of CK-2127107,
our second fast skeletal muscle troponin activator. We believe Cytokinetics is
executing well on our key milestones for 2013 and we are looking forward to
Phase IIb clinical trial results from each of ATOMIC-AHF and BENEFIT-ALS."
Company Highlights
Cardiac Muscle Contractility
omecamtiv mecarbil
* In March, Cytokinetics announced that ATOMIC-AHF completed patient
enrollment in its third and final cohort. ATOMIC-AHF (Acute Treatment with
Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) is a
Phase IIb international, randomized, double-blind placebo-controlled
clinical trial designed to evaluate the safety, tolerability and efficacy of
an intravenous formulation of omecamtiv mecarbil in patients with left
ventricular systolic dysfunction who are hospitalized with acute heart
failure.
* In March, Cytokinetics announced that patient dosing initiated in COSMIC-HF
(Chronic Oral Study of Myosin Activation to Increase Contractility in Heart
Failure). This Phase II, double-blind, randomized, placebo-controlled,
multicenter, dose escalation study is designed to evaluate three modified-
release oral formulations of omecamtiv mecarbil in patients with heart
failure and left ventricular systolic dysfunction. COSMIC-HF is expected to
inform the selection of an oral formulation for potential advancement into
the Phase III clinical development program.
* During the quarter, dosing completed in Part A of a Phase I open-label,
single-dose clinical trial designed to evaluate the pharmacokinetics, safety
and tolerability of omecamtiv mecarbil in patients with various degrees of
renal insufficiency and in patients undergoing hemodialysis.
The trials described above are being conducted by Amgen in collaboration with
Cytokinetics. Additional information on these and other clinical trials
relating to omecamtiv mecarbil can be found at www.clinicaltrials.gov.
Skeletal Muscle Contractility
tirasemtiv
* During the quarter, Cytokinetics continued enrollment in BENEFIT-ALS
(Blinded Evaluation of Neuromuscular Effects and Functional Improvement with
Tirasemtiv in ALS). This Phase IIb, multi-national, double-blind,
randomized, placebo-controlled clinical trial is designed to evaluate the
safety, tolerability and potential efficacy of tirasemtiv in patients with
amyotrophic lateral sclerosis (ALS). To date, Cytokinetics has enrolled over
200 patients in this clinical trial. A recent review of the double-blind,
aggregate data from BENEFIT-ALS indicated that the actual standard deviation
about the primary endpoint (i.e., the change from baseline in the ALS
Functional Rating Scale in its revised form) is slightly higher than the
estimate used to initially calculate the sample size for the trial.
Consequently, in order to preserve the intended statistical power for the
trial, the company is amending the protocol to allow approximately 500
patients to be enrolled. Additional information about BENEFIT-ALS can be
found at www.clinicaltrials.gov.
* In March, Cytokinetics announced the presentation of data from CY 4023, a
Phase IIa Evidence of Effect clinical trial of tirasemtiv in patients with
generalized myasthenia gravis (MG), during the Emerging Science Program at
the American Academy of Neurology Annual Meeting. CY 4023 was a double-
blind, randomized, three-period crossover, placebo-controlled,
pharmacokinetic and pharmacodynamic trial evaluating single doses of
tirasemtiv. Tirasemtiv treatment was associated with statistically
significant, dose-related increases in skeletal muscle endurance in the
patients with MG studied, as determined by the Quantitative MG score (QMG).
This clinical trial and preclinical research related to tirasemtiv in MG
were funded by a grant from the National Institute of Neurological Disorders
and Stroke (NINDS).
CK-2127107
* In April, Cytokinetics announced the initiation of CY 5011, a first-time-in-
humans, Phase I clinical trial of CK-2127107, a novel small molecule
activator of the fast skeletal muscle troponin complex, in healthy male
volunteers. CY 5011 is a double-blind, randomized, placebo-controlled study
designed to assess the safety, tolerability, and pharmacokinetics of single
ascending oral doses of CK-2127107 administered in a three-period crossover
design.
Pre-Clinical Research
* During the quarter, Cytokinetics scientists continued to conduct research in
our muscle biology programs.
* During the quarter, Cytokinetics and Amgen agreed to extend a collaborative
research program directed to the discovery of next-generation cardiac
sarcomere activator compounds. Amgen will reimburse Cytokinetics for
certain research expenses incurred in connection with agreed activities
performed under the collaboration.
* In March, Cytokinetics and Families of Spinal Muscular Atrophy (FSMA)
announced the award of a grant from FSMA to support Cytokinetics'
preclinical research with tirasemtiv related to muscle function in a mouse
model of SMA.
Corporate
* In February, Cytokinetics announced that B. Lynne Parshall had been
appointed to the company's Board of Directors. The company also announced
that Steve Dow provided notification that he will not stand for re-election
to the Board of Directors at the Annual Meeting of Shareholders.
Financials
Revenues for the first quarter of 2013 were $0.8 million, compared to $1.8
million during the same period in 2012. Revenues for the first quarter of 2013
included $0.4 million of revenue from our collaboration with MyoKardia, Inc.,
$0.3 million of revenue from our collaboration with Amgen, and $0.1 million of
grant revenue from the NINDS. Revenues for the first quarter of 2012 included
$1.2 million of revenue from our collaboration with Amgen, $0.3 million in grant
revenue from the NINDS, and $0.3 million of revenue from our collaboration with
Global Blood Therapeutics, Inc.
Total research and development (R&D) expenses in the first quarter of 2013 were
$9.8 million, compared with $8.7 million for the same period in 2012. The $1.1
million increase in R&D expenses for the first quarter of 2013, compared with
the same period in 2012, was primarily due to increased spending for outsourced
clinical and personnel-related costs, partially offset by decreased spending for
outsourced preclinical expenses.
Total general and administrative (G&A) expenses for the first quarter of 2013
were $3.6 million, compared with $3.1 million for the same period in 2012. The
$0.5 million increase in G&A expenses in the first quarter of 2013, compared
with the same period in 2012, was primarily due to increased spending for
personnel-related costs, outside services and legal expenses.
Annual Stockholders' Meeting
Cytokinetics' Annual Stockholders' Meeting will be held at the Embassy Suites
Hotel located at 250 Gateway Boulevard in South San Francisco, CA at 1:30 PM on
Wednesday, May 22, 2013.
Company Milestones
Cardiac Muscle Contractility
omecamtiv mecarbil
* In mid-2013, Cytokinetics expects to report results from ATOMIC-AHF.
Skeletal Muscle Contractility
tirasemtiv
* By mid-2013, Cytokinetics anticipates completion of enrollment in BENEFIT-
ALS.
* By the end of 2013, Cytokinetics expects to report results from BENEFIT-
ALS.
Conference Call and Webcast Information
Members of Cytokinetics' senior management team will review the company's first
quarter results via a webcast and conference call today at 4:30 PM Eastern Time.
The webcast can be accessed through the Investor Relations section of the
Cytokinetics' website at www.cytokinetics.com. The live audio of the conference
call can also be accessed by telephone by dialing either (866) 999-CYTK (2985)
(United States and Canada) or (706) 679-3078 (international) and typing in the
passcode 92569832.
An archived replay of the webcast will be available via Cytokinetics' website
until May 7, 2013. The replay will also be available via telephone by dialing
(855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and
typing in the passcode 92569832 from April 30, 2013 at 5:30 PM Eastern Time
until May 7, 2013.
About Cytokinetics
Cytokinetics is a clinical-stage biopharmaceutical company focused on the
discovery and development of novel small molecule therapeutics that modulate
muscle function for the potential treatment of serious diseases and medical
conditions. Cytokinetics' lead drug candidate from its cardiac muscle
contractility program, omecamtiv mecarbil, is in Phase II clinical development
for the potential treatment of heart failure. Amgen Inc. holds an exclusive
license worldwide (excluding Japan) to develop and commercialize omecamtiv
mecarbil and related compounds, subject to Cytokinetics' specified development
and commercialization participation rights. Cytokinetics is independently
developing tirasemtiv and CK-2127107, both fast skeletal muscle activators, as
potential treatments for diseases and medical conditions associated with aging,
muscle wasting or neuromuscular dysfunction. Tirasemtiv is currently the subject
of a Phase II clinical trials program and has been granted orphan drug
designation and fast track status by the U.S. Food and Drug Administration and
orphan medicinal product designation by the European Medicines Agency for the
potential treatment of amyotrophic lateral sclerosis, a debilitating disease of
neuromuscular impairment in which treatment with tirasemtiv produced potentially
clinically relevant pharmacodynamic effects in Phase II trials. All of these
drug candidates have arisen from Cytokinetics' muscle biology focused research
activities and are directed towards the cytoskeleton. The cytoskeleton is a
complex biological infrastructure that plays a fundamental role within every
human cell. 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 Act's Safe Harbor for forward-looking
statements. Examples of such statements include, but are not limited to,
statements relating to Cytokinetics' and Amgen's research and development
activities, including the conduct, design, enrollment, progress and results of
clinical trials, the anticipated timing for the availability of clinical trial
results, and the significance and utility of clinical trial results; Amgen's
reimbursement of certain Cytokinetics research expenses; and the properties and
potential benefits of Cytokinetics' drug candidates. 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:
Cytokinetics anticipates that it will be required to conduct at least one
confirmatory Phase III clinical trial of tirasemtiv in ALS patients which will
require significant additional funding, and it may be unable to obtain such
additional funding on acceptable terms, if at all; potential difficulties or
delays in the development, testing, regulatory approvals for trial commencement,
progression or product sale or manufacturing, or production of Cytokinetics'
drug candidates that could slow or prevent clinical development or product
approval, 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 or conduct of clinical trials may be difficult or
delayed, Cytokinetics' drug candidates may have adverse side effects or
inadequate therapeutic efficacy, the U.S. Food and Drug Administration or
foreign regulatory agencies may delay or limit Cytokinetics' or its partners'
ability to conduct clinical trials, and Cytokinetics may be unable to obtain or
maintain patent or trade secret protection for its intellectual property;
Amgen's decisions with respect to the design, initiation, conduct, timing and
continuation of development activities for omecamtiv mecarbil; Cytokinetics may
incur unanticipated research and development and other costs or be unable to
obtain additional financing necessary to conduct development of its products;
Cytokinetics may be unable to enter into future collaboration agreements for its
drug candidates and programs on acceptable terms, if at all; standards of care
may change, rendering Cytokinetics' drug candidates obsolete; competitive
products or alternative therapies may be developed by others for the treatment
of indications Cytokinetics' drug candidates and potential drug candidates may
target; and risks and uncertainties relating to the timing and receipt of
payments from its partners, including milestones and royalties on future
potential product sales under Cytokinetics' collaboration agreements with such
partners. For further information regarding these and other risks related to
Cytokinetics' business, investors should consult Cytokinetics' filings with the
Securities and Exchange Commission.
Contact:
Joanna L. Goldstein
Manager, Corporate Communications & Marketing
(650) 624-3000
Cytokinetics, Incorporated
Condensed Statements of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months
Ended
March 31, March 31,
2013 2012
--------------- --------------
Revenues:
Research and development $ 821 $ 1,820
--------------- --------------
Total revenues 821 1,820
--------------- --------------
Operating Expenses:
Research and development 9,834 8,745
General and administrative 3,634 3,056
Restructuring - (41)
--------------- --------------
Total operating expenses 13,468 11,760
--------------- --------------
Operating loss (12,647) (9,940)
Interest and other, net 28 12
--------------- --------------
Net loss (12,619) (9,928)
Net loss per share allocable to common
stockholders - basic and diluted $ (0.09) $ (0.13)
Weighted average shares used in computing net
loss per share allocable to common
stockholders - basic and diluted 144,061,001 76,081,592
Cytokinetics, Incorporated
Condensed Balance Sheets
(in thousands)
(unaudited)
March 31, December 31,
2013 2012
------------- ---------------
Assets
Cash and cash equivalents $ 13,160 $ 14,907
Short-term investments 48,438 59,093
Related party receivables 328 4
Other current assets 1,739 2,423
------------- ---------------
Total current assets 63,665 76,427
Property and equipment, net 898 997
Other assets 127 127
------------- ---------------
Total assets $ 64,690 $ 77,551
------------- ---------------
Liabilities and stockholders' equity
Current liabilities $ 5,819 $ 7,105
Long-term liabilities 441 361
Stockholders' equity 58,430 70,085
------------- ---------------
Total liabilities and stockholders' equity $ 64,690 $ 77,551
------------- ---------------
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Cytokinetics, Inc. via Thomson Reuters ONE
[HUG#1698159]
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Datum: 30.04.2013 - 22:01 Uhr
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